Module 44

Legal & Other Requirements

What is required of the standard? Th PI h ll t k i t t li bl l l• The PI shall taken into account applicable legalrequirements, NUS OH&S policies, standardoperating procedures, best practices and otheruniversity requirements when establishing the lab’suniversity requirements when establishing the lab sOH&S management system.

Th PI h ll i t l t i f ti• The PI shall communicate relevant information onlegal and other requirements to all laboratorypersonnel.

Legal Requirements

Legal & Other Requirements

• Procedures to identify and access applicable legal & other requirements

• Keep information up to date

• Communicate requirements to :-

– Staff

– StudentsStudents

– Visitors

OSH RegulationsOSH Regulations• Workplace Safety and Health Act (WSHA)• Fire Safety (Petroleum & Flammable Materials)

regulationsregulations• Chemical Weapons Convention (NACWC)• Poisons Act

E i t l P t ti A d M t A t • Environmental Protection And Management Act (EPMA)

• Environmental Public Health Act Sewerage and Drainage Act• Sewerage and Drainage Act

• Misuse of Dug Act• SPF, Arms & Explosive Act – Explosive Precursors

RegulationsRegulations• Radiation Protection Act• Biological Agents and Toxins Act• Guidelines for Research on Genetically • Guidelines for Research on Genetically

Modified Organisms (GMOs) by GMAC

A t / R l tiAct / RegulationAct – provide framework of how a ministry regulate an

iissue

Regulation - develop after an Act is passed- provides specific requirements of Act.

Singapore

Environmental Environmental

Singapore Standards (SS) And Codes of Practice (CP)

ACT Regulations

Environmental Protection and ManagementAct (EPMA)

Protection and Management

(Hazardous Substances) Regulations

( )CP98 (Preparation and use of MSDS) SS586 (Hazardous

Eg.

Regulations (Chemical

Communication)

Workplace Safety & Health Act (WSHA)

A A l i h f h l h d • An Act relating to the safety, health and welfare of persons at work in workplaces, and to repeal the Factories Act and to pmake consequential amendments to certain other written laws.

• Schedule of workplaces– Any laboratory or other premises where the Any laboratory or other premises where the

testing, examination or analysis of any article is carried out.

WSHA Regulations applicable to NUS

• WSH (General Provisions) Regulations

• WSH (Incident Reporting)

• WSH (First-Aid) Regulations

• WSH (Risk Management) Regulations

Workplace Safety And Health (General Provisions) Regulations 2006

• Autoclaves – Regulation 31 Pressure vessels which include steam

boiler, steam receiver and air receiver (Test & Examination by authorized examiner)

Annual examination by Professional Engineers– Annual examination by Professional Engineers

• Lifting Devices Lifting Devices – Regulation 21 Lifting appliances and lifting machines

(Test & Examination by authorized examiner)

Workplace Safety And Health (General Provisions) Regulations 2006

• Precautions with regards to explosive or flammable dust, gas, vapor or substance– Minimize release levels to prevent explosion,

acute or chronic illness.

• Permissible exposure levels of toxic substances– Minimize exposure levels to toxic substances to

prevent acute or chronic problems.

Oth A li bl R l tiOther Applicable Regulations

• Factories (Noise) Regulations • Factories (Noise) Regulations - take all practicable measures to reduce or controlnoise from any machinery, equipment or process suchthat no person is exposed to excessive noise above85dBA (8 Hours/day).

-Measures taken must include one or more of theMeasures taken must include one or more of thefollowing where appropriate: Elimination, Substitution,Engineering, Administrative or PPE.

- Where 10 or more persons employed are exposed or are likely to be exposed to excessive noise, to conduct noise monitoring at least once every 3yrs.g y y

LOCKOUT REQUIREMENT

1. Purpose of LOCKOUT• Prevent inadvertent activation• Mandatory requirements (lockout procedures/training)

2. What is LOCKOUTLockout is a procedure carry out to ensure all energy

t th l t l t hi i tsources to the relevant plant, machinery, equipment orelectrical installation are isolated, disconnected ordischarged.

Apart from that, it helps to prevent any part of the plant,machinery, equipment or electrical installation from beinginadvertently activated or energised.inadvertently activated or energised.

LOCKOUT REQUIREMENT

3. Legislative RequirementThe occupier of a factory must establish andi l t t f l k t d f h fimplement a set of lockout procedures for each ofthe plant, machinery, or equipment whereinspection, cleaning, repair or maintenance workp , g, pmay have to be carried out and where accidentalstart-up is possible.

Reference: WSH (General Provisions)Regulations,Section 16(1-3)

WSH (Incident Reporting)

i fReporting of Work-Related Accidents

• Under the WSH (Incident Reporting) Regulations:

– Duty of employer to report work-related accidentsinvolving employeesinvolving employees

– Duty of occupier to report work-related accidentsinvolving person not at work, or any self-employedpersonperson

• In the case of accidents involving contractors engaged bythe school, it will be the duty of the contractor as thethe school, it will be the duty of the contractor as theemployer to report the accident to the authority and informthe contract awarding parties (NUS Staff) concurrently.

• The contract awarding parties (NUS Staff) will report theid t / i id t th h AIRS taccident / incident through AIRS system.

Workplace Safety And Health (Incident Reporting)( p g)

• These Regulations shall apply to everyworkplace whether or not it is a workplaceworkplace, whether or not it is a workplacespecified in the First Schedule to the Act

• MOM reportable cases:p•Fatal accident•Injured for more than 3 consecutive days of MC•Admitted to hospital for at least 24 hrs for observation orptreatment•Suffer an occupational disease•Dangerous occurrence

• OSHE will report to MOM

Incident/Accident ReportingIncident/Accident Reporting

All accidents and incidents to be reported t ll t OSHE ithi 24 h tcentrally to OSHE within 24 hours at

https://staffweb.nus.edu.sg/oshe/submit_airs.htm

For more information on the categories of reportable accident / incident to authoritiesFor more information on the categories of reportable accident / incident to authorities https://staffweb.nus.edu.sg/oshe/category.htm

Workplace Safety And Health Workplace Safety And Health (First-Aid) Regulations 2006

Workplace Safety And Health (First-Aid) Regulations 2006

• Every workplace shall be provided with the relevant first-aid box as follows:

– one Box A first-aid box for every 25 persons or less employedone Box A first aid box for every 25 persons or less employedin the workplace;

– one Box B first-aid box or 2 Box A first-aid boxes for every 50persons employed in the workplace;

– one Box C first-aid box, 2 Box B first-aid boxes or 4 Box Afirst-aid boxes for every 100 persons employed in theworkplace.

• The number of first-aid boxes required on a floor of the building in which the workplace is located shall be determined by the number of persons on that floor.

First-aiders & First Aid Room

• There shall be appointed in the workplace asfirst-aiders who shall be readily availablefirst aiders who shall be readily availableduring working hours such number ofpersons

• One to every 26 employees for laboratories

Workplace Safety And Health (Risk Management) Regulations 2006

• Enforced from 1st September 2006

• The WSH (Risk Management) Regulations requireemployers, the self-employed and principal(including contractor and sub-contractor) toconduct risk assessments for the purpose ofidentifying workplace safety and health risks andy g p yimplementing measures to control the hazardsand reducing the risks.

Workplace Safety And Health (Risk Management) Regulations 2006

• Compliance achieved via Lab (OH&S) • Compliance achieved via Lab (OH&S) Certification Scheme

ENVIRONMENTAL PROTECTION AND MANAGEMENT ACT

(EPMA)

Environmental Protection and Management Act (EPMA)

• National Environment Agency -http://app.nea.gov.sg/

• Safety and Health Officer in the faculty holds the license

• Regulates the storage and transportation of g g pchemicals

• Licence is required for any person whowishes to import sell export purchasewishes to import, sell, export, purchase,store and/or use any hazardous substance

• Permit is required for any person whowishes to purchase store and/or use anywishes to purchase, store and/or use anyhazardous substance

Environmental Protection and

Li P it R i t

Environmental Protection and Management Act (EPMA)

License or Permit Requirement :1) A person shall not use, keep or have in his possession or under his

control any hazardous substance specified in the schedule unless he is authorized to.

2) The Hazardous Substance Permit held by faculty level.3) Regulated hazardous substances must not be brought or used

without approval and license applied for through Faculty Safety and Health Officer.and Health Officer.

4) Administered by National Environment Agency (NEA)

i l i d

Responsibilities for any users of Hazardous Substances (HS):

Environmental Protection and Management Act (EPMA)

Responsibilities for any users of Hazardous Substances (HS):1) Ensure that personnel who are required to handle HS are conversant with the law.2) Maintain and update inventory list of the quantity of such substances stored with

inventory check every 6 month and it can only be used for the intended purpose as stated in the permit.

3) i i d d k il bl S f Sh lidi f S S i hi3) Maintain, update and make available Safety Data Sheets. Ensure validity of SDS within 5 years.

4) The percentage and quantity refer to the maximum percentage and maximum aggregate storage quantity allowed for the HS; including preparation and solutions containing the HS.

5) HS shall be labeled according to the Singapore Standard 586:2008 (Hazard communication for hazardous chemicals and dangerous goods)

6) HS in packaging's such as drums, carboy etc are to be kept in a sheltered store with adequate security, ventilations and control facilities to contain spillage or leakage.

7) HS shall be transported and stored separately from the incompatible substances.8) Safety measures such as gas leak detector, alarm system and gas clearing devices shall be

installed to ensure the safe storage of toxic gases.9) Establish and keep up-to-date adequate emergency response plan to deal with any

spillage. 10) Liquid chemical must be stored within a secondary containment tray that can capture ) q y y p

20% of the total chemicals stored in a tray.11) Disposed through toxic industrial waste collector.

Petroleum & Flammable Materials (PFM) RegulationMaterials (PFM) Regulation

Fire Safety (P&FM) Regulations 2005

• Singapore Civil Defence Force (SCDF) -http://www.scdf.gov.sg/

• Import , transport and storage of petroleumand flammable materials are under the SCDFlicencing controllicencing control

• Anyone intends to import, transport or storepetroleum or flammable materials beyondthe stipulated exemption quantities isrequired to obtain a licence from SCDF

i S f ( & ) l i

Li P it R i t

Fire Safety (P&FM) Regulations 2005

License or Permit Requirement :1) Under Fire Safety (Petroleum & Flammable Materials) Regulation 2005, the import, transport and storage of PFM are regulated under the Singapore Civil Defense Force.g p2) SCDF requires yearly declaration of the all petroleum and flammable liquids, solids and gases which include flammable liquid waste.3) PFM falling under regulation must be stored within Maximum Allowable Quantity (MAQ) and storage requirements as stipulated by SCDFQuantity (MAQ) and storage requirements as stipulated by SCDF.4) Laboratory & workshop storing PFM are required to submit annual inventory declaration of PFM in a prescribed NUS format to OSHE.5) OSHE is the single license holder for all NUS laboratories & workshop storing PFM except for eating establishments.6) Chemical with mixture flash point below 61 degree is classified as PFM regulated. Please refer to the SDS for the flash point.

i S f ( & ) l i

Responsibilities for any users of PFM:

Fire Safety (P&FM) Regulations 2005

Responsibilities for any users of PFM:1) Ensure that personnel who are required to handle PFM are conversant with

the regulatory requirement. In accordance to NUS requirements, all flammable liquids shall be categorized as Class 1.

2) Maintain and update inventory list of the quantity of such substances stored 2) Maintain and update inventory list of the quantity of such substances stored with inventory check every 6 months.

3) Maintain, update and make available Safety Data Sheets. Ensure validity of SDS within 5 years.

4) Keep within the established MAQ of PFM per lab unit. Limit the quantity of 4) Keep within the established MAQ of PFM per lab unit. Limit the quantity of PFM on lab benches / fume cupboard within allowable limit (i.e 10% of total MAQ).

5) Ensure OSHE is notified for any of the following changes:- Lab layouty- Fire protection system- Fire compartmentation- Type of PFM stored

6) Liquid chemical must be stored within a secondary containment tray that can 6) Liquid chemical must be stored within a secondary containment tray that can capture 20% of the total chemicals stored in a tray.

7) Disposed through toxic industrial waste collector.

R i t F St f Fl bl Requirements For Storage of Flammable Materials in Laboratory

Maximum Allowable Quantity (MAQ)

Per lab area Maximum storage limit per lab unit500 Litres

Total storage within lab(ie quantity inside and outsideflammable safety cabinet)

1.6 Litres x Lab area (m2) 500 Litres (labs without sprinklers)

750 Litres (labs with sprinklers)

Max quantity within each flammable safety cabinet is restricted to 250L

(labs with sprinklers)

Max quantity within each flammable safety cabinet is restricted to 250L.Max quantity on bench top: 10% of MAQ.

Maximum Allowable Quantity For Gases Per Lab Work Area (with sprinkler system)

• Flammable Gases– 170L for 50 sq meters and less– Y (L) = 3.4 x Lab work area for > 50 sq meters

• Oxidising Gases– 170L for 50 sq meters and less– Y (L) = 3.4 x Lab work area for > 50 sq meters

Liquefied Flammable Gases• Liquefied Flammable Gases– 30L for 50 sq meters and less– Y (L) = 0.6 x Lab work area for > 50 sq meters

• Toxic Gases• Toxic Gases– 8L for 50 sq meters and less– Y(L) = 0.16 x Lab work area for > 50 sq meters

Additional Requirements by SCDF - Compressed Gasesp

• Maximum of three compressed gas cylindersto be serving each instrument/machine

• This group of cylinders must be six metersaway from the next group of cylindersaway from the next group of cylinders

• For any gas manifold system or gas tubingconnection of more than 2 m, there must bepressure relief valve along the tubing line.

Additional Requirements by SCDF - Flammable liquids

• Secondary containment for all flammable liquidsshould be made of metal and not plastic.Mi i l t f th t t b 20%Minimal capture of these trays must be 20%.

• Flammable liquids containers for Class I and IIcannot exceed four liters.

• Only two 4.5 kg LPG cylinders per laboratoryunit

• Wherever possible activities involving• Wherever possible activities involvingflammable liquids should be performed in afume cupboard, to prevent the build up of aflammable mixture in the roomflammable mixture in the room.

Notification to SCDF

N ifi i SCDF i i d f• Notification to SCDF is required for:– Exceeding the declared quantity of flammable

materials in the laboratoryy– Relocation of flammable cabinets, compressed gas

cylinders etc.Any changes to fire safety equipment and/or– Any changes to fire safety equipment and/orinfrastructure

– PI to report to the safety and health officerfor their faculty/office on the above changes

Poisons Act

Poison Act

H l h S i A h i • Health Sciences Authority -http://www.hsa.gov.sg/index.html

• List of Scheduled Poisons found in OSHE • List of Scheduled Poisons found in OSHE website:– http://www.nus.edu.sg/osh/legislation/poisonlist.d

oc

• Keep Poisons under lock and key• Inventory Management• Inventory Management

Poison ActLi P it R i t License or Permit Requirement :1) The Poison Act regulated the importation, possession and

sales of potent medical substances (poison) so as to prevent misuse / illicit diversion of poison.prevent misuse / illicit diversion of poison.

2) Poisons are listed under the Poison Act and are identified by their chemical / generic names.

3) License is held by faculty level.) y y4) Regulated poison must not be import without approval and

license applied for through Faculty Safety and Health Officer.

5) Administered by Health Science Agency (HSA)

R ibiliti f f P i

Poison ActResponsibilities for any users of Poison :1) Ensure that personnel who are required to handle poison are

conversant with the law.2) All imported poison shall obtained licensed from HSA) p p3) Poisons must be kept under lock and key in a designated poison

cupboard. 4) Maintain and update Inventory List with inventory check every 6

monthmonth.5) Maintain, update and make available Safety Data Sheets. Ensure

validity of SDS within 5 years.6) Name of the substance contained therein and bearing some

distinction or mark indicting that it contains poison.7) Liquid chemical must be stored within a secondary containment

tray that can capture 20% of the total chemicals stored in a tray.8) Disposed through toxic industrial waste collector.8) Disposed through toxic industrial waste collector.

Chemical Weapons Convention (CWC)( )

Chemical Weapons Convention R l h i l l ifi d d• Regulates chemicals classified underchemical weapons.

• All chemicals must be stored, used anddisposed in accordance to the requirementsof the regulations

• These chemicals must not be bought or used• These chemicals must not be bought or usedwithout approval and license applied forthrough OSHE

Controlled ChemicalsControlled Chemicals• Scheduled 1 Chemicals (ie. 1A & 1B)- A total of 12 chemicals or groups of chemicalsA total of 12 chemicals or groups of chemicals- Little or no commercial applications (eg. Pesticide

development)

• Scheduled 2 Chemicals (ie. 2A, 2A* & 2B)- A total of 14 chemicals or groups of chemicals- Have moderate number of commercial applications

(eg. Dyes or photographic industries)

• Scheduled 3 Chemicals (ie. 3A & 3B)- A total of 17 chemicals- Have large number of commercial applications Have large number of commercial applications

(eg. Isocyanates)

Responsibilities for any users of NACWC:1) Ensure that personnel who are required to handle CWC are conversant with the

Chemical Weapons Convention 1) Ensure that personnel who are required to handle CWC are conversant with the

law.2) The Principal Investigator (PI) will seek approval by OSHE prior to the purchase

of any chemicals listed under the Chemical Weapons (Prohibition) Act. 3) PI must inform OSHE if he or she intends to use the chemicals of purposes

either than those stipulated in the initial application 4) A copy of the SDS provided by the supplier must be made available in hardcopy

in the laboratory at all times. Validity of SDS within 5 years.5) The Principal Investigator must inform OSHE of the transfer of ownership of the

scheduled chemicals The Principal Investigator must inform OSHE of the loss scheduled chemicals .The Principal Investigator must inform OSHE of the loss of any scheduled chemicals within 24 hours.

6) These chemicals must be kept in a storage cabinet or fridge under lock and key. The key shall be kept by the Principal Investigator. Only personnel authorized by the Principal Investigator will be allowed to use the chemical weapon. y p g p

7) Maintain and update Inventory List with inventory check every 6 month.8) Maintain, update and make available Safety Data Sheets. Ensure validity of SDS

within 5 years.9) Liquid chemical must be stored within a secondary containment tray that can

capture 20% of the total chemicals stored in a tray.10) Disposed through toxic industrial waste collector.

A d E l i Arms and Explosives (Amendment) Act( )

A d E l i Arms and Explosives (Amendment) Act

- Regulate the use of 15 chemicals that are classified as Explosive precursors. Previously 13 of the precursors were regulated by NEA.

- The applicant will be the one directly involved in the handling of the explosive precursors.

• It is a requirement that the holder of the license has relevant experience and knowledge in handling the explosive precursors and a register book shall be kept and maintain on the datas of the explosive chemical.

Arms and Explosives

Li P it R i t

Arms and Explosives (Amendment) Act

License or Permit Requirement :1) Under the Singapore Police Force Regulations on Arms and

Explosive (Amendment Act, Cap 13, 15 chemicals which are identified as explosive precursors will required the application of license for possession and storage (in NUS context).

2) License is held by faculty level.3) Regulated explosive precursors must not be possess or store

without approval and license applied for through Faculty Safety without approval and license applied for through Faculty Safety and Health Officer.

3) The applicant will be the one directly involved in the handling of the explosive precursors.

4) It is a requirement that the holder of the license has relevant 4) It is a requirement that the holder of the license has relevant experience and knowledge in handling the explosive precursors and a register book shall be kept and maintain on the data of the explosive chemical.

) d i i d b i li ( )5) Administered by Singapore Police Force (SPF)

d l i

Responsibilities for any users of Explosive Precursors (EP):

Arms and Explosives (Amendment) Act

Responsibilities for any users of Explosive Precursors (EP):1) Ensure that personnel who are required to handle EP are conversant with the law.2) Ensure appropriate security measures as to prevent any loss or theft of any EP in his

possession or under his control.3) The licensee shall not sell, supply or transfer the licensed EP to any person without the ) pp y y p

written approval from the Licensing Officer.4) Ensure that all activities involving any EP in the licensed premises are carried out in a

manner that ensures the safety and security of all persons and property exposed to the risk.

5) Ensure that any person who are engaged in the handling of the any EP in the licensed 5) Ensure that any person who are engaged in the handling of the any EP in the licensed premises are adequately training in the safe handling of the explosive precursor.

6) Ensure that any EP that has expired and that is unsafe for storage is immediately removed from the licensed premises and disposed to the licensed toxic contractor.

7) Maintain and update record of the register book with the information listed in the regulation with inventory check every 6 monthregulation with inventory check every 6 month.

8) Maintain, update and make available Safety Data Sheets. Ensure validity of SDS within 5 years.

9) Liquid chemical must be stored within a secondary containment tray that can capture 20% of the total chemicals stored in a tray.

10) Disposed through toxic industrial waste collector.

Regulated Chemical Identifier(http://www.nus.edu.sg/osh/policies/RegulatedChemicalIdentifier.htm )

R di ti P t ti A tRadiation Protection Act

Centre for Radiation Protection and Nuclear Sciences (CRPNS), NEA

R di ti P t ti A tRadiation Protection Act

– Radiation Protection Act 2007– Radiation Protection (Ionizing Radiation)

Regulations, 2000Radiation Protection (Non ionizing Radiation) – Radiation Protection (Non-ionizing Radiation) Regulations, 1991

– Radiation Protection (Transport of Radioactive l ) l 2000Materials) Regulations, 2000

SingaporeRadiationRadiationIonizingLicensingLicensing

C t ll d N I i i Controlled Non-Ionizing Radiation Apparatus

• Ultraviolet sunlamps• Microwave ovens• Medical and Industrial Ultrasound

apparatus include Sonicator• Magnetic Resonance Imaging (MRI) Magnetic Resonance Imaging (MRI)

apparatus• Entertainment Lasers

Hi h I d t i l & M di l l • High power Industrial & Medical lasers Class 3B and 4

Type of Licenses for Non-Type of Licenses for Non-Ionizing License

Types of Description of LicenceypLicences

p

N1 License to manufacture or deal with any ultraviolet sunlamps, microwave ovens, fetal heart monitoring Doppler non-imaging ultrasound apparatus and any other industrial ultrasound apparatus with power not more than 50W, and any apparatus with any or combination of the above as part of the apparatus. This apparatus with any or combination of the above as part of the apparatus. This license is also applicable to apparatus in N2.

N2 License to keep or possess for use of any medical diagnostic imaging ultrasound and therapeutic ultrasound, industrial ultrasound apparatus with power output of 50 W or more, magnetic resonance imaging apparatus, entertainment lasers, Class 3b and 4 lasersClass 3b and 4 lasers.

N3 License to use any of entertainment lasers and Class 3b and Class 4 lasers.

N4a License to import any of the irradiating apparatus such as microwave ovens, UV sunlamps, medical & industrial ultrasound, MRI, Class 3b & 4 medical & industrial p , , ,lasers and entertainment lasers.

N4b License to export any of the irradiating apparatus such as medical ultrasound devices, high power industrial ultrasound, MRI, Class 3b & 4 medical & industrial lasers and entertainment lasers.

Classes of Lasers

• Class 1 (<0 39 uW)• Class 1 (<0.39 uW)

• Class 2 (<1mW)

• Class 3a (<5mW)

• Class 3b (<500mW)

• Class 4 (>500mW)

E i t l P bli H lth A tEnvironmental Public Health Act

Environmental Public Health Act

a Environmental Public Health (General Waste Collection) Regulations Collection) Regulations

b Environmental Public Health (Toxic Industrial Waste) Regulations) g

Environmental Public Health Act

Regulates disposal of toxic and environmentally hazardous chemicals.

Only licensed waste collector must be engaged to collect hazardous waste engaged to collect hazardous waste generated.

All generated toxic & hazardous waste must be treated & properly packed in specified containers with appropriate labeling containers with appropriate labeling

S d D i A tSewerage and Drainage Act

Sewerage and Drainage Sewerage and Drainage (Trade Effluent) Regulations

Regulates the discharge of waste water into public sewers.

The regulations specify allowable limits for trade effluent discharge into the public for trade effluent discharge into the public sewer.

Staff and students not to dispose hazardous materials into the sewer

Biosafety Related Biosafety Related Legislations & Publications

Biosafety Related Legislations Biosafety Related Legislations & Publications

• Biological Agents and Toxin Act (BATA), 2005

• Guidelines for Research on Genetically Modified Organisms (GMOs) by GMAC, 2006

• WHO Laboratory Safety Manual

NUS Bi f t & A i l Bi f t P• NUS Biosafety & Animal Biosafety Programmes

Info accessible at www.nus.edu.sg/osh

Biological Agents and Toxin Act (BATA)

E d J 2006 d Mi i f • Enacted January 2006, under Ministry of Health Singapore

• Regulates the possession, use, import, • Regulates the possession, use, import, transfer and transportation of biological agents and toxins that are known to be hazardous to human healthhazardous to human health

• Sets forth safe practices and security requirementsq

http://www.biosafety.moh.gov.sg/bioe/index.do

MOH-Biosafety websitey

http://www.biosafety.moh.gov.sg/home/

LIST OF SCHEDULED AGENTS

BATA S h d l d tBATA Scheduled agents

Scheduled agents Risk Group

• 1st Schedule• 2nd Schedule• 3rd Schedule

• RG1• RG2

RG3• 3rd Schedule• 4th Schedule• 5th Schedule

• RG3• RG4• Toxin• 5 Schedule • Toxin

BATA S h d l d A t• Biological agents and toxins are classified into

diff t h d l di t t d

BATA Scheduled Agents

different schedules according to agents and intended research activities:

A ti it t lScheduled agents

Activity control

• Biological agents• Possession• Use• Biological agents

(Schedule 1-4)

Mi bi l t i

• Use• Import• Transportation• Microbial toxins

(Schedule 5)

p• Transhipment• Large-scale production• Inactivation

BATA Scheduled AgentsBATA Scheduled Agents

First Schedule – Risk Group 3 microorganismsp g• Part I – can cause serious disease• Part II – Bioterrorism potential

Second Schedule – Risk Group 4 microorganismsSecond Schedule Risk Group 4 microorganisms• Can cause severe/lethal disease and of high risk to

individuals and community• Bioterrorism potential

Third Schedule – Risk Group 2 microorganisms• Large scale production ( ≥ 10liters)

Fourth Schedule – Risk Group 2 microorganismsFourth Schedule Risk Group 2 microorganisms• BAs that can infect humans

Fifth Schedule – Microbial toxins • Bioterrorism potential• Bioterrorism potential

Approvals and permitsApprovals and permits

How to Apply for Approvals/Permits

Schedule 1, 2, 3 and 5 agents:• To be endorsed by the Institutional Biosafety

Committee before applications for approvals and pp pppermits are submitted to MOH

• OSHE will assist with applications

Schedule 4 agents:- Import permit required- Application for import permit can be made Application for import permit can be made

directly through: Singapore Customs Tradenet System

Genetic Modification and Genetic Modification and Genetic Modification and Genetic Modification and Advisory Committee (GMAC)Advisory Committee (GMAC)

1. Singapore Biosafety Guidelines for Research on Genetically Modified Organisms (GMOs)Genetically Modified Organisms (GMOs)

2. Singapore Guidelines on the Release of Agriculture-Related GMOs

http://www.gmac.gov.sg

Singapore Biosafety Guidelines Singapore Biosafety Guidelines for Research on GMOs

• Covers experiments involving construction and/or propagation of all biological entities (cells, organisms, prions, viroids or viruses) which

are made by genetic manipulation and are of a – are made by genetic manipulation and are of a novel genotype, and

– which are unlikely to occur naturally or which could cause public health or – which could cause public health or environmental hazards

E f t i t h dli d t t f • Ensure safe containment, handling and transport of GMOs used in research

Categorization of experiments

Cat A Regulated Experiments with significant risksCat A – Regulated Experiments with significant risks– Require IBC and GMAC approval

Cat B – Notifiable Experiments with low risksCat B Notifiable Experiments with low risks– Require IBC approval and GMAC notification

Cat C – Experiments with No significant risksp g– Exempt from guidelines

(Section 3 and 4 of guidelines)http://www gmac gov sg/Index Singapore Biosafety Guidelines forhttp://www.gmac.gov.sg/Index_Singapore_Biosafety_Guidelines_for_Research_on_GMOs.html

z

Import of Genetically manipulated Import of Genetically manipulated organisms (GMOs) or material

-- Work with imported GMOs or material falls under Work with imported GMOs or material falls under extent of guidelines (Section 6.6 of guidelines)extent of guidelines (Section 6.6 of guidelines)

-- Approval from GMAC required application for approvals Approval from GMAC required application for approvals Approval from GMAC required application for approvals Approval from GMAC required application for approvals and permits to relevant regulatory agenciesand permits to relevant regulatory agencies

-- Importation of GMOs, not relating to human health, is Importation of GMOs, not relating to human health, is l t d d A i l d Bi d A t (AVA)l t d d A i l d Bi d A t (AVA)regulated under Animals and Birds Act (AVA)regulated under Animals and Birds Act (AVA)

-- Importation of GMOs specified under the BATA First, Importation of GMOs specified under the BATA First, Second, Fourth and Fifth Schedules, is regulated under Second, Fourth and Fifth Schedules, is regulated under Second, Fourth and Fifth Schedules, is regulated under Second, Fourth and Fifth Schedules, is regulated under the Biological Agents and Toxins Act (MOH)the Biological Agents and Toxins Act (MOH)

AVA-Agri-Food & Veterinary Authority of SingaporeMOH-Ministry of HealthGMACGMAC--Genetic Modification and Advisory CommitteeGenetic Modification and Advisory Committee

Lentiviral Vectors-

Obt i l f MOH (BATA S h d l 1 P t • Obtain approval from MOH (BATA Schedule 1, Part 1 (RG-3)

• The work can only commence upon :• The work can only commence upon :(i) a laboratory inspection and risk assessment approval by OSHE/ IBC(ii) Genetic modification work with lentiviral (ii) Genetic modification work with lentiviral vectors must be endorsed by the Genetic Modification Advisory Committee (GMAC)

• NUS has to notify MOH of any work approved by NUS-IBC and GMAC.

Additional Documentation would need to be submittedAdditional Documentation would need to be submitted to MOH, in addition to the Lab OSH certification

Requirements:

D i t d BSL 2 f ilit• Designated BSL-2 facility

• Researchers-trained

• SOP for use of lentiviral vectors

• Lab inspection by OSHE (initial & annual)

• Annual report of lentiviral work done by each PI

to be submitted by end of yeary y

Application procedurepp pPI to submit

(i) Project Risk Assessment and (ii) GMAC Application to OSHE for approval by IBC

Upon Project risk assessment approval, OSHE will forward GMAC application to GMAC for approval

PI to prepare application letter to MOH (with all supporting documents) and submit via

OSHE to MOH for approval

Third generation and above lentiviral vectors

First and second generation lentiviral vectors

No submission to MOH required.NUS has obtained umbrella approval

OSHE to MOH for approval.

Lentiviral work can commence upon GMAC

PI to provide facility and personnel details to OSHE for registration purposes.

endorsement and MOH approval.

OSHE register PI’s facility details with MOHand apply online to MOH for additional lentiviral vectors

OSH Legal Register OSH Legal Register

What is required at the What is required at the Lab level?

Legislations applicable to the lab

L i l ti / id li A li bl t l b?Legislations/ guidelines Applicable to lab?(Specify Yes/No)

Workplace Safety and Health ( )Act (WSHA)

Petroleum And Flammable Materials (PFM) Regulations

Chemical Weapons Convention

Poisons Act

Environmental Protection and Environmental Protection and Management Act (EPMA)

Misuse of Drug Act

Biological Agents and Toxin Act

Other Requirements

NUS, Institutes, Faculty or Departmental Level Policies, Manuals

d SOPand SOPs

NUS Policies, Manuals and SOPs

NUS S f t d H lth • NUS Safety and Health Policies

• NUS Safety and Health M l Manuals – Chemical Safety

Manual – http://www.nus.edu.s

g/osh/manuals.htm

Thank You!