a guide to biological risk management

A GUIDE TO BIOLOGICAL RISK MANAGEMENT

Hardcop ies o f th is document are cons idered uncont ro l l ed . P lease re fe r to the Heal t h & Safe t y in ternet s i te fo r la tes t vers ion .

Source: Manager, Health & Safety Created: April 2012 Document No: 115 Revised: February 2013 Version No: 2

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Contents

Introduction………………………………………………………………………………..….3

Risk management process…………………………………………………………………4

Completing your risk assessment………………………………………………………..4

Safe Working Procedures…………………………………………………………………..6

Risk Groups…………………………………………………………………………………...7

Biosafety Levels……………………………..…………………………………………….…8

The role of the Chief investigator and Researcher…………………………………..…9

General safety in PC1 and general laboratories…………………….………………….10

Work practices to be followed in PC2 laboratories…………………………………….11

Work practices in PC1 and general animal facilities……………………………….….12

Disinfectants……………………………………………………………………………….….12

Biological Spills and Clean up procedures………………………………………………13

Further reading………………………………………………………………………………..15

A GUIDE TO BIOLOGICAL RISK MANAGEMENT



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Introduction

Despite the advancement in technology such as Biological Safety Cabinets, and Personal Protective Equipment, laboratory/animal acquired infections can still occur. A large percentage of laboratory acquired infections are believed to come from aerosol inhalation (Source: AS/NZ 2243:3:10)

This guide supports the University’s Biosafety Workshop and induction training and provides guidance in completing the University Biohazard risk assessment form which can be found at:

http://www.hr.mq.edu.au/HealthAndSafety/PoliciesFormsGuidelines/OHSOperationalInstruction.html

When working in laboratories researchers should make themselves aware of the contents of the Australian Standard AS 2243 – Safety in laboratories. The Standard (Parts 1-10) relates to safety in

laboratories. AS 2243 Part 3 – ‘Microbiological Safety and Containment’ is particularly relevant to

microbiological risk. The safe systems and risk management approach at Macquarie University reflect this standard and other global best practice. The Standard can be accessed via the library online portal. This standard will assist you in completing Biohazard risk assessments. It is important to follow the policies and procedures which have been put in place by the university to ensure your safety and health.

If you have any questions please contact your supervisor or laboratory manager.

You can also contact:-

The University Biosafety Officer: Elsa Mardones

Email: [email protected]

In addition the university has a Health and Safety unit for advice and guidance

Email: [email protected]

http://www.hr.mq.edu.au/HealthAndSafety/PoliciesFormsGuidelines/OHSOperationalInstruction.html

mailto:[email protected]




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The Risk Management Process

The University has two committees to ensure the safety of investigators and others who are working with biological materials. It is important to submit your risk assessments to the relevant committee. This will prevent unnecessary delay in getting your research started.

Completing your risk assessment

According to the World Health Organisation a Biohazard is an infectious agent, or part thereof, that presents a real or potential risk to the well-being of man, animals or plants. It can occur directly through infection or indirectly through the disruption of the environment.

In terms of biological risk this is described as the probability or chance that a particular adverse event, possibly leading to harm will occur.

Does Your Work Involve Biological Material?

YES NO

No requirement to submit Biological risk

assessment. Safe working procedures

managed by Academic Supervisors/Chief

Investigators

Is this work subject to Office of Gene Technology Regulations?

YES NO

Risk Assessment submitted to

Institutional Biosafety Committee

at: - [email protected]

Risk Assessment submitted to

Biohazard Committee at:-

[email protected]

Complete Biohazard GMO

Risk Assessment & Application

Complete Biohazard NON-GMO

Risk Assessment



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Any research, teaching or operational work with biohazards must only be done following a risk assessment.

The questions on the university risk assessment forms are necessary to give the committees enough information to decide if the work can be carried out as safely as is reasonably practicable.The form also covers legal compliance and best practice. The following section explains what to include against each question on the risk assessment form.

Chief Investigator

The chief investigator is the researcher leading the project. The chief investigator has a responsibility for the safety and health of anyone who may be affected by the research.

Additional approval required

The university requires certain approvals to be granted prior to work being carried out.Examples of approval may include animal or human ethics approval or in the Faculty of Science approval by the Fieldwork manager before fieldwork can take place .

Animal Ethics Human Ethics Fieldwork Manager Other (state)______

Title Research

In a few words the Investigator will describe the research. For example, Oxytocin levels in human saliva .

The Exact Location

The exact location of the research is important because it allows the committee to confirm the environment is suitable for biological materials e.g PC2 laboratories.

The Hierarchy of Contols

The risk assessment form follows a globally accepted risk management process known as ‘the hierarchy of controls’.

Eliminate risk Substitute the hazard Isolate the hazard Implement engineering controls

Administration PPE

The use of Personal Protective Equipment (PPE) should only be considered if other more acceptable levels of risk reduction are not possible, or for added protection and to support a combination of the more desired control measures.

If a hazard can be eliminated or the risk removed, then it should be. This will obviously depend upon the proposed work being undertaken but one example would be irradiation of the material prior to use.

Substituting a hazard for one with less risk is another option,for example substituting an organism for one of less risk (see risk groups below)

Isolating the biological hazard may include restricting access and engineering controls may include the use of a biological safety cabinet, microisolator cages for containing excreted biohazards; and bedding dump stations for containing contaminated bedding.



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Administrative controls includes safe working procedures,supervision, training and reading guidance material such as safety data sheets (SDS).

Safe Working Procedures

Once you have completed your risk assessment it may be necessary to reduce the risk by following Safe Work Procedures (SWP). The SWP is intended to give a person sufficient information and instruction to perform a task as safely as possible.

Safe Working Procedures are specific to the process and are not general instructions on how to operate machinery,for example detailing how to turn equipment on may not impact on safety but it may include how to turn it off in an emergency.

If the risk assessment has identified the need to complete a safe Work Procedure then this will be submitted for approval with the risk assessment. Blank forms can be found on the WHS webpage under General forms – Standard Safe Work Method Statement Template:-

http://staff.mq.edu.au/human_resources/health_and_safety/policies-procedures-guidelines_forms/

If you refer to Safety Data Sheets or Safe Working Procedures it is your responsibility to follow the directions contained within them. They must be readily available during your work and approved by the manager, Health and Safety.

The Safe Working Procedure should be included with your submission unless a link can be included for the committee to readily view it.

Type of Biological Material

In order to control the risks you need to identify the hazards which create them.

A hazard is anything that has the potential to cause harm. In terms of biological risk the potential to cause harm comes from material and substances such as:-

Bacteria Fungi Virus Cell Line Tissue Parasite Animal Plant Soil

Toxin Prions Nucleic Acid other _______________

This information gives the committee important information about the details of the material and associated risks. Once you have identified the materials you should consider how they may cause harm. The name of the biological agent is also required.

Personal Protective Equipment

Gloves Eye protection Clothing Footwear Respiratory Protection Other

Personal Protective Equipment must be appropriate for the individual wearing it. It is important to be specific e.g. if there is a risk of splashing to the eyes then goggles or wrap around glasses should be worn and these should be noted on the form. AS 2243:3:2010 (10.2.5) contains a table of recommended Respiratory Protective Equipment (RPE)



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If a project is being repeated one risk assessment will cover the other projects. There is no need to complete separate risk assessments for multiple repeats of the same project if biohazard risk, location, controls or processes have not changed. You must review the existing assessment prior to starting a new project and revisit the assessment if circumstances change.

Q. What are the risk groups?

The following risk groups are contained in the AS/NZ standard 2243:3:2010 and are based on:-

Pathogenicity of the agent,

Mode of transmission and host range of the agent

Availability of effective preventative measures

Availability of effective treatment

Human and Animal

Group 1- Low Individual and community risk - microorganism that is unlikely to cause human, or animal disease.

Group 2- Moderate individual risk, limited community risk – microorganism that is unlikely to be a significant risk to laboratory workers, the community, livestock, or the environment, laboratory exposures may cause infection but effective treatment and preventative measures are available and the risk of spread is limited.

Group 3- High individual risk, limited to moderate community risk – microorganism that usually causes serious human or animal disease and may present a significant risk to laboratory workers. It could present a limited to moderate risk if spread in the community or the environment, but there are usually effective preventative measures or treatment available.

Group 4- High individual and community risk - microorganism that usually produces life threatening human or animal disease, represents a significant risk to laboratory workers and may be readily transmissible from one individual to another. Effective treatment and preventative measures are not usually available.

The risk assessment form contains an explanation against each risk group. This is taken from the Australian Standard in relation to human and animal infectious microorganisms and is given as an example. It is important to remember that biohazards do not just come from microorganisms and it is acceptable to change ‘microorganisms’ for ‘organisms’ or ‘substances’ or other description of the biohazard.

Where there is doubt the chief investigator should contact the biohazard committee for direction.

If you are observing animals from a distance and are not handling them, you may be exempt from submitting a Biohazard risk assessment. Contact the Biohazard Committee for advice.

[email protected]

In addition to human and animal infectious microorganisms there are risk groups containing similar descriptions for plant and invertebrates. Refer to Section 6 AS/NZ 2243:3:2010 for further details.




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Biosafety levels

The biosafety level relates directly to the risk group and the level of containment necessary to control the risks i.e. Risk Group 2 will require Biosafety Level 2. (BSL)

The BSL 2 is often known as the Physical Containment level or PC. The containment level or BSL will generally be classified as the corresponding risk group (Risk Group 2 = BSL 2 = PC2)

If the research is to be performed in a general laboratory not classified as PC1 or above this must be noted in the column headed ‘Biosafety Level’. Ensure the room and building number is included in the location.

Processes and equipment to be used

It is important that you include enough information to satisfy the Committee that the work is being carried out safely. To prevent approval being delayed include

Brief description of work,

Control measures including how aerosols will be controlled,

Storage and transport of samples,

Clean up and spill procedures,

Disinfectant and waste disposal.

Emergency procedures.

Laboratory work containing hazardous microorganisms which are transmissible through the respiratory route should be conducted in a Biological Safety Cabinet and when cleaning up a spill or animal cages respiratory protection should be worn.

An extensive table containing recommended applications for chemical disinfectants in microbiological laboratories is contained in the 2243:3.

Please note that after you have received comments from the Biohazard Committee you have

one month to respond. If you do not respond within this time frame then the Committee will

assume that you do not wish to proceed with the research.



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The Chief Investigator must ensure;

Investigators have read risk assessments and a copy is available before work starts.

Investigators have received sufficient training and/or supervision to allow them to work and handle biological agents and materials in a safe manner.

Faulty equipment is reported and removed from service where a danger exists.

Safe Working Procedures are followed and regularly reviewed.

Safety rules are followed.

Emergency equipment is serviced.

The physical containment level is appropriate for the risk group.

Incidents, accidents and near miss occurrences are reported to the health and safety unit and sufficiently investigated.

Regular compliance checks and safety tours are carried out and any findings are documented.

Familiarise themselves with the AS/NZ standards (see further reading)

Researchers must;

Read the relevant risk assessment and relevant guidance material.

Follow any Safe Work Procedures and guidelines.

Report any faulty equipment.

Attend required training.

Speak to a supervisor or laboratory manager about any safety concerns.

Comply with the safety rules and guidelines contained in this and other literature.



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General Safety in PC1 and general laboratories

This section contains information on current procedures based on the AS/NZ 2243 standard. Human error, poor management systems and inadequate risk assessments all contribute to the risk of harm from biohazards. Following the safety rules outlined below can reduce the risk of harm and assist in completing the risk assessment.

1. Do not commence work unless the potential hazards have been identified and control

measures are in place.

2. Enclosed footwear with appropriate grip must be worn.

3. No food and drink for human consumption is allowed in the laboratory (including chewing

gum).

4. Personal Protective Equipment (PPE) and devices must be appropriate to the operation being

carried out. Not all gloves afford the same level of protection. PPE must fit correctly.

5. Secure long hair, don’t apply cosmetics, handle contact lenses or wear jewellery that can be

tangled in equipment or be contaminated.

6. Consider all chemicals and microorganisms to be hazardous unless there is definite

information that they are not hazardous.

7. Notify your supervisor if you have any medical condition that may cause life threatening or

dangerous situations.

8. Use safety carriers for chemicals in glass or plastic containers with 2L or greater capacity

(trolleys with a safety rail should be used for heavier items or when transferring from

buildings)

9. Storage of chemical containers exceeding 10L must not be stored in the laboratory overnight.

10. Don’t carry mutually reactive substances together – use enclosed containers or secondary

containment when carrying materials.

11. Keep only minimum quantities of chemicals in the laboratory work area.

12. Wash skin area that comes into contact with biohazards or chemicals immediately.

13. Immediately wash hands before leaving laboratory.

14. Immediately clean spills – dispose of spill safely and without risk to others.

15. Keep fire escape routes clear from obstructions.

16. Label all safety equipment and maintain it in good condition. Clean and inspect equipment in

accordance with manufacturer’s instructions.

17. Mouth pipetting of any substance is prohibited

18. Remove gloves after handling bio-hazardous material to prevent cross contamination to

equipment, door handles etc.

19. Segregate waste (general, biological etc.)

20. Dispose of sharps in appropriately constructed sharp containers. Never recap a sharp.



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Work Practices to be followed in PC2 laboratories

In addition to the laboratory safety rules described above the following work procedures must be followed.

1. Laboratory access will be to ‘authorised personnel’ only. 2. Close the laboratory doors after entering. Do not wedge/hold open doors. 3. Follow the training and instruction you have received from the university.

4. PPE will comply with AS/NZ 2243:1 and gloves will be removed after handling infectious

materials, hands will be washed and gloves discarded with infectious laboratory waste. Laboratory coats will be worn. (Lab coats which protect the front of the body should be worn). Gloves should be worn when handling blood and bodily fluids or liquids within risk group 2.

5. Aerosols must be controlled to minimise their production especially on open benches. Where

there is a risk of aerosol dispersal or a respiratory risk a biological safety cabinet (BSC)

should be used. Allow sufficient time for the aerosol to settle before opening the containers in

a BSC. All work with risk group II organisms must be carried out in a class II BSC.

6. Centrifuge should not be opened after a run until sufficient time has elapsed to allow aerosols

to settle. (Alternatively use a centrifuge lid that is aerosol tight and open in BSCII)

7. Any containers containing clinical or diagnostic specimens that are leaking must be placed in

a biological safety cabinet and the exterior of the container decontaminated.

8. When transporting any container with potentially viable organisms outside the laboratory it

must be in a second unbreakable and closed container.

9. When disinfecting pipettes, they must be placed upright, tip first and fully immersed in the

chemical solution.

10. The dissemination of Microbiological materials should be kept to a minimum when using a

flaming loop by drawing it from the cooler to the hottest parts of the Bunsen burner flame or

use a hooded or electric Bunsen burner.

11. Cultures should be clearly identified dated and should not remain on open benches longer

than is necessary.

12. Cover fungi producing spore cultures to prevent dispersal. Be aware that diagnostic kits,

controlled sera and products manufactured from microbiological sources may still contain

infectious microorganisms.

13. Communal used items and furniture such as doors, cupboards, telephones and keyboards

must be regularly cleaned and sanitised.

14. Work benches should be cleaned after use.

15. Clean waste and spillage according to any safe working procedures or training.

16. Take off laboratory coats before leaving the laboratory.

17. Make sure you warn others of microbiological hazards especially contractors and

maintenance personnel. Sanitise equipment before any service/maintenance work.

18. Wash hands at nearest exits before leaving the PC2 laboratory.

Note: Refer to 2243:3:2010 Section 6 for Animal Containment Facilities and Operational guideline – Working with research animals:-

http://www.research.mq.edu.au/__data/assets/pdf_file/0019/195202/WorkingWithResearchAnimals.pdf

http://www.research.mq.edu.au/__data/assets/pdf_file/0019/195202/WorkingWithResearchAnimals.pdf



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Work Practices in PC1 and general animal facilities will include:

1. Access to the facility shall be restricted to authorised personnel. 2. The facilities must be locked and secure when not being directly supervised. 3. Checks must be made of the perimeter fencing every 3 months or after storms and high

winds for signs of damage. 4. Food and water provided for the animals will be subject to regular inspections. 5. Suitable controls will be in place to prevent animals from escaping and doors will be kept

closed when any experiments with animals is taking place. 6. Appropriate PPE will be worn when working with animals and personal clothing will be

covered with overalls or a lab coat or gown. Enclosed footwear will be worn. Further details can be found in AS 2243:3:2010 6.4.3 (f)

7. Workers will be trained in animal handling techniques. 8. Workers will be competent in inoculation procedures. 9. Spillage containers and containers will be used for instruments. Safe Working procedures

will be followed to avoid cuts from sharp instruments. 10. PPE will be removed and hands decontaminated before leaving the animal facility. 11. Drinking, smoking and eating in the facility are prohibited. Where human pathogens are

not present and there is a risk to workers from dehydration drinking facilities may be provided but only after approval from the biosafety committee following a risk assessment.

12. Waste will be segregated as per the university waste policy. 13. All incidents, injuries and illness should be reported to your supervisor and online

https://safety.mq.edu.au/eventmanager/incidents/reportincident.aspx.

A full list of requirements for PC2 PC3 PC4 can be found in Section 6 AS2243:32010

Disinfectants (refer to - AS/NZ 2243:3:2010)

Benches and surfaces not obviously contaminated: wiped with 70% w/w (=80% v/v) ethyl or 60-70% v/v isopropyl after completion of experiment.

Spills of blood (or viral cultures) and bacterial cultures can be disinfected with a high concentration of chlorine at 5000-10000ppm (0.5 – 1%) with 10 minutes contact time.

Waste must be disposed of safely and in accordance with university policy and procedure.

Biological Safety cabinet working surfaces: 70% w/w (=80% v/v) ethyl –swabbed or high concentration chlorine disinfectant at 5000-10000 p.p.m (0.5 – 1%) or other disinfectant depending on the organism (see Appendix’ F’ AS/NZS2243:3:2010).

https://safety.mq.edu.au/eventmanager/incidents/reportincident.aspx



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Biological Spills and Clean up procedures

This section details steps to take in the event of a spill which can produce hazardous aerosols or other risk to human health and safety. The level of compliance with these steps will depend upon the material and identified risk. It is intended to be a guide only. The Chief Investigator will ensure workers have the necessary level of training and information to deal with a spill.

The Chief Investigator will identify as part of the risk assessment process the level of equipment required to contain and clean a biological spill. This will include a suitable and sufficiently stocked biological spill kit. If the kit is not suitable steps must be taken to ensure one is present before work starts.

Appropriate Personal Protective Equipment must be worn when cleaning spills as identified in the risk assessment and with reference to any available technical or safety data. Care should be taken not to generate aerosols and if there is a risk of hazardous aerosols respiratory protective equipment (RPE) may be required. Spill kits should include absorbent material appropriate to contain the spill and reduce aerosols.

All biological spills must be attended to immediately. The approach you take will depend on the risk group of the biological material, the volume and location of the spill.

Small spill of Risk group 1 or 2 material outside of Biological Safety cabinet (< 100mls)

1. Put on appropriate PPE. 2. Contain the spill do not spread it, wipe material towards the centre. 3. Remove any sharp objects with forceps. 4. Cover the biological spill with absorbent material such as paper towels. 5. Dispose of contaminated paper towels in the biological waste bin. 6. Cover area with suitable disinfectant and leave for the appropriate contact time. 7. Autoclave or disinfect any equipment used in the clean- up. 8. Do not autoclave anything that has been in contact with chlorine as this will produce chlorine

gas when heated. 9. Remove and decontaminate any PPE (including lab coats) according to laboratory protocols

Large spill of Risk group 1 material outside of a Biological safety cabinet (> 100 mls)

1. Get help if required. 2. Clean up procedure is the same as for small risk group 1 spills only on a larger scale. 3. Notify the lab manager or supervisor that there has been a spill

Large spill of Risk group 2 material outside of a Biological safety cabinet ( >100mls)

1. Get Help. 2. Contact the PC2 lab manager immediately. 3. Keep people out of the area 4. If the spill is potentially infectious the area must be vacated for 30 minutes to allow aerosols to

settle before the clean- up procedure can commence. 5. Follow the instructions inside the Biohazard Spill kit. 6. Remove and decontaminate any PPE (including lab coats) according to laboratory protocols. 7. Report the incident to the lab manager and the University Health & Safety unit.



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Spill in a Biological Safety Cabinet

1. Ensure that the cabinet is on and continues to operate during the clean-up procedure 2. Put on PPE 3. Remove any sharp objects with forceps 4. Cover the spill with absorbent material and dispose of in the biological waste bin 5. All surfaces must be decontaminated. Cover the affected area with suitable disinfectant

and leave for the appropriate contact time. 6. Ensure that the surfaces below the work area are also treated. 7. Remove and decontaminate any PPE (including lab coats) according to laboratory protocols. 8. Report incident.

Risk group 1: Lab manager or supervisor

Risk group 2: Lab manager and the University Health & Safety unit

Spill in a centrifuge

A biological spill in a centrifuge has the potential for creating aerosols. As soon as the operator becomes aware of a spill immediate action is required.

1. Turn off centrifuge. 2. If hazardous or infectious aerosols have been generated then close the centrifuge. 3. Notify others working in the area of the potential hazard. 4. Allow 30 minutes settling time before clean up procedures commence. 5. Put on PPE. 6. Remove debris. 7. Place contaminated equipment in leak proof bag and if possible transfer to Biological Safety

cabinet for disinfection 8. Disinfect inside of centrifuge 9. Remove and decontaminate any PPE (including lab coats) according to laboratory protocols. 10. Report spill.

Risk group 1: Lab manager or supervisor

Risk group 2: Lab manager and the University Health & Safety unit



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Further reading

AS/NZ 2243:1:2005 – Safety in laboratories: Planning and operational aspects.

AS/NZ 2243:3:2010 – Safety in laboratories: Microbiological safety and containment.

Laboratory Biosafety Manual – third edition (download link below)

www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf

Australian Guidelines for the Prevention and Control of Infection in Healthcare (2010)

http://www.nhmrc.gov.au/node/30290

Website information

Genetically Modified Organisms

www.ogtr.gov.au

Macquarie University Health and Safety

http://www.hr.mq.edu.au/HealthAndSafety.html

http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf

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

http://www.hr.mq.edu.au/HealthAndSafety.html

a guide to biological risk management

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