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Public good research which might triangulate, affirm or challenge industry claims relating to long- and short-term risk from the chemicals, commercial products and technologies produced by industry, is persistently underfunded at global scale. Similarly, public good research which focuses on nutrition - nutrient mixtures - for neurological health and the prevention of disease at all life stages, is surprisingly under-resourced.

A critical challenge affecting the publics’ right to be independently informed, arises from the pervasive difficulty of accessing and assessing scientific and research information that is independently produced in the public interest. The production of science and research produced by industry-related institutions, dwarfs science and research allocated for public good research. Perhaps the clearest example of this, is the recent declaration by the Stockholm Resilience Institute that the planetary boundary for novel entities, which include manmade chemicals and biotechnologies, has been exceeded, simply because the releases now exceed monitoring and stewardship efforts.

How do we judge scientific information as being credible and trustworthy, when a large proportion of the scientific and peer reviewed literature is funded by institutions with political and/or financial conflicts of interest? How do we weigh such information, if we are to steward health over the longer term?

The points where harmful technologies and/or pollutants - or absence of desirable inputs - fundamentally alter a biological system to a point where there are irreversible tipping points, are rarely linear. Stressors can decouple vital feedback loops, disrupting homeostasis (self-regulating processes that maintain health). They can be subtle and difficult to predict. Pick any biological system - it is impossible to categorically announce when stressors impacting that system will disrupt regulation, and long-term resilience. When do endocrine disruptors disrupt intelligence, mating signals, or egg viability? When do assaults on microbiome diversity - in soil, water or the gut - result in dysbiosis and dysregulation?

The point where technology/pollution - and - biology meets - is fundamentally complex, nuanced and uncertain.

Risk is never black and white, and navigation of uncertainty and complexity will always be an inexact science, because biological vulnerability and/or action to protect a biological space in order to prevent an adverse tipping point - whether a river catchment or a young child - persistently requires human judgement in pervasively uncertain informational environments. Therefore, granularity around risk ultimately obliges decision-makers to traverse ethical and moral questions of system vulnerability. Such judgement should encompass an appreciation of strategic influences that shape the informational landscape.

In 2022-2030 and beyond, it is not just health that must be stewarded, but the scientific and research spaces that are separate from political and private interests.

For twenty-five years, PSGR have occupied a unique space, focussing on the provision of scientific and medical information in often contested political environments, where commercial interests habitually shape, and often control the provision of science information into policy and regulatory environments.

Therefore, for public, barriers not only include time; informational paywalls and techno-biological complexity. Barriers arise from the difficulty of navigating information, disinformation and misinformation. Conflicts of interest can often be hidden by sophisticated public relations messaging, including the construction of websites designed to look as if they are independent. These barriers make it difficult to identify and judge the potential for bias, or conflicts of interest that might impair the integrity of such information and prevent it being trustworthy. These barriers increase with the sequestering of financial and political conflicts of interests inside lobbyist think tanks; private-public partnerships, trade and treaty agreements; political and media financing and regulatory processes. Much of this has arisen from off-shore webs of influence that eclipse New Zealand owner-operator models. Multi-national investment fund managers oversee portfolios of trillions of dollars of assets that not only span agriculture, biotechnology, pharmaceutical, media and the digital sectors, but extend through supply chains.

INSTITUTIONAL IGNORANCE - THE UNDERFUNDING OF NON-COMMERCIAL SCIENCE

Policy and legislative shifts over the past 30 years have prioritised and directed funding to science, law and policy research that promotes innovation and economic advancement.

However, over the same period, science, law and policy experts that might traverse the complex issues that revolve around ethics, risk and judgement, which do not fit the 'innovation' definition - have been deprioritised. For 30 years this work has been asymmetrically underfunded. It is not surprising. Provision of unbiased, public interest information - can conflict with the principles and priorities of powerful institutions. Interdisciplinary science, legal research and ethics-based work has become wickedly difficult to fund if such research lies outside, or potentially contradicts, the policy aims of the state.

When scientific and research communities lack autonomy to carry out such work - scholars, policy-makers, the judiciary, medical doctors and the general public are left on the back-foot when discussing complex socio-biological issues. The barriers to research promote systemic ignorance and the science remains undone. Independent voices can be rare, and careers may be threatened if they deviate from established norms.

Market-driven (neoliberal) trends in governance have directed resources towards market-oriented science/law/deliberation, and away from public good research that might triangulate claims of safety and efficacy by institutions. These trends shape the focus of many of our public science institutions. Many of these institutions, including public universities and Crown Research Institutes fund science using income derived from royalties and patents. These same institutions can then have a vested interest in deregulating technologies - they're developing innovations which will potentially produce an income stream. Deregulation, where institutions do not have to declare research, potentially enable the institutions to expand their research capacity.

As these institutions are tasked in production of innovation, no equal weight is placed upon (often complex and interdisciplinary) stewardship issues, such as exploring pollution or disease risk. This information becomes blackboxed. These issues do not have immediately identifiable opportunities for the production of intellectual property (such as royalties and patents). The incentives, to produce IP, steer research communities in a different direction, resulting in governance failures - remember, these are taxpayer funded, public sector institutions - to provide informational feedback loops into regulation and policy.

This funding distortion excises independent expert communities who could be available to contest industry claims and provide evidence-based feedback loops back into the regulatory 'sphere'. Regulators are then not pressured to engage with complex ethics and uncertain risk-based issues by 'experts'. It is then easier for regulators to dismiss public (lay) claims of harm - noting that the science regulators habitually depend on, is unavailable, due to commercial in confidence clauses that privilege the industry provider.

In current academic and science research funding environments, scholars and scientists are unlikely to publicly criticise technologies and pollutants, because science and research funding is precarious and difficult to secure. They might try to do such work, but it is more likely to be short term and piecemeal. For those outside the royalties and patents merry go-round, where human or environmental research is approved, it is predominantly approved incrementally as short-term funding, with little slack to widen and extend research.

NEW TECHNOLOGIES IDENTIFY RISK - & CAN TRANSFORM SCIENCE & INNOVATION... FOR GOOD

Market prices of technologies and anthropogenic emissions frequently do not reflect the associated costs, as harms or externalities that arise when the exposures from these technologies and emissions are persistent, toxic and bioaccumulative. These harms may produce systemic, knock-on effects.

New technologies have enabled scientists to confirm that environmental risk factors outweigh genetic influences in risk to health and wellbeing. A substantial literature provides evidence that healthy genetic function arises when surrounding environments support optimal health (such as nutrition, beneficial feedback loops, and absence of persistent stressors). Conversely, environmental exposures can contribute to sub-optimum or poor genetic function, and drive disease and disorder. New technologies, such as biomarker assisted technologies, can assist researchers to understand the biological interactions following exposure to a technology.

Harm can occur through (but not limited to) disruption of epigenetic coding and/or endocrinological function; and/or by promoting inflammation and oxidative stress which can produce the conditions for vulnerability to multiple diseases and disorders. These stressor exposures, through their impact on biological and genetic functioning, can potentially impair fertility; intelligence and behaviour; predator-prey relationships; sexual development; and learning and produce the conditions for disease later in life, not just for humans but for all vertebrates.

Unwittingly, blind, or captured environments delay transformative innovation, critical to human resilience and, arguably, national security. For example, it is unlikely New Zealand scientists are testing drinking water for mixture toxicity effects, and conducting laboratory research to identify biomarkers from exposure synergies. As a consequence, there is no research investment at scale looking at enhanced filtration technologies to strip hormone-level chemicals from drinking water, but also to prevent emission of waste stream chemicals into rivers. In parallel, New Zealand's nutritional research environment is poor, and there is no evident science institute engaged in evaluating the relationship of undernutrition with not only metabolic disease, but mental illness and educational performance. Increasing levels of disease and disorder in the human population, lowers productivity, alters intelligence and impairs the capacity to contest future threats. Such high-level work is not undertaken.

SCIENCE ADVICE

The public, scientists and physicians, have legitimate expectations that governments and their regulatory institutions will act to intervene to prevent market failure. This is stewardship, where governing bodies will take precautionary action to protect the public and future generations, from unintended, off-target or accumulating risks that arise from free market activities.

We propose that the provision of science at arm's length from the industry with the political and/or financial conflict of interest will continue to be fraught, due to the challenges and pervasive private-public sector relationships (as institutional contradictions to good governance) that are forecast to intensify in the period 2020-2030.

We continue to observe that white papers, conferences and policy papers relating to governmental science advice, and the role of science advisors, avoid introspection that would draw attention to the problem of science advice when the science used by advisors, primarily is produced by an industry sector with financial or political conflicts of interest, relating to a favourable policy outcome.

Governance and regulatory arenas are intensely political. Billions of dollars are dedicated to science used specifically to support regulatory decision-making and on political lobbying to media interests, officials, elected members and science advisors. Vested commercial interests habitually present scientific evidence to support sufficient safety to authorise release of a technology as certain. However, once deployed into the environment, once there is evidence of human or environmental harm, their energies turn to the production of scientific information that perpetuates uncertainty and doubt in order to avoid and delay regulation.

Our work continues to reflect our charity objectives which include the provision of information and critical analysis in the service of the public’s right to be independently informed on issues concerning genetics, including genetic engineering and biotechnology, and other relevant matters of science and technology. Our Objectives emphasise the importance of informed public debate on issues of science, medicine and technology.

REASONING TO COUNTER TECHNOCRACY

Shifts have occurred from local government, up to the global level, and feedback into local media and regulatory environments, embedding technical processes which make it impossible for decision-makers to reason and weigh uncertain issues against ‘the economy’. This results in often contradictory environments where officials and elected members fail to soundly articulate reasons for their decisions. Instead, institutional patterns persistently operate to deny, dismiss, divert (or decoy) and displace meaningful discussion relating to the evidence in the scientific literature and the stewardship of technologies and regulation of pollutants. However, the processes - as institutional failure to reason are taken outside of the public arena, and rarely elaborated on by the legacy media.

Such contradictory environments consequently inflame and encourage accusations of misinformation and disinformation in the public arena. All too often, many of these intractable issues have been ethically corrupted at an early stage, through the privileging of private interests through secret confidentiality agreements that prohibit transparency and accountability relating to the provenance and quality of the scientific information.

As such it is important for the public, for scientists and physicians, to recognise the political shifts and influences that distort the political and regulatory landscape, if they are to critically assess claims made by powerful interests.

Support for and encouragement of robust transparent and accountable knowledge-making, across lay-public, policy-makers, scientists and expert communities, in order to promote 'public-good' spaces of knowledge and information, is what we do.

Endocrine-disrupting chemicals (EDCs) are chemicals that mimic, block, or interfere with hormones in the body's endocrine system. More than a thousand chemicals have been identified as endocrine disruptors, and many of them are in common use.

Recent studies continue to confirm and solidify decades old research that pointed to the potential for endocrine disrupting chemicals to cause outside-harm at ultra-low doses - such as at parts per billion. An endocrine disruptor might not impact a system at a higher level - where it is not obviously toxic, but also not recognised by the body as hormonally relevant. But once the dose is lower, an outsize effect at this lower dose - a nonmonotonic dose–response curve (NMDRC), can occur.

The relationship contrasts with conventional toxicological perspectives, which accepts that as a dose increases, so does the toxicity. Endocrine disrupting substances, by contrast, can exert a non-linear relationship between dose and effect.

It's not unexpected that evidence that common chemicals cause harm at ultra-low doses - doses that have been accepted by regulators as safe - would be largely downplayed or ignored by regulatory agencies.

However, studies which were once dismissed as 'descriptive' now 'provide a firm basis on which to build a solid theoretical framework.'

As EDC pioneer researchers Ana Soto & Cass Sonnenschein recently stated

In the span of more than 3 decades since we and others pioneered the field of endocrine disruptors, overwhelming evidence has been gathered in animal models and epidemiological studies showing that exposure levels to certain endocrine disruptors, such as BPA, are above those that produce deleterious health effects in animals. It is now well established that humans are exposed to mixtures of numerous endocrine-disrupting chemicals and that these mixtures can produce adverse health effects.

Despite three decades of science, New Zealand lacks policy articulating the health risk of endocrine disrupting chemicals. As PSGR principal researcher Jodie Bruning discovered, New Zealand not only lacks such a policy, but the science policy and research system lacks pathways for scientists to research endocrine disrupting compounds.

Linda Birmbaum has described the endocrine system beautifully:

‘A delicately balanced system of glands and hormones that maintain homeostasis and regulate metabolism, growth, responses to stress, the function of the digestive, cardio‑vascular, renal and immune systems, sexual development and reproduction, and neurobehavioural processes including intelligence. In fact, it governs - virtually every organ and process in the body.’

Scientists are increasingly drawing attention to the ‘tremendous economic as well as human health costs of endocrine-disrupting chemicals’, as a proportion of GDP, (2.3 percent of the USA’s and 1.28% of Europe’s gross domestic product) that are impacting health budgets. (Trasande et al 2015) (Trasande et al 2016) (Attina et al 2016) The 2015 paper concluded that:

‘endocrine disrupting chemical exposures in the EU are likely to contribute substantially to disease and dysfunction across the life course with costs in the hundreds of billions of Euros per year.’[1](Trasande et al 2015)

The 2016 study by Teresa Attina and colleagues advised:

‘Annual healthcare costs and lost earnings in the United States from low-level but daily exposure to hazardous chemicals commonly found in plastic bottles, metal food cans, detergents, flame retardants, toys, cosmetics, and pesticides, exceeds $340 billion.’ (Attina et al 2016)

What is startling, is that scientists could see studies demonstrated many of these problems in epidemiological and laboratory studies over two decades ago - including the potential for transgenerational effects from parental (or grandparental) exposures. The problems extend from neurological risk to the nervous system, intelligence and behaviour; to immunological, reproductive and sexual differentiation and cancer risk. Of course, these problems are not separate.

In 1996 the book Our Stolen Future by Theo Colborn, Dianne Dumanoski and Pete Myers was written thirty years ago. This book remains essential reading for those interested in hormone function and human and environmental health. These issues were evident in 1996:

DDT was known to have estrogenic effects in 1950 - many pesticides since that time have been found to exert estrogenic like effects
Exposure to pesticides in the animal kingdom causes complex problems: thinning eggs, feminisation (lacking males, female birds try to raise eggs together), failure to
Breast milk (and other body fats) accumulates toxins - breast milk can contain levels of endocrine disrupting chemicals 10-40 times the levels greater for daily exposure to an adult
Prenatal exposure to elevated levels synthetic or natural estrogen reduced sperm counts, increased risk in undescended testicals, hypospadias, and possibly testicular tumours in offspring
Sperm count has dropped from 1940 levels (Scientist have known for decades that humans are inefficient breeders, rats much more efficient)
Endometriosis was known to be spontaneously develop in monkeys a decade after their exposure to dioxin (which affects the immune as well as the endocrine system).
Estrogen receptors are the same across the animal kingdom - the paper noted that 'scientists have marvelled over the lack of changeover millions of years of evolution.
The estrogen receptor has been known to be 'promiscuous' for decades in that it so easily consorts with synthetic estrogens
5% of breast cancers were known to be genetic. The single most important risk factor for breast cancer is total estrogen exposure.
The book theorised 20 years ago that an 'imprinting' process sensitised women to estrogen exposure - when men are exposed to excess estrogen they become sensitised and produce excess androgen receptors - making prostates hypersensitive to testosterone and vulnerable to enlargement.
Children exposed to high levels chemicals were found to have frequent ear infections, abnormal immune systems, their bodies wouldn't produce an antibody response when vaccinated.
A single 'hit' at a vulnerable development stage can create problems years later
Behavioural effects and stress response: Rats fed fish contaminated with PCBs were fine in pleasant environments but would 'hyper-react' to even mildly negative events.The effects reached across two generations.
'Every little stress will be magnified' (Helen Daly p.192) This was observed in children exposed to similarly contaminated fish. Babes whose mothers were expsosed showed a 'larger number of abnormal reflexes, a greater immaturity in a lower automatic response score and a poor abituation to repeated disturbances. p.194
Humans and rats both 'habituated poorly' - reacting much more negatively to unpleasant events. The startle response normally erodes as a baby becomes accustomed to a disturbance.
'Scientists understand far more about the role of hormones in development than they do about the biological events that give rise to cancer. Moreover, the evidence shows that humans and animals respond in generally the same way to hormone-disrupting chemicals. The available human data and the effects seen in lab animals show 'a perfect correlation.' Our Stolen Future, 1996, p.86

Example: The thyroid

What is not well understood by the general population, is that it is not just humans that are impacted by endocrine disruptors. All vertebrates can be similarly vulnerable to the health and intelligence impact from exposure to endocrine disruptors. For example, all vertebrates can be harmed by chemicals that impair thyroid function.

Developing babies require the right amount of thyroid hormone, at the right time. Iodine deficiency, which hampers thyroid function, is the world’s main source of mental retardation. The thyroid hormone is central to the metabolism of nearly all tissues, and central to the development of the central nervous system. It's well understood that:

Insufficient iodine during pregnancy and infancy results in neurological and psychological deficits in children.

If this is considered more broadly - the implications of not researching and not understanding chemical exposures to soil, water, air and food are immense. As Barbara Demeneix has written:

‘all vertebrates, from fish and frogs to humans, produce and use thyroid hormone, and that thyroid hormone in all these different species has exactly the same chemical structure.’

This is why, as discussed in Toxic Cocktail, tadpoles can be used to measure the effects of chemicals on thyroid hormone action. The amphibian model is relevant to humans, and importantly, relevant to brain development. Demeneix quotes Jaques Legrand who has said:

‘Without a minimum of thyroid hormone at the right time, a tadpole fails to become a frog and a human baby becomes a cretin’.

Policy & research steps to protect human & environmental health in Aotearoa New Zealand from EDCs:

Doing nothing – not researching human health effects, not monitoring, nor establishing controls where there is evidence that endocrine disrupting substances and mixtures are present, ensures that only the polluting industries are protected. There are policies, principles and research strategies that can ensure nations can move forward responsibly and iteratively to address the knowledge gaps, - including to act where there is evidence of harm, but uncertainty remains, and to regulate in favour of human and environmental health so that future generations are protected:

Confirm EDCs constitute a distinct class of health hazard, equivalent to carcinogens & mutagens.
Adopt legal protections requiring neonatal and paediatric exposure to EDCs are avoided.
Require that substances identified as known or presumed EDs should not be authorized (“no exposure” logic) in products with general population exposure (Demeneix & Slama, 2019, p. 98).
Institute data collection by Statistics New Zealand of synthetic organic compounds and active ingredients imported and produced in New Zealand. This will ensure top-down measuring to assess risk, that may then be bottom up monitored for environmental and human health exposures.
Data collection can identify high volume chemicals that currently evade regulatory controls. e.g. glyphosate.
Once degraded water regions are detected, commence national screening for diffuse levels of synthetic chemicals (agrichemicals, plastics, industrial chemicals, pharmaceuticals, heavy metals, and sewerage).
Precaution must operate at a meta-level. Caution must not be one factor that a decision-maker must take into account. A precautionary approach is more than just part of risk assessment. Precaution is meant to guard against the unknowns and unanticipated consequences’(Iorns, 2018, p. 47).
Fund predictive analytics (data modelling, machine learning) to predict mixture stress from endocrine disruptors, carcinogens and mutagens to biological systems (human and aquatic) (Soil & Health Association and PSGR, 2019).
Monitor oestrogenic, androgenic, thyroid, steroid loads in drinking water.
Institute public funding for environmental and public health expert taskforces (in endocrinology and toxicology) separate from chemical industry influence to:
- Research endocrine disruptors in the New Zealand environment and in human tissues;
- Research pathways EDC can harm health from a basic science ‘public interest’ perspective;
- Share knowledge & work with international public health agencies to develop guidance documents;
- Develop a public health mandate to accelerate test development and validation protocols.
Recognise that in the interests of public health, export markets and environmental integrity, supporting, liaising with and harmonising with best practice jurisdictions (e.g. European Commission) may be the most effective, up to date and transparent method for controlling EDCs in the New Zealand environment.

PSGR have developed a short PDF with these recommendations, much drawn from recommendations by Catherine Iorns, from a 2019 paper by submitted to the European Parliament by Barbara Demeneix and Remy Slama and from our 2019 Freshwater paper:

Download

References

Attina, T., Hauser, R., Sathyanarayana, S., Hunt, P., Bourguignon, J., Myers, J., . . . Trasande, L. (2016). Exposure to endocrine-disrupting chemicals in the USA: a population-based disease burden
and cost analysis. Lancet Diabetes Endocrinol 2016; 4: 996–1003. Lancet Diabetes and Endocrinology, 996-1003.

Colborn, T., Myers, J., & Dumanoski, D. (1997). Our Stolen Future: Are We Threatening Our Fertility, Intelligence, and Survival? A Scientific Detective Story. Plume.

Demeneix B., Toxic Cocktail. Oxford University Press, 2017. p.30.

Demeneix, B., & Slama, R. (2019). Endocrine Disruptors: from Scientific Evidence to Human Health Protection. requested by the European Parliament's Committee
on Petitions. PE 608.866 - March 2019. Brussels: Policy Department for Citizens' Rights and Constitutional Affairs.

Gore, A., Chappell, V., Fenton, S., Flaws, J., Nadal, A., Prins, G., . . . Zoeller, R. (2015). 2015. EDC-2: The Endocrine Society’s Second Scientific Statement on
Endocrine-Disrupting Chemicals. Endocr Rev, 36(6), E1-E150.

Iorns, C. (2018). Permitting Poison: Pesticide Regulation in Aotearoa New Zealand. EPLJ, 456-490.

Trasande, L. (2019). Sicker, Fatter, Poorer: The Urgent Threat of Hormone-Disrupting Chemicals to Our Health and Future . . . and What We Can Do About It. Houghton Mifflin Harcourt.

Introduction Dental "silver" amalgam, a mixture of approximately 50% mercury with a powder of copper, silver, tin and zinc, has been in widespread use since the late 19th century. After considerable initial toxicity concerns by the professions it was soon uncritically endorsed by all western dental associations with successive generations of dental students graduating with a firm belief in amalgam being a safe, effective and durable restoration.

As a restoration for dental decay, it has some useful properties being cheap, durable and easy to use. The tooth does not even need to be dry or the surfaces etched as with the more technically demanding microcrystalline composites. It is therefore a pity that it poisons people as mercury is an accumulative toxic element. The time taken, the degree of harm and the presentation will merely depend on the individual's genetic makeup and the dose.

In 1991, the World Health Organisation (WHO) in an up-date on inorganic mercury, listed dental amalgam as being the largest source of mercury vapour in the non-industrial populations at up to six times the amount from all other combined sources. (1) The WHO based their conclusions on an average of 6-8 fillings. In 1992, the Swedish Government passed legislation to start a 5-year phase-out of dental amalgam that would also allow dentists to be properly trained in safe amalgam removal procedures. In the following decade, the legislation was amended to approve State funded dental treatment when a doctor diagnosed mercury toxicity. However, following escalating complaints that doctors were not helping, the legislation was finally changed so that from 2005 any Swedish citizen could get subsidised amalgam replacement if they thought that they were suffering from adverse mercury effects. This remarkable and so far unique legislation was based on the findings of the Swedish Dental Materials Commission that included representatives from the Swedish Dental Association, the dental schools, the Swedish National Board of Health and Welfare, and the Swedish Association of Dental Mercury Patients. The Commission had tasked Professor Emeritus Maths Berlin with giving an updated risk analysis in environmental medical terms on mercury in dental fillings, based on an overview of scientific literature published between 1997 and 2002 and current knowledge. Berlin had previously led two World Health Organization Task Groups with one on inorganic mercury and the other on methyl-mercury.

The U.S. EPA mercury health standard (2) for elemental mercury exposure (as vapour) is 0.3 micrograms per cubic meter of air (0.3 ug/m3 ). For the average adult breathing 20 m3 of air per day (3) , this amounts to an exposure of 6 micrograms (ug) per day. The corresponding tolerable daily exposure developed in a report for the Canadian Health Agency, Health Canada, is .014 ug/kg body weight or 1 ug/day for average adult. (3) The U.S. Agency for Toxic Substances and Disease Registry (ASTDR) standard Minimum Risk Level (MRL) for chronic- duration inhalation exposure (365 days or more) to mercury vapour is 0.2 ug Hg/m3 , which translates to approximately 4 ug/day for the average adult. (4) The range of mercury exposure levels found in people with amalgam fillings by the World Health Organization Scientific Panel on Mercury was 3 to 70 ug per day (3) , with other medical studies finding up to 200 ug/day in gum chewers or people who grind their teeth. (6) (11) (16) (17) (18) The average exposure was above 10 ug/day3- . (18) The average mercury exposure for a Canadian adult with amalgam fillings was found in the Health Canada study to be 9 ug/day. (2) In a large German University study with 20,000 tested subjects, the average exposure from fillings was over 10 ug/day and over 50% of all those with six or more amalgam fillings had daily exposure exceeding the EPA health guideline. (17)

Studies have consistently found modern high copper non gamma-two amalgams have greater release of mercury vapour than conventional silver amalgams. (21-23) Recent studies have concluded that because of the high mercury release levels of modern amalgams, mercury poisoning from amalgam fillings is widespread throughout the population. (17) (18) (22)

Levels found in persons with amalgam fillings can be over 10 times the Health Canada TDI, and more than the EPA health standard for mercury vapour. Thus persons with amalgam fillings have levels of intraoral mercury vapour and body exposure levels higher than the level considered to have significant health risk and proportional to the number and extent of amalgam surfaces, but other factors such as chewing gum and drinking hot liquids influence the intake. Swedish research by Skare et al concluded that the average citizen was conservatively estimated to have 32 micrograms of mercury in faeces daily with an uptake of 12 micrograms of mercury into their bloodstream and tissues every 24 hours. (6) The worst case individual in the study was measured at 190 micrograms per day of mercury in faeces, with an estimated bloodstream and tissue uptake of 70 micrograms per day. Thus the average citizen could have absorbed up to or over 100mg of mercury after 25 years. Skare’s findings need to be compared with the EPA limit of 2 parts per billion for safe drinking water. Notably, the WHO Scientific Panel concluded that a safe level of mercury exposure below which no adverse effects occur has never been established. (3)

The majority of New Zealand children born in the 50-60s have lived with dental amalgam fillings since primary school when the school dental nurses in the “murder houses” drilled and filled any tooth that had the slightest surface defect or even a deep natural groove. This went by the euphemistic name of “filling the valleys” or essentially prophylactic odontotomy, i.e. making a hole and filling it to prevent a hole. Regarding this, a Health Department paper revealed that in 1968 21-year-old adults had an average of 16 amalgam fillings with 15-year-old teenagers averaging 13 fillings. (24)

In 1976, the New Zealand Health Department sent out an unusual notice to all dental personnel that essentially requested that they only drill into teeth showing decay. The underlying reason for this has remained mysterious but there are some interesting and plausible reasons. The first fluoride experiment was carried out in Hastings in the preceding years and had been a complete failure with the control town of Napier actually showing the same or even less dental “decay”. Estimation of decay was based on the numbers of decayed, missing or filled teeth (the DMF score). However, most of the results related to the F or filled teeth. The inspectors thus counted the number of fillings but it was then realised that the dental nurses had been instructed to treat all teeth that had even minor surface defects as being decayed but were essentially non-carious. The research protocol was therefore covertly altered and concealed in the published document.

Some 20 years later a revealing paper appeared in the New Zealand Dental journal where the author euphemistically stated that “changes in dental practice” resulted in a decrease in dental fillings. That decrease was identified as 30% in 1977 and an astounding 64% by 1981. (25) This would have dropped the average from 16 to between 7 and 8 or what is generally accepted as the norm by the WHO. Obviously that decrease in “decay” had far less to do with fluoride than the fact that dental nurses and dentists were no longer making the holes or “filling the valleys”. However, the 1996 Health Canada report on dental amalgam revealed that the maximum tolerable daily intake (TDI) of mercury vapour would be reached from 4 average sized amalgam fillings (or 8 tooth surfaces) for a 70kg adult when based on industrial safety levels (3) and this needs to be additionally considered in view of the current amalgam loading.

The symptoms and signs of mercury toxicity listed by amalgam manufacturers Dentsply-Caulk and IvoclarVivadent in their 1997 Manufacturer’s Safety Data Sheets (MSDS) included the following adverse health effects from chronic inhalation and/or ingestion: tremor, fatigue, headaches, irritability, excitability, depression, insomnia, loss of memory, hallucinations, psychiatric disorders, mental deterioration and resentment of criticism. (26) However, the covert underlying common denominator is usually missed as all of these symptoms and signs can occur with other more readily diagnosable conditions, and as medical students let alone doctors have not been instructed to look at teeth. Mercury release from amalgam has to occur when dissimilar metals are placed in the hot, salty and frequently acidic saliva due to oral galvanism and electrolysis. This is fundamental school chemistry.

Alzheimer's Senile Dementia (AD)

The genetic factor in AD is well known. There is a blood test for AD called Apo-lipoprotein E genotyping or apo-E for short. Two papers on this appeared between ’96 and ‘98 when Dr. Alan Roses from Duke University revealed that Apo-E genotyping was related to the risk of early onset AD. (27) There are 3 genotypes E2, E3 and E4 with 6 possible combinations as we inherit from both parents, i.e. E2/2, E2/3, E2/4, E3/3, E3/4, E4/4. The last of these has the greatest risk at 70% chance of early onset AD before age 70. The onset of AD in those with E3/4 comes about 10 years later and the E3/3 again about 10 years later. Those with the E2 have to live to a very old age before any signs develop. Research subsequently revealed that about 1-2% of the population has the E4/4, 15-20% the E3/4 and 50-60% E3/3. However, the underlying reason remained a mystery and further research only complicated matters. For instance, one paper revealed that Africans in Africa with E4/4 did not get AD but Africans in the USA did and the authors wondered about different diets.

In 1999, Professor Boyd Haley, Chair of Chemistry, at Kentucky University, Lexington, and a leading researcher into mercury, revealed to a group of doctors that there was no mystery about the underlying reason for apo-E genotyping. It lay in the biochemistry. Apo-E has 299 amino acids with different ratios of cysteine and arginine at position 112 and 158. Apo-E2 has 2 cysteines, apo-E3 one cysteine and one arginine, and apo-E4 two arginines. As arginine, unlike cysteine, lacks the sulphydryl (SH) groups to potentially bind bivalent metals such as mercury, lead, copper or zinc, it would be logical to suspect the possibility of increased metal accumulation in those chronically exposed individuals who had not inherited apo-E2. Notably, mercury has been proven to cause all the unique microscopic brain lesions that are found in the AD brain at autopsy. Rats exposed to mercury vapour at levels found in people’s mouths with dental amalgam for a few hours a day, developed AD lesions within 2 weeks (28) and a remarkable research paper came out of Calgary University in 2001 showing how in a nerve cell culture the nerve sheath “melted away” when minute amounts of mercury were placed in the culture solution. (29)

Apo-E genotyping was then performed on hundreds of New Zealand patients considered to be suffering from adverse health effects from their dental amalgam to see if there was a statistically valid association and in 2003, the journal of Alzheimer’s Disease published the first paper showing the association between amalgam and the risk of developing AD. (30) This was followed 3 years later with a second paper showing that chronic fatigue, depression and memory loss were also markedly increased in those with the apo-E4 and amalgam fillings, together with evidence that removal of amalgam combined with proper protection and detoxification resulted in a significant reduction of the symptoms. (31) This research has been independently confirmed by the findings of another research group at Uppsala University, Finland, who also investigated the effects of protected amalgam removal. (32)

It would seem appropriate that all patients with memory loss and the other symptoms listed above need to be evaluated for mercury toxicity from dental amalgam. AD could be either preventable or at least prevented from deteriorating in those with dental amalgam. Proper advice and where to get the best treatment in the USA is available (33) and it is of paramount importance that the process is done correctly. Good science is now therefore proving that mercury is related to the onset of these common problems and, as the WHO had confirmed, that amalgam is the biggest source of mercury vapour in the non-industrially exposed populations1 , we need to seriously look at this dental material.

Mercury and the blood

It is an established fact that approximately 80% of inhaled mercury is retained to then travel to the main target organs, namely, brain, heart and kidneys. However, although levels in the blood may not be significantly elevated, mercury covertly does two highly relevant things. Firstly, it binds to haemoglobin and reduces that red cell’s oxygen binding capacity and secondly, it kills lymphocytes. Unfortunately, standard laboratory tests will detect neither. The laboratory checks total haemoglobin and an assumption is made that the oxyhaemoglobin (OxHb) proportion was normal. However, research at Colorado University with a Co-oximeter differentiating total Hb, OxHb and CarboxyHb has confirmed in some hundreds of symptomatic patients with amalgam that their OxHb levels were at least 20 per cent lower confirming what other research has shown. (34) This would equate to having a litre of blood missing as far as oxygen carrying capacity and would quite likely result in being "tired all the time" or chronic fatigue syndrome, a diagnosis that does nothing to help the patient.

The lymphocyte effect was discovered when fresh blood was centrifuged and the white cell layer removed. A propidium iodide viability stain then identified the viable vs. the non-viable proportion with a significant incidence of the latter being found. Subsequently, a culture of lymphocytes was exposed to a level of mercury usually found in the blood of people with amalgam fillings and considered safe. (35) After 4 days incubation over 80 per cent had become non-viable compared to only 3 per cent in the control culture. This could be a reason why the white blood cell reference range has progressively widened over the past century as the body’s internal monitoring systems may be detecting a lymphocyte “deficiency” as the lymphocyte “policemen” are being eliminated as soon as they leave the academy and go on the beat.

Two papers on cancer with one on breast (36) and another on colon (37) have studied natural Killer (NK) lymphocyte activity and outcome. Both found that those patients with “active” lymphocytes had a much better outcome than those with “inactive” NK cells. There was a 47% 5-year mortality in the breast cancer patients with non-reactive NK cells vs. 4% in those with active NK cells. Neither of the papers' authors discussed what, if anything, could influence activity but a definitive cause is there if this description is changed from active to viable and inactive to dead as non-viable mercury contaminated NK cells would certainly be inactive.

Michael E Godfrey, MBBS, FACAM, FACNEM, is Medical Director of the Bay of Plenty Environmental Health Clinic and head of Clinical Thermography, both of Tauranga, New Zealand

With acknowledgement to B Windham PhD, Research Director for DAMS International, for relevant links and references.

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(Europe) http://caulk.com/MSDSDFU/DispersalloyMSDS. Accessed February 1998
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disease. Int. Psychogeriatr. 9 (Suppl.1)(1997):277-288 and 317-321
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binding of GTP to tubulin in rat brain. Similarity to molecular lesion in Alzheimer’s disease brain,
Neurotoxicology 1997;18(2):315-324
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integrity of nerve growth cones following in vitro exposure to mercury. NeuroReport 12 (2001):733-737
(http://movies.commons.ucalgary.ca/mercury)
30. Godfrey ME, Wojcik DP and Krone CA. Apolipoprotein E genotyping as a potential biomarker for
mercury neurotoxicity. J.Alz.Disease 2003;5:189-195
31. Wojcik DP, Godfrey ME, Christie D and Haley BE. Mercury Toxicity presenting as Chronic Fatigue,
Memory Impairment and Depression : Diagnosis, Treatment, Susceptibility, and Outcomes in a New
Zealand General Practice Setting. (1994- 2005)Neuroendocrinological Letters 2006
32. Lindh U, Hudecek R, Danersund A, Eriksson S, Lindvall A. Removal of dental amalgam and other metal
alloys supported by antioxidant therapy alleviates symptoms and improves quality of life in patients with
amalgam-associated ill health. Neuro Endocrinol Lett. 2002;23(5-6):459-482
33. www.hugnet.com
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1967;1:323–327. MEDLINE | CrossRef
35. Huggins HA Medical Implications of Dental Mercury: A Review. Explore (2007)3; 2:110-117
36. Head J, Wang R, Elliott RL and McCoy JL. Assessment of immunologic competence and host reactivity
against tumor antigens in breast cancer patients. Prognostic value and rationale of immunotherapy
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37. Imai K, Matsuyama S, Miyake S, Suga K, et al. Natural cytotoxic activity of peripheral-blood
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25;356(9244):1795-9

Further reading:

Genchi G, Sinicropi M, Carocci A, Lauria G, Catalano A. Mercury Exposure and Heart Diseases

Published: 12 January 2017 International Journal of Environmental Research and Public Health 14(1),74 doi:10.3390/ijerph14010074

In this series of PSGR discussions (click on the image), JR Bruning talks with physicians and scientists who are independent thinkers and courageous leaders in breaking out of siloed approaches to human and environmental health. PSGR is working to draw attention to expert approaches that, while reflecting knowledge established in the scientific literature, may challenge existing paradigms, commercial perspectives and conventional practice/research patterns.

Go to @PSGRNZ on YouTube or Odysee to watch, and @PSGRNZ on Substack or Spotify to listen to the podcast version.

This work often draws attention to different conceptions of risk and resilience; science and critical scholarship that can navigate open-ended environments; and intractable feedback loops. I.e., systemic uncertainty. This work requires courage, curiosity and the application of different forms of interdisciplinary expertise and judgement that can appear daunting for many.

Dr Bruce Lanphear. Professor of Health Sciences at Simon Fraser University and public health physician & paediatric epidemiologist: Chemical Exposures & the Toxic Risks. Making Sense of Science, Public Health & Economic Benefit.

Dr David Bell. Public health physician, co-lead University of Leeds REPPARE project, former medical officer and scientist at the WHO: Public resources into a big biotech push? Ethically dubious imagined returns.

Interview with Professor Jack Heinemann, Director of the Centre for Integrated Research in Biosafety (INBI); Tessa Hiscox and Andrew McCabe. Centre for Integrated Research in Biosafety (INBI), at New Zealand's University of Canterbury, & some of the co-authors of INBI's Submission to the Parliament Health Committee on the Gene Technology Bill 2024.: Proposed NZ Gene Tech Bill: Scientists say risk tiering framework is not risk proportionate 'scientific case is not made'. 'New Zealand would have the most extreme combination in the world of proposed species breadth (microorganisms, plants, animals) and process (e.g. SDN2) exemptions.'

Professor Julia Rucklidge. Director of Te Puna Toiora, the Mental Health and Nutrition Research Lab at the University of Canterbury. Multinutrients for pregnancy & depression. 1st ever RCT NUTRIMUM trial. Benefits for mum & babies. 'What should mums be getting during pregnancy to make sure that their kids have the best opportunity of a good start to life.'

Professor Ian Brighthope. Founding Director, World of Wellness International - Beyond surviving, towards thriving. wowintl.org, Founding President ACNEM. Principle lecturer 1980-2007. What advice would an integrative medicine trailblazer give recent graduates? 'If we mess up the biochemistry then we mess up the genes.'

Professor Ashley Gearhardt. University of Michigan, Clinical Science Area Chair. Ultraprocessed food. Can UPFs meet the same benchmarks for an addictive substance as tobacco & alcohol? 'We're seeing those same behavioural indicators of addiction - the loss of control & the intense cravings. The inability to cut down, even if you know you have a life-threatening illness.'

Dr Jen Unwin. 2-part interview. Chartered Clinical & Health Psychologist - 30 years UK NHS. D.Psy, FBPs, C.Psychol. PhD. Co-Founder: Food Addiction Solutions (FAS) UK. [1] Game-changing UK doctors' clinic. 10 years of reversing diabetes!

Dr Jen Unwin. Part 2 [2] If we don't recognise food addiction as a substance use disorder, how can we treat it?

Professor Pablo Gregorini. 2-part interview. Lincoln University, Head of the Centre of Excellence in Designing Future Productive Landscapes and Pastoral Livestock Production Lab. [1] Is eating meat ethical? Taking another look at climate & environment & animal production systems.

Professor Pablo Gregorini. Part 2. [2] What happens when we give livestock more choice in a grazing system? Animal plant choice influences human cellular health - Metabolomic profiling & phytonutrients.

Dr Simon Thornley. MBChB, MPH (hons), PhD. Public Health Physician, lecturer and researcher in the department of Epidemiology and Biostatistics, University of Auckland. Having a good hard look at the evidence. On public health & locked in med school paradigms. 'If you look at the nutrition world from an insulin-carbohydrate-sugar perspective, there's no discordance between trying to improve your overall metabolic health with a diet that both helps your waistline, your pancreas & your coronary arteries.'

Professor Grant Schofield. Professor of Public Health at Auckland University of Technology (AUT) & Director of AUT's Human Potential Centre. Extending your health span to live your best (mental & metabolic) life. 'They were right. I should never have been appointed. It's a hopeless job for someone who wants to be outspoken about public policy.'

Dr Anna Goodwin. 2-part interview. Retired oncologist and secondary prevention consultant. Part 2: Getting your Best Cancer Outcome.

Dr Anna Goodwin. 2-part interview. Part 1: Unravelling the Biological Drivers of Cancer. ‘The science of cancer knows that it’s an injury response, but the clinical management of cancer has not yet figured this out for the most part.’

Too busy & just want a quick snapshot of Dr Goodwin's interview? Go here to pick a topic from the playlist.

Professor Philippe Grandjean. University of Southern Denmark (October 2023) 2023 study on fluoride & IQ contradicts so-called 'safe' levels in drinking water. Grandjean et al. 'That's what I think the fluoride decision is. It's outdated. Now we have fluoride in toothpaste.'

Professor Jack Heinemann. University of Canterbury. Director, Centre for Integrated Research in Biosafety (INBI) (January 2023) Biotechnology - Risk that scales up as efficiency increases. Heinemann on risk management & policy. 'Where harm can accumulate at scale transition, that's precisely where regulation is a solution to mitigate risks.'

Dr Glen Davies. 2021 New Zealand GP of the Year. (October 2022). Reversing Type 2 Diabetes in New Zealand. Science, support, keto & community-driven change. 'We can save a lot of money by doing this better.'

Dr Emma Sandford MBChB, FRCOphth, B.Nat.Med. (September 2022). Eye Health - Beyond Clinical Medicine & Towards Natural Ophthalmology. 'The way we have become more sub-specialised in each specialty has assisted in that siloing of understanding, knowledge, experience, exposure - in the clinical setting.'

Dr Charles 'Merf' Merfield (September 2022). Head of the Future Farming Centre, HND Comm. Hort., M.Appl.Sci. Hons, PhD, MRSNZ. Regenerative agroecology organic - how does it all fit together? 'Quite simply, intensive agriculture is eating itself.'

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In order to protect the environment, the precautionary approach shall be applied widely by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation. (UNCED 1992)

When Germany established the Clean Air Act in 1974, it included the requirement for Vorsorgeprinzip, or foresight. This was the first formal application of the precautionary principle.

In 1992 the Precautionary Principle was included in the Rio Declaration on Environment and Development, to aid UN member states with the protection of the environment and the prevention of environmental degradation. The step to incorporate the Precautionary Principle to protect human health, in addition to an obligation to prevent environmental harm, was taken in 2005 by UNESCO:

When human activities may lead to morally unacceptable harm that is scientifically plausible but uncertain, actions shall be taken to avoid or diminish that harm. Morally unacceptable harm refers to harm to humans or the environment that is:

Threatening to human life or health; or

Serious and effectively irreversible; or

Inequitable to present or future generations; or

Imposed without adequate consideration of the human rights of those affected.

The judgement of plausibility should be grounded in scientific analysis. Analysis should be ongoing so that chosen actions are subject to review. Uncertainty may apply to, but need not be limited to, causality or the bounds of the possible harm.

Actions are interventions that are undertaken before harm occurs that seek to avoid or diminish the harm. Actions should be chosen that are proportional to the seriousness of the potential harm, with consideration of their positive and negative consequences, and with an assessment of the moral implications of both action and inaction. The choice of action should be the result of a participatory process. (UNESCO 2005, p.14)

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity reaffirmed the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development (1992).

Principle 15 In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.

The objective of the Cartagena Protocol is set out in Article 1 as follows:

In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health, and specifically focusing on transboundary movements.

The precautionary principle is detailed in Article 191 of the Treaty on the Functioning of the European Union, page C 202/132 where it is mentioned once.

Union policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Union. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay.

The European Commission further clarify in the document: Brussels, 2.2.2000 COM(2000) 1 final COMMUNICATION FROM THE COMMISSION on the precautionary principle that (page 3):

Where action is deemed necessary, measures based on the precautionary principle should be, inter alia:

proportional to the chosen level of protection,

non-discriminatory in their application,

consistent with similar measures already taken, based on an examination of the potential benefits and costs of action or lack of action (including, where appropriate and feasible, an economic cost/benefit analysis),

subject to review, in the light of new scientific data, and

capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment.

Karlsson, O., Rocklov, J., Lehoux, A., Bergquist, J., Rutgersson, A., Blunt, M., & Birnbaum, L. (2020). The human exposome and health in the Anthropocene. International Journal of Epidemiology, 1-12.

WHY THE PRECAUTIONARY PRINCIPLE IS A USEFUL POLICY TOOL

In 2004 the World Health Organization released a white paper: The precautionary principle: protecting public health, the environment and the future of our children. Key findings (pages 3-6, edited/abridged):

The PP helps people navigate uncertainty. As “modern” potential risk factors become more complex and far-reaching, the precautionary principle addresses uncertain risks and seeks to shift the ways in which science informs policy from a strategy of “reaction” to a strategy of “precaution”. Together with related approaches such as health impact assessment, precaution provides a useful means of guiding public health decisions under conditions of uncertainty, in a manner that appropriately addresses the issues of power, ownership, equity and dignity.

The PP supports policy-makers and officials in decision-making. Substantial evidence supports the conclusion that contemporary environmental health risks result from complex interactions among genetic, nutritional, environmental and socioeconomic factors. The precautionary principle can be used to encourage research, innovation and cross-disciplinary problem-solving in the face of these complex risks.

The PP helps clarify the role of environmental science in policy-making. This includes policy-making and evidence-based decision-making and how to weigh and judge evidence.

There is no contradiction between pursuing scientific progress and taking precautionary action. Indeed, applying precaution demands more rigorous science in order to characterize complex risks, clarify gaps in knowledge and identify early warnings and unintended consequences of actions. It also means using science not only for the diagnosis of environmental hazards but to identify, develop and assess safer alternatives to potentially harmful activities.

The PP is especially important in countries with weaker regulatory jurisdictions, including developing countries. The PP can inform decisions under the great uncertainty that prevails, can help build public confidence, can raise research and innovation capacities, can ensure that mistakes made in the past in industrialized countries are not repeated, and can help shift burdens from the public institutions to those creating the risks.

There is no single recipe for applying precaution. Flexibility in applying precaution is critically important, since each decision is different – with different types of risk, evidence, uncertainty, affected communities, availability of alternatives, and technical and financial resources. Consistency thus comes from using the same precautionary framework and process in each case. What is considered an “acceptable risk” or sufficient evidence to act is a function not only of the level of risk and the strength of evidence and uncertainty, but also of the magnitude, reversibility and distribution of the risk, the availability of opportunities to prevent risk, the public’s risk aversion, society’s culture and values, and the pros and cons of alternative options.

Preventive precautionary actions aim at continuously reducing and if possible, removing exposures to potentially harmful substances, activities and other conditions.

- encourage the replacement of dangerous substances and activities with less dangerous substances or technologies where suitable alternatives are available;

- reconsider production processes, products and human activities so as to minimize significant adverse effects on health and the environment.

- establish public health goals for protecting the health of humans and ecosystems (such as for reducing blood lead levels or improving fisheries);

- provide information and education to the public to promote empowerment and accountability;

- integrate precautionary considerations into the research agenda to facilitate rapid interventions to prevent damage to health; and

- minimize, so far as possible, unintended adverse consequences that may be caused by precautionary actions.

PRECAUTION IN NEW ZEALAND – GMO/HAZARDOUS SUBSTANCES

New Zealand ratified the Cartagena Protocol for Biosafety in 2005. New Zealand was one of the 175 countries who signed the 1992 Rio declaration.

In such an environment, information and guidance on the application of the precautionary principle can support policy and decision-making by officials. In New Zealand, implementation of the precautionary principle is inconsistent and poor. There is no evidence of policy work/briefings undertaken to develop decision-making frameworks and guidelines, and make such information generally available and easily accessible to officials (including legal counsel) across central government agencies, or who work for territorial and local authorities.

Hazardous Substances and New Organisms (HSNO) Act 1996 specifies (s.7)

'All persons exercising functions, powers, and duties under this Act including, but not limited to, functions, powers, and duties under sections 28A, 29, 32, 38, 45, and 48, shall take into account the need for caution in managing adverse effects where there is scientific and technical uncertainty about those effects.'

Government officials would be unlikely to consider precaution without guidance.

The Ministry for the Environment administers the HSNO Act, but has not produced guidance material for officials or for the public, relating to their obligation to take caution into account.

Since 1996 the New Zealand Environmental Protection Authority (NZEPA) does not appear to have released guidance for officials in taking a precautionary approach. The NZEPA operates under the HSNO Act, but their Risk Assessment Methodology (Updated 2022) does not provide a decision-making pathway to support decision-making when there is scientific and technical uncertainty about the potential adverse effects from the hazardous substances (biotechnologies and hazardous chemicals) stewarded by that Authority.

The lack of resource materials to support government officials in the use of the Precautionary Principle may not only lead to officials under-appreciating the tool - this may be a determining factor in the Precautionary Principle deliberately being set aside (in 2024-2025) by New Zealand's Attorney General, Judith Collins. Government officials and the Crown Law Office may be deliberately excluding the Precautionary Principle in proposed legislation which will aim to steward the release of biotechnologies into New Zealand's environment. The public, academia and media lack a language/expertise on this issue, and this issue is rarely addressed by public law experts and so push-back is unlikely.

Such an action would likely contradict New Zealand's commitment as per the Cartagena Protocol for Biosafety.

2024 COURT DECISION - SOUTH AFRICA

In a 2024 South African Supreme Court of Appeal judgement, African Centre for Biodiversity NPC v Minister of Agriculture, Forestry and Fisheries and Others five judges unanimously ruled that evidence provided by the applicant (in this case Monsanto) in support of a gene edited maize (MON87460) was inadequate to prove safety of the product. The African Centre for Biodiversity's appeal was upheld:

The thrust of the appellant’s case is that the State respondents accepted, at face value, the claims made by Monsanto and failed to independently and critically evaluate Monsanto’s application to satisfy themselves that the health and safety risks associated with the general release of MON87460 had been properly addressed. The appellant contends that the expert evidence that served before the State respondents, ought to have triggered the application of the precautionary principle enshrined in s 2 of NEMA. This, for two main reasons: first, there was a lack of scientific data from which conclusions about the safety of MON87460 could be drawn; and second, the 7 data that had been made available supported concerns about health risks arising from the use of MON87460.'

The precautionary principle was triggered and ought to have been applied.

WITHOUT MONITORING & RESEARCH FUNDING, ARE WE 'RIDING BLIND'?

Relative ignorance concerning the application of the precautionary principle dovetails with underfunding for monitoring and scientific research on risk of technologies. These issues are two sides of the same coin. While governments have provided funding for biotechnology research and development to support release onto the market of biotechnologies, they have vastly underfunded research to identify risks and harms that might be associated with the development and release of these GMOs, including GMOs created using modern gene editing techniques.

The speed of production and release of novel entities, which include man-made chemicals and genetically modified organisms (GMOs), exceeds the pace of monitoring and risk assessment. A small range of crops have been commercialised globally. In the last 25 years, GM crop production has experienced over 100-fold increase. The pace and scale is particularly notable with newer gene editing techniques, which have amplified development speed and shortened the bench-to-market timeline. Academia has joined with industry in the rush to commercialise the technologies (here and here) used along the development chain. Whether a patented food crop reaches the market is highly dependent on the success of trials, including the extent to which transparency in trial outcomes is demanded by government regulators. Trials should not only test for dietary safety, but should include tests for crop vulnerability to unintended disease outcomes, for impact on non-target organisms and for yield.

If governments can fund research and development using new gene editing technologies, they can fund risk-based research. The New Zealand government does not provide funding for long-term interdisciplinary research. Without recognised expertise, media, officials and the courts cannot develop a language of risk and precaution. They are unlikely to turn repeatedly to a single expert. When very few independent experts, who have no conflicts of interest, are willing to speak about risks, these experts can become sidelined or ostracised, simply for pointing out actual or potential hazards.

Empty funding pots for long term, interdisciplinary, risk-based research is not an exclusive problem for would-be GMO researchers. The funding black hole encompasses a much wider spectrum of technology-based harm. This includes exploring risk from hazardous substances (such as pesticides or fluoride) and risk from electromagnetic radiation (EMR) exposures. The barriers limit discovery into how technology might be impacting productivity and economic growth. For example, without long-term funding, local scientists cannot assess how diets high in ultraprocessed foods drive a wide range of disease including neurological disorders, and explore how ultraprocessed foods hasten environmental degradation.

Funding is available to develop new, gene-manipulated organisms, to create new food-based technologies, and technologies and systems which integrate wireless communication and surveillance technologies. Funding is not available to monitor and assess their risks.

It is important to recognise that the absence of funding pathways creates a dearth of experts who can raise issues about risk from technologies, their emissions and their impact on vulnerable or non-target organisms.

For decades young scientists have studied biology and ecology, often with the thought that by studying how life works, from the cellular to the ecosystem level, their research may support human endeavours to protect planetary life, from the cellular level to the functioning of ecosystems.

People want to monitor and identify how harm is created so that governments are informed, and human health and our ecosystems can be protected. But many young scientists find it impossible to monitor and research these issues, because the funding frameworks instead steer them towards research in innovation and pipeline development.

Research on risk is vital, but it is barely happening. This research needs to be funded and the work carried out a safe distance from the developers and patent-holders.

REGULATORY AGENCIES CAN USE NEW TECHNOLOGIES TO ESTIMATE HOW HARM CAN, AND MIGHT, OCCUR

Governance risks are frequently complex, uncertain and ambiguous. Safe regulation of technologies is an especially complex endeavour. The decisions made by governments, scientists and regulatory authorities are values-based. At what level of potential or demonstrable harm do we say 'no more' when man-made technologies interact with open-ended biological systems?

This depends on expertise and the curiosity and values of the policy-maker and researcher. Does that official have the capacity and willingness to recognise and publicly discuss perhaps-controversial risk-based issues when they arise in the literature? This can include focussing on the developmental origins of health and disease, and integrating new information relating to genetic and epigenetic impacts, neurodevelopmental/neurodegenerative risks, cancer risk and endocrine (hormone-level) impacts when published in the scientific literature.

Precaution is based on our capacity to anticipate harm. While companies use the latest technologies to develop their products, regulatory authorities do not proactively integrate new technologies, such as metabolomics analyses and metabolic enrichment pathway analysis into regulatory assessment to assess risks from the technologies they are charged with stewarding.

Why aren't new technologies adopted to assess the risk from gene edited foods?

The Food Standards Authority of Australia and New Zealand (FSANZ) is currently part of the way through a years long P1055 consultation, where the FSANZ believe that many new gene edited foods are substantially equivalent to conventionally produced foods and do not require (precautionary) pre-market approval. PSGR's submission heavily critiqued this FSANZ belief, emphasising that the reports claiming this by FSANZ lacked appropriate rigor (there were no systematic reviews to demonstrate how potential risk was impartially assessed).

Institutions such as the NZEPA and FSANZ could be doing much more work to explore and understand how pesticides and newer gene edited technologies may produce dietary and ecosystem risks. Hoeppers et al (2024) recently modelled how outdoor gene-editing could impact non-target organisms. The researchers used the in silico tools used by genetic engineers to predict efficacy, to assess the potential for non-target organisms to also be impacted from the outdoor gene-editing process.

Hoepers AM, Heinemann JA, Zanatta CB, Chu P, Hiscox TC, Agapito-Tenfen SZ (2024) Predicted multispecies unintended effects from outdoor genome editing Ecotoxicology and Environmental Safety 282, 1 September 2024, 116707.

In a 2022 Public consultation on the Food Regulatory System Strategic Plan (Australia, 2022) PSGR discussed how omics technologies might be applied in risk assessment science.:

Omics technologies (adductomics, epigenomics, proteomics, metabolomics and transcriptomics) traverse a broader biological space, and can complement the traditional biomarker endpoints and play an important role in understanding mixture effects, and the early molecular events in the pathways leading to disease which to date has been largely excluded from regulatory considerations.

Such technologies can help scientists predict systems level impact, whether at the cellular level, the metabolic and organism level, or at the level of a given system (i.e. an ecosystem or population-based level). But these sorts of technologies are currently outside the skillsets (and funding programmes) of technologies and emissions regulators. These regulatory agencies rarely engage in cross-talk with non-industry scientific experts who research risk, but extensively engage in cross-talk with the industry groups who apply for market access and supply the data for risk assessments.

ARE REGULATORS HAMSTRUNG BY CONVENTIONS WHICH PRIORITISE INDUSTRY DATA?

Without the autonomy to investigate and review new scientific understandings, regulators default to industry data using regulatory guidelines which ensures that supplied data conforms to guideline parameters.

PSGR consider that when regulatory guidelines fail to acknowledge new risks, and cling on to antiquated modelling rules instead of integrating new information and acknowledging new pathways of harm, the data supplied by corporate industry may be more accurately be described as propaganda.

‘Propagandistic practices such as secrecy, misdirection and silence effectively corrupt constitutions of countries and therefore their public law principles. These practices effectively allow government officials to abandon legal norms of transparency and accountability.’

We reiterate, in New Zealand, funding pathways to assess actual and potential harms of biotechnologies, hazardous substances and EMR over time do not currently exist. Only overseas data and publications on risk assessment can be used to broaden knowledge on this topic. So, they are unlikely to be studied.

Government officials, and the courts require independent experts, but the lack of funding has hampered this research. The identification of how a technology might be hazardous and cause harm, and the likelihood of a harm occurring (the risk) is challenging, particularly if harms occur at the biochemical level, which can result in slow-moving but significant harms over time (such as inter-generationally, for the species which might be impacted).

Scientists will be familiar with the Mertonian norms - communism, universalism, disinterestedness, and organized scepticism. Regulatory science is an inherently political endeavour - vulnerable to challenges by special interests; predominantly path dependent; culturally situated and dependent on (local and global) peer-group values. These factors (and more) interact to shape how regulatory agencies approach and determine risk and hazard over time.

WHAT HAPPENS WHEN RISK IS NOT RECOGNISED, AND 'REGULATED OUT' OF EXISTENCE?

Aspects of risk can fail to be recognised because such factors are outside guideline. A single class of pesticides which accrue in ground-water is not considered an accumulative risk. Cumulative mixtures of man-made chemicals released in urban waste-water are not assessed for toxicity. Herbicides which synergistically promote antibiotic resistance are not considered in risk assessment. The risks from GMO technologies released at scale and pace are not evaluated. Trials for the COVID-19 genetic vaccine failed to screen for carcinogenicity risk. Non-ionic EMF exposures are not considered a hazard.

This undone science results in regulators not having to apply the precautionary principle with regards to these risks, as scientific knowledge is outside the boundaries of risk.

How might the Precautionary Principle be applied if, for example, the Food Standards Authority of Australia and New Zealand (FSANZ) decides that most gene edited organisms in our food will be of equivalent risk to conventionally bred organisms, and therefore be excluded from pre-market assessment? FSANZ legislation does not require the Precautionary Principle to be applied in their decision-making. It appears as if the Precautionary Principle will be undermined if this decision is taken, as gene edited organisms would likely be recategorized into a different risk bracket.

The FSANZ has arrived at such a belief by producing reports that don't adhere to the fundamental principles that define the advancement of science. No reports transparently declare how the FSANZ searched the scientific literature, reviewed the quality of the publications, so as to arrive at a belief of substantial equivalence. Trust in science is based on the following of fundamental norms which are democratic in nature, they not only promote transparency and accountability, but ensure there is a place where controversial and contested claims can be publicly debated. Regulatory agencies which permit submissions for consultation, but do not address the concerns of submitters, effectively short-circuit this process.

THE PRECAUTIONARY PRINCIPLE DURING COVID-19.

The precautionary principle is relevant to public health,

'because it can help to prevent unintended consequences of well-intentioned public health interventions by ensuring a more thorough assessment of the problems and proposed solutions'.

Historically, the precautionary principle applies to the prevention of a particular activity taking place. Health is protected by reducing or stopping harmful exposures. Kriebel et al (2001) noted the different challenges presented: Concluding a phenomenon or association exists when in truth it does not (a Type I error), failing to detect something that actually does exist (a Type II error). Type I errors are guarded by setting the error rate low (5%) while Type II errors set the error rate higher (20%). 'The test is set up to be more cautious about falsely detecting something than about failing to detect something.' Then there is a Type III error - when one provides an accurate answer to the wrong problem, i.e. looking in the wrong place. Health effects from exposures can be difficult to accurately assess.

Interventions in a public health emergency, to act when information is uncertain to implement a pharmaceutical or non-pharmaceutical intervention broadly across a population, is a misapplication of the precautionary principle. The temptation is to over-state risks from the pathogen, and under-state risks from the intervention, in order to secure public confidence and consequently, public compliance with the measures.

During COVID-19 government policies pivoted to enact rules as interventions at the population level. There was no discretion by age or stage. Vulnerable, young people and children were required to submit to interventions in order to socially interact and to access public institutions. Unfortunately, the problem discussed above, where scientists are not funded to produce information that might contradict the policies of governments, equally applied during COVID-19.

During COVID-19 governments applied the precautionary principle in making decisions about whether to restrict free movement, such as in Canada, by enforcing the mandatory quarantining of travellers who arrive by air in a country, when a global health event has been determined.

In New Zealand Judge Cooke cited the Canadian case of quarantining when discussing the use of the precautionary principle and the importance of acting to protect public health, 'based on the best available scientific evidence'. The Judge noted:

Viewed in light of the precautionary principle, the fact that the Order may not provide perfect protection is not particularly significant. The evidence shows that the challenged measures are a rational response to a real and imminent threat to public health, and any temporary suspension of them would inevitably reduce the effectiveness of this additional layer of protection. This, in turn, would have a significant – perhaps deadly – effect on the wider Canadian public, based on the experience thus far.'

As the New Zealand's judges' comment reveals, the judge viewed COVID-19 in late 2021-early 2022 as a 'real and imminent threat to public health' at the population level. The judiciary and the public were broadly unaware of information in March (and here) and October 2020 that demonstrated that SARS-COV-2 was less harmful than the World Health Organization claimed. The judiciary and the public were possibly unaware that a pandemic could be announced that did not presume a high death rate. Before mandates arrived in New Zealand, it was understood that COVID-19 hospitalisation and death risk was exceedingly low for children and adults. However, it was unlikely that government officials charged with oversight of the pandemic were disclosing this information in the courts, while judges would struggle to value and weight information that contradicted official statements.

Historic understandings that restriction of freedom of movement and compulsory medicalisation could have (often difficult to establish) different adverse consequences by age, stage, socio-economic status and the extent to which isolated people would be socially supported, were set aside. Different sub-groups could be adversely harmed by the states' policies (resulting in net harm - reduced health equity) where they might have been unharmed, or less harmed, if exposed to the pathogen.

A judge that believes a pathogen has broad existential risk across an entire population will view that their action to uphold mandates regarding non-pharmaceutical and pharmaceutical interventions is precautionary, and will be unlikely to interpret precaution from taking contradictory or controversial measures that would conflict with peers in the courts or government.

It is noteworthy that during COVID-19, authorities interpreted the 'best available scientific evidence' but failed to give weight to formerly established public health policies on norms on population management from a highly transmissible respiratory, influenza-type virus, based on changing evidence of risk of hospitalisation and death by age. In 2019, the Global Influenza Programme stressed non-pharmaceutical measures. Contrary to historic norms, in 2020-2023, public health surveillance systems equated risk with infectivity rather than hospitalisation and death risk.

Proportionality, even though outlined in overarching legislation, was not debated, nor was scientifically established evidence relating to the pattern of infectivity, pathogenicity and host-resistance or susceptibility. Historic norms which recognised that healthy people would play a role in a population achieving natural immunity, and that natural immunity provided broad-based protection were not accepted.

Interventions (including the role of employer mandates) excised personal choice and obstructed informed consent, the capacity of a person to judge their own risk and make a decision based on their best available evidence. Early on in the pandemic, respected public health scientists released a statement urging that lockdowns and restrictions cease, because of the risk of creating far more harm, than the harm authorities sought to prevent. They were publicly vilified, despite their respected academic backgrounds.

Drugs and nutrients with a long history of safe use and clear knowledge about side effects, i.e. that reflected long-held precautionary norms held by the medical community, first do no harm, were broadly dismissed by health and regulatory agencies due an absence of randomised control trials specifically concerning COVID-19. As COVID-19 was a respiratory virus with known thrombotic effects, scientists and doctors globally advocated for precautionary measures to prevent viral replication, and reduce the likelihood of disease progression, and hospitalisation in vulnerable groups. They were unsuccessful. Advice from medical doctors urging precaution in submissions to a major New Zealand consultation, went unheeded in the committee report.

Governments were reluctant to permit discussion which might promote public doubt on the states' choice of intervention, and states often created barriers to both declaring an adverse event, but also sourcing information about the possibility of risks and the extent of adverse events. Contamination was an identified risk of biologic drugs (and may be the case with the COVID-19 injection), and their mode of action is different from conventional immunisations. The public probably weren't aware that mandates centred around a biologic drug that encoded genetic information, instructing the body to produce a potentially harmful protein, where the production of that protein (the dose) was uncertain, for which a trial was cut short and the placebo group muddied, and for which efficacy centred around two weeks of not getting a cold after the second dose and for which there were no carcinogenicity studies.

Principles of democratic, constitutional and constitutional equity laws which also define the advancement of science and promotes and sustains trust in governing bodies - transparency, impartiality and accountability - were sidelined.

The government did not undertake systemic reviews of the scientific literature, which would include disclosure on how the scientific information was selected and weighted. 'Science Updates' contained no disclosure of any systemic analysis of the relevant literature. There was no disclosure of the scale of adverse events observed in February 2021 by the company with market access in New Zealand, that was reported to the government, but not publicly disclosed. The under-reporting of vaccine-injury was a recognised problem, and this was a completely novel biotechnology implemented at scale and pace.

The process in New Zealand of the mandate rollout was legislated via secondary legislation by the Minister in charge, but there was no requirement for a review of the independently published evidence base for safety and efficacy, by age and status for each new tranche of legislation as the months progressed.

In effect, the precautionary principle if applied, was not applied using traditional evidence-based collation of information, that conformed to principles of scientific rigour and that ensured that the principle of first do no harm, would be a guiding value.

The example of COVID-19, where interventions were enacted under emergency provisions, where critical or dissident scientists were not funded to research risk in COVID-19, and not permitted to engage in debate with senior policy-advisers, politicians and the Director-General of Health, where healthy young people were required to submit to the same measures as frail older people, where uncertainty acted in favour of compulsory, population-wide interventions, - this example has potential to serve as a precedent for future public health emergencies.

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For over 20 years the Physicians and Scientists for Global Responsibility New Zealand Charitable Trust (PSGR) has produced reports and submitted to government Bills and Inquiries.

We’ve been extraordinarily busy over the past 2 years with our work.

This Update aims to inform members and colleagues – and act as a go-to summary of our recent work.

2022 UPDATE - PDF

As well as our recent work All PSGR’s submissions are available to the public on our Submissions pages. In addition, we are now on LinkedIn, Twitter, Odysee & Instagram.

MEMBERSHIP

Please – without your support and membership PSGR cannot do this work. We’ve kept our fees deliberately low because your membership is important to us.

MOVING FORWARD 2022+

The PSGR recognise that the perspectives that have been expressed by the PSGR from 2020 onwards will not necessarily reflect the perspectives of all trustees and all members.

However, we sincerely hope that PSGR’s perspectives are more likely to reflect the perspectives of the majority of our membership and of collegial organisations – which represents a diverse quorum of inquiring minds.

We hope that we have demonstrated a consistency to our work, that reflects and upholds the principles reflected in 20 years of research, information communications and submissions to policy

Reports and Papers

Royal Commission

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