The changes, announced on 13 August, come as Food Standards Australia New Zealand (FSANZ) also consults on a proposal determining how it should define genetically modified food.
Businesses can submit on the FSANZ proposal and will have opportunities over the coming year to have input into the government’s changes which could impact on a wide range of sectors from the food and beverage industry, to health and biotechnology.
Submissions on the FSANZ proposal will be open until 10 September, while the government is working toward having relevant gene technology legislation passed and the regulator in operation by the end of 2025.
Regulatory overhaul
The sweeping changes announced by Science, Innovation and Technology Minister the Hon Judith Collins KC will align New Zealand’s approach to genetic modification with that of Australia, taking inspiration from Australia’s Gene Technology Act 2000. The government intends to end restrictions on genetically engineered or modified organisms outside the lab, imposed nearly thirty years ago by the Hazardous Substances and New Organisms Act 1996.
It will also introduce a biotechnology regulator, set up as a dedicated business unit within the Environmental Protection Authority. The regulator will have the ability to exempt specific gene technologies from regulations if they pose minimal risk, or are indistinguishable from conventional breeding techniques.
The Minister said that risks associated with gene technology are better understood now than they were in 1996. The changes represent a “major milestone” in modernising laws with impacts on health, climate adaptation and economic outcomes, she said.
The science and research sector has been largely supportive of the developments. Professor Richard Newcomb, Chief Scientist at Plant & Food Research, said in a press release that the changes will allow the agrifood sector to “adapt at the speed required to meet fast-moving challenges”.1 Others take a different view, with GE-Free NZ last year warning that New Zealand may lose “its point of difference as having superior standards for food safety” if it introduced such changes.2
FSANZ proposal
Meanwhile FSANZ is similarly considering its approach to genetic modification.
The second public call for submissions on FSANZ’s Proposal P1055, Definitions for gene technology and new breeding techniques opened in late July and will close on 10 September.
This follows a consultation and subsequent report on the proposal in 2021. During the first consultation period, the proposal aimed to amend the definitions in the Australia New Zealand Food Standards Code (the Code) for “food produced using gene technology” and “gene technology”. Such amendments intended to clarify which foods are considered genetically modified under the Code. Together, these definitions determine which foods are subject to pre-market assessment and approval.
FSANZ prepared the first iteration of the proposal following a review, which concluded that the definitions are no longer fit for purpose because they are unclear and do not reflect the diversity of techniques now in use, or which may emerge in the future.
The trajectory of the latest version of the proposal has changed somewhat due to submissions made during the first call.
One of the key issues up for discussion is whether “new breeding technique” (NBT) foods should be considered “genetically modified” in terms of the Code.3 Some submitters objected to the exclusion of NBT foods and “refined ingredients” from the relevant definitions. However, FSANZ “maintains that sufficient scientific justification exists to exclude NBT foods and refined ingredients from pre-market assessment and approval as [genetically modified] foods when they are equivalent in characteristics and of similar low risk as conventional foods”. It said:
FSANZ stands by its conclusion from the [first call for submissions] that certain NBT foods and refined ingredients will be equivalent in risk to conventional foods and should not require pre-market assessment and approval as [genetically modified] foods under the Code. FSANZ also confirms its decision to amend the definitions in the Code for [genetically modified] food to give effect to the conclusion.
Rather than two interacting definitions for “food produced using gene technology” and “gene technology”, the second call for submissions proposes a single definition for “genetically modified food” in their place. Repealing the two interacting definitions, FSANZ instead proposes new definitions for “genetically modified food”, “null segregant”,4 “novel DNA”, and “novel protein”. These new definitions derive from an understanding that food from null segregant organisms, NBT food similar to conventional food, and refined ingredients where no novel DNA or novel protein is present in the food for sale, should be excluded from pre-market safety assessment and approval.
The second call for submissions also proposes explicit exemptions for substances used in cell culture to support the growth and viability of cells, and for the production of cell-cultured food. The second call for submissions also focuses on an “outcomes-based definition” of “genetically modified food”, as opposed to a “process-based” definition. It is intended that the new definitions will focus on the outcome of a process, rather than the process itself. Importantly, “outcome” refers to any genome change that has been introduced, or any resulting change to the derived food.
Submissions for the proposal close on 10 September.
If you have any questions on the matters raised in this article, or would like assistance with your own submission on these proposals, please get in touch with the contacts listed or your usual Bell Gully adviser.
[1] GE-Free New Zealand “Liberalisation of Genetic Engineering Threatens the Environment, Farmers and New Zealand” (press release, 27 November 2023).[2] Plant and Food Research “Plant & Food Research Welcomes Changes To Gene Technology Regulations” (press release, 13 August 2024).[3] NBT foods are derived using the latest set of techniques for altering the genetic makeup of plants and animals.[4] Null segregant organisms descend from genetically modified organisms but do not contain genetic modifications themselves.