Policy for managing non-compliance related to new organisms, unwanted organisms and uncleared (risk) biological products

Purpose

The University of Otago is committed to providing a safe workplace for staff, students and visitors. The purpose of this policy is to ensure that the University complies with the Environmental Protection Authority and the Ministry for Primary Industries specific compliance requirements for the use of new organisms (includes genetically modified organisms), unwanted organisms and restricted biological products in research and teaching. Breach or non-compliance of these requirements may result in loss of the ability for the University to continue working with these organisms or uncleared (risk) biological products for teaching and research.

Organisational scope

This policy applies to all University of Otago Approved Users who are authorised to use new organisms (includes genetically modified organisms), unwanted organisms or uncleared (risk) biological products for teaching or research.

Definitions

Approved Users

University of Otago staff who have been approved through the IBSC for the use of new organisms (includes microorganisms, plants, vertebrates and invertebrates) or uncleared (risk) biological products.

BCO

Biological Compliance Officer.

CTO

Chief Technical Officer ( MPI ).

EPA

Environmental Protection Authority.

IBSC

Institutional Biological Safety Committee.

MPI

Ministry for Primary Industries.

Minor Non-Compliance

Matters that represent a failure to meet legal compliance but do not immediately cause or lead to a biosecurity risk: including but not limited to failure to maintain appropriate records or cage cards; failure to record the destruction of items that must be held in a facility; failure to notify the BCO of the importation of an uncleared (risk) biological product; failure to display the correct signage at the entrance to containment facilities; failure to comply with HSNO Act approvals or CTO directions (only where this does not lead to a biosecurity risk).

Major Non-Compliance

Failure of containment controls that may cause or lead to an increased biosecurity risk: including but not limited to failure to have appropriate HSNO Act approvals; failure to have appropriate records; failure to comply with HSNO Act approvals; failure to comply with CTO directions; failure to follow MPI requirements for the import or transport of new organisms or uncleared (risk) biological materials into or between transitional/containment facilities; failure to report a missing animal; failure to complete training without good reason; failure of an Approved User to train staff or students working under their supervision.

New Organism

Any organism not present in NZ on 29 July 1998 (includes genetically modified organisms).

Operator

The person or organisation, approved by the Director-General, who has overall responsibility for a facility, under section 40 of the Biosecurity Act 1993. Every approved facility must have an approved operator. This person will have overall responsibility for the transitional/containment facility. A facility operator must have the authority to make changes at a facility when directed to do so by MPI and have delegated financial authority. The University of Otago is the Operator in this instance and the delegated authority is the Deputy Vice-Chancellor ( DVC ), Research and Enterprise.

Unwanted Organism

Any organism a CTO believes capable of causing unwanted harm to any natural and physical resources or to human health (Biosecurity Act 1993).

Uncleared (Risk) Biological Product

Any product imported into NZ on a permit issued pursuant to the Biosecurity Act 1993 that is directed to a transitional or containment facility.

Content

1. In the case of non-compliance of containment controls, the following steps apply to rectify the situation.

   1. Identification of issues either through self-reporting, internal monitoring by Sector Managers, or audits by the Institutional Biological Safety Committee ( IBSC ) and Ministry for Primary Industries ( MPI ):
      1. Corrective action requests for major and minor infringements identified during internal auditing are documented in Vault. The corrective actions will include a reasonable period for completion. Issues identified by MPI will be included in the report to the Operator and a copy of the audit report will be provided to Sector Managers and the relevant Head of Department by the Biological Compliance Officer ( BCO ). Any corrective actions arising from MPI audits will have a reasonable timeframe for completion.
   2. Minor infringements of containment controls will be managed by:
      1. Notification to the Sector Manager via Vault or in the case of vertebrate laboratory animal infringements notification via Vault to the Approved User with concurrent notification to the Sector Manager. In the case of repeated minor non-compliances, these will be elevated and considered major infringements of containment controls (see clause 1(c) below).
      2. The Approved User or Sector Manager will provide a written explanation of the reasons for the infringement and what remedial action will be undertaken to prevent a repeat of the infringement. In addition, as decided by the BCO and the IBSC Chair, the Approved User and members of their research team may be required to undergo additional training, and/or additional audits by the IBSC .
   3. Major infringements of containment controls will be managed by:
      1. Concurrent notification to the Approved User, the IBSC , the Operator, Sector Manager and the Head of Department by the BCO . Notification to the Approved User will include reference to this policy and notification that in the case of repeated major non-compliances, Approved User status may be revoked.
      2. The Approved User will provide a written explanation of the reasons for the infringement and the remedial action that will be undertaken to prevent a repeat of the infringement. In addition, as decided by the Operator in consultation with the BCO and appropriate members of the IBSC , the Approved User and members of their research team may be required to undergo additional training and/or additional audits by the IBSC , and their right to work with uncleared (risk) biological products or new/unwanted organisms may be suspended until the IBSC and Operator are satisfied with the corrective actions taken.
      3. The Approved User must notify the BCO , IBSC , Animal Practices and Compliance Officer (for vertebrate laboratory animal infringements), the Operator and the Head of Department when the corrective action is complete.
   4. Repeated major infringements or non-compliance will be managed by:
      1. The Approved User will be notified in writing by the BCO that their permission to use uncleared (risk) biological product or new/unwanted organisms is in jeopardy.
      2. The Approved User will be advised by the BCO that any further non-compliance events will result in withdrawal of their Approved User status and their access to the containment facilities will be removed. The Operator, Sector Manager, Head of Department ( HOD ) and the IBSC will be copied into all correspondence with respect to this notification.
      3. The Operator may withdraw the Approved User status.
      4. If the Approved User status is withdrawn the BCO , IBSC , Sector Manager, and HOD will be notified.
      5. Any reinstatement of Approved User status will be considered by the Operator, IBSC , Sector Manager and BCO following discussions with the Approved User and the HOD involved.
   5. Additional Management strategies:
      1. If Approved User status is withdrawn, responsibility for materials and new organisms (includes genetically modified micro-organisms/unwanted organisms and uncleared (risk) biological products) that must be held in the facility must be transferred to another Approved User or the materials destroyed at the time status is withdrawn.

Related policies, procedures and forms

Health and Safety Policy

Contact for further information

If you have any queries regarding the content of this policy or need further clarification, contact:

The Biological Compliance Officer
Email biological.compliance@otago.ac.nz