Biosafety and Biosecurity

Biosafety and Biosecurity

SUMMARY

The Biosafety and Biosecurity Policy establishes the safety framework for research and teaching involving microorganisms and biohazardous materials. Implementation of this policy will facilitates Macquarie University compliance with relevant legislation, promotes high-quality research and teaching, and minimises risks to human and animal health, and the environment.

POLICY

1     PURPOSE

The purpose of the Biosafety and Biosecurity Policy is to establish and maintain the safety framework for research and teaching involving microorganisms and biohazardous materials. The implementation of this policy will facilitate compliance with relevant legislation, promote high-quality research and teaching, and minimise risks to human and animal health, and the environment.

2     BACKGROUND

Macquarie University is dedicated to managing its biohazards in a responsible manner while maintaining its research, teaching and service missions. To this end, Macquarie University is committed to ensuring that individuals using microorganisms and other biohazardous materials are suitably trained and supervised.

All research at the University is governed by the Macquarie University Code for the Responsible Conduct of Research. Also applicable to all research, teaching and services involving microorganisms and biohazardous materials is the AS/NZS 2243.3:2010 Microbiological safety and containment standard. Further Acts, regulations and guidelines become applicable when dealings involve the use of GMOs, SSBAs or biological materials requiring quarantine containment. The list below highlights the legislation applicable to each of these dealings:

GMOsGene Technology Act 2000 and Gene Technology Regulations 2001
SSBAsNational Health Security Act 2007, National Health Security Regulations 2008 and the SSBA Regulatory Scheme
QuarantineQuarantine Act 1908*

*The Biosecurity Act 2015 will come into effect from 16th June, 2016 and will replace the Quarantine Act 1908. Until commencement of the new legislation, the Quarantine Act 1908 remains the primary piece of biosecurity legislation in Australia.

3     SCOPE

The policy covers research, teaching and services involving biohazards, GMOs, SSBAs and biological materials requiring quarantine containment. This policy applies to all persons (including Macquarie University employees, students, researchers, service providers, contract employees or any other persons) involved with the acquisition, handling, storage, removal or disposal of biohazardous materials on University premises.

4     DEFINITIONS

Commonly defined terms are located in the University Glossary. The following definitions apply for the purpose of this Policy:

Biohazard – Any organism or biologically derived infectious agent that is hazardous to humans or animals, or which may negatively impact the environment. Biohazardous material includes microorganisms, animals, blood, body fluids and tissues from humans and animals, cell cultures and human oncogenes.

GMO – Genetically modified organism (as defined in Part 2 of the Gene Technology Act 2000)

IBC – Institutional Biosafety Committee

Microorganism – An organism too small to be seen without the aid of a microscope e.g. virus, bacteria, protozoa, and some algae and fungi

NLRD – Notifiable Low Risk Dealing (as defined in the Gene Technology Regulations 2001)

OGTR – Office of the Gene Technology Regulator which acts under the Gene Technology Act 2000 and Gene Technology Regulations 2001

Risk group - a numerical classification of infectious microorganisms as defined in the AS/NZS 2243.3:2010

SSBA – Security sensitive biological agent

5     POLICY STATEMENT


ACCREDITATION

The University will:

  • Maintain OGTR accreditation
  • Maintain internal processes to effectively monitor work involving biohazards and GMOs at the University.
  • Maintain an appropriately constituted IBC that is provided with the resources required for institutional monitoring.

CERTIFICATION
The University will:

  • Ensure it maintains certification of OGTR and quarantine approved premises.
  • Inspect these facilities at least annually to ensure they remain compliant with current standards.
  • Restrict access to certified facilities to those persons who are inducted, adequately trained and have approval to enter.

INSTITUTIONAL BIOSAFETY COMMITTEE
The University will:

  • Maintain an IBC as required by legislation, with an agreed Terms of Reference and Procedures.
  • Ensure, through the IBC, that all research, teaching and services at the University that involve biohazards, GMOs, SSBAs and agents requiring quarantine containment are conducted in accordance with the relevant legislation, regulations, standards, guidelines and codes.
  • Provide the IBC with resources and powers to fulfil its Terms of Reference and operate as set out in the relevant legislation and guidelines.
  • Employ a Biosafety and Quarantine Officer to assist the IBC in monitoring and reporting.
  • Respond effectively to recommendations from the IBC to ensure that all biohazardous activity within the University remains in accordance with the relevant legislation, regulations, standards, guidelines and codes.

BIOSAFETY AWARENESS
The University will:

  • Conduct an institutional biosafety workshop at least annually for personnel involved in the acquisition, handling, storage, removal or disposal of biological materials on University premises to ensure that such personnel are aware of potential risks.
  • Ensure that any research, teaching or services using biological materials are only undertaken after a risk assessment has been performed and, if appropriate, has been approved by the IBC.

REVIEW AND REPORTING
The University will:

  • Require all persons involved in dealings with GMOs, using agents or animals containing agents classified as risk group 2 and above, SSBAs or agents requiring containment or approval under the Quarantine Act 1908, to submit research applications, risk assessments, teaching protocols, progress reports and final reports to the IBC.
  • Ensure dealings with GMOs, the use of agents classified as risk group 2 and above, SSBAs or agents requiring containment or approval under the Quarantine Act 1908, are not commenced without the prior approval of the IBC.
  • Ensure the IBC reviews all applications, risk assessments and reports so that they may assess the risks associated with the biological dealing being undertaken and ensure these risks have been adequately controlled.
  • Enable the IBC to conduct monitoring inspections, at least annually, of the University’s laboratories in which biohazards are handled to ensure compliance with the relevant legislation, regulations, standards, guidelines and codes.
  • Require the IBC to report annually to the DVC-R.
  • Require the IBC to report annually to the OGTR in accordance with the Guidelines for Accreditation of Organisations 2012 and the Explanatory Information on the Guidelines for Accreditation of Organisations v 1.4 issued by the OGTR.
  • Maintain transparent procedures to manage and report any adverse events or complaints that may arise during the conduct of activity using microorganisms or biohazardous materials, in accordance with the Macquarie University Code for the Responsible Conduct of Research and the IBC Terms of Reference and Operating Procedures.
  • Treat seriously, monitor, pursue and address any breaches.

6     RELEVANT LEGISLATION

Gene Technology Act 2000 (Cwth)

Gene Technology Regulations 2001 (Cwth)

National Health Security Act (Cwth) 2007

National Health Security Regulations 2008

Quarantine Act 1908 (Cwth)

Biosecurity Act 2015 (Cwth)

Animal Research Act 1985 (NSW)

Animal Research Regulations 2010 (NSW)

7     KEY RELATED DOCUMENTS

AS/NZS 2243.3:2010 Safety in Laboratories – Microbiological safety and containment

Guidelines for the Transport, Storage, and Disposal of GMOs

Institutional Biosafety Committee Terms of Reference and Procedures

Australian Code for the Responsible Conduct of Research

The Macquarie University Code for the Responsible Conduct of Research

The Macquarie University Biosafety and Biosecurity Manual

The Australian Code for the care and use of animals for scientific purposes (8th Ed. 2013)

Guidelines for Accreditation of Organisations 2012 issued by the OGTR

Explanatory Information on the Guidelines for Accreditation of Organisations v 1.4

8     NOTES

8.1
Contact Officer
Manager, Research Policy & Contracts
8.2
Implementation Officer
Biosafety Advisor and Secretary to the IBC
8.3
Approval Authority / Authorities
Deputy Vice-Chancellor Research /
Institutional Biosafety Committee
8.4
Date Approved
8 February 2016
8.5
Date of Commencement
8 February 2016
8.6
Date for Review
1 December 2018
8.7
Documents Superseded by this Policy
Nil
8.8
Amendment History
n/a
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