2024 Proposal P1055 (2nd Call) Definitions for gene technology and new breeding techniques

P1055 is a proposal to amend the definitions for 'food produced using gene technology' and 'gene technology' in the Australia New Zealand Food Standards Code (the Code).

Deadline for second call for submissions round - September 10, 2024

For the original PDF and our responses to the Second round P1055 Consultations please go to a copy of our response (PDF) emailed to FSANZ.

PREFACE

FSANZ questions revolve around an unsuitable ‘regulatory outcome’ that exclusively concerns the change of a proposed new definition, not whether the ‘paradigm shift’ proposed might impair officials to fulfill the obligations of Food Standards Australia New Zealand Act 1991 [hereafter, the Act]. Therefore, people outside the scope of questioning will be dismissed by FSANZ in their review of submissions, even if they speak to issues relevant to ensuring a high standard of health protection.

Further, PSGRNZ reluctantly considers that it is likely that FSANZ will also, as it has in the past, ignore or dismiss public input into this consultation through techniques that undermine people who discuss uncertainty and risk in relation to GMOs as they are out of scope with FSANZ chose line of questioning. FSANZ will then, as they have done previously, consequently dismiss and downplay themes which challenge the FSANZ new position of substantial equivalence for gene edited organisms not containing a detectable novel protein/s or detectable novel DNA. Our points follow.

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.

1. FSANZ has repeatedly failed to transparently disclose the balance of comment following the asking of questions in these last two NBT consultations. FSANZ does not report the number of approvals/ disapprovals from responses to the 2018 and 2021 proposal questions, and does not critically engage with expert comment or criticism. [1]

FSANZ then contracted a University of Adelaide study^[2] which conducted two online focus group with only 79 participants, where 33% considered the material to be biased in favour of gene technology. When asked about the Fact Sheet they were provided with, study participants noted they would prefer more information on risks. Participants were expected to judge different scenarios. Graphs were then designed which suggested most participants were ‘generally positive’ about the scenarios.

Such in-depth work can be contrasted against FSANZ failing to disclose the weight of response when, for example, in the November 2022 review, after 1764 people participated in a FSANZ consultation.

2. FSANZ is undermining public trust when it claims to have consulted on their approach to claiming that GMOs that do not contain novel DNA or a novel protein are substantially equivalent to conventionally bred food, but do not quantify the weight of opinion, nor address issues of risk, raised by respondents.

3. This 2024 consultation is flawed in that it does not place consumer safety as a consultation outcome in a consultation that FSANZ itself states is a ‘paradigm shift’. Rather FSANZ seeks approval on ‘clarity’ and other consultation questions that appear primarily designed to foster consent and make it difficult for people to contest the taken-for-granted as safe position of FSANZ. Such comments would likely be outside the scope and then be discounted because they have not directly responded to the submission questions.

4. FSANZ evades discussing uncertainty, risk and precaution. FSANZ has not articulated the changing nature of scientific information, nor disclosed any methodology for evaluating FSANZ’s position on off-target risk from gene edited organisms.

FSANZ has not conducted a risk assessment (RA), not methodologically reviewed the literature to ensure that their approach is unbiased. FSANZ have instead resorted to a proxy ‘safety’ assessment which is a distortion of regulatory RA convention.

5. FSANZ has questions relating to the ‘food industry’ – however this lumps industrial processed food producers working high volume, low margin products with artisan farmers, growers and producers marketing premium quality goods who lack industrial foods power, reach and turnover.

FSANZ does not acknowledge the price-premium when consumers recognise food is GMO-free, and the discounted prices that will be paid when consumers consider the food is tainted, or likely to be tainted with GMOs of an uncertain risk-status.

FSANZ should distinguish between conventional growers and farmers who are likely to benefit from case-by-case process-based risk assessment where GMOs are always transparently declared and industrial suppliers who will benefit from non-declaration.

6. FSANZ thus evades discussion which call attention to fundamental differences in the scale and pace of biotechnology development and the incentivisation of market release of patented GMO products that derive from stronger IP rights than developers using conventional breeding techniques can access.

7. FSANZ demonstrated in an as yet unpublished August 2, 2024 webinar that it has arrived at an internally agreed consensus position that unless a gene edited NBT contains novel DNA or a novel protein, it will be regarded as safe because any other genome alterations occur in nature (i.e. conventionally bred food products).

It is likely, based on 2018 and 2022 summaries of feedback that FSANZ will resort to equivalent evasive tactics. These will discount public, including expert opinion, that contradicts FSANZ white papers which contain the reasoning which underpins FSANZ apparent internal consensus position.

8. The substantial equivalence claim is a technique historically applied by the biotechnology industry to infer that GMOs are as safe as conventionally bred foods. The technique enables regulatory authorities to avoid comprehensive risk assessment. Information and data which contradicts this viewpoint, which fails to address not only alterations at the biochemical level, but the potential for adverse off-target environmental effects, has been discounted and dismissed in the past.

9. FSANZ does not structure the questions to ascertain if respondents agree that this second round consultation will achieve the object of the Act. Their concern is narrow and unfit for policy-making.

10. FSANZ does not permit people to simply disagree with the proposed new definition, while it acknowledges that this a ‘paradigm shift’ in FSANZ’s regulatory approach to regulating and defining genetically modified organisms.

11. The questions in this consultation constrain the capacity for respondents to criticise broader claims and in-house reasoning that justify FSANZ paradigm altering regulatory approach, from process to outcomes based. The wording used does not clearly provide an avenue for the public to disagree with the new definition for genetically modified foods that would be inserted into the Code.

By constraining question scopes to clarity on specific terms, and then shaping questions which involve asking for evidence that is difficult to access due to the absence of funding channels and policy to support such work, FSANZ have forced the public to respond in such a way that eliminates specific disagreement with their proposal and tacitly concurs with their position.

12. The text of this current consultation has been drafted so that FSANZ can claim that it has been consulted.

13. FSANZ does not permit people to talk more broadly of safety and risk. FSANZ controls the scope of response to reflect s.3(c) of the Act, but not s.3(a), (b) and (d). The questions in the consultation do not ask if the public and stakeholders consider that the intended regulatory outcome will ensure a high standard of public health protection.

Public health protection arises from FSANZ taking account of the full spectrum of hazard and risk. This has been ‘written out’ by FSANZ claiming that gene-edited food that does not result in a novel protein is not a GMO, and is therefore substantially equivalent to conventional food. FSANZ has then conducted a safety assessment as a proxy for a process-based methodological risk assessment which would follow established protocols.

FSANZ do not allow for uncertainty pertaining to known unknowns and unknown unknowns which may be revealed in future. Neither FSANZ nor expert communities, can know if novel proteins/metabolites are present, if genome changes are outside the consideration of the screening authority. Detection methods have a particular protein or compound in mind, and will not usually detect new substances (for example genetic contamination by foreign DNA).

16. Safety should always come first. Yet FSANZ regulatory outcome focuses on the biotechnology/GMO developer industry-friendly the definition for GM food, so that it will be easy to comply with and enforce, and is consistent. To all appearances, FSANZ hijacks the public purpose, while bending to accommodate industry/developer demands.

CONSULTATION QUESTIONS:

Q 1a. Is the new definition for ‘genetically modified food’ clear? If not, which parts of the definition could be clearer?

Q 1b. Will the new definition for ‘genetically modified food’ produce the intended regulatory outcomes, as described in section 3.2 and Table 3?

Q 2a. Is the new definition for ‘novel DNA’ clear? If not, which parts of the definition could be clearer?

Q 2b. Will the new definition for ‘novel DNA’ produce the intended regulatory outcomes, as described in section 3.3 and Table 3?

Q 3. Do you believe additional clarifying information would be helpful to accompany the proposed new definitions? If yes, what additional information would be most helpful?

Q 4. Do you have any information (e.g. studies or data) that may be able to quantify the impacts to consumers that may arise from the proposed changes?

Q 5. Have all the major impacts to consumers from the proposed approach been identified in the consideration of costs and benefits? Please provide evidence (where possible) to support the inclusion and magnitude of other impacts.

Q 6. Do you have any information (e.g. studies or data) that may be able to quantify the impacts to the food industry that may arise from the proposed changes?

Q 7. Have all the major impacts to the food industry from the proposed approach been identified in the consideration of costs and benefits? Please provide evidence such as studies or data to support the inclusion and magnitude of other impacts.

Q 8. Have all the major impacts to government from the proposed approach been identified in the consideration of costs and benefits? Please provide evidence such as studies or data to support the inclusion and magnitude of other impacts.

For the original PDF and our responses to the Second round P1055 Consultations please go to a copy of our response (PDF) emailed to FSANZ.

REFERENCES:

[1] E.g. discussed here: JR Bruning (September 7, 2024) Is our food safety authority failing the fairness and impartiality test? https://dailytelegraph.co.nz/opinion/is-our-food-safety-authority-failing-the-fairness-and-impartiality-test/

[2] Ankeny RA and Harms R (2021) Focus groups on consumers' responses to the use of New Breeding Techniques (NBTs) in food production. https://digital.library.adelaide.edu.au/dspace/handle/2440/137654

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