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Transcript of Module 4 - Legal with BATA GMAC (20110114)bioeng.nus.edu.sg/people/PI/trau/Lab_safety/risk...
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 & 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)
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 (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)
• 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.
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
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 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
- 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.
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
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)
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
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 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
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
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
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
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
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