FSANZ’S paradigm shift in gene-edited food regulation to excluding a wide range of gene edited foods from being categorised as GMOs.
FSANZ claim these GMO foods are 'substantially equivalent' to conventional foods, but a key element of risk assessment - the scale & pace of biotech development and release - is out of the question.
I’m grateful to The Spectator Australia for publishing this latest piece today. You can get the first month free if you sign up. This is the first article published in mainstream media in Australia or New Zealand discussing the FSANZ proposal to render a large chunk of gene edited foods ‘new breeding techniques’ (NBTs) as non-GMO.
If the broad categories of NBT food are declared non-GMO because of the proposed ‘paradigm change in regulation’ NBTs will evade all labelling requirements.
Points I am making here:
FSANZ must provide: ‘adequate information to make informed choices’.
If NBT GMO ‘substantially equivalent’ to conventional food. No label needed.
AU/NZ joins a global push to exclude some NBTs from pre-market assessment.
Reports of NBT consultations fail to disclose weighting of public responses.
FSANZ used to recognise the value of process-based risk assessment.
FSANZ pivot to technical clarity, prioritising the demands of corporate sector.
Framing compares NBTs to conventional food but dismisses scalar development.
Reviews/assessments lead with conventional food equivalence - predetermination.
The public recognise NBTs as a category of GMO.
FSANZ ignores the evidence that consumers pay a premium for GMO-free food.
My conclusion - FSANZ would rather place a burden on consumers by forcing them to navigate around a ‘not knowing’, i.e. contradict FSANZ's legal obligation to support ‘informed choices’; than conduct pre-market safety process-based safety assessments (place the burden on industry) and require NBTs to be labelled.
1. FSANZ has a legal obligation: ‘provision of adequate information to make informed choices’.
The object (s.3) of the Food Standards Australia New Zealand Act 1991 - requires that FSANZ staff work to protect health and achieve 4 goals:
2. If Gene edited food is declared ‘substantially equivalent’ to conventionally bred food it won’t be labelled.
If there is novel DNA or novel protein it will be declared a GMO.
But FSANZ claim that insertions, deletions and nulls segregants that don’t end up as novel DNA or novel proteins will be excluded - because … this also happens with conventional food.
But if the legislation changes to a rule that is based around this single functional outcome (has the corporation declared it to have novel DNA or novel protein?) the ‘rule’ (based on substantial equivalence of NBTs with conventional food) is locked in.
Current process-based, case-by-case regulation aims to judge risk as risk changes.
For example, if the ‘novel DNA/protein’ GMO definition got locked in the legislation - changing knowledge (e.g. that shows gene editing changes really are different from natural changes) would simply not have to be considered.
FSANZ proposes to also exempt the following, (even if a big fat biotech patent is slapped on it):
Cell-cultured food: Food derived from animal cell lines grown in cell culture and then further processed to resemble traditional meat or seafood products.
Food derived from null segregants: A GMO that lost the insertion. End effect after biotech scientists have segregated chromosomes or deleted insertions. ‘The implication is that ‘segregants’ have been rebuilt into organisms that are not genetically modified.’
Food from grafted plants: where that part does not contain novel DNA or *novel protein.
Food additives, processing aids and nutritive substances.
A wide range of food that has undergone the process of genetic modification, will not be declared a GMO. But - FSANZ is legally obliged to ensure that people have ‘adequate information to make informed choices’.
3. AU/NZ joins a global push to exclude some NBTs from pre-market assessment (and labelling).
‘New breeding techniques’ (NBTs) = ‘precision breeding techniques’ (PBTs in the UK) and ‘new genomic techniques’ (NGTs in Europe).
UK groups have protested that the UK policy-makers moved too quickly and didn’t listen to them.
In Europe the organisation tasked with assessing NGTs, ANSES, stated in 2023 that
‘certain potential risks appear repeatedly in these case studies’ and that ‘These include risks linked to unexpected changes in the composition of the plant, which could give rise to nutritional, allergenicity or toxicity problems, or medium- and long-term environmental risks, such as the risk of gene flow from edited plants to compatible wild or cultivated populations.’
Recently, the European Food Safety Authority (EFSA) an published a July 2024 opinion that NGT plants would be equivalent to conventionally bred plants.
Professor Michael Antoniou and Claire Robinson disagreed, stating that:
EFSA ignores scientific publications showing that NGTs can create mutations that are different from those arising naturally, from conventional breeding, or even from random mutagenesis breeding (where plant material is subjected to radiation or treatment with chemicals to induce mutations). Therefore, scientists have warned that the mutations arising from the application of NGTs can present very different and more serious risks compared with conventional or random mutagenesis breeding.
While deregulation serves the biotech revolution; and the dominant agri-food system players retailing FMCGs: shelf stable ultraprocessed foods and the ultra-refined and synthesised inputs, not all EU companies agree.
4. Reports of NBT consultations fail to disclose weighting of public responses.
FSANZ has conducted several consultations on ‘new breeding techniques’ (NBTs):
February 2018. Consultation paper: Food derived using new breeding techniques
August 2018. Preliminary report: Review of food derived using new breeding techniques – consultation outcomes
December 2019. Final report: Review of food derived using new breeding techniques.
October 2021. (1st call for submissions.) Safety assessment: full technical report. P1055 – Definitions for gene technology and new breeding techniques.
November 2022. The Stakeholder Feedback Summary Report. Proposal P1055 – Definitions for gene technology and new breeding techniques.
And now this latest one, deadline Sept 10:
FSANZ August 2018 Preliminary report: consultation outcomes, and the November 2022 Stakeholder Feedback summary failed to transparently disclose the weight of opinions of the public, corporate industry, biotech developer groups, and groups concerned with human and environmental health. Instead FSANZ stated ‘views are divided’ and ‘many submitters desire’ and a number of concerns’.
While FSANZ have a duty to ensure food is safe, trustworthy and people must have access to information so as to make an informed choice, FSANZ has not disclosed the balance of opinion following the questions.
5. FSANZ used to recognise the value of process-based risk assessment.
December 2019. Final report: Review of food derived using new breeding techniques.
FSANZ notes that process-based definitions for triggering pre-market approval of GM foods have been widely adopted around the world. In terms of their advantages, such definitions can provide a simple and clear way to signal the regulatory status of certain products and make regulations more predictable in terms of outcome 9 . Capturing products on the basis of the process used can also provide an effective mechanism to prevent regulatory gaps in coverage and ensure comprehensive risk assessments are applied equally to all products derived using a specific technology.
The main disadvantage of process-based definitions is that they can quickly become outdated and therefore require periodic review and potentially need amendment as technology changes. Also, because some NBTs can result in foods that are identical or equivalent to conventional foods, a further disadvantage of process-based definitions is that they can result in identical products being regulated differently.
The second paragraph is correct. But this equally applies to decisions where legislation locks in NBTs as not a GMO and not suitable for pre-market assessment because the regulator claims any risks are the same as in conventional food. But in time, the proposed legislation might age badly - scientists might find that gene edited food may have unintended changes from gene editing that differ from random mutations in conventionally bred food.
Risk assessment should not stand still, and regulators should look for new ways to target risk. Companies will only declare what is required. Without curiosity-driven research, risk may not be understood.
6. FSANZ pivot to technical clarity, prioritises the demands of corporate sector.
FSANZ has adopted a simplified proposal in the 2nd Call for submissions claiming that feedback following the 1st call for submissions that the proposed approach was ‘too complex’ (November 2022 The Stakeholder Feedback Summary Report).
The proposed definitions revolve around ease of use for biotechnology developers and applicants. Is FSANZ undermining section 3, Object of the Act??
We can ask if there is bias towards large corporate industries? The public are not privy to information that may suggest that particular industry sectors considered the approach too complex, while many groups considered that complexity, i.e. process based to understand the elements of hazard and risk was necessary.
7. NBTs are compared with conventional food. Scalability - a key element of risk is ignored.
FSANZ is considering whether pre-market safety assessments are ‘justified in terms of risk’. However, their interpretation of risk when it concerns a single functional outcome, and declare equivalent risk in conventional breeds, is narrowly framed and patently disingenuous.
FSANZ in August 2018 stated:
key questions for FSANZ are whether the definitions in the Code remain fit for purpose, given the rapid pace of technological change, and whether requiring a pre-market safety assessment for foods derived from NBTs is justified in terms of risk.
Yet as I have stated, FSANZ appear unconcerned with:
‘the scale and pace with which NBTs can be developed in the laboratory and deployed into the environment, including into human bodies. It is important to understand scale and pace because risk assessment must not only identify hazards, the potential of an organism to cause harm to human health and/or the environment; but must concern itself with risk, the likelihood of a harm to occur and the severity of the estimated damage. … And what of scale gearing? Risk must be considered along the entire technological trajectory.’
The Centre for Integrated Research in Biosafety, University of Canterbury’s 2021 submission was quoted by FSANZ in the November 2022 Stakeholder Report:
‘Conventional breeding is limited by the spontaneous mutation rate, generation time of the organism, species, size of the organism, power of applicable intellectual property rights instruments, and number of breeders. NBTs have far fewer limitations. Their difference in radicalism and pace is, after all, why they have value and concomitantly how they can cause harm.’
The November 2022 The Stakeholder Feedback Summary Report reveals how FSANZ circled around concerns about the scale and pace of development, failing to evaluate the merit in the concerns. Again, FSANZ preferred to simply contrast some submitters concerns against others claims that there is no risk and not evaluate the context of assertions.
Biotech development as scaled up, incentivised by the relative ease and lower barriers to use with new gene editing tools. FSANZ have not attempted to recognise the potential increase in risk when both laboratory development, and release into human bodies and the environment is scaled up, which may be amplified should NBTs evade being declared a GMO.
The October 2021 Safety assessment reveals how FSANZ continues to persistently frame discussion regarding off-target risk by directing the reader to examples of the equivalent risks occurring with natural breeding.
8. FSANZ habitually deflects concerns citing ‘substantial equivalence’ with conventional food.
In a recent webinar FSANZ staff drew on the 2019 review as central to their belief that NBTs are equivalent to conventional food, unless they produce a novel DNA or a novel protein.
The Final report: Review of food derived using new breeding techniques - where (p.17)
The comparison focussed on the presence of foreign DNA in the final organism used for food as well as the potential for novel characteristics to be present in derived food products. A food characteristic is considered novel if it has not previously been present in a conventional food, or if it has been altered and now falls outside the documented biological range for conventional food.
Off-target and unintentional changes are discussed in the October 2021 Safety assessment. Somewhat misleadingly, FSANZ leads with a discussion on changes that occur in conventional food (part 2), before discussing the potential for this to occur in genome editing (part 3). The section on Food derived using new breeding techniques repeatedly emphasises the equivalence of NBTs with conventional food.
The language strongly suggests that FSANZ has crafted the text of the 2024 consultation to persuade the public to agree with their position that the end-point of a novel DNA/protein must be the only characteristic to declare a GMO - a GMO.
It’s evidence FSANZ’s top level priority in this submission is to arrive at a definition that is ‘not complex’ but is clear and objective, easy to comply with and enforce, and consistent.
9. The public recognise NBTs as a category of GMO.
‘general consumers do not conceptually separate NBTs from other genetic technologies’
10. FSANZ ignores the evidence that consumers pay a premium for GMO-free food.
Consumers globally prefer to pay a premium for GMO-free. Historically, food fraud, adulteration and contamination has been a major challenge at the consumer and regulatory level. Parents of infants and young children pay most attention to ingredient labels. But by relegating many ingredients to not being declared, people must then search specifically for GMO-free labels. Biotech developers and agri-food corporations have less onerous obligations - with the burden being placed on the consumer.
Globally there is strong evidence people will choose to avoid GMO food and pay a price premiums for non-GMOs. Much of the literature involves researchers researching the willingness to pay for GMOs and identifying strategies to reduce barriers to negative perceptions of GMO food. This may reflect funding parameters.
FSANZ assessment of Costs and Benefits consider none of these issues and the so-called benefits are unproven and hypothetical:
‘because new technologies, such as NBTs, although not widely available, could be useful tools that may contribute to more sustainable food production, climate change resilience and mitigation, cheaper food and innovative food products which benefit the food and agriculture sectors, where eventually consumers will benefit from these products of innovation (Brookes & Barfoot 2020; Qaim 2020; Kovak et al. 2022).’
The claim of ‘cheaper, higher quality and new food products’ has not been demonstrated in the USA, the most deregulated country with the highest level of GMO plantings. GMO’s targeted for food use in the USA is commonly used as stockfeed and as refined ingredients in ultraprocessed foods.
Real-world results reveal common aversion to GMO including gene edited foods.
People observe gene edited (NBT) foods in a continuum of foods modified using earlier technologies and would choose not to eat them, but would choose not to eat them less than foods modified with older technologies. Researchers often conclude that while people’s preference is values based, with more education and different language, particularly that emphasises nutrition, that gene edited food may become more acceptable. Language centres around potential nutritional benefits and educating people, for example:
Consumer preferences - Snapshot of recent studies:
Australia. (2022) P1055 – Consumer Survey Report Consumers’ perceptions of and attitudes towards genetically modified foods. FSANZ
China. David L. Ortega, Wen Lin, Patrick S. Ward, (2022) Consumer acceptance of gene-edited food products in China, Food Quality and Preference. doi: 10.1016/j.foodqual.2021.104374.
France and USA. Stéphan Marette, Anne-Célia Disdier, John C. Beghin, A comparison of EU and US consumers’ willingness to pay for gene-edited food: Evidence from apples, Appetite, doi:10.1016/j.appet.2020.105064.
Japan. Akihiro Mine, Sawako Okamoto, Tomoya Myojin, Miki Hamada, Tomoaki Imamura. (2023) Willingness of Japanese people in their 20s, 30s and 40s to pay for genetically modified foods (Preprint). doi: 10.1101/2023.10.29.564581
Russia. Anthony R. Delmond, Jill J. McCluskey, Mirzobobo Yormirzoev, Maria A. Rogova, (2018) Russian consumer willingness to pay for genetically modified food, Food Policy, doi: 10.1016/j.foodpol.2018.02.004.
Vietnam. Tong, Yen Dan Khuu, Dong Toan, Truong Duc Nguyen, Phuong Duy Pham, Nhai (2021) Consumer Responses Towards Non-GM Food: Evidence From Experimental Auctions In Vietnam. International Journal of Food and Agricultural Economics. doi: 10.22004/ag.econ.316274
Koralesky KE, Sirovica LV, Hendricks J, Mills KE,von Keyserlingk MAG,Weary DM (2023) Social acceptance of genetic engineering technology. PLoSONE 18(8):e0290070. doi:10.1371/journal.pone.0290070
One of the biggest barriers to consumer trust is the absence of independent funding for scientists, at a distance from the institutions who develop GMOs, who might independently research new knowledge of risk and advance knowledge on human biology and exposure to genetically modified foods.
Because right now the data supported by industry and by research institutions with problematic financial ties and conflicts of interest, predominantly controls the scientific information that is produced.
In effect there is no scientific freedom to conduct long-term research adverse outcomes from GMO foods in western countries.
In the meantime, consumers are right to be cautious.
@PSGRNZ: recent podcast discussing the consultation.
GE Free NZ: submission template.
Organics Aotearoa: P1055 information.
BioGro: Information on P1055.
Organic and Regenerative Investment Co-operative: Information, survey and template.
Biotechnology - Risk that scales up as efficiency increases. Heinemann on risk management & policy.
I wish to thank J R Brunning for this determined and far reaching analysis. Many of us have become weary more than wary of the battering ram that these bioweapon vaccines represent. I have watched Dr. Harchard print alarming warnings on open ranch GM introduction. He is ignored by a captured Parliament which is a collective imbecile .