Biological Risk Management and Containment Standard


Application


This standard applies to all staff members (including contractors and visitors) and students at the University who direct or participate in deliberate work that requires biological risk management and containment.

Purpose


To:

  • ensure optimal planning and preparation is carried out for the safe use, containment, transfer and disposal of all genetically modified organisms (GMOs) and biological materials that present a potential biosecurity risk, in the University’s containment/transitional facilities
  • ensure that all potential hazards are identified and appropriate controls put in place
  • facilitate the adoption of the Biological Risk Management and Containment Protocol across the University

Background


The approach taken by the University is to employ good practice controls to manage the containment of genetically modified organisms (GMOs) and all biological materials that present a potential biosecurity risk, while also complying with the requirements of the Hazardous Substances and New Organisms (HSNO) and Biosecurity Acts.

Standards


When working with New Organisms, Unwanted Organisms, genetically modified organisms (GMOs), biological materials that present a potential biosecurity risk and micro-organisms with a risk classification of Risk Group 2 or higher (hereafter referred to as “risk biologicals”), the University requires that:

Approvals

1. All prior approvals required under the HSNO Act for work with GMOs are to be obtained in advance of starting the work

2. Applications must be made in the first instance to the University of Auckland Biological Safety Committee (BSC)

3. Applications to import or develop GMOs that are not low risk (defined by the HSNO (Low Risk Genetic Modification) Regulations, 2003) will be made to the Environmental Protection Authority (EPA)

4. Applications to the EPA are to be made to the BSC in the first instance

5. Work with micro-organisms with a risk classification of Risk Group 2 or higher (as per the US National Institutes of Health/Centers for Disease Control (NIH/CDC) risk classification) must receive prior approval from the BSC. This requirement also applies to clinical specimens that have been shown to contain such micro-organisms

6. All approvals required under the Biosecurity Act for work or transfer of Unwanted Organisms are to be obtained in advance of starting the work

7. Persons obtaining University and statutory approvals are to inform their Director of Faculty Operations (DFO), directors of large scale research institutes (LSRIs), heads of school/department and floor managers

8. Work must not start until control measures imposed as a result of approvals obtained under the HSNO and Biosecurity Acts have been implemented and monitored to ensure they are effective

9. When New Organisms are discovered to be present, and where there is no reasonable evidence to suggest that these organisms were present in NZ prior to July 1998, work must cease and not resume until the appropriate HSNO approval is obtained

Physical environment/facilities

10. Work with risk biologicals is to be conducted in laboratories constructed in accordance with the appropriate construction requirements of AS/NZS 2243.3

11. Variations from these construction requirements must be approved by the BSC

12. Repairs to laboratories used for risk biologicals must be undertaken according to University protocols, to ensure that training is undertaken and clear lines of responsibility are maintained during the repair process

13. Any breach or potential breach in containment must be reported to those persons with responsibilities in containment (DFOs, directors of LSRIs, heads of school/department and floor managers) along with any proposed control measures

Security

14. Work with risk biologicals is to be conducted in facilities with approved security measures that may include perimeter security and controlled access to laboratories

15. Visitors entering containment laboratories are to be accompanied and must sign into entry logs

16. All contractors and Property Services staff entering containment facilities must notify floor managers or technical managers, where appropriate, before entering laboratories containing risk biologicals

17. Information regarding risk biologicals (including electronic sources) is to be stored in secure University premises or on devices meeting the minimum standards of security, defined by University policy

Health surveillance

18. Any requirement for health surveillance or vaccination identified as part of a risk assessment carried out under HSNO or BSC approvals is to be implemented and documented

19. Those working with micro-organisms with a risk classification of Risk Group 2 or higher, conducting work with animals where zoonotic transmission of these agents is likely, or where directed by the BSC, are to inform their general practitioner (GP)

20. The Hazards and Containment Manager (acting as the biological safety officer) is to be informed of any illness resulting or potentially resulting from exposure to micro-organisms with a risk classification of Risk Group 2 or higher

Training/supervision

21. Persons involved in the receipt, storage, handling, transport, use and disposal of risk biologicals must receive appropriate induction, training and management supervision, and this training must be documented

22. Persons involved in the receipt, storage, handling, transport, use and disposal of micro-organisms with a risk classification of Risk Group 3 or higher must demonstrate competence in handling the micro-organisms and containment equipment, and this competence must be documented

23. Students involved in the receipt, storage, handling, transport, use and disposal of risk biologicals are to be actively supervised by a principal investigator (PI) at the University

Cleaning/decontamination/waste management

24. Risk biologicals and surfaces that have come in contact with risk biologicals are to be decontaminated with approved decontaminating agents

25. Risk biologicals are to be disposed of in accordance with controls, risk assessments and local procedures that comply with University waste disposal standards

26. Biological toxins are to be deactivated in accordance with HSNO controls and University of Auckland Safe Methods of Use

Equipment/work practices

27. Equipment providing control measures (biological safety cabinets, HEPA filters, screens and autoclaves) is to be inspected, checked, calibrated, maintained and validated in accordance with University requirements

28. PIs in charge of research involving risk biologicals must ensure that all such materials are either disposed of properly or are transferred to another responsible PI three months before leaving employment at the University or before absences of more than three months

29. No one under minimum school leaving age may conduct work in containment laboratories

Import/transfer/export

30. Importation and transfer (including export) of risk biologicals must meet the requirements of the Biosecurity Act

31. Risk biologicals must be labelled, packed and declared to comply with International Air Transport Association (IATA) and Ministry of Transport regulations before leaving the containment facility

Procurement/record keeping/inventory

32. Purchase of risk biologicals is to be conducted through SciQuest ERM

33. Storage and disposal of risk biologicals must be accurately recorded in SciQuest ERM, in a timely manner

Emergency and contingency planning

34. Emergency response and contingency plans must be in place so that containment of risk biologicals is maintained at all times, as far as is reasonably practicable

Performance monitoring

35. Monitoring performance (including auditing, inspection and close out of any corrective action) against this standard is to be documented in a timely manner according to University protocols  

36. Results of performance monitoring must be reported to those persons with responsibilities in containment (DFOs, directors of LSRIs, heads of school/department and floor managers) and the BSC

37. Monitoring this standard is to be undertaken with care to ensure there is opportunity for feedback undertaken in a culture of constant improvement, with informed, fair and just decision-making

Roles and responsibilities


38. In the management of biological risk in all its containment and transitional facilities, these responsibilities are assigned to the following roles:

Deputy Vice-Chancellor (Research) is to:

  • assume overall legal responsibility for the University’s containment/transitional facilities (as the licensed operator)
  • provide leadership and governance that supports and strengthens the adoption of the Biological Risk Management and Containment Protocol
  • ensure sufficient resourcing and funding to support the service delivery model
  • formally sign off the annual programme of internal inspection and review
  • recognise exemplars of good practice and high performance levels

Associate Director, Health, Safety and Wellbeing is to:

  • ensure specialist support is available to licensed operators
  • work in partnership with the Vice-Chancellor’s senior leadership team, deans/directors of service, directors of LSRIs and heads of school to support and strengthen engagement with the Biological Risk Management and Containment Protocol
  • analyse and approve internal inspection and review results, ensuring that incidents and breaches are investigated and communicated, and critical issues are escalated
  • act as the University’s representative to the Ministry for Primary Industries (MPI) and Environmental Protection Authority (EPA), and be their principal contact
  • approve HSNO/containment training programme design and ongoing validation
  • direct core communications (themes, principles etc.)
  • identify exemplars of good practice and recommend to Deputy Vice- Chancellor (Research)

Hazards and Containment Manager is to:

  • advise Associate Director of Health, Safety and Wellbeing on biological risk management and containment performance
  • manage the development of the Protocol collateral: standard(s), procedures and guidance
  • ensure the implementation, monitoring and evaluation of the Protocol
  • capture and communicate learning of practitioners
  • ensure that appropriate training is undertaken by practitioners
  • follow up on assessed risks
  • advise on technical matters
  • raise any substantial issues of non-conformity, non-compliance or breach with the Associate Director of Health, Safety and Wellbeing
  • contribute to the development of internal inspectors and reviewers with respect to regulatory compliance
  • work in partnership with faculty executive management teams to ensure that:
    • professional practice requirements are clear and understood
    • they are informed of changes and updates
    • advice and support is available to deal with unforeseen events
  • manage a programme of internal inspection and review
  • identify exemplars of good practice and recommend to Deputy Vice- Chancellor (Research)

Deans/heads of school/directors of faculty operations/directors of LSRIs are to:

  • provide active leadership and governance to support and strengthen the BiologicalRisk Management and Containment Protocol
  • implement standards, procedures and practices for biological risk management and containment
  • actively engage with the University of Auckland Biological Safety Committee (BSC)
  • ensure that assigned staff are aware of their specific responsibilities for meeting biological risk management and containment requirements
  • ensure that containment/transitional facilities are clearly identified and demarcated
  • ensure that staff and students receive training as appropriate and are   competent to undertake their respective tasks, and that records are kept and communicated to the Hazards and Containment Manager
  • ensure that succession plans are in place for key personnel
  • monitor and review biological risk management and containment performance within their remit
  • provide input to the annual programme of internal inspection and review

Group services managers are to:

  • ensure adequate resource within their remit to meet biological risk management and containment requirements
  • ensure that succession plans are in place for key personnel
  • ensure that change management practices are in place to support the uptake of the Protocol (in consultation with their DFO)
  • ensure that professional staff and contractors are aware of standards, procedures and practices appropriate to their role in biological risk management and containment
  • monitor and review biological risk management and containment performance within their remit
  • provide input to the annual programme of internal inspection and review

Principal investigators/academic leaders are to:

  • ensure that all work involving GMOs has prior HSNO approval, and that all ongoing work remains compliant
  • scrutinise proposals for material transfer agreements to ensure principal investigators (PIs) have appropriate facilities and permissions
  • foster continuous improvement in biological risk management and containment practices
  • ensure that staff and students are aware of their responsibilities, receive training as appropriate and are competent to undertake their respective tasks
  • ensure that records are kept and communicated to the Hazards and Containment Manager
  • provide technical compliance support to staff and students
  • raise any issues of non-conformity, non-compliance or breach through their line management structure
  • contribute to faculty action plans in response to internal audits and reviews

Research fellows are to:

  • assist principal investigators in carrying out their responsibilities with regard to containment and in fostering continuous improvement in biological risk management and containment practices
  • ensure that all work involving GMOs has prior HSNO approval, and that all ongoing work remains compliant
  • contribute to faculty action plans in response to internal audits and reviews

Sector and floor managers (including technical team leaders) are to:

  • ensure that staff and contractors working within their remit are aware of standards, procedures and practices appropriate to their role in biological risk management and containment facilities
  • organise import permits and associated documentation
  • manage transfers and approvals
  • participate in the internal inspection and review processes
  • conduct internal checks as required by the Hazards and Containment Manager
  • raise any issues of non-conformity, non-compliance or breach through their line management structure
  • ensure that their lab/floor areas are in compliant condition at all times

University Property Services personnel are to:

  • ensure that prioritisation of maintenance and building works takes account of the need for biological risk management and containment facilities to achieve and maintain compliant conditions at all times
  • ensure that professional staff and contractors working within their remit are aware of standards, procedures and practices appropriate to their role in biological risk management and containment facilities

Staff and students are to:

  • carry out their work, research and study safely and in accordance with the University’s Health and Safety Policy, protocols, local arrangements and any relevant legislation
  • undertake any containment health and safety training and induction required by the University
  • bring any potential breaches of containment to the attention of the academic leader, sector or floor manager

Definitions


The following definitions apply to this document: 

Autoclave is an apparatus used to sterilise/decontaminate materials by dry steam under pressure

Biological risk management and containment means applying good practice controls to manage the containment of genetically modified organisms (GMOs) and all biological materials that present a potential biosecurity risk, while also complying with the requirements of the HSNO and Biosecurity Acts

BSC means the University of Auckland Biological Safety Committee

Control refers to an item or action designed to remove a hazard or reduce the risk from it

Genetically modified organisms as per s2 HSNO Act are: “Any organism in which any of the genes or other genetic material

a)    have been modified by in vitro techniques, or

b)    have any number of replications, from any other genes or genetic material which has been modified by in vitro techniques”

Deliberate work is work which involves a deliberate intention to handle hazardous biological materials or where hazardous biological materials are known to be or are likely to be present — this includes laboratory work e.g. pathology, diagnostics, hospital laboratories; veterinary laboratories; research laboratories; also biotechnology where microorganisms form part of the process.

Deliberate work is distinct from incidental contact, where exposure to hazardous biological material may occur but only incidentally, i.e. the activity does not involve direct work with the hazardous biological material itself (there is no intention to isolate, concentrate or propagate).

Hazard refers to anything that has the potential to cause harm (injury or ill-health) or damage to property or equipment in connection with a work activity

HEPA filter is a high efficiency particulate air filter

Higher-risk micro-organisms are Risk Group 2, 3 and 4 micro-organisms (whether genetically modified organisms (GMOs) or unmodified micro-organisms as defined by the United States National Institute of Health “Guidelines for Research Involving Recombinant DNA Molecules

HSNO means “Hazardous Substances and New Organisms”

Incident refers to any unplanned event resulting in, or having a potential for injury, ill health, damage or other loss

Minimum school leaving age: By law children in New Zealand aged six to 16 years old must be enrolled in school. However there are some situations where a 15 year-old can get permission to leave school early, to go on to other training or a job. Hence the minimum school leaving age is 15.

New Organism refers to:

  • an organism belonging to a species that was not present in New Zealand immediately before 29 July 1998
  • an organism belonging to a species, subspecies, infrasubspecies, variety, strain, or cultivar prescribed as a risk species, where that organism was not present in New Zealand before 29 July 1998
  • a genetically modified organism
  • an organism that belongs to a species, subspecies, infrasubspecies, variety, strain, or cultivar that has been eradicated from New Zealand

Not low risk (genetic modifications) are those defined in Schedule 1 of the Hazardous Substances and New Organisms (HSNO) (Low Risk Genetic Modification) Regulations 2003

Principal Investigator (PI): In the context of hazard containment and transitional facilities, a principal investigator is the holder of an independent grant administered by the University and the lead researcher for the grant project, usually in the sciences, such as a laboratory study or a clinical trial. The phrase is also often used as a synonym for "head of the laboratory" or "research group leader." The Principal Investigator is responsible for assuring compliance with applicable University standards and procedures, and for the oversight of the research study and the informed consent process. Although the PI may delegate tasks to members of their research team, they retain responsibility for the conduct of the study

Risk refers to the likelihood a hazard will cause harm (injury or ill health) and the degree of harm (consequence)

Risk assessment is the process of evaluating the risk(s) arising from the hazard(s), taking into account the adequacy of any existing controls, deciding whether or not the risk(s) is acceptable, and taking further action as required

Risk biologicals are New Organisms, Unwanted Organisms, genetically modified organisms (GMOs), biological materials that present a potential biosecurity risk and micro-organisms with a risk classification of Risk Group 2 or higher, as defined by the United States National Institute of Health “Guidelines for Research Involving Recombinant DNA Molecules

SciQuest ERM is the software used by the University as an inventory system for hazardous and controlled substances and risk biologicals

Sector or floor manager means a manager who has responsibility for containment procedures within a designated area of the containment facilities. This person is either a lab manager for the floor (FMHS) or a technical team leader (SBS)

Technical manager means the research laboratory technical manager (FMHS) or technical manager (SBS)

Staff member refers to any individual employed by the University on a full or part time basis

University means the University of Auckland and includes all subsidiaries

University of Auckland Safe Methods of Use (from HSNO): Generic safety information and methods of use, handling, storage and disposal of hazardous substances. A Safe Method of Use provides a means of undertaking a hazard assessment and recommending mitigating measures

Unwanted Organism: this is defined in the Biosecurity Act 1993 as any organism a chief technical officer (CTO) believes capable of causing unwanted harm to any natural and physical resources or human health. Unwanted Organisms are listed on the Unwanted Organisms Register: https://www1.maf.govt.nz/uor/searchframe.htm

Volunteer is a person authorised to participate in the operation of part or all of a planned laboratory activity

Zoonotic transmission is the transmission of a disease from an animal host to a human

Document management and control


Owner: Director, Human Resources

Content manager: Associate Director Health, Safety and Wellbeing

Approved by: Vice-Chancellor

Date approved: September 2016

Review date: September 2019