Proposed changes to GMO regulations

Earlier this year, the Government released its ‘Interim Regulatory Impact Statement: Improving our GMO regulations for laboratory and biomedical research’, to obtain feedback on proposed changes to regulations for genetically modified organisms (GMOs).
New Zealand’s legislation and regulations for GMOs were set over 20 years ago when this field was still in its early stages, and given the risks associated with GMOs at the time, the stringent regulations set in place reflected that perception. It is now generally considered by our scientific community that given the significant advancements in what we know in the area of biotechnology, it is time to review our regulatory framework for GMOs.
Genetic modification involves the modification of an organism’s genetic makeup (such as DNA) resulting in the creation of a GMO. GMOs are primarily regulated under the Hazardous Substances and New Organisms (HSNO) Act 1996, and the changes being considered would require amendments to this act.
The issues being addressed by the proposals set out in the impact statement, came out of work the Ministry for the Environment (MfE) carried out in 2021 when it canvassed stakeholders from the New Zealand research community regarding their experience working with the current GMO regulations. Based on this consultation and further analysis by MfE, the issues identified were the:
• overly stringent requirements for very low risk and lab-dependent GMOs
• over regulation of gene editing technologies (based on their mechanisms of action)
• application, amendment and approval requirements (including for medicines/therapies)

• administrative requirements for laboratory research (especially record-keeping)
• import, export, and transfer/movement requirements
• lack of clarity of the regulatory status of certain biotechnologies
• assessments and approvals for low-risk fermentation
• need for the regulatory framework to be future proof
To address these issues, the impact statement lays out 10 proposals to improve the GMO regulatory framework. The aim of these proposals is to help researchers, universities and businesses by reducing unnecessary regulatory barriers to laboratory and biomedical research that use GMOs.
The Hon David Parker emphasized that “these changes apply only to laboratory settings and for biomedical therapies that use biology and organisms, like cells, to create products that improve human health.” He stated “We’re not changing the rules that relate to field trials and releases of GMOs into the environment, such as plants or animals.” But rather the proposed changes would “remove barriers to research and help foster biotech companies producing high-value products in New Zealand, while retaining a considered approach to GMOs.”
One sentiment that comes through is that although the Government wishes to take a cautious approach to updating the regulations, it doesn’t want to be left behind in developing technologies in an area that would benefit New Zealanders.
National has developed its own policy that goes further, including allowing for “trials or use of biotech products where these have already been approved by at least two other OECD countries (or the EU and at least one OECD country outside the EU)”. The Act Party has also indicated it would liberalise our laws on genetic engineering.
Consultation began on July 3. If you would like to have your say, submissions close 25 August 2023.