Memorandum 29
Submission from the British High Commission,
Wellington, New Zealand
EXECUTIVE SUMMARY
The regulation of the importation and propagation
of hazardous organisms in New Zealand is governed by the Hazardous
Substances and New Organisms Act 1996 and the Biosecurity Act
1993 and by standards, policies and methodologies developed by
the New Zealand Environmental Risk Management Authority and the
Ministry of Agriculture and Forestry Biosecurity New Zealand.
Criteria for the classification of micro-organisms
into risk groups and the requirements of laboratories designed
to contain hazardous organisms are laid out in the Australian/New
Zealand Standard AS/NZS 2243.3:2002, Safety in Microbiological
laboratories.
SUBMISSION
1. The importation and handling of hazardous
organisms in New Zealand is governed by the Hazardous Substances
and New Organisms Act 1996 and the Biosecurity Act 1993 and by
standards, policies and methodologies developed by the New Zealand
Environmental Risk Management Authority (ERMA) and the Ministry
of Agriculture and Forestry Biosecurity New Zealand (MAFBNZ).
2. New Zealand laboratories are classified
as physical containment (PC) level 1, 2 or 3 in accordance with
Australian/New Zealand Standard Safety in laboratories, Part 3:
Microbiological aspects and containment facilities, (AS/NZS 2243.3:2002).
Facilities handling hazardous organisms are subject to audit against
this standard. Audits are undertaken by the facilities approval
group of MAFBNZ. MAFBNZ's own PC3 containment facility is subject
to external audit by an independent third party. There are no
PC4 laboratories in New Zealand.
3. MAF/ERMA New Zealand Standard 154.03.02
Facilities for Microorganisms and Cell Cultures: 2007 covers the
handling of organisms that have been identified as risk goods
under the Biosecurity Act 1993. Work with these organisms, which
include genetically modified organisms, unwanted organisms, risk
species and restricted organisms, is subject to compliance with
statutory regulations specified in the Biosecurity Act 1993 and
the Hazardous Substances and New Organisms (HSNO) Act 1996. This
standard sets specifications for holding micro-organisms and animal
cell cultures, that are new to New Zealand and includes the minimum
requirements that must be met for the containment of unwanted
or restricted micro organisms.
4. Micro-organisms that are considered by
a MAF Chief Technical Officer (CTO), appointed under section 101
of the Biosecurity Act, to be risk goods are required to be held
in transitional facilities. Risk goods are those for which it
is reasonable to suspect constitute, contain or harbour an organism
that may cause unwanted harm to natural and physical resources
or human health in New Zealand or interfere with the diagnosis,
management, or treatment, in New Zealand, of pests or unwanted
organisms.
5. If these organisms are new to New Zealand,
approval for these organisms to be imported into containment facilities
is given subject to containment controls specified by ERMA. Once
approved by ERMA, permission to import such organisms is given
through a permit to import and an import health standard and may
be subject to conditions specified by MAF.
6. In addition to approval to import exotic
organisms by ERMA and MAF, propagation of organisms declared unwanted
under the Biosecurity Act requires approval of a CTO.
7. The containment facility operator is
responsible for ensuring mechanisms are in place for resourcing
the facility to operate to the MAF/ERMA standard and ensuring
that the requirements of a Quality Management System can be met.
8. An Operator must be approved by the Director-General
of MAF in accordance with section 40 of the Biosecurity Act 1993,
if the Director-General is satisfied that the applicant:
— is a fit and proper person to operate
the facility;
— has the authority to resource and
operate the facility; and
— has the technical and financial resourcing
mechanisms in place to maintain that facility.
9. The Operator must document and implement
a Quality Management System (QMS) for the facility based on the
principles of, but not requiring accreditation to, AS/NZS ISO
9001: 2000, NZS/ISO/IEC 17025: 2005, or similar recognised quality
management system. The QMS should be documented as a "containment
manual" or in an alternative format that clearly documents
requirements and enables ready access for practical use and inspection.
10. All people working in the facility must
have appropriate working knowledge commensurate with their responsibilities.
The QMS must include a training programme that describes how people
working in the facility will be made aware of, and understand:
— the purpose of the facility;
— the statutory and regulatory requirements
which relate to work with microorganisms being held in containment;
— the principles and practices of containment,
as established in AS/NZS 2243.3: 2002;
— the procedures used in the facility
to maintain containment and fulfill the purpose of the type of
facility;
— the purpose of, and controls specified
by, any HSNO Act Approval for import of new microorganisms contained
in the facility; and
— the conditions specified by MAF in
any permit(s) to import, import health standard(s) and/or CTO
permission(s) relating to any unwanted microorganism.
11. The QMS must also specify how the training
programme is to be implemented, evaluated and improved and must
stipulate the frequency of refresher courses. Records of training
must be documented for all people working in the facility.
12. Access to the facility should be limited
to trained personnel authorised to work in the facility. However,
visitors may be permitted entry provided they are accompanied
by such personnel. Visits must be recorded in a visitors log book
for security purposes, and visitors must adhere to access procedures.
Entry and exit procedures must be made available at the entrance
to the facility, specifying essential requirements such as laboratory
coats and protective clothing, signing access log books, and hand
washing.
13. Staff and students and contractors working
in MABNZ's containment facility are required to have a security
clearance. The security clearance process is overseen by MAF Human
Resources staff.
14. Transport of microorganisms must comply
with the International Air Transport Association (IATA) Dangerous
Goods Regulations, according to the level of risk.. Although the
IATA Dangerous Goods Regulations are written specifically for
air transport, the packaging and labeling requirements must be
applied to all transport to final facility destinations in New
Zealand. Operators must ensure, to the best of their ability,
that goods being imported into, and within, New Zealand are packaged
as per the IATA Dangerous Goods Regulations. The minimum requirement
is for micro-organisms to be packaged according to Packing Instruction
No 650 of the IATA Dangerous Goods Regulations. All products that
are infectious or potentially infectious for humans or animals
must be packaged according to Packaging Instruction No. 602 of
the IATA Dangerous Goods Regulations.
15. Facilities approved to the MAF/ERMA
standard are audited every 6 months by a MAF Inspector or Enforcement
Officer. The audit is a compliance audit, where the facilities'
defined systems are compared against those required by the standard.
It will necessarily include a process audit, which will validate
the processes and procedures in place. The Operator must provide
Inspectors access to the facility, records and documents for inspection
and audit or to investigate non-compliances with this standard.
16. The Operator must ensure that an internal
audit programme is carried out to assess the effectiveness of
containment policies, risk management, and operational procedures.
During the internal audit, particular emphasis must be placed
on verifying that the registers of micro-organisms are accurate
and up to date, the training programme is being implemented and
is effective, and any corrective actions have been resolved in
a timely manner.
17. New Zealand has a limited number of
laboratories designed to handle hazardous micro-organisms. The
highest level of containment is at the MAF owned facility at the
National Centre for Biosecurity and Infectious Disease, Wallaceville,
Upper Hutt. This facility is designed to meet the requirements
of AS/NZS physical containment level 3 and also incorporates the
additional features of OIE containment level 4. It is shared by
MAF BNZ's Investigation and Diagnostic Centre and Environmental
Science and Research, New Zealand's medical diagnostic reference
laboratory. For the purposes of the remainder of this submission
only organisms causing significant animal disease will be considered.
18. Organisms handled in New Zealand's veterinary
laboratories are classified into Risk Groups 1, 2, 3 and 4 according
to criteria contained in the AS/NZS 2243.3:2002, Part section
3, Degree of hazard from micro-organisms. The classification has
been drawn up by modification of the WHO guidelines and is based
on the pathogenicity of the agent, the mode of transmission and
host range of the agent, the availability of effective preventative
measures and the availability of effective treatment. For organisms
of veterinary significance, the criteria in the OIE Terrestrial
Animal Health Code (2007) Chapter 1.4.5 which include whether
an organism is exotic, endemic or subject to official control
as well as host range, transmission and availability of prophylactic
or therapeutic treatments are also considered.
19. In May 2006, ERMA considered an application
by MAFBNZ to import any micro-organisms that may cause disease
of significance to animals that have the biological characteristics
of Risk Groups 1, 2 or 3 into containment for diagnostic purposes.
ERMA considered the risks, costs and benefits of the proposed
importation. After consultation with the public and industry bodies,
consultation with other Government Departments and a public hearing,
ERMA approved the application with controls. The controls included
limitation of use to MAFBNZ's Investigation and Diagnostic Centre
Physical Containment level 3 laboratory which is on the National
Centre for Biosecurity and Infectious Disease campus at Wallaceville,
Upper Hutt. The approval was for importation of any micro-organisms
that may cause disease of significance to animals that have the
biological characteristics of Risk Group 1, 2 or 3 as defined
in AS/NZS 2243.3:2002 and therefore capable of being contained
within a PC3 level containment facility. Viruses that cause vesicular
diseases of animals such as foot and mouth disease and organisms
that fall with in Risk Group 4 were not included in the application
and were specifically exclude from the ERMA approval.
20. Controls covered Laboratory registration
requirements, sources of organisms, identification of organisms,
sources, transport packaging and labelling, operating procedures,
storage, exclusion of unauthorised people from the facility, control
of the effects of accidental release or escape, inspection and
monitoring requirements, and qualifications required of persons
responsible for implementing the controls. The approval also specifically
excluded using the organisms to deliberately infect live animal
hosts.
21. Research on organisms in Risk Group
4 or organisms causing vesicular disease of livestock is not carried
out in New Zealand although diagnostic tests that do not require
access to the living organisms are available for many of these
diseases.
22. Most hazardous organisms affecting animal
health, including organisms causing zoonotic human disease, are
exotic to New Zealand thus all work undertaken with these organisms
is carried out under MAF's control in its physical containment
level 3 laboratory. The ERMA approval excludes infection of animals
thus research work with these organisms is confined to in vitro
studies.
January 2008
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