Food safety regulator Food Standards Australia New Zealand (FSANZ) is holding a second round of public consultation on a new definition for genetically modified food.
FSANZ’s chief executive said a new Code definition for GM food was necessary to ensure regulation keeps pace with new techniques for genetic modification, collectively referred to as new breeding techniques (NBTs).
FSANZ says feedback provided through the first round of consultation has been taken into account in developing new and revised definitions that are simpler and clearer. This latest feedback round closes on 10 September.
The SMC asked experts to comment.
Dr Revel Drummond, Senior scientist, Plant & Food Research Ltd, comments:
“FSANZ is a strong and trusted regulator, they are well connected and respected as members of the global food safety regulatory network.
“FSANZ has a history of using good processes to update rules and regulations. This current review of gene technologies in food has followed an excellent and wide-ranging consultative approach in an effort to deliver the best possible regulations. Technologists might generally wish for these reviews to be faster but good process comes first.
“This update of the regulations is needed urgently as the science and food technology that uses and/or relies on gene technologies is now well beyond what the regulators were able to anticipate at the time of writing. Further, in the words of FSANZ, ‘a clear distinction between GM techniques and conventional breeding no longer exists’ (see page 4, paragraph 2 of the consultation document). These facts pose significant challenges in the application and enforcement of the regulations as they are currently written.
“The current proposal, in a major change from the original, has moved to suggesting an outcome-based rule for the new regulations. FSANZ have admirably taken on comments from their stakeholders during the consultation process. I welcome this change as it is both scientifically defensible and inherently future proof. Many countries are moving towards (or already have) similar frameworks so global regulatory alignment will also be improved. However, closer to home how these new rules interface with the OGTR in Australia and the new (soon to be announced) regulator in New Zealand will be an area needing immediate consideration.
“In the new regulations much will hinge on the use of the term novel DNA which is newly (re)defined in the proposal. Any food determined to contain novel DNA will be regulated as a ‘GM food’. It is my opinion that the careful consideration of what constitutes novel in this context is vital to these regulations working in the future, and that taking prescriptive approaches here will ultimately fail. It is my sincere hope that stakeholders will submit ideas to further improve the definition of novel DNA, without generating a long list of prescribed novelty.
“In the counter case, where a food does not contain novel DNA, but nonetheless has had its genome altered by gene technologies other parts of the Food Standards Code may well still apply. Under the current and proposed system, no matter how it is made, any food can require FSANZ approval if it is deemed to be a novel food (See page 18 section 2.3.4 of the consultation document and Sections 1.1.2-8 and 1.5.1 of the Code). This part of the code is invoked when a food has no history of consumption in Australia or New Zealand due to, amongst other things, an altered composition or structure.
“Despite FSANZs own comment (quoted above) what is missing from the current proposal is the ability to regulate more than the binary state of ‘like traditional breeding’ vs. ‘not like traditional breeding’. I would prefer to see a tiered risk assessment structure for the different types of modification from traditional breeding, wide crosses, and mutation breeding up to simple edits, complex edits, DNA replacement, and DNA addition. In its current state or this tiered structure how the regulations would interact with the definition of novel when applied to the DNA but also to the final food product would need to be carefully considered.
“The use of GM and gene editing in food is now well established and FSANZ states ‘it should be noted that no safety issues have been identified in any GM food assessed by FSANZ over the last 25 years’ (See page 18 footnotes of the consultation document). Originally the products were focussed on production traits that made it easier to grow certain crops. However, recently more consumer-focused products have been developed and these are likely to make more of an impact on the average consumer’s day to day life. All the examples given below are designed to have a trait that significantly enhances some aspect of the consumer experience compared to the existing cultivars.
- Golden Rice (GM): contains provitamin A – treats vitamin A deficiency
- GABA tomato (GenEd): contains GABA – may help lower hypertension
- Empress tomato (GM): contains anthocyanins – increases dietary antioxidants
- PinkGlow Pineapple (GM): contains lycopene – increases dietary antioxidants
- Conscious greens (GenEd): removes bitter compound – makes nutrient dense leafy greens palatable
- Arctic Apple (GM): prevents browning in cut fruit – reduces food waste”
Conflict of interest statement: Dr Revel Drummond is employed by Plant and Food Research, which has a research investment portfolio that includes both genetic modification and gene editing. He is investigating the potential of gene technologies to improve production and consumer traits in plants in a New Zealand context.
Dr Alec Foster, Portfolio Lead Bioproducts, Scion, comments:
“As New Zealand reviews its Genetic Engineering legislation to align more closely with Australia and international standards, it’s timely that FSANZ is amending the definitions for ‘food produced using gene technology’ and ‘gene technology’ in the Australia New Zealand Food Standards Code. The proposed amendments are important for New Zealand, aligning our regulatory frameworks with modern technologies. The CSIRO estimates synthetic biology opportunity in Food and Agriculture sector alone could be worth $19.2 billion and create 31,000 jobs by 2040. New Zealand could realise similar benefits.
“The changes to the code are important because they provide a tangible route to market for innovations that are in development across research institutes and universities in both countries. The previous outdated definitions did not take into consideration the technological developments that have occurred. The new definition for ‘genetically modified food’ is based on the presence of novel DNA in the genome of an organism, providing a clearer, more scientifically accurate framework. This is in line with the international practices and recent changes proposed in the EU in regard to their regulations.
“At Scion, New Zealand’s leading institute for industrial biotechnology, we welcome these proposed changes. The exemption for precision fermentation products used as food additives, processing aids, or nutritive substances is particularly promising. This could enable companies we collaborate with to develop high-value nutritional intermediates for our dairy industry, enzymes for production processes, and functional foods with health benefits. These innovations have the potential to significantly enhance New Zealand’s food and biotechnology sectors, creating new economic opportunities and improving product offerings.
“The proposed changes in the definitions are also important to other research institutes who are using New Breeding Techniques (NBTs) in both plant and animal breeding for food products. These technologies allow us to achieve our goals more precisely, efficiently, and often more quickly than traditional breeding methods. Importantly, it reiterates that the risk between products developed using NBTs and those developed through current breeding methods are similar. The benefits for consumers and farmers are substantial: foods with longer shelf lives reducing waste, increased resistance to pests and diseases, and reducing the need for pesticides and fertilisers. Cheaper food, that is better for the environment.
“These amendments also maintain clear distinctions for products involving novel DNA insertion. Such products will continue to be regulated by FSANZ under existing frameworks, including labelling requirements. This ensures consumer awareness of traditionally defined genetically modified organisms while allowing for innovation in other areas. The approach balances scientific advancement with transparency and consumer choice.
“Overall, the proposal represents a positive step forward. While some refinements are needed to enhance clarity, transparency, and implementation details, the proposed changes appear to be a significant improvement. These amendments have the potential to modernise our regulatory framework and foster innovation in the food and biotechnology sectors.
“We anticipate that greater alignment with Australia in genetic technology regulation and through FSANZ is crucial for New Zealand. It enables collaborative research, facilitates public education, and opens up new markets for our products. Harmonisation will make New Zealand more competitive on the global stage and attract investment in our biotechnology sector. I believe with the regulatory changes, New Zealand has the opportunity to become a leader in sustainable, innovative food production, benefiting our economy, environment, and health of our population.”
Conflict of interest statement: Dr Alec Foster is an Executive Committee Member BiotechNZ, and Part of the Technical Advisory Group for Genetic Technologies for MBIE
Professor Jack Heinemann, Professor of Genetics, University of Canterbury, comments:
“FSANZ proposes to de-regulate some products of gene technology by defining them as not products of gene technology rather than requiring evidence that they are safe to use as food. To achieve this, FSANZ makes several logical leaps that I don’t believe are sound science or policy.
“First, that only the addition of DNA to an organism can make an organism with ‘novel DNA’. Removing DNA from a genome leaves that genome with a novel combination of DNA sequences too. Traits that matter to consumers, such as plants resistant to herbicides and thus likely to be contaminated with higher herbicide residues, can be created by removing particular DNA sequences. Consumers that want fewer herbicides in their food may not want to accelerate the number of kinds of herbicide tolerant plants being produced.
“Second, that similarities – between conventional plants, animals, fungi, or bacteria and their GMO counterparts created using NBTs – rather than their differences is enough to presume the safety of the GMOs made using NBTs.
“Third, that those who make genetically modified organisms will have the incentive and traceable liability to ensure that products of NBTs are exactly alike conventional organisms, for example, by having no unintentionally inserted novel DNA. We already know that this isn’t likely to work.
“There is the recent case of a company removing DNA from the cattle genome to make hornless cows. This is exactly the kind of product that FSANZ would de-regulate. The manufacturer failed to report the insertion of thousands of additional unintended ‘novel DNA’ sequences, including whole antibiotic resistance genes. It was a one-off review by the US FDA that found them, not the company that first claimed no new DNA had been inserted. Other research shows that NBTs are so efficient that during their use, DNA contaminating necessary laboratory reagents are routinely inserted into the organism.
“De-regulation could massively increase the scale of production using NBTs to make products FSANZ wants to remove from regulatory oversight, without substituting any commensurate standard of product verification. Anyone, not just companies, could use NBTs to modify food producing organisms. At scale, it could be impossible to know who released a harmful organism or to find a diagnostic for the organism causing harm. The mandatory pre-market characterisation that FSANZ proposes to remove is also an insurance policy for those who want to release safe GMOs into the food supply.”
Conflict of interest statement: “Expert witness for councils on GMO provisions and High Court on determination of genome editing as a process that creates GMOs, former member of the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management of the Convention on Biological Diversity, author IPCC 6th Report.”