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Biological Safety Manual Curtin University of Technology 2009 Author – David Townsend Please refer any queries regarding information in this document to David Townsend In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone 1
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Page 1: Biological Safety Manual · Web viewBiological Safety Manual Curtin University of Technology 2009 Author – David Townsend Please refer any queries regarding information in this

Biological Safety Manual

Curtin University of Technology2009

Author – David TownsendPlease refer any queries regarding information in this document to

David Townsend

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone1

Page 2: Biological Safety Manual · Web viewBiological Safety Manual Curtin University of Technology 2009 Author – David Townsend Please refer any queries regarding information in this

Administration of Biological Safety at Curtin University of Technology.......................................5Role of Curtin Occupational Safety and Health...........................................................................5Occupational Health and Safety Policy Committee.....................................................................5Institutional Biosafety Committee (IBC).....................................................................................5

Australian Standards and Government Regulations for Handling Biological Agents.....................6Australian/New Zealand Standards for Laboratory Safety..........................................................6Australian Customs Service (Customs)........................................................................................6Australian Pesticides and Veterinary Medicines Authority (APVMA).......................................7Australian Quarantine and Inspection Service (AQIS)................................................................7Office of the Gene Technology Regulator (OGTR).....................................................................7Office of Health Protection (OHP)...............................................................................................7Therapeutic Goods Administration (TGA)..................................................................................7

Legal Status of Safety Standards......................................................................................................8Legal Status of Regulations..............................................................................................................8Classification of Organisms into Risk Groups.................................................................................9Security-Sensitive Biological Agents.............................................................................................10

Introduction................................................................................................................................10Entity..........................................................................................................................................10Facility........................................................................................................................................10List of SSBAs.............................................................................................................................10Approval to Handle SSBAs........................................................................................................11Reporting SSBAs to DoHA........................................................................................................11Reporting Incidents to Police and National Security Agencies..................................................11Physical Security of Facility.......................................................................................................12Consequences of Non-compliance with NHS Act.....................................................................12Forms and Links to Further Information....................................................................................12

Biological Material Subject to Quarantine Regulations.................................................................16Working with Imported Biological Material in Quarantine Approved Premises (QAPs).........16Containment Levels of QAPs.....................................................................................................16Forms and Links to Further Information....................................................................................17

Genetically Modified Organisms (GMOs).....................................................................................18Definition of GMO.....................................................................................................................18Definition of a Dealing...............................................................................................................18Types of Dealings.......................................................................................................................18

Exempt dealings.....................................................................................................................18Notifiable Low Risk Dealings (NLRDs)................................................................................19Dealings Not Involving Intentional Release (DNIR).............................................................19Dealings Involving Intentional Release (DIR).......................................................................19

Storage of GMOs........................................................................................................................19Forms and Links to Further Information....................................................................................20

General Laboratory Safety.............................................................................................................22General Responsibilities for Laboratory Safety.........................................................................22Personal Responsibilities for Laboratory Safety........................................................................22

Injuries and Infections............................................................................................................22

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone2

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Immunization..........................................................................................................................22Staff and Students at High Risk of Infection..........................................................................22Female Staff and Students......................................................................................................23

Safety for New Students.................................................................................................................24Safety for Laboratory Programs and Exercises..............................................................................25Classification of Laboratories.........................................................................................................26Safety in a PC1 Laboratory............................................................................................................27

PC1 Laboratory Facilities...........................................................................................................27Personal Protective Clothing and Equipment.............................................................................27Safety Rules and Practices..........................................................................................................27Additional Safety Rules and Practices for PC1 Facility Handling GMOs.................................28Additional Safety Rules and Practices for PC1 Laboratory Handling AQIS Quarantined Biological Materials (QAP 5.1)..................................................................................................29

Safety in a PC2 Laboratory............................................................................................................31PC2 Laboratory Facilities...........................................................................................................31Protective Clothing and Equipment............................................................................................32Containment Equipment.............................................................................................................32Safety Rules and Work Practices...............................................................................................32Additional Safety Rules and Practices for PC2 Laboratory Handling GMOs...........................33Additional Safety Rules and Practices for PC2 Laboratory Handling AQIS Quarantined Biological Materials (QAP 5.2)..................................................................................................34

Safety in a PC3 Laboratory............................................................................................................35Disposal of Hazardous Waste.........................................................................................................36

Safe Collection of Laboratory Waste.........................................................................................36Non-infectious Materials........................................................................................................36Sharps.....................................................................................................................................36Infectious Materials................................................................................................................36Co-mingled Materials.............................................................................................................36Radioactive Infectious Materials............................................................................................37

Treatment and Disposal of Infectious Waste..............................................................................37Sterilisation.............................................................................................................................37Disinfectants...........................................................................................................................38

Disposal of Drugs.......................................................................................................................38Disposal of Cytotoxins...............................................................................................................38Disposal of Radioactive Research Waste...................................................................................39

Cleaning and Maintenance of Laboratories....................................................................................40Laminar Flow Clean Air Benches and Biological Safety Cabinets...............................................41

Laminar Flow Clean Air Benches..............................................................................................41Biological Safety Cabinets.........................................................................................................41

Safety Precautions for Special Laboratory Equipment..................................................................42Centrifuges.................................................................................................................................42Freeze-Drying or Lyophilisation................................................................................................42Bunsen Burners..........................................................................................................................42

Safe Treatment of Spills.................................................................................................................43Biohazardous Spill Inside a Biological Safety Cabinet..............................................................43Biohazardous Spill Outside a Biological Safety Cabinet...........................................................43

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone3

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Radioactive Biohazardous Spill Outside a Biological Safety Cabinet.......................................43Risk Group 1 Agents or Risk Group 2 Agents <100 ml........................................................44Risk Group 2 Agents >100 ml................................................................................................44

Chemical Biohazardous Spill Outside a Biological Safety Cabinet...........................................45Transport and Shipping of Infectious and Other Biological Materials..........................................46

Transport of GMOs....................................................................................................................47Working Alone in a Laboratory.....................................................................................................48Appendix A: Risk Groups of Micro-organisms.............................................................................49

Bacteria.......................................................................................................................................49Parasites – Infective stages only.................................................................................................51Fungi...........................................................................................................................................52Viruses and Prions......................................................................................................................53

Appendix B: Reporting Procedures for Spills, Accidents and Injury............................................58

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone4

Page 5: Biological Safety Manual · Web viewBiological Safety Manual Curtin University of Technology 2009 Author – David Townsend Please refer any queries regarding information in this

Administration of Biological Safety at Curtin University of Technology

Role of Curtin’s Health & SafetyAll safety issues are overseen by the Health & Safety team which provides professional advice and services for the following matters.

Workplace Health & SafetyPhone: 9266 4900 or ext 4900 on campusEmail: mailto:[email protected] site: http://www.healthandsafety.curtin.edu.au

Curtin Occupational Safety and Health web site has links to University policies and an extensive knowledge base dealing with all aspects of health and safety for staff and students on campus.

Occupational Safety and Health Policy CommitteeCurtin University has established an Occupational Safety and Health Committee and various sub-committees, which are advisory to the Pro Vice Chancellor, Academic Services. The Committee is responsible for all matters relating to occupational safety and health.

Email queries to the Chair of the OSH Policy Committee.

Institutional Biosafety Committee (IBC)This committee is primarily responsible for ensuring compliance with government legislation that regulates work with potentially hazardous biological agents. The roles of IBC include:

Advise on legislative requirements for the handling of potentially hazardous biological materials.

Advise on the development and implementation of safety rules and work practices for the handling, storage and disposal of biologically hazardous materials.

Administer all of the requirements of the IBC as prescribed by the Gene Technology Act 2000 and Gene Technology Amendment Act 2007 on behalf of Curtin University of Technology and associated bodies.

Monitor compliance with legislative requirements of Acts of Parliament that regulate handling and manipulation of biologically hazardous materials including but not restricted to Gene Technology Act 2000, Gene Technology Amendment Act 2007, National Health Security Act 2007 and the Quarantine Act 1908.

Inspect laboratories working with Risk Group 2, 3 and 4 microorganisms and GMOs. Review safety audits. Review accident reports.

Email queries to the Chair of the IBC.

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone5

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Australian Standards and Government Regulations for Handling Biological Agents

In Australia there are many laws, regulations and standards concerned with safe handling of biological agents. It is important that all staff and students handling biological agents and their managers/supervisors are aware of these standards and regulations, their obligations under them and penalties associated with breaching them.

The following is a list of the major agencies that address handling of biological agents.

Australian/New Zealand Standards for Laboratory SafetyThe general laboratory safety guidelines in this document are based on AS/NZS 2243: 2002 Safety in Laboratories, prepared by the Joint Standards Australia/Standards New Zealand. The original documents should be consulted for complete guidelines.

AS2243: 2002 is presented in 10 parts:

Part 1: General safety

Part 2: Chemical aspects

Part 3: Microbiology

Part 4: Ionizing radiations

Part 5: Non-Ionizing radiations

Part 6: Mechanical aspects

Part 7: Electrical aspects

Part 8: Fume cupboards

Part 9: Re-circulating fume cupboards

Part10: Storage of chemicals

These standards are available for loan from Curtin Occupational Safety and Health or online through the Curtin University Library - Standards Australia database. The online access via the library is limited to staff and students.

Australian Customs Service (Customs)Customs manages the security and integrity of Australia’s borders, in part, by controlling the import and export of certain goods including biological agents. These may be:

Prohibited goods which are not allowed to be imported or exported in any circumstances Restricted goods which require prior written permission to be imported or exported.

For further information visit Customs Information and Support Centre at http://www.customs.gov.au/

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone6

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Australian Pesticides and Veterinary Medicines Authority (APVMA)The APVMA is responsible for the assessment and registration of pesticides and veterinary medicines and managing the parts of the National Registration Scheme that oversee the supply and use of animal health and crop protection products in Australia. The APVMA operates in accordance with its governing legislation, the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemicals Code Act 1994.

For further information visit APVMA - Home Page

Australian Quarantine and Inspection Service (AQIS)AQIS manages quarantine controls to prevent importation of exotic pests and diseases into Australia. AQIS also provides inspection and certification of facilities used to store and handle imported biological agents. AQIS is part of the Australian Government Department of Agriculture, Fisheries and Forestry.

For further information visit http://www.daffa.gov.au/aqis

Office of the Gene Technology Regulator (OGTR)OGTR administers the Commonwealth Gene Technology Act 2000. The objective of this legislation is to protect the health and safety of people, and the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms (GMOs).

For further information and safety guidelines and regulations for the manipulation of genetically modified organisms can be obtained from the official web site at http://www.ogtr.gov.au/.

Office of Health Protection (OHP)OHP within the Department of Health and Ageing is responsible for implementing the National Health Security Act 2007 (NHS Act) which sets out the obligations for entities handling security-sensitive biological agents (SSBAs).

For further information and safety guidelines and regulations for handling SSBAs can be obtained from the official web site at Department of Health and Ageing - Security Sensitive Biological Agents (SSBA)

Therapeutic Goods Administration (TGA)The TGA safeguards public health and safety by regulating supply and access to medicines, medical devices, blood and tissues. The TGA operates in accordance with its governing legislation, the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990.

For further information visit http://www.tga.gov.au/

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone7

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Legal Status of Safety StandardsThe Standards provided in AS/NZS 2243:2002 are not required by law unless specifically incorporated by an Act of Parliament however they are recognised in common law as defining current knowledge and “best practice” for laboratory safety. This should be interpreted as a warning that if personal injury or infection results from non-compliance with these Standards then Curtin is liable for civil damages. Alternative safety procedures may be used but only if they can be shown to fulfill the requirements of the Standard.

Legal Status of RegulationsRegulations are mandated by an Act of Parliament and therefore must be adhered to by law. Non-compliance or breaches of these regulations can attract severe penalties. As an example, if the laboratory deals with genetically modified organisms (GMOs) then all work within the laboratory is regulated by the Gene Technology Act 2000. Breaches of this Act may be dealt with by a Criminal Court. Examples of the penalties that may be handed out to individuals include:

Unauthorized dealing with a GMO: - $55000 fine or 2 yrs imprisonment

Aggravated offence (caused harm): - $220000 fine or 5 yrs imprisonment

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone8

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Classification of Organisms into Risk GroupsMicro-organisms have been classified into Risk Groups based on their ability to cause infection and disease, mode of transmission, host range and availability of effective preventive measures and treatments.

Risk Group 1 organisms are unlikely to cause human, plant or animal disease. Risk Group 2 organisms are pathogens but unlikely to be a serious hazard to laboratory

workers, community or the environment. Effective treatment and prevention measures are available and the risk of spread is limited.

Risk group 3 organisms are pathogens that may present a serious hazard to laboratory workers. They spread in the community or environment but there are effective treatments or preventative measures available.

Risk Group 4 organisms are pathogens that produce life-threatening infections, represent a serious hazard to laboratory workers, easily transmitted and not readily treated or prevented.

Diagnostic specimens are regarded as belonging to Risk Group 2. This applies to all clinical specimens processed in microbiology laboratories as well as other pathology laboratories including haematology and biochemistry.

See Appendix A for a list of microorganisms classified into their respective Risk Groups. If a micro-organism is not listed then consult other sources of micro-organisms classified into Risk Groups:

AS/NZS 2243.3 Safety in the laboratory Part 3 – Microbiology. Public Health Agency of Canada: http://www.phac-aspc.gc.ca/msds-ftss/index-eng.php Center for Disease Control: http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm or

download entire document from http://www.cdc.gov/od/ohs/pdffiles/4th%20BMBL.pdf Health and Safety Executive: http://www.hse.gov.uk/pubns/misc208.pdf

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone9

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Security-Sensitive Biological Agents

IntroductionSecurity-sensitive biological agents (SSBAs) are biological agents that may be deliberately misused by terrorists to harm human health or the Australian economy. They consist of infectious agents, such as bacteria and viruses, as well as toxins derived from plants or microorganisms. The acquisition, isolation, storage, handling, transport and disposal of SSBAs is governed by the National Health Security Act 2007 (NHS Act), National Health Security Regulations 2008 and the SSBA Standards and implemented by the Federal Department of Health and Ageing (DoHA).

EntityUnder the NHS Act an entity is described as those people or bodies likely to handle SSBAs. The term has been broadly defined to capture individuals, corporations and government bodies. An entity is required to comply with the reporting requirements and the SSBA Standards provided in the NHS Act. An entity is also liable for the offences provided in the NHS Act.

FacilityUnder the NHS Act a facility is described as physical structures where SSBAs may be handled and includes buildings, parts of buildings and laboratories, including mobile laboratories.

List of SSBAsSSBAs are grouped into two tiers. Regulation of Tier 1 agents began in 2009 and regulation of Tier 2 agents will begin in 2010.

Tier 1 SSBAsAgent Quantity Comments

Abrin ≥5 mg

Bacillus anthracis Virulent strains of anthrax

Botulinum toxin ≥0.5 mg Does not apply to forms of toxin approved for use under Therapeutic Goods Act 1989, eg BotoxTM

Ebolavirus

Foot-and-mouth disease virus

Influenza virus Only highly pathogenic strains infecting humans

Marburgvirus

Ricin ≥5 mg

Rinderpest virus

SARS coronavirus

Variola virus (Smallpox)

Yersinis pestis (Plague)

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone10

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Tier 2 SSBAsAgent Comments

African swine fever virus

Capripoxvirus Sheep pox virus and Goat pox virus

Classical swine fever virus

Clostridium botulinum (Botulism) toxin-producing strains

Francisella tularensis (Tularæmia)

Lumpy skin disease virus

Peste-des-petits-ruminants virus

Salmonella typhi (Typhoid fever)

Vibrio choleræ (Cholera) serotypes O1 and O139 only

Yellow fever virus non-vaccine strains

Approval to Handle SSBAsHandling of any Tier 1 or Tier 2 SSBA must be approved by the IBC and no work with the SSBA can commence until the entity and facility have been registered with DoHA.

Reporting SSBAs to DoHAThe NHS Act requires entities and facilities handling SSBAs to report their holdings to DoHA for inclusion on a National Register and comply with relevant security standards. The following events must be reported to the DoHA within 2 business days.

The entity starts to handle an SSBA The entity starts to handle an SSBA that has not previously been included on the National

Register An entity that is not registered to handle a SSBA at a facility and, as a result of its normal

testing procedures, a SSBA is at least presumptively identified.

Reporting Incidents to Police and National Security AgenciesThe following incidents must be reported:

Theft of a SSBA Attempted theft of a SSBA Unauthorized access to a place in which a SSBA is handled, including its storage

container Attempted unauthorized access to a place in which a SSBA is handled, including its

storage container Loss of a SSBA Unsuccessful transfer of a SSBA Suspicious behaviour and activities, including theft of equipment and related information

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone11

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In order of priority contact: In an emergency on Curtin campus dial “5” or Security on “9266 4444” and request

police attendance. If it is not an emergency, contact Police directly on 131 444 The National Security Hotline on 1800 123 400 The Department of Health and Ageing (DoHA) on 02 6289 7477

Physical Security of FacilityThe facility must be able to meet requirements for physical security under the SSBA standards including:

A clearly defined perimeter that allows control of access to the area Lockable doors when a facility is unattended Windows that are non-opening and sealed at all times Tier 1 facilities must have two forms of access control; entry and exit must be recorded Tier 2 facilities must have at least one form of access control; entry must be recorded.

Consequences of Non-compliance with NHS ActThere are several options open to the DoHA in the event of non-compliance. For example:

DoHA may provide advice on rectifying the non-compliance DoHA may direct the entity to dispose of the SSBA DoHA may direct a particular individual not to handle SSBAs, or to handle the agents

only after fulfilling specified conditions A facility or entity may be prosecuted with an offence under the NHS Act.

Forms and Links to Further InformationReport forms to be submitted to DoHA and IBC

SSBA Standards

.pdf

This document provides:

(a) Standards for security of Tier 1 SSBAs

(b) Standards for security of Tier 2 SSBAs

(c) Standards for secure transport of SSBAs.

Initial registration / Notifying IBC

.pdf

.doc

If you handle security sensitive biological agents (SSBAs), you must register with the Department of Health and Ageing (DoHA). You are required to submit your initial registration within two business days of commencing to handle an SSBA. This registration must be provided in hard copy and posted to DoHA. A copy must also be sent to the Chair of the IBC.

Bi-annual report / Notifying IBC

.pdf

.doc

Registered facilities are required to submit regular six monthly reports (Tier 1), if any information regarding the entity or facility has changed. A copy must also be sent to the Chair of the IBC.

Administrative changes report / Facilities must report the following administrative changes to the Department of Health and Ageing

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone12

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Notifying IBC

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(DoHA) as soon as possible and within two business days of the change occurring.

Changes to Responsible Officer(s) details

New purpose for handling an existing SSBA

Starting to handle a new SSBA

A copy must also be sent to the Chair of the IBC.

Notifying incident to DoHA / Notifying IBC

.pdf

.doc

Please complete this form for the following incidents.

Loss of SSBA

Theft of SSBA or sensitive information relating to SSBAs

Attempted theft of SSBAs or sensitive information relating to SSBAs

Unauthorised access to SSBAs or sensitive information relating to SSBAs

Attempted unauthorised access to SSBAs or sensitive information relating to SSBAs

Accidental release of SSBAs

Infection with SSBAs acquired from handling.

You are required to submit this form within two business days of the discovery of the incident to DoHA. A copy must also be sent to the Chair of the IBC.

Transfer of SSBA into facility

.pdf

.doc

Facilities must report transfers of SSBAs into the facility as soon as possible and within two business days of the event occurring. A copy must also be sent to the Chair of the IBC.

Transfer of SSBA out of facility

.pdf

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Facilities must report transfers of SSBAs out of the facility as soon as possible and within two business days of the event occurring. A copy must also be sent to the Chair of the IBC.

Disposal and/or destruction of SSBA / Notifying IBC

.pdf

.doc

Facilities must report destruction of SSBAs to the DoHA when the entire holding of an SSBA is destroyed or if the SSBA is a toxin and the remaining quantity falls below the threshold. You are required to submit this form within two business days of the event occurring. A copy must also be sent to the Chair of the IBC.

Non-Registered Facility Report / Notifying IBC

If you are an entity or facility that is not currently registered with DoHA and have received a SSBA, you

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone13

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must complete this notification form. This must be provided to DoHA within two business days of receiving the SSBA. A copy must also be sent to the Chair of the IBC.

SSBA security risk template

.pdf

.doc

Entities are required to conduct a security risk assessment on each registered facility to comply with the SSBA Standards. This template is designed to help identify potential security risks and develop appropriate mitigation strategies. A copy must be sent to the Chair of the IBC.

Guidelines

SSBA web site:

www.health.gov.au/ssba

Provides links to NHS Act, regulations, standards, guidelines and fact sheets. Use these links to obtain up-to-date information and SSBA newsletters.

Confirmatory testing for SSBA and retention of samples sent for testing

.pdf

This guideline provides information for entities or facilities where there is uncertainty about the identity of an SSBA and the services of another entity or facility are required to confirm the identity of the SSBA

Handling Samples from a Person or Animal Infected with an SSBA

.pdf

This guideline provides information to entities, facilities and individuals regarding the interpretation of the NHS Regulations pertaining to the handling of samples from a person or animal infected with an SSBA.

Loss of SSBA

.pdf

This guideline provides information to entities, facilities and individuals regarding their obligations in situations in which an SSBA is lost or stolen or accidentally released during its handling by a person at a facility

Reporting to Law Enforcement and National Security Agencies

.pdf

This document outlines the requirements for reporting reportable events and other incidents to both law enforcement and national security agencies

Reportable events

.pdf

This document provides information regarding reportable events under the NHS Act, the NHS Regulations; and reporting requirements to DoHA

SSBAs in the natural environment

.pdf

This guideline is intended to provide general information to entities, facilities and individuals who have concerns regarding their obligations for SSBAs occurring in the natural environment

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone14

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SSBA toxins

.pdf

This guideline provides information:

to entities and facilities handling toxins on the List of SSBAs;

regarding the reportable quantities for toxins on the List of SSBAs; and

regarding when to register for a Tier 1 and Tier 2 SSBA if handling Clostridium botulinum.

Transport Requirements for SSBAs

.pdf

This guideline provides information to entities and/or facilities transporting SSBAs

What is an entity and a facility?

.pdf

This guideline provides information to entities, facilities and individuals to determine what is an entity or facility for the purposes of reporting to DoHA

Fact sheets

Fact sheet – Disposal

.pdf

Disposal of a SSBA under the NHS Act means to either transfer or destroy the agent

Fact Sheet – Security

.pdf

A brief outline of measures to be taken to ensure the security of facility and information

Fact sheet – Frequently asked questions

.pdf

Provides a brief explanation of SSBAs and their regulation under the NHS Act

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone15

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Biological Material Subject to Quarantine RegulationsAustralia has very strict quarantine measures and limitations on the importation of biological materials. There are Commonwealth, State and Territory laws regulating quarantine. The basic Commonwealth law is contained in the Quarantine Act 1908 (the Quarantine Act) and regulations emanating from this Act are summarized in the Quarantine Regulations 2000. There are severe penalties for breaches of these regulations.

As a general rule any plants, animals, insects and microorganisms and material that may harbour them will require an import permit issued by the Australian Quarantine and Inspection Service (AQIS). To import material into Australia fill in the Import Application Form, send a copy to the Chair of the IBC and post the original along with payment to AQIS:

Australian Quarantine and Inspection ServiceGPO Box 858 Canberra ACT 2601

Working with Imported Biological Material in Quarantine Approved Premises (QAPs)All work with biological material imported with an AQIS permit is subject to AQIS regulations whether you were the primary importer or it was imported by someone else.

All handling and storage must be carried out within a QAP. AQIS requires that premises comply with the design and construction aspects of the Australian/New Zealand Standards AS/NZS 2982.1:1997 (Laboratory Design and Construction) and AS/NZS 2243.3:2002 (Safety in Laboratories).

All QAPs must have a quarantine sticker prominently displayed on the door. Access to QAPs shall be restricted to authorized personnel. QAPs shall be inspected at least annually as part of Curtin’s workplace safety inspections.

Every third year the QAPs shall be inspected by AQIS or an AQIS approved inspector.

Consult the AQIS website for further information: http://www.daff.gov.au/aqis

Containment Levels of QAPsQAPs utilised for research, analysis and/or testing of imported biological material including micro-organisms, animal and human products and soil are categorized as Class Five QAPs and must meet the containment levels set out in the Class Five Criteria and any other conditions imposed by AQIS. There are four levels of containment established by the criteria which are similar to the four levels of containment set out in the Australian/New Zealand Standards but may have additional requirements. These are the four levels in ascending order of stringency:

Quarantine Containment Level 1 (QC1) similar to PC1 and designated as QAP 5.1 Quarantine Containment Level 2 (QC2) similar to PC2 and designated as QAP 5.2 Quarantine Containment Level 3 (QC3) similar to PC3 and designated as QAP 5.3 Quarantine Containment Level 4 (QC4) similar to PC4 and designated as QAP 5.4

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone16

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Forms and Links to Further InformationApplication forms

Application to Import Biological Materials / Notifying the IBC

.pdf

To import material into Australia fill in the Import Application Form, send a copy to the Chair of the IBC and post the original along with payment to AQIS:

Australian Quarantine and Inspection Service

GPO Box 858

Canberra ACT 2601

Application for Transfer of Quarantine Material / Notifying the IBC

.pdf

To transfer biological material subject to an AQIS permit you must fill in this form and submit copies to AQIS and the Chair of the IBC

Guidelines and regulations

Quarantine Regulations 2000

.pdf

This is a guide to the Quarantine Regulations 2000. It is not part of the law and is not intended to replace reading these Regulations. It is also not a complete summary of the law of quarantine in Australia

Criteria for Quarantine Approved Premises 5.1

.pdf

This document sets out the criteria, which will achieve the structural and procedural requirements of a Class 5.1 QAP under section 46A of the Quarantine Act 1908.

Criteria for Quarantine Approved Premises 5.2

.pdf

This document sets out the criteria, which will achieve the structural and procedural requirements of a Class 5.2 QAP under section 46A of the Quarantine Act 1908.

Criteria for Quarantine Approved Premises 5.3

.pdf

This document sets out the criteria, which will achieve the structural and procedural requirements of a Class 5.3 QAP under section 46A of the Quarantine Act 1908.

Criteria for Quarantine Approved Premises 5.4

.pdf

This document sets out the criteria, which will achieve the structural and procedural requirements of a Class 5.4 QAP under section 46A of the Quarantine Act 1908.

Additions to the Criteria for Class 5 Containment Facility

.pdf

This summary provides details of the changes made to the criteria documents for class 5 containment released in November 2008

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone17

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AQIS web site

http://www.daff.gov.au/aqis

Provides links to Quarantine Act 1908, regulations, standards, guidelines and fact sheets. Use these links to obtain up-to-date information, fees and payment methods.

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Genetically Modified Organisms (GMOs)The Gene Technology Act 2000 and Gene Technology Amendment Act 2007 (Act), the Gene Technology Regulations 2001 and Gene Technology Amendment Regulations 2007 (Regulations) and corresponding State and Territory legislation provide the legislative framework for Australia’s national scheme of laws for the regulation of gene technology and handling of GMOs. The Office of the Gene Technology Regulator (OGTR) implements and monitors compliance of these laws.

Definition of GMOA GMO is a viable biological entity capable of reproduction or transferring genetic material that has had its genetic material modified by any technique apart from:

Sexual reproduction Homologous recombination Somatic cell nuclear transfer

Note this definition of a GMO does not include hybridomas, plants formed by protoplast fusion and organisms resulting from naturally occurring DNA exchange.

Definition of a DealingThe Act categorises experiments with GMOs into ‘dealings’ reflecting the level of risk associated with each. Dealings include:

Conducting experiments with a GMO Making, developing , producing or manufacturing a GMO Breeding or propagating a GMO Using a GMO to make something else Growing, raising or culturing a GMO Importing a GMO

Types of Dealings

Exempt dealingsExempt dealings have been assessed over time as posing negligible risks to the health and safety of people and the environment. They comprise basic molecular biology techniques that are used extensively in laboratories worldwide. A complete description of Exempt Dealings is provided in Schedule 2 of the Regulations. Prior to or at the time of commencing work on an Exempt Dealing fill in the notification form and email to the Chair of the IBC. An Exempt Dealing does not require the approval of the IBC or the OGTR. There is no specified level of containment required (a PC1 laboratory is sufficient) but there must be no intention to release a GMO and measures must be taken to prevent accidental release of a GMO.

See “Guidance Notes for the Containment of Exempt Dealings”

Notifiable Low Risk Dealings (NLRDs)NLRDs have been assessed as posing minimal risk to the health and safety of people and the environment provided certain management conditions and levels of containment are met. A

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complete description of NLRDs is provided in Schedule 3 of the Regulations. An NLRD must not involve intentional release of a GMO and must be:

o Conducted by persons with appropriate training and experience within a certified PC1 or PC 2 facility

o Assessed and approved by the IBC o Transported in accordance with the OGTR guidelines (see Guidelines for the

Transport of GMOs)Work with a NLRD must not commence until approval has be granted by the IBC. Fill in the appropriate application form and email to the Chair of the IBC.

Dealings Not Involving Intentional Release (DNIR)Dealings that do not meet the criteria for Exempt Dealings or NLRDs and do not involve intentional release of the GMO are classified as DNIRs. A DNIR licence must be issued by the OGTR before any work may commence. Fill in the application form and email to the Chair of the IBC for evaluation by the IBC. Once approved and signed by the Chair of the IBC mail the documents to the OGTR. Notification of the OGTR’s decision will be made within 90 working days. A DNIR licence will be issued subject to statutory conditions which must be complied with.

Dealings Involving Intentional Release (DIR)A DIR is the most scrutinised category of dealings. An application for a DIR licence must be made to the OGTR and notification of the decision will be made within 150-255 working days depending on details of the dealing. Consideration of a DIR licence will include a comprehensive risk assessment and management plan and extensive consultation with a wide range of experts, agencies, authorities and the public. Work with a DIR must not commence until a licence has been issued by the OGTR. A DIR licence will be issued subject to statutory conditions which must be complied with. The application process is complex and requires inputs and approval from the Vice-Chancellor and the IBC at Curtin University. Please contact the Chair of the IBC for more information.

Storage of GMOsAll GMOs including all those generated prior to the implementation of the Act in 2000 must be stored correctly.

Stored in sealed containers that are labelled with details of the GMOs. Stored inside a PC2 facility or in cold storage (< 0oC) that may be located outside the PC2

facility and is lockable or located in a secure area accessible by authorised personnel only. The storage facility must display the biohazard symbol supplied by the OGTR. Personnel must wear gloves when handling the primary storage container.

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Forms and Links to Further InformationApplication forms

Exempt Dealings Notification Form / Notifying the IBC

.doc

Carefully read the fact sheet “Types of GMO Dealings” and “Dealings with GMOs classified as Exempt Dealings 2007” and if your dealing is classified as an “Exempt Dealing” then fill in this form and submit it to the Chair of IBC. You may start work with the GMO immediately and you do not need to notify the OGTR.

NLRD Notification Form / Notifying the IBC

.pdf

Carefully read the fact sheet “Types of GMO Dealings” and “Dealings with GMOs classified as NLRDs 2007” and if your dealing is classified as an NLRD then fill in this form and submit it to the Chair of IBC for consideration. You may not start work with the GMO until you have received approval from the IBC. You do not need to notify the OGTR.

Guidelines

Gene Technology Act 2000

.pdf

The object of this Act is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs.

Gene Technology Amendment Act 2007

.pdf

An Act to amend the law relating to gene technology.

Gene Technology Regulations 2001

.pdf

The Gene Technology Regulations 2001 provide additional detail to assist the interpretation and operation of the provisions in the Gene Technology Act 2000. For example, the Regulations describe in detail the type of information that must be submitted in an application for a licence to deal with a GMO, and also set out the types of dealings with GMOs that are exempt from the national regulatory scheme and NLRDs.

Gene Technology Amendment Regulations 2007

.pdf

The amended Regulations commenced on 31 March 2007. These changes offer more streamlined processes for lower risk dealings.

OGTR Handbook 2001 The Handbook includes chapters on each of the key In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone

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.pdf

aspects of the OGTR scheme and application forms for organisations wishing to apply to deal with GMOs under the legislation. The Handbook is explanatory only and is provided only as an aid to the interpretation of the national regulatory scheme.

Types of GMO Dealings 2008

.pdf

Guidelines to the types of GMO dealings and authorizations required for each.

Dealings with GMOs classified as Exempt Dealings 2007

.pdf

This guideline outlines Schedule 2 of the Regulations. Part 1describes the type of dealings with are classified as exempt and Part 2 determines the host/vector system suitable for exempt dealings and relevant NLRDs.

Guidance Notes for the Containment of Exempt Dealings 2007

.pdf

Exempt dealings are dealings described in Part 1 of Schedule 2 of the regulations. These Notes provide assistance to organisations or persons to undertake exempt dealings and avoiding intentional release of GMOs.

Dealings with GMOs classified as NLRDs 2007

.pdf

This guideline outlines Schedule 3 of the Regulations. Part 1 describes the types of dealings with GMOs that are classified as NLRDs suitable for PC1 laboratories and Part 2 describes the types of dealings that are classified as NLRDs suitable for PC2 laboratories.

Guidelines for Storage and Disposal of NLRDs 2008

.pdf

These guidelines outline the requirements for storage and disposal of GMOs where the dealings have been assessed by the IBC as a NLRD.

Guidelines for the Transport of GMOs 2007

.pdf

These guidelines outline the requirements for all movements of a GMO from a certified facility to any location outside the facility.

OGTR Requirements for PC2 Lab

.pdf

This document describes the requirements for a PC2 laboratory handling GMOs and includes physical properties of facility, personal protective clothing and equipment, containment equipment and work practices.

OGTR Web site

http://www.ogtr.gov.au/

Provides links to the Acts and Regulations, guidelines and fact sheets. Use these links to obtain up-to-date information and revisions.

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General Laboratory SafetyCurtin University has a Policy document for laboratory safety; a copy can be downloaded from this site: http://healthandsafety.curtin.edu.au/policies.cfm

General Responsibilities for Laboratory SafetyIndividuals shall:

Take reasonable care of their health and safety. Acknowledge they have a responsibility for the health and safety of others. Familiarise themselves with emergency and evacuation procedures for each laboratory. Familiarise themselves with the recommendations and requirements in this document;

Biological Safety Manual and any safety protocols specific to each laboratory. Familiarise themselves with the procedures for correct use of safety facilities and

equipment and always use the appropriate safety equipment in the correct manner. Comply with the instructions given by emergency response personnel such as emergency

and first-aid wardens. Ensure that equipment and materials are processed in accordance with laboratory safety

procedures before disposal or maintenance. Ensure that visitors to the laboratory are provided with protective clothing and equipment. Report all incidents, hazards and 'near miss' incidents on Curtin Occupational Safety and

Health website http://www.healthandsafetyincident.curtin.edu.au

Personal Responsibilities for Laboratory Safety

Injuries and Infectionso Minor cuts and abrasions should be covered and kept dry.o All injuries shall be reported to the Laboratory Supervisor or Safety Officer.o Staff and students with existing infections must be assessed on an individual basis

as to whether they be allowed to continue work in the laboratory.o Immediate medical action must be taken after exposure to human blood or body

fluid and injury from contaminated sharps.

Immunizationo Personnel working with infectious agents should be immunised with suitable

vaccines under medical advice.o The Australian Immunisation Handbook published by the NHMRC should be

consulted for the latest information on vaccination.

Staff and Students at High Risk of Infectiono All persons who are immuno-suppressed or immuno-compromised should inform

their supervisor so that appropriate action may be taken.o Medical advice may be sought to determine whether it is appropriate for the

person to continue working in the laboratory.

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Female Staff and StudentsFemale staff and students who know they are pregnant or are trying to fall pregnant must advise their supervisor to ensure that any relevant risks can be managed appropriately. Manipulation of the following microorganisms presents a significant risk to the unborn child or the pregnant woman.

o Toxoplasma gondiio Listeria monocytogeneso CMVo Parvovirus B19o Rubella viruso HIVo Coxiella burnetiio Hepatitis viruses B, C and E

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Safety for New StudentsAt the beginning of each subject with a practical class component, students should be introduced to the guidelines necessary to conduct the practical classes safely. A short introductory talk should be scheduled before practical work commences at the beginning of each semester. The talk should:

Provide a comprehensive introduction to the safety rules in each laboratory for all new students. Point out the location of emergency exits, telephones and all safety equipment. Ensure that students are aware of emergency and evacuation procedures for the laboratory.

Ensure that students under your supervision are given a written copy of Emergency Procedures and Laboratory Safety: Guidelines for Students .

Ensure that students acknowledge receipt and understanding of the Emergency Procedures and Laboratory Safety: Guidelines for Students by signing the appropriate form.

Demonstrate correct use of all safety equipment and aseptic procedures to students. Demonstrate correct procedures for dealing with spills, accidents and injuries to students. Procedures for the reporting of incidents and 'near miss' incidents which occur in practical

classes. Introduce personnel who assist with emergency, first aid and safety procedures. Actively practice, and develop in the students, proper attitudes towards health and safety

matters.

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Safety for Laboratory Programs and ExercisesBefore each class that includes procedures or substances that may pose some degree of risk to students, specific issues relating to health and safety in that laboratory class should be brought to the attention of students by the lecturer, demonstrator-in-charge or technical staff. The safety issues discussed should include:

An outline of the risks involved in the laboratory class and the procedures to follow to minimise those risks.

The appropriate personal protective equipment to be worn. Training in the correct use of equipment and apparatus. Waste disposal procedures. Students should be encouraged to report any medical conditions or allergies that could put

them at risk during the conduct of the class to the staff in charge. Ensure that students comply with the safety rules for each laboratory and exclude those

students who do not comply. Ensure that a suitably qualified and/or experienced person is present in the practical class

at all times.

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Classification of LaboratoriesLaboratories have been classified into four different levels of physical containment and these reflect the Risk Group of the micro-organisms that may be manipulated within the laboratory

PC1 laboratory is suitable only for manipulation of microorganisms belonging to Risk Group 1. Work may be carried out on the open bench. Specimens that have been inactivated or fixed may be handled in a PC1 laboratory.

PC2 laboratory is applicable to clinical, diagnostic, industrial, teaching and other premises where work is carried out on microorganisms belonging to Risk Group 2 or material that is likely to contain these microorganisms. If there is a significant risk of aerosols, a biological safety cabinet shall be used.

PC3 laboratory is applicable to clinical, diagnostic and other premises where work is conducted on microorganisms belonging to Risk Group 3 or material that is likely to contain these microorganisms. These microorganisms pose a risk of serious infection to humans, animals or plants but there are effective treatments or control measures available.

PC4 laboratory is applicable to premises where work is conducted on microorganisms belonging to Risk Group 4 or material that is likely to contain these microorganisms. These microorganisms pose a risk of serious, life-threatening infection to humans, animals or plants and may be easily spread throughout the community.

Laboratories handling GMOs and AQIS quarantine material are also classified using the same or similar schemes but special additional provisions are required. Information can be obtained from the Chair of the IBC or elsewhere in this manual.

Please note: Curtin University does not have laboratories with a higher level of physical containment than PC3 so micro-organisms belonging to Risk Group 4 cannot be manipulated or stored on this campus.

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Safety in a PC1 LaboratoryA PC1 laboratory is suitable for work with microorganisms in Risk Group 1. Most procedures can be conducted on an open bench.

PC1 Laboratory Facilities Bench tops shall be able to withstand heat generated by general laboratory procedures. Furniture shall be ergonomically suitable for use in the laboratory. Surfaces shall be smooth and impervious to facilitate cleaning. Wash basins with potable hot and cold water services shall be provided inside the

laboratory near the exit. Open spaces between and under benches, cabinets and equipment shall be accessible for

cleaning. Fire control systems shall meet local, State or Federal regulations.

Personal Protective Clothing and Equipment A laboratory coat or gown with long sleeves that affords protection to the front part of the

body shall be worn within the laboratory. A laboratory gown that ties at the back is preferred.

Closed footwear shall be worn. Safety glasses, face shields and other protective devices shall be worn under instruction

from staff to protect eyes and face from splashes and other hazards.

Safety Rules and Practices Do not work in isolation in a laboratory; ensure that at least a second person is within call.

See Curtin’s policy on “Working in Isolation”. Do not bring food or drink for personal consumption into the laboratory. Eating, drinking, smoking and the application of cosmetics and contact lenses is prohibited

in laboratories. Hands, pencils and pens should be kept away from the face. Long hair shall be tied back as it constitutes a fire risk and contamination risk. Never run in the laboratory or along corridors. Never indulge in reckless behaviour in the laboratory. Always exercise care when opening and closing doors and entering or leaving the

laboratory. Keep all fire-escape routes completely clear at all times. Prepare and practice fire drill

instructions at least annually and display them in the laboratory. Ensure all emergency and safety equipment is kept and maintained in accordance with the

manufacturer’s instructions. Ensure all safety equipment is readily accessible at all times to personnel in the laboratory. Always use safety carriers for transporting chemicals in glass or plastic containers with a

capacity of 2L or greater. Never carry containers of mutually reactive substances at the same time. Ensure chemicals are stored in the laboratory in accordance with AS 2243.10. Keep only the minimum required quantities of hazardous substance in the laboratory work

area.In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone

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Always use a fume cupboard when working with toxic, volatile, corrosive or odoriferous substances.

Wash skin areas which come in contact with chemicals, irrespective of concentration. Do not pipette using your mouth. Blowing out residual volumes from pipettes creates

aerosols so it is preferable to use pipettes calibrated to deliver the correct volume. Label all cultures with identity and date. Do not store cultures for long periods on the

bench. Transfer them to a refrigerator or cool room for storage. Cultures of spore-bearing fungi should be sealed with plastic stretch film to prevent

dispersal of spores. Handle diagnostic kits and control sera with care as the exclusion of all pathogens cannot

be guaranteed. Take care to minimize production of aerosols.o Do not shake cultures or blow cultures out of a pipette.o Do not place hot wire loops onto the surface of culture plates or break the film of

liquid culture in a wire loop.o The hand holding a wire loop should remain stationary, the other hand should

bring culture plates, bottles etc. to the hand holding the loop.o Do not plunge a contaminated loop into the hottest part of a gas flame as it will

splatter the culture and create an aerosol: lower the loop gradually down into the hottest parts of the Bunsen burner flame.

When using a Bunsen burner equipped with a pilot light always have the gas valve in the fully “ON” or “OFF” position, never half-way between as this may result in the flame “striking back” into the tube of the Bunsen burner. If this happens there is a risk of severe burns and fire.

Ensure reading and writing materials do not become contaminated. Keep your work area free of non-essential materials.

Do not use labels that need to be moistened by licking; use self-adhesive labels. Clean up spills immediately and decontaminate the area according to the instructions

elsewhere in this manual. Report all spills and accidents immediately to the laboratory supervisor.

Decontaminate work benches daily or after each laboratory session. Segregate and dispose of all waste in the appropriate waste bins. Remove laboratory gowns and thoroughly wash hands and fingernails before leaving the

laboratory. Ensure that all incidents and 'near miss' incidents that occur are reported on the University

Hazard & Incident Report procedure at Curtin Occupational Safety and Health web site.

Additional Safety Rules and Practices for PC1 Facility Handling GMOs Protective clothing contaminated or suspected to be contaminated with GMOs should be

removed as soon as reasonably possible and decontaminated prior to reuse. Protective clothing that has not been contaminated with GMOs may be washed using normal laundry methods.

All cultures of GMOs should be labelled. Any equipment that is, or may be, contaminated with GMOs should be decontaminated

prior to being removed from the facility.

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GMOs may be stored outside the facility in a storage unit (freezer, fridge, controlled temperature room or other container). Access to the storage unit should be restricted or controlled to prevent unintentional release of GMOs into the environment.

GMOs being stored outside the facility should be stored in a labelled, sealed, unbreakable primary container to prevent the escape or release of the GMO.

All cultures of GMOs being stored inside the facility should be sealed during storage to prevent dissemination of the GMOs.

Except during the entry and exit of personnel, supplies and/or equipment, doors of the facility should be closed while procedures with animals containing GMOs are being conducted. Windows and doors should be locked when facility personnel are not in attendance.

Handling of and any experimental procedures conducted on the animals containing GMOs should be carried out in a way that minimises the chance of escape.

When not being handled, the animals containing GMOs should be kept in containers or cages designed to prevent the escape of the animals being contained.

All animal cages or containers should be labelled. Cages or containers must be labelled to enable identification of the animals containing GMOs being contained and to indicate the number of animals in the containers. Large animals containing GMOs should be clearly marked so that they can be readily identified (eg. with a tattoo, permanent tag, microchip or permanent brand). Some documented system of accounting for the animals containing GMOs in the facility should be used.

If an animal containing GMOs escapes within the facility, trapping devices should be used to capture the animal and the animal should be returned to its container or cage or euthanased.

Additional Safety Rules and Practices for PC1 Laboratory Handling AQIS Quarantined Biological Materials (QAP 5.1)

Solid quarantine wastes must be bagged and placed in an unbreakable container with a secured lid for transport to an approved disposal place.

If waste cannot be disposed of immediately, it must be:o double bagged;o stored in a separate device/area for the temporary holding of goods that must be

AQIS approved and be within the QAP to prevent loss, spillage or unauthorised access;o stored in lidded bins/containers of an appropriate size which are leak and pest

proof and labelled ‘Quarantine Waste’. All quarantine waste water must be disposed of by an AQIS approved method and may

include disposal by an approved municipal sewage system. A quarantine sign must be displayed on the entry door to the facility and state

Microbiological Containment - QC1 Facility. Containers holding quarantine goods must be clearly labelled using standard scientific

nomenclature. The label must enable clear reconciling of quarantine goods with the following information:

o Quarantine Entry Number (where relevant),o Import Permit Number or AQIS in vivo approval number and expiry dates,o Importation date

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Gloves shall be removed and hands thoroughly washed after handling quarantine goods, and before leaving the facility. Used gloves shall be discarded with the quarantine waste

To prevent cross contamination while work is being undertaken, there must be separation of quarantine work from other work

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Safety in a PC2 LaboratoryA PC2 laboratory is suitable for work with microorganisms in Risk Group 2. These require additional conditions of access, safety equipment, staff training and work practices to those used for PC1 laboratories.

PC2 Laboratory Facilities A biological hazard symbol and PC2 level of containment shall be prominently displayed

at each entrance of the laboratory. Additional signs detailing restricted access may be displayed.

An additional sign approved by the OGTR must be displayed if GMOs are manipulated within the laboratory.

An additional sign approved by AQIS must be displayed if quarantine materials are manipulated within the laboratory.

All freezers, refrigerators and other storage units for micro-organisms located outside the PC2 facility shall display the biological hazard symbol.

Measures to limit public access to the laboratory. Mandatory training for all staff working in these areas. Ceilings, walls and floors shall be smooth, easy to clean, impermeable to liquids and

resistant to commonly used reagents and disinfectants. The floors should have a non-slip finish. Internal fittings and fixtures shall be selected and fitted to minimise the horizontal surface

area on which dust can settle. Hand-washing facilities shall be provided next to the exit door and shall have hands-free

operation. Water supplies to the laboratory shall be provided with back-flow prevention (AS/NZS

3500) Emergency drench showers and eyewash stations shall be provided (AS/NZS 2982.1).

Where this is not possible then single-use packs of sterile eye irrigation fluids shall be provided.

A directional air flow shall be maintained by extracting room air. Recirculation is permitted but not into areas outside the PC2 laboratory.

An autoclave shall be provided where steam sterilisation of infectious waste is required. Laboratory gowns and hanging space shall be provided inside the laboratory adjacent to

the entrance door. Provide protective covers for equipment that would be difficult to decontaminate eg

computer keyboards. Supply containers for infectious materials. Supply clearly labelled disinfectant solutions for decontamination purposes. A biological safety cabinet (Class I or II) shall be installed and maintained if the

manipulations involve micro-organisms that are transmitted by the respiratory route or there is a significant risk of aerosol production (AS/NZS 2647).

A centrifuge with either sealed rotors or safety cups shall be supplied and used where large volumes (>100 mL) or high concentrations of infectious material are used.

Sharps containers shall be provided at each point of use in the laboratory (AS 4031).

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Reference documents and papers shall be stored separate from the work bench areas. A facility should be provided outside the PC2 laboratory for writing reports. Worksheets for recording results may be used on the work bench.

A pest control program against insects, birds and animals shall be instituted and applied on a regular basis.

Protective Clothing and Equipment Staff and students working in PC2 laboratories will be supplied with laboratory gowns.

These gowns must not leave the laboratory. The gowns will be laundered regularly. If students wish to use their own gowns they must clearly label the gown with their name

and provide a plastic zip-lock bag in which to store it. The gown must not leave the laboratory until the completion of the semester. The gown will be autoclaved and then returned to the student. NB: Students must provide a separate gown for each PC2 facility they use.

Personal items must be kept to a bare minimum, preferably just laboratory notes, pen and paper to record results. No bags, additional clothing etc will be allowed in the laboratory

Gloves shall be worn when working in a biological safety cabinet and when handling blood and body fluids.

Goggles or visors shall be worn when appropriate to protect eyes from contaminated or dangerous materials or from UV light.

Containment Equipment A biological safety cabinet shall be used when working with microbial pathogens

transmissible by the respiratory route or when there is a significant risk of aerosol production.

A laminar flow cytotoxic drug safety cabinet shall be used when working with materials containing prions.

A centrifuge fitted with sealed rotors or safety cups shall be used when large volumes or high concentrations of infectious material are used.

Safety Rules and Work Practices Access to the laboratory shall be limited to laboratory personnel and persons specified by

the laboratory management. Laboratory doors should remain closed when work is in progress. Laboratory personnel shall receive instruction and training in handling pathogens and this

will be updated regularly. The use of syringes and needles shall be restricted to parenteral injection and aspiration of

fluids from laboratory animals and diaphragm-capped bottles. After use, the needle and syringe shall be placed in a sharps container for disposal by incineration. Sharps containers shall be provided at each point of use. Before disposal, needles shall not be removed, bent, sheared or replaced in a sheath or guard.

Laboratory staff shall advise maintenance and service personnel of the special microbiological hazards in the laboratory. Potentially contaminated surfaces shall be disinfected before maintenance of equipment is conducted.

All clinical specimens shall be regarded as potentially hazardous. Leaking containers shall be handled in a biological safety cabinet and the outside container decontaminated.

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A biological safety cabinet shall be used for all procedures likely to generate an aerosol including shaking, mixing and ultrasonic disruption. A period of at least 5 minutes shall be allowed for aerosols to settle before opening containers of aerosols in a biological safety cabinet.

No reading, writing and recording equipment shall be used in the biological safety cabinets.

The subculture of some Risk Group 2 microorganisms requires special precautions. Consult the tables in Appendix A for further information.

Work with highly infectious substances and when handling human blood, serum, other body fluids and substances that are visibly contaminated with blood requires that:

o disposable gloves must be worn.o hands must be disinfected after removing gloves in case any perforation of the

gloves has permitted the entry of micro-organisms. o must be performed in areas provided with wash basins equipped with elbow or

foot operated taps. o an emergency shower must be readily accessible. o all work should be carried out in biosafety cabinets. Where the work poses an

extreme risk, use of biosafety cabinets is mandatory. Any container of viable microorganisms shall be transported between laboratories or to an

autoclave within the building inside a second unbreakable and closed container which can be readily decontaminated.

Potentially contaminated re-usable containers shall be sterilized or chemically disinfected prior to washing and re-use. For chemical disinfection, pipettes shall be placed in a disinfectant solution, tip-first and fully immersed, to minimize production of aerosols.

Active sniffing of bacterial cultures for odours should not be allowed. A pest control program against insects, birds and animals shall be implemented and

regularly maintained.

Additional Safety Rules and Practices for PC2 Laboratory Handling GMOsThe Gene Technology Act 2000 imposes standards for the manipulation of GMOs that are in addition to those outlined in AS/NZS 2243.3:2002. These standards are enforceable by law. Officers of the Office of the Gene Technology Regulator (OGTR) may inspect the facilities at any time and without warning!

Staff and students must seek and receive special training and instructions before commencing any laboratory manipulations with GMOs in a PC2 laboratory.

The manipulation of GMOs classified as a “Notifiable Low Risk Dealing” by the OGTR are usually conducted in a certified PC2 laboratory but under some circumstances in a PC1 laboratory.

All activities within a PC2 facility must comply with the regulations even if the activity does not involve a GMO.

Only trained personnel shall clean contaminated equipment and surfaces or handle hazardous materials.

All manipulations that might create an aerosol shall be conducted in a biological safety cabinet.

There must be in place a procedure to report unintentional release of a GMO to the IBC and OGTR.

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All work benches, surfaces, equipment etc must be decontaminated after any spills with a GMO.

All materials and laboratory waste contaminated with GMOs must be decontaminated prior to disposal. Appropriate methods include sterilisation with an autoclave, chemicals or incineration.

Autoclaving of GMOs must be done under the following conditionso The load must be packed to allow steam penetration throughout.o A temperature of at least 121oC must be maintained throughout the load for a

period of 15 minutes.o All sterile and non-sterile loads must be differentiated usually by labelling with

autoclave tape.o Control the autoclave by continuous recording of internal temperature over time,

use chemical indicators within each load or use spore strips.o Test the autoclave on a monthly basis with a spore strip and post the results next to

the autoclave.

Additional Safety Rules and Practices for PC2 Laboratory Handling AQIS Quarantined Biological Materials (QAP 5.2)

Solid quarantine wastes must be bagged and placed in an unbreakable container with a secured lid for transport to an approved disposal place.

If waste cannot be disposed of immediately, it must be:o double bagged;o stored in a separate device/area for the temporary holding of goods that must be

AQIS approved and be within the QAP to prevent loss, spillage or unauthorised access;o stored in lidded bins/containers of an appropriate size which are leak and pest

proof and labelled ‘Quarantine Waste’. All quarantine waste water must be disposed of by an AQIS approved method and may

include disposal of waste water by an approved municipal sewage system. A quarantine sign must be displayed on the entry door to the facility and state

‘Microbiological Containment – QC2 Facility. Containers holding quarantine goods must be clearly labelled using standard scientific

nomenclature. The label must enable clear reconciling of quarantine goods with the following information:

o Quarantine Entry Number (where relevant),o Import Permit Number or AQIS in vivo approval number and expiry dates,o Importation date Gloves shall be removed and hands thoroughly washed after handling quarantine goods,

and before leaving the facility. Used gloves shall be discarded with the quarantine waste To prevent cross contamination while work is being undertaken, there must be separation

of quarantine work from other work

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Safety in a PC3 LaboratoryA PC3 laboratory is suitable for work with microorganisms in Risk Group 3. There are very stringent levels of safety, security and containment. Curtin has a PC3 facility and anyone wishing to use this facility must undergo an induction and training course before they will be given a security pass and permission to enter. Please contact the Manager of the facility for further details.

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Disposal of Hazardous WasteHazardous medical waste must be safely and correctly disposed of and meet the University's obligations under;

Occupational Safety and Health Act 1984 Poisons Act 1964 Radiation Safety Act 1975 Australian Universities Academic Staff (Contract of Employment and Other Matters)

Interim Award 1988 Australian Universities Academic Staff (Conditions of Employment) Award 1988 Curtin University of Technology Agreement on Enterprise Bargaining (Academic Staff)

1997 Curtin University of Technology General Staff Enterprise Agreement 1997, and as

amended from time to time.

Safe Collection of Laboratory Waste Hazardous medical waste must be handled only by persons wearing the appropriate

protective clothing. Containers for the safe collection of laboratory waste will be provided and clearly

identified according to the following categories:

Non-infectious Materialso Waste paper, plastics and paper products shall be collected in a single layer plastic

bag.

Sharpso All sharps must be kept separate from other waste and must be disposed of as soon

as possible.o Syringes with needles, broken glass, scalpel blades etc shall be collected in a rigid,

puncture-proof container (AS 4031). The container must be clearly labelled "SHARPS ONLY" and must comply with the Guidelines for the Storage, Transport and Disposal of Medical Waste issued by the Health Department of Western Australia.

Infectious Materialso Cultures, used Petri dishes, culture bottles, disposable equipment, gloves,

biological tissues, fluids, infected animal carcasses and bedding shall be collected in a robust plastic bag displaying the biohazard symbol, which can be sterilised in an autoclave and is retained in a solid-based container with a non-sealing lid.

Co-mingled Materialso The disposal of mixed wastes (biological, chemical and radioactive) shall be

conducted in a manner that addresses all hazards.

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Radioactive Infectious Materialso Collect solid waste into robust plastic containers and label with isotope and date.

Place in a secondary solid container.o Collect liquid waste into a container for disinfection.

Treatment and Disposal of Infectious WasteAfter collection the waste will be treated and disposed of by one of the following methods.

Sterilised in a steam autoclave using validated sterilisation conditions. Treated by a chemical disinfectant. Incinerated in a high-temperature, high-efficiency, EPA-approved incineration facility.

Other points to be observed are as follows. After sterilisation or chemical disinfection, solid waste should be disposed by incineration

or landfill according to Government regulations. Adequate containment shall be provided for transport of infectious waste from the

laboratory to the incinerator. Chemical wastes shall be disposed of in accordance with AS/NZS 2243.2. Radioactive wastes shall be treated in accordance with AS 2243.4. Consult the Radiation

Safety Officer for further details. Liquid cultures from PC2 laboratories should be sterilised before being discarded into the

sewer. Uncontaminated laboratory wastes may be disposed of in the same manner as household

waste.

SterilisationTwo types of equipment used for sterilisation are the autoclave and the hot air oven. The same precautions and conditions apply to both types of equipment and are as follows.

o Only properly trained staff must use autoclaves and care must be taken to ensure the load reaches the required temperature and remains at that temperature for the prescribed length of time.

o Autoclaves must be fitted with temperature and pressure gauges and a chart recorder.

o A temperature-sensitive chemical indicator such as autoclave tape must be used with every load.

o Monthly checks of sterilising efficiency must be carried out using spore strips.o Times for sterilisation must be determined according to the load. Minimum

sterilisation times after the required temperature has been attained by all items and parts of items are as follows.

o Autoclave 15 minutes at 121 oC or 3 minutes at 134 oCo Hot air oven 60 minutes at 160 oC or 20 minutes at 180 oC

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DisinfectantsDisinfectants should only be used where sterilisation is not possible, such as large spaces or surfaces and delicate instruments. Disinfectants must be chosen for their effectiveness to deal with the specific type of micro-organism and must be used at the correct concentrations.

The main uses for disinfectants are as follows.

o Decontaminating surfaces and equipment o Washing re-usable items o Wiping down benches and work surfaces at the end of the day o Regular cleaning of equipment, such as water baths, incubators, centrifuges,

freezers and refrigerators Commonly used disinfectants include the following.

o 70% ethanol volume for volume aqueous solution o Chlorine as hypochlorite solution o Iodophores - aqueous or alcoholic providone - iodine o Phenolic disinfectants such as Medol o Chlorhexidine - aqueous or alcoholic

Disposal of DrugsAll drugs which are listed in the Eighth Schedule of the Poisons Act 1964 must be collected and/or disposed of by the Pharmaceutical Services Branch of the Health Department of Western Australia. Under no circumstances are these drugs to be collected and/or disposed of by others.

Pharmaceutical waste containers approved by the Pharmaceutical Services Branch of the Health Department of Western Australia must be used for the disposal of all drugs.

Approved pharmaceutical waste containers which are ready for disposal must be placed in a designated pick up place ready for removal by the approved waste disposal contractor.

Disposal of Cytotoxins The disposal of material used with cytotoxins must not involve cutting, bending or any

other unnecessary manipulation which could release aerosols or result in the splatter of cytotoxins.

Unless manipulation of needles is essential for a procedure, needles must not be clipped, broken or recapped.

As soon as possible after use, all cytotoxic waste must be disposed of into a suitably labelled, non-reactive container which complies with the Safe Handling of Cytotoxic Drugs issued by the Health Department of Western Australia.

This container must be kept separate from containers used for sharps, pharmaceuticals and infectious waste.

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Disposal of Radioactive Research WasteThe disposal of radioactive research waste is subject to the Radiation Safety Act 1975 and attendant Regulations. Therefore, such disposal must be conducted in accordance with the requirements laid down in the following.

Radiation Safety (General) Regulations (1983) Code of Practice for the Disposal of Radioactive Wastes Arising From Medical and

Research Use in Western Australia, published by the Health Department of Western Australia

Code of Practice for the Disposal of Radioactive Wastes by the User (1985), published by the National Health and Medical Research Council

Radiation Safety policy and procedures formulated by Curtin University of Technology

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Cleaning and Maintenance of Laboratories Cleaning and maintenance staff shall be advised of the hazards in the laboratory and

adequately trained. PC1 and PC2 facilities do not require dedicated cleaning equipment. Laboratory staff must decontaminate benches and equipment prior to maintenance work. Benches and work surfaces shall be cleared at the end of each working session and

disinfected. Avoid vigorous cleaning and use of abrasive cleaners to prevent damage to smooth

surfaces. Cleaners shall confine themselves to cleaning floors and walls. No vacuum cleaners can be used unless fitted with a HEPA filter on the exhaust. No sweeping is allowed as this produces airborne dust. Wet mopping is the preferred method for cleaning floors. One mop and bucket for

spreading the floor cleaner and disinfectant and another mop and bucket to remove the dirty fluid from the floor.

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Laminar Flow Clean Air Benches and Biological Safety CabinetsBiological safety cabinets and laminar flow clean air benches have different purposes and it is essential that staff and students are aware of the difference.

Laminar Flow Clean Air Benches Laminar flow clean air benches protect the work from contamination. They do not protect

the worker. The air passes unfiltered onto the worker and into the laboratory. Laminar flow clean air benches must not be used when handling pathogenic materials as

any aerosols formed will be directed at the worker.

Biological Safety CabinetsAny procedure which is likely to produce infectious aerosols, such as blenders, shakers and sonicators involving highly infectious organisms must be handled in a biosafety cabinet in which highly contaminated air is passed through a High Efficiency Particulate Air filter. There are three classes of biological safety cabinet.

Class I - inward flow of air away from the operator. The air is passed through a HEPA filter before being discharged from the cabinet.

Class II - an air barrier protects the operator and a flow of filtered air is passed over the work to prevent it becoming contaminated. The air is passed through a HEPA filter before being discharged from the cabinet.

Class III - completely enclosed unit with built-in air locks for introducing and removing materials. Both incoming and outgoing air passes through HEPA filters. Class III cabinets are intended for use with highly hazardous micro-organisms.

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Safety Precautions for Special Laboratory EquipmentIt is impractical to provide safety precautions for all items of equipment that may be used in a laboratory. Each laboratory should develop a Standard Operating Protocol (SOP) for each item of equipment which includes a guide to its safety features and procedures. The following are common items of equipment that require specific safety precautions.

Centrifuges Centrifuges shall not be placed in Class I or II biological safety cabinets as air turbulence

caused by the centrifuge may compromise containment by the cabinet. Tubes with properly fitting caps shall be used when centrifuging infectious materials. The rotor, buckets, tubes etc will be carefully balanced before centrifuging. Logbooks shall be kept for medium and high speed centrifuges to ensure timely

maintenance and safety inspections of the rotors.

Freeze-Drying or Lyophilisation Freeze-drying shall be carried out in containment facilities appropriate to the Risk Group

of the cultures being handled. The manufacturer’s instructions shall be strictly followed when operating the equipment. The freeze-drier shall be fitted with a 0.2 μm hydrophobic membrane filter in the chamber

exhaust line to protect the oil in the vacuum pump from contaminated aerosols. Freeze-dry ampoules containing cultures shall be opened in a biological safety cabinet.

The ampoules shall be wrapped in material such as gauze to protect the operator from being cut by broken glass.

Opened ampoules shall be sterilized by heating to 160oC for 2 hours, prior to discarding, or shall be discarded into a sharps container for incineration.

Bunsen BurnersSome Bunsen burners are equipped with a pilot flame and a gas valve at the base of the burner. The gas valve must always be positioned in the fully “OFF” position, in which case only the pilot flame will be alight, or the fully “ON” position when the main gas flame will be alight. If the valve is positioned between these settings there is every likelihood that the main gas flame will “strike back” into the tube of the Bunsen burner. When this happens a flame is burning inside the metal tube, which rapidly gets very hot and may melt the gas tubing. This can result in a fire or severe burns if the metal components of the burner are touched.

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Safe Treatment of Spills

Biohazardous Spill inside a Biological Safety CabinetChemical decontamination procedures should be initiated at once while the cabinet continues to operate to prevent escape of contaminants from the cabinet.

Spray or wipe walls, work surfaces, and equipment with a decontaminant that is effective against the agent in use. Generally a 1% solution of an iodophor decontaminant is effective against most viruses, fungi, vegetative bacteria, and most non-encysted amoeba. The operator is to wear gloves and lab coat during this procedure.

Flood the top work surface tray, and, if a Class II cabinet, the drain pans and catch basins below the work surface, with a decontaminant and allow stand 10-15 minutes.

Remove excess decontaminant from the tray by wiping with a sponge or cloth soaked in a decontaminant. For Class II Cabinets, drain the tray into the Cabinet base, lift out tray and removable exhaust grille work, and wipe off top and bottom (underside) surfaces with a sponge or cloth soaked in a decontaminant. Then replace in position and drain decontaminant from Cabinet base into appropriate container and autoclave according to standard procedures. Gloves, cloth, or sponge should be discarded in an autoclave pan and autoclaved.

Biohazardous Spill outside a Biological Safety Cabinet If you have spilled a Risk Group 1 agent or a small (unconcentrated) amount of a Risk

Group 2 agent then remove any contaminated clothing, wash hands, put on fresh protective garments and gloves and proceed to step 7.

If you have spilled more than 100ml of a risk group 2 agent, hold your breath, leave the room immediately, and close the door.

Warn others not to enter the contaminated area. Remove and put contaminated garments into a container for autoclaving and thoroughly

wash hands and face. Wait 30 minutes before re-entering area to allow dissipation of aerosols created by the

spill. Put on a long sleeved gown, mask, and rubber gloves before re-entering the room. Pour a decontaminant solution (1% iodophor or 10% hypochlorite are recommended)

around the spill and then place towels over the spill. Soak the towels with the decontaminant. To minimize aerosol production, avoid pouring the decontaminant solution directly onto the spill.

Let stand 20 minutes to allow an adequate contact time. Using an autoclavable dust pan and squeegee, transfer all contaminated materials (paper

towels, glass, liquid, gloves, etc.) into a deep autoclave pan. Cover the pan with aluminium foil or other suitable cover and autoclave according to standard directions.

The dust pan and squeegee should be placed in an autoclave bag and autoclaved according to standard directions.

Radioactive Biohazardous Spill outside a Biological Safety CabinetIn the event that a biohazardous spill also includes radioactive material, the cleanup procedure will have to be modified. The biological component of the spill will have to be inactivated prior

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to disposal of the radioactive waste. Call the Radiation Safety Officer or Curtin Occupational Safety and Health (extension 4900) for instruction and assistance.

Risk Group 1 Agents or Risk Group 2 Agents <100 mlo Warn others not to enter the contaminated area.o Remove protective clothing (lab coat, gloves, etc.) and isolate in a plastic bag or

appropriate container. o Monitor yourself for radioactive contamination. If contaminated then

decontaminate yourself and re-monitor yourself. o Thoroughly wash your hands and face.o Monitor the removed protective clothing for radioactive contamination. If

positive, isolate this waste and hold for disposal by the Radiation Safety Officer.o Pour a decontaminant solution (1% iodophor or 10% hypochlorite are

recommended) around the spill and then place towels over the spill. Soak the towels with the decontaminant. To minimize aerosols, avoid pouring the decontaminant solution directly onto the spill.

o Let stand 20 minutes to allow an adequate contact time.o Using a dust pan and squeegee capable of withstanding an autoclave, transfer all

contaminated materials (paper towels, glass, liquid, gloves, etc.) into a plastic bag. Place the bag in the appropriate radiation waste container.

o The dust pan and squeegee should be monitored for radioactive contamination. Decontaminate and re-monitor as necessary.

o Contact the Radiation Safety Officer or Curtin Occupational Safety and Health (extension 4900) to report the spill.

Risk Group 2 Agents >100 mlo If you have spilled more than 100 ml of a Risk Group 2 agent, hold your breath,

leave the room immediately, and close the door. o Warn others not to enter the contaminated area. o Remove protective clothing (lab coat, gloves, etc.) and isolate in a plastic bag or

appropriate container. o Monitor yourself for radioactive contamination. If contaminated then

decontaminate yourself and re-monitor yourself.o Thoroughly wash your hands and face. o Monitor the removed protective clothing for radioactive contamination. If

positive, isolate this waste and hold for disposal by Radiation Safety Officer. o Prior to re-entering the laboratory or spill area, wait 30 minutes to allow

dissipation of aerosols created by the spill. o Before cleaning the spill area, contact Radiation Safety Officer or Curtin

Occupational Safety and Health (extension 4900) for assistance. If the spill occurs after hours or on weekends, activate the Emergency response system by dialling “5” or Security on 9266 4444.

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Chemical Biohazardous Spill outside a Biological Safety Cabinet Before attempting to clean up the spill determine which chemical decontaminant(s) is

compatible with the chemical(s) that may have become biologically contaminated and if the contaminated chemical(s) can be autoclaved. Contact Curtin Occupational Safety and Health (extension 4900) for assistance.

If you have spilled more than 100ml of a Risk Group 2 agent, hold your breath, leave the room immediately, and close the door.

If you have spilled a Risk Group 1 agent or a small amount of a Risk Group 2 agent then proceed to the next step.

Warn others not to enter the contaminated area. Remove and put in a container contaminated garments for decontamination or autoclaving

and thoroughly wash hands and face. If garments are chemically contaminated, autoclaving may not be advisable, consult with an industrial hygienist.

If you have had to evacuate the laboratory, wait 30 minutes to allow dissipation of aerosols created by the spill.

Consult Curtin Occupational Safety and Health (extension 4900) for chemical spill procedures. If the chemical(s) in the spill present a greater hazard then the biological agent(s) proceed with chemical decontamination first.

Put on a long sleeved gown, mask, and rubber gloves before re-entering the room. For high risk agent or hazardous chemical, a jumpsuit with tight-fitting wrists and use of a respirator (consult Curtin Occupational Safety and Health) should be considered.

Use a decontaminant that is compatible with the chemical(s) in the spill. Pour the decontaminant solution around the spill and then place towels over the spill. Soak the towels with the decontaminant. To minimize aerosol production, avoid pouring the decontaminant solution directly onto the spill.

Let stand 20 minutes to allow an adequate contact time. If the chemical(s) are compatible with autoclaving, use an autoclavable dust pan and

squeegee to transfer all contaminated materials (paper towels, absorbent, glass, liquid, gloves, dust pan, squeegee, etc.) into an autoclavable pan. Cover the pan with aluminium foil or other suitable cover and autoclave according to standard directions.

If the chemical(s) are not autoclavable (or if you do not know), then transfer the decontaminated, contaminated materials into a screw cap container and call Curtin Occupational Safety and Health (extension 4900).

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Transport and Shipping of Infectious and Other Biological MaterialsThe transport and shipping of biological materials is regulated by the following documents:

International Air Transportation Association (IATA), Dangerous Goods Regulations. This is the most comprehensive set of regulations and should be consulted in the first instance.

Australia Post, Dangerous and Prohibited Goods Packaging Guide. Australian Code for the Transport of Dangerous Goods by Road and Rail. International Maritime Organisation (IMO), International Maritime Dangerous Goods

Code (IMDG Code).

As a general guide the following requirements must be met. Biological materials known not to contain infectious agents may be transported without

restrictions. A biological product known to carry a micro-organism from Risk Group 1 and not

pathogens from Risk Groups 2, 3 or 4 may be transported without restrictions. Diagnostic specimens known not to contain pathogens in Risk Groups 2, 3 and 4 may be

transported without restrictions. Diagnostic specimens with a low probability of containing pathogens in Risk Groups 2 or

3 shall be transported in packages complying with Packing Instruction N0. 650 of the IATA Dangerous Goods Regulations.

Diagnostic specimens and biological products expected to contain pathogens in Risk Groups 2 and 3 and where a low probability exists that pathogens of Risk Group 4 are present shall be transported in packages complying with Packing Instruction No. 602 of the IATA Dangerous Goods Regulations.

All materials containing GMOs but are unlikely to be infectious for animals or humans shall be packaged according to Packing Instructions No. 913 of the IATA Dangerous Goods Regulations.

All materials thought to be infectious for humans or animals or contain GMOs likely to be infectious for humans or animals shall be transported in packages complying with Packing Instruction No. 602 of the IATA Dangerous Goods Regulations.

A Shipper’s Declaration for Dangerous Goods shall be completed indicating origin, contents and date of dispatch and shall be attached to the external surface of the packaging. Documentation enclosed in a package shall be placed between the primary and secondary packages in a separate impervious bag to protect it from contamination by the contents of the package. Recipients shall be informed in advance of delivery of all known hazards associated with the contents of the package.

The transport and shipping of biological materials is complicated and carries severe penalties for breaches of the regulations. A person should be trained in the policies, regulations and procedures and should be made responsible for all shipping and transport of biological materials. Alternatively there are private companies who can perform this task and will take responsibility for compliance with the regulations.

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Transport of GMOs Transport includes all movement of GMOs outside a facility for whatever reason. The OGTR provides guidelines for the transport of GMOs depending on the nature of the

GMO and its level of risk. The document “Guidelines for the Transport of GMOs 2007” should be consulted for all relevant information.

The School must ensure that the person(s) transporting the GMOs are made aware of the conditions for transportation.

The transportation of GMOs must meet the following conditions.o The GMOs must be wholly contained within a primary sealed container (plastic

tube with cap, Petri dish sealed with plastic film etc).o The primary container must be packed in a secondary sealed, unbreakable

container (Tupperware).o The secondary container must be labelled with the identity of the GMOs and

telephone number of the person who can assume responsibility for them in case of an emergency.

o Records must be kept that account for the sending and receiving of the containers.o The containers must be decontaminated after use.

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Working Alone in a LaboratoryStaff and students are not generally permitted to work alone in laboratories. Where there is no other reasonable alternative staff and students are permitted to work alone in strict accordance with the provisions of the Curtin’s Working in Isolation policy available at this site: http://healthandsafety.curtin.edu.au/policies.cfm

Staff and students must complete a risk assessment of the proposed work to be undertaken alone or isolation and submit it to their supervisor for approval prior to the commencement.

Staff and students working alone or in isolation must carry their staff or student identification and be able to produce on request, their approval from their supervisor or manager to work alone or in isolation.

There must be a means of communication available which will enable the student to call for help in the event of an emergency.

All individuals are required to notify Security (ext. 4444 or other relevant number for ex-metropolitan campuses) immediately prior to commencement and at the completion of the work or as otherwise required by the risk assessment undertaken.

Staff and students must be trained in emergency and safety procedures.

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Appendix A: Risk Groups of Micro-organisms

BacteriaScientific name Risk

GroupSpecial precautions

Acinetobacter spp. 2Aeromonas hydrophila 2Bacillus anthracisBacillus cereus

32

G, E, C

Bartonella henselae, quintana, vinsonii, elizabethiae, weisiiBartonella bacilliformis

2

3 G, E, CBordetella pertussis 2Borrelia spp. 2 EBrucella ovisBrucella spp.

23 G, E, C

Burkholderia pseudomalleiBurkholderia mallei

23

O, TG, E, C

Campylobacter coli, fetus, jejuni 2Chlamydia spp.Chlamydia psittaci (avian)

23 G, E, C

Clostridium botulinum 2 G, SClostridium tetani 2 VCorynebacterium diphtheriaeCorynebacterium renale, pseudotuberculosis

22

V

Coxiella burnetii (smears and serum samples)Coxiella burnetii (cultures and concentrates)

23

V, PG, E, C, V, P

Edwardsiella tarda 2Eikenella tarda 2Enterococcus spp. (Vancomycin-resistant strains) 2Erysipelothrix rhusiopathiae 2Escherichia coli (pathogenic strains)Escherichia coli VTEC strains (O157, O111)

22 G, T

Francisella tularensis type A 3 G, E, CFusobacterium spp. 2Gardnerella vaginalis 2Haemophilus influenzae, ducreyi 2Helicobacter pylori 2Klebsiella spp. 2Legionella spp. 2Leptospira interrogans 2 EListeria monocytogenesListeria spp.

22

P

Moraxella spp. 2In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone

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Scientific name Risk Group

Special precautions

Mycobacterium spp.Mycobacterium tuberculosis complexMycobacterium tuberculosis multi-drug resistant

223

C, GC, G, V

C, E, G, V, TMycoplasma pneumoniae, fermentans 2Neisseria gonorrhoeaeNeisseria meningitidis (except serogroup B)Neisseria meningitidis (serogroup B)

222

V, CC, E, G

Nocardia spp. 2Pasteurella spp. 2Rickettsia spp. 3 C, E, GSalmonella serovarsSalmonella typhi

22 G, V

Shigella spp.Shigella dysenteriae type 1

22 G

Staphylococcus aureus 2Streptobacillus moniliformis 2Streptococcus pyogenes, pneumoniae 2Treponema pallidum, pertenue 2 G, EUreaplasma ureolyticum 2Vibrio cholerae, parahaemolyticus, vulnificus 2Yersinia spp.Yersinia pestis

23 C, E, G

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Parasites – Infective stages onlyScientific name Risk

GroupSpecial Precautions

Ancylostoma duodenale 2Ascaris lumbricoides 2 G, CBabesia divergens, microti 2Cryptosporidium spp. 2 GEchinococcus spp. 2 GEntamoeba histolytica 2 GGiardia lamblia 2Hymenolepsis diminuta, nana 2 GLeishmania spp. 2 GLoa loa 2Nagleria fowleri 2 G, CNecator americanus 2Plasmodium spp. 2Strongyloides stercoralis 2 GTaenia saginata, solium 2 GToxocara canis 2 GToxoplasma gondii 2 XTrichinella spiralis 2 GTrypanosoma brucei, cruzi 2 C, GWuchereria bancrofti 2

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FungiScientific name Risk

GroupSpecial Precautions

Aspergillus fumigatus, flavus 2 CBlastomyces dermatitidis 3 C, E, GCandida albicans 2Coccidioides immitis 3 C, E, GCryptococcus neoformans 2Epidermophyton floccosum 2Histoplasma spp. 3 C, E, GMicrosporum spp. 2Paracoccidioides brasiliensis 3 C, E, GPhytophthera cinnamoni 3 C, E, GSporothrix schenckii 2 GTrichophyton spp. 2

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Viruses and PrionsScientific name Risk

GroupSpecial

PrecautionsAdenoviridae

Adenovirus 2Arenaviridae

Arenaviruso Guanaritoo Junino Lassao Lymphocytic choriomeningitis (LCM)o LCM neurotropic strainso Machupoo Mopeia viruses

Sabia

44423444

Bunyaviridae Group Co Oropoucheo Phleboviruso Hantaviruso Hantaan and related viruses Nairoviruso Crimean-Congo hemorrhagic fever

Hazara

33

3

44

A

Caliciviridae Feline calicivirus Norwalk-like Sapporo-like Largoviruso Rabbit haemorrhagic disease

222

2Coronaviridae

Coronavirus 2Filoviridae

Ebola Marburg

44

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Scientific name Risk Group

Special Precautions

Flaviviridae Flaviviruso Absettarovo Central European encephalitiso Dengue 1, 2, 3, 4o Japanese encephalitis (Nakayama)o Japanese encephalitiso Hanzalovao Hypro Kumlingeo Kunjino Kyasanur Forest diseaseo Murray Valley encephalitiso Omsk hemorrhagic fevero Russian spring summer encephalitiso St Louis encephalitiso Tick-borne viruseso Tick-borne encephalitiso West Nileo Yellow fever (17D) Hepaciviruso Hepatitis C

442234442424433432

2

VV

V

G

Hepadnaviridaeo Dick hepatitis B

Hepatitis B22 GV

Herpesviridae Alpaherpesvirinaeo Herpes virus simiae (B virus)o Simplexo Varicella Betaherpesvirinaeo Cytomegalovirus Gammaherpesvirinaeo Herpes 6, 7

Lymphocryptovirus

422

2

22

EE, V

X

Orthomyxoviridae Influenza 2 V

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone55

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Scientific name Risk Group

Special Precautions

Paramyxoviridae Paramyxovirinaeo Henipavirus

HendraNipah

o MorbillivirusMeasles

o RubulavirusMapueraMenangleMumpsNewcastle disease (non-virulent)Newcastle disease (exotic strains)

o PneumovirusRespiratory syncytial virus

o RespirovirusParainfluenza 1, 2, 3, 4

44

2

32223

2

2

V

Parvoviridae Human parvovirus 2 X

Picornaviridae Encephalomyocarditis virus Enteroviruso Coxsackieo Echoo Enteroo Parechoo Polio 1, 2, 3 Rhinovirus Hepatoviruso Hepatitis A

2

222222

2

V

Poxviridae Orthopoxviruso Vaccinia Parapoxviruso Orf

2

2

V

Prions Gerstmann-Straussler syndrome Kuru Creutzfeldt-Jakob

222

C, GC, G

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Reoviridae Orbiviruso Bluetongue viruses Rotaviruso Rotavirus

2

2Retroviridae (clinical samples)

Oncovirinaeo Human lymphotropic virus 1o Human lymphotropic virus 2 Lentivirinaeo Human immunodeficiency virus

Retroviridae (cultures and concentrates) Oncovirinaeo Human lymphotropic virus 1o Human lymphotropic virus 2 Lentivirinaeo Human immunodeficiency virus

22

2

33

3

G, EG, E

G, E

G, EG, E

G, E

Rhabdoviridae Lyssaviruso Australian bat lyssavirus

Rabies fixed strain (CVS II)33

VV

Togaviridae Alphaviruso Eastern equine encephalitiso Marmah Foresto Ross Rivero Semliki Foresto Western equine encephalitiso Venezuelan equine encephalitis Arteriviruso Equine viral arteritis Rubiviruso Rubella

322233

2

2

V

V, X

Unclassified Hepatitis D Hepatitis E

22 P

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Codes for special precautionsCode Description of Special PrecautionA Animal inoculation performed under Risk Group 4 requirementsC Use a biological safety cabinet to contain aerosols.E Use eye protection.G Use gloves.O Do not sniff colonies for odor.P Dangerous to pregnant women.S Treat spills with 0.1% Na hypochlorite or 0.1N Na hydroxide to

inactivate toxin.T Only staff with appropriate experience and training.V Vaccine available.X May be teratogenic.

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Appendix B: Reporting Procedures for Spills, Accidents and InjuryIt is important that all accidents/incidents, near-misses and hazards are reported and recorded so that:

Investigations (where appropriate) can be performed, and action taken to prevent a recurrence of the incident.

Trend analyses of the collected information can be performed, allowing the organisation to focus preventative efforts on areas of most concern.

A formal record is kept for the University and student, should it be required at a later date as evidence that the event took place.

Legal requirements connected with reporting of injury and worker’s compensation are adhered to.

What should be reported? All injuries (events that cause an illness or injury requiring medical attention). All incidents (events that cause a minor injury of a first aid nature). All near-misses (events that do not cause injury but have the potential to do so). All hazards (anything that has the potential to cause ill health or injury).

Who should report the accident/incident, near miss or hazard? The injured person, or person(s) involved in the near miss or identifying the hazard.

Supervisors and/or eye witness(es) may assist the injured person when appropriate or necessary.

When should the report be completed and submitted? As soon as is practicable after the incident or hazard is identified.

How can accidents, incidents, near-misses or hazards be reported? Complete details on Curtin’s Health and Safety website You will be kept informed of the progress of your report and any feedback via email.

In Case of Emergency: Dial “5” on internal phone or “9266 4444” on mobile phone59


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