Biosafety is governed in New Zealand’s domestic legislation under the Hazardous Substances and New Organisms Act 1996 (the HSNO Act). This regulates all activities in New Zealand regarding GMOs (which are equivalent to LMOs for nearly all intents and purposes), including importation, development, and release of GMOs. Additionally, New Zealand has several pieces of secondary legislation (regulations) governing the risk assessment methodology (the HSNO (Methodology) Order 1998) and low-risk assessment criteria (the HSNO (Low-Risk Genetic Modification) Regulations 2003), the use (the HSNO (Genetically Modified Organisms-Information Requirements for Segregation and Tracing) Regulations 2008) and movement (the Imports and Exports (Living Modified Organisms) Prohibition Order 2005) of GMOs, as well as organisms that are exempt from regulation as GMOs under the HSNO Act (the HSNO (Organisms Not Genetically Modified) Regulations 1998).

Risk assessments and approval functions for GMOs (essentially equivalent to LMOs) are undertaken by the Environmental Protection Authority (EPA). Many activities involving GMOs under New Zealand's relevant national legislation, the Hazardous Substances and New Organisms (HSNO) Act require public notification, and potentially public hearings regarding contained field trials and release of GMOs. All decisions regarding GMOs are publicly available on the EPA website (www.epa.govt.nz). Compliance functions regarding GMOs under the HSNO Act, including transboundary movement, are administered by the Ministry for Primary Industries (MPI). Compliance with New Zealand’s Cartagena Protocol obligations regarding exports of LMOs are met through the Imports and Exports (Living Modified Organisms) Prohibition Order 2005 regulations under the Imports and Exports (Restrictions) Act 1988. As a compliance function regarding GMOs, export of LMOs is administered by MPI. Compliance actions for GMOs are published on MPI’s website (www.mpi.govt.nz) Food approvals of LMOs are regulated under sections 397-401 of the Food Act 2014, via the Australia New Zealand Food Standards Code. Under this code, public submissions regarding LMO food approval applications are sought and considered by Food Standards Australia/New Zealand (FSANZ). All FSANZ risk assessments and decisions are publicly available on the FSANZ website (www.foodstandards.govt.nz) and the Biosafety Clearing House (http://bch.cbd.int), in accordance with paragraph 5, Annex III of the Cartagena Protocol. Biosafety is thus effectively mainstreamed into New Zealand legislation and national policy through these pieces of legislation and the implementation of their public notification provisions, as well as the ready public availability of all applications, risk assessments and decisions.

The HSNO Act requires that all GMOs, including pharmaceutical and/or therapeutic GMOs/LMOs, must undergo environmental risk assessments before they can be approved by EPA for importation and/or release into the environment. Such environmental release approvals do not constitute approvals of any pharmaceutical/therapeutic LMOs as medicines, as this is a function of Medsafe (https://www.medsafe.govt.nz/) under the Medicines Act 1981.

At the date that this report was written, and in the 29 years since the Hazardous Substances and New Organisms Act 1996 came into force, the New Zealand Environmental Protection Authority (including its predecessor the Environmental Risk Management Authority (ERMA)) has issued 2054 approvals for the import/use into containment and development in containment of genetically modified organisms under the HSNO Act. In the last ten years, the EPA has issued many overarching approvals for the importation into containment of LMOs. Importation approvals (unlike approvals for the development of LMOs), may be used by anyone who can comply with the controls. This has resulted in fewer applications and approvals required. Additionally, these overarching approvals are being used to manage the containment of many organisms imported under earlier approvals. This transfer to such broad approvals has substantially simplified compliance for holders of LMOs and for compliance officers themselves.

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To date, New Zealand has approved only medicines for release into the environment under the HSNO Act. Under this legislation, all LMOs, including pharmaceuticals, other medicines and medical devices require an environmental risk assessment, Article 5 of the Cartagena Protocol notwithstanding.

To date, the only approvals covered under Article 11 given in New Zealand have been for food. These have all been reported to the BCH in accordance with paragraph 5 of Annex III (ie “LMOs or products thereof”) of the Cartagena Protocol.

The Agreement between Australia and New Zealand establishing a System for the Development of Joint Food Standards was signed on 5 December 1995.

Elaborating on Question 69: In its risk assessments, EPA is required by law to use the Hazardous Substances and New Organisms (Methodology) Order 1998 (the Methodology) as guidance. The Methodology describes the roles of EPA, other government departments and advisory committees in decision making on GMOs/LMOs. The Methodology prescribes the procedure for public notification of applications, how information is submitted to EPA, and how that information must be considered and used, including: 1) Recognition of the risks, costs, and benefits of the LMO to the intrinsic value of ecosystems, environmental sustainability, public health, Māori (New Zealand’s indigenous people), and the potential for: a) significant displacement of native species, b) significant deterioration of natural habitats c) significant adverse effects on human health and safety d) significant adverse effects on New Zealand’s inherent genetic diversity e) the ability of an organism to establish an undesirable self-sustaining population in New Zealand f) the ease of the eradication of the organism in the event that established an undesirable self-sustaining population. g) the ability to cause disease, be parasitic, or be a vector for human, animal, or plant disease. 2) Recognition and provision for people and communities (including indigenous peoples and local communities) to provide for their own well-being and the needs of future generations 3) Submissions on application and expert advice The Methodology further prescribes the process to be used for decision making, as well as the consideration of aspects of an application where the EPA encounters scientific and technical uncertainty. The Methodology describes matters to which the EPA must have regard in its approach to the evaluation of risk, as well as the application of controls to mitigate risk. Finally, the Methodology prescribes the process by which EPA must present its decisions to the public. Elaborating on Question 70. In its approvals, for the use of LMOs, EPA imposes controls on the approval holders regarding the management of GMOs/LMOs. Thus all users of the approval are involved and must be trained in the risk management of LMOs, with MPI ensuring compliance with the controls. Therefore, more than 100 people in New Zealand are involved in the risk management of LMOs.

Plant material, such as seeds and leaves, are tested overseas at Ministry of Primary Industries-approved facilities located in different countries. The MPI national laboratory, located in New Zealand, is approved for handling of GM bacteria and plants, but it is not accredited to detect GM microorganisms or plants. To elaborate on question 82, New Zealand uses Movement Authority Forms for domestic movement, as well as for export of LMOs. Elaborating further on Question 92, New Zealand has only limited access to certified reference material for the detection and identification of LMOs.

As it pertains to our answer to Question 102(f), and to Article 6, paragraph 2, in the 29 years since the Hazardous Substances and New Organisms Act 1996 came into force, the New Zealand Environmental Protection Authority (and its predecessor the Environmental Risk Management Authority (ERMA)) has issued 2054 approvals for the import into containment and development in containment of genetically modified organisms. ERMA previously submitted these containment approvals to the BCH, but removed them several years ago under the Secretariat's direction (and in line with other BCH Country Profiles). These records are all available on the EPA website (www.epa.govt.nz).

New Zealand publishes all its biosafety-related risk assessments and decisions for LMOs on the Environmental Protection Authority’s website (https://www.epa.govt.nz/). Similarly, all risk assessments and decisions for foods derived from LMOs are published on the Food Standards Australia New Zealand website (http://www.foodstandards.govt.nz/). The bulk of New Zealand’s biosafety-related publications are accessible from these two sources.

Biosafety is mainstreamed in New Zealand’s national domestic legislation under the Hazardous Substances and New Organisms Act 1996. This law requires public notification, and potentially public hearings regarding contained field trials and release of GMOs (for nearly all intents and purposes equivalent to LMOs), except for medicines and veterinary medicines. All decisions regarding GMOs are publicly available on the Environmental Protection Authority’s (EPA) website (www.epa.govt.nz). Food approvals of LMOs are regulated under sections 397-402 of the Food Act 2014, via the Australia New Zealand Food Standards Code. Under this code, public submissions regarding LMO food approval applications are sought and considered by Food Standards Australia/New Zealand (FSANZ). All FSANZ risk assessments and decisions are publicly available on the FSANZ website (www.foodstandards.govt.nz). Elaborating on question 134, all eight of New Zealand’s universities hold approvals for LMOs from the Environmental Protection Authority, and as such, they all offer biosafety education and training courses and/or programmes for students and staff. Elaborating on question 138, the Association for Biosafety Australia New Zealand (https://www.absanz.org.au/) hosts a webinar series that is available to the public. Elaborating on question 131, FSANZ consulted the public in relation to LMO food approvals. In the current reporting period, all approvals for the release of LMOs were for medicines under the Hazardous Substances and New Organisms Act. This Act specifies an approval pathway for medicines that are or contain LMOs (among others), that does not require public notification or consultation.

Sources of socio-economic information include: public submissions, submissions from indigenous tribal groups (iwi Maori), and published information. This information is assessed by the Environmental Protection Authority, and incorporated into its decisions. All of New Zealand’s decisions on GMOs/LMOs are peer-reviewed, and are published on the Environmental Protection Authority’s website (https://www.epa.govt.nz)

With regard to question 156, New Zealand has a representative on the Biosafety Clearing-House Informal Advisory Committee (BCH-IAC). This Committee meets periodically, and makes recommendations to the Secretariat on improvements to the BCH aimed at facilitation of access to Biosafety Information, including approved LMOs, methods for detection and identification of LMOs and facilitation of the use of BCH information in national biosafety websites, among others. With regard to question 157, any application for the field testing or release of an LMO requires public consultation, including IPLCs and relevant stakeholders.

New Zealand is not undertaking activities toward the implementation of the Supplementary Protocol. Our domestic legislation is sufficient to address these matters.