Procedures

Working with Potentially Hazardous Biologicals - Procedures

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1. Purpose and Objectives

This procedure outlines the actions required to apply for permission to work with potentially hazardous biological organisms or their products at The University of Queensland. The procedure is to be read in conjunction with the PPL 2.40.01 Biosafety Policy, and other relevant procedures and requirements in place within Schools and Institutes at The University of Queensland.

2. Definitions, Terms, Acronyms

ABSA – American Biological Safety Association

DSGL – Defence Strategic Goods List, identified in Regulation 13E of the Customs (Prohibited Exports) Regulations 1958 (C’th)

High Risk Biological Material – Also known as potentially hazardous biological material as explained in section 5.1.

LD50 - Individual dose required to kill 50 percent of a population.

OGTR – Office of the Gene Technology Regulator

PC1, PC2, PC3 certified facilities – Physical Containment facilities certified by the OGTR.

PC1, PC2, PC3 Biological Hazard facilities - Physical Containment facilities for infectious microorganisms as described in AS/NZ 2243.3 2010. Sometimes refered to as BSL (Biosafety Laboratories).

PSDS - Pathogen safety data sheet

Risk Group 1-4 – Infectious micro-organisms as defined in AS2243.3 2010, Risk Group 1 being the lowest risk and Risk Group 4 being the highest risk.

SDS - Safety data sheet (formerly MSDS)

SOP - Safe operating procedure

SSBA – Security Sensitive Biological Agents, as defined by the National Security Act 2007 (C'th) and controlled under the SSBA Regulatory Scheme

Workers – Workers include staff, students (undergraduate and postgraduate), visitors and contractors.

UQ IBC - The University of Queensland Institutional Biosafety Committee

UQ IBSC - The University of Queensland Institutional Biosafety Subcommittee

3. Procedures Scope/Coverage

These procedures apply to all staff, students, visitors and contractors who are intending to work with potentially hazardous biological material as defined in this document.

4. Procedures Statement

Hazardous biological material has the potential to cause harm to the environment and/or persons if not correctly contained and handled during research activities. This includes organisms that can cause harm to plants, animals or humans. Any researcher who is intending to work with high risk biological material in any premises owned or controlled by The University of Queensland requires the written permission of The University of Queensland Institutional Biosafety Sub-Committee prior to the commencement of this work.

5. Identifying Hazardous Biological Material

It is important to determine whether the organism or product of an organism on which the work is to be performed is classified as potentially hazardous biological material. There are several sources of information that can assist in determining whether or not, the organism or product falls into this category as explained below. Potentially hazardous biological material may also be referred to as high risk biologicals.

5.1 Potentially hazardous biological material (including animals)

The following classes and types of organisms and biological material may be considered as hazardous:

  • Risk Group 2 microorganisms* cultured in large volumes (10L or greater);
  • Risk Group 2 microorganisms which require special precautions;*
  • Risk Group 3 or 4 microorganisms;*
  • Infectious/potentially infectious animals, tissues or fluids (involving microorganisms of the categories mentioned above);
  • Unscreened Specimens (i.e. human tissue or body fluids that are known to contain microorganisms listed above, or have not been screened for infectious disease; animal tissue or body fluids that could contain zoonoses or have not been screened for such);
  • Poisonous or venomous animals (e.g. snakes, spiders, cone-shells);
  • Biological toxins (excluding toxoids)
  • Biological material on the Defence Strategic Goods List (DSGL)
  • Security sensitive biological material (SSBAs)

*As listed in AS/NZS 2243.3 2010, Section 3 or any microorganism categorized as Dangerous Goods Class 6.2 (Infectious Substances) or those falling under UN2814 & UN2900 in the Dangerous Goods Regulations (IATA). 

Note: there may be other potential high risk biologicals not stated in the list above. If you are not sure, please contact UQ Biosafety.

5.1.1 Defence Strategic Goods List (DSGL) and Security Sensitive Biological Agents (SSBAs)

Any material identified on the Defence Strategic Goods List and/or as Security Sensitive Biological Agents, require extra requirements such as upgraded security and police background checks.

The DSGL is identified in Regulation 13E of the Customs (Prohibited Exports) Regulations 1958 (C’th). Goods included in the DSGL may not be exported from Australia unless a licence or permission has been granted by the Minister for Defence, or an authorised person, and that licence or permission is produced to a Collector of Customs before exportation. This includes some biological materials and toxins.

SSBAs are biological agents such as viruses, bacteria, fungi and toxins that if they were deliberately released, would have the potential to cause significant damage to human health, the environment and the Australian economy. SSBAs are regulated under the National Health Security Act 2007 (C’th) by the SSBA Regulatory Scheme. You should consult the current list of SSBAs to determine if your material is included.

The process of obtaining permission to work with such material may take a considerable time to process. Please contact UQ Biosafety if you intend to work with such materials.

5.1.2 Sources of information on hazardous biological material

The following can be used to source information on the potential risk group and hazard level of potential hazardous biological organisms:

  • AS/NZ 2243.3:2010 Section 3, Degree of hazard from microorganisms. Available from SAI Global via the UQ Library website, you must use your UQ username to gain access.
  • American Biological Safety Association (ABSA) Risk Group Classification for Infectious Agents and Risk Group Database
  • Public Health Agency of Canada - Pathogen Safety Data Sheets (PSDS) and Risk Assessments.
  • Contact a UQ Biosafety Advisor at UQ OHS Division.

6. Process for Applying for Permission to Work with Hazardous Biological Material

6.1 Proposal to work with potentially hazardous biologicals

The Biosafety proposal for work involving "Potentially Hazardous Biological Material" form is available online. The form must be accompanied by a relevant risk assessment, and submitted to a UQ Biosafety Advisor at least two weeks prior to the next UQ IBC Sub-committee meeting (dates available on IBC website) so that the work can be assessed and brought to the UQ IBSC for final decision.

The following sections will assist you in filling out the form.

6.1.1 Title of project

A brief title outlining what the research project is examining.

6.1.2 Supervisor

This is the person who will assume control of the project and is responsible for the safety of the group working on it. In the case of the application covering a class or series of classes this person should be the subject convenor. This will be the primary contact person for the application.

Please ensure that all contact details are correct and current and that the date of their biosafety training is included.

6.1.3 Other key staff

Please include the details of staff, students, visitors and contractors who will be working on the project. If this application covers an undergraduate class or series of undergraduate classes, please include the names of the demonstrators, tutors and other academic staff members responsible for delivering the tuition. There is no need to include the students' names.

Please ensure that all contact details are correct and current and that the date of their biosafety training is included.

6.1.4 Aims of project

Provide a succinct description of the project. This does not require an in-depth detail but should give enough information so that the Biosafety Advisors and the IBC have a good understanding of what the project entails.

6.1.5 Main experimental procedures

Provide in depth information regarding the experimental procedures that will be undertaken. Examples of the information required include:

  • Names and Risk Groups of organism being use in the project.
  • Volume, concentration or numbers of organisms
  • If toxins, poisons or venom, stocks and dilutions concentrations, lethal does on vertebrates (LD50)
  • Applicable Safety Data Sheets (SDS)or access numbers
  • Storage conditions
  • Any storage special storage requirements (i.e. for toxins)
  • Any vaccinations that are required
  • Details of decontamination of waste products and unused biological material
  • SOPs or details of protocols, procedures (as attachments) of decontamination methods, disposal methods, emergency procedures etc.
  • Copies of relevant School or Institute forms that are required (travel checklists, safety checklists)

6.1.6 Facility requirements

If you intend to work with Risk Group 2 or 3 organisms, the work must be conducted in a Physical Containment Facility that meets the required conditions to contain material of the particular risk group. Physical Containment ranges from Level 1 to Level 4 (as defined by AS/NZS: 2243.3 2010). Risk Group 2 organisms require a minimum of a PC2 facility, Risk Group 3 organisms require a minimum of a PC3 facility and Risk Group 4 organisms require a PC4 facility.

As The University of Queensland does not have any PC4 facilities, work cannot be performed on Risk Group 4 organism without construction of such a facility. This would take a considerable time and money with lead time of greater than 24 months being required before work could commence.

Ensure that you have the correct facility certification before submitting a Biosafety proposal. You may check this with your local Safety Manager or Building Manager. If you intend to work with animals, insects, aquatic organisms or plants, containing any of the listed risk group pathogens, then specialist PC facilities will be required. If you are unsure of your facility or need to arrange for certification of your facility, then contact a UQ Biosafety Advisor.

Include location details, room numbers and if you have been given approval to use these facilities.

6.1.7 Risk assessments

Provide approved risk assessment/s of possible hazards associated with the work (e.g. biological, chemical, physical, field work), including emergency procedures, health surveillance and vaccination considerations if applicable. This can be a list of Task IDs obtained from the Risk Management Database.

If working on organisms that may have a negative impact on the health of the worker, then you must seek advice the UQ Occupational Health Nurse Advisor (OHNA) in the OHS Division and provide evidence of the advice given by the OHNA in this application.

6.1.8 Completion date

Please provide an expected completion date. If the application covers an ongoing project (i.e. teaching class), then insert a nominal end date of two years from the application. This will allow long term projects to be re-assessed on a regular basis.

Any substantial changes made to the experimental procedures (i.e. new biological material, increased dosages) must be approved by either the UQ Biosafety Advisors or the UQ IBSC before the work with the changes commences.

6.2 Training

It is the responsibility of the Project Supervisor to ensure the safety of person undertaking the experimental work and protection of the environment from harm from the biological material. Thorough and relevant training in all aspects of the research project involving hazardous biological material must be undertaken by the workers. This will include the workers undertaking the online UQ Biosafety training module which is available via UQ Blackboard as an OHS module.

As part of the application, you must provide training records of the workers involved in the project.

If requested by the UQ Biosafety Advisors, you must also produce the training packages, procedures, protocols or SOPs that you have developed and are in use.

6.3 Other requirements

6.3.1 Ethics

If your research project involves the use of animals or humans or products of humans or animals, ensure you have the appropriate approvals in place from either the Animal Ethics Committee or the Human Ethics Committee before you commence work. Please contact your ethics officer or research manager in your School/Institute for further advice.

6.3.2 Health surveillance

If your research project involves infectious material or animals that are contain or exudate toxins or venoms or harbor infectious agents (ie. bats), you may benefit from Health Surveillance. The Occupational Health Nurse Advisor will be able to provide advice on precautions that you may or must undertake before the work commences.

7. Contact for Additional Information

Biosafety Advisor
UQ OHS Division
Phone: 336-52365
Email: biosafety@uq.edu.au

Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael

Forms

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Potentially Hazardous Biological Material - Form

Potentially Hazardous Biological Material - Form

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Description: 

Use this form to seek permission from The University of Queensland Institutional Biosafety Sub-Committee to work with high risk biological material on any premises owned or controlled by The University of Queensland.

Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael
Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael
Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael