At present, gene technology and GMOs are regulated under the Hazardous Substances and New Organisms Act 1996 (HSNO Act). However, there have been major advances in gene technologies and there is now a better understanding of how risks to people and the environment can be managed. The HSNO Act is now widely seen as outdated and not reflective of best practice and new editing technologies like CRISPR.¹ Modern international practice assesses risks associated with a new trait in each organism on a case-by-case basis, while the HSNO Act focuses on the risks of the processes.

New Zealand’s rules are considered among the strictest in the OECD. The assessment and decision-making requirements make it complex and costly to gain approval for biotechnology research and innovation. Over time, amendments and court rulings have made the regime even tighter. As a result, almost no genetically modified organisms have been approved for use outside labs. Since 1998, only three GMOs have been released into the environment without conditions. Many promising domestic research projects that could have been conducted in New Zealand have instead had to be carried out overseas, in less restrictive regimes.

The bill is modelled on Australia’s Gene Technology Act 2000, with relevant updates and adaptations where required for the New Zealand context.

The bill would regulate activities relating to gene technologies and regulated organisms—broadly defined to cover future developments. Activities involving regulated organisms would be prohibited unless authorised or exempt. A new risk-tiered system would manage the risks to the health and safety of people and the environment from activities relating to regulated organisms and gene technologies.

The bill would also establish a Gene Technology Regulator, who would be an independent statutory decision-maker within the Environmental Protection Authority (EPA), appointed by the Minister responsible for the Act. The Regulator would be supported by a Technical Advisory Committee (TAC) and a Māori Advisory Committee (MAC). The Ministry for Primary Industries would be the enforcement agency.

To give better effect to Treaty obligations, we recommend inserting a definition of “non-indigenous species of significance” in clause 7. This term would mean “a species of organism believed to have been brought to New Zealand before 1769 on waka migrating from other parts of the Pacific region”, and that is listed in the regulations as a non-indigenous species of significance. This definition is modelled on the Plant Variety Rights Act 2022 (PVR Act). We also recommend amending the definition of “kaitiaki relationship” in clause 7 to include non-indigenous species of significance. Consequential changes throughout the bill would include non-indigenous species of significance in clauses that reference indigenous species.

The Plant Variety Rights Regulations 2022 list ten non-indigenous plant species of significance. We acknowledge this list is limited to plant species. We recommend inserting a new regulation-making power in clause 155 to allow the Minister to recommend regulations be made to specify non-indigenous species of significance, in keeping with the procedure for making regulations.

We agree with suggestions that the appointment criteria and requirements for membership of the Māori Advisory Committee should be similar to those for the Māori Plant Varieties Committee in the PVR Act. To this effect, we recommend inserting subclauses (2A) and (2B) in clause 121.

Some of us raised concerns that a lack of timeframes for the Māori Advisory Committee may cause delays in decision making. However, we understand that this is something that can be dealt with in secondary legislation.

Submitters commented on the importance of the Regulator being independent, and expressed concern that the role of the Minister in the appointment could affect this independence. We also noted concerns regarding performance management of the Regulator. The bill would require the Regulator to be an EPA employee, but to be appointed by and accountable to the Minister for the performance of their functions and duties. As we noted in our legislative scrutiny of the bill, this would be an unusual arrangement.

We consider that the EPA should administer the recruitment process in consultation with the Minister. We recommend amending clause 108 to reflect that the Minister’s appointment of the Regulator will be on the recommendation of the EPA, having run the recruitment process. We also recommend adding clause 111(3A) to specify that the Regulator would be accountable to the EPA for their obligations as an employee. These amendments would retain the ministerial appointment of the Regulator but clarify the employee–employer relationship between the Regulator and the EPA.

We recommend inserting clause 108A to make explicit the Regulator’s term of office, vacation of office, and suspension or removal from office. This would specify that the Minister must appoint the Regulator for a maximum of 5 years, and may reappoint them. New clause 108A(4) would prescribe the grounds under which a Regulator may be removed or suspended (misconduct, inability to perform the functions of office, or neglect of duty). We also recommend inserting new clause 108B to provide for the appointment of an Acting Regulator by the Minister, on the recommendation of the EPA.

Under clause 106(d), the Minister may give directions to the Regulator. To ensure that the Regulator’s decisions on authorisations under the new regime remain independent, we recommend inserting clause 106A to set parameters for ministerial directions. Proposed clause 106A specifies that the ministerial direction is to be aligned with the purpose of the bill and the Regulator’s objective. It makes clear that the Minister may not intervene in individual decisions by the Regulator. It also sets out consultation and publication requirements before and after the Minister gives a direction.

To maintain the public’s trust, the new regime must remain transparent. Our suggestions below aim to enhance transparency.

Part 2, subpart 8 of the bill would require the Regulator to maintain a register of matters relating to the Act (such as licences, authorisations and determinations), on a website readily accessible to the public.

Clause 15 as introduced sets out conditions that may be imposed by the regulator in relation to the authorisation of activities involving regulated GMOs. We recommend amending clause 15(i) to refer to “location” in addition to “geographic area” so that the Regulator could constrain an activity to a particular location, such as a laboratory.

Clause 15(f) relates to the Regulator’s ability to impose conditions on authorised users relating to data and sample collection for a study. However, it is unclear on the ability to impose conditions to verify the genetic changes of a regulated GMO at the conclusion of the study. We recommend adding “verification” to clause 15(f).

Clause 37(1)(c) would require the licence holder to notify the Regulator in writing as soon as is reasonably practicable if the licence is for an activity that is not a transhipment activity, and if the circumstances of clauses 35(1)(a) to (c) or (e) apply and the Regulator has not been made aware of them. The circumstances in clauses 35(1)(a) to (c) or (e) are to do with whether a person is fit and proper to hold a licence. To avoid ambiguity, we recommend omitting the reference to the Regulator not being made aware of the circumstances.

We recommend amending clause 37(1)(f)(i), which currently requires the licence holder to publish the conditions of a licence within one month of being issued a licence. Replacing “1 month” with “20 working days” would be consistent with similar clauses.

The bill as introduced would permit an eligible person who is directly affected by a decision of the Regulator to appeal to the High Court. We have heard concerns from submitters that the meaning of “eligible person” is ambiguous. We consider that those who have asserted a kaitiaki relationship to an indigenous or non-indigenous species of significance affected by the Regulator’s decision should be able to appeal to the High Court. We also consider that those who have submitted on the draft risk assessment or the draft risk management plan should be given the same right. Accordingly, we propose amendments to clause 142(4). We recommend consequential amendments to clauses 143 and 144.

Although the Regulator would have an employment relationship with the EPA, performance of the Regulator’s independent statutory functions would not be covered by the insurance taken out by the EPA for its employees. That insurance would cover acts or omissions by those employees who perform the EPA’s functions, whereas the Regulator would have independent statutory functions.

We recommend inserting clause 112B, which provides for the EPA to effect comparable insurance cover for the Regulator’s independent statutory functions. We consider that without this insurance cover, the position of Regulator might seem unattractive to candidates, given the possibility of personal liability.

We see merit in clarifying which organisms and technologies are not regulated, so the public has more certainty as to their regulatory status. As introduced, the bill would not regulate:

• things that are determined by the EPA under section 26 of the HSNO Act not to be genetically modified organisms

• gene technology to which the HSNO Act does not apply by being listed in the Hazardous Substances and New Organisms (Organisms Not Genetically Modified) Regulations 1998

• organisms specified in Schedules 1 and 1A of the Australian Gene Technology Regulations (2001).

This was intended to ensure that the proposed regime is not more restrictive than the current HSNO Act.

Instead of referring to the specific legislation in this way, we consider that it would be preferable to specify the items that are not regulated by the legislation. We recommend inserting Schedule 3A to list the organisms that are not regulated GMOs, and technologies that are not gene technologies for the purposes of the bill. Consequently, we recommend removing clause 163(4) and replacing it with new clause 162AB, which sets out that items in Schedule 3A are not regulated by this regime. This change also addresses the concern that clause 163(4)(c) would inadvertently allow ongoing incorporation of changes made by Australian lawmakers to the schedules of Australian regulations into the New Zealand regime.

We note that the science of gene technology is an evolving field. Therefore, in addition to the list in our proposed schedule 3A, we recommend adding clause 162B to introduce a regulation-making power enabling declarations to be made about the regulatory status of entities, organisms, and technologies. This would allow other organisms or technologies to be declared as outside the scope of regulation in the future, if appropriate. Specifically, this clause would allow regulations to declare:

• that specified entities are or are not organisms

• that specified organisms or categories of organisms are or are not regulated GMOs

• that specified technologies are or are not gene technologies.

To ensure appropriate oversight and scientific rigour, the Minister would need to receive advice from the Regulator before recommending such regulations, and any regulations would need to be consistent with that advice. We consider that this would provide certainty and transparency to both industry and the public, while retaining flexibility.

As introduced, clause 163(1) would enable regulations to be made exempting organisms, categories of organisms, gene-editing techniques, or gene technology from the legislative regime. We recommend amending this clause to provide that regulations may not exempt gene technologies from the operation of the Act but may still exempt specified organisms.

In addition, we recommend inserting clause 163A, which would permit regulations to be made requiring a person who first introduces into the environment an organism or a category of organisms that is exempted to register that organism with the Regulator. It would also require the person undertaking the registration to provide the Regulator with their contact details, and details of the organisms or categories of organisms.

For transparency to the industry and the public, we recommend inserting clause 58(ja). This would require the Regulator to maintain a register with details of all introductions to the environment of an organism or category of organisms registered under regulations referred to in section 163A.

We also propose amending clause 163(2)(a) to provide that regulations cannot be made unless that organism or class of organisms is indistinguishable from those that are either not regulated by the bill or could be produced using a technology that is not regulated by the bill.

Clause 60 would allow the Regulator to withhold information on certain grounds when publishing information under the Gene Technology Act, in instances such as consulting on a licence application publicly, or publishing details on the register. We are concerned that clause 60 could be interpreted as overriding the Privacy Act 2020. We therefore recommend deleting clause 60.

Clause 151 sets out how information could be disclosed between agencies that perform functions under this bill and related legislation. We recommend several amendments to this clause to ensure it aligns with the Privacy Act, supports efficient agency cooperation, and allows for appropriate flexibility in information handling.

We are aware of concerns about how the information-sharing powers in the bill relate to the Information Privacy Principles (IPPs) set out in the Privacy Act. We recommend inserting clause 151(4A) to clarify its relationship with IPPs 2 and 11.

We recommend similar amendments in clause 152, which deals with information sharing outside New Zealand. In particular, we propose adding subclause (4) to clause 152 so that its relationship with IPP 11 is clarified.

We recommend clarifying clause 153, which provides for the disclosure of information to a recognised overseas authority where there is an agreement to undertake joint assessments of licence applications.

As introduced, clause 153 refers to joint assessments with applications under the HSNO Act. This reference should be removed, as clause 153 relates specifically to joint assessments under this bill with recognised overseas authorities.

We also consider that the wording as introduced may unduly restrict the Regulator’s ability to disclose information for the purpose of compliance monitoring. We therefore recommend amending clause 153(2)(b)(ii) to clarify that information may be disclosed where it would help monitor compliance with this bill or with a relevant law in the overseas country.

To ensure that New Zealand complies with reporting requirements under the Cartagena Protocol, we suggest inserting clause 153A to permit disclosure of information overseas, subject to confidential information provisions in the bill.

As introduced, Part 2, subpart 5 of the bill would require the Regulator to authorise the gene technology component of a medical activity within a certain period if it has already been approved by two recognised overseas gene technology regulators.

We note that the word “mandatory” in the term “mandatory medical authorisations” may result in misinterpretation that the bill mandates medical treatment. We recommend replacing “mandatory” with “equivalent” in relevant parts of the bill to clarify the intent.

We are aware of concern that the requirement in Part 2, subpart 5 could cause reliance on foreign approvals or result in the Regulator forgoing accountability for certain decisions.

We are satisfied that drawing on authorisations made by recognised overseas authorities would shorten the timeframe for authorisations, compared to a typical licence application. As introduced, the bill would require each authorisation to be published in the Gazette, be available on the Regulator’s website, and be presented to the House of Representatives. The Register on the Regulator’s website would have to include details of all equivalent medical authorisations.

We propose clarifying that the process of granting an equivalent medical authorisation should be initiated if a person notifies the Regulator that two or more recognised overseas authorities have granted the medical authorisation. Our amendments to clause 50(1) reflect this.

To improve transparency and robustness, we recommend amending clause 50 to:

• clarify that the Regulator may seek advice from the TAC or any person it considers necessary on conditions to apply to an authorisation (clause 50(5)(b))

• require the Regulator to notify on its website that it is beginning the process to grant an authorisation (clause 50(3)(a).

Should the Regulator decide to vary the conditions of an equivalent medical authorisation, we consider that they must have particular regard to the conditions imposed by the recognised overseas authorities. Accordingly, we recommend adding subclause (1AAA) to clause 51.

We recommend inserting clauses 50(6), 50(6A), and 50(6B) to make clear that an equivalent medical authorisation must be granted in respect of the activities, regulated GMOs, and persons that are covered by the recognised overseas medical authorisations. We recommend clarifying that the authorisation may cover specified classes of, or all, activities and persons, and specified categories of regulated GMOs.

Clause 114(3) lists the skills, knowledge, and experience required of a person on the Technical Advisory Committee. We recommend adding plant or animal breeding, and seed production to the list.

We recommend amending clause 204(3). This clause would replace section 28A(3) of the Biosecurity Act to reflect the actual scope of determinations that could be made under clause 12 of the bill. As introduced, clause 204(3) refers to determinations about whether something is an authorised regulated organism or the conditions of its storage or release. However, clause 12 in the bill refers to determinations about whether an organism is a regulated organism.

The bill interacts with several standards in the Biosecurity Act, which provide for a process to update standards. This process may not be able to be completed in time to enable the regime in this bill to be operational within expected timeframes. Our proposed new clause 210A would insert new section 166B into the Biosecurity Act. This would permit the Director-General to make changes to standards that they consider to be necessary or desirable to give in connection to legislation without following the process set out in the Biosecurity Act. We recommend inserting clause 237A to add new section 148A into the HSNO Act to give the EPA similar powers.

We recommend amending clause 2(2) so that subpart 9 of Part 6 of the bill (amendments to the Resource Management Act 1991) comes into force on the day after Royal assent, and not by Order in Council as specified in the bill as introduced.

We also recommend that clauses 23, 26–29, and subparts 4, 7, and 8 of Part 2 come into force on the day after Royal assent. This would ensure that the powers for the Regulator to declare activities as non-notifiable, notifiable, and pre-assessed come into force ahead of the rest of the bill. Important aspects of the regime could therefore be operational as soon as the Regulator was appointed.

We recommend amending clause 5 to remove the requirement on people other than the Regulator to have regard to the Convention on Biological Diversity and the Cartagena Protocol. We consider that this requirement is unnecessary and unfeasible. Our amendment would mean that only the Regulator, as the statutory decision-maker, must have regard to these international agreements.

We recommend several changes to the interpretation clause (clause 7), and other definitions at clause 8, to clarify and make more consistent the meanings of various terms as they relate to this bill. We cover our main recommended amendments below.

Direct modification of life at the genetic level and the creation of novel organisms and products is a powerful technological ability that should be applied with utmost precaution, dispassionate consideration of scientific evidence, and consideration of wider ecological, ethical, economic, and Te Tiriti o Waitangi implications. The Gene Technology Bill fails to achieve these basic criteria.

We acknowledge the need for an updated regulatory framework for genetic modification (GM) technology that takes into account much broader considerations than the narrow scope of this legislation. We support a risk-tiered framework for GM regulation which does not exempt any genetically modified organism. As it stands, the bill affects a radical liberalisation and deregulation of GM technology in New Zealand and removal of appropriate protections for the environment including the right of food producers to be free from novel genetic contamination.

As such the bill has proved to be a missed opportunity to create a lasting legislative framework to facilitate more appropriate pathways for use of GM technology including experimental use and development in containment, and particularly medical use—which is widely supported and uncontentious.

Potential frameworks for environmental release or agricultural applications required far more rigorous consideration and development than the Government’s timeframe allowed. The bill could have been split into two parts, with the first covering contained and medical use that could have been completed and passed in a timely way, and the second covering outdoor use which could have been given more appropriate time and rigour given its significant complexity, potential impact, and irreversibility.

The Green Party opposes this bill, and a future Green Government would amend any law substantially to enshrine the precautionary principle and provide sufficient protections and provisions for environmental, safety, ethics, animal welfare, trade, Te Tiriti o Waitangi, and te Ao Māori considerations.

The Government’s hyperbolic promises for what gene technology can do are unhelpful for developing a sober risk-based approach to gene-tech which undeniably has valuable uses and potentials across multiple disciplines. However, even advocates for the technology, such as Sir Peter Gluckman, acknowledge that its actual capabilities are somewhat speculative.² Hence the original determination of the Royal Commission on Genetic Modification that we should “proceed with caution” is as relevant now as it was then.³

Evidence from over 30 years of extensive commercial production of genetically modified organism (GMO) crops abroad shows that far from being used to improve environmental outcomes or increase yields, GMOs are overwhelmingly used as an agriculture intensification strategy that combines monocultures with mechanised delivery of fertiliser and pesticides, primarily benefitting multi-national seed and agrichemical corporations in the production of low value commodity crops (used mostly as stock feed) that have led to increased herbicide use, higher seed costs to farmers, and in most instances, lower yields.^{4 5} Far from being a liberating silver-bullet, they are industrial agricultural business-as-usual.

The Green Party is left believing that New Zealand’s current non-GMO producer status should be protected as offering a valuable point of difference in a global marketplace seeking high-quality naturally produced food and fibre goods.

While regarding the bill as having fundamental structural flaws the Green Party sought in good faith to find positive changes to improve the bill through seeking additional advice from officials and directly proposing amendments during the select committee process. Most of the amendments were voted against by Government members.

We wish to note that within the constrained time there was often constructive willingness of members across the committee to discuss these questions through the positive facilitation of the Chair. More in-depth scrutiny of details of the bill with officials were often constructive in increasing our shared understanding and we acknowledge the extensive work of ministerial staff and PCO. The Green Party believes that a willingness to take sufficient time could have led to greater cross-party consensus in creating lasting law on this significant field of science and technology.

These processes led to some constructive changes in the bill. Most notably the determination to change the terminology from “regulated organisms” to genetically modified organisms, noting that the EPA supported this change.⁶ Another important clarification in official advice: MBIE correctly acknowledging that gene-editing is genetic modification. Blurring this line of definition is both unscientific and unhelpful for a regulatory framework.

The other notable change was the creation of a public register of GMOs exempted from regulation. The Greens strongly oppose any exemption of GMOs from regulation but, as was agreed by the committee, there can be no semblance of the possibility of tracing or avoiding GMO products if there is no record of what products are being used; therefore a publicly available register of these is necessary as a bare minimum.

Other proposed amendments included:

• Shift the purpose of the regulatory framework to focus on the Act’s role to protect the health and safety of people and the environment.

• Require the regulator to specify the conditions that sit alongside a risk management plan including an assessment of trade and market access risks and specified conditions for risk management.

• Require that all regulatory decisions made in this system are made by the New Zealand Regulator and approvals from overseas authorities will not be transferrable to support regulatory sovereignty.

• Require that one of the conditions a licence is subject to is that GMO must be traceable. The bill has no standards set for segregation, and no responsibilities allocated for who will run the systems and who will pay, so no assurance about the levels of purity in a supply chain.

• Add a Te Tiriti o Waitangi clause to ensure that all persons exercising powers and functions under this Act must give effect to Te Tiriti o Waitangi.

• Require the Regulator, as well as all those operating under the Act, to consider the risks to trade and market access alongside other prescribed risks.

• Enable local authorities to continue to regulate activities in their area relating to GMOs to align with the local government GMO-free provision in the Resource Management Act 1991.

• Require that mandatory containment remains required for all gene technology processes so that all development is done in containment.⁷

• Delay the commencement of clauses relating to environmental release to provide time for the development of proper process for environmental release regime.

Fundamental problems with the bill that remain and are hereby outlined as the basis of the Green Party’s opposition to the bill: