'Increasing evidence that endocrine disruption (EDC) exposures play a substantive role in disease causation or progression.'

The responsiveness of mammalian hormones to chemicals at low doses is widely accepted in the medical literature – hormonally active drugs are actively developed and marketed. There is increasing evidence that the growing synthetic chemical load that the public consume and absorb in daily life, is disrupting the bodies’ delicate hormone systems - the endocrine system - affecting multiple biological pathways in human bodies, and significantly contributing to illness and bad health.  Scientists working in the public interest consider that children are born 'pre-polluted' and disproportionally affected.

Yet when it comes to chemicals in the environment that act, (as hormonally active drugs do), but in a negative way, and cause disruption – regulators haven't adopted techniques to assess the impact of these chemicals. To put it simply, regulators, including the US Environmental Protection Authority (US EPA); the European Food Safety Agency (EFSA); and the World Health Organisation (WHO), (which unites with the Food and Agriculture Organisation (FAO) to form an assessment panel, the Joint Meeting on Pesticides Residues - JMPR) - including nationally operating environmental protection agencies - simply don’t do risk assessment safely. Their methods, in comparison with the state of scientific knowledge today - are decades out of date.

Regulators never consider full formulation toxicity and how this affects the endocrine system.

Regulators never consider the greater inhalation rate of children. Those  living close to heavily sprayed pesticide zones (page 12) are profoundly more exposed than adults. Whether a backyard treatment, the next door orchard or intensive floriculture or even a strawberry field. No science is held today discussing children's significantly greater exposure of full formulation chemicals and mixtures of chemicals.

Children breathe more than adults do.

Regulators and the media apparently find it simpler to deflect attention to genes and genetic markers, precise endpoints and industry-stacked ‘weight of evidence’ conclusions reliant on ancient guidelines that fail to acknowledge the multiplicity of modern pathways of disease. Trade based interests appear to trump population and public health interests – the chemical industry nurtures relationships with cash and resource-strapped regulators and industries' deep pockets to facilitate risk assessment. They helpfully work with agencies to establish guidelines and protocols to ensure the studies supplied for risk assessment are exactly what is required - and supply the important studies which inevitably become the endpoints (which go on to derive recommended quantities of a particular pesticide applied to crops per hectare).

If guidelines and industry friendly protocols (OECD is an industry organisation, after all) do not allow for full formulation toxicity - the risk assessment agencies won't consider it.

Even if for example - the IARC (eg. glyphosate) which is pretty much every regulators authority for information on cancer - considers full formulation effects. One wonders if wilfully ignoring the IARC when it is a considered authority - renders a government to be acting illegally.

Risk assessors ignore the moral imperative (and legislative imperative of protection the public health) appear to prevaricate and distract and reinforce outdated methods - arguably acting unlawfully when the Acts and legislation under which they operate, which demand that they put the health of the public first - are taken into consideration.

Current scientific knowledge should demonstrate that governments and regulators should be acting with more caution. When harmful effects of endocrine disruption (which can lead to chronic diseases including cancer, obesity, neurological challenges) are combined with potential for long term epigenetic changes that demonstrates clearly that these chemicals can cause harmful multigenerational effects to, for example, great grandchildren the regulators should have adopted public interest strategies a long time ago.

Mohammad Shahidehnia discussed in the paper,  Epigenetic Effects of Endocrine Disrupting Chemicals: 

'A few years ago we thought that our life starts with the DNA we receive from our parents, but currents studies have shown that we receive more than just DNA from our parents. Famine, stress, fear and even drug use could all leave chemical marks on parent’s genetic material. Environmental exposure to EDCs during early development and pregnancy can modify epigenomes and induce trans-generationally asthma, autism, cancer, cardiovascular dysfunctions, diabetes, obesity, schizophrenia, infertility, reproductive diseases and dysfunction later in life. There is evidence showing that EDCs can induce epigenetic gene alterations by which these altered genes can be transferred into subsequent generations.'

We now know that chemical exposures in one generation can have harmful transgenerational effects in the F4 generation.

In reality, with so many unknowns and a climbing toxic load, the only answer for so many of the chemicals around us where the science is showing harm, should be to institute the precautionary principle - particularly for agrichemicals applied to food. But what seems to happen is where there is uncertainty, the regulator will always prefer to take the 'side' of industry. Rather than - in uncertainty - to take the 'side' of public health.

There is an enormous amount of literature that we are seeing profoundly harmful effects that many scientists understand to have intergenerational ramifications, yet risk assessment agencies seem hamstrung, and it increasingly appears to be hamstrung via form of regulatory arbitrage.

At what level does the public interest – particularly the rights of the unborn infant, baby and child – rise above trade, or industry based interests?

Endocrine disruption – or hormone related adverse health effects - is a quiet, sinister slinky thing. Understanding biological system pathways and the myriad complex chemical interactions is a challenge of such mind numbing and overwhelming complexity that it is no surprise that the response of many, is to ignore multiple chemical exposures and put endocrine related health effects into the ‘too hard basket.’  This stuff keeps slipping under the radar.

Let regulators put off a final decision for another year, with another paper, or another ‘consideration’.

Yet there is clearly a disconnection – an incompatibility - with established evidence that environmental pollutants and mixtures of pollutants are significantly contributing to the overwhelming and undeniable increase in hormone, or endocrine related cancers and other chronic diseases disabling world populations today, which did not occur in the generations before. Quite simply, genes don’t change that quickly, they are only directly responsible for some 10-20% of illness. Between eighty and ninety percent of illness is from environmental stressors.

Long term buildup in waterways is transporting to groundwater. Mixture effects are never considered.

We should be acting with caution.

1. Precautionary Principle

Frequently governments have the precautionary principle written into their legislation - UNESCO defines the precautionary principle as follows:

'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.'

Perhaps it is time for health strategy leaders to acknowledge that in the twenty first century ‘there is increasing evidence that endocrine disruption (EDC) exposures play a substantive role in disease causation or progression, or may alter the susceptibility to disease over a lifetime’. [1]

A World Health Organisation, 2012 paper noted ‘Increases in disease incidence rule out genetic factors as the sole plausible explanation for their occurrence. Environmental and other non-genetic factors, such as nutrition, the age of the mother, viral diseases and exposure to chemicals, also contribute but are difficult to identify.’  [2]

It is of concern that much of the information regarding the chemicals used in agricultural formulations are unavailable to the public via commercial confidentiality agreements. Regulators are slow to respond, as conventionally they have sourced the scientific studies used in regulatory assessments directly from industry. Close relationships with industry - across regulatory agencies internationally - that may result in conflicts of interest and accusations of bias are well documented. 

Much of it has to do with money. Industry provides free science. Regulators have no money. They seem to forget there could be another model. However levels of disease and the inability of governments to pay for healthcare are resulting in increasingly strident calls for regulators to better manage the toxins produced by industry.

There is urgency for modern guidelines and analysis to synchronise with modern scientific understanding, and for greater transparency in regulatory assessment. In September 2016, PAN Europe 'won a legal case at the European Court of Justice against the EU Commission (DG Trade), for refusing to provide access to documents with information on endocrine disrupting chemicals (EDCs)'. 

The risk tolerant disclosure based model cannot keep up with modern science.

 

2. ENDOCRINE DISRUPTION - HISTORY & DEFINITION

The term ‘endocrine disruptor’ (EDC) is a recently new one, arrived at in 1991.[3]  Dr Theo Colborn was a pivotal scientist involved with many early papers on the subject.  Dr Colburn established the Endocrine Disruptor Exchange (the very first TEDX). Much of her work centred on the role of hormones and the impact of chemicals and chemical messengers that impact development, of both animals and humans. She was a co-author of the 1996 book ‘Our Stolen Future.’[4]

Today’s estimated synthetic chemical load is estimated at 84,000 plus, and less than one percent of these chemicals have been tested for safety. [5]

Hormones are tricky to understand - a healthy hormone system is critical to system balance, (known as homeostasis regulation), which is essential for maintaining a stable metabolism. Metabolism is all the chemical reactions involved in the daily management of a biological system. A human is a chemical reaction system.

The Endocrine Disruptor Exchange describes the situation beautifully:  ‘The endocrine system is the exquisitely balanced system of glands and hormones that regulates such vital functions as body growth, response to stress, sexual development and behaviour, production and utilization of insulin, rate of metabolism, intelligence and behaviour, and the ability to reproduce. Hormones are chemicals such as insulin, thyroxin, estrogen, and testosterone that interact with specific target cells. The interactions occur through a number of mechanisms, the easiest of which to conceptualize is the lock and key.’ [6]

The endocrine system is, to put it mildly, awesomely complex. Massive research advances have occurred over the last 5 years, we now know that hormones exhibit complex dose response curves (the effects of low doses cannot be predicted by effects observed at higher doses); and hormones affect other hormones, which can affect other hormones - like dominoes. Chemicals affect us in many ways and can imitate hormones. The hormonal feedback loops which have been so critical for the successful development of mammalian species – are mystified and crazed when ‘pretend’ hormones (from external chemicals), known as xenohormones, pop in and make themselves at home.

The following extract clearly outlines to what extent ‘high dose’ testing is antiquated, contrasting the acknowledgement of modern medicine of hormone responsiveness to low doses – by way of established and accepted contemporary development of drugs that interact with the hormone system. Myers, Zoeller and vom Saal noted in 'A Clash of Old and New Scientific Concepts in Toxicity, with Important Implications for Public Health':

‘The approach of using very high-dose testing to predict consequences of much lower doses that are typically within the range of widespread human exposure emerges from a 16th-century observation by Paracelsus that toxicologists paraphrase as “the dose makes the poison” (Gallo 1996).

Paracelsus’ logic holds if and only if a chemical’s effects follow a monotonic dose–response curve, in which more of the chemical leads to a greater effect. Monotonicity and nonmonotonicity refer to changes in the slope of the curve describing dose and response. Monotonic curves may be linear or nonlinear, but the slope never reverses from positive to negative or vice versa. The slope of a nonmonotonic curve changes sign, from positive to negative or vice versa. Biologically relevant nonmonotonic curves include “U-shaped” or “inverted-U–shaped” dose–response relationships.

When toxicologists began to focus on potential health effects of EDCs, endocrinologists raised questions about the appropriateness of assuming monotonicity as a basis for chemical risk assessments, because nonmonotonicity is a general characteristic of endogenous hormones, hormonally active drugs, and environmental chemicals with hormonal activity.

Indeed, Paracelsus’ assumption is directly contradicted by decades of research in endocrinology and clinical medicine showing that hormonally active compounds have dose–response curves in which low doses can cause effects opposite to those at high doses. This issue is so central to hormone action that it is a critical component of determining the dose required for hormonally active drugs.’[7]

Alongside this massive growth in hormone system knowledge has been the rise in prominence as to the role of the digestive tract, in particular, of the gut microbiome and its’ inherent vulnerability to environmental chemicals. Where ‘we’ stop – and microbes start – is the intersection referred to as microbiology endocrinology. The interrelationship between these two relatively recently ‘discovered’ systems is not considered when assessing chemicals for toxicity.

 

EDC’S & CRITICAL DEVELOPMENT WINDOWS – THE DEVELOPING FOETUS, & CHILDREN.

The 2008 WHO report, which advises that foetuses and babies ‘are not little adults’ and have age-specific periods of susceptibility, known as "critical windows of exposure," and "critical windows of development." [8] 

Established science acknowledges that prenatal doses of chemicals can result in what science politely calls, altered health outcomes. Science accepts that in the twenty first century, the developing foetus is exposed to endocrine disruptors. Pregnant women have tested positive for multiple chemicals, including banned chemicals, and concentrations found in the body were found at levels that are associated with negative effects in children. [9]

We now know that ‘low level exposure to endocrine disrupting chemicals (EDCs) especially during early development, lead to both transient and permanent changes to endocrine systems. This results in impaired reproduction, thyroid function, and metabolism, and increased incidence and progression of hormone-sensitive cancers’. [1]

 In 2010 the President’s Cancer Panel noted that, ‘to a disturbing extent, children are born pre-polluted’. [10]

Unfortunately, we have known EDCs damage the child in the womb for over twenty years. The 1993 paper by Dr Colborn and colleagues noted

‘Many of these chemicals can disturb development of the endocrine system and of the organs that respond to endocrine signals in organisms indirectly exposed during prenatal and/or early postnatal life; effects of exposure during development are permanent and irreversible.’ [1]

Laura Vandenberg and colleagues noted in 2012 that

‘the weight of the available evidence suggests that EDCs affect a wide range of human health endpoints that manifest at different stages of life, from neonatal and infant periods to the aging adult.’ This leads to the conclusion by the same authors that ‘Assumptions used in chemical risk assessments to estimate a threshold dose below which daily exposure to a chemical is estimated to be safe are false for EDCs.’ [11]

Research and education regarding endocrine disruption appears to rest with non-government organisations, yet the increasingly documented harm lends weight to an increasingly urgent demand for cautionary measures in the public interest by governments and regulatory agencies. Governments and regulators do not take into account the fact that the probability of harm is significantly high, and growing – and are reluctant to acknowledge there is an economic cost to EDC exposure, that the exposure is cumulative and advancing at a reckless pace.

 

3. OUTDATED CHEMICAL RISK ASSESSMENT

It can be quite challenging to comprehend the exponential growth of chemicals on earth today. Children are exposed to vastly more chemicals than their grandparents or great-grandparents.

Governments are reticent on this topic. It’s not that they don’t know. For example, Dr Linda Birnbaum, testifying to the US House of Representatives, asserted ‘Over the past fifty years, researchers observed increases in endocrine-sensitive health outcomes.’ [12]

A significant body of evidence demonstrates the far reaching and harmful roles ubiquitous endocrine disrupting chemicals play in food and environment. No regulator has the resources to thoroughly test - using twenty first century state of the art science - and evaluate - the toxicity of these chemicals that interfere with hormones, frequently at low concentrations far below levels conventionally considered in the safety data.

Risk assessment, across many sectors, today follows a risk tolerant disclosure based model.  When undertaking risk assessment, regulators historically rely on unpublished studies selected and supplied by the industry that manufactures the chemicals. They do not require full disclosure of all studies. Industry has a leading role in developing data guidelines and protocols (eg. GLP – Good Laboratory Practice and OECD developed test guidelines) that form the framework for these organisations, and the rules that laboratories use when conducting toxicity studies. The guidelines are decades behind modern scientific understanding of carcinogenesis, endocrine disruption and will now lag in relation to epigenetics - and neglect to include requirement for testing full formulations and at environmentally relevant dose levels. 

Chemicals have not been assessed at (1) environmentally relevant levels nor (2) the low levels that can result in endocrine disruption. In relation to understanding dose levels and toxicity, regulators are in the dark ages.

Papers come and go, largely ignored by the mainstream media, with certainly no progressive investigating reporting keeping this issue above surface level.

The problem is not limited to the fact that it is industry controlled studies that regulators including the US Environmental Protection Authority (US EPA); the European Food Safety Agency (EFSA); and the World Health Organisation (WHO), which unites with the Food and Agriculture Organisation (FAO) to form an assessment panel, the Joint Meeting on Pesticides Residues (JMPR) – use to evaluate toxicity and safety.

Guidelines push unpublished, papers that have never been peer-reviewed data out, while accepting private, industry studies

The guidelines act as loopholes, they appear to be a form of regulatory arbitrage, which result in greater ‘weight’ or priority, given to industry science over open peer-reviewed scientific literature. Good Laboratory Practice is a narrow, tick the box laboratory management system.  OECD (a development and trade organisation) test guidelines, are testing requirements that are simply not sensitive enough to deal with complex, extremely low dose chronic exposures.[13]

A paper discussing ‘Why Public Health Agencies Cannot Depend on Good Laboratory Practices as a Criterion for Selecting Data’ concluded:

‘Public health decisions should be based on studies using appropriate protocols and the most sensitive assays. They should not be based on criteria that include or exclude data depending on whether or not the studies use GLP. Simply meeting GLP requirements is insufficient to guarantee scientific reliability and validity.’ [14]

Industry developed guidelines repeatedly fail to keep up with scientific advances, but work to provide regulators with an excuse to exclude non-guideline research in regulatory assessment.

Endocrine related diseases are increasing, and industry developed data guidelines still do not take into account the requirements for safe development of the most vulnerable, the unborn infant and young child. This has been known for twenty years. Regulators and governments ignore the fact that children consume more per bodyweight and thus may exposed to three times the chemical mixture as an adult. For example. developmental studies for pesticide toxicity do not dose the rodent in the first trimester. Frequently there are no chronic, or long term, studies for neurotoxicity supplied for assessment.

To date, regulators are ignoring the increased vulnerability of foetuses, babies, children, teenagers to endocrine disruption at miniscule exposures. Industry selected and supplied studies used in assessments simply don’t investigate these delicate levels. However, human hormone systems operate, and are chemically sensitive, at these delicate levels.

Individual governments may be more proactive, for example France has conducted investigations into glyphosates action as an endocrine disruptor, but most countries accept the regulatory conclusions and use them to provide assessment information data for their own purposes.

Scientific literature demonstrates that it is not only the active chemical glyphosate that causes endocrine disruption, but that the co-formulants, the adjuvants, are also potential endocrine disruptors. [15]

What do the regulators say regarding endocrines and hormones? As an example, a recent WHO FAQ advised:

Q11. Do residues of glyphosate disrupt hormonal balance of adults and children who eat food containing the residues?

Glyphosate was tested in a range of validated "in vivo" and "in vitro" assays for its potential to interact with the endocrine system. The studies considered by JMPR as adequate for the evaluation demonstrate no interaction with estrogen or androgen receptor pathways or thyroid pathways.[16]

While this may look as if endocrine disruption is adequately considered, it is important to note the words ‘The studies considered by JMPR as adequate for the evaluation.’

As of writing this article, the studies used in the 2016 glyphosate evaluation have not been released. The authors of the studies, and whether they were published and available for peer review, do not appear to be transparently available to the public. [17]

However the model is repeated in different areas of risk assessment. Many are in no doubt that delays in declaring Bisphenol A harmful were primarily due to industry influence and bias that influenced risk assessment of the chemical:

‘Both the U.S. FDA (2008a) and European Food Safety Authority (ESFA 2006) have recently published documents demonstrating that their decision to continue to declare BPA safe at current exposure levels was based primarily on the results of a few industry-funded studies that followed GLP guidelines. These decisions stand in stark contrast to the decisions concerning the potential risks to human health reached by a panel of 38 experts at a U.S. National Institutes of Health (NIH)-sponsored conference, who published The Chapel Hill Consensus Statement (vom Saal et al. 2007), as well as five review articles (Crain et al. 2007Keri et al. 2007Richter et al. 2007aVandenberg et al. 2007aWetherill et al. 2007). These peer-reviewed articles covered approximately 700 articles concerning BPA and represented a comprehensive review of the literature as of the end of 2006.’[13]

The issue of public trust is essential if a regulator is to retain relevance.

 

4. REGULATORS: MEANINGLESS VALUES & MISSON STATEMENTS?

The actions of various food safety regulators around the world aren’t living up to their values and missions. Europe’s Food Safety Authority strives to use ‘high quality scientific evidence, remain separate from undue external influence and protect human health and life.’ [18]

The US FQPA requires that the US EPA make a ‘safety finding when setting tolerances, i.e., that the pesticide can be used with ‘a reasonable certainty of no harm’ and that the EPA consider cumulative exposure to pesticides that have common mechanisms of toxicity’. [19]

Yet unless contemporary science is used, evaluations that should stay relevant for 12-15 years currently fail to future-proof citizen health. The evaluations are out of date, and arguably irrelevant, before they are published.

Perhaps the most confusing is the World Health Organisation. Some areas of the WHO have a strong public health focus, and others are inextricably linked to trade and industry.

A 2012 WHO UNEP paper advised ‘For many endocrine disrupting effects, agreed and validated test methods do not exist, although scientific tools and laboratory methods are available.’ Significantly, it noted ‘Disease risk due to EDCs maybe significantly underestimated.’ [2] 

In 2015, another arm of the WHO, the International Agency for Research on Cancer, reviewed published a Monograph on the herbicide glyphosate to arrive at a decision that the chemical was genotoxic, and probably caused cancer. [20]

The arm of the WHO that links with the FAO to form the JMPR and evaluate chemical toxicity in risk assessment, for example in relation to the chemical glyphosate, has recently to a great degree, ignored the IARC finding of probably carcinogenic, the WHO FAO 2016 glyphosate reassessment [17] still, for all appearances, relying primarily on unpublished data supplied directly by industry (using out of date guidelines) to arrive at the same limited toxicity findings as in 2004. As noted, the data, released as a monograph, is yet to be accompanied by study references and appears biased in favour of industry data.

The example of glyphosate is important, as the chemical is sprayed widely on cereal and oilseed crops, and as such is present in staple foods and has been widely tested and found to be present in food, human urine and human breast milk.

A scientific consensus statement recently identified many of the data gaps and noted

‘A thorough and modern assessment of GBH toxicity will encompass potential endocrine disruption, impacts on the gut microbiome, carcinogenicity, and multigenerational effects looking at reproductive capability and frequency of birth defects’. [14]

The paper went on to state ‘Regulatory estimates of tolerable daily intakes for glyphosate in the United States and European Union are based on outdated science. [14]

It appears so.

Jump to Avaaz Petition to FAO.

 

5. Multiple gaps and deficiencies in toxicity assessment for childhood exposure.

In a recent 2016 document concerning assessment of pesticides for toxicity, the World Health Organisation appears to crudely allow for a bodyweight of 15 kg for children aged 6 and under and 60 kg for the general population (potentially solely for estimating dietary intake)

'In selecting the appropriate body weight an ad hoc meeting (1999) recommended the use of 15 kg for children aged 6 and under and 60 kg for the general population.'  [21]

Yet a decade ago, in 2005 a paper noted ‘Infants and small children might have a higher rate of consumption relative to body weight.’ The paper advised ‘Endocrine toxicity is a rather new discipline and as such the guidance given is considered to be interim’. [22]

A September 2016 release from the US EPA’s Office of Pesticide Programs confirms what we now understand, in the ‘Glyphosate Issue Paper: Evaluation of Carcinogenic Potential’ revealing that children are exposed to more chemicals relative to body-weight, and, in relation to the agrichemical glyphosate, may consume three times the amount of adults.

‘In residential/non-occupational settings, children 1-2 years old are considered the most highly exposed subpopulation with oral exposures from dietary (food and water) ingestion and incidental oral ingestion (e.g., hand-to-mouth activities) in treated areas. There is also potential for dermal exposures in previously treated areas.... a high-end estimate of combined exposure for children 1-2 years old is 0.47 mg/kg/day.’ [23]

DEVELOPMENTAL WINDOWS IGNORED IN ALL FOOD AND AGRICHEMICAL RISK ASSESSMENT

Toxicity evaluations extend into the future for twelve years plus – it will be over a decade before the chemicals assessed today are again considered. There should be an obligation that guidelines harmonise with current scientific knowledge. However the 'health department' appears to exist in a different universe from the 'safe pesticides department' in government and agency.

Delay and prevarication ensures regulators are slow to adopt urgent measures, and affirm science that is in many cases, is decades old. This, in combination with relative infrequency of chemical assessment, (between 12-15 years) appears to demonstrate that regulators are blatantly captured by industry science.

Current guidelines for, for example, pesticides, simply do not require testing at environmentally relevant exposures – at the delicate low levels we now know can be endocrine disrupting. Nor do they consider the combined effects of full formulations, or mixtures, commonly applied to food crops that can also exert hormone disrupting effects. Nor do they incorporate testing principles from endocrinology.

As long as industry friendly risk tolerant disclosure based model is followed -  rather than established public health protocols harmonised to established and recognised scientific understanding within the public sector - risk assessment in pesticides cannot be considered for safe, at a minimum for the developing foetus or infant, let alone the rest of the population.

While many families may not recognise the systemic breakdown that underlies the existing paradigm, in the current context, it appears mothers may inherently understand that all is not well with the current strategic agenda within risk assessment regulation, as demand for organics and food free of genetic modification (GMO free - risk assessment for which follows a similar risk tolerant model, and does not consider long term chronic feed studies in combination with the full formulation of herbicides that frequently GM crops are designed to tolerate) – continues to surge.[24]

The World Health Organisations’ Constitution, first two principles [25] state:

1.       Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.

2.       The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.

Furthermore, the Constitution notes that one of the primary functions of the WHO is to ‘promote co-operation among scientific and professional groups which contribute to the advancement of health’.

The Basic Documents of the WHO recognise that parties working with the WHO will ‘promote and protect the health of all peoples.’

Yet the breakdown of best practice, when it comes to protecting the health of children is evident.

The discrepancy between arms such as the IARC and the toxicity evaluation coalition demonstrate a profound inconsistency in commitment to health protection and illness prevention.

6. FULL FORMULATIONS - SYNERGISTIC TOXICITY

Sometimes an ingredient is found to be toxic. Producers and regulators engage in a game of ‘remove the known dangerous chemical from the formulation, and declare it Eg.BPA or POEA free’. However, the substitute product has normally not undergone rigorous undergone safety testing to understand if it too, is an endocrine disruptor at delicate levels. Frequently substitute products exhibit similar toxicities to the earlier product. This however, is left to researchers to unravel over the following 5 to 500 years.

Frequently that research work comes from less financially flush NGOs, and industry depends on these underfunded NGOs moving more slowly so that in the meantime, brisk sales may ensure good corporate returns. And note, industry developed test guidelines and protocols frequently act to restrict inclusion of these studies when undertaking assessment. And note, again, pesticide evaluations tend to happen every 12-15 years.

A very small and restricted window, for safe toxicity assessment.

When mixtures of daily exposure to environmental chemicals and the formulations and mixtures applied to food products are taken into account, and the synergies between these chemicals are explored, the only practical solution is to chemical minimise exposure.

Regulators cannot claim safety using outdated science that fails to take account of full formulation toxicity.

We have arrived at a situation where ‘It simply is not reasonable to assume a chemical is safe until proven otherwise’.  [26]

Yes, it costs a lot more to produce products without the convenience of cheap and efficient chemicals. Trade based considerations play a quiet consistent role in helping to push through chemical approvals in toxicological safety, while gently but firmly pushing the subject of endocrine disruption off the table, into some file to arrive at consensus ‘another day’.

Accusations of bias and conflicts of interest to date have not changed the procedure of regulators using industry selected science for critical studies that go on to determine daily exposures - acceptable daily intake (ADI) or reference dose (RfD).

Papers that evaluate the costs of chemical disruption, that indicate the economies could be severely impacted by the detrimental health costs of these chemicals, are dismissed or ignored by regulators and governments.  [27] [28]

As part of twenty first century risk assessment, open peer-reviewed scientific literature should be used to consider complexity and risk in terms of contribution to acute and chronic disease, and risk assessment include evaluation of endocrine disruption at environmentally relevant levels.

Subtle parameters that demonstrate complexity and uncertainty are excluded, instead industry guidelines subscribe to definite end-points.

This does not protect children from endocrine disruption and chronic disease, including cancer.

 

7. MEDICAL SYSTEMS FAILING TO DEAL WITH CHRONIC CUMULATIVE TOXICITY

Human systems are complex, and quite often, domino like effects badly tax interrelated body systems. This doesn’t suit the one medicine for one illness, allopathic medical system. Conventional medicine rarely addresses the subtle complexities inherent within chronic (long term) toxicity.  Public hospitals and medical institutions may bring in a toxicologist for an acute case but long term exposures do not invite a specialist in toxicology.

Scientists are unravelling the complex science that connects low dose exposures with endocrine disruption and immune system impairment that can contribute to development of cancer. [29] [30]

Chemical exposures resulting in multiple symptoms can be considered idiopathic, even when the frustrated patient sources direct medical literature demonstrating similar cases with a harmful chemical origin. Farmers quietly acknowledge the role of chemicals in disease progression, some of which may be endocrine related, impotently acknowledging it as a cost of farming. How can you blame a tool you have always used?

Cancer research organisations rarely research environmental toxicities that lead to increased cancer susceptibility. When did a cancer research organisation lately lobby against chemicals in food, or lack of regulatory rigor in chemicals approvals? These organisations tend to seek a cure, not a cause. Prevention is rarely addressed. However, I don’t want children or their parents coming home with a cancer diagnosis in the first place. The trauma of this is ignored in the cheery optimism of discussion of improved survival rates.

Pulling away from trade based considerations to acknowledge the economic and health costs of chemical disruption to hormones is a gargantuan mission, and industry capture of government regulatory organisations, regulators who depend on ‘experts’ paid by industry, makes safe assessment all the more fraught.

How do farmers get reimbursed, what economic tools can be utilised to enable farmers to be fully reimbursed for the cost of farming, to prevent chemical exposure and accelerated soil degradation? Farmers deserve wide ranging conversations about this. However the media that surrounds farmers is restricted by advertiser and other stakeholder interests.

It is profoundly troubling to acknowledge that in the 21st century respected international chemical regulators do not account for toxicity in children nor do they utilise current scientific knowledge to understand toxicity at delicate exposure levels.

 

 

8. AVAILABLE PAPERS & PRESENTATIONS: ENDOCRINE DISRUPTION

USA

2015. The Endocrine Society's Second Scientific Statement on Endocrine-Disrupting Chemicals provided recommendations beyond research for the next 5 years include:

•          Educate the public, the media, politicians, and governmental agencies on ways to keep EDCs out of food, water, and air and to protect developing children in particular.

•          Develop industrial partners such as “green chemists” and others who can create products that test and eliminate potential EDCs.

•          Recognize that EDCs are an international problem and develop international collaborations.

•          Cultivate the next generation of EDC researchers, green chemists, physicians, and public health experts with expertise in endocrine systems.

•          Funding agencies need to go beyond the “one scientist, one project” and “one clinician, one patient” perspective to fund team science and healthcare.

•          Funding agencies need to prioritize EDC research in the basic, clinical, and epidemiological realms, especially considering that the cost of research and prevention will result in substantial cost savings in treatment and mitigation.

•          Emphasize the need for precaution and prevention.

•          Determine how much evidence is enough based on rigorous, peer-reviewed science—keeping in mind that absolute proof of harm or proof of safety is not possible.

Executive Summary to EDC-2: The Endocrine Society's Second Scientific Statement on Endocrine-Disrupting Chemicals. Gore et al 2015.  DOI: http://dx.doi.org/10.1210/er.2015-1093   

2010. The director of the US National Toxicology program, Dr Linda Birnbaum, testified to a US subcommittee of the US House of Representatives, and advised that there were four aspects of exposure that elevated endocrine disrupting chemicals (EDC) to that of a public health concern. She noted in particular, the 1. Effect of low doses; 2. Wide range of effects; 3. Persistence of effects; and 4. Ubiquity of exposure.

 Linda S. Birnbaum, Ph.D., DABT, ATS. Director, National Institute of Environmental Health Sciences. National Institutes of Health. Director, National Toxicology Program Department of Health and Human Services on Endocrine Disrupting Chemicals in Drinking Water: Risks to Human Health and the Environment before Committee on Energy and Commerce Subcommittee on Energy and Environment. United States House of Representatives.

2009. The 2008-2009 Report from the President’s Cancer Panel advised ‘It is vitally important to recognize that children are far more susceptible to damage from environmental carcinogens and endocrine-disrupting compounds than adults. It advised that ‘A growing body of research documents myriad established and suspected environmental factors linked to genetic, immune, and endocrine dysfunction that can lead to cancer and other diseases’ and noted ‘Children Are at Special Risk for Cancer Due to Environmental Contaminants and Should Be Protected’ and that ‘Some chemicals indirectly increase cancer risk by contributing to immune and endocrine dysfunction’. Once again knowledge is expressed regarding the vulnerability of the developing foetus to chemicals: ‘Numerous environmental contaminants can cross the placental barrier; to a disturbing extent, babies are born “pre-polluted.”

The report noted ‘these substances typically are not listed as carcinogens by regulatory agencies, but the body of evidence linking EDCs to breast and other cancers is growing.’

The Presidents Cancer Panel recommended self advocacy:

'Each person can become an active voice in his or her community. To a greater extent than many realize, individuals have the power to affect public policy by letting policymakers know that they strongly support environmental cancer research and measures that will reduce or remove from the environment toxics that are known or suspected carcinogens or endocrine-disrupting chemicals. Individuals also can influence industry by selecting non-toxic products and, where these do not exist, communicating with manufacturers and trade organizations about their desire for safer products.'

2009. Endocrine-disrupting chemical: an Endocrine Society scientific statement. Diamanti-Kandarakis E, Bourguignon JP, Giudice LC, Hauser R, Prins GS, Soto AM, Zoeller RT, Gore AC. 2009.  Endocr Rev 30:293–342. 

The Endocrine Society has called for such a reduction and the use of the precautionary principle, i.e. action in the presence of concerning information but in the absence of certainty to eliminate or cut the use of questionable chemicals even when cause-effect relationships are not yet established

 

Europe

2016: Endocrine Disrupting Chemicals and Future Generations: Time for EU to Take Action. Opinions from the scientific community. Pesticide Action Network. A series of essays and speeches by respected scientists and toxicologists.

2016: Epigenetic Effects of Endocrine Disrupting Chemicals. Shahidehnia, M.  J Environ Anal Toxicol 2016, 6:4 http://dx.doi.org/10.4172/2161-0525.1000381

2015: Estimating burden and disease costs of exposure to endocrine-disrupting chemicals in the European union.

A study by panel of experts on endocrine science pegs established median annual health costs of exposure to EDCs at €157bn (or US209billion). The estimates, which approximated to 1.23% of the continent’s GDP were drawn from EDCs with a high probability of causation. The main illnesses associated with a greater than 20% probability of being caused by EDCs, included ‘IQ loss and associated intellectual disability, autism, attention-deficit hyperactivity disorder, childhood obesity, adult obesity, adult diabetes, cryptorchidism, male infertility, and mortality associated with reduced testosterone.’

The study authors concluded ‘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. These estimates represent only those endocrine disrupting chemicals with the highest probability of causation; a broader analysis would have produced greater estimates of burden of disease and cost.’ [14]

‘The EU is taking the lead on regulating EDCs, through legislation such as REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) and regulations on pesticides and biocides. The outcome of these policy discussions will be crucial not only for consumer and public health protection in the EU, but also for setting scientific and regulatory policy precedents for other national policies including those consistent with implementation of global agreements such as SAICM (the Strategic Approach to International Chemicals Management) (26). A critical element in the regulation of EDCs in EU policy will be the criteria by which test outcomes for EDCs are translated into regulatory action.' 

Estimating burden and disease costs of exposure to endocrine-disrupting chemicals in the European union. Trasande L, Zoeller RT, Hass U, Kortenkamp A, Grandjean P, Myers JP, DiGangi J, Bellanger M, Hauser R, Legler J, Skakkebaek NE, Heindel JJ.  J Clin Endocrinol Metab. 2015 Apr;100(4):1245-55. doi: 10.1210/jc.2014-4324. Epub 2015 Mar 5.  PMID: 25742516

March 2015. EDC 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. (Guardian article) 

Europe might be moving to regulate EDCs, but faces trade pressure from the USA over international treaties may stall or corrupt this process.

2014: Health Costs In the European Union: Exposure to food and everyday electronic, cosmetic and plastic products containing endocrine disrupting chemicals (EDCs) may be costing up to €31 billion per year in the EU, according to a report launched by HEAL. Endocrine disruption may contribute to increasing obesity, cancer, reproductive problems and neurological disorders and challenges.

2014 Pan Europe  According to the pesticides and biocides regulations, substances having endocrine disrupting (ED) properties should not be approved. The European Council and the Parliament have actually agreed that approval of pesticides should be based on specific “cut-off” criteria, also known as the “hazard approach”, i.e. the production or use of a chemicals with any kind of ED properties will not be permitted. Yet, several years later, instead of obtaining a consensus on what the criteria that define EDCs are, we receive a roadmap, which describes how the initially hazard-based approach could be completely modified.

The main reason for the delay in decision-making is because the criteria for EDC are seen by industry as a major threat to their business. Industry is used to a “risk assessment approach”, where it is assumed that exposure to a substance at low doses may be of “low risk” and consequently “harmless”. This is not the case for EDCs where smaller doses may be even more potent, especially during sensitive periods of development such as in embryos and newborn babies and hence the “hazard approach” was decided for their identification.

PAN-Europe EDC expert Angeliki Lysimachou said “we are highly concerned with the possibility of adding risk assessment and socioeconomic elements in the evaluation of EDCs as the adverse effects of these compounds upon human health and the environment should not be evaluated with economic terms, since economy is not constructed to protect human health and as tiny exposures at the wrong moment in life may induce dramatic consequences: adverse sex organs development, impaired cognition, cancer, diabetes, obesity etc.”.

European Commission: Report on Public consultation on defining criteria for identifying endocrine disruptors in the context of the implementation of the Plant Protection Product Regulation and Biocidal Products Regulation. July 22 2015.

27,000 responses to the public consultation. The respondents came from various parts of society and included doctors, farmers, NGOs, representatives of the chemical, electronic, food and medical devices industries, water companies and scientists. T Many respondents raised issues related to food safety, the threat that endocrine substances might pose to human health and/or the environment and the impact of the different options proposed in the roadmap on agriculture, industry, health and the environment. In particular farmers and agri-business highlighted the potential serious implications of setting scientific criteria to identify substances with endocrine disrupting properties on agriculture.

The overall message from respondents is that there is a need for the EU to identify criteria for endocrine disruptors.

http://ec.europa.eu/health/endocrine_disruptors/docs/2015_public_consultation_report_en.pdf

November 2014 The Government signs letter on ‘Reach up’.   At the initiative of Denmark, the environment ministers of Sweden, Denmark, Belgium, France, the Netherlands, Germany, Austria and Norway signed a letter addressed to incoming Commissioners Bieńkowska and Vella at the Environment Council on 28 October. The letter states that compliance with the commitments in the EU’s Seventh Environmental Action Programme requires better and more effective implementation of the EU Chemicals Regulation (Reach), reduced exposure to endocrine disruptors and adequate consideration of nanomaterials in all relevant legislation.  http://www.government.se/press-releases/2014/11/eu-must-act-on-endocrine-disruptors/

2014. Missed & Dismisssed: Pesticide Regulators Ignore the legal obligation to use independent science for deriving safe exposure levels. Pesticide Action Network Europe and Generation Futures. September 2014.

2012. CHEM Trust (2012) A CHEM Trust and HEAL Briefing: Challenges and solutions in the regulation of chemicals with endocrine disrupting properties. http://www.env-health.org/IMG/pdf/36-_heal_ct_edc_criteria_briefing_paper.pdf

2011. Effect of Endocrine Disruptor Pesticides: A Review. Mnif et al 2011. Int J Environ Res Public Health. 2011 Jun; 8(6): 2265–2303. 2011 Jun 17. doi:  10.3390/ijerph8062265

This paper noted that risk assessment should include investigation of toxicity of the presence of pesticide by-products and the cumulative exposure to pesticides multiple residues.

2010. CHEM Trust and WWF-EPO proposals for the regulation of chemicals with endocrine disrupting properties under REACH (EC 1907/2006) and under the Plant Protection Products Regulation (EC No 1107/2009). Joint discussion paper. http://www.chemtrust.org.uk/wp-content/uploads/CHEM-Trust-WWF-EDC-Classification-Paper-Dec-2010.pdf

Defra- Department for Environment Food and Rural Affairs(2012) Extended impact assessment study of the human health and environment criteria for endocrine disrupting substances proposed by HSE , CRD. - PS2812

 

INTERNATIONAL

2014: WHO Europe Identification of risks from exposure to ENDOCRINE-DISRUPTING CHEMICALS at the country level.  2014. ISBN 978 92 890 5014 2http://www.euro.who.int/__data/assets/pdf_file/0008/245744/Identification-of-risks-from-exposure-to-ENDOCRINE-DISRUPTING-CHEMICALS-at-the-country-level.pdf

Abstract: This document provides information on activities being carried out in the area of endocrine-disrupting chemicals (EDCs) in selected countries, including epidemiological studies on exposure to and the effects of EDCs. It also outlines action needed in the future to prevent the negative impact of EDCs on human health in accordance with the Parma Declaration on Environment and Health (2010) and resolution III/2/F on endocrine-disrupting chemicals of the Strategic Approach to International Chemicals Management (SAICM).

2014: Soubry et al. A paternal environmental legacy: Evidence for epigenetic inheritance through the male germ line. Bioessays. 2014 Apr; 36(4): 359–371. Published online 2014 Jan 16. doi:  10.1002/bies.201300113

2014:  Zoeller et al.2014. A path forward in the debate over health impacts of endocrine disrupting chemicals. Environmental Health 2014 13:118.   http://www.ehjournal.net/content/13/1/118

2012: The Weybridge Report. 2012. The impacts of endocrine disrupters on wildlife, people and their environments – The Weybridge+15 (1996–2011) report http://www.eea.europa.eu/publications/the-impacts-of-endocrine-disrupters

2012: State of the science of endocrine disrupting chemicals. WHO/UNEP 2012.  Edited by Åke Bergman, Jerrold J. Heindel, Susan Jobling, Karen A. Kidd and R. Thomas Zoeller. http://www.unep.org/hazardoussubstances/Portals/9/EDC/StateOfEDCScience.pdf.

2011: State of the Art Assessment of Endocrine Disruptors, Final Report.  Kortenkamp A, Martin O, Faust M, Evans R, McKinlay R, Orton F, Rosivatz E (2011).  http://ec.europa.eu/environment/chemicals/endocrine/pdf/sota_edc_final_report.pdf

 

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 [2] WHO Europe. State of the Science of Endocrine Disrupting Chemicals – 2012. WHO UNEP.

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[10] 2008–2009 Annual Report. President’s Cancer Panel. REDUCING ENVIRONMENTAL CANCER RISK What We Can Do Now Suzanne H. Reuben for The President’s Cancer Panel April 2010. (vii)

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[13] Why Public Health Agencies Cannot Depend on Good Laboratory Practices as a Criterion for Selecting Data: The Case of Bisphenol A. Environ Health Perspect. 2009 Mar; 117(3): 309–315. doi:  10.1289/ehp.0800173

[14]  Myers J P et al (2016). Concerns over use of glyphosate-based herbicides and risks associated with exposures: a consensus statement. Environmental Health 15(19). DOI 10.1186/s12940-016-0117-0. Open access:http://ehjournal.biomedcentral.com/articles/10.1186/s12940-016-0117-0

[15] Defarge et al 2016. Co-Formulants in Glyphosate-Based Herbicides Disrupt Aromatase Activity in Human Cells below Toxic Levels. Int. J. Environ. Res. Public Health 201613(3), 264; doi:10.3390/ijerph13030264

[16] Frequently asked questions JMPR secretariat 27 May 2016

[17] FAO Plant Production and Protection Paper 227, Pesticide residues in food 2016 REPORT 2016, ISSN 2070-2515.  http://www.fao.org/3/a-i5693e.pdf

[18] European Food Safety Authority. Programming document 2016 – 2019 Protecting consumers’ health with independent scientific advice on the food chain  Sue Davies. March 2016

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[23] US EPA’s Office of Pesticide Programs ‘Glyphosate Issue Paper: Evaluation of Carcinogenic Potential’ P.133.

[24] 10 questions about GM foods. C Robinson et al. http://www.gmwatch.org/files/10-Questions-about-GM-Foods.pdf

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[26] Executive Summary to EDC-2: The Endocrine Society's Second Scientific Statement on Endocrine-Disrupting Chemicals. Gore et al 2015.  DOI: http://dx.doi.org/10.1210/er.2015-1093   

[27] Estimating burden and disease costs of exposure to endocrine-disrupting chemicals in the European union. Trasande L, Zoeller RT, Hass U, Kortenkamp A, Grandjean P, Myers JP, DiGangi J, Bellanger M, Hauser R, Legler J, Skakkebaek NE, Heindel JJ.  J Clin Endocrinol Metab. 2015 Apr;100(4):1245-55. doi: 10.1210/jc.2014-4324. Epub 2015 Mar 5.  PMID: 25742516

http://www.theguardian.com/environment/2015/mar/06/health-costs-hormone-disrupting-chemicals-150bn-a-year-europe-says-study

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[30] Goodson et al 2015. Assessing the carcinogenic potential of low-dose exposures to chemical mixtures in the environment: the challenge ahead.

Youtube clip:   2014 Beyond Pesticides Forum: Epigenetic Transgenerational Actions of Endocrine Disruptors on Reproduction and Disease.  32nd National Pesticide Forum, April 11-12, 2014 Portland, OR - Portland State University. Presented by Michael Skinner, PhD, professor, school of Biological Sciences, Washington State University, Pullman, WA

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