The Gene Technology Bill: Our Feedback – aka ‘Submission’

Feedback to the Health Committee on the Gene technology Bill

From:

Drs Matthew Shelton, Alison Goodwin and Cindy de Villiers (officers), on behalf of New Zealand Doctors Speaking Out with Science (NZDSOS) Inc Society.

NZDSOS is a society of health professionals who advocate for health freedom and sovereignty. We represent over 300 doctors, dentists, veterinarians and pharmacists and are supported by over 50,000 active subscribers.

We request to speak to this submission at the Select Committee.

Abbreviations:

GMO: Genetically modified organisms

GE: Genetic editing

Bill: Gene Technology Bill

NZ BORA: New Zealand Bill of Rights Acts

Position

NZDSOS is strongly opposed to the Bill.

Summary Points

• Inadequate safety data.
  • The Bill allows for deregulation of genetic modification techniques such gene editing and synthetic biology, techniques that do not have sufficient short-term and no long-term safety data.
  • The Bill would lower the regulatory burden but substantially increase risks to human health and the environment.
• The abandonment of the Precautionary Principle.
  • The Bill abandons this principle of decision making that is widely adopted in situations that impact the environment, human health and food safety.
• New Zealanders’ Sovereignty is threatened.
  • The Bill is a very real and unacceptable threat to the sovereignty of citizens and the country given its mandatory authorisation of modified organisms, its ignoring of the NZ BORA and its removal of choice from consumers.
• Covid pandemic lessons learnt.
  • The time frame of the Bill appears to be deliberately ignoring the current Phase 2 of the Royal Commission on Covid-19, which is looking at safety issues of the covid-19 vaccinations that are novel biotech / genetic medical interventions. It is premature to assume the injections will be found to be safe.
  • Covid-19 with its biotech origins could not be contained, prevented, recall or remediated. It spread without limit and has become an enduring part of the hill health landscape. Decreasing regulation of gene technologies will increase risks of similar incidents.
• Emergency authorisation.
  • The Bill contains vague wording regarding emergency use, seemingly to allow genetically modified biological products to be mandated again on the New Zealand population without due consultations
• There is a social contract between the people and the government, and between both and private industry, that is being breached, That contract disallows what this Bill intends, to declare open season on the human genome and biosphere for commercial profits, hidden behind the ideological excuse of climate change, the Prime Minister’s declared justification. Again, this notion is far from “settled” science.
• Other considerations as outlined.

Recommendations

Withdraw the Bill and continue New Zealand’s GE free status.

Discussion of the Summary Points

Inadequate Safety Data

The Bill appears to operate on the principle that GMOs are generally safe and appears not to require thorough proof of safety. We note the following points which fly in the face of the position of automatic safety of these products that the government appears to be taking.

• No long-term human health studies have adequately addressed safety issues, with the scientific community calling for research on these risks. https://www.nature.com/articles/s41591-021-01333-6. 
• The following points are extremely concerning.
  • The government’s contention that gene editing using CRISPR has become more exact and therefore the need for testing, regulation, labeling, etc is reduced and in most cases eliminated. This is highly disputable, and anyway accuracy does not equate with safety and to suggest this is to ignore fundamental scientific understanding, as well as the Precautionary Principle that advocates for caution when a policy might cause harm to the public or the environment.
  • CRISPR gene editing has been shown to lead to “functional aberrant DNA fragments and altered cell proliferation” which will need to be proven not to cause long-term harm before GE can be considered safe.https://pubmed.ncbi.nlm.nih.gov/36180232/ 
  • Off-target adverse effects are inherent in the process of GE, making bio-synthesis “more difficult to characterise and manage properly”. These off-target effects are poorly understand with unknown long-term effects.  GMOs can not be considered safe in the medium and long-term.  https://www.mdpi.com/2227-9040/11/5/298
  • Given the lack of traceability that is proposed, the effects of these genetic changes that may appear years later will be almost impossible to detect as consumers will not be aware whether they have consumed GMO products or not.
  • We are unable to find research regarding the cumulative health effects of multiple gene edits which could enter humans or the environment, nor research into multi-generational effects. Without understanding these effects, safety cannot be assured or assumed.
• The effect of genetic modifications in humans, such as using CRISPR technology are poorly understood but very concerning. As expressed by Dr Guy Hatchard (paraphrased):
  • Gene editing by definition crosses the cell membrane, where it edits the command and control system of the whole organism and redefines genetic processes known to be fundamental to our physical health and mental well being. In the case of humans and animals this necessarily affects the conscious capacities of the organism.
  • Thus everything that we as humans treasure in life, our immunity, strength, health, appearance, intelligence, growth, ambition, emotions and our unique personal identity is threatened.
  • Living systems – from cellular processes to entire ecosystems – are in intricate balance and the effects on these cellular processes from GMOs cannot be fully anticipated or controlled. Even minor errors in manipulation may have cascading, irreversible and potentially devastating impacts.
  • Biotechnology experimentation and GE is putting someone’s else’s creation into the midst of our path of individual evolution. Not only can it disrupt memory and thereby alter our future thoughts and actions, as is known to happen following organ transplants, but it can disrupt our capacity to connect with the source of life itself. It can disconnect the individual from the flow of the bliss of life.
    • “Multiple studies have demonstrated that memories can be encoded and stored in cells. Evidence suggests that these memories can then be transferred between individuals through organ transplantation….but there has been a noticeable lack of research focused on cellular memory, and more rigorous investigations are needed to uncover how cells participate in memory and the extent to which these processes influence human behaviour and cognition.” https://pubmed.ncbi.nlm.nih.gov/39640131/
  • The introduction of gene altered and synthetic foods cut off the supply of nature’s intelligence to our digestive system. Even more powerful effects of genetic medical interventions will disrupt our health and well being.
• Genetic engineering carries with it risks of “contamination/inbreeding, competition with natural species, ecosystem damage…horizontal gene transfer, new kinds of outbreak disease; creation of drug resistant germs; accidental escape of laboratory strains and increase disease burden if the recipient organisms is a pathogenic microorganism”.https://www.researchgate.net/publication/337632444_Genetically_modified_foods_GMOs_a_review_of_genetic_engineering
• GE techniques can produce unintended effects which predicated increased risk assessment rather than decreased regulation. https://pubmed.ncbi.nlm.nih.gov/36365450/  https://enveurope.springeropen.com/articles/10.1186/s12302-020-00361-2
• There is considerable evidence which should concern every human, that GE can control human behaviour. https://globe.global/can-biotechnology-control-human-behaviour/
• A long history of credible research has highlighted health concerns in animals including:
  • intestinal damage and immune dysregulation.
  • significant kidney, liver, pancreas and pituitary (hormone controller) disease.
  • cancers.
  • increased mortality. Effect of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine – PubMed; Republished study: long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize – PubMed
• Concerningly, this peer-reviewed scientific research was met with dismissal and hostility. https://www.jstor.org/stable/43671260
• Independent scientific researchers and scholars have in a joint statement noted that the “claimed consensus [on GMO safety] is shown to be an artificial construct that has been falsely perpetuated through diverse flora.” https://www.researchgate.net/publication/271832528_No_scientific_consensus_on_GMO_safety
• Once GMOs are released into the environment, this action and its consequences are irreversible.

We can thus find no evidence of any benefits that outweigh the substantial risk of harm to human and environmental health as well as the economy and trade.

Abandonment of the Precautionary Principle

The Precautionary Principle

• advocates for caution when a policy might cause harm to the public or the environment
• advocates for decision makers to foresee and prevent harm before it occurs
• places the burden of proof regarding safety with the proponent
• has been widely adopted, particularly in situations that impact environmental protection, health and food safety

NZDSOS is thus extremely concerned that this principle appears to be abandoned. This is evidenced by the safety of GE being assumed and that safety does not have to be proven by government, regulatory bodies or industry.

Furthermore, this approach was disastrous in ensuring the health of New Zealanders during the covid pandemic, with harms well exceeding benefits of the GE covid-19 vaccinations now being well established. 

The Bill allow for the introduction of genetically modified food and organisms, the latter which are likely to include gene-based medical interventions which can be approved for emergency use without consideration of the Precautionary Principle.

As stated by Koller et. al., “it is therefore, crucial to not only assess the risks of the individual events, but also their potential interactions which can trigger direct and indirect effects with adverse impacts. It is necessary to develop hypotheses and specific scenarios to explore interactions between NGT [New Genomic Techniques] organisms and possible pathways to harm from the perspective of the precautionary principle.” https://link.springer.com/article/10.1186/s12302-023-00734-3

Sovereignty and Consumer Choice

Clause 50 of the Bill requires that “medical activities” be granted mandatory medical authorisation if approved by 2 “recognised overseas authorities” in equivalent circumstances.  This does not apply ONLY if the (sole) Regulator considers that doing so would result in imminent risk of death, serious illness or serious injury to people or the environment. 

However, the Bill does not seek to address either the criteria by which the Regulator makes this assessment of imminent risk, nor does it address the potential medium and long-term risks of the activity to people or the environment. 

We posit that it is dangerous for regulated organisms to be granted mandatory authorisation without assessment by local institutions. It would not be uncommon for individual regulators to miss vital factors that may be relevant to New Zealand. Furthermore, it is good practice, and in the case of GMOs, essential for widespread consultation and assessment prior to authorisation.

Furthermore, global consumers have consistently rejected genetically modified foods. https://www.treasury.govt.nz/sites/default/files/2024-05/pc-inq-nzfrff-dr-064-sustainability-council-attachments-2-5.pdf

The Bill will completely exempt most gene altered products from any kind of scrutiny, regulation or labeling. New Zealanders expect transparency when accessing health and food. This Bill would remove choices in these domains, exposing New Zealanders to possible serious long-term effects on their health and the environment of the country, not to mention the impact on the fundamental rights as citizens. 

Given the very early science on GE, the negative data of the past thirty years and the lack of long-term research, these products are by nature experimental. Yet again we see the New Zealand government attempting by stealth to violate the NZ BORA provision 10 which states that “Every person has the right not to be subjected to medical or scientific experimentation without that person’s consent.”

This Bill is a very real and unacceptable threat to the sovereignty of citizens and the country.

Covid Pandemic Lessons

The time frame of the Bill appears to be deliberately ignoring the current Phase 2 of the Royal Commission on Covid-19 which is looking at safety issues of the covid-19 vaccinations, which are novel biotech / GE medical interventions.

The intended and unintended consequences of gene technology were highlighted during the covid-19 pandemic. Arguments are rightly made for enhanced regulation rather than less given:

• the now largely accepted origins of SARS-Cov-2 as being a lab-leak. https://www.telegraph.co.uk/news/2024/11/21/prof-tim-spector-covid-likely-to-have-come-from-a-lab-leak/ and https://www.wsj.com/politics/national-security/fbi-covid-19-pandemic-lab-leak-theory-dfbd8a51?mod=Searchresults_pos1&page=1
• that lab accidents appear to be common. https://pmc.ncbi.nlm.nih.gov/articles/PMC9142354/#:
• that covid-19 could not be contained, prevented, recalled or remediated and has now become an  enduring part of the spectrum of infectious illnesses.
• that research continues on biological weapons that could be far deadlier than covid-19 with engineered SARS viruses that have a 10 000 to 1 million increase in viral growth and a “3x increase in lethality in mice”. https://www.hsgac.senate.gov/wp-content/uploads/imo/media/doc/Ebright%20Testimony%20Updated.pdf

The consequences of the rushed authorisation of the covid-19 vaccines are born out by the findings of significant DNA contamination and the documented mechanisms of harm. Urgent Letter to the NZ Prime Minister: Evidence on Comirnaty DNA Contamination.

Calls are now being made to ban DNA/RNA vaccines in humans, animals and agricultural produce. https://zenodo.org/records/14873302

How on earth are people to trust what minimal provisions for safety the Bill contains? Two governments of opposing ideologies have overseen the dismantling of pharmacovigilance, and allowed the deaths and disability of many people (and the hiding of this calamity) and certainly many more into the future, from ‘whoopsie’ contamination of their first flagship biotech product, forced onto the world’s population.

These facts, along with many others will be presented by NZDSOS and other groups to the Royal Commission.  It is hard to believe that the government is in all honesty trying to pass this Bill for the good of the New Zealand people it is supposed to serve when it has not examined the consequences of the GE origins of SARS-CoV-2 nor the effect of the GE covid-19 vaccines.

Emergency authorisations

Clause 52 enables the Minister to grant emergency authorisation in relation to regulated organisms if there is a threat to the health and safety of people or the environment, where such a threat likely outweighs the risks of the activity. It grants extensive powers to the government that even with the best of intentions can be misused.

While the Minister is required to be satisfied that the risks outweigh the harm, the Minister only needs to be reliant on “a relevant Minister” and the Regulator to make this assessment. Given that automatic approval of GMOs will be mandated by this bill, the Regulator is unlikely to be fully aware of the risks, due to not having undertaken its own assessment. Furthermore, the manner in which a relevant Minister makes a decision regarding a threat is not outlined and would be open to trivial justification.

Widespread consultation is particularly vital in the case of an emergency as the pressure “to do something” in a moment of crisis can outweigh considered and essential assessment of the intended and unintended effects of authorisation of GMOs, as the last 5 years have proven.

This clause also raises the possibility of mandatory medical interventions of genetically engineered organisms, once again in contravention of the NZ BORA.

Other points of concern

• Inadequate regulation.
  • The Regulator will be a single decision-maker supported by a Technical Advisory Committee and a Māori Advisory Committee. The position appears to be conflicted given that the Regulator will be an “independent statutory officer” acting independently of the Environmental Protection Authority and the Minister but will be “subject to general policy directions given by the Minister”. We are thus gravely concerned that the Regulator
    • will not be subject to criticism and feedback from the scientific and medical community.
    • will be unable to act independently but would rather be “rubber stamping” government policy.
  • The Regulatory Impact Statement warns of a rushed process and significant gaps. This report appears to have been ignored in the preparation of this Bill.
• Removal of liability.
  • Clause 187 of the Bill removes liability for mistakes, accidents and misjudgements and protects those involved in GE from civil and criminal liability as long as actions have been taken in “good faith”. This clause is extremely concerning as if liability is removed, harmful actions can continue to be wrought on the New Zealand public and environment for any means, such as profit,  without any regard for consequence.
• Risks to farming and economy.
  • New Zealand will lose its reputation as “clean and green” which may significantly impact its economy.
  • Control and traceability of new GMOs will be non-existent.
  • Farmers will lose the ability to preserve the integrity of GE-free crops due to removal of supply chain segregation.
  • New Zealand produce may face public backlash as happened in the UK and Australia in response to the use of Bovaer in cattle.
  • GE farming is the antithesis of regenerative farming, which is increasingly considered as the gold standard for environmental and human health. Furthermore the use of GE products in farming, facilitates the use of patents which would result in the corporatisation of New Zealand farms, threatening the long-held heritage of family farms.
  • Any clean-up is at the cost of the contaminated party rather than the producer. This is immoral and unethical and increases the burden on New Zealand producers unacceptably.
• Ethical considerations.
  • Ethical challenges relating to moral and religious views need to be debated in public rather than ignored.
  • Robust regulation needs to be in place to ensure animal welfare in relation to genetic engineering research and farming.
  • The Bill ignores the recommendation of the Royal Commission on GM which has identified the need for a Bio Ethics Council and national biotechnology strategy.
• Renaming of GMOs.
  • GMOs would be defined as “regulated organisms”; a step that not only creates confusion but is also deceptive to the public.
• Betrayal of Social Contracts.
  • There is a social contract between the people and government, and between both and private industry, that is being breached. That contract disallows what this bill intends, to declare open season on the human genome and biosphere, for commercial profits, hidden beyond the ideological excuse of climate change, the Prime Minister’s declared justification. Again, this notion is far from “settled’ science, if such a thing exists and robust public discussion about this ideology has not taken place.  

Recommendations

The Bill in its entirety needs to be scrapped. It completely misrepresents major threats. It does not accord with the principle of legality –  that legislation must be viewed first and foremost through NZ BORA, which dictates how a government must treat its people, not the other way round.

Health needs to be built from the bottom up rather than the top down as is the current pharmaceutical and vaccination model. Resources are best spent improving access to nature, encouraging the benefits of sun exposure, providing clean, GE-free food and unadulterated water.  These measures can truly be considered safe.

Government must recognise the abrogation of its duty to its electors (who have NOT consented nor been properly consulted) that this Bill represents.

An inquiry should take place into the circumstances of this Bill, its timing and rushed nature, and any conflicts of interest amongst its proponents. Those employed in biotech cannot be allowed to endanger citizens. 

NZDSOS supports and endorses the submissions of Physicians & Scientists for Global Responsibility, GE-Free New Zealand and Dr Guy Hatchard amongst many others that are opposed to this Bill.