Did FSANZ just dismiss statute & develop new guidelines in the same month they released a massive proposal (that depends on the new guidelines)?

Stakeholder Satisfaction Survey. PSGR responds in the context of the ongoing P1055 survey. Should Australians and Kiwis trust FSANZ based on the last 6 years? You tell us!

Please correct PSGR if our evaluations and conclusions here are wrong, or we are missing important information. This is a discussion piece. Comments are open.

Key points:

• FSANZ Stakeholder Satisfaction Survey ends Nov 15, 2024.

• PSGR respond to this survey in light of our experience with the P1055 consultation and research in this document.

• Food Standards Australia New Zealand (FSANZ) Act 1991: Statutory legislation requires risk analysis using the best available scientific evidence.

• New proposed standards are not based on the ‘risk analysis using the best available scientific evidence’ because FSANZ altered the guidelines in the same month the 2024 stage of the P1055 consultation (‘2nd Call’) was released.

• Conventional risk assessment has not been undertaken at all for the P1055 proposal - the science claims that support FSANZ position rests on a ‘2019 review’ and a ‘2021 safety assessment’.

• Risk assessment is claimed to be no longer required because on July 1, 2024, FSANZ updated the Application Handbook.

• FSANZ defer to trade-based Codex which ‘uses the concept of a scientific comparison of the GM food to a conventional counterpart having a history of safe use.’

• The July 30, 2024 2nd Call Consultation ‘Proposal Objectives’ downplayed statutory obligations and emphasised regulatory standards (i.e. the new information in the Application Handbook).

• Then FSANZ us substantial equivalence to claim their proposal is OK - ‘because they have been determined by FSANZ to present the same low risk as conventional food’ does.

• FSANZ claim no risk assessment is required because of the substantial equivalence ‘concept’ even though the FSANZ Act 1991 which gives FSANZ it’s powers, requires this.

• The safety assessment used by FSANZ to claim substantial equivalence carries none of the rigour of standard risk assessment process, including evidence of a systemic review to arrive at the ‘best available evidence’ as required by the FSANZ Act 1991, but merely forms an argument based around substantial equivalence.

• The doctrine of substantial equivalence often fails in the courts, as data excluded by regulatory agencies will be considered by judges and juries.

• The effect, as a European study suggests, may be to ‘disappear’ 94% of GMOs. They would not fulfil the proposed criteria for a GMO and so would not undergo pre-market assessment as a GMO. In addition, FSANZ built in a wide range of exclusions.

• FSANZ new definition based on safety, not risk assessment, would exclude many molecular changes that are detectable through omics and other technologies that may contradict the ‘substantial equivalence’ claim.

• FSANZ cost-benefit analysis did not assess the extent to which New Zealand export industries recognise GMO-free status as a value added benefit; and ignored the fact that global consumers will pay a premium for GMO-free food.

• As PSGR showed in our response, FSANZ ignored more cautious European measures around new breeding technologies.

• This is the largest deregulatory effort in the history of FSANZ.

• Our comments on the Stakeholder Consultation are at the end of the document.

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Food Standards Australia New Zealand (FSANZ) are currently surveying Stakeholder Satisfaction. Consultation ends November 15.

PSGR’s response to the Stakeholder consultation is made in light of the background activities by FSANZ which have led to the 2024 P1055 consultation which proposes to amend the definitions in the Australia New Zealand Food Standards Code. PSGR’s response is based around how FSANZ have approached the scientific evidence relating to the safety of gene edited foods consulted in the past few years, how this then positions FSANZ as a regulator, particularly with regards to FSANZ’s legal obligations to protect food safety and the importance of process in ensuring public trust.

FSANZ have a clearly predetermined position on the safety of ‘emerging techniques for genetic modification’ and they believe a new code definition is ‘necessary to ensure regulation keeps pace’ with the technology.

In the Aug 2024 proposal FSANZ confirmed that their assessment concluded that food from NBTs was equivalent:

The ‘low risk’ language is also in the 2023/2024 Annual Report:

FSANZ continued work on Proposal P1055 – Definitions for gene technology and new breeding techniques. The proposal seeks to address new technologies in genetic modification by clarifying what foods should be regulated as genetically modified (GM) foods under the Code. Following consideration of feedback from 1736 submissions received in response to the first round of public consultation in late 2021, FSANZ undertook further assessment and is proposing a new definition for GM food. The proposed new definition will exclude some foods from pre-market assessment and approval as GM foods because they have been determined by FSANZ to present the same low risk as conventional food. A second and final round of public consultation is being held from 30 July – 10 September 2024. Following this consultation, FSANZ will decide whether to approve the proposed change to the Code.

FSANZ’s position - ‘new breeding techniques’ (NBTs) ‘present the same low risk as conventional food - predominantly centres around findings in this paper a ‘a detailed safety assessment’: Final report Review of food derived using new breeding techniques (Dec 2019). However other papers have been released to support FSANZ’s position.

• 2018, August: Preliminary report Review of food derived using new breeding techniques –consultation outcomes.

• 2021 October: Safety assessment: full technical report P1055 – Definitions for gene technology and new breeding techniques.

• Then there is the information that details the actions of foreign jurisdictions.

As FSANZ state: ‘The 1st CFS released on 7 October 2021 sought feedback from interested parties on FSANZ’s assessment and preliminary conclusion about whether to prepare a variation to the Code.’

FSANZ Act 1991:

Under S.13 Functions

(d) to promote consistency between standards in Australia and New Zealand with those used internationally, based on the best available scientific evidence; and

Then there is the issue of risk assessment:

In developing or reviewing a variation of a food regulatory measure: ‘standards to be based on risk analysis using the best available scientific evidence’

The difference between a safety assessment and a risk assessment is subtle but important. Risk assessment is far more comprehensive than safety assessment.

Let’s be clear here - there is no discretion between risk assessment of chemicals or of GMOs in the 2001 legislation. But what we do see, and this is part of the erosion of regulatory quality, is that FSANZ have carved out caveats for GMOs. On page 2:

Case-by-case reviews use ‘safety assessment’ which is conducted within the established risk assessment framework used by FSANZ.

A safety assessment conventionally concerns a one-off application. FSANZ has now adopted the ‘safety assessment’ to justify the P1055 proposal to amend the Code.

As FSANZ stated in 2024 (page 10), a safety assessment is ‘FSANZ’s preferred approach to amending the definitions’.

But this is a shift that may be inconsistent with their obligations in law, and which imposes a lower bar on evidence gathering. As this 6 December 2023 screenshot shows - risk assessment is commonly used to assess risk when a proposal to change the Code is in place - and it’s likely FSANZ hasn’t been audited for 15 years.

FSANZ 2013 paper, Risk Analysis in Food Regulation, explains the term:

But what we can see in the 2013 paper, is a subtle shift away from risk assessment for GMOs.

SUPPLANTING GUIDELINES TO GET THE PROPOSAL OVER THE LINE?

On July 1, 2024, exactly one month before the 2nd Call was announced, FSANZ updated its Applications Handbook for the first time since 2007.

This is no coincidence. It was updated to ensure that their own regulations permitted them to avoid risk assessment.

It explains why on page 7 of the 2nd Call, FSANZ downplayed its statutory obligations.

Wow.

Sorry FSANZ - statutory objectives trump regulatory objectives.

WHAT IS AN NBT?

Interestingly, this 2021 FSANZ FactSheet inform the public that NBTs are a vague term ‘new methods’ that can be applied to just about any new technology they want it to apply to.

The P1055 proposal will involve many GMOs becoming eligible for exemption (pages 23-24).

See PSGR’s Sept 8, 2024 submission here.

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PAST P1055 CONSULTATIONS HAVE IGNORED PUBLIC INPUT

There is substantial evidence FSANZ have - from 2018 - jettisoned good scientific process as required by the FSANZ Act 1991, to build a story around the lack of risk from new breeding techniques.

1. FSANZ did not do risk assessment, as discussed above.

2. FSANZ failed to meaningfully respond to and weigh public concerns about risk.

•   August 2018. 664 Submissions. Preliminary report: Review of food derived using new breeding techniques – consultation outcomes.

•       November 2022. 1736 Submissions. The Stakeholder Feedback Summary Report. Proposal P1055 – Definitions for gene technology and new breeding techniques.

Firstly: FSANZ refused to address scientific and public health issues raised by scientists and the public regarding risk. They commented on comments in an ‘impartial’ manner but refused to engage with salient concerns made by experts and the public. To put it more plainly, the ignored issues raised that concerned risk from new gene edited technologies.

Secondly: As discussed above, the supporting documents used to justify the P1055 proposal contain no evidence of a government agency even trying to apply risk analysis using the best available scientific evidence.

According to PSGR, FSANZ’s governance failure concerns not only replacing ‘risk assessment or analysis’ and supplanting it with vague reviews that contain no systemic review (methodology) to help us understand how FSANZ are transparent and accountable - i.e. trustworthy; but in failing to taking public concerns seriously and assessing the veracity of their concerns.

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WORLD LEADING STANDARDS - OR A RACE TO THE BOTTOM?

FSANZ: Our primary responsibility is to protect public health and safety by ensuring a safe food supply.

FSANZ have a vision. They want to have ‘world-leading standards, safe food for life.’  What does ‘world-leading standards’ mean?

How do ‘world-leading standards’ ensure that the food is safe if FSANZ is undermining its statutory obligations by writing out the obligation to use the best scientific evidence in decision-making?

Does ‘world leading’ ensure our food is safe?

The effect (removing the best available evidence) produces an irreconcilable contradiction that ultimately infers that the ‘world-leading standards’ inevitably defaults FSANZ to elevate one of their strategic objectives above all other objectives.

FSANZ’s strategic objectives set the food safety agency on this conflicted and contradictory path.

-       Food you can trust

-       Helping consumers make informed choices

-       Supporting food systems innovation.

Yes, lower order objects of the FSANZ Act (3(d)) urge FSANZ to establish common rules and promote consistency between regulations - but specifically states:

without reducing the safeguards applying to public health and consumer protection.

And yes, the Functions at 13 require that the Authority facilitates the harmonisation of standards, participates in international negotiations on matters that may be included in standards. At 18c it is noted that the Authority must have regard for

the desirability of an efficient and internationally competitive food industry

Supporting ‘Food systems innovation’ isn’t in the legislation.

An agency that must prioritise ‘supporting food systems innovation’, without the resourcing capacity to dedicate resources to exploring and reviewing the best available scientific evidence on the uncertain safety profile of genetically modified food and highly processed food additives, produces an agency that ultimately is deeply compromised - or corrupted - in day-to-day decisions, as well as long-term strategic decisions.

The looming problem. As industry increases output and release of genetically edited foods, there has not been a commensurate scaling up by FSANZ to assess and weigh (or judge) how risk differentiates when industrial processes advance, production scales up, and the capacity to deploy onto the market at speed, also scales up.

Deregulation of 94% of GMO food product using the proposal that would render GMOs out of scope for pre-market assessment, would further incentivise releases.

The context that is apparent from the P1055 consultation is that FSANZ desire to support food systems innovation has left FSANZ entirely acting as a captured agency, acceding to long-held biotech industry and developer aims to deregulate GMOs as much as possible, to ensure market releases are not impeded by cautious government agencies.

For example, if the ‘world leading’ context where FSANZ focus on ‘supporting food systems innovation’ concerns the current P1055 consultation, does it mean that FSANZ want to be the world leader in broadly deregulating new gene edited ‘new-breeding technologies’ NBTs?

This would have the direct effect of injecting greater quantities of undeclared patented and altered gene edited foods in consumer and export product. Up to 94% of NBTs might avoid premarket assessment.

FSANZ has not developed policy guidelines to enable the agency to navigate uncertainty, nor to demonstrate how the agency might make precautionary decisions to protect health, when the evidence on safety is uncertain but indicative of harm. FSANZ may increasingly be identified as a regulator that cherry-picks solutions to harmonise with industry-based preferences. This includes what information is selected to harmonise with globally.

Ultimately these gaps (and more) position FSANZ as an agency who are directed to fulfilling the objectives of their commercial ‘stakeholders’ rather than community stakeholders and indigenous populations.

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ON THE SURFACE: FSANZ’S CURRENT CORPORATE TRAJECTORY PRODUCES A CAPTURED REGULATOR WHO IS UNABLE TO PROTECT FOOD SAFETY.

Previous consultations for P1055 demonstrates that FSANZ do dismiss, downplay and ignore relevant concerns relating to safety and uncertainty.

After looking at the policy papers, they seem to have revised their own rules so they don’t have to listen to the public, or consider the best available evidence.

The question might be, when the drafters of the FSANZ Act 1991 wrote into the Act that one of the objectives included the prevention of misleading or deceptive conduct - were they talking about the Authority they were establishing?

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PSGRNZ’s RESPONSE TO THE STAKEHOLDER SURVEY

As we stated earlier, PSGR’s response to the Stakeholder consultation is made in light of the background activities by FSANZ which have led to the 2024 P1055 consultation which proposes to amend the definitions in the Australia New Zealand Food Standards Code.

What is evident from the survey text, is that the perspective of corporate industry and the institutions who develop technologies and food products that are regulated by FSANZ, and society and expert communities focussed on food safety, will likely have entirely different perspectives.

FSANZ does segment its ‘stakeholders’ into separate groups. So theoretically, once separated the resulting data might make sense to the Authority.

PSGR can only wonder, in light of the discussion above, whose opinions, expert, lay or industry-focused, are really valued by FSANZ?

Q8 ‘FSANZ is competent’ - the question may be asked ‘at serving whose interests’. As FSANZ is downplaying the ‘best available evidence’ in favour of a ‘comparative approach’ using reasoning that lacks a rigorous scientific approach (in 2019 and 2021) - PSGR perhaps consider FSANZ less competent than interests who seek to avoid pre-market assessment.

Q 10 ‘effective food standards’ - effective for whom? For the GMO developer who would like to evade pre-market assessment, or the consumer who, like consumers all over the world, seeks to be accurately informed of the food they consume, and will pay a premium for GMO-free product?

Q11. What is ‘positive change’? Is it for institutional applicants with financial interests, or the public who would like to trust that their food is safe and nutritious?

What is ‘robust debate’ when, as we have seen in many P1055 consultations, the Authority simply notes different perspectives without considering what might be based on the ‘best available evidence’ for food safety?

Q12 Would industry believe that the ‘best available evidence’ for NBT safety is as FSANZ states in their 2024 Application Handbook, Codex guidelines from nearly 20 years ago which argue for ‘comparative approach’ (also referred to as ‘substantial equivalence’), without assessing new evidence on the literature on how DNA can become rearranged following gene editing processes in target and non-target organisms?

Does ‘facilitating information sharing’ ultimately result in FSANZ being more likely to share information between the industry/institutional sectors who are most resourced to work with FSANZ, due to commercial priorities?

Q13. Working collaboratively with stakeholders - in the interest of new regulatory objectives in the Applications Handbook, or the Objects of the FSANZ Act 1991?

Q14. If an Authority is cautious and rigorous in risk analysis, and transparently and methodologically assesses risk to ensure that babies and children can safely consume food, and that people can know whether the food is genetically modified or it isn’t, we are would consider that this might slow down decision-making, in the public interest.

Q16. When PSGR responded to the P1055 2nd Call we didn’t realise that the Applications Handbook had just been released, and that it’s contents directly related to the consultation we were submitting to. This was not transparently declared.

Response to Q19. 19. FSANZ is considering improvements to the way it communicates information about applications and proposals with stakeholders, including through the Work Plan, dedicated web pages and the FSANZ Consultation Hub supported by notification circulars and the FSANZ News. What changes or additional information would you like included?

This Survey helps the public recognise that FSANZ service orientation is directed to supporting industry applicants as it alludes to regular meetings, actively following up with stakeholders, and working collaboratively with stakeholders.

As a charity who has sent in information to submissions over the years, we have never been invited to such events. Application and planning is usually for industry applicants who wish to ensure market access for their technologies and food products.

It is likely that the 'stakeholders' who would most benefit from any Q19 changes are most likely to be corporate industry and institutions involved in GMO development and release.

We are concerned that these changes would further cement relationships with industry and continue to leave independent scientists and society in general, far less resourced than the chemical and biotechnology sectors.

Q20. FSANZ provides information for Applicants on amending the Food Standards Code primarily through the Application Handbook. Excluding the mandatory requirements for applications, what improvements could be made to the way FSANZ provides information about the process, the costs and any supporting information to assist applicants?

As a civil society charity we would appreciate a question along the lines of 'what areas in the Application Handbook' result in higher order statute and legislation being undermined and trust in FSANZ capacity to steward food safety being put at risk' and 'what risks need to be included and how can we improve risk assessment for food chemicals and GMOs?

It appears that FSANZ are most interested in servicing industry applicants.

Q21. We heard about this survey through a direct email (segmented to stakeholder groups).

22. Thank you for completing the survey. Is there any other constructive feedback you would like to include in your response?

This survey in addition to public documents produced by FSANZ demonstrates that FSANZ is defaulting to a strategic objective of supporting food systems innovation, and that this objective is undermining not only the other strategic objectives (trustworthy food and helping consumers make informed choices), but the statutory legislation that gives FSANZ its powers.

It's highly evident that FSANZ language around being 'world leading' is unfortunately non-sensical when utilised on its own. World leading in defaulting to substantial equivalence in the deregulation of new breeding technologies to avoid pre-market safety assessment? World leading in failing to stop glyphosate being applied as a desiccant to food crops?

'World leading' in a food safety context can only be applied meaningfully to reflect the Object of the FSANZ Act 1991, if FSANZ undertakes risk assessment using robust methods which include a declaration of the methods used to identify information and analyse information. This is not being done.

Best scientific evidence includes reviewing the scientific literature to understand new ways of identifying risk. But we see that this is not happening.

We see that FSANZ recrafted the Application Handbook one month before the P1055 2nd call - to further remove risk assessment as a requirement for alterations to the Code and embed substantial equivalence more strongly into the material. The capacity for consumers to make informed choices would further erode.

FSANZ defer to decades old Codex task force claims and guidelines in the Handbook and fail to draw attention to European Food Safety Authority decisions for new genomic techniques. As you note (p.35) the Codex (Codex 2009) multidisciplinary approach to GM food safety assessment uses the **concept** of a scientific comparison of the GM food to a conventional counterpart having a history of safe use.

The ‘comparative approach’ which is also referred to as ‘substantial equivalence’ is a contested concept which has frequently failed in the courts.

We note that Codex levels for glyphosate rest upon old industry data from decades ago. Codex lock industry data in and fail to address new knowledges of risk.

We understand that FSANZ has no intention of reviewing the best available evidence.

When we look at statements about competency and honesty, when we look at statements that say 'I trust FSANZ' to do what is right' -

We know that industry and developer institutions are far more likely to agree with 'right' and to not question whether FSANZ July 2024 new Application Handbook simply further erodes FSANZ standards, and simply acts as a tool to get P1055 over the line and your proposal passed.

We understand that industry may view FSANZ as driving 'positive change' - when FSANZ deregulate in favour of new technologies, while for the public, 'positive change' would be about ensuring that food safety is far more important than being a 'world leader'.

Fundamentally, this survey sets industry and the public as misaligned characters, inferring different meanings for different issues. We wonder why it is even undertaken.

Unfortunately, FSANZ currently exhibits many of the characteristics of an organisation for which the term 'regulatory capture' provides the best explanation.

ID is ANON-WDGV-A2GV-8