Massey University Policy Guide
NEW, INFECTIOUS, OR PATHOGENIC ORGANISMS
AND BIOLOGICAL PRODUCTS POLICY
Section
People & Organisational Development
Contact
Health and Safety
Last Review
May 2007
Next Review
May 2009
Approval
VCEC 07/09/129
Purpose:
To provide for safe and responsible use of new, infectious, or pathogenic organisms and biological products at
Massey University in a way that protects the environment and the health and safety of people and communities.
Policy:
Institute owned Transitional and Containment Facilities
1
Transitional and containment facilities must have a designated “operator” which at Massey University is the Head of
the Institute, Centre or equivalent. The position can only be delegated to a staff member who has sufficient authority
to control all staff using the facility, all research/teaching work in the facility and maintenance of the facility.
Responsibility for each Institute transitional and containment facilities is with the Head of Institute or Centre (HoI).
The HoI is to ensure adequate controls are in place for risks associated with new, infectious, or pathogenic organisms
or biological product. Steps to achieve these responsibilities are detailed in the New, Infectious, or Pathogenic
Organisms and Biological Products Procedure.
All transitional and containment facilities on a campus within the Institute should be regarded as one facility, an
2
approved to the required MaF standards applicable to that facility .
Where facilities or conditions do not meet the required criteria specified in the application approval, the use of those
facilities must not occur until the substandard matters are remedied. Until remedial work is carried out arrangements
are to be made for interim relocation of the new, infectious, or pathogenic organisms or biological products in facilities
that meet the required criteria.
3
The Institutional Biological Safety Officer must be kept informed of all current MaF approved transitional and
containment facilities and audit results within an Institute.
Leased or Shared Facilities
1
See legislative compliance section of this policy for rationale for HOI or equivalent appointment.
As such transfers can occur within the facility in the Institute, but not to other Institutes without Maf notification. If some facilities in an Institute are
distinctive (eg insect housing) and there is limited transfer within the Institute more than one facility can be created.
3
The University Institutional Biological Safety Officer is a legal appointment required as part of the delegated approval by ERMA to the Vice
Chancellor for low risk genetic engineering work. The GTC processes should be consulted for more detail.
2
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Massey University Policy Guide
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Where facilities are leased or shared the owner of the facility is responsible for the control of the facility and work
occurring in the facility. Where a facility is shared by Institutes, one Institute must be nominated as “owner” and take
responsibility for control of the activities in the facility, training of users and facility maintenance."
As such, the owner of a leased or shared facility needs to have a quality assurance system for control of new,
infectious, or pathogenic organisms and biological products, and train the users of the facility in the protocols that
need to be followed in the use of the facility to ensure containment or transitional status is retained.
Collection and Project Notification
The HoI (or owner of leased facilities) must be notified by users of the facility of matters relating to import,
maintenance, transfer, transport and disposal of new, infectious, or pathogenic organisms and biological products in
accordance with MaF guidelines. This will enable the facility owner can maintain an up to date register of collections
or projects, including MaF, GTC, and ERMA permits as applicable.
Approvals
The lead researcher must arrange to obtain Environmental Risk Management Agency (ERMA) and Ministry of
Agriculture and Forestry (MaF) approvals, for all new, infectious, or pathogenic organisms and biological products
imported, developed, field tested or released with or without controls.
Controls may also be applied by Resource Management Act 2003 and Animal Welfare Act 1999.
All import applications for genetically modified organisms must also obtain the approval of the Genetic Technology
Committee.
Hazard management
The lead researcher must ensure appropriate transitional and containment practices prescribed by ERMA, or MaF,
are followed for new, infectious, or pathogenic organisms and biological products. Any inability to follow transitional
and containment practices must be advised to HoI and alternative arrangements made for adequate compliant
controls.
All work with infectious or pathogenic samples must follow Universal Precautions or equivalent infection control
measures to minimize risk to staff, students, and laboratory organisms.
Definitions:
A new organism is
a) An organism belonging to a species that was not present in New Zealand immediately before 29 July 1998:
b) 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 at the time of promulgation of the relevant
regulation:
c) An organism for which a containment approval has been given under the Hazardous Substances and New
Organisms Act:
d) An organism for which a conditional release approval has been given:
e) A qualifying organism approved for release with controls:
f) A genetically modified organism:
g) An organism that belongs to a species, subspecies, infrasubspecies, variety, strain, or cultivar that has been
eradicated from New Zealand.
An infectious organism is
© This Policy is the property of Massey University
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An organism capable of invading a susceptible host and multiplying in it, which may or may not cause disease.
A pathogenic organism is
An organism capable of causing disease in a host.
Organism
a) does not include a human being:
b) includes a human cell:
c) includes a micro-organism:
d) includes a genetic structure, other than a human cell, that is capable of replicating itself, whether that
structure comprises all or only part of an entity, and whether it comprises all or only part of the total genetic
structure of an entity:
e) includes an entity (other than a human being) declared to be an organism for the purposes of the Biosecurity
Act 1993:
f) Includes a reproductive cell or developmental stage of an organism.
Biological products are
Non-viable products that have been derived from living organisms, or are identical to products derived from living
organisms.
Facility
Containment or transitional facilities is a place approved in accordance with section 39 of Biosecurity Act for
inspection, storage, treatment, quarantine, holding, or destruction of organisms, or goods without Biosecurity
clearance.
Audience:
All staff.
Relevant Legislation:
Hazardous Substances and New Organisms Act 1996
Biosecurity Act 1993
Resource Management Act 2003
Animal Welfare Act 1999
New Zealand Nuclear Free Zone, Disarmament, and Arms Controls Act 1987
Health and Safety in Employment Act 1992
Legal Compliance:
Ss 34 – 39, Hazardous Substances and New Organisms Act specifies requirements for approval by ERMA for all new
organisms imported, developed, field tested or released with or without controls. Approvals may also be required
from MaF, in order to meet requirements under the Biosecurity Act, and Animal Welfare Act. Approvals may also be
required from Local Authorities in order to meet requirements under the Resource Management Act.
Ss:40 of the Biosecurity Act 1993 requires facility operators (transitional or containment) to be approved by MaF
Director. The operator must be a fit and proper person to be the operator of the transitional or containment facility
specified in the application; and able to comply with the operating standards for that facility.
The facility operator is further defined in various MaF transitional or containment standards as “The person who has
overall responsibility for the transitional or containment facility, its maintenance and operation, in terms of Section 40
© This Policy is the property of Massey University
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of the Biosecurity Act”. Standard 154.03.01 specifies responsibility as including resourcing and day to day operation.
The resourcing and supervision compliance requirement (including if necessary instructions to cease a particular
piece of work) has to rest with a senior manager. As such the “Operator” responsibility is allocated to Heads of
Institutes.
The HoI needs to designate an Institute Transitional and Containment Manager to ensure quality control systems are
implemented for all collections covered by MaF standards and permits.
In addition Ss:8, New Zealand Nuclear Free Zone, Disarmament, and Arms Controls Act 1987 prohibits manufacture,
storage, acquiring or possessing, or controlling any biological weapon.
Related Procedures:
New, Infectious or Pathogenic Organisms and Biological Products Procedure
Massey University code of ethical conduct for the use of live animals for teaching and research
Genetically Modified Organisms Policy
Document Management Control:
Prepared by: Manager – Health and Safety
Authorised by: Deputy Vice-Chancellor (Research and Academic),
Pro Vice-Chancellor College of Sciences
Approved by: VCEC 07/09/129
Date issued: May 2007
Next review: May 2009
© This Policy is the property of Massey University