Select Committee on Innovation, Universities, Science and Skills Written Evidence

Memorandum 29

Submission from the British High Commission, Wellington, New Zealand


  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.


  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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