Hazard, risk & babies.

IARC 2b twitter.jpg

Government chemical regulators responsible for ensuring public safety traditionally undertake:

(1) Hazard assessment - a chemical's potential to cause adverse effects to different body systems eg. neurotoxicity, carcinogenicity, reproductive and developmental toxicity; and

(2) Risk Assessment - the likelihood the hazard will occur based on specific exposures (what level of substance can be absorbed or consumed each day before adverse effects occur).

When we visit the beach with a toddler, hazard is constantly present. The likelihood of surviving being swiped by a wave and dragged out to sea, presents a varying level of risk. Parents at the beach become surprisingly alert risk managers. Sugar is another example. In recent years scientific literature has identified sugar as much more hazardous (toxic) than previously recognised, affecting multiple pathways (brain, liver, hormonal system). Science is also recognising smaller doses than previously recognised present risk, particularly to children. 

Trust in government - a fiduciary duty to protect citizens from hazardous chemicals

Senior government decision-makers appear to comment off-handedly that if the herbicide glyphosate is probably carcinogenic as rated by the International Agency for Research on Cancer, it is as risky to the public as hairdressing or nightshift.

They avoid or ignore the fact that undeclared chemicals in staple foods, like lighting up a cigarette in a car with a toddler looking balefully at you in the rear-view mirror, constitutes an unavoidable exposure. 

Risk is always dependent on the circumstances of the exposure. In a child, an adverse effect may happen at lower doses, may cause greater harm in later life than for an adult. Frequently scientists are finding that the lower our technologies enable us to investigate, the lower we find harm occurring. 

Most of these government decision-makers operate under legislation that legally requires that they consider vulnerable groups such as pregnant women or children. Babies and children do not work nightshift.  By ignoring their duty to take this fact into account, decision-makers are potentially misleading the public, or acting illegally, or both.

Trust in responsible governance requires that these vulnerable groups are not exposed to a probable carcinogen. For government agencies to turn around and say, but a little bit is fine, inspires the question - how much?

A little bit of each of the probable carcinogens on the Wikipedia page is fine? Because cumulative toxicity is, well, a 'thing'. Low level adverse endocrine disrupting exposures is also a 'thing'. And of course, the 'thing' regulators never talk about - the complete pesticide formulation that includes  other (commercial in confidence) chemicals in the formulation to create patentable toxic synergies, is also a, 'thing.'

In relation to glyphosate, a herbicide formulation sprayed on food crops, the IARC conducted a hazard assessment in 2015 to understand whether glyphosate, but also the retail formulation, and breakdown products, could cause cancer. The IARC limited scrutiny to published and publicly available studies (whether laboratory or real world, epidemiological studies) concerning cancer and glyphosate. IARC concluded that glyphosate, the formulation sold in shops, and the breakdown product that persists in the environment (AMPA) are all probable carcinogens. It also concluded, that, because there were more animal studies, glyphosate caused cancer in animals.

Public health - act with precaution & protect the most vulnerable in society

If we consider the public interest, Europe is a linchpin here, as European legislation directive 1107/2009 requires that if a chemical is probably carcinogenic to humans it cannot be sold.

This is hazard based legislation – it is precautionary, and considers that exposure at any level constitutes an unreasonable risk to the European population.

Europe is the wealthiest continent, with the greatest public funding for health and wellbeing. It considers prevention an integral part of public health management. European legislation considers that precautionary health based decisions best serve the publics’ interest. Thus Europe appears to have a higher bar in order to protect the public. This is also why Europe is at the forefront of decision-making (and controversy) surrounding glyphosate. 

If we come back to the massive list of probable carcinogens, a logical mind will commence calculating small permitted exposures and quickly arrive at the undeniable fact that the precautionary principle and restriction at any level is the only sane solution, when faced with a mountain of chemical exposure of varying complexity. 

Only the greatest amount of cognitive dissonance could push those thoughts away, dismiss any notion of complex system dynamics and the vulnerability of a 6 month old starting on solids. (Which is why Roundup should not be sprayed on food crops before harvest).

Regulators including the US EPA, NZ EPA, EFSA and WHO-FAO claim that they take into account the likelihood of exposure. Thus they consider toxicity studies (hazard) and then look at potential exposures (evaluate risk).

But they don't for babies and they don't for kids. They don't even dose the pregnant mum in the first trimester to see if a baby might be harmed developmentally over this period. They don't think about the toxicity of the full formulation, and their decisions are dependant on industry science. And most of these regulators appear to think the precautionary principle should be adopted when they are 95-100% certain - instead of when they should - when spraying Roundup on wheat and oats could lead to 'morally unacceptable harm that is scientifically plausible but uncertain.'

Yet because Europe’s legislation specifically says that a probably carcinogenic chemical or substance must not be exposed to the public, it is hazard based. There is no ‘acceptable level’ that a probable carcinogen can be poured on food crops and sprayed in public parks. Latter risk assessment becomes obsolete.

Government decision-makers must have courage to act with integrity and place the public interest first, or face increasing distrust in the public sector. 

 

Regulatory risk assessment currently has severe deficits that are impacting public health trust:

  • Full formulation toxicity is not considered by NZ EPA, US EPA, WHO-FAO, EFSA (despite being in legislation - this is because industry supplies the studies for assessment and they are usually active ingredient only).
  • Combination of adverse synergistic hazard from different pathways (neurotoxic, endocrine, carcinogenic etc) is never considered
  • Gives weighting to serious endpoints (eg.mutation) rather than placing priority on sensitive endpoints that are hallmarks of disease (eg. Oxidative stress)
  • IARC considered many tumour incidences highly significant, whereas they were dismissed by regulatory agencies
  • Ignores greater vulnerability pregnancy, with infants, children and teenagers.
  • IARC used published and publicly available data whereas regulatory agencies used data and evaluations directly supplied by the industries dependent on a positive outcome.
  • Industry selects and supplies data for assessments

Depression in farmers - how pesticides are another mental health stress.

Like any complex chronic disease, depression in farmers and farming families is, well complex. It usually has its origins in stress. This can include economic, family, traumatic stress. But there is a type of stress less well known, but clearly documented within the scientific literature.

It’s agrichemical, pesticide stress, which is clearly documented to contribute to higher than average levels of depression. It's arguably disingenuous to look a farmer in the eye and say - just be resilient, but keep using that mix of sprays on your cereal or horticultural crop.

Chemicals don't work like that.

What do we know?

A landmark 20 year National Institute of Health (NIH) which surveyed 84,000 farmers demonstrated the connection between depression in farmers and use of pesticides.

A 2008 paper ‘Depression and Pesticide Exposures among Private Pesticide Applicators Enrolled in the Agricultural Health Study’ considered the data in the NIH study and confirmed that:

‘after adjusting for state, age, education, marital status, doctor visits, alcohol use, smoking, solvent exposure, not currently having crops or animals, and ever working a job off the farm, pesticide poisoning was more strongly associated with depression than intermediate or high cumulative exposure or a high pesticide exposure event.’

However – there need not be an acute poisoning event to have a higher level of depression:

‘In analysis of a subgroup without a history of acute poisoning, high cumulative exposure was significantly associated with depression.’

The Scientific American & Environmental Health News reported another study using NIH data, writing in 2014:

‘experts say that some of the chemicals used to control pests may make matters worse by changing farmers’ brain chemistry.

Recent research has linked long-term use of pesticides to higher rates of depression and suicide. Evidence also suggests that pesticide poisoning – a heavy dose in a short amount of time – doubles the risk of depression.’

The article discussed the results of September 2014 study using the same NIH data: ‘Pesticide Exposure and Depression among Male Private Pesticide Applicators in the Agricultural Health Study’. The paper advised that:

 ‘two pesticide classes, fumigants and organochlorine insecticides, and seven individual pesticides—the fumigants aluminum phosphide and ethylene dibromide; the phenoxy herbicide (2,4,5-trichlorophenoxy)acetic acid (2,4,5-T); the organochlorine insecticide dieldrin; and the organophosphate insecticides diazinon, malathion, and parathion—were all positively associated with depression’

In this study, use of organochlorine insecticides and fumigants increased the farmer’s risk of depression by 90% and 80%.

The Modern Farmer, which also covered the findings questioned whether ‘farmers were likely to simply have higher levels of depression than the norm, given the difficulties of the job — long hours, low wages, a lack of power due to government interference’ and questioned whether depression may have been over-reported.  The 2014 study lead author Dr. Freya Kamel did not consider so, stating that:

‘In fact, only 8% of farmers surveyed sought treatment for depression, lower than the norm, which is somewhere around 10% in this country. That doesn’t mean farmers are less likely to suffer from depression, only that they’re less likely to seek treatment for it, and that makes the findings, if anything, even stronger.’

An earlier study ‘A cohort study of pesticide poisoning and depression in Colorado farm residents’ which researched the long-term influence of pesticide poisoning on depressive symptoms advised that:

'Pesticide poisoning was significantly associated with depression in three years of follow-up after adjusting for age, gender, and marital status. Depression remained elevated after adjusting for health, decreased income, and increased debt and was primarily due to significant associations with the symptoms being bothered by things and feeling everything was an effort.'

The paper concluded:

'Feeling bothered and that everything was an effort were persistently associated with a history of pesticide poisoning, supportive of the hypothesis that prolonged irritability may result from pesticide poisoning.'

A UK study ‘Neuropsychological and psychiatric functioning in sheep farmers exposed to low levels of organophosphate pesticides’ wanted to understand whether low level exposure to organophosphate pesticides (OPs) causes neuropsychological or psychiatric impairment. The study compared 127 agricultural workers with a history of low level exposure to organophosphate pesticides with 78 non-exposed controls. The study authors noted:

‘A range of emotional, physical and cognitive problems were identified in agricultural workers. In terms of emotional and physical health, over 40% of the exposed cohort complained of clinically significant levels of anxiety and depression compared to less than 23% of controls, the highest rates of distress being found in retired farmers. Farmers also report a range of physical symptoms which they describe as being moderate to severe, the most prominent being fatigue, memory problems, joint stiffness, sleep disturbance, irritability and feeling mentally slowed down.

In terms of cognitive function, general intellectual ability, reasoning, visuo-spatial and verbal ability were relatively well preserved, but agricultural workers obtained lower scores on tests of response speed, working, verbal and visual memory, mental flexibility and fine motor control, than controls.’

A 2013 study 'Pesticide exposure and depression among agricultural workers in France' concluded that herbicides were nearly twice as likely to have been treated for depression than those who didn’t use herbicides, and that this increased if farmers had been using herbicides for more than 19 years.

The scientific literature demonstrates the cost of constant agrichemical exposure to our farming families. Families experience in their own very separate ways, the stress and trauma and misery that accompanies depression and suicide.

Any policy framework, any strategic direction to combat agrichemical stress in farming has an obligation to clearly acknowledge and outline the risks to farmer mental health – but also consider the implications of exposure to neurotoxic pesticides to the family. Particularly women of childbearing age and infants and children. This includes teenagers who have been demonstrated to have vulnerable windows of exposure to developmental toxicants during this time.

This is not happening - risk assessment for pesticides does not pay special attention to full formulation epidemiological studies. Nor does it seek to understand the mechanisms for depression, nor the mechanisms for childhood developmental neurotoxicity. 

The Scientific American article concluded with this comment from a farmer:

“Even if they hear my message, they have to make choices: Do I need to use this chemical for the good of my farm, or do the negative factors – what it could be doing to the insects, food supply and possibly people – make it not worth it?”

Should farmers pay this cost? Or can farmers realistically transition to organic and biological farming with old fashioned state support - bringing back public extension services and government support to facilitate a move in agriculture to agro-ecological farming that will also benefit climate (more carbon in the soil) and environment (less diffuse chemicals in the environment).

It's not just our drinking water, our soil health, our climate that suffers from industrial chemical agriculture.

References:

Beseler CL, Stallones L, Hoppin JA, Alavanja MC, Blair A, Keefe T, et al. 2008. Depression and pesticide exposures among private pesticide applicators enrolled in the Agricultural Health Study. Environ Health Perspect 116:1713–1719; doi: 10.1289/ehp.11091.

Freya Kamel et al, “Pesticide Exposure and Depression among Male Private Pesticide Applicators in the Agricultural Health Study.”  Environmental Health Perspectives, DOI:10.1289/ehp.1307450

Beseler CL, Stallones L. 2008. A cohort study of pesticide poisoning and depression in Colorado farm residents. Ann Epidemiol 18:768–774.

Mackenzie Ross SJ, Brewin CR, Curran HV, Furlong CE, Abraham-Smith KM, Harrison V. 2010. Neuropsychological and psychiatric functioning in sheep farmers exposed to low levels of organophosphate pesticides. Neurotoxicol Teratol 32:452–459.

Marc G. Weisskopf et al, “Pesticide Exposure and Depression Among Agricultural Workers in France.” American Journal of Epidemiology, doi: 10.1093/aje/kwt089

 

2016 WHO FAO Glyphosate Evaluation

glyphosate IARC WHO

Is the exclusion of a wide body of scientific evidence that demonstrates that glyphosate and its formulations cause long term (chronic) harmful effects at environmentally relevant levels by the WHO FAO JMPR panel a contravention of Constitution of the World Health Organisation?  Particularly when the arm of the World Health Organisation that deals with cancer (IARC) sets the standard for twenty-first century scientific knowledge of carcinogenesis and disease development - drawing information from a wide range of studies that includes consideration of full formulation toxicity?

On 16th May the Joint Meeting of the Food and Agriculture Organisation of the United Nations (FAO) Panel of Experts on Pesticide Residues in Food and the Environment and the World Health Organization (WHO) Core Assessment Group on Pesticide Residues (JMPR) released a summary report for glyphosate, diazinon and malathion. The FAO JMPR Page is here

The constitutions requires that these agencies place health as a priority:

Constitution of the World Health Organisation. 

Chapter I – OBJECTIVE Article 1
The objective of the World Health Organization (hereinafter called the Organization) shall be the attainment by all peoples of the highest possible level of health.

Food & Agriculture Organisation:

'Our mandate is to support members in their efforts to ensure that people have regular access to enough high-quality food.'

Yet it appears that the World Health Organisation (WHO) and Food and Agriculture Organisation (FAO) Joint Meeting on Pesticides Residues (JMPR) 2016 evaluation utilises antiquated guidelines and old scientific studies while neglecting to consider new scientific methods for understand toxicity at low exposures.

A 2015 scientist consensus statement advised

'Regulatory estimates of tolerable daily intakes for glyphosate in the United States and European Union are based on outdated science.'[1]

The 2016 WHO FAO evaluation for glyphosate, diazinon and malathion was released in May 2016. In relation to the glyphosate studies, it appears to draw from old data, exclude new science, and avoids providing references for scientific studies.

Current available JMPR 16 May summary noted:  Meeting reaffirmed the group ADI for the sum of glyphosate and its metabolites of 0–1 mg/kg body weight on the basis of effects on the salivary gland.'    http://www.who.int/foodsafety/jmprsummary2016.pdf

Detailed information is in the more comprehensive 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

Problems with the FAO/WHO JMPR panel 2016 Special Session evaluations: Outdated science & unpublished studies

1. Exposure levels for the world population - daily glyphosate acceptable daily intake (ADI) for life - stays the same from the 2004 toxicological evaluation.  

The 2016 panel retained the 2004 ADI ADI at 1mg per kg bodyweight per day. 

The Meeting reaffirmed the group ADI for the sum of glyphosate, AMPA, N-acetyl-glyphosate and N-acetyl-AMPA of 0–1 mg/kg bw on the basis of the NOAEL of 100 mg/kg bw per day for effects on the salivary gland in a long-term study of toxicity and carcinogenicity in rats and application of a safety factor of 100.  Page. 24

Unless otherwise confirmed, it would appear that the 'salivary gland study' may be an unpublished twenty-three year old Cheminova paid study from 1993. 

Atkinson, C., Strutt, A.V., Henderson, W., Finch, J. & Hudson, P. (1993b) Glyphosate: 104 week combined chronic feeding/oncogenicity study in rats with 52 week interim kill (results after 104 weeks.). 

Pesticide residues in food – 2004    Joint FAO/WHO Meeting on Pesticide Residues  EVALUATIONS  2004  Part II—Toxicological Pages 127-129.  Long-term studies of toxicity and carcinogenicity

  • Target/critical effect:  Reduced body weights, loose stools, liver (toxicity), salivary glands (organ weight, histology), eye (cataracts, lens fibre degeneration)
  • Lowest relevant NOAEL: 100 mg/kg bw per day (2 years; rat) Carcinogenicity. Not carcinogenic in rats; could not exclude possibility of carcinogenicity in mice at very high doses

It would seem the JMPR are relying on old data. This has the effect of maintaining permitted population daily exposures (ADI, RfD). The result of this, is to maintain permitted current levels of glyphosate applications to staple food crops, including cereals, oilseeds, sugar, peas and lentils.

2. Ignoring 21st century science: Scope was restricted to the active ingredient.

It is understood that the adjuvants are frequently toxic - yet while regulatory agencies acknowledge increasing evidence, they resist allowing for cumulative and synergistic toxicity in risk assessment - despite the fact that the population is exposed to full formulation mixtures, and mixtures of various formulations of insecticides, fungicides, herbicides and growth promotants that may be applied to a single food crop. 

A wide range of science demonstrates that the full formulation is more toxic than the active ingredient. By ignoring this fact the WHO and FAO JMPR committee fail to evaluate glyphosate and its co-formulants safely. The constitution of the WHO prioritises ' the highest possible level of health.'

For decades, the chemical industry have discussed formulations in terms of 'acid equivalents' - different formulations will express different toxicity dependent on the ingredients in the formulation. It is not enough to say that it is only the active ingredient that may cause adverse effects.

The 2015 IARC Working Group on glyphosate included full formulation studies because it is commonly accepted that formulation mixtures exhibit synergies and can therefore be more toxic than the active ingredient.

As a leading authority on carcinogenesis and cancer the IARC establishes a level of scientific rigor in understanding toxicity that responsible regulators including the FAO & WHO should adopt, in order to be relevant and authoritative.

Agricultural manuals reflect this and discuss 'acid equivalents,' as formulation ingredients may result in less of the 'active ingredient' (in this case, glyphosate) in the end formulation. 

A Consensus Statement on glyphosate published in 2015 noted:- 

‘The distinction in regulatory review and decision processes between ‘active’ and ‘inert’ ingredients has no toxicological justification, given increasing evidence that several so-called ‘inert’ adjuvants are toxic in their own right.’ [1]

It appears the outdated guidelines and protocols which insist on 'active ingredient' assessment only are outdated and do not reflect modern scientific understanding.

3. Ignoring 21st century science: Environmentally relevant exposures not considered

Codex Alimentarius increased permitted levels of glyphosate on crops in 2006 after the 2004 evaluations and crop residue trials to allow for pre-harvest desiccation.  A US EPA screening report reveals significantly high residues across food crops. 

Maximum residue levels (MRLs) on food crops are obtained from trials on crops to assess levels of pesticide residue. Once the crop levels are agreed on they are formalised as MRLs within, for example, Codex Alimentarius and the US Code of Federal Regulations (Title 40 Protection of Environment) .

As toxicological evaluations to assess whether a pesticides causes adverse harm to health are not conducted at environmentally relevant levels - there is no requirement for MRLs to be adjusted for health reasons. MRLs are set much lower than the industry paid studies regulators use to assess cancer, reproductive toxicity etc. 

An increasing range of studies are demonstrating harm from pesticides at the environmentally relevant levels (for example, parts per billion) but conventionally regulators only use studies selected and supplied by the industry concerned with the active chemical in question.

As a result the JMPR summary declares there is no risk from food. 

Testing reveals that glyphosate is present in the population, and at higher levels in children: 'In the urine tests, glyphosate was detected at an average level of 3.096 parts per billion (PPB) with children having the highest levels with an average of 3.586 PPB.'  

European politicians excreted glyphosate in urine at surprisingly high doses. Where previously it was assumed only farm workers and spray applicators had constant exposure, it is now understood that city dwellers are exposed via food. It appears a substantive contribution to exposures may come from pre-harvest treatments, which were increased in 2006.

It is well known that glyphosate is increasingly present in groundwater. Maintenance of current exposure rates and hence crop application rates by definition will result in continued increases in groundwater and drinking water sources. Risk assessment within the World Health Organisation is yet to address the potential downstream effects of increased residues of glyphosate, its formulations - and the increasing synergies of various pesticide formulations in groundwater at environmentally relevant levels.

Downstream effects may include increased rates of chronic disease including cancer, endocrine disruption, reduced antibiotic effectiveness, reduced IQ and neurological harm. 

Regulators and risk assessment agencies have traditionally downplayed the risk of glyphosate entering groundwater and drinking water sources. It is now understood this this is assumption is incorrect. The Consensus Statement noted:

Studies have shown that soil sorption and degradation of glyphosate exhibit great variation depending on soil physical, chemical, and biological properties. The risk of long-term, incremental buildup of glyphosate contamination in soil, surface water, and groundwater is therefore driven by highly site-specific factors, and as a result, is difficult to predict and costly to monitor.[1]

Much of the current protocols and guidelines have been followed by the JMPR for decades - they appear sufficient to exclude twenty first century published data that a chemical under evaluation causes harm at very low levels. Simply put, the JMPR does not consider toxicity at environmentally relevant levels.

This needs confirmation, as scientific reviews must normally disclose the authors of the data that they review, contrary to normal procedure, this the JMPR does not appear to have done so at time of writing.

The older studies apparently used by the JMPR in this evaluation consider levels much higher than those present in food and water.

The Committee downplay the long term absorption and exposure aspects and appear to rely on decades old science. Furthermore, many old industry paid studies are used: for example, the claim that ‘Less than 1% of the administered dose was retained in tissues 168 hours post-administration.’ Appears to be from a 1988 unpublished study produced in a Monsanto laboratory and used in the 2004 evaluations:

Ridley, W.P. & Mirly, K. (1988) The metabolism of glyphosate in Sprague-Dawley rats. Part I. Excretion and tissue distribution of glyphosate and its metabolites following intravenous and oral administration. Unpublished report, study No. 86139, project No. ML-86-438, dated March 1988, from Monsanto Environmental Health Laboratory, St. Louis, Missouri, USA. Submitted to WHO by Monsanto Int. Services SA, Brussels, Belgium

The complexity and potential for adverse harm from low levels exposures are not addressed by the JMPR in the 2016 paper, yet are recognised by scientists:

‘Unless and until regulatory agencies incorporate modern endocrinologic principles into their risk assessment paradigms, they will continue to provide false assurances of “safety” and fail to recognize the actual health risks posed by chronic low-level exposure to an increasing number of chemicals found in commonly used products.'[2]

3. Ignoring 21st century science: Chronic toxicity - 'pretend' studied......

In 2004 (the last FAO WHO glyphosate evaluation) the JMPR declared glyphosate was fully excreted.

It is evident that this is now, not the case.  Science understands that due to extensive applications on staple food crops and animal feed, the population receives chronic low dose exposures from conception onwards and that babies are born pre-polluted. Non-agricultural and agricultural populations are exposed.

Studies demonstrate risk from chronic (long term) toxicity is of profound concern. Due to the demonstrated accumulation in food and urine we have evidence of low level exposures. The JMPR panel criteria that establishes the ADI does not address chronic toxicity at environmentally relevant exposures.

The longest studies held with risk assessment agencies are at 24 months - in rat years, that is 60 years. If long term studies were to accurately depict lifetime exposure, they would continue till 36 months, 90 years. This would make research even more expensive, but the challenge is that when tumours are detected at 24 months, these private studies frequently dismiss the tumour due to historical data, not considered related to the active ingredient - yet these studies cannot be peer reviewed nor subject to replication. 

For example. the JMPR advised that the overall NOAEL for systemic toxicity in rats was 100 mg/kg bw per day, and the overall LOAEL was 300 mg/kg bw per day.

chemicals children babies sick

3. Ignoring 21st century science: Pregnancies and infants ignored. 

In every instance, children are exposed to higher levels than adults. The JMPR do not consider toxicity studies that would apply to an infant under 15kg. This is unaccounted for.  In reproductive studies supplied for risk assessment, the rodent is not dosed in the first trimester. As the WHO says 'children are not little adults' - they are more vulnerable.

The 2016 Report advises: The lowest NOAEL for embryo and fetal toxicity was 300 mg/kg bw per day, based on delayed ossification and an increased incidence of fetuses with skeletal anomalies observed at 1000 mg/kg bw per day.

It appears that, without providing a reference, that the 2016 JMPR are again relying on old data – Pages 139-140 of the 2004 evaluations provide the same information, citing the study authors:

Brooker, A.J., John, D.M., Anderson, A. & Dawe, I.S. (1991b) The effect of glyphosate on pregnancy of the rat (incorporates preliminary investigation). GLP yes. Unpublished report No. CHV 43 & 41/90716, dated 14 October 1991, from Huntingdon Research Centre Ltd., Huntingdon, England. Submitted to WHO by Cheminova A/S, Lemvig, Denmark.

Internationally, twenty first century science clearly demonstrates the increased vulnerability of the developing infant – yet the JMPR rely on twentieth century unpublished science to arrive at a NOAEL for the developing baby.

New science points to the adverse effects cause by low level neonatal chemical exposures that can contribute to carcinogenesis via endocrine disruption and epigenetic influences.

This 1993 paper demonstrates that potential for adverse harm from chemicals at low levels has been known for over twenty years:

‘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’. [3]

Yet the studies considered by the JMPR are a narrow range of chemical industry studies, rather than a wide section of published and peer reviewed studies that today would indicate that agencies and regulators should move with caution in permitting chemical exposures on staple food crops.

4. Ignoring 21st century science: Hormone damaging? Epigenetic effects? 

In the WHO FAO data call out there was no request for studies concerning endocrine disruption - the public literature indicates that glyphosate is likely an endocrine disruptor (EDC). 

Page 22 of the Report states:- 

‘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 that the Meeting considered adequate for the evaluation clearly demonstrate that there is no interaction with estrogen or androgen receptor pathways or thyroid pathways.’

Yet there are no references to elucidate as to which studies were reviewed.

The IARC made allowances that when it comes to the endocrine system, low doses may exert greater effects than higher doses, therefore linear dose response curves cannot be assumed.

Yet current risk assessment will dismiss a response at a lower dose that does not consistently increase at a higher dose. 

‘When the potential for non-linear dose-response relationships is combined with the possibility of synergism between and amongst low doses of mixtures of individual chemicals in the environment, it appears plausible that chemicals that are not individually carcinogenic may be capable of producing carcinogenic synergies that would be missed using current risk assessment practices.’ [4]

It is understood that glyphosate can adversely affect hormones at 0.1PPB.   

5. Conflicts of interest - with the JMPR panel

2016 May JMPR panel of experts 2016 September JMPR expert bios. 

The Guardian reported May 2016, in 'UN/WHO panel in conflict of interest row over glyphosate cancer risk:

'Professor Alan Boobis, who chaired the UN’s joint FAO/WHO meeting on glyphosate, also works as the vice-president of the International Life Science Institute (ILSI) Europe. The co-chair of the sessions was Professor Angelo Moretto, a board member of ILSI’s Health and Environmental Services Institute, and of its Risk21 steering group too, which Boobis also co-chairs.'

The Centre for Media and Democracy's SourceWatch advises:

International Life Sciences Institute (ILSI) is a Washington-D.C. based lobby group funded by food, chemical and drug companies. Primarily it acts on behalf of the global food manufacturing industry, but it also includes operations involved with agriculture and genetic modification; pesticides and pharmaceuticals; confectionery; and even with such dubious consumables as cigarettes.

SourceWatch notes that ILSI has over 400 companies listed as members, including Dow Agrosciences/Dow Chemical , Monsanto, DuPont and Bayer AG.

ILSI has valuable 'insider' status at WHO governing body meetings and the chairmanship of Professors Boobis and Moretto may inevitably facilitate close industry relationships.

6. Conflicts of interest - data. 

The FAO released FAO Plant Production and Protection Paper 227, Pesticide residues in food 2016 REPORT 2016, ISSN 2070-2515.  This is a Summary Report - rather than a Toxicological Monograph. At time of writing (5 months after release) there are no references for the data nor advice regarding exactly which organisations or individuals selected and supplied the studies used. 

It appears that the World Health Organisation (WHO) and Food and Agriculture Organisation (FAO) Joint Meeting on Pesticides Residues (JMPR) appear to be using old unpublished industry selected and supplied studies to arrive at the recommended exposure levels for the world population. 

Traditionally the manufacturers (industry) carefully select and supply the critical data that supply the NOAELs that contribute to establishing the daily permitted expsoures (ADI or RfD). 

It is critical these studies are transparently available as the high ADI justifies ongoing glyphosate applications to food and feed crops and lack of testing in groundwater and retail food products.  Is the data widely sourced and published for peer review? 

Peer review enables scientists to look critical at data and ensure a study has been produced using good science - every good study must be replicable. The chemical industry avoids publishing data, instead they produce studies according to 'Good Laboratory Practice' and 'OECD guidelines' - fulfilling the requirements of these protocols and guidelines enable the chemical industry to avoid public disclosure of the studies. Yet these protocols and guidelines in many respects are not keeping up with twenty first century science and the increasing knowledge of how chemicals, and chemical mixtures affect humans (particularly baby humans) at surprisingly low levels.

The JMPR derive international levels of chemical exposure for glyphosate and glyphosate formulations to the human population from an extremely narrow range of private, industry produced single dosing studies and private 2 year chronic toxicity studies of the single active chemical glyphosate.

The current Summary Report appears demonstrate an increasingly opaque and outdated approach to risk assessment.

7. The JMPR brushes off the IARC genotoxicity and 'probable carcinogen' finding. 

Hazard based assessment looks at the inherent toxicity of a substance, while risk assessment is concerned with exposure, primarily concerning risk related to dietary exposure. The IARC conclusion is primarily hazard based assessment, but as it looked at current exposure levels, it also addressed risk. 

Typically, regulatory findings follow risk based assessment - yet we find there is a breakdown in what constitutes 'risk' in light of current scientific knowledge that is unravelling the complex mechanisms by which cancer establishes itself - and the significant influence of environmental factors in carcinogenesis.

While the IARC Monograph of course, focused on cancer, it is important to note it included  genotoxicity and oxidative stress as mechanisms for cancer. Regulators have minimised these effects in risk assessment and barely consider oxidative stress.

The JMPR 2016 has largely ignored the role of oxidative stress in cancer. Oxidative stress can facilitate genetic mutations or epigenetically regulate gene expression.

‘Cancer is a multistage process defined by at least three stages: initiation, promotion, and progression. Oxidative stress interacts with all three stages of this process.'

What is risk without understanding caution? 

Evident from the JMPR paper is the focus on particular antiquated unpublished studies to retain the exposure levels, and lack of scrutiny and transparent consideration of the wide range of studies in the publicly available scientific literature.

8. Requirement to future proof. Risk assessment only happens every fifteen years. 

JMPR periodic reviews are scheduled for every 15 years – due to the rare occasions on which pesticides are evaluated it would not be unreasonable to expect every effort to be undertaken to ensure best practice.

The 'business as usual' toxicological evaluation scenario that does not permit consideration of full formulation adverse harm - effectively pushes evaluations that may consider full formulation exposures into the far distant future.

http://www.fao.org/fileadmin/templates/agphome/documents/Pests_Pesticides/JMPR/FAO_manual2nded_Oct07.pdf

9. Probability - the Precautionary Principle - where a chemical is applied to staple food crops.

Unlike cancer from cigarettes, or even chronic disease arising from dietary choices - glyphosate based herbicides are applied to staple food crops - oilseeds, cereals (including oats and wheat), legumes - as well as on animal feed crops.

The majority of the world population cannot exercise a choice to buy organic - therefore the application of a chemical on staple food crops where the science is highly contentious - should mean that responsible regulators and agencies act with caution.

However where there is doubt, today, regulators and agencies do not appear to act with caution in the public interest. Where there is uncertainty they do not elect to remove the chemical from public exposures - instead they act with caution to retain chemical registration and maintain sales of the chemicals.

Actions of regulators to fail to account for full toxicity of a formulation, and to push aside modern advances in understanding cancer development undermines the trust of civil society, fails to adhere to primary purposes of acts which give them an obligation to prevent or manage risks to public health.

Much of this comes back to resourcing - regulatory risk assessment agencies do not have the money to conduct their own research to understand toxicity of chemicals in food and environment. Thus they are dependent on studies supplied directly from the relevant chemical industry and necessarily maintain close relationships with industry when evaluating chemicals.

(I don't think many scientists working in this environment, are happy about it.)

This leads to issues of transparency, and stagnation in scientific rigour as the chemical industry traditionally work with regulators to set and maintain guidelines and protocols that help derive 'weight of evidence' findings that work to ensure regulators select chemical industry studies over public domain, peer reviewed science (the OECD is a trade organisation, rather than a scientific organisation, after all).

Current risk assessment of chemicals, including glyphosate, reveals the deep fraying and decay that demonstrates the dis-ease between the founding constitutions and other legislation that these high profile agencies and regulators must act under - and the reality of actually who sets the agenda to establish and define toxicity, and what studies will actually be considered - for the world population.

This is not just a problem for the World Health Organisation and Food and Agriculture Organisation's JMPR. It is repeated in nearly every national government risk assessment agency.

Current risk assessment reflects the lack of resourcing of these agencies and hence ability to act independently from industry, and reflects the necessary close relationships with the chemical industry that prevent regulators and agencies from acting directly in the public interest and necessarily implementing public health measures that reflect twenty-first century scientific understanding.

 

References:

[1] 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. 

[2] Myers et al 2009b. A Clash of Old and New Scientific Concepts in Toxicity.

[3] Colborn T, vom Saal FS, Soto AM. 1993. "Developmental effects of endocrine-disrupting chemicals in wildlife and humans". Environ. Health Perspect. 101 (5): 378–84.  doi:10.2307/3431890. 

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

[5] D.A.Hanahan & R.A.Weinberg. Review: The Hallmarks of Cancer. Cell. Vol. 100, pp57–70, 2000 http://dx.doi.org/10.1016/S0092-8674(00)81683-9
Reuter et al 2010. Oxidative stress, inflammation, and cancer: How are they linked? Free Radical Biology and Medicine Vol. 49, 1 December 2010, Pp 1603–1616. http://dx.doi.org/10.1016/j.freeradbiomed.2010.09.006

 

 

WHAT IS THE JMPR? 

Content sourced from AGP - The Joint FAO/WHO Meeting on Pesticide Residues (JMPR)

'The current JMPR comprises the WHO Core Assessment Group and the FAO Panel of Experts on Pesticide Residues in Food and the Environment. The WHO Core Assessment Group is responsible for reviewing pesticide toxicological data and estimating Acceptable Daily Intakes (ADI), acute reference doses (ARfDs) and characterizes other toxicological criteria.

The FAO Panel is responsible for reviewing pesticide data residue and for estimating maximum residue levels, supervised trials median residue values (STMRs) and highest residues (HRs) in food and feed. The maximum residue levels are recommended to the Codex Committee on Pesticide Residues (CCPR) for consideration to be adopted by the Codex Alimentarius Commission (CAC) as CXLs.

The output of JMPR not only constitutes the essential basis for Codex MRLs for food and agricultural commodities circulating in international trade, its health-based guidance for pesticides (i.e. ADIs and ARfDs) and recommends maximum residue levels also benefit to the governments of the member countries and regions.'

Get Glyphosate Based Herbicides off our Food!

Rite-Demands.Org Has United With MothersAcrossTheWorld.Com To Start A Global Petition. Please Support Us.

Go Direct to the Petition to Sign: 'FAO Director General Graziano Da Silva: Get Glyphosate Off Our Food!'

We call on FAO Director-General Graziano Da Silva, to respond to the independent, published science and get glyphosate off our food now! We need you to urgently revise the recommended maximum residue levels of glyphosate on our human food crops and animal feed crops to NEGLIGIBLE – zero tolerance, which can be defined as ‘must not contain glyphosate residues greater than 0.01 mg/kg.’

If the FAO can increase these levels of a probably carcinogenic pesticide on our food – they have the power to reduce those same levels to zero tolerance. FAO’s Goal no. 1 is ‘Access of all people at all times to sufficient nutritionally adequate and safe food.’ Mothers today know that glyphosate sprayed on staple food crops are damaging to their children.

FAO’s Goal no. 1 includes ‘Access of all people at all times to sufficient nutritionally adequate and safe food.’  WHO core principles include health as a fundamental human right.

We have ancient private research dominating risk assessment, data demonstrating that the full formulation exacerbates harm to ourselves and our environment that is ignored by regulators, and increasing levels of chronic disease.

The recent JMPR May 2016 Report 'FAO Plant Production and Protection Paper 227, Pesticide residues in food 2016 REPORT 2016, ISSN 2070-2515'  that claims to evaluate toxicity of glyphosate, still, as at September 2016, has not declared the authors and studies used to arrive at it's 2004 conclusion.

'The Meeting reaffirmed the group ADI for the sum of glyphosate, AMPA, N-acetyl-glyphosate and N-acetyl-AMPA of 0–1 mg/kg bw on the basis of the NOAEL of 100 mg/kg bw per day for effects on the salivary gland in a long-term study of toxicity and carcinogenicity in rats and application of a safety factor of 100.' P.24

The 'salivary gland study appears to be a 23 year old 1993 Cheminova study a 23 year old unpublished and not peer reviewed (Atkinson et al. 1993b). As a result of not undergoing public peer review, there has been no ability to scrutinise the study to ensure replicability and reliability. However this appears to be the study that ensures glyphosate based herbicides can be applied widely to food crops - it keeps the ADI -exposure levels - high.

It is surprising the authors a yet to be included - this would be impossible if the review was published within the scientific literature.

Strangely, the above 2016 document appears difficult to retrieve on the JMPR site

Current risk assessment is not safe. It hides behind outdated narrow guidelines - it never assesses full formulation at the environmentally relevant doses the populations are exposed to - and has failed to keep up with modern scientific understanding.

These problems apply to agrichemicals applied to our food, and food chemicals applied during the production process. This is not just a problem for the active ingredient glyphosate.

Increasing childhood illness, concern regarding increasing resistance to fungicides and antibiotics - and growing understanding that environmental chemicals including pesticides play a role - should elevate this. conversation to a higher public health priority.

Outline: How the W.H.O. and F.A.O and Codex Alimentarius work together to set international maximum residue levels (MRL) for pesticides - & why the glyphosate assessments are WAY OUT OF DATE

Many groups across the world are calling for glyphosate to be removed from parks and gardens. The issue yet to be addressed is the extent of glyphosate based herbicides directly sprayed on our staple food crops. This insidious chemical does not wash off and we are consuming it at alarming levels. New studies have shown significant harm from glyphosate at the levels we are exposed to.

If our regulators are to act in the public's interest, they need to remove glyphosate residues from our food.

It is essential that regulators reduce permitted glyphosate on food to zero residues, as a natural response to the IARC condemnation of glyphosate as a probable carcinogen and genotoxic. Numerous new scientific studies show serious harm from glyphosate as a neurotoxin, causing breast cancer cell growth, placental cell death, Non Hodgkin’s Lymphoma and the destruction of gut bacteria which harbors our immune system.  A recent August 2015 study shows glyphosate to cause teratogenic, tumorigenic and hepatorenal effects at levels below ADI’s recommended by the FAO.

The WHO have just set up a task force with a panel of experts with conflicts of interest to review their own findings that glyphosate is probably carcinogenic. This is  a way of putting off the inevitable – taking glyphosate off our food.  

The last true WHO/FAO/Codex assessment of glyphosate was in 2004 - and decades old science using private industry data - was used to prove safety even in this assessment! Following this, in 2006 residue levels on our staple food crops were increased astronomically to permit the application of products like Roundup ONTO our food crops just prior to harvest (rather than traditionally on weeds and soil before planting new seed crops). Current science demonstrates the systemic harm this is causing to us - and details just how dangerous the full formulations that are used within the 'glyphosate based herbicides' mix actually are, to us and to our children at the levels we are exposed to today. But our regulators are very busy ignoring a lot of this science, frequently cherry picking the science supplied for major reassessments (as in the case of Europe) and refusing to consider the full formulation and how this impacts subtle endocrine effects at very low doses. We are worried an IARC committee stacked with industry contacts will try to use the full formulation 'excuse' to dismiss the findings. The precedent for safe risk assessment is not very safe.

It is important to understand that our regulators - whether they are the US EPA, the W.H.O., EFSA, Health Canada, etc etc. - NEVER CONSIDER the more toxic full formulation. This is outdated science that works in the favour of the chemical company (known as the applicant). Most of the time the applicant selects the studies for consideration by the regulator. Today, Risk Assessment (RA) for pesticides are completely unsafe and are carried out along outdated twentieth century parameters.

How does the international system of arriving at permitted Codex maximum residue levels (MRLs) - actually work?

  1. WHO sets our daily allowances (ADI/RfD) of pesticide (Eg. Glyphosate P.95) exposure using usually only industry selected toxicological studies which only take into account the active ingredient within the full pesticide formulation. (If we wait for daily allowances to change, it may be years before this affects permitted residues.)

  2. The FAO Panel of Experts on Pesticide Residues in Food reviews pesticide data residue and estimates maximum residue levels (MRLs). Crop tests from various countries are supplied and the residues advised. The upper levels found in the crop trials tend to be used to form the recommended MRL. These upper levels that then go onto establish the permitted MRLs tend to be unaffected by any results from the JMPR toxicological evaluations which set the ADI/RfDs. These MRLs are then recommended to the Codex Committee on Pesticide Residues (CCPR) for consideration to be adopted by the Codex Alimentarius Commission (CAC) as a CXL (Codex MRL). (Eg. Pesticide Residues in food – 2005 – glyphosate P.122) The CAC tends to directly implement the FAO Panel of Experts recommendations without question.

  3. The combined groups are called the Joint Meeting on Pesticides Residues (JMPR). The output of JMPR constitutes the essential basis for Codex MRLs for food and agricultural commodities circulating in international trade, its health-based guidance for pesticides (i.e. ADIs and ARfDs) and recommends maximum residue levels which are then frequently applied and adopted by governments of the member countries and regions. Alternatively, members may establish their own MRL but use Codex MRLs for imported produce. There is a JMPR meeting on Pesticides Residues set for 15-24 September in Geneva. Glyphosate is not listed for discussion. The WHO advises glyphosate was last evaluated in 2011. However the only content covered in 2011 was an addendum in to look at metabolites of GMO Maize - the science was only supplied by Dupont. The last true assessment was in 2004, and that of course, only used seller sponsored science to arrive at critical NOAELs.

  4. 186 governments, and Europe are members of the CAC.  As members, government decisions regarding permitted pesticide maximum residue levels are influenced by Codex recommendations. The Commission reports and make recommendations to the Conference of FAO and the appropriate body of WHO through their respective Directors-General. The CAC chairperson is Awilo Ochieng Pernet, a senior food safety official in Switzerland.

Go Direct to the Avaaz Petition to Sign: 'FAO Director General Graziano Da Silva: Get Glyphosate Off Our Food!'

Key references: 
[1] WHO IARC Monographs Volume 112: evaluation of fiveorganophosphate insecticides and herbicides.Glyphosate http://monographs.iarc.fr/ENG/Monographs/vol112/mono112-010.pdf
[2] Mesnage, R, Defarge, N, Spiroux de Vendômois, J, Séralini, G.E, Potential toxic effects of glyphosate and its commercial formulations below regulatory limits, Food and Chemical Toxicology (2015), doi: 10.1016/j.fct.2015.08.012.
[3] Pesticide residues in food – 2004. Joint FAO/WHO Meeting on Pesticide Residues, EVALUATIONS. Part II—Toxicological. Sponsored jointly by FAO and WHO With the support of the International Programme on Chemical Safety (IPCS) Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group http://apps.who.int/iris/bitstream/10665/43624/1/9241665203_eng.pdf
[4] Pesticide residues in food – 2005. FAO PLANT PRODUCTION AND PROTECTION PAPER 183. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group on Pesticide Residues http://www.fao.org/fileadmin/templates/agphome/documents/Pests_Pesticides/JMPR/JMPR05report.pdf
[4] Codex Alimentarius. Pesticide Residues in Food and Feed. Glyphosate 158.http://www.codexalimentarius.net/pestres/data/pesticides/details.html?d-16497-o=2&id=158&d-16497-s=3
[6] JOINT FAO/WHO MEETING ON PESTICIDE RESIDUES Geneva, 9–13 May 2016 SUMMARY REPORT. http://www.who.int/foodsafety/jmprsummary2016.pdf
[7] UN/WHO panel in conflict of interest row over glyphosate cancer risk. May 17 2016. A.Neslen. http://www.theguardian.com/environment/2016/may/17/unwho-panel-in-conflict-of-interest-row-over-glyp.... Glyphosate: Is science the playground of industry?Testbiotech requests that experts with strong affiliations to industry are removed from the FAO/WHO panelTuesday, 31 May 2016 http://testbiotech.org/en/node/1651
[8] 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
[9] WHO’s first global report on antibiotic resistance reveals serious, worldwide threat to public health.30 APRIL 2014. http://www.who.int/mediacentre/news/releases/2014/amr-report/en/ 

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

Key studies showing toxic effects of glyphosate and Roundup.Earth Open Source.  GMO Myths & Truths

A Generation in Jeopardy: How pesticides are undermining our children’s health & intelligence. PAN North America.http://www.panna.org/publication/generation-in-jeopardy

This is a joint petition by: www.mothersacrosstheworld.com and www.rite-demands.org

You can find Mothers Across the World on Facebook

Glyphosate's impact on farming systems

Farmers have been applying glyphosate based herbicides (GBH), commonly known as Roundup on their pastures, silage and forage for several years. GBH’s dry out the feed and increase the metabolisable energy, they’re considered a useful harvest aid. But it may be a minor benefit, and perhaps, more likely a detriment to the sensitive systems that underpin soil and stock health.

This popular tool may need revisiting, if we take recently released hard data into account. There are significant reasons why you might want to pull back from applying GBHs like Roundup to your pastures and stockfeed. It’s got to do with your soil microbiome and your mammalian microbiome, your livestock health and your economic outlook.

In June 2015 the International Agency for Research on Cancer (IARC) declared glyphosate a probable carcinogen, noting that there was strong evidence the chemical was genotoxic. Many of the studies considered in this metastudy involved the full formulation. Every farmer knows the full formulation, and many off-patent mixes, are considerably more toxic than the active ingredient.

The studies used by regulatory agencies, including the US EPA, European Food Safety Authority, WHO/FAO, APVMA and NZ EPA, that arrive at critical endpoints that go on to establish daily exposure levels (Eg. ADI and RfD) and permitted rates on agricultural crops and weeds - are private, remain unpublished and never peer reviewed in the public domain. The studies are also narrower in focus and do not take into account the full formulation consumers and applicators are exposed to.

The carcinogenicity studies used by these agencies in the last twenty years to arrive at the 'low toxicity' finding for glyphosate, simply cannot compete with the breadth and variety of studies considered by the IARC to establish the glyphosate is a 'probable carcinogen' finding.

This message is very difficult to get through to farmers and pesticides applicators. The agricultural media is reluctant to discuss this fact.  

Regulators rely on old protocols and old science.

International regulators, including the Environmental Protection Agency (EPA), never consider the full formulation when they evaluate the toxicity of pesticides in risk assessment. It is not just POEA, many ingredients in the formulation add to toxicity. What lets our farmers down - who may be exposed to glyphosate on a weekly basis – is that the EPA has repeatedly ignored published science indicating harm at very low levels – and used unpublished studies directly supplied by the chemical manufacturer to arrive at critical exposure levels. There’s a lack of rigorous science underpinning regulatory actions that places trade health before long term farm health. As risk assessment occurs only rarely, (for example the last glyphosate reregistration occurred in 1993), it is critical that regulatory actions reflect modern knowledge.  A 2015 scientist consensus statement clearly noted ‘Regulatory estimates of tolerable daily intakes for glyphosate in the United States and European Union are based on outdated science.’

Simply put, our farmers, at the coalface, deserve more.

A quick glance at the NPIC Fact sheet can help clarify just how outdated the science is, that is used to arrive at exposure levels. The Fact Sheet advises the chronic reference dose (RfD) for glyphosate is 1.75 mg/kg/day (RfD). The study that was used to establish this level is a private, unpublished Monsanto study, known as ‘Rodwell DE; Tasker EJ; Blair M; et al. (1980). The EPA used this study in the September 1993  Reregistration Eligibility Decision Document Case 0178 (Glyphosate). Note that this unpublished 1980 study, was already then, 13 years old. Since 1993 there has been a cartload of published and peer reviewed science demonstrating that GBH’s are much more toxic than previously considered.

As of 2016, the EPA has been sitting on the current registration review for seven years – the docket was opened for submissions in 2009. Science released since 2009 should be considered, but there is no promise of this. The delay, for this chemical regularly sprayed on staple food crops and along drains that lead to drinking water sources, reflects the politicisation of chemical. Children are widely exposed as glyphosate is used as a harvest aid on food crops. The time taken appears to many, to be unconscionable, particularly when re-registrations occur only rarely.

The NPIC today advises the acceptable daily intake (ADI) is 1 mg/kg day, derived from the 2004 World Health Organisation JMPR toxicological evaluation of glyphosate. The study that established this is a private, 1993 Cheminova paid study.

Somewhat astonishingly, the USA’s maximum permitted level in drinking water is 700ppb (0.7 mg/L), making the US a world leader in permitted exposure levels.

Many farmers may express dismay that, in addition to drinking water, glyphosate has been found in beer at concerning levels. All the old studies held with regulators assumed glyphosate would be ‘fully excreted’ – but constant exposure via food and water today results in chronic exposures over a lifetime.

For years, control of supplying scientific studies directly between manufacturer and risk assessment agency has quietly… worked. But as industry has, naturally, extended product use, from a pipecleaner, a weedkiller to a desiccant and harvest aid higher exposure levels have resulted and the product has become more conspicuous.

To many, it is not a broken system, it is a system that works conveniently well. By limiting toxicity by only considering the active ingredient, by industry controlling the studies submitted in risk assessment, reregistration has been a smooth process. Particularly if regulatory agencies are emasculated with insufficient staff and resources to barely approve new chemicals, let alone time to review older, off patent products using commercially confidential formulations.

But safe risk assessment is a different thing altogether. Twenty first century science can, and should be taking into account full formulations, endocrine disruption; systemic feedback loops, digestive system effects, and critically, effects of exposure at the delicate levels the population is exposed to.

Because we can. Yet none of this is happening. It’s archaic.

Do GBHs affect stock health and impact fertility?

While my own farming family probably will consider themselves bulletproof, the following information may strike a raw nerve because livestock health is economic health. The health effects as a result of GBHs on stockfeed have never been studied.

The USA pegs MRLs for stockfeed at about 400mg/kg. Usually permitted maximum levels are just a little bit higher than trials indicate, as protocol demands.

Industry (pesticides manufacturer) studies reveal that current exposures are harmful. (Studies produced by independent scientists with no financial conflicts demonstrate that the situation is more serious.)

A journey through old industry studies held with USA EPA, the World Health Organisation and the European Commission reveals decreased pregnancy rate, litter size, survival rate and increased dystocia, abortions, and reabsorptions.  These studies indicate lower growth rates (from diarrhoea, soft stools, decreased food consumption); increased gastrointestinal disturbances/congested stomach; changes in liver (organ weight increases); salivary glands; and stomach mucosa and bladder epithelium (histology). The studies recorded eye cataracts; focal tubular dilation of the kidneys and heart malformations (dilated heart, interventricular septal defect).

When industry supplied these studies, it was not common practice to apply glyphosate on stockfeed. (It was before residue levels were increased in 2006).

A European NGO has queried how GBH’s can contribute to birth defects, but farm based impacts – direct risk to the farmer and the farm, are rarely considered.

There has been a lot of discussion about reproduction rates. When older farmers are advised of current repro rates they’re surprised. While many factors must be taken into account, research looking at GBH on feed and fertility impact is all but non-existent. Published studies have demonstrated since 1995 that GBHs impact fertility, and I have questioned why no research has been conducted on this issue. Questions are surfacing regarding how glyphosate may impact the fusarium fungi that produces the harmful and estrogenic zearalenone toxin. It is difficult to get these questions in mainstream agricultural media.

Scientists have noted the ‘consistent association between previous glyphosate use and Fusarium infections.’ Many papers have called for more research to understand how glyphosate impacts soil fungal communities and alters plant resistance to pathogens including fusarium. 

When faced with the unvarying drawl of agribusiness to ‘feed the planet’ it would seem the casual disregard in evaluating causes of disease - crop failure and disease growth – the reluctance to commit significant public monies to independent research funding and low prioritisation of soil science, is staggering in its moronic-ness. It fits the same narrowness as the constant call for a cancer cure without financial commitment nor intention to prevent it in the first place. Our genes and plant genes, haven’t changed that much. It’s the environment, stupid.

The IARC also concluded that there was strong evidence that GBH’s are genotoxic - cell damaging and could affect DNA. Of course, a substances’ ability to impact herd epigenetics (genetic expression) and affect resultant offspring is naturally, of concern to farmers.

US media and research institutions have steered clear of investigating impacts of full formulation toxicity (Eg.Roundup) and herd health. Research on stock health is rare. In Europe, a team at the University of Leipzig demonstrated there is reason to be cautious regarding glyphosate and its formulations. European scientists have investigated gut dysbiosis, and considered glyphosate impact on animal health and nutrition.

A 2009 study demonstrated how glyphosate reduces essential mineral nutrient availability in plants. A 2015 study of dairy cows clearly found that glyphosate was toxic to the normal metabolism of dairy cows. A 2013 study discussed that strong biocides like glyphosate could explain the observed increase in levels of C. botulinum associated diseases, and that glyphosate in particular could be the significant predisposing factor that is associated with the increase in C. botulinum mediated diseases in cattle. A 2014 study demonstrated that glyphosate caused dysbiosis which favoured the production of the botulinum neurotoxin in the rumen. The authors stated ‘We believe that glyphosate will have a greater influence on cattle herd health in the near future due to increasing application rates of glyphosate to crops and much higher residual levels especially in glyphosate-resistant GM crops.’

Soil Health – new research.

New studies are demonstrating that glyphosate negatively impacts underground arbuscular mycorrhizal fungi (AMF) networks. AMF plays critical roles aiding nutrient uptake for over 80% of plants, improving soil quality, water retention and contributing to erosion prevention. Historically, it is considered that as AMF are shielded below ground, and don’t receive a direct application of glyphosate based herbicides, AM fungi have been protected.

farmers trust.jpg

A 2014 study by Zaller et al using Roundup Speed (glyphosate active ingredient 7.2 g l−1) noted 'We found a 40% reduction of mycorrhization after Roundup application in soils amended with the mycorrhizal fungi G. mosseae. This is in contrast to what we hypothesized, based on the allegedly fast biodegradation of the herbicide and the very plant-specific mode of action. '

Please note, this study was of the formulation. Another 2011 study found that the same AMF strain was not affected. However it only researched effects of the active ingredient.

Results demonstrating impacts of glyphosate on earthworms have been mixed, but Zaller et al also found ‘Interestingly, earthworms significantly increased glyphosate leaching only in absence of AMF, while in presence of AMF earthworms tended to decrease glyphosate leaching. It remains to be tested whether this is due to glyphosate uptake and accumulation by AMF or whether these AMF hyphae might have been consumed by earthworms thus protecting glyphosate from leaching.’

It is always complex.  Perhaps what this study did was demonstrate just how narrow the focus of earlier studies have been.

US patent no.7771736 B2 (2010) advises how glyphosate formulations affect cell viability of plant based pathways – it is an antiprotozoal agent. Yet protozoa play an important role in mineralizing nutrients, making them available for use by plants and other soil organisms. This has not been studied in great depth to assess economic impact. 

It is also worth considering a 2011 Chinese study by Sheng et al which used Roundup Weathermax (450 g active in-gredient·ha–1). This study detected a shift in the identity of dominant AMF species but did not detect an overall reduction.

Little research has focussed on AMF spore viability.  A 2012 Argentinian grassland study found that even at the lower rates, ‘spore viability in herbicide untreated soils was between 5.8- and 7.7-fold higher than in treated soils’. Furthermore, ‘root colonization was significantly lower in plants grown in glyphosate treated soil than in untreated ones.’

A latter 2013 grassland study by the same authors advised that ‘glyphosate application can damage AMF directly (through contact with spores and external hyphae) or indirectly through the changes it generates on host plants.’ Spore viability was reduced only when the soil was directly treated with glyphosate.

When it comes to earthworms, again due to variable environments and inputs, we are in early stages of understand impact. A recent 2015 study was extremely definite, however. The scientists, including J.G. Zaller demonstrated ‘that the surface casting activity of vertically burrowing earthworms (Lumbricus terrestris) almost ceased three weeks after herbicide application, while the activity of soil dwelling earthworms (Aporrectodea caliginosa) was not affected. Reproduction of the soil dwellers was reduced by 56% within three months after herbicide application. Herbicide application led to increased soil concentrations of nitrate by 1592% and phosphate by 127%, pointing to potential risks for nutrient leaching into streams, lakes, or groundwater aquifers.’

This study used the full formulation of Roundup.

We have been aware that pesticides can negatively alter the reproductive output of earthworms (Eisenia fetida) for some time. However the relationship of the glyphosate metabolite AMPA to earthworms has rarely been studied. This 2015 study came to the conclusion that persistent AMPA impacts juveniles, reducing earthworm size, which may limit their beneficial role.

How glyphosate based herbicides affects farmer health

Most farmers understand that glyphosate is a broad spectrum organic phosphate chelator that immobilizes positively charged minerals (such as manganese, cobalt, iron, zinc, copper, etc.) Glyphosate damages the gut biota, as it harms the critical plant based Shikimate pathway (contained in gut based bacteria, fungi, algae, parasites) essential for the synthesis of essential aromatic amino acids.

Our cells can't make aromatic amino acids because they don't have this pathway.  Stephanie Seneff advises ‘the aromatics are very important molecules, biologically, including being precursors to all the neurotransmitters (serotonin, dopamine, adrenalin) as well as the B vitamin folate, thyroid hormone, the hormone melatonin, and the skin tanning agent melanin.’

Glyphosate based herbicides - what can they do to farmers and their families? :

1.            Suppresses beneficial bacteria in the gut, impacting the immune system.

2.            Chelator which reduces access to mineral nutrients (Mg, Cu, Zn etc)

4.            Act as an environmental trigger and contribute to increased prevalence of genetic disease. Once the microbiome and gut breaks down individuals kick into whatever illness or disease they are predisposed to.  Autoimmune and allergic disease development (pathogenesis) involves 3 factors which may act like dominoes.  a) Exposure to environmental triggers and b) Loss of intestinal barrier function - gut permeability (leaky gut); then you become ill according to c) Genetic predisposition.

5.            Probably cause cancer including non-hodgkins lymphoma

6.            Contribute to liver and kidney problems including Chronic Kidney Disease CkD

7.            Affect the hormone (endocrine) system and may contribute to hormone related cancers

8.            Contribute to depression due to gut dysbiosis (90% of serotonin is made in the gut).

9.            A new classification in Europe would warn that glyphosate “may cause damage to organs through prolonged or repeated exposure”

Many farmers, particularly in orcharding and cropping, on retirement, acknowledge the cost of chemicals to their health, whether it’s a struggle with Parkinsons, skin conditions, depression, new cancers. Of course, rarely are non-chemical systems put forward by the farming media that surrounds them, or industry bodies. There appears no alternative. To the average farmer, there appears too much economic risk associated with moving away from chemicals. So instead, they get sick.

 

Economic Health: Residues in food.

Farmers are all too familiar with increased regulation surrounding chemical use in, for example, the dairy shed, the potential for chemicals to get into the system via teat sprays and so on. This is happening because food safety is moving from not just microbial hygiene. It now takes into account chemical hygiene.

Simply put, mums want safe food. It’s one of the reasons demand for organic is surging.

Mothers are waking up to the fact that kids who are healthier, are eating real food – not processed, not with added chemicals, just the same stuff that their grandparents grew up on. This is an international revolution. Food processors are waking up and changing decades old patterns to remain appealing to the kitchen dollar.

In fact as PwC states ‘High-profile food safety and quality scandals are damaging public trust in the food industry and increasing consumers’ concerns about their food.

With the ubiquity of social media and increasing media and public interest, more food scares are turning into damaging scandals – pushing governments and food companies to improve standards.’

The difference is now, these mums can test for glyphosate content in food product. Scientists are finding glyphosate in breast milk and in urine, even breakfast foods.  It’s proven to get through the placental barrier, and the Environmental Protection Authority acknowledged last year it may test food products. Glyphosate has evaded food testing for so long, because industry tests have quietly ensured regulators considered the chemical ‘of low toxicity,’ thus avoiding public testing in food and groundwater.

Slowly, ever so slowly, we are realising immune health is at the centre of health – human and plant. We now know soil microbes, like human microbes function as an immune system and help prevent (plant) diseases from developing. Yet profoundly, dismayingly - much of the media that surrounds farmers prevents access to the facts – the growing pile of hard data that supports the reality that multiple chemicals on food are not regulated safely, and cannot be proven to be safe.

The knowledge that consumer concern is driving safer food production, whether to reduce chemical exposure or increase nutritional content. This delay leaves food production systems on the back foot and farmers not knowing why no-one wants their glyphosate sprayed sugar beets or their conventionally produced, glyphosate treated grain based milk production systems.

International scrutiny leaves exporters vulnerable and the public exposed – which is why agile countries are adopting safer food production systems, while others can’t sell their commodity product. All countries deserve risk assessment that is internationally competitive and fits with international best practice.

Profoundly, we need risk assessment that places the health interests of both the regular user (the farmer) and the most vulnerable citizen (from the elderly to a pregnant mother) above trade based interests.

Tainted product gives foreign markets the opportunity to reject or downprice product. Risk assessment must be impeccable.

It’s about time the economic impact of this toxic endocrine disruptor and probable carcinogen was fully assessed. Glyphosate is simply the tip of a massive chemical iceberg that has not been scrutinised for its toxic cost to earth systems, it's potential to degrade soils and cause intergenerational harm to stock and human health.

In the meantime, there is enough scientific evidence across the board to make it worth questioning your own and your livestocks’ exposure to this demonstrably harmful product, and asking the question – what is the long term risk of this on our food?

I welcome any conversations to discuss this issue further.

International toxicity assessments & independence

European Glyphosate Review  - Timeline to June 2016.

12 November 2015. Europe’s Food Safety Authority announce ‘Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate.’  Commission Regulation (EU) No 1141/2010  EFSA recommended an increase in the glyphosate ADI based 2 unpublished studies dated 1991 and 1996.  

27 November 2015. 96 Scientists write to Commissioner Andriukaitis to advise concern over the EFSA decision,  (based on the German Renewal Assessment Report (RAR), which was comprised of studies supplied on behalf of industry group Glyphosate Task Force, by Monsanto, and excluded many studies included in the published literature. Many studies supplied to the GTF have not been published and are not available for public scrutiny. 

1 December 2105:  EFSA Executive Director Bernard Url addresses European parliament’s environment committee.

13 January 2016. EFSA Executive Director Bernard Url response to the 27 November letter 2016. 

22 February 2016.  European Ombudsman criticized the Directory of Health (DG Sante) for maladministration, authorising pesticides with data gaps in their evaluation that may have serious consequences for human and environmental health. Case: 12/2013/MDC

2 March 2016. European Parliament’s Environment Committee facilitates Expert Debate on Glyphosate in the European Parliament.

2 March 2016. European based NGOs: Global 2000, PAN Europe, PAN UK, Generations Futures, Nature et Progrès Belgique and Wemove.EU sue Monsanto and the European Food Safety Agency (EFSA) for 'allegedly distorting scientific data on the carcinogenic effects of controversial weedkiller glyphosate.'

3 March 2016. 94 scientists published ‘Differences in the carcinogenic evaluation of glyphosate between the International Agency for Research on Cancer (IARC) and the European Food Safety Authority (EFSA). Portier et al. 

4 March 2016. France announces it will vote against EU re-licensing of glyphosate. Netherlands parliament oppose EU re-licensing of glyphosate until separate evaluation held. Swedish environment minister advises analysis to date insufficient. Guardian.

8 March 2016. Vote to re-license glyphosate postponed.

22 March 2016. European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) voted through a resolution, 38 votes to 6 (with 18 abstentions), to block the European Commission’s renewal of a 15 year authorisation for use in the EU of glyphosate, the world’s most widely used herbicide and pesticide. The decision has been made as a result of “serious concerns on [glyphosate’s] carcinogenicity and endocrine disruptive properties.” ENVI called on the Commission to ‘commission an independent review and disclose all the scientific evidence EFSA used to assess glyphosate’.

13 April 2016. The European parliament voted to adopt resolutions. The Ecologist advised 'While the 374 to 225 vote is non-binding on the Commission and EU governments, it will nonetheless carry strong moral weight since it comes from the EU's only elected body directly representing EU citizens and will force a discussion of the issues raised.'

European Parliament news advised that the resolutions included:

  • The EU Commission should renew its marketing approval for just 7 years, instead of 15
  • Glyphosate based herbicides are utilised professional uses only - the EU Commision should not approve any non-professional uses of glyphosate
  • MEPs call for an independent review and the publication of all the scientific evidence that the European Food Safety Authority (EFSA) used to assess glyphosate.
  • Advice that it should reassess its approval of glyphosate in the light of its pending classification by the European Chemicals Agency (ECHA), under separate legislation. ECHA, based in Helsinki, is likely to advise in 2017.
  • Requirement that the Commission table a new draft in order to better address the sustainable use of herbicides containing glyphosate and also to launch an independent review of the overall toxicity and classification of glyphosate, based not only on data relating to carcinogenicity but also on possible endocrine-disruptive properties.
  • A demand for more transparency in the science used to prove safety of glyphosate. MEPs urge the Commission and the European Food Safety Authority to “immediately disclose all the scientific evidence that has been a basis for the positive classification of glyphosate and the proposed re-authorisation, given the overriding public interest in disclosure”.
  • MEPs also condemn as “unacceptable” the use of glyphosate in a farming practice known as “green burndown”, (pre-harvest treatment, desiccation) i.e. the killing of the actual crop plant prior to harvest in order to accelerate ripening and facilitate harvesting. This practice leads inter alia to increased human exposure.
  • Glyphosate should not be approved for use in or close to public parks, public playgrounds and public gardens.

21 April 2016. Munich Environmental Institute (Umweltinstitut München) and Pesticide Action Network (PAN) Germany join Global 2000, PAN Europe, PAN UK, Generations Futures, Nature et Progrès Belgique and Wemove.EU (see March 2). PAN Europe advised 'The EU environmental organizations, in an initiative taken by Global 2000 Austria file new evidence to the state attorney in Berlin today showing that the responsible institutions misinterpreted research studies during the assessment procedure in order to conceal the carcinogenic risks associated with glyphosate and facilitate its re-approval.'

The Munich Environmental Institute joined the coalition after testing glyphosate in beer and detecting the probable carcinogen in all samples tested. Germany has Beer Purity Laws, a series of regulations which limit ingredients in beer.

18 May 2016. Next meeting scheduled of the  Standing Committee on Plants, Animals, Food and Feed (Phytopharmaceuticals Section) to vote to adopt or reject the Commission proposal by qualified majority. If no majority, the decision passes to the European Commission.

6 June 2016. The European Commission had proposed a 'technical extension' of the current approval until after the European Chemicals Agency (ECHA) delivered its opinion on glyphosate towards the end of 2017. There was insufficient support at a meeting of the EU standing committee on plants, animals, food and feed to obtain the extension.

The EC qualified majority vote (QMV) requires 55% of countries which represent 65% of the EU population to adopt or reject a proposal in order for a vote to succeed.

20 June 2016 (estimated). To committee of appeal.. The European Chemical Agency will also be asked to give its scientific assessment on the substance.The European approval for glyphosate was due to expire late June 2016.

24 June 2016. Committee of appeal fail to reach a QMV either for or against the re-authorisation of glyphosate. Instead, the EU member states voted on the proposal to extend the current approval of glyphosate for a limited period of time, until the European Chemicals Agency (ECHA) gives an opinion on the substance.

29 June 2016. The European Commission Press Release database advised on a glyphosate fact sheet:

The Commission adopted the extension of the current approval of glyphosate for a limited period until the European Chemical Agency (ECHA) has concluded its review (before end 2017) - since Member States failed to take responsibility (no qualified majority was reached at either the Standing Committee or the Appeal Committee).

In parallel to the extension of the approval, the Commission has already presented to Member States a series of recommendations on the use of glyphosate. Discussions with the Member States have started at expert level, and the Commission will work to have them adopted as soon as possible. The decision will contain three clear recommendations:

1) ban a co-formulant called POE-tallowamine from glyphosate based products;
2) minimise the use of the substance in public parks, public playgrounds and gardens;
3) minimise the pre-harvest use of glyphosate.

It must be noted that it is primarily the responsibility of Member States to decide upon and enforce such measures.

End press release.

NOTE: The above EC recommendations are not binding or restrictive, and many other ingredients in the final glyphosate formulation are toxic, in addition to POE-tallowamine.


End 2017: European Chemicals Agency (ECHA) expected to finalise evaluation of glyphosate.

Further reading: EU member states fail to back re-authorisation of glyphosate

Oral Submission to the New Zealand Foreign Affairs, Defence and Trade Committee at Parliament regarding the TPPA - ISDS Boom time in Arbitration

UNCTAD 2015. Recent Trends in IIAs and ISDS.

UNCTAD 2015. Recent Trends in IIAs and ISDS.

PDF original

I am a farmer’s daughter, married to a farmer’s son. A researcher with an agribusiness degree. This trade agreement is a fundamentally different beast from earlier trade agreements. But most Kiwi’s don’t know that.

A quick search on Stuff, NZ Herald and our RNZ is dismaying in its lack of well researched investigative journalism regarding the TPPA & ISDS – investor state dispute settlement. It’s a study of agnotology. We all know Professor Kelsey’s airtime is limited. Op-Eds that never see the light of day.

Our public radio continually sports International trade expert Charles Finny – but never once has NZR declared his interests as a corporate lobbyist with Saunders Unsworth.  Charles Finny tells us we are safe because ISDS tribunal decisions have historically required scientific “proof”. [1] This is too simple. Let’s talk about scientific ‘proof.’

Our regulatory bodies/ governments have a duty of care. Acting in the public interest often requires them to employ the precautionary principle (aka prudent avoidance), a critical tool in public policy-making. Establishing the toxicity or safety of chemicals or understanding the underlying causes in disease development is a slow and difficult process and takes much time and resources. How do we regulate amidst uncertain science when we require absolute proof?

I’m interested in chemicals and the increasing evidence that they profoundly harm us. Right now, Europe understands the economic cost of endocrine (hormone) disruptors to be above 1.2% of GDP [2] and growing – ruling on endocrine disruption would require use of the precautionary principle, because science is limited and it is difficult to finance independent studies. None of this fits in with the ISDS MO.

Gentleman, you must acknowledge that wide ranging health and environmental effects take years to understand – narrow ISDS scientific ‘proof’ fails on every level. But national discussion never looked at this. What else has not been covered thoroughly?

My neighbours would be shocked to understand that ISDS tribunals have rejected requests to defer to government rulings when made in good faith.

 My kid’s school teacher would be surprised to understand investor rights trump public interest rights. Because she hears from our media that there are provisions to ensure government’s ability to protect the environment and public health. She doesn’t know those provisions can be trumped by other agreement provisions that protect investor rights.  That’s TPPA 9:15.

Most young adults around me don’t know that ISDS Tribunals undermine democracy, public discussion and dissent. They’d be pissed off to learn that a big settlement payout and even agreements can be made that if discussed publicly, would have been different. They’d be grumpy to understand that because these tribunals are offshore – they can’t participate.

My grandparents would be saddened and dismayed to learn that our own judges and courts cannot arbitrate. They would think we are bonkers to choose a judicial system we have no control of.

ISDS arbitration mechanisms can undermine domestic public interest regulation. They are cloaked in secrecy and, public participation, when allowed, lacks key aspects of basic procedural fairness. This is obvious – because most ISDS arbitration ends up concerning health and environment. 70% of cases have been challenges to natural resource and environment policies. Of course they want protestors shut out. [3]

Policy makers in local government are concerned about the TPPA. They know local government regulations and by-laws are vulnerable. Frequently local councils are at the coalface of environmental and health based calamities – and frequently are early adopters to regulate to benefit local health & economies because they see the urgency of the situation. But their decisions can be overridden by a government anxious to reach a less costly settlement.

And ‘scientific proof’? Frequently decisions are made in councils while the science is still grey and follow the precautionary principle. In the public interest.

Local entrepreneurs that surround me in the Bay of Plenty would feel betrayed if they knew that this agreement is fundamentally discriminatory against locally owned New Zealand businesses, as only multinationals can sue for potential lost profits. This trade deal could stifle New Zealand innovation and competition.  Where’s the fair go.

Finny recently advised RNZ ‘In terms of ISDS we have had these provisions and agreements for 25-30 years, I haven’t seen a huge number of problems being faced by NZ on this.’

This comment is disingenuous. Right now is boom time for investment arbitration lawyers.

The last decade has seen a tripling of average claims per year. Corporations realise the benefit of suing governments. [4]

And yes, ISDS provisions were included in the P4 [5] and other agreements (ASEAN, China) but the provisions are less onerous than the US-style provisions under TPPA. Also those countries are far less litigious.

ISDS cases are expensive, the average cost ‘USD 8 million with costs exceeding USD 30 million in some cases.’ [6] Translate that to ‘paralysing.’

Australia may have escaped the Philip Morris catastrophe but it still had to stump up $50 mill in legal fees.

Canada has faced 36 ISDS claims from NAFTA investor lawsuits, more than any other developed country in the world, and since 2005 Canada has been hit by 70% of all NAFTA investor lawsuits.

Canada currently faces nine pending investor–state claims involving some highly sensitive regulatory matters. 5 of these cases concern big oil, fracking, pharmaceutical patents, renewable energies. Total penalties sought in just these five cases: about $2 billion. [7] Each of the three countries in NAFTA have faced rigorous ISDS lawsuits.

Exempting tobacco is nothing compared to all this stuff. And our tobacco ‘carve out’? It’s weak.[8]

Of course, in an investor state dispute, we will no longer recognise the Supreme Court as our highest court, it's superseded by ISDS. We always thought constitutional changes must be undertaken through a proper, transparent, democratic process. Most of us think our law courts are perfectly equipped to manage disputes with foreign investors. Due process is provided under our more transparent legislative and judicial systems.

Andrew Geddis notes, In New Zealand ‘When judges are appointed, they cease to act as lawyers. In fact, they can never practice as lawyers again, precisely to remove any possible conflict between their lawyerly role as advocates for particular clients and their judicial obligations.’

ISDS tribunal members appointed to adjudicate disputes frequently have a commercial law background. They lack public policy experience. Your adjudicator could be a corporate lawyer whose next gig could be with Pfizer or Coca Cola Amatil.

And precedent? Here I quote Andrew Geddis: There is no concept of "precedent" in ISDS arbitration. Each case is considered sui generis - there's no hierarchy of tribunals, no appeal mechanisms, no doctrine of stare decisis. These are not "court" proceedings, but arbitrations.

ISDS agreement ignores NZ precedent, and undermines the jurisdiction of our own courts. And because this is ‘arbitration’ our government can’t appeal once the corporate lawyers have handed down their decision.

Not forgetting that under ISDS our governments can’t sue these corporations. How convenient.

This is a barbaric agreement – it degrades our ability to protect environment, health, equity and human rights.

Why don’t Kiwi’s know all this? Pragmatically, NZ media is owned by offshore financial industry.  The financial sector welcomes this agreement and can neatly use the TPPA via ISDS to challenge new financial regulation. That’s why my friends, neighbours, community don’t know the full story. Another conflict of interest.

You will write a report to the House of Representatives. Whoop whoop.

The treaty has been negotiated and signed by our National stacked Cabinet. National and Labour have blocked previous attempts to bring treaty agreements under Parliamentary consideration. This whole process is a farce.

It’s boom time in corporate arbitration & we’re signing up to an agreement with the most litigious country in the world.  We are lowering the barriers that protect our health and our natural resources - our most precious possessions. Please do not proceed with the TPPA.

 

REFERENCES:

Much of the information sourced for this talk is from:  Kathleen Cooper, Kyra Bell-Pasht, Ramani Nadarajah, and Theresa McClenaghan, Seeking a Regulatory Chill in Canada: The Dow Agrosciences NAFTA Chapter 11 Challenge to the Quebec Pesticides Management Code, 7 Golden Gate U. Envtl. L.J. 5 (2014).

I have previously detailed much of the above information here and here on this blog. 

[1] (a) Seeking a Regulatory Chill in Canada: The Dow Agrosciences NAFTA Chapter 11 Challenge to the Quebec Pesticides Management Code  Pp.4-6; 29;34-43 (Note page number lower RHS)

(b) The impact of the Trans-Pacific Partnership on health: Why an independent, comprehensive health impact assessment is crucial prior to signing. J Freeman, G Keating, R Jones, G Laking, M Head, A Macmillan

[2] Endocrine disruption.

(a) Estimating Burden and Disease Costs of Exposure to Endocrine-Disrupting Chemicals in the European Union  $209 billion, corresponding to 1.23% of EU gross domestic product

(b) HEALTH COSTS IN THE EUROPEAN UNION HOW MUCH IS RELATED TO EDCS?       €636 – 637.1 billion per year in the EU

[3] As the OPEN LETTER FROM LAWYERSTO THE NEGOTIATORS OF THE TRANS-PACIFIC PARTNERSHIP URGING THE REJECTION OF INVESTOR-STATE DISPUTE SETTLEMENT (8 May 2012), advised, 'Over $675 million has been paid out under U.S. FTAs and BITs alone, 70% percent of which pertained to challenges to governments’ natural resource and environmental policies, not to traditional expropriations.' 

[4] BOOM TIME. Increasing costs of ISDS.

While the USA is the most litigious country, Investors from the EU Member State are the largest users of ISDS. ISDS was originally intended create a favourable climate for investors in potentially volatile countries.  However the bulk of claims are held within the West.

Feb 2015. Recent Trends in IIAs and ISDS. UNCTAD

Updated: A transatlantic corporate bill of rights - investor privileges in EU-US trade deal threaten public interest.

Legalised Profiteering: How corporate lawyers are fuelling an investment arbitration boom. Corporate Europe Observatory.

Investor-to-State Dispute Settlement (ISDS): Some facts and figures. European Commission. http://trade.ec.europa.eu/doclib/docs/2015/january/tradoc_153046.pdf

Keystone Lawsuit Illustrates Enviros’ Big Problem With TPP. Moyers & Company.

The US-EU trade treaty that could let corporations sue governments. Al Jazeera May 2015. D Mackey.

[5] 'The P4 agreement doesn’t cover investments, with the exception of investment relating to some services. These are set out in Chapter 12 of the Agreement - Trade in Services [PDF, 157 KB]'. 

[6] ROUNDTABLE ON FREEDOM OF INVESTMENT 15 - 5 December 2011 – Paris, France

Summary of Roundtable discussions by the OECD Secretariat.  

[7] Battered by increasingly aggressive NAFTA lawsuits, will Canada fare any better under TPP? Scott Sinclair, Nov 10 2015. Citizen Monitor. 

[8] The Trans Pacific Partnership Treaty and tobacco: no cause to celebrate. Posted on December 21, 2015.  Louise Delany, Senior Lecturer, Assoc Prof George Thomson*    

‘At best, the partial ISDS exclusion is a step towards recognising that more extreme forms of investor protection conflict with public health. But the fundamental inconsistencies between agreements such as the TPP and public health are left untouched. The implications of the TTP as a whole may, arguably, strengthen the position of non-health interests in New Zealand. This may make it more difficult to progress future measures for both tobacco control and public health in general.’

ADDITIONAL NOTES - RISK & PROBABILITY: 

The following image was recently tweeted by Nassim Nicholas Taleb with the comments:

'The Precautionary Principle Simplified: Started rewriting.'

'What every risk taker knows but academics in decision theory/econ don't: space&time probabilities are NOT the same.'

Unravelling Evidence Based Policy & Industry Managed Risk Assessment

When we consider evidence based policy – perhaps we should consider the origins of the ‘evidence’ policy makers use in decision making. Shouldn't resultant policy be based on unbiased scientifically credible information that is free from conflicts of interest?

It appears that 'evidence based policy' is useful - as long as it acts for the benefit of establishing certainty in narrow disciplinary fields (silos). 'Evidence based policy' has not been harnessed effectively in the wider realm of risk assessment relating to the public interest. The evidence to establish risk of adverse effects from a given exposure (for example), in the public interest, need not require certainty, more probability that adverse harm will occur across a range of risk scenarios.

In the paper by Brownson et al 2009 the authors state ‘Policy change involves both science and art and, therefore, evidence for policy-making can take several forms. The concept of evidence often originates from legal settings in Western societies. In law, evidence comes in the form of stories, witness accounts, police testimony, expert opinions, and forensic science.  For policy-relevant evidence, both quantitative data (e.g., epidemiological) and qualitative information (e.g., narrative accounts) are important.’

The authors noted that there is no single, ‘best’ type of evidence and that ‘evidence-based policy is developed through a continuous process that uses the best available quantitative and qualitative evidence’.

To date, the science - and hence the information we base our evidence on -  that establishes exposure levels for pesticides and confirms safety of genetically modified crops (most of which are herbicide tolerant and treated post emergence with herbicides) are industry, rather than regulator selected. There is a fundamental conflict in the way this risk assessment is carried out. Critical decisions are based on core data that comprises, essentially, a narrow range of unpublished and private studies.  

These studies are kept secret from public scrutiny by ‘trade secrets’ or commercial confidentiality agreements that protect the interests of industry. Inclusion of published literature that may show harm at lower, more delicate levels are ignored or excluded by regulators who frequently dismiss studies that do not sit within narrow industry guidelines.

So what good is ‘evidence based science’ if it cleverly excludes independently published science and limits risk to one component of a chemical formulation? Does this act in the best interests of the environment or human population?

There is good data and bad data – both will be produced by industry and independent scientists alike – but as of 2016, internationally, industry data is exclusively used to establish pesticide exposure levels. It's a rigged system.

Glyphosate is the most pervasive pesticide in use today, applied to city streets, rainwater drains, throughout parks; on soils to control weeds, but perhaps most worryingly, it is applied across a wide range of human food crops (genetically modified and conventional). Recently the WHO International Agency for Research on Cancer (IARC) conducted what much of industry and our regulators are referring to as a ‘hazard assessment’ rather than a ‘risk assessment.’ The IARC did not establish the level at which glyphosate would be harmful – such as a dose that would cause harm – the IARC simply concluded that glyphosate was ‘probably carcinogenic’. As a result, much of industry and many regulators are dismissing the extensive review, stating ‘IARC data does not indicate any credible risk to users of glyphosate.’

The data used for the IARC monograph was sourced from 'openly available scientific literature’ and ‘data from governmental reports that are publicly available’. It was impartial.

Does the WHO’s International Agency for Research on Cancer form a credible platform from which to form an ‘evidence based policy’ to request urgent reassessment of this ‘probable carcinogen’?  Apparently not, according to our regulators and their current advisers. It can be ignored as it was only a 'hazard assessment.'

(I note that every pesticide risk assessment undertaken is based on exposure of the chemical to a 60kg adult, rather than a week old foetus or recently arrived baby. I also note that frequently, published literature indicates harm at endocrine disrupting levels much lower than those considered within the narrow range of studies supplied by the manufacturers to our regulators. [1] There are massive data gaps in current risk assessment that have not kept up with current scientific knowledge.)

Our regulators are failing us when they dismiss the findings of the most thorough review of glyphosate carcinogenicity studies ever undertaken. Traditionally, regulatory carcinogenicity risk assessment has considered a narrow range of industry studies and used only industry data to establish NOAELs - No Observed Adverse Effect Level. US carcinogenicity reviews have to date, only considered a narrow range of industry supplied and sponsored studies. Fact.

Simply put, we require integrity in scientific decision making. We require transparency and we require decisions regarding our daily exposure load of chemicals, including glyphosate, to be unbiased and free from conflicts of interest. We need policies to protect our children from the effects at the very delicate levels that affect our endocrine systems – but which remain outliers in pesticides risk assessment in 2016. There is bucketloads of science depicting harm from pesticides to the endocrine system, to children – and from published studies demonstrating the greater harm from exposure to the full formulations sold and applied to the crops we eat.

Without integrity and impartiality, evidence based policy is disingenuous load of dross.

Sir Peter Gluckman, New Zealand’s chief science adviser wrote an article for the online journal Nature, in 2014. The article concerned the provision of science advice to government, and he listed his top ten principles, or guidelines, that guide his work.

As Sir Gluckman noted, ‘Crucially, science advisers are obliged to advise in the context of the policy process. This means elucidating the evidence-informed options, rather than simply advocating a course of action’. We can't agree more.

The second of his ten principles: ‘protect the independence of advice’ is listed from the perspective of an adviser to government – but this same requirement underpins international condemnation released almost weekly from the NGO and public health and environment sectors – that regularly challenges global regulators reliance on corporate sponsored, or manufacturer supplied science.  

Risk assessment of pesticides undertaken by the three most influential regulators, the US Environmental Protection Agency, European Food Safety Authority and the joint committee of the World Health Organisation and Food and Agriculture Organisation (the WHO/FAO JMPR) influences government decision making internationally.

These regulators routinely use unpublished seller selected and sponsored studies to provide the NOAEL. This level will tend to be divided by a factor of 100 to give the ADI – acceptable daily intake. The ADI is the presumed safe level an adult can consume safely each day for the rest of his or her life. The most recent example comes out of Europe, where a recent glyphosate assessment and the following increased ADI level relied exclusively on data provided by industry.

Yes, these secret, unpublished studies are routinely supplied by the pesticides manufacturers – a significant conflict of interest. For the ADI can then be extrapolated to become recommended residue levels on individual crops – which directly links to sales of agrichemicals.

Chemical toxicity is without doubt the raging elephant in the room, and it should simply be good science to impartially research and understand the long term implications as quickly as we can. The costs of routinely testing for a chemical such as glyphosate, appear to be beyond most regulators - let alone the slow dawning that follows when we realise the consequences of rising levels in our groundwater of a chemical that regulators simply claim ‘is of low toxicity’.

Why is the biotech industry so interested in defending glyphosate? This organophosphate, that is sectioned of as a phosphanoglycine, is applied to more than 80% of GM crops, together with other chemicals the crops are additionally engineered to resist (as stacked traits). And no, the resultant GM soy, canola, sugar beet or corn (there are other crops) have never been tested for safety by regulators complete with the full formulations of the recommended herbicides these crops are specifically developed to tolerate.  And of course, to date, the safety studies for risk assessment of GMO's are exclusively provided by the, you guessed, it developer of the GMO.

Sigh. It should be about good science.

As Sir Gluckman noted in his 2011 Discussion Paper, in Section 5.3, page 14 - 'when relying on the use of external scientific advice, steps should be taken to ensure the advice is:

• focused on the data and its appropriate interpretation;

• unbiased with respect to its use of data;

• open about what is known and not known;

• able to communicate in terms of probabilities and magnitude of effect;

free from conflicts of interest, provided apolitically and independent of any particular end-user perspective.'

In discussion regarding ‘evidence based policy’ – good policy can only be developed if it comes from sound infrastructure.

As Sir Gluckman commented, policy formation ‘can involve additional political, ethical, economic and social dimensions’.

Evidence based policy should have the agility to respond to new knowledge - yet entrapment via the very industries that profit most is the current MO.

 

What use is evidence based policy if it....?

Narrowly serves the chemical’s producer

Creates a buffer or barrier that fails to consider the new (and multiple) pathways by which science now understands a commonly used chemical to be harmful.

Fails to follow the precautionary principle.

Underestimates probability in the public interest for the public. Current risk assessment policies do not assess risk of harm across a wide range of disease pathways - rather the regulator selects the 'most dangerous' pathway and simply defines risk from the one discipline.

Fails to take into account increasing knowledge regarding neonatal, prenatal, childhood and adolescent vulnerability.

Does not take into account environmentally relevant levels of exposures of complete formulations.

Cannot transparently assess industry derived data.

 

References

[1] Buonsante, V. A.; Muilerman, H.; Santos, T.; Robinson, C.; Tweedale, A. C. Risk assessment’s insensitive toxicity testing may cause it to fail. Environ. Res. 2014, 135C, 139−147

 

 

 

 

Proposed new European increase in ADI for glyphosate based on flimsy science?

The European Food Safety Agency has proposed an increase of 60% for permitted exposure levels for the European population to glyphosate. After releasing the Conclusion on glyphosate, the EFSA advised in an explanatory promotional document:

'The acceptable operator exposure level (AOEL) has also been set at 0.1 mg/kg body weight per day and an acceptable daily intake (ADI) for consumers has been set in line with the ARfD at 0.5 mg/kg body weight per day.'

The study that is proposed to establish the new European ADI is a developmental or teratology study where animals are dosed throughout pregnancy and then the offspring inspected for health related effects. The study cites 50 mg/kg bw/d as the level that is the NOAEL - no observable acceptable dose level. The level that the foetus is healthy.

However study data on Pp 627-634 indicate there were effects at the same level.

Note: it is industry standard to NOT dose with the chemical in the first 7 days - effectively the first trimester. Thus the test period ran from from gestation days 7-19. Animals were then euthanised on day 29 of gestation. 

  • The laboratory for the Syngenta study is undeclared
  • The author for the Syngenta study is undeclared
  • The guidelines are outdated
  • The studies are 19 and 24 years old and unpublished.
  • EFSA has ignored the IARC findings and scientific literature that demonstrates toxicity at much lower levels of population exposure.

Health based effects dismissed:

  • Syngenta study: 10/18 pregnant rabbits at the 50 mg/kg bw/day had scours.
  • At all days noted, animals at 50 mg/kg bw/day had weight significantly lower than the control
  • Syngenta study: At 50mg/kg bw/d - 27.8% of the litters had 'anomalous' foetuses (Anomalous foetus: a foetus with one or more congenital defects.)
  • Cheminova study: The previous European assessment declared 'since a treatment related impact on fetal viability at this dosage is considered possible, the mid dose level of 150 mg/kg bw/day is assumed to represent a more reliable NOEL for fetotoxicity'.

Farmers and herbicide contractor/applicators should be concerned -

all the studies used to derive the Accepted Operator Exposure Level are 1990's private, unpublished studies. (See pp 108-9  of the Final Addendum - link below). The Rapporteur Member State (RMS), Germany, who compiled the Addendum, ignored published literature that demonstrate that current low exposure levels are dangerous. In deriving the AOEL the RMS only considered old studies at much higher dosage levels.

Unfortunately because the all studies used to derive the AOEL and ADI are private and not available for public scrutiny, further evaluation by public domain scientists are not possible.

 

Data located in Background Documents.  Click on Peer Review Report and revised Renewal Assessment Report and select Final Addendum (PDF).

Final addendum to the  Renewal Assessment Report - public version -   
Risk assessment provided by the rapporteur Member State Germany  and co-rapporteur Member State Slovakia for the active substance  
GLYPHOSATE  
according to the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC laid down in Commission Regulation (EU) No. 1141/2010

In rabbits, the overall NOAEL for maternal toxicity was 50 mg/kg bw/day, based on mortality and gastrointestinal disturbances from 100 mg/kg bw/day onwards. The lowest NOAEL for developmental effects was also established at 50 mg/kg bw/d, based on post-implantation loss at 200 mg/kg bw/day. Other developmental foetal effects comprised lower foetal weight and a delay in ossification. 

2.6.12 Toxicological end point for assessment of risk following long-term dietary exposure - ADI     p.105 .   (Page 105 does not give this information - rather it gives 'Overview of glyphosate residues and its metabolites following hydroponic treatment')

 Volume 1, Level 1. Page 37.  The proposed ADI and AOEL for glyphosate are both based on the lowest NOAEL for maternal and developmental toxicity in the rabbit at 50 mg/kg bw/day since this was the most sensitive animal model. Applying the safety factor of 100, the resulting ADI is 0.5 mg/kg bw.  The ADI for glyphosate is applicable also to AMPA if health evaluation of residues is needed

For setting the AOEL, correction for 20 % oral absorption must be made. Accordingly, an AOEL of 0.1 mg/kg bw/day was established. 

TWO STUDIES WERE USED TO ARRIVE AT THE NEW ADI - 

[1] 1996 Syngenta unpublished study ASB201211499 (Study details below)

[2] 1991 Cheminova unpublished study  TOX9552391:  Believe this study to be, Brooker et al., 1991.

Details found:  Glyphosate – Volume 1, Level 1  revised 29 January 2015; 31 March 2015. Pp 77-82

[1] Table 2.6-12: Developmental toxicity studies in rabbits reviewed for previous EU evaluation that are still to be used for risk assessment 

Reference;  Study identification; Batch,  purity; Owner: 1991; TOX9552391 206-Jak-25-1, 98.6%; Cheminova

Study type, strain, duration, route: Developmental,NZW rabbit, d 719 p.c., gavage

Dose levels: 0, 50, 150, 450 mg/kg bw

NOAEL: Maternal: 50 mg/kg bw/d, dev.: 150 mg/kg bw/d

LOAEL: Maternal: 150 mg/kg bw/d, dev.: 450 mg/kg bw/d

Targets/Main effects: Maternal: GI-tract, food & bw gain ↓: dev.: late embryonic death, post implantation loss, cardiac malformations* 

Outcome of re-evaluation: Study acceptable, previous evaluation partly confirmed

[2] Table 2.6-14: New developmental toxicity studies in rabbits reviewed for EU evaluation 2012

Study reference, identification, batch, purity, owner: 1996; ASB201211499; H95D161A, 95.3%; Nufarm .

Study type, strain, duration, route: Developmental, NZW rabbit, d 719 p.c., gavage.

Dose levels: 0, 50, 200, 400 mg/kg bw/d . NOAEL: Maternal & dev.: 50 mg/kg bw/d ; LOAEL: Maternal& dev.: 200 mg/kg bw/d;

Target/Main effects: Maternal: bw gain ↓,  Dev.: postimplantation loss ;

Outcome of RMS Evaluation: Study acceptable

 

Page 81: In conclusion, the previously known and newly submitted studies have clearly shown a particular vulnerability of pregnant females of this species. The overall NOAEL for maternal toxicity was 50 mg/kg bw/d as found by   (1996, ASB2012-11499) and by  (1991, TOX9552391). It is further supported by the (supplementary) study of  (1980, TOX2552390) who had established 75 mg/kg bw/day and is well between the NOAEL of 20 mg/kg bw/day and the LOAEL in the (supplementary) study by  (1993, TOX9551106). However, in the latter study, mortality occurred already at the LOAEL of 100 mg/kg bw/day. This finding might suggest a rather steep dose response curve and provided the lowest dose at which mortality was noted in any study and species following administration of glyphosate. In other developmental studies in rabbits, maternal deaths were seen at 175 mg/kg bw/day and above ( ., 1980, TOX2552390; ., 1991, TOX9552391;  1995, ASB2012-11498). Thus, the (pregnant) rabbit proved more sensitive than the other species which were employed in toxicological testing of glyphosate. Surprisingly, there were other studies in which the does tolerated similar or even higher amounts of glyphosate (300 to 500 mg/kg bw/day) much better, i.e., without mortality at least ( , 1989, TOX9551960;  1996, ASB2012-11499;  1996, TOX2000-2002). Apart from mortality in some studies, maternal toxicity was characterised by gastrointestinal signs, lower body weight (gains) and reduced food consumption and, occasionally, abortions. The lowest LOAEL was found in the study by  (1993, TOX9551106) whereas the respective values in the other experiments ranged from 150 to 500 mg/kg bw/day.  


The lowest NOAEL for developmental effects was 50 mg/kg bw/day, based post-implantation loss at 200 mg/kg bw/day in the study by  (1996, ASB2012-11499). Due to dose spacing, the NOAELs in other studies were higher ( 1980, TOX2552390; ., 1991, TOX9552391;  1996, TOX2000-2002) but consistently below 200 mg/kg bw/day. Beside post-implanation losses and late embryonic death ( 1989, TOX9551960;  1991, TOX9552391), developmental findings at higher dose levels included a lower foetal weight and delayed ossification.

P 107: The ADI of 0.5 mg/kg bw and the approach taken for its setting as proposed by the RMS were confirmed on the Pesticides Peer Review 125 expert meeting (25 – 27 February 2015)

Details of the two studies that provides the NOAEL of 50 mg/kg bw/day justifying the increased European ADI from .3 mg/kg to .5 mg/kg

[1] 1996 Syngenta unpublished study ASB201211499

Page 627. 

Reference: IIA, 5.6.11/02 Report:  (1996) Glyphosate technical: Oral gavage teratology study in the rabbit   
Data owner: Nufarm SPL project no.: 434/020 Date: 1996-07-04 GLP: yes not published ASB2012-11499

Guidelines: OECD 414 (1981), JMAFF 59 NohSan 4200 (1985), US-EPA 83-3 (1984) Deviations: None  Acceptability: See RMS comment  
Dates of experimental work: 1995-10-13 - 1995-12-12  


Materials and methods  
Test material:  Identification: Glyphosate technical Description: White powder Lot/Batch #: H95D161A Purity: 95.3 % Stability of test compound: not reported Vehicle and/ or positive control: 1 % carboxymethyl cellulose Test animals: Species: Rabbit Strain: New Zealand White  Source: XXXXXXX  Age: 17 - 19 weeks Sex: Females (time-mated) Weight at dosing: 2.2 - 4.1 kg Acclimation period: At least 4 days Diet/Food: SQC Standard Rabbit Diet (SDS Ltd., Witham, Essex, UK), ad libitum Water: Tap water, ad libitum Housing: Individually in stainless steel cages with grid floor Environmental conditions: Temperature: 20 ± 3 °C Humidity: 50 ± 20 % Air changes: 15/hour 12 hours light/dark cycle

p.628

Study design and methods:  In life dates: 1995-10-13 - 1995-12-12  
Animal assignment and treatment in the preliminary study: Twenty-four time-mated females were supplied. Sexually mature, virgin females were paired with stud males. The day of copulation was designated Day 0 of gestation. The females were delivered to Safepharm Laboratories Ltd. at or before Day 3 of gestation and were allocated randomised to treatment groups. Groups of 6 mated New Zealand white female rabbits received 0, 50, 200 or 400 mg/kg bw/day test substance in 1 % carboxymethyl cellulose by gavage (5 mL/kg bw) from gestation Day 7-19. The dose levels were chosen based on results of a preliminary dose finding study with 6 female nulliparous rabbits, where administration of 500 or 1000 mg/kg bw resulted in toxicity signs (scours, fluid filled caecum, stomach ulceration, body weight loss, reduced food consumption). Based on these findings dose levels of ≥ 500 mg/kg bw were considered to be too high for a prolonged study.  


Animal assignment and treatment in the main study: Seventy-two time-mated females were supplied as described for the preliminary study (see above). Groups of 18 mated New Zealand white female rabbits received 0, 50, 200 or 400 mg/kg bw/day test substance in 1 % carboxymethyl cellulose by gavage (5 mL/kg bw) from gestation Day 7-19.  
Dose formulation and analysis For each dose level, the test material was suspended daily in 1% carboxymethyl cellulose by weighing the required amount into a glass jar and adding vehicle to make the appropriate final volume. Homogeneity was assured by mixing the formulation with a homogeniser. The concentration, stability and homogeneity of the test material were analysed. The formulation was stable for at least 1 h.  
Clinical observations A check for clinical signs of toxicity, ill-health or behavioural changes was made once daily during the pre- and post-dosing periods and twice daily (before and after dosing) during the dosing period.  


Body weight Individual body weights were recorded on Day 3, 7, 10, 13, 16, 19, 22, 25 and 29 of gestation.   


Food consumption Food consumption of females was recorded on Days 3 to 7, Days 7 to 10, Days 10-13, Days 13-16, Days 16-19, Days 19-22, Days 22-25 and Days 25-29 of gestation.  
Sacrifice and pathology Females were euthanatized by an i.v. injection of an overdose of sodium pentobarbitone into the auricular vein on Day 29 of gestation, examined for macroscopic abnormalities and subjected to caesarean sectioning. The ovaries and uteri were removed, weighed and then examined for the number of corpora lutea and for the number and position of implants and dead or live foetuses. Resorptions and foetal deaths were classified into implantation sites, placental remnants, and macerated foetuses according to the difference in developmental stage at which deaths had occurred. After examination of the ovaries and conceptuses, each female was necropsied. 

Developmental parameters The foetuses were killed by intrathoracic injection of sodium pentobarbitone. All foetuses were dissected and examined for visceral abnormalities macroscopically. The heads of alternate foetuses were removed and identified using an indelible marker and placed in Bouin‘s fixative. After a minimum of 14 days, the heads were transferred to 90 % industrial methylated spirits (IMS) in distilled water and examined for visceral anomalies under a low power binocular microscope. All foetuses were identified using colour coded wires and placed in 70 % IMS in distilled water. The foetuses were eviscerated, processed and the skeletons stained with alizarin red.The foetuses were examined for skeletal development and anomalies.   


Statistics in the main study Female bodyweight change (relative to Day 7 of gestation) and food consumption were analysed statistically by one-way analysis of variance with the Bonferroni multiple comparison test followed by pair wise analysis of control values against treated group values using Students ‘t‘ test where appropriate.  All foetal parameters, skeletal development, group incidence of specific visceral and skeletal anomalies were analysed statistically by Kruskall-Wallis non parametric analysis of variance followed by pair wise analysis of control values against treated values using the MannWhitney U - test where appropriate.  


Results and discussion

Analysis of dose formulations The test substance was detected at the levels of 81-102% of the target concentrations in each dosing solution.  


Food consumption In the preliminary study, significantly reduced food consumption was observed while administering in the high dose level of 400 mg/kg/day (Days 7 to19 of gestation).  This observation was confirmed in the main study. At the high dose level, there was a reduction in food consumption during the dosing period compared to controls (Days 10 to 13, p < 0.05; Days 13 to 19, p < 0.01). No other significant changes were observed in the remaining groups during the main study.  


Mortality In the preliminary study, two does were killed in extremis in the high dose group, one had aborted foetuses and the other was bleeding from the vagina. No mortalities occurred at any dose up to 400 mg/kg/day in the preliminary study.    


In the main study, two rabbits were found dead or moribund at the high dose level. One female was found dead prior to dosing on Day 19 of treatment. One female was killed in extremis on Day 20 of treatment. Clinical observations noted at this time included hunched posture, lethargy, ptosis, hypothermia and blood on the litter tray. At the intermediate dose level, one female was found dead after dosing on Day 16 of treatment. Necropsy findings of reddened lungs, a fluid filled thorax and test material in thoracic cavity are consistent with mal-dosing. At the low dose level, no mortalities occurred. One female was found dead two minutes after dosing in the control group. Necropsy findings of blood in thorax, inflated appearance of lungs and a large area of congestion on the right caudal lobe are consistent with mal-dosing.

P.630

Clinical Observations

In both the preliminary and the main study, the clinical signs were in general the same. There was a toxicologically significant increase in the incidence of clinical observations, particularly scours, reduced faecal output and diarrhoea at the high dose level (400 mg/kg bw/day). Observations of lethargy, ptosis, hunched posture, hypothermia and blood on tray were noted for one animal of the main study killed in extremis.  At 200 mg/kg bw/day, vaginal bleeding and blood on tray were noted for one animal of the main study. Scours were also noted in animals at 200 and 50 mg/kg bw/day as well as in the control group, but the incidence and duration were not as severe as at the high dose level (see Table B.6.6-28). No other treatment-related observations were evident. Thus, for the findings observed at doses below 400 mg/kg bw/day, a clear dose-response could not be established.

 
Table B.6.6-28: Observed clinical signs during the dosing period

Background document on the conclusion on the peer review of the risk assessment of glyphosate . Addendum.

Background document on the conclusion on the peer review of the risk assessment of glyphosate . Addendum.

 Body weight

In the preliminary, study a toxicologically significant decrease in body weight gain from Day 13 to 19 post coitum was evident at the high and intermediate dose levels. Likewise a reduction in group mean body weight gain from Days 9 to 29 post coitum was observed in the high dose level group during the main study. The difference in group mean bodyweight change compared to controls was statistically significant (P<0.05 to 0.01) from Days 13 to 29 post coitum. Also in the intermediate dose level group a slight reduction (although not statistically significant) in group mean body weight gain from Day 9 to Day 29 post coitum was noted. In the low dose level group body weight gain was comparable to controls throughout the study period (see Table B.6.6-29).  

P.631
Table B.6.6-29: Mean body weight gain during gestation

Background document on the conclusion on the peer review of the risk assessment of glyphosate . Addendum.

Background document on the conclusion on the peer review of the risk assessment of glyphosate . Addendum.

Pathology Necropsy

The macroscopic necropsy findings of the two does of the high-level dose group that died or were killed in extremis included fluid filled large intestines, haemorrhage, ulceration and sloughing of the stomach, duodenum congested and colon, rectum and appendix gas distended. These findings indicate that the test material may affect the gastrointestinal tract. The animal killed in extremis at this level also had both uterine horns containing blood and dead foetuses in the uterus. This may be a result of maternal toxicity. All other necropsy findings were not treatment-related.  


Observations on the ovary and uterus

No treatment related effects were evident in both the preliminary and the main study.  


In the control, low, intermediate and high dose level groups 14, 18, 16, and 16 females, respectively, survived to termination of the main study and were proven to be pregnant. The number and distribution of females that were not pregnant indicate that there were no treatment-related effects on pregnancy rates. Litter size at caesarean necropsy was comparable in all treatment groups.  


Developmental parameters

Number and viability of foetuses The litter size at caesarean section was comparable in all treatment groups. In the high dose level group, there were slight, but not statistically significant, increases in late foetal deaths and post implantation loss, mainly due to one animal that had nine late deaths, resulting in a post implantation loss of 69.2 %. This was therefore considered not to be a treatment-related effect. At 200 mg/kg bw/day, there were statistically significant increases (p<0.05) in total foetal deaths and post implantation loss. These increases were caused by a slight, but not statistically significant, rise in early foetal deaths. As at this dose level, there was no rise in late foetal deaths, as seen at the high level; the effect on early foetal deaths was considered not to be treatment-related.   

Foetal body weights  

No statistically significant differences were noted in the mean foetal body weights between the control group and the treated groups. Mean total litter weights were comparable in all treatment groups.   


External, visceral and skeletal examination

At the high dose level, there was one litter with one foetus with major malformations. This foetus was found to have spina bifida and clubbed and malrotated hind limbs. At the intermediate dose level, two foetuses of two different litters had major malformations. One foetus had retinal infolding and a haemorrhage in the retinal layer, the other acephaly, small kinked tail, bilateral forelimb flexure, interrupted aorta and an intraventricular septal defect. At skeletal examination, this foetus was found to have multiple rib and vertebral column abnormalities. At the low dose level, three foetuses of two different litters had major abnormalities. In one litter, one foetus had forked ribs with a displaced vertebral centrum. In another litter, one foetus had a small eye with retinal infolding and aphakia. A second foetus from this litter had nostrils close together, and a thin nasal septum not attached at posterior pole near the front of the nasal passages. In the control group, there were two foetuses from two different litters with major abnormalities. One foetus had gastroschisis and the other foetus had an extra vertebral arch resulting in scoliosis. These findings were considered to be within the range of normal variation for this species. There were no treatment-related effects on the degree of skeletal development. 


Table B.6.6-30: Incidence of foetal malformations and variations in rabbits treated with glyphosate acid
Foetal findings  Dose level (mg/kg bw/day) 0 50 200 400

Background document on the conclusion on the peer review of the risk assessment of glyphosate . Addendum.

Background document on the conclusion on the peer review of the risk assessment of glyphosate . Addendum.

Conclusion by the Notifiers

The oral administration of glyphosate technical to pregnant rabbits by gavage from gestation Day 7-19 resulted maternal toxicity at 400 mg/kg bw/day. There were no treatment-related effects on pregnancy or foetuses at any dose level. Therefore the ‘No Observed Adverse Effect Level’ (NOAEL) was considered to be 200 mg/kg bw/day for maternal toxicity. The ‘No Observed Adverse Effect Level’ (NOAEL) for developmental toxicity was considered to be 400 mg/kg bw/day.  


Comment by RMS:  

The study is considered acceptable. The NOAEL of 200 mg/kg bw/d for maternal toxicity is not supported. The NOAEL is considered to be 50 mg/kg bw/d due to slight reduction in body weight gain at 200 mg/kg bw/d.  The NOAEL of 400 mg/kg bw/d for developmental toxicity is neither supported. The NOAEL is considered to be 50 mg/kg bw/d due to significantly increased post-implantation loss at 200 mg/kg bw/d. The statement, that this increase was caused by a slight rise in early foetal deaths and not in late foetal deaths, as seen at the high dose level and therefore considered not to be treatment-related, cannot be followed, because there is no information given regarding the mechanism behind this foetal deaths. Due to some reporting deficiencies, it remains unclear, whether the heart was part of visceral examination.  


Comment by GTF on the first draft of the RAR (July 2013):

1. The GTF believes the developmental NOAEL in  is 400 mg/kg/day, with no evidence to test substance related dose-response, citing the published expert review: Kimmel et al., 2013, (ASB2013-3462) Evaluation of developmental toxicity studies of glyphosate with attention to cardiovascular development, Crit Rev Toxicol, 2013; 43(2): 79– 95.  


2. Regarding  (1996, ASB2012-11499) the RMS notes that “it remains unclear whether the heart was part of visceral examination”. The study sponsor contacted the contract laboratory and the response is noted….The contract laboratory Head of reprotox at the contract notes Reprotox “The examination of the heart is conducted on the fresh fetus for rabbit developmental toxicity studies. This is mentioned in our standard operating procedure“. This is reflected the draft RAR Volume 3, B.6.6.11, noting “All foetuses were dissected and examined for visceral abnormalities macroscopically”………..  


RMS comment (August 2013): 1. As already stated, the NOAEL is considered to be 50 mg/kg bw/d due to significantly increased post-implantation loss at 200 mg/kg bw/d. The statement, that this increase was caused by a slight rise in early foetal deaths and not in late foetal deaths, as seen at the high dose level and therefore considered not to be treatment-related, cannot be followed, because there is no information given regarding the mechanism behind this foetal deaths (please refer to the additionally inserted table below. Considering the individual animal data: at low dose level of 50 mg/kg bw/d 4/18 pregnant animals revealed post implantation losses, which was comparable to control animals (4/14 animals). Whereas at the mid dose of 200 mg/kg bw/d 10/15 animals were affected and at 400 mg/kg bw/d 9/15 animals. Currently, RMS does not see the need to change the assessment.  [Remark: The published expert review by Kimmel et al. (2013, ASB2013-3462) was already available and considered when preparing the first draft of the RAR, please refer to B.6.6.12- Published data] 

[2] 1991 Cheminova unpublished study  TOX9552391:  Believe this study to be, Brooker et al., 1991.

By the: European Commission.  Health & Consumer Protection Directorate-General

The legislation is here: It includes glyphosate in Annex I of Directive 91/414/EEC – Overall conclusion in the context of Directive 91/414/EEC is that it may be expected that plant protection products containing glyphosate will fulfill the safety requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.

The details for the previous EC assessment of glyphosate final decisions as to glyphosate toxicity are in  Document No. 6511/VI/99-final.

Study data was located in: APPENDIX II – END POINTS AND RELATED INFORMATION GLYPHOSATE/GLYPHOSATE TRIMESIUM:

Brooker, A.J., Brennan, C., John, D.M., Anderson, A. & Dawe, I.S. (1991a): The effect of glyphosate on pregnancy of the rabbit (incorporates preliminary investigations). Unpublished.  “GLP like”. Report No. CHV 45 & 39 & 40/901303, dated 14 October 1991, from Huntingdon Research Centre Ltd., Huntingdon, England. Submitted as part of a joint dossier by Monsanto and Cheminova.

Glyphosate given by oral gavage daily to 16-20 mated NZW female rabbits at dose levels of 0, 50, 150 and 450 mg/kg bw/day from days 7-19 of pregnancy.  Results:  One mortality observed in high dose group following abortion and body weight loss. Gastro-intestinal signs of toxicity and inappetence were observed at doses of 450 and 150mg/kg bw/day.  Mean food consumption and body weight gain were reduced during the treatment period at these dose levels. Thus the lowest dose of 50mg/kg bw/day was considered NOEL for maternal toxicity. At day 29, at terminal sacrifice, 18, 12, 15 and 13 litters were available for examination in the control, low, mid and high dose groups, respectively.  There was a significant increase in embryonic deaths in treated groups compared to the controls.  Accordingly the percentage of post implantation loss was elevated.  Accordingly, a comparison with historical control data from the performing laboratory revealed that the incidence in the study group was atypically low.  In addition, a clear dose-related pattern was not demonstrated.  On the other hand, note that an increase in the occurrence of late embryonic deaths at the top dose level was also studied in a further study below.

Conclusion: Note the lowest dose of 50 mg/kg bw/day was considered NOEL for maternal toxicity by study authors.  It was concluded that no convincing indications of teratogenicity were obtained in this study up to the highest dose of 450 mg//kg bw/day.  There was some concern about the more frequent occurrence of foetuses with heart malformations like the interventricular septal defect in the high dose group, however, the incidence was still in the range of historical background data.  On the other hand, anomalies of the heart have been described in other rabbit teratogenicity studies with glyphosate too.  NOEL for fetal effects at the top dose level of 450 mg/kg bw/day.  However, since a treatment related impact on fetal viability at this dosage is considered possible, the mid dose level of 150 mg/kg bw/day is assumed to represent a more reliable NOEL for fetotoxicity.

European reassessment of glyphosate shows how broken EFSA is.

On November 12th, the European Food Safety Agency released its conclusion on the risk assessment and peer review of glyphosate. 

This risk assessment is internationally recognised as faulty and rife with conflicts of interest. The German Rapporteur (known as the Rapporteur Member State - RMS) compiled the RAR - Renewal Assessment Report for EFSA - solely used studies selected and supplied by the Glyphosate Task Force  - an industry coalition.

The WHO IARC recently advised glyphosate was a probable carcinogen and that there was strong evidence glyphosate and its formulations were genotoxic using published studies available in the scientific literature. IARC Monograph Vol 112-10.  PDF here

The EFSA reassessment excluded much published, peer reviewed scientific literature. including studies for genotoxicity. 'Deficiencies include neglect and wrong description of important scientific publications, lack of applying up-to-date statistical analyses to the data provided by industry and false statements about historical control data'. (toxicologist Dr Peter Clausing). Links to three papers follow:

  1. The 31 August 2015 Addendum to the Renewal Assessment Report on Glyphosate: A Critical Analysis. Dr. Peter Clausing, PAN Germany. Hamburg November 2015. 

  2. The Glyphosate Renewal Assessment Report: An Analysis of Gaps and Deficiencies.   Dr. Peter Clausing

  3. Testbiotech comment on the  German Renewal Assessment Report (RAR)  on the active ingredient glyphosate.  Andreas Bauer-Panskus, Testbiotech October 2014

PAN Europe call it an 'un-scientific opinion' - and PAN Europe’s Chemicals Officer Hans Muilerman noted "in case of doubt they (EFSA) give the advantage of the doubt to industry instead of giving priority to the protection of human health and the environment”. 

Europe has now increased the ADI from .3 to .5mg/kg - the daily level European citizens can 'safely' be exposed to for the rest of their lives - despite the WHO finding. This increase flies in the face of caution and safety, and a huge range of science that declares glyphosate unsafe at ultra low doses - at levels the population is exposed to. 

The increase the knowledge that daily sub-lethal doses of glyphosate are harmful. The European population cannot avoid this - glyphosate is applied on staple foods - it is not just used as a weed destroyer - it is sprayed on staple food and animal feed crops.

GMWatch stated 'EFSA says it considered more studies than the IARC, as if that made its report more authoritative. Yes, it did consider studies that IARC didn’t. But what EFSA omits to mention is that the extra studies were done by industry. That means they are not peer-reviewed or published and are kept secret from the public and scientists. IARC only took into consideration published studies – a policy that ensures transparency for the public and the scientific community'

PAN Germany noted in its Critical Analysis of the Addendum to the RAR released on 31 August: 'In case of glyphosate, five mouse studies and two rat studies have been identified that show a statistically significant increase in tumour incidences. In addition, mechanistic evidence exists as documented and analysed in the IARC monograph demonstrating the biological significance of these findings in relation to humans.   

The RMS therefore has an amount of evidence available that vastly exceeds the requirements of the applicable legislation. The RMS’s invalidation of this factual basis is based on an inappropriate application of the relevant OECD guidance and EU legislation. A revision of the assessment of the carcinogenic hazard posed by glyphosate appears unavoidable.

Government and regulatory sectors will face increasing scrutiny and criticism from a widening sector of the community that understands the tragedy that stands behind this lack of scientific rigour.  When risk assessment places at it's heart - science that has been carefully selected and provided by the chemical pesticide industry - risk assessment can ONLY be faulty and ridden with conflicts of interest.

This useless and unsafe reassessment by a faulty regulatory authority - perfectly captures why there is increasing consumer distrust in the conventional food system.

 

Is Roundup on my food?

Screenshot from the Codex Alimentarius site.

Screenshot from the Codex Alimentarius site.

Yes, glyphosate based herbicides are on your food. Even if your country has very strict regulations that look safe - imported food usually comes under Codex Alimentarius Maximum Residue Limits - MRLs. These permitted high residues ensure that glyphosate based herbicides can be sprayed on the crops during the growing season.

RITE and Mothers Across the World are petitioning the international agency - the FAO - that recommends MRLs to Codex - to GET GLYPHOSATE OFF OUR FOOD.

NO country in the world is testing across all the staple food commodities for presence of glyphosate, and every country is importing food that can have the levels the FAO recommend on them - called Codex residue levels. Individuals, sick of the lack of regulatory control, have started testing, and glyphosate is being found at levels in the human body, in breastmilk and urine that are of concern.

The IARC has condemned glyphosate as a probable carcinogen and advised there is strong evidence glyphosate and its formulations are genotoxic.  Scientists have found that the levels of glyphosate in our food that our regulators (Eg. EFSA, US EPA etc) say are safe - have been found by independent scientists to be unsafe - to cause harm.

A task force has evaluated the IARC findings and advised that 'IARC and JMPR had used “significantly different” databases and that “many studies, mainly from the published peer reviewed scientific literature", that had not been evaluated by JMPR were available to IARC.'

The 2011 JMPR evaluation was a minor toxicological evaluation of glyphosate's metabolites: AMPA, N-acetyl-glyphosate and N-acetyl-AMPA. Referred to as 'Glyphosate (addendum) 375–388 JMPR 2011'  - the slim range of studies supplied were submitted to WHO by E.I. du Pont de Nemours and Company, Wilmington, DE, USA. 

No other research was consulted.

The previous WHO JMPR Toxicological evaluation was in 2004, and studies submitted for risk assessment was predominantly supplied by glyphosate producers and marketers, published data was excluded. The new WHO glyphosate ADI that came out of that was from a ancient unpublished corporate study Atkinson et al 1993b - a  2-year study in rats (salivary gland effects) that went on to be the NOAEL that established the ADI of 1.0mg/kg bw (pp127-129). The private, unpublished ten year old study was submitted to WHO by Cheminova A/S, Lemvig, Denmark. It was already old when it was submitted.

How does this impact you?

It impacts regulatory decision making. As an example, the New Zealand government dismissed consumer groups calling for more rigorous risk assessment and monitoring, stating 'Glyphosate’s toxicity and dietary risk has been reviewed in detail by the Joint World Health Organization/Food and Agriculture Organization Meeting on Pesticide Residues (JMPR), who concluded it is of very low toxicity. MPI has adopted this conclusion in our assessment of the dietary risk of glyphosate to New Zealand and international consumers.'

As we see above - the NZ government's rationale is based on narrow unpublished science and ignores all recently released published and peer reviewed research. I bet their risk assessment arm has little funding and the scientists are simply unable to undertake a thorough evaluation. Fair enough. But the NZ government does not consider glyphosate toxic despite a barrage of science indicating we should not be exposed to it and logically, it should not be sprayed on our food and animal feed crops.

The science does not stack up and our regulators are sitting on a false stack of cards. 

We're now at a stage where the science will simply not go away. A recent study demonstrated that glyphosate based herbicides can be toxic to the kidney and liver at PARTS PER TRILLION. 

 Regulators dismiss all science concerning the full formulation. Yet frequently, scientists research the full formulation - because this is how the pesticides industry intend us to consume these toxic products. Roundup is much more toxic than its active ingredient glyphosate for several reasons. And your children are consuming all of them. They're call adjuvants, penetrants and there is no requirement for these to undergo risk assessment, yet they are just as critical as the active ingredient when it comes to effectiveness, or toxicity of the pesticides. 

Until our regulators - including the FAO who recommend the international levels for glyphosate that 99% of countries in the world subscribe to - look at the full formulation of these neurologically damaging, endocrine disrupting, carcinogenic and genotoxic formulations - our food is unsafe.

PLEASE sign this Avaaz community petition asking the FAO Director General to Get Glyphosate Off Our Food. Please understand that it is not the type of Avaaz petition that gets mailed to millions of people - so without your support it will go nowhere.

Tell the FAO to GET GLYPHOSATE OFF OUR FOOD!

WHO IARC Monograph Vol 112 Glyphosate.

10 reasons why trade ‘agreements’ & ISDS tribunals undermine public interest regulation

Trade agreements like the TPPA, TTIP & TISA can lead to a regulatory chill - threatening our health and the environment.

1. ISDS tribunals have rejected requests to defer to government regulations when these have been enacted in good faith with no intent to harm corporate profits. 

2. ISDS tribunals' decisions have historically required scientific “proof”. However regulatory bodies/ governments have a duty of care. Acting in the public interest often requires them to employ the precautionary principle (aka prudent avoidance), a valuable tool in public policy-making.  Establishing the toxicity or safety of chemicals is a slow and difficult process and often takes much time and resources. (Many are eventually proven, with scientific certainty, to be carcinogens, endocrine disruptors, mutagens, environmental toxins etc.)     

3. Investor rights can trump public interest rights. A trade agreement may contain provisions that appear to ensure a government’s ability to protect the environment and public health, may be trumped by other agreement provisions that protect investor rights.  

4. ISDS Tribunals undermine democracy, public discussion and dissent:

a. Early settlement avoids big payouts but may result in undemocratic regulation. Settlement prior to ISDS arbitration may still result in environmental or health based settlement decisions or ‘agreed principles’ that, with due consultation in the public sphere, may have not been taken.

b.  The tribunals choose if public can participate or contribute. Public participation in ISDS disputes are decided by a panel of 3 lawyers (only 1 of whom is independent). 

c. Trade agreements may create environments hostile to journalists and whistleblowers and may compromise internet freedom. Online action targeting corporate wrongdoing may be prohibited. 

5. ISDS claims frequently target environmental and health policy measures. Analysts noted that “the provisions designed to ensure security and predictability for the investors have now created uncertainty and unpredictability for environmental (and other) regulators.”

 6. It’s simply not democratic. Frankly, our judicial system looks after us better. ISDS arbitration mechanisms can undermine domestic public interest regulation - providing the public with greatly limited ability to engage in these disputes. It’s cloaked in secrecy and public participation, when allowed, lacks key aspects of basic procedural fairness. This compares to the sophisticated procedural tools available to the public within the modern judicial system. Here, specific regulatory by-laws can be developed and become the subject of legal challenges - due process is provided under more transparent legislative and judicial systems.

 7. It’s based on estimated future profits – and only multinational corporations can engage. ISDS arbitration is only for multinational, and not domestic corporations.

8. Corporate lawyers lack public policy experience. Tribunal members appointed to adjudicate disputes frequently have a commercial law background. Arbitrators may lack the necessary expertise to consider broader public policy implications.

9. Local government regulations and by-laws are vulnerable. Local regulations may regulate to benefit local health & local economies. However they can be overridden by a government anxious to reach a less costly settlement.

10. Tribunals are not bound by rules of precedent. This creates even more uncertainty over ISDS outcomes and a “chilling effect” on government regulation.

Further reading. (Much of the information used to identify the above 10 reasons has been extracted from): Kathleen Cooper, Kyra Bell-Pasht, Ramani Nadarajah, and Theresa McClenaghan, Seeking a Regulatory Chill in Canada: The Dow Agrosciences NAFTA Chapter 11 Challenge to the Quebec Pesticides Management Code, 7 Golden Gate U. Envtl. L.J. 5 (2014).

 

10 environmental sectors ISDS arbitration could affect as a result of free trade agreements:

Water quality management – marine & freshwater

Air quality regulation

Regulation of extraction industries – mining, oil drilling, fracking etc.

Regulation to address climate change

Agricultural water use regulation

Animal welfare regulation

Health regulation

Hazardous substances regulation

Regulation requiring compulsory labelling of genetically modified food

Restrictions on imported agricultural product that carry unwanted pests and diseases

 

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 logic of precautionary avoidance is that, in the face of scientific uncertainty, before and until “proof” is established, action should be taken to avoid or diminish possible major harm until “proof” is established

TRADE AGREEMENTS WILL SLOW REGULATORY RESPONSE TO TOXIC PESTICIDES BECAUSE OF OFFSHORE LAWSUITS

New Zealand lobbyist Charles Finny whose company represents corporations involved in the current TPPA push recently advised Radio New Zealand ‘In terms of ISDS We have had these provisions and agreements for 25-30 years, I haven’t seen a huge number of problems being faced by NZ on this.’

I would suggest this comment is disingenuous – why? Because right now it is boom time for investment arbitration lawyers.

In the last decade there has been a tripling of average claims per year. By February 2015, 3,268 international investment treaties had been signed. UNCTAD’s graph reveals this surge in legal claims at international arbitration tribunals, as corporations realise the benefit of suing governments.

This is troubling, trade agreements are increasingly challenging government regulations and laws that seek to protect citizens from chemicals and pesticides that pose a hazard to health. These laws, that are democratically enacted, are weakened because trade and investment agreements guarantee rights to foreign investors. 70% of cases have been challenges to natural resource and environment policies. 

ISDS cases are expensive, in 2012 OECD advised the average cost ‘USD 8 million with costs exceeding USD 30 million in some cases.’ [1] Translate that to ‘paralysing’ for small countries when facing potential lawsuits as a result of taking restrictive measures foreign corporations may not like.

International investment treaties are agreements made between states that determine the rights of investors in each other’s territories. They are used by powerful companies to sue governments if policy changes – even ones to protect public health.

‘The costs of these legal actions weigh on governments in the form of large legal bills, weakening of social and environmental regulation and increased tax burdens for people, often in countries with critical social and economic needs… Across the world these tribunals have granted big business millions of dollars from taxpayers’ pockets – often in compensation for the alleged impact on company profits of democratically made laws that protect the environment, public health or social well-being.’ [2]

ISDS provisions in trade agreements have a chilling effect on countries making regulatory decisions to protect citizens from toxic chemicals. As Corporate Europe notes, ‘Arbitration lawyers also encourage their clients to use the threat of investment disputes as a way to scare governments into submission.’ According to German law firm Luther: “A settlement, which you should always aim for, is easier to reach under the shadow of a looming investment treaty claim” [3]

Chemtura v Canada (NAFTA Chapter 11) Year of claim 2001.  

Furthermore, the tribunal ordered the investor to pay the costs of the arbitration ($US 688,000) and to pay 50% of the Government of Canada’s costs in defending the claim ($CAD 5.778 million).

Canada still had to pay 50% of the CAD5.778million.

IIAPP comments:

Chemtura lobbied against the bans in Canada and the U.S., challenged Canada’s measures in the Federal Court of Canada, and then sued Canada for USD83 million under NAFTA Chapter 11.

COMMENT: The case has been cited by some proponents of investment arbitration as putting to rest concerns that NAFTA Chapter 11 impedes public health and the environmental regulation. Yet the award itself is troubling on this point. First, the tribunal, like the earlier Glamis Gold v United States tribunal, rejected submissions by Canada that tribunals should defer to good faith regulatory measures of governments.

Second, the tribunal noted repeatedly that lindane was banned in many other countries, making it unclear whether the ban would have been upheld had Canada been a regulatory first-mover in limiting the pesticide on health or environmental grounds.

Third, the tribunal declined to adopt the approach of the earlier Glamis Gold tribunal, which required the claimant to provide affirmative evidence of any alleged expansion of the NAFTA minimum standard of treatment beyond its established content in international custom. Canada, Mexico, and the U.S. have argued that claimants must satisfy this requirement. However, arbitrators in numerous NAFTA cases have rejected this position, thus facilitating investor claims.

Dow AgroSciences v. Government of Canada 

March 2009, Dow AgroSciences LLC alleged Canada had breached its obligations under Section A of Chapter 11 of NAFTA, under Article 1105 (Fair and Equitable Treatment in Accordance with International Law) and Article 1110 (Expropriation).

DowAgroSciences alleging Quebec’s 1991 pesticide bylaw, banning the cosmetic use of pesticides on private property, was in breach of two NAFTA obligations (Page 30 here) contained in Chapter 11. (The Quebec decision set a precedent that was followed by dozens of municipalities throughout Canada). 

The Notice of Intent filed in 2008 sought $2 million from the Government of Canada as well as “further relief including additional damages,”

On May 25, 2011, the parties reached a settlement under which Dow withdrew its claim. In return, the Government of Quebec formally acknowledged that 2,4-D does not pose an “unacceptable risk” to human health. The disputed regulatory measures related to pesticides are maintained and no compensation has been paid to the claimant. 

No costs were paid to either party, yet the ‘agreed principles’ are concerning -as they were reached in an external court without due consultation within the Canadian judicial system.

Further reading on this case: Kathleen Cooper, Kyra Bell-Pasht, Ramani Nadarajah, and Theresa McClenaghan, Seeking a Regulatory Chill in Canada: The Dow Agrosciences NAFTA Chapter 11 Challenge to the Quebec Pesticides Management Code, 7 Golden Gate U. Envtl. L.J. 5 (2014).

REFERENCES

[1] ROUNDTABLE ON FREEDOM OF INVESTMENT 15 - 5 December 2011 – Paris, France
Summary of Roundtable discussions by the OECD Secretariat

[2] Profiting from injustice: How law firms, arbitrators and financiers are fuelling an investment arbitration boom.  Brussels / Amsterdam, November 2012
Published by Corporate Europe Observatory and the Transnational Institute

[3] Chapter 3: Legal vultures: Law firms driving demand for investment arbitration
November 27th 2012  Corporate Europe Observatory and the Transnational Institute

Trade Agreements: How ISDS provisions can undermine domestic public interest regulation

PAPER: Seeking a Regulatory Chill in Canada: The Dow Agrosciences NAFTA Chapter 11 Challenge to the Quebec Pesticides Management Code

Kathleen Cooper, Kyra Bell-Pasht, Ramani Nadarajah, and Theresa McClenaghan, Seeking a Regulatory Chill in Canada: The Dow Agrosciences NAFTA Chapter 11 Challenge to the Quebec Pesticides Management Code, 7 Golden Gate U. Envtl. L.J. 5 (2014).

http://digitalcommons.law.ggu.edu/gguelj/vol7/iss1/4

Seeking a Regulatory Chill in Canada: The Dow Agrosciences NAFTA Chapter 11 Challenge to the Quebec Pesticides Management Code: This insightful and thoughtful 45 page document is well worth reading – below are a series of extracts contained within 7 A4 pages – an attempt to consolidate a lot of the text into a shorter document but to still help people grasp the implications of ISDS arbitration –  with full references to which page information comes from within the original document. The only intent in transcribing sections of the longer document is to facilitate more understanding of how ISDS provisions within trade agreements have the potential to challenge decisions by governments that act with public and environmental welfare as the first priority. RITE's hope is that reading the shorter extracts will lead the reader to consult the complete original document.

Part I Introduction – Extract:

In 2008, NAFTA’s Chapter 11 investor rights provisions intersected with this twenty-year effort to limit cosmetic pesticide use. Dow AgroSciences (Dow), a United States-based chemical manufacturer, gave notice that it would challenge the Québec Pesticides Management Code arguing that Canada was in breach of the minimum standard of treatment and expropriation provisions of Chapter 11. These provisions, and subsequent sections of Chapter 11, allow companies to sue countries if their expected returns on investment are reduced by government actions. (Page 3)

Dow sought $2 million in compensation, based on an alleged lack of due process in the passage of Québec’s law and damage to its investment in Canada. Notably, the Dow claim was focused on its commercial interest in a single pesticide, 2,4-Dichlorophenoxyacetic acid (2,4-D). Though 2,4-D was among the pesticides heavily used for cosmetic purposes the Québec law and many local by-laws in Québec and across Canada, as well as other provincial statutes, had to do with many more pesticides. (Page 3.)

Part II COSMETIC PESTICIDE BANS IN CANADA

RITE note: Outlines the situation in Canada, increasing environmental awareness, the actions of Hudson, Québec in adopting a by-law restricting pesticides in 1991 on public and private property. In 1992 the municipality charged 2 landscaping companies with breach of the by-law. The Québec Superior Court affirmed the ruling restricting pesticides. Nearly ten years later the companies appealed to the Supreme Court of Canada. In 2001 the Supreme Court upheld that the by-law was valid. (Page 8)

After the decision many municipalities across Canada, following public demand, enacted similar by-laws. Today there are over 170 pesticide by-laws in Canada.

In 2008 Québec implemented legislation banning certain pesticide uses on a province-wide basis. (Page 12)

‘More generally, the precautionary foundation of the Québec law derived from the opinion of public health experts who stated in an earlier report from the Québec National Public Health Institute that based on “data which are presently available, the fact that certain aspects remain poorly understood, and the increased vulnerability of certain groups provide ample reason to justify taking a prudent approach and applying the precautionary principle with respect to pesticide use.’ (Page 14.)

‘In May 2008, PMRA finalized its re-evaluation process and allowed the continued sale and use of certain products containing 2,4-D, including those used for lawn and turf…… Despite the results of PMRA’s re-evaluation of 2,4-D, both Quebec and Ontario maintained their approach of banning this pesticide for cosmetic purposes.’ (Page 14/15)

‘In summary, for more than fifteen years diverse civil society groups in Canada sought and obtained precautionary public policy support to reduce health and environmental risks from the non-essential use of pesticides.103 While 2,4-D often received the most attention throughout this debate,104 the bans were never intended to be confined to this single pesticide.’ (Page 16)

‘… in the courts, particularly in Canada’s highest court, procedural rights enabled public interest organizations and citizens to bring much broader considerations of public policy than just the arguments advanced by the pesticide companies in Hudson……the judgment set a precedent in guiding municipalities on how they may legitimately use municipal powers to protect health and environment and, more broadly, incorporated a public interest perspective by interpreting By-law 270 in a manner that was consistent with international law’s precautionary principle.’ (Page 17)

III DOW’S NAFTA CHALLENGE TO QUÉBEC’S PESTICIDES MANAGEMENT CODE Page 17.

A. INTRODUCTION AND NAFTA CONTEXT

‘The parallel story unfolding in the late 1990s and early 2000s was the use of NAFTA Chapter 11’s ISDS mechanism to make claims challenging environmental and health regulations. Analysts pointed to “the unexpectedly broad and aggressive use of this process to challenge public policy and public welfare measures, including environmental measures.”’ (Page 17)

 ‘Trade scholars commented on the significant imbalance between private investors’ rights and the protection and promotion of the broader public goods under NAFTA’s Chapter 11 regime. 111 They noted that this disparity is exacerbated by the lack of transparency and public access to the process, the limited opportunity for public participation, and the cloud of secrecy over the actual adjudication of arbitration proceedings. (Page 18)

In contrast, investors contemplating initiating a claim face virtually no constraints other than to follow the procedural requirement set out in Section B of Chapter 11.1’ (page 18)

‘Under NAFTA, ISDS claims have proliferated against Canadian public interest measures. By January 2013, thirty-four NAFTA investor claims had been commenced against Canada. Close to half of those claims were related to environmental and health policy measures (see Table 1). Commenting on this trend as early as 1999, analysts noted that “the provisions designed to ensure security and predictability for the investors have now created uncertainty and unpredictability for environmental (and other) regulators.”  (Page 19)

‘There is rich irony here. The ISDS mechanism originated as a means to protect the rights of investors from unfair or arbitrary action by countries with less developed judicial systems. However, in Canada the NAFTA ISDS arbitration mechanism can undermine domestic public interest regulation while providing the public with greatly limited recourse to engage in these disputes when compared to the sophisticated procedural tools available to them within Canada’s modern judicial system.’ (page 19)

1. Adjudication of Chapter 11 Disputes. Critics have charged that Chapter 11 is problematic when issues of public welfare and public policy are placed against private interests. The ability of each Party to choose its arbitrator is also a significant difference between domestic courts and the arbitration process.128 Tribunal members appointed to adjudicate disputes generally tend to have a commercial law background, leading to concerns that arbitrators may lack the necessary expertise to consider the broader public policy implications that arise in the context of Chapter 11. (Page 20)

While there is now a well-established precedent for the public to participate in Chapter 11 arbitration through the amicus process, this right remains subject to the discretion of the panel and is determined on a case-by-case basis. Moreover, the extent to which the public will be able to gain complete access to documents filed by the Parties to the arbitration proceedings is unclear.

Overall, these reforms, and suggested reforms, have not changed the fact that public participation in the Chapter 11 arbitration proceedings remains generally limited to the filing of amicus curiae briefs, at the discretion of the tribunal, in contrast to broader rights and proceedings available before domestic courts. Nor have these reforms changed the fact that public interest, environmental, and health measures continue be targeted by foreign investors under Chapter 11, as illustrated by the Dow claim and other similar claims, as summarized in Table 1. (Page 23)

2. Chapter 11 Overrides Environment and Health Measures in NAFTA. Despite the fact that NAFTA contains provisions that appear to ensure a government’s ability to protect the environment and public health, namely within NAFTA’s preamble and Articles 1101 and 1114, these are trumped by other provisions to protect investor rights…. However, in order to benefit from these provisions’ protection. The measures must be “otherwise consistent with this Chapter [11]. As a result, Articles 1101 and 1114 have not effectively shielded many public interest measures, nor deterred investors from bringing claims. (Page 24)

3. Chapter 11 Minimum Standard of Treatment—Article 1105.  The legal test established for Article 1105 although vague and not easily definable, broadly requires determining whether a government measure was developed according to due process with transparency, in good faith, and according to natural justice. (Page 25)

4. Chapter 11 Expropriation—Article 1110. The provision provides that governments are allowed to expropriate an investment only: (a) for a public purpose, (b) on a non-discriminatory basis, (c) in accordance with due process of law and Article 1105(1), and (d) on payment of compensation…. The expropriation provision covers both direct and in expropriation. (Page 26)

B. OVERVIEW OF DOW’S CLAIM (Page 27)

‘Following the Supreme Court decision in Hudson as pesticide bylaws proliferated across Canada and both Québec and Ontario considered enacting provincial statutes, environmental organizations in Québec and Ontario heard persistent rumours of a possible NAFTA challenge. Such a challenge came in 2008 against Québec’s provincial ban, three months after PMRA finalized its decision to allow the continued registration of 2,4-D,173 and two months after Ontario passed legislation to ban cosmetic pesticide use province-wide.’ (Page 27)

First, the specific claimed breaches of NAFTA obligations were with respect to the provisions of Article 1105.197 Canada was accused of failing to treat Dow “in accordance with international law, including fair and equitable treatment and full protection and security.” Further, Dow claimed that Article 1105 was individually and cumulatively breached by Québec’s actions “in improperly imposing the Ban, in failing and refusing to review and repeal the Ban, in breaching the Claimant’s legitimate expectations, in conducting biased and improper reviews and advancing improper conclusions, and in prohibiting the sale and use of 2,4-D.”199 Further, Dow maintained that Canada was “in breach of international law and its obligations under Article 1105 in respect of basic due process, transparency, good faith and natural justice.”

The second claimed breach was with provisions of Article 1110.201 Dow claimed that the effect of Québec’s actions from 2003 to 2009, individually and cumulatively, amounted to measures tantamount to expropriation of Dow’s investment.202 Citing Article 1110, Dow noted that such measures could be justified “only if they are: for a public purpose; on a non-discriminatory basis; in accordance with due process and Article 1105(1); and on payment of compensation on a prescribed basis.” Dow stated that none of these criteria had been met by Québec—“most particularly, no compensation has ever be ne paid or offered”204—and thus Canada was in breach of Article 1110 obligations to avoid direct or indirect expropriation of an investor, except in accordance with the four criteria listed in Article 1110, noted above. (Page 29)

C. INITIAL REACTIONS FROM NONGOVERNMENTAL ORGANIZATIONS AND POLITICIANS

Dow’s action was widely perceived as an attempt to bring a regulatory chill on efforts across Canada, particularly in Ontario, Canada’s most populous province with a government actively considering a sweeping ban on hundreds of pesticide products. As one legal commentator observed, the claim by Dow appeared to be aimed “as much at deterring other governments from taking similar steps to reduce pesticide use for health and environmental reasons, as much as it [was] meant to win compensation of $2 million, as claimed, for the incidental impacts on Dow’s sales in Québec.”

D. TRADE-FOCUSED NOTIONS OF FAIRNESS AND DUE PROCESS: IRONIC CONSEQUENCES

As noted above, ISDS mechanisms originated in agree between developed and less developed nations to provide measures that would protect investors from unfair or arbitrary action by countries with less developed judicial systems.212 The unexpected and ironic consequence of including such mechanisms in NAFTA has been to undermine domestic public interest regulation using a dispute resolution mechanism that denies the public the procedural fairness that exists in their modern judicial system. This consequence is largely due to the narrow purview of NAFTA, with its overall objectives focused on trade and the paramount importance assigned to investor rights by the terms of Chapter 11. (Page 32)

It is also important to note that as specific by-laws were developed and became the subject of legal challenges, the due process that was provided under Canada’s legislative and judicial systems stands in sharp contrast to the NAFTA arbitration process, which has largely been cloaked in secrecy and where public participation, when it is allowed, lacks key aspects of basic procedural fairness. (Page 33)

…despite many years of due process, a tribunal operating within the narrow objectives of NAFTA’s trade focus would make the determination as to whether Québecs pesticide ban amounts to expropriation. As noted above, members of these tribunals have expertise that rarely extends beyond commercial law. Further, their proceedings provide limited opportunity for broader public input as compared to that available under the Canadian legislative and judicial system. (Page 33)

Thus, Article 1110, like Article 1105, provides far greater emphasis on the investor’s legitimate commercial expectations as opposed to the public’s legitimate expectations that their government will enact environmental measures to protect their welfare. (Page 33/34)

Equiterre, a Québec-based environmental group, and the David Suzuki Foundation, a Canadian environmental organization based in Vancouver, British Columbia, expressed these concerns in response to Dow’s Notice of Arbitration.222 They announced their intention to file a joint amicus curiae submission once a tribunal was established.

However, both groups expressed concerns that even in cases such as Dow, where “matters of the public interest are engaged, NAFTA Chapter 11 only guarantees legal standing to eligible investors, leaving other civil society actors to engage in a limited fashion (in writing only) at the discretion of the arbitrators.”224 Given how the amicus curiae process has developed in Chapter 11 case law, the organizations claimed they had no confidence that even when the panel was established, it would have the discretion to benefit from oral submissions from non-disputing parties with a distinct interest and expertise in the matter. The groups noted that this was in sharp contrast with the rules of practice for intervention before domestic courts such as the Supreme Court of Canada. (Page 34)

E. THE MAIN STICKING POINT: PRECAUTIONARY DECISION MAKING

As described above, Dow’s Notice of Arbitration focused on the contention that Québec had no scientific basis to impose a ban on 2,4-D, and had acknowledged as much. (Page 34)

It can be concluded from a review of Dow’s arguments that a clear assumption is being made that precautionary decision making is not scientific. Further, when the Québec ban on 2,4-D was not reversed after the PMRA and other regulatory agencies concluded that continued registration was acceptable, the arguments made in Dow’s Notice of Arbitration indicate that Dow clearly considered Québec’s prior commitment to review its ban was the same as agreeing to reverse it.

In contrast, environmental organizations disputed the results of the PMRA’s risk assessment of 2,4-D. In this circumstance, these groups note the ability of risk assessment to reach a conclusion as to a chemical’s acceptable risk on the basis of an incomplete consideration of potential health effects.  For example, they pointed out that the European Union Strategy for Endocrine Disruptors had proposed that 2,4-D be considered a Category II chemical on its priority list of suspected endocrine disrupting chemicals, a health outcome not considered in the PMRA risk assessment. Although the PMRA did note that evidence indicated possible endocrine disruption effects of 2,4-D, this evidence was not considered in the re-evaluation decision due to a lack of validated test protocols.

An extensive debate exists, ..:

1. Applying Precaution and Risk Assessment—Both Are Science Based Decision making

…the statement from the Rio Declaration on Environment and Development has been followed sufficiently often that for some, it is the most authoritative version.243 The Declaration states that “[i]n 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 scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.” (Page 37)

“Uncertainty” in this context means more than speculation,248 and is about the extent of the harm, as well as causation. It is science based because there must be a basis on which to conclude that a threat of harm is serious and perhaps irreversible. While this latter point may con to be disputed, within the precautionary principle debate, most agee that is a tool for bringing science and policy together for effective decisionmaking on difficult subjects where much is at stake. (Page 37)

Closely related, an equally extensive critique exists challenging the notion that chemical risk assessment, as conducted by the PMRA and other regulatory agencies, is a purely science-based exercise. The limitations of risk assessment have been extensively described, including, for example:

·         limits on criteria for the selection of hazards to assess;

·         the practice of leaving out some hazards due to bias or lack of knowledge;

·         the inability to factor impacts of cumulative effects, additive or synergistic effects;  

·         limits on the ability to quantify impacts;

·         the role of professional judgment to assess and/or fill data gaps;

·         the limitations arising from health or other impact endpoints under consideration such as endocrine disruption or other complex conditions involving complex dose-response and/or long latency periods, and lack of data about such impacts

·         lack of data about substances, processes, and ecosystem variables;

·         tendency to make type II errors as a result of designing studies to rigorously avoid type I errors

·         potential for surprise in behaviour of systems and so on                               (Page 38)

2. What Would a Tribunal Have Done?                                 (Pages 39-41)

Legitimate expectations of investors are held to include measures based on scientific studies and international guidelines, not measures based on the precautionary principle, which is often inaccurately conflated by NAFTA tribunals as a political basis.  This focus on a scientific basis underlying the measures in dispute occur the Ethyl and Chemtura cases, which preceded Dow. Page 39

Similarly, in 2010 Canada successfully defended against an investor claim by Chemtura on scientific grounds. Chemtura’s claim was also based on alleged breaches of the minimum standard of treatment and expropriation provisions as a result of a ban on lindane, a pesticide used in the production of canola.261 The tribunal held that the government of Canada’s scientific review of lindane “falls within acceptable scientific parameters,”262 but that it was “not for the Tribunal to review the scientific basis of the PMRA’s decision.”263 As such, the Chemtura decision is an example of adjudicators putting emphasis on the scientific process underlying the risk assessment and regulatory action. (Page 40)

Although NAFTA’s text does not explicitly preclude a public interest precautionary measure from being considered as a legitimate measure, tribunals have not upheld such an interpretation. Rather, they have held such measures to be legitimate on the basis that they were supported by a scientific study, or by an established international guideline, rather than a precautionary approach.(page 40)

F. STALEMATE: ALL SIDES CLAIM VICTORY

In May 2011, almost three years after Dow brought its Notice of Arbitration claim, no further filings occurred and a settlement was reached without the case proceeding before a NAFTA tribunal. The Settlement Agreement269 refers to an exchange of letters between the Government of Canada and the Government of Québec wherein the parties agree to the terms of the Settlement Agreement,270 including that Québec’s ban on 2,4-D be upheld,271 the withdrawal of Dow’s Notice of Arbitration,272 and that no compensation be provided. (Page 41)

As well as a ‘full and final settlement,”274 the Government of Québec also acknowledged several ‘agreed principals that essentially restate the reality of the tri-level regulatory regime that exists in Canada to regulate pesticides 276 as this was enumerated by the Supreme Court of Canada in  Hudson. (Page 41/42)

The first principle includes the definition of “acceptable risk” as it is stated in the federal Pest Control Products Act. It then specifies that the Government of Québec acknowledge the results of this determination of acceptable risk for 2,4-D in the 2008 PMRA re-evaluation decision, namely that the risk is acceptable if label directions are followed. The second principle enumerates the nested authority of provinces to regulate pesticides in a manner more restrictive than the PMRA.279 The third notes that, subject to applicable laws, municipalities may also apply a pesticide regulation that is more restrictive than the PMRA or the provincial government, in this case, the government of Québec.280 (Page 42)

IV. CONCLUSION

In hindsight, early warnings were prescient about two issues addressed in this Article: the threat of key NAFTA provisions to public interest environmental law 289 and the need for precautionary responses in the face of widespread exposure to low levels of multiple toxic substances.

The wisdom of the latter continues to be confirmed by extensive and credible scientific evidence, notably, but not limited to multiple challenges of low-level exposure to endocrine disrupting chemicals. (page 43)

Despite varied perspectives on the outcome, the Dow case others like it, illustrates how NAFTA’s Chapter 11 ISDS mechanism can be, and have been, used to try and reverse, and arguably similar domestic public interest measures.

Under Chapter 11, investor rights can trump public interest rights, chiefly on account of provisions concerning the legitimate expectations of investors in Articles 1105 and 1110, the singular trade focus in NAFTA overall, and the arbitral procedures with their lack of accompanying judicial safeguards.302 (Page 44)

In the unlikely event that Chapter 11 were removed from NAFTA, it would be in keeping with recent steps taken in Australia where, in April 2011, the Australian government refused to enter into any further international investment agreements with developed countries containing ISDS provisions on the basis that they:

[do] not support provisions that would confer greater legal rights on foreign businesses than those available to domestic businesses. Nor will the Government support provisions that would constrain the ability of Australian governments to make laws on social, environmental and economic matters in circumstances where those laws do not discriminate between domestic and foreign businesses.

This recognition by the Australian government underscores the problem illustrated by the use of ISDS provisions under NAFTA, including the rich irony in the Dow case.304 Such investor rights originated in ISDS mechanisms intended to protect investors from the vagaries of less developed legislative and judicial systems.305 Yet,, those same mechanisms can be used to undermine domestic public interest regulation that, in this case, was the result of many years of due process in Canadian lawmaking and the Canadian courts.306 Moreover, the procedural mechanisms to protect these investor rights under Chapter 11 also deny the public the same rights to fully participate in the arbitration process.307 The Dow case illustrates that Chapter 11 investor rights are misplaced within an investment agreement between nations that have equally sophisticated legislative and judicial systems. (Page 49)

END TRANSCRIPT.

Kathleen Cooper, Kyra Bell-Pasht, Ramani Nadarajah, and Theresa McClenaghan, Seeking a Regulatory Chill in Canada: The Dow Agrosciences NAFTA Chapter 11 Challenge to the Quebec Pesticides Management Code, 7 Golden Gate U. Envtl. L.J. 5 (2014).

Modified swedes, high in glucosinolates sprayed with toxic chemicals.

Article first appeared in Agrigator - New Zealand Agricultural Views 

New Zealand dairy farmers are starting to get a little bit grumpy. Cows are dying after eating swedes.


Hundreds of cows have died, liver damage appears to be a part of the story, and it is mainly cows that in-calf that are affected. Farmers have fed brassicas to dairy cows for decades, and are well used to managing the transition period. What’s new? The type of brassica (mutagenic – i.e. Not naturally developed) sprayed with a little researched herbicide called Telar (chlorsulfuron).


Science regarding the chemical?


These brassicas are herbicide tolerant to chlorsulfuron. Chlorsulfuron is a known reproductive/developmental toxin. (Also here). However that data is old. There is very little information regarding chlorsulfuron and its risk.

Fact is, it has hardly been studied for toxicity. The studies used by regulatory agencies are over 20 years old (see pages 23 & 24) The chemical companies design and pay for the toxicity studies (known as seller sponsored science) and directly supply them to regulatory agencies for assessment. There are no publicly available (Ie. Published in scientific journals) studies investigating the toxicity of chlorsulfuron. The agrichemical corporations that pay for the studies don’t want them publicly disclosed.


The US EPA’s toxicity data is limited. Occupational (farmer) exposure for chlorsulfuron is based on a NOAEL of 75mg/kg day is based on a 1991 Prenatal Developmental Toxicity Study (rabbit) (1991a).[1] Of course, toxicity has been established at lower levels (page 7), (page 13) but ignored. More information can be found in the US Federal Register. [2]
The only toxicity studies held with the WHO and FAO appear to be thirty years old(p.17-19). Europe’s recent EFSA Scientific Report reviewing Chlorsulfuron in 2008 used ancient, private 1991 studies (MRID 41983101) to provide the maternal (75mg/kg) and developmental (200mg/kg) NOAELs. Europe’s ADI of 0.2 mg/kg bw/day based on an unknown, unpublished 2 year rat study (possibly Wood 1980, as EFSA discussesinterstitial cell tumors).

Europe’s AOEL is 0.43 mg/kg bw/day based on the 1-year dog study for which there is no cited reference. [3]


Dupont’s 2012 safety data sheet lists 3 unpublished studies from 1980 and 1981. [4] New Zealand doesn’t appear to list a NOAEL for Telar/Chlorsulfuron. NZ’s HSNO database reveals little other than chlorsulfuron is very ecotoxic in the soil and aquatic environment. If you dive into the NZ EPA 2005 decision document for chlorsulfuron (link is a downloadable word doc.), which forms the basis of ongoing approval, you will find it contains no information regarding reproductive and developmental toxicity. [5] Since 2005 there has been no consideration of toxicity or recent research investigated of Telar/chlorsulfuronin New Zealand. [5]


Science regarding the combined chemically mutated seed (HT) and the chemicals applied?
Despite producing the HT line of brassicas that are tolerant to Telar – no-one scientifically assessed whether the full formulation which includes chlorsulfuron and its adjuvants on HT brassicas will be toxic to in-calf dairy cows – who are the most affected stock connected to swede deaths. It appears there were no safety trials.

As discussed, no-one has considered the toxicity of chlorsulfuron for over a decade, yet the application rates that are set for chlorsulfuron are based on the established NOAEL – from 20+ years ago. It is the authors opinion that due diligence has not been carried out. If residue tests for chemicals used in production have been carried out all farmers should have access to all the data, in addition to testing methodologies used by the laboratories.

Laboratories may be formally accredited but not follow transparent international testing protocols that extract the chemical properly. This can result in a false negative, not detected by the laboratory though present.


Confidentiality agreements are held between the corporation, select farmers, veterinary associations and Dairy NZ. It would appear that information is suppressed. Dairy cows dealing with transition onto swedes (with glucosinolates) have to deal with the combined toxicity of Telar (chlorsulfuron), but also glyphosate based herbicides, possibly diazinon (which like glyphosate inhibits acetylcholinesterase and is classified as a probable carcinogen), and chlorpyrifos insecticide (associated with birth defects) which are all approved for use over the growing season. Where is the science on cumulative toxicity?

Pregnant animals are always more susceptible to toxins.

Not just chlorsulfuron that may be contributing towards cumulative toxicity.


An integral part of most farmers spray regimes before drilling HT Brassica seed is Roundup. GBH is liberally applied to pasture, silage and forage. Its worrying toxicity, published in respected journals is not discussed in agricultural newspapers. In a study on Danish dairy cows, elevated glyphosate urinary levels were linked to a marked increase in biomarkers indicative of damage to liver and kidney function. Glyphosate has also been found to suppress beneficial gut bacteria. [6] If a cow’s gut is compromised by glyphosate, can it deal with transition onto brassicas? Particularly HT brassicas, chemically changed, with levels of glucosinolates which are toxic to cattle, up to 16 times higher than in an unmodified plant.

No science on that one. (Interestingly, glyphosate based herbicides like Roundup now have a quantity of published science advising of its reproductive, developmental, endocrine and carcinogenic toxicity and how it’s bad for the gut (and therefore immune system) and reproductive performance – but glyphosate is used a lot more so subject to more investigation. Chlorsulfuron has passed under the radar.)


When chlorsulfuron was assessed for toxicity it definitely wasn’t assessed as part of a modified stock feed that had undergone chemical mutagenesis.

Definitely not a GMO – but risky all the same.

New Zealand mainstream agricultural media also appear reluctant to consider possible toxicity of the Herbicide Tolerant (HT) swedes. They are not transgenic, instead, produced through chemical mutagenesis using chemical Ethylmethane Sulfonate (EMS). [7] These brassicas are as a result, genetically different from standard swedes, otherwise there would not be a patent held on them.


The WHO definition of a genetically modified organism is one where the genetic material (DNA) has been altered in a way that does not occur naturally by mating and/or natural recombination’ [8]

Chemical mutagenesis is certainly not natural, so why is it evading regulation? Perhaps Dairy NZ and farmers should be questioning why there are no released stock feeding trials where cows are eating the brassica plant, but also trials including dosages of the full formulation of herbicides contained in the spray regime recommended to partner the brassica product?
The non-GMO status of these brassicas does result in less risk assessment. Many scientists consider breeding via chemical mutagenesis as risky and unpredictableYet these HT brassicas follow similar procedure with GMO seed crops overseas.

Farmers who purchase HT seed are given a product endorsement to sign – no seed is delivered unless this is signed. PGG Wrightson’s Seed Manager David Green advised in October last year that this endorsement would be changed to state that pregnant dairy cows should not be fed the product. Therefore if more in-calf cows die, farmers can’t sue. … if liability was established.

Doesn’t an altered endorsement reflect an understanding that this product is in all likelihood, toxic to pregnant dairy cows?


Published studies have confirmed that genetically modified feed can compromise fertility, but also the uterus and gut of animals. [9] Most ruminants fed genetically modified feed are slaughtered within two years, unlike the longer lifetime of our dairy cows. But again, though the genes are altered chemically, this is not a GMO product, we simply have to assume safety.
It is important to recognise that the growth in patented seed product overseas has resulted in variety decline in existing, naturally bred seed stock. Seed prices in the US for (usually GMO) patented seed have increased along with less market choice and the patented product in the hands of a small amount of companies.

With these facts in mind, it is imperative that standard, safer, non-chemically altered brassica seed is kept in ample quantities for New Zealand farmers. Noting PGG Wrightson control 85% of New Zealand’s brassica seed supply.


Media coverage and Dairy NZ since September last year has shown a remarkable disinclination to discuss the potential systemic toxicity of the chemically mutated swedes in combination with the chemical regime they are associated with.

Much of mainstream media and Dairy NZ are quite content to discuss high levels of glucosinolates though.

LET’S CONSIDER CURRENT STATUS

It appears that:


1. Toxicity studies for chlorsulfuron are ancient, unpublished and private.
2. PGG Wrightson have amended the endorsement ‘not for pregnant dairy cows.’
3. It’s not just transitioning to a different feed type – there is more to the story.
4. The glucosinalate levels were off the chart – still classed as safe.
5. Where are the feeding trials of a plant modified by chemical mutagenesis with the dosages to mimic the recommended full formulation chemical regime?
6. No apparent analysis and testing or investigation of the chemicals used in the brassica crop may have interacted to contribute to systemic toxicity of in-calf cows.


Thorough transparent analysis is expensive. So are dairy cows. It is all about the science.

 

References and information:

[1] US EPA NOAEL: Alvarez, L. 1991a. Teratogenicity Study of DPX–W4189 (Chlorsulfuron) in Rabbits. E.I. du Pont de Nemours & Company, HaskellLaboratory for Toxicology and Industrial Medicine, Newark, DE, Laboratory Project ID:306–390, August 12, 1991. Unpublished

[2] Details of toxicity studies (only provided by the chemical company, in this case DuPont) appear most clearly in the US EPA Federal Register. 

[3] EU study – unclear as no reference provided – possibly:

Wood, C.K., Wollenberg, E.J., Turner, D.T., et al. 1981a. Long-Term Feeding Study with 2-chloro-N-6(4-methoxy-6-methyl-1,3,5- triazin-2- yl)aminocarbonylbenzenesulfonamide (INW– 4189) in Rats. E.I. du Pont de Nemours & Company, Haskell Laboratory Report No. 557–81, November 13, 1981. MRID 0086003. Unpublished. (interstitial cell tumors present)

NOTE: The Wood study was repeated and replaced by the following study (with no tumors):

Mylchreest, E. (2005b) Chlorsulfuron (DPX-W4189) Technical: Multigeneration Reproduction Study in Rats. Laboratory Project ID: DuPont-13475. E.I. du Pont de Nemours and Company, Wilmington, Delaware 19898, U. S. A.

 [4] Dupont Telar Herbicide Safety Data Sheet refers to 3 animal studies:

Schneider, P.W., Jr., Smith, L.W., Barnes, J.R., et al. 1980. Six-Month Feeding Study in Dogs with 2-Chloro-N-o(4-methoxy-6-methy-1,3,5-triazin–2yl)amino carbonyl benzenesulfonamide (INW–4189): Report No. 108–80. Final rept. (Unpublished study including pathology report no. 53–79, received Jun 16, 1980 under 352–EX–105; submitted by E.I. du Pont de Nemours & Co., Wilmington, DE; CDL:099461–A).  (4 female 4 male dogs were studied)

Wood, C.K., Wollenberg, E.J., Turner,D.T., et al. 1981a. Long-Term Feeding Study with 2-chloro-N-6(4-methoxy-6-methyl-1,3,5-triazin-2-yl)aminocarbonylbenzenesulfonamide (INW–4189) in Rats. E.I. du Pont de Nemours &Company, Haskell Laboratory Report No.557–81, November 13, 1981. MRID 0086003. Unpublished.  (80 rats were studied)

Wood, C.K., Wollenberg, E.J., Turner, D.T., et al. 1981b. Long-Term Feeding Study with INW–4189 in Mice. E.I. du Pont de Nemours & Company, Haskell Laboratory Report No. 836–81, December 28, 1981. MRID 0090030. Unpublished.

LD50: Content only available in Russian. Not possible to verify. Rakitsky, V.N. and Beloyedova, N.S. 2009. Toxicity and Hazardousness of Sulfonylurea Herbicides. Toxicology Herald.

[5]  The NZ application was for Agronica Chlorsulfuron Herbicide, a water dispersible granule containing 750 g/kg chlorsulfuron. ‘The substance will be used for the control of broadleaf weeds in wheat, barley and oats’. To be diluted before application to a concentration of 20 g in a minimum of 60 litres of water per hectare with a non-ionic surfactant. The application rate was set at 15 g ai /ha in cereals, once per season.

[6] a. Glyphosate suppresses the antagonistic effect of Enterococcus spp. on Clostridium botulinum. Krüger M1, Shehata AA, Schrödl W, Rodloff A. Anaerobe. 2013 Apr;20:74-8. doi: 10.1016/j.anaerobe.2013.01.005. Epub 2013 Feb 6.

http://www.gmoevidence.com/dr-kruger-roundup-suppresses-growth-of-beneficial-gut-bacteria/

b. Krüger M, et al. (2013) Field Investigations of Glyphosate in Urine of Danish Dairy Cows. J Environ Anal Toxicol 3: 186.

[7] Cleancrop™ Brassica System: The development of herbicide resistant brassica crops for New Zealand farming systems A. DUMBLETON1 , S. GOWERS2 , A. CONNER3 , M. CHRISTIE4 , P. KENNY1 , H. MULCOCK1 , and B. CHARTERIS1 1 PGG Wrightson Seeds Limited, PO Box 175, Lincoln 2 The New Zealand Institute for Plant and Food Research Limited, Private Bag 4704, Christchurch 3 AgResearch Ltd, Grasslands Research Centre, Private Bag 11008, Palmerston North

[8] WHO classification: Genetically modified organisms (GMOs) can be defined as organisms (i.e. plants, animals or microorganisms) in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating and/or natural recombination. The technology is often called “modern biotechnology” or “gene technology”, sometimes also “recombinant DNA technology” or “genetic engineering”.

European Commission: In recent times, it has become possible to modify the genetic make-up of living cells and organisms using techniques of modern biotechnology called gene technology. The genetic material is modified artificially to give it a new property (e.g. a plant's resistance to a disease, insect or drought, a plant's tolerance to a herbicide, improving a food's quality or nutritional value, increased yield).

Such organisms are called "genetically modified organisms" (GMOs). Food and feed which contain or consist of such GMOs, or are produced from GMOs, are called "genetically modified (GM) food or feed".

[9] A long-term toxicology study on pigs fed a mixed GM diet. Adverse effects of GM crops found. By Dr. Judy Carman 11 June 2013

Pesticides in baby food: New Zealand Government decides current status OK.

Sent to New Zealand Herald. Unpublished.  22.06.2015

The decision of the New Zealand government Primary Production Select Committee report, to not implement a zero pesticides policy in baby food, a restriction which applies to European baby food (1) should be greeted with dismay by families.

As should the decision not to increase pesticides residue surveillance, also recommended by the Safe Food Campaign.

But Kiwis don’t know this, as mainstream media did not think these decisions were worth reporting.

These decisions directly impact families. Many pesticides cause cancer, endocrine disruption and impact gut health. They contribute to the tipping point that sends many New Zealanders into the chronic disease crisis we witness today. Yet this message is blanked out.

The New Zealand EPA approves use of pesticides like Roundup on human and animal food using studies only supplied by the same corporations that sell the pesticides to prove safety. Pesticide use on food has escalated in the last decade.

The Safe Food Campaign reported in their (ignored) press release ‘Pesticides were found in over 30% of baby food samples in the last Total Diet Survey in 2009. Ms White contrasted this to the EU: “New Zealand baby food had 533% more pesticide residues. The EU had an average of less than 6% of baby food samples positive for pesticide residues over 6 years.”

Studies that give us our pesticides ADI –acceptable daily intake – are carefully selected by pesticides corporations. They’re ancient, unpublished and unavailable for review by health specialists. Monsanto’s 1981 Lankas study gives us NZ’s ADI, with tumours at the same levels the corporate paid toxicologists declared safe.

Our EPA is yet to consider the WHO/IARC condemnation of glyphosate as a probable carcinogen.

Testing does not include testing for Roundup. Twenty years ago, Roundup was only applied to soil rather than directly applied to staple foodstuffs.  New Zealand does not test for this most heavily used pesticide in our National Dietary Survey, Groundwater Survey or Chemical Contaminants Program. Risk assessment failure 101.

The system is broken. We need more testing. More research.

No pesticide corporation will fund research assessing gut health of mammals consuming fungicides, herbicides and insecticides. Nor will the food industry.

Where is funding to assess benefits of an organic diet versus families on a conventional food diet – to help understand how sickness and disease may be related to dietary chemical loads? We need financially independent science to understand this.

Many people try to eat organic or sprayfree. But the poorest can’t afford this. Conventional food must be safe. 

We have a situation where government has permitted increased levels of Roundup on our food, but advise consumers they cannot afford to test for Roundup.

Let’s acknowledge that the NZ EPA does not have resources to independently assess all chemicals in food, and that every pesticide approval is based only on the studies carefully selected by the corporation seeking to sell that chemical. Let’s understand that chronic disease is out of control, our children are sicker than ever, and depression is escalating. 

Do you think we should allow pesticides in baby food?

 

Reference

(1) COMMISSION DIRECTIVE 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC.

Article 10
1.   Infant formulae and follow-on formulae shall not contain residues of individual pesticides at levels exceeding 0,01 mg/kg of the product as proposed ready for consumption or as reconstituted according to the instructions of the manufacturer.

Mums say Food Matters but Governments & Regulators hooked on industry science.

Motherly momentum is on the rise. Mothers seeking healthy children are challenging food safety, and the close ties between the companies who sell crop seed and pesticides and governments and agencies who approve of these products.

Illness suffocates, exhausts, and disables. When it arrives, the only option is to learn, fight and regain your life.  It’s a bottom line kind of thing. Happiness and health are ancient bedfellows.

Today’s non-communicable disease levels have surged beyond levels held by our grandparent’s generation. Today’s incidence levels extend beyond genetic predisposition to disease. Here in New Zealand, illnesses have a similar profile to growing disease loads in Australia, the USA and UK. Strikingly, a considerable proportion of these illnesses have a common co-factor: the presence of a permeable gut before onset of disease.

At the heart of complexity is simplicity. The digestive system is the bodily system with greatest exposure to toxins. There are multiple routes of exposure – but primary exposure is via food (except for people working directly with particular toxins, such as farm or factory workers). 

When families seek help to heal, they ask doctors, they research and information share. Frequently, they learn how a sick gut effects them. It (a) can’t process nutrients properly due to reduced microbiological activity; and (b) becomes permeated, letting unprocessed food particles through the gut barrier into the bloodstream. These families learn how bodies set up an immune response to a foreign invader – leading to the allergic and other autoimmune responses they live with. Leading to mental health problems and/or depression in the people they love. This learning curve is repeated in countless households.

Food matters. Gut health is critical to our wellbeing. As clinical psychologist Julia Rucklidge explains ‘It’s not ‘we are what we eat’ – it's - ‘we are what we absorb.’  Today there is a subtle but determined shift to real food, to higher nutrition organic, or spray free – and an avoidance of the chemicals that are frequently stored as toxins in our bodies. There are a panoply websites discussing 'real food',  gut restoration and remission from immune related disease. We see distrust of the ‘food system’ and increasing cynicism regarding how our governments view ‘food safety’. What’s behind this?

Close ties between industry and regulatory agencies

Connect the dots and you build a picture. International and government regulatory agencies favour some (frequently private, corporate) studies over others, which they use to support their assessments and approve of pesticides and GMOs in food. While in a parallel universe families and medical communities witness a tsunami of gut related illness which have direct links back to food quality. Evidence that pesticides and modern crop varieties, including GMOs, are contributing to this tsunami is frequently shouted down or ignored. Furthermore, public funding to pull together a picture of gut related health statistics related to toxicity and nutrition across these many related illnesses is as rare as rocking horse shit (if you’ll excuse the slang).

It’s a three monkey’s management system that many believe has contributed to a broad swathe of disease. Close ties between governments, regulatory agencies and corporations have enabled suppliers (of crop seed and pesticides) to help mould safety standards and influence regulators while providing their own studies to facilitate approval of their own products. Conflicts of interest? Most certainly. At the core of much of the GM debate is the assumption that the genetically modified products are substantially equivalent to naturally bred products (except when it comes to applying utility patents and licensing agreements, of course). Wedded to this is a flat refusal to conduct independent long term feeding studies. Important? Undeniably.

If mothers can understand that nowhere in the world are long term feeding studies held by our governments - testing the GMO food (whether natural or processed into the familiar soy or vegetable oil based foods littering supermarkets) critically, in combination with the regime of pesticides sprayed on it throughout the growing season.  If families understand that simple fact, they will understand how broken our governments are, when it comes to protecting our children and our health. And our broken regulatory agencies dismiss or ignore the only study that did this, by a scientist whose PhD was on carcinogens (a study of pollutants in food which cause pathologies dependent on sexual hormones). Who was working in the public interest.

Even in countries with a no-GMO policy like New Zealand and the U.K., you will find GMOs in canola and soy based products, as regulatory agencies may ignore GM if it is below (a) a certain level in the food, or (b) if the product is processed to remove the GMO DNA. But where is the testing confirm this? It simply doesn’t exist.

Take it a step further and understand that it is only the active chemical in the pesticide formulation (frequently sprayed on our food crops) that is assessed. The studies that prove safety and give us our ADI/RfD for these chemicals are seller sponsored, ancient and unpublished.  Recent scientific studies show that the other additives (adjuvants) in the complete pesticide formulation (for example Roundup or Confidor) can be over a >1000 times more toxic than the active chemical. Yet these ingredients are usually ignored by regulators. Imagine only testing one ingredient of a cigarette. Or consider testing the brakes of a car by removing them from the car rather than testing their ability to stop the car in which they are installed.

Then ponder that Roundup, applied to 90% of GMO crops, but can also be sprayed, confrontingly, on sugar cane, oats, barley, wheat, lupins etc – yet is rarely tested in our food supply. This represents without doubt, absolute failure of due diligence by our governments, particularly now the toxin is considered a probable carcinogen. Getting Roundup off gardening shelves is one thing, but the elephant in the room is the fact that the junk is sprayed directly on a considerable proportion of our staple food.

It’s as if governments, industry and influential scientific groups are sticking their fingers in their ears, screwing their eyes shut and going ‘LaLaLaLaLaLaLaLaLaLaLaLaLaLa’.

Desperate times create desperate measures

Would families prefer a more robust system, with greater transparency in research and better regulation?  Without doubt.

Food safety, or lack of it, is what parents understand, either intellectually or intuitively. Pro-industry bloggers may poke fun, marginalise, ‘out’ and vilify the scientists and writers who talk about food safety, pesticides and GMOs in our diet. However, mothers are starting to understand the network of financing and self-interest that frame the conversations of these individuals. Of course, bloggers don’t have to meet the same standards as those who publish in the peer reviewed literature, nor professional journalists who have obligations to be fair.

Mothers like the indefatigable Zen Honeycutt and Robyn O’Brien; courageous scientist-interviewing mothers on GMO Free News and in the UK, Sally Beare a nutritionist and member of UK based Mums Say No to GMOs are speaking up to tell the story of how industrial corporations unite with governments to claim ‘it’s OK, we don’t need to do long term testing of these soy, corn, canola and cotton oil products in your supermarket convenience food’. These people also look darkly at governments that say ‘pesticide levels in baby food are safe because we subscribe to World Health Organisation standards’. Perhaps they know that the WHO only use hidden, decades old corporate studies to establish our ‘safe’ pesticide residues levels, our RfD or ADI. However it is not just the WHO. It's the EPA, APVMA, EFSA, NZ EPA, FSSAI, ANVISA etc. etc..  No full formulation studies, no independent science and no testing of Roundup in our food.*  These agencies all fail when it comes to due diligence and food safety of pesticides and GMOs.

For mothers with sick kids, when symptoms don’t go away, or new ones arrive, change becomes the only option. Relapses, different symptoms, heightened allergic responses occur but family distress stays the same. That’s when (frequently) mothers look up and wonder what’s going wrong. What is causing this? So then they ‘go organic’. Go to the ‘dark side’.  Frankly, many parents who purchase organic now wouldn’t have dreamt that they would change age old purchase habits.

Corporations and bloggers can marginalise and ridicule these actions as ‘unscientific’.  These groups respond with ‘bring me the research money’. Mothers like don’t necessarily want to become political animals. They just want a happy healthy family and a stimulating life. Sickness and sick kids make you look at the world differently, and when change works for you, you want to tell the world.

Scientific deficit not science denialism

Illness isn’t left or right. Illness doesn’t have political allegiances. Growth in disease with permeable gut must exist on both sides of the spectrum. It’s interesting to ponder. I want to ask bloggers that lash out the hardest against those that are simply asking for more cautious science, less chemicals in food, how their bowel movements are.

Who gets the most whip lashing? Mainly scientists who go to the trouble of publishing their research in international journals following rigorous anonymous peer review. These scientists are usually unaligned with either industry or science professional groups. Industry and professional societies can extract explicit or subtle demands on scientists to conform. If they don't, they face a barrage of accusing and negative publicity, denigrating their work or making it difficult for them to publish. These quietly determined scientists, including Professor SeraliniDr Arpad PusztaiProfessor Don Huber, and Dr Judy Carman (and more) from all corners of the world are building a picture of the hazardous effects of the genetically engineered crops and pesticide-laden food consumed globally. Scientists are also providing convincing evidence that pesticides destroy our health, and the effects are completely under estimated as long as the full formulations avoid scrutiny.  

Dr Meriel Watts has intensively researched the ways pesticides act as endocrine disruptors, carcinogens, and create systemic havoc in children in her paper Poisoning our future: Children & Pesticides. Her research is ignored by her government …. Even when she describes the knock on effects of citizens which include lower IQ’s (and their reduced tax paying potential – writers note).

These scientists are asking for more research, more science. So too are mums and dads. These people are not the science deniers.

This scientific deficit has created a perfect storm of illness, suffering and anxiety.

How do I know that there is a paradigm shift in how mothers care for their families? It’s all in the money. There’s a spending shift. The compound annual growth rate of organics are exploding at between 12 and 16% for the world.

Right now – with government regulatory failure, in every country, conventional food is not safe. However not everyone can afford organic. The system is broken.

Mums know that food matters.  Conventional food must be safe. In Asia, Europe, the Americas – for every family throughout this world.

Bring it on.

Great links to mother based groups (email RITE to add to this) :

Mums Say No to GMOs UK

MADGE Australia

Moms Across America

Moms Across Canada

 

*US EPA tests soybeans and EFSA requires testing of cereals for glyphosate.

Canadian Families PLEASE Submit to Health Canada Before 11 JUNE!

Proposed Re-evaluation Decision PRVD2015-01, Glyphosate
Pest Management Regulatory Agency 13 April 2015
ISSN: 1925-0967 (PDF version) Catalogue number: H113-27/2015-1E-PDF

Appendix IIa Registered Commercial Class Uses of Glyphosate in Canada


Canadian mothers!  –Health Canada has given you 60 DAYS to respond to the document:

Proposed Re-evaluation Decision PRVD2015-01.  

PLEASE USE THE FOLLOWING INFORMATION & THE LINKS BELOW TO SUBMIT INFORMATION!


The most important thing you can tell Health Canada – is current risk reduction measures are not sufficient. You don’t want glyphosate sprayed on your children’s food. At all.
This includes animal feed that is then turned into meat and dairy products that your children eat. This includes any product that is used to manufacture infant formula.

The current re-evaluation is FAULTY because it doesn't look at recently released science.

The re-evaluation states: 'An evaluation of available scientific information found that products containing glyphosate do not present unacceptable risks to human health or the environment when used according to the proposed label directions'.

Health Canada you only evaluated scientific information provided by the registrant - the chemical company. That is NOT all the available scientific information. You are not properly evaluation the risks to human health and the environment.

Health Canada dismisses the IARC findings. Health Canada states: 'The World Health Organization’s (WHO) International Agency for Research on Cancer (IARC) recently assigned a hazard classification for glyphosate as “probably carcinogenic to humans”. It is important to note that a hazard classification is not a health risk assessment. The level of human exposure, which determines the actual risk, was not taken into account by WHO (IARC). Pesticides are registered for use in Canada only if the level of exposure to Canadians does not cause any harmful effects, including cancer. '

1. Health Canada, you can't know the risk because you don't look at recently published studies.

2. Health Canada, you don't know the level of exposure because you don't test glyphosate in food - not in dairy, fruit and vegetables, meat and cereals. Your only testing is private crop testing, this does not reflect what our children are exposed to every day.

3. Health Canada, by ignoring 21st Century science you refuse to acknowledge the damage done to our children's gastric, endocrine and neurological systems, you refuse to look at toxicity of glyphosate based herbicides in relation to cancer - you are failing Canadian children and families.

NOTE: All the studies used by Health Canada to establish are supplied by the registrants - applicants - chemical companies. RITE revieiwed the original Re-evaluation document - Page 250:

B. Studies Considered for the Toxicological Hazard Assessment  
LIST OF STUDIES/INFORMATION SUBMITTED BY REGISTRANT

The studies are all OLD INDUSTRY toxicity studies - these are the studies that say 'glyphosate is safe' - Health Canada is hiding behind private, unpublished, old industry (the critical studies giving us our ADI/RfD dated between 1970-2001) studies and ignoring the published recently released studies that demonstrate that glyphosate based herbicides are dangerous at the levels we consume. These old studies, even if they are also used by the WHO, US EPA and Europe, are all private, unpublished corporate paid studies - they are last century's science. 

NOTE: Health Canada doesn't want to hear from you. They don't want you to tell them they need to change their ways, that the current status of the re-evaluation document is flawed and not scientific because it only uses SELLER SPONSORED SCIENCE to establish glyphosates 'low toxicity' and that what they are doing is unsafe for your children.


Follow their questions as below as a guide - or submit your own content BEFORE 11 JUNE.


Here is the comment form – with spaces for comment (up to 20 lines) : 
(If on Google Chrome download and then email)


3. Science-based comment on health?


a. Health Canada's dismissal of the IARC findings is not science based and fails Canadian families.

WHO IARC Glyphosate Monograph Vol 112


b. The full formulation of glyphosate based herbicides are significantly more toxic to human cells. Major Pesticides Are More Toxic to Human Cells Than Their Declared Active Principles. R. Mesnage et al 2014.

c. Your  re-evaluation of glyphosate fails to take into account its action as an endocrine disruptor at  low levels:
1. Glyphosate alone acts as an estrogen substitute (xenoestrogen) in human hormone-dependent breast cancer cells, stimulating growth at minute concentrations as low as 10-12 (1ppt) Thongprakaisang et al 2013
2. A 24h exposure to a concentration of Glyphosate (in Roundup) at 0.72mg/L caused significant cytotoxicity in vitro. Young et al 2014
3. Glyphosate formulation diluted in water at 1ppb caused severe organ damage, endocrine tumours & pituitary tumours. Seralini et al 2014 republished study.

d. Health Canada is failing to consider the sustantial costs incurred as a result of endocrine disruption: Expert panels achieved consensus at least for probable (>20%) EDC causation for 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 Journal of Clinical Endocrinology and Metabolism, 2015, 100(4):1245-55. doi: 10.1210/jc.2014-4324. Epub 2015 Mar 5. As a chelator glyphosate action in soil reduces nutrient availability in our food.

e. Accepted Operator Exposure Levels (AOELs) are outdated and unsafe. They are private unpublished studies from the 1980s and 1990s, this is not good enough.


f. Glyphosate use on human food, including cereals, oilseeds, legumes and vegetables; and animal feed including grains, pasture and silage should be immediately suspended due to toxicity & EDC at low levels.


4. Do you have any science-based comment on the environment?


Environmental and agronomic effects of glyphosate focus mainly as its actions as a chelator of minerals and its contribution to soil degradation - reducing availability of micronutrients, nitrogen, microbial activity. 

Effects on soil, crop and plant health: glyphosate use is associated with increase in plant disease. Glyphosate harms soil microbes, reduces nutrient availability. As a chelator of critical metals and micronutrients, glyphosate also then negatively impacts plant enzymes which are vital in the plants immune system. This can lead to increased plant disease. (Professor Don Huber) (Eker, S et al 2006) 

 Populations of micro-organisms that suppress disease-causing fungi have been found to decrease in soils treated with
glyphosate (Kuklinsky-Sobral J et al 2005) Glyphosate can damage beneficial macro and micro organisms. (Professor Don Huber)

Glyphosate has been shown to interfere with the uptake of essential minerals in agricultural crops leading to nutritional deficiences in human populations (Zobiole LHS et al 2011a) Glyphosate has been shown to reduce nitrogen fixation of plants. (Zobiole et al 2009 doi:10.1016/j.apsoil.2009.12.003)

Diseases of livestock: Scientists and veterinarians are documenting increased infertility, nutrient deficiencies, frequently connected to manganese deficiency. Problems include high levels of stillbirths and birth defects, abnormal bone formations. (Huber) (Kruger et al 2014) (H.Vleiger)

Health Canada cannot properly assess the impact of glyphosate if it only assesses science provided by the registrant.

5. Do you have any comment on the value?

Healthcare burden of these conditions listed in Comment on Health - among the European population, and concluded that EDCs are likely responsible for some 150 million Euros, or 200 billion dollars, in healthcare expenses.
The economic burden and suffering as a result of disease including inflammatory illness, autoimmune conditions and some cancers arising from glyphosate based herbicides is considerable. Science is demonstrating that the health burden of glyphosate desiccation on our food resulting in the levels the Canadian population is exposed to, far outweighs the perceived economic advantages from applications of this endocrine disruptor and carcinogen to Canadians food.

Health Canada currently ignore the impact of glyphosate as an endocrine disruptor and xenohormone, and therefore ignore the burden of health cost.

Furthermore, Health Canada, by dismissing the independent IARC findings ignores the demonstrated toxicity of glyphosate as a probable carcinogen. Health Canada may be aware of original industry studies from the 1980's and 1990's that dismiss tumours at the level declared safe. Atkinson et al 1993b. Lankas & Hogan 1981.

Current exposure levels do not achieve value to the Canadian population - they represent increased chronic disease, endocrine disruption, cancer and result in systemic soil degradation. 

Use of glyphosate based herbicides represent a severe cost that is to date, ignored by all governments and regulatory authorities that choose to select seller sponsored science for risk assessment of toxic pesticides.

6. Please provide us with an overview of your opinion and additional comments?

At this stage Health Canada, in its review of glyphosate, appears to be only considering seller sponsored science, science put forward by the applicants, the pesticides corporations. 

Health Canada are not considering recently released, published peer reviewed science regarding glyphosate that demonstrates its action as an endocrine disruptor, posing considerable harm at extremely low levels (parts per trillion). Current exposure levels are unsafe. The excuse that Health Canada does not consider the IARC findings because 'level of human exposure, which determines the actual risk, was not taken into account by WHO (IARC)' is scandalous. As of this date Health Canada does not consider science independent of corporations, nor does the Canadian Food Inspection Agency test for glyphosate in food produced for Canadian families. Old outdated, industry science gives you the excuse to not test the food of Canadians, not to consider recently published science, and not to consider the health costs as a result of glyphosate's considerable toxicity - this is scandalous and reprehensible.

FURTHER CRITICAL CONCERNS REPORTED BY PUBLIC INTEREST ENTERPRISE:

'Feds Plan to Rubber Stamp Glyphosate, which is “Probably Carcinogenic to Humans”, by Skewing the Risks to Children and the Environment'.

HANDY LINKS, REFERENCES & INFORMATION FROM:

GMO Free USA: Glyphosate studies.

ISIS:  Institute of Science in Society Special Report 10/10/12 Why Glyphosate Should Be Banned

GMO Myths & Truths: 4.2 Myth: Strict regulations ensure we are only exposed to safe levels of Roundup

www.thesparc.net : web resource that providing free open access for scientists and the general public to scientific papers.

FOE Europe: The environmental impacts of glyphosate Friends of the Earth Europe, June, 2013

 

USDA doesn't test for Roundup. #healthcrisis

No-one in the USA tests for glyphosate residues in food before the food hits our mouths.  Maximum residue levels establish how much glyphosate is allowed on food, but no-one actually checks these levels.

To quote a USDA employee: "Glyphosate was not tested on any commodity in the Pesticide Data Program (PDP) 2010 Survey.  The 2011 PDP Annual Summary, which should be published in early 2013, will show glyphosate findings for soybeans."

Soybeans?  That's all?  Noting that in the last 8 years the residue limit for pasta and bread (wheat) has been increased to higher levels than for GMO foods like soybeans.

Glyphosate used to be expensive to test for. But not any more. As a result of 9/11 and the toxic dusts that enveloped the site, the US government placed a priority on developing extremely good toxin testing machines that could detect traces of chemical and toxic residues to parts per trillion. So today consumers can test.

So why has it not been important to test for glyphosate on food?

The really, really limited research studies (for example in the areas of reproductive and developmental toxicity, and the carcinogenicity studies used to establish the ADI/RfD), are selected and supplied by Monsanto and big agrichemical organisations like Syngenta and Cheminova. So we have 25-35 year old secret, unpublished studies declaring safety of glyphosate at the levels we are exposed to.

The EPA doesn't really look at the results of independent science (searchterm: glyphosate) that work in the public interest and look at toxicity at residue levels at the levels we actually consume.

Therefore companies like Monsanto control the critical studies used for establishing the ADI/RfD, and, as a result, our government considers that glyphosate is not really that toxic. It's fine!  Perhaps consider the last time the USDA assessed glyphosate in the 1993 Reregistration Elegibility Decision , refer to Appendix C and review the names of who put forward the studies.

Monsanto and Co. dominate the submissions, followed by Ciba-Geigy, and then possibly less than 2% of submissions are from other parties.  Imagine if the tables were turned, there was a industry fund that resulted in another independent organisation, acting in the interest of the American (and global) public putting forward the studies without the self interest of potential profits.

Perhaps the USA would be monitoring glyphosate more closely.

The EPA is currently reassessing glyphosate, called the Glyphosate Reregistration Review.  It is critical they review independent studies undertaken in the public interest by scientists and organisations with no financial interest in the result.

To find out about what pesticides the USDA does actually check for, visit the Agricultural Marketing Service or download the actual The 2013 Pesticide Data Program Annual Summary (2013 most recent). Only soybeans.

(Press ‘control+f’ to  search for glyphosate, the most widely used pesticide in the USA.)

Unfortunately - this has a domino effect which can cultivate and excacerbate public misinformation. The Environmental Working Groups well written paper 2015 Shopper's Guide to Pesticides in Produce pulls its information from the USDA PDP summary. But because the USDA PDP doesn't consider glyphosate, we are missing the full picture. The 'Dirty Dozen' and the 'Clean Fifteen' don't give us a broader picture. The EWG and the American public therefore have no idea of Roundup/glyphosate levels in our bread, milk, convenience foods and other staples in modern American diets. I wish someone would whizz McDonalds fries and hamburgers and put them through a glyphosate detection test. A minimum standard should be Single Residue Methods (EURL-SRM) LC-MS/MS. Many testing labs use old equipment so you really need to know. 

People, it is so much more than fruit and vegetables..

This is why we need clever startups like Feed the World - doing what our governments are failing to do. These are great platforms to pressure failing, inept governments and regulatory authorities, and they help change the power base in favour of parents and kids. Because that's who should have the power to limit toxins in food.

Demand your bread is tested, for glyphosate.  Understand what fungicides and insecticides are commonly sprayed on your bread. Testing for abstract fungicides that were commonly used 10 years ago is failure. It is time we were looking at our food staples right across the spectrum, not just fruit and vegetables. It's about understanding that conventionally produced food cannot be safe for our kids as long as the companies control the studies.

Because our governments are not testing for the true elephant in the room.

 

USDA Agricultural Marketing Service. Science and Technology Program. Pesticide Data Program. Annual Summary. Calendar year 2013. Released December 2014.

Regulatory history of glyphosate carcinogenicity reviews in USA

Of course Monsanto is unimpressed with the IARC classification of glyphosate as a probable carcinogen.  And for good reason. To date Monsanto has submitted nearly every study used by the US EPA to decide glyphosate's carcinogenicity rating. For decades.  Perhaps it is time the IARC, the US EPA and the European Union (and my own country New Zealand) looked at studies other than studies selected by the same corporation that sells the product.

Back in 1985, glyphosate was declared a Class C carcinogen. Why and how did it change?

Carcinogenicity assessments to date appear to include only pesticide company directly-funded studies submitted by the company. I believe that Monsanto has submitted every study.  

NB: When I started documenting glyphosate regulatory assessment and toxicity studies the EPA 1993 Glyphosate Reregistration Eligibilty Decision (RED) document was freely available on the net including references and data for all studies. In the past year it has been removed. Here is a PDF link.

These assessments conveniently exclude a broad swathe of independent studies by scientists working in the public domain. And they never, of course, study the full solution, or formulation, of Roundup.

Very few studies have been used to establish the classification of Group E - non-carcinogenic.  A very small pool to establish this status for the USA population of 314 million people. Please feel free to demand the original documents from the EPA to confirm this.

There are significant effects dismissed - these studies should be publicly released for transparent consultation & peer review by independent scientists.

4 March 1985 :

Toxicology Branch Ad Hoc Committee, comprised of members of the Toxicology Branch of the Hazard Evaluation Division.  The Committee in a consensus review dated 04-MAR-1985 classified glyphosate as a Group C Carcinogen based on an increased incidence of renal tubular adenomas in male mice. According to the consensus review, the tumour is rare, it occurred in a dose-related manner, and the incidence was outside the reported historical control range. The Committee also concluded that dose levels tested in a 26 month rat feeding study were not adequate for the assessment of glyphosate’s carcinogenic potential in this species.

Knezevich, A.; Hogan, G. A chronic feeding study of glyphosate (Roundup technical) in mice. Unpublished Report no. BDN-77420, project no. 77-2061, 1983, submitted to U.S. Environmental Protection Agency by Monsanto Company, prepared by BioDynamics, Inc. Reregistration Eligibility Decision (RED) Glyphosate; EPA-738-F-93-011; U. S. Environmental Protection Agency, Office of Prevention, Pesticides, and Toxic Substances, Office of Pesticide Programs, U.S. Government Printing Office: Washington, DC, 1993.  MRID 00130406

McConnel, R. A chronic feeding study of glyphosate (Roundup technical) in mice: pathology report on additional kidney sections. Unpublished project no. 77-2061A, 1985, submitted to U.S. Environmental Protection Agency prepared by BioDynamics, Inc. Reregistration Eligibility Decision (RED) Glyphosate; EPA-738-F-93-011; U. S. Environmental Protection Agency, Office of Prevention, Pesticides, and Toxic Substances, Office of Pesticide Programs, U.S. Government Printing Office: Washington, DC, 1993.Study:  MRID 00150564

Further content Pp 5 & 6.

Extract from the EPA 1993 Glyphosate Reregistration Eligibilty Decision (RED) P.14 : This is the study that decided the classification of Group C Carcinogen - though it is unclear as it appears under 2 study authors (as above):

A carcinogenicity study in mice was conducted with CD-1mice fed diets containing 0, 150, 750 or 4500 mg/kg/day of glyphosate for 18 months. No effects were observed in the low-doseand mid-dose groups. The following findings were observed in thehigh-dose group: (1) decreased body weight gain in males and females; (2) increased incidence of hepatocellular hypertrophy, hepatocellular necrosis and interstitial nephritis in males; (3)increased incidence of proximal tubule epithelial basophilia and hypertrophy in females; and (4) slightly increased incidence of renaltubular adenomas, a rare tumor, in males. Based on these effects,the systemic NOEL and LOEL were 750 mg/kg/day and 4500mg/kg/day, respectively. The Agency concluded that the occurrenceof these adenomas was spontaneous rather than compound-induced because the incidence of renal tubular adenomas in males was not statistically significant when compared with the concurrent controls. An independent group of pathologists and biometricians alsoconducted extensive evaluations of these adenomas and reached the same conclusion. Therefore, glyphosate was not considered to be carcinogenic in this study.  (MRIDs 00130406, and 00150564End extract.

McConnel, R. (1985) A Chronic Feeding Study of Glyphosate (Roundup Technical in Mice): Pathology Report on Additional Kidney Sections: Addendum to Final Report Dated July 21, 1983: Project No. 77-2061A. Unpublished study prepared by Bio/dynamics Inc. 59 p. MRID 00150564 (Bio/dynamics studies are usually Monsanto paid)

24 Feb 1986:

The kidney slides from the long-term mouse feeding study were subsequently re-examined by several pathologists, and one pathologist diagnosed an additional kidney tumour in the control males. These findings were presented to the FIFRA Scientific Advisory Panel (SAP) which proposed glyphosate be classified into Group D (inadequate animal evidence of carcinogenic potential).  The SAP in their meeting of 11/12 FEB-1986 (report dated 24-FEB-1986), concluded that, after adjusting for the greater survival in the high dose mice compared to the concurrent controls, no statistically significant pairwise differences existed, although the trend was significant.  The SAP further noted that, although comparison of these findings to historical incidences yielded a statistically significant result, this finding did not override the lack of pairwise significance of comparisons to concurrent controls.

The SAP determined that the carcinogenic potential of glyphosate could not be determined from existing data and proposed that rat and/or mouse studies be repeated in order to clarify these equivocal findings.  A new 2 year rat study was performed up to the limit dose of 20,000 ppm. (Stout & Ruecker 1990)

Information:  EPA Memorandum date 17 August 2000 : Glyphosate in/on Alfalfa hay and forage; Field corn forage; Stover and straw of the cereal grains crop group; numerous minor crops; and flax in Northern Dakota. HED Risk Assessment. Page 6.

Information repeated: 30 October 1991 - US EPA Second Peer Review of Glyphosate. Memorandum 1071-83-6.  P.3/4

26 June 1991 - Second Peer Review:

The Health Effects Division (HED) Carcinogenicity Peer Review Committee (CPRC) convened on 26-JUN-1991 to discuss and evaluate the weight of the evidence on glyphosate with particular emphasis on its carcinogenic potential. The Committee concluded that glyphosate should be classified as a Group E chemical (evidence of non-carcinogenic to humans), based upon a lack of convincing carcinogenicity evidence in adequate studies in two animal species.

As part of their consideration the CPRC examined data on the following tumours observed in the second rat study: pancreatic islet cell adenomas in males, thyroid C-cell adenomas and/or carcinomas in males and females, and hepatocellular adenomas and carcinomas in males. None of them were considered to be biologically significant. As for the mouse study, the CPRC concluded that the renal tubular neoplasms in high dose male mice were not compound-related due to the lack of pairwise significance and the lack of pre-neoplastic kidney lesions in males.

This is discussed in a Cornell University paper:

This classification is based on the following findings: (1) None of the types of tumors observed in the studies (pancreatic islet cell adenomas in male rat,thyroid c-cell adenomas and/or carcinomas in male and female rats, hepatocellular adenomas and carcinomas in male rats, and renal tubular neoplasms in male mice) were determined to be compound related; (2) glyphosate was tested up to the limit dose on the rat and up to levels higher than the limit dose in mice; and (3) there is no evidence of genotoxicity for glyphosate. Accordingly, EPA concludes that glyphosate has not been "found to induce cancer when ingested by man or animal." 21 U.S.C.348(c)(3).

Memorandum 30 October 1991 - Second Peer Review of Glyphosate (thank you www.momsacrossamerica.com for retrieving this paper).

Memorandum 1071-83-6

D. Evaluation of Carcinogenicity Data. (Second Peer Review)

1. Lankas, G.R.; Hogan, G.K. (1981) A Lifetime Feeding Study of Glyphosate (Roundup Technical) in Rats: Project No. 772062. (Unpublished study received Jan 20, 1982 under 524-308; prepared by Bio/dynamics, Inc., submitted by Monsanto Co., Washington, D.C.; CDL:246617-A; 246618; 246619; 246620; 246621)   MRID 00093879

Groups of 50 male and 50 female Charles River Sprague-Dawley rats were fed technical glyphosate in their diets at dose levels of 3, 10,or 31 mg/kg b.w./day (males) and 3.4, 11, or 34 mg/kg b.w./day(females) for approximately 26 months.

Discussion of Tumor Data: An increase in the incidence of interstitial cell tumours of the testes was observed in male rats. Because of the absence of a dose-response relationship, the lack of preneoplastic changes, the wide variability in the spontaneous incidence of this tumor, the the similarity in incidences between the high-dose group and the historical controls, and lack of any evidence of genotoxicity, it was concluded by the previous Peer Review Committee that the observed incidence did not reflect a carcinogenic response.

Additionally, there was the question of possible thyroid carcinomas in high-dose females. After a review of the slides by a consulting pathologist, and a reassessment of all relevant data, including the fact that no effect of the treatment on timor latency of the combined incidences of adenoma and carcinoma was apparent, the earlier Peer Review Committee concluded that the data did not demonstrate a carcinogenic response in the thyroid.

Further reading Second Peer Review page 5.

  1. Incidence of tumors of the testes dismissed, primarily because no dose response relationship. Effects on the thyroid dismissed. (EDC?)

2. Stout, L.; Ruecker, F. (1990) Chronic Study of Glyphosate Administered in Feed to Albino Rats: Lab Project Number: MSL- 10495: R.D. 1014. Unpublished study prepared by Monsanto Agricultural Co. 2175 p.    MRID 41643801 (The study 41643801 continued for 2 years - this review is half way through the study) 

This chronic toxicity/carcinogenicity study in the rat was submitted to the Agency as a replacement study for the 26 month 1981 chronic toxicity/carcinogenicity study in the rat. In this study randomised groups of 60 male and 60 female young (8 weeks old) Sprague Dawley rats were fed dietary levels of 0, 2000, 8000, or 20,000 ppm or the equivalent of 0, 100, 400, and 1000 mg/kg/day of technical glyphosate for 2 years. At 12 months 10 animals sex/group were sacrificed.

Discussion of Tumor Data: Age adjusted statistical analyses of the tumor data are presented. The most frequently observed tumors in this study were pancreatic islet cell adenomas in males, thyroid C-cell adenomas and/or carcinomas in males.  Further reading Second Peer Review tumor type page 5-13.

  1. It appears these rats were not dosed until 8 weeks old - adult - doesn't that miss a vital development gap?
  2. The results are unclear - I cannot see the results of the 20 animals sacrificed at 12 months?
  3. Committee interpretation: Dismiss incidences that exceed historical control range. Dismiss effects where no dose related trend. Declare not compound related. How? (pp 7 & 8) (EDC?)

3. Hogan, G.K. (1983). A chronic feeding study of glyphosate in mice. Unpublished report prepared by Bio/Dynamics Inc., dated July 21, 1983. Report No. 77-2061. EPA Acc. Nos. 251007-251009, and 251014.

Also referred to as: Knezevich, A.L. and Hogan, G.K. (1983) A Chronic Feeding Study of Glyphosate (Roundup technical) in Mice: Project No. 77-2061. (Unpublished study received Aug. 17, 1983 under 524-308; prepared by Bio/dynamics, Inc., submitted by Monsanto Co. Accession #251007-251014  MRID 130406

Groups of 50 male and 50 female CD-1 mice were administered glyphosate in the diet at concentrations of 1000, 5000 or 30,000 ppm for 18 months. Glyphosate produced an equivocal carcinogenic response in males characterised by an incidence of renal tubular neoplasms of 1/49, 0/49, 1/50 in the control, low, mid, high dose groups respectively.

Extract from the EPA 1993 Glyphosate Reregistration Eligibilty Decision (RED) P.14: A carcinogenicity study in mice was conducted with CD-1 mice fed diets containing 0, 150, 750 or 4500 mg/kg/day of glyphosate for 18 months. No effects were observed in the low-dose and mid-dose groups. The following findings were observed in the high-dose group: (1) decreased body weight gain in males and females; (2) increased incidence of hepatocellular hypertrophy, hepatocellular necrosis and interstitial nephritis in males; (3) increased incidence of proximal tubule epithelial basophilia and hypertrophy in females; and (4) slightly increased incidence of renal tubular adenomas, a rare tumor, in males. Based on these effects, the systemic NOEL and LOEL were 750 mg/kg/day and 4500 mg/kg/day, respectively. The Agency concluded that the occurrence of these adenomas was spontaneous rather than compound-induced because the incidence of renal tubular adenomas in males was not statistically significant when compared with the concurrent controls. An independent group of pathologists and biometricians also conducted extensive evaluations of these adenomas and reached the same conclusion. Therefore, glyphosate was not considered to be carcinogenic in this study. (MRIDs 00130406, and 00150564) End Extract.

Further reading Second Peer Review including extensive discussion tumors pp 13-15.

E. Additional Toxicology Data on Glyphosate (Second Peer Review)

1. Metabolism

Ridley, W.; Mirly, K. (1988) The Metabolism of Glyphosate inSprague Dawley Rats--Part I. Excretion and Tissue Distribution of Glyphosate and Its Metabolites following Intravenous and OralAdministration: Laboratory Project No. 86139 (MSL-7215): R.D.No. 877. Unpublished study prepared by Monsanto Co. 587 p.

Howe, R.; Chott, R.; McClanahan, R. (1988) Metabolism ofGlyphosate in Sprague-Dawley Rats. Part II. Identification,Characterization, and Quantitation of Glyphosate and ItsMetabolites after Intravenous and Oral Administration:Laboratory Project No. MSL-7206: R.D. No. 877. Unpublished study prepared by Monsanto Co. 155 p.

2. Mutagenicity - there are no references - however these are the studies held with the US EPA RED 1993 for mutagenicity.

Kier, L.D.; Flowers, L.J.; Hannah, L.H. (1978) Final Report onSalmonella Mutagenicity Assay of Glyphosate: Test No. LF-78-161.(Unpublished study received Apr 25, 1979 under 524-308; submitted by Monsanto Co., Washington, D.C.; CDL:238233-B)  MRID 00078620

Li, A.; Kier, L.; Folk, R. (1983) CHO/HGPRT Gene Mutation Assaywith Glyphosate: EHL Study No. ML-83-155. Final rept. (Unpublished study received Nov 15, 1983 under 524-308; submitted by Monsanto Co., Washington, DC; CDL:251737-B) MRID 00132681

Li, A.; Kier, L.; Folk, R. (1983) In vivo Bone Marrow Cytogenetics Study of Glyphosate in Sprague-Dawley Rats: Study No. 830083. (Unpublished study received Nov 15, 1983 under 524-308; submitted by Monsanto Co., Washington, DC; CDL:251737-D)   MRID 00132683

Shirasu, Y.; Moriya, M.; Ohta, T. (1978) Microbial MutagenicityTesting on CP67573 (Glyphosate). (Unpublished study received Apr25, 1979 under 524-308; prepared by Institute of EnvironmentalToxicology, Japan, submitted by Monsanto Co., Washington, D.C.; CDL:238233-A) MRID 00078619

3. Developmental and Reproductive toxicity. Pp 16 & 17 (studies extracted from US EPA RED 1993 p. 15 & 16)

Rodwell, D.E.; Tasker, E.J.; Blair, A.M.; et al. (1980)Teratology Study in Rats: IRDC No. 401-054. (Unpublished studyincluding IRDC no. 999-021; received May 23, 1980 under 524-308; prepared by International Research and Development Corp.,submitted by Monsanto Co., Washington, D.C.; CDL:242516-A) MRID 00046362

Rodwell, D.E.; Tasker, E.J.; Blair, M.; et al. (1980) Teratology Study in Rabbits: IRDC No. 401-056. (Unpublished study received May 23, 1980 under 524-308; prepared by International Research and Development Corp., submitted by Monsanto Co., Washington, D.C.; CDL:242516-B) MRID 00046363

Street, R. (1982) Letter sent to R. Taylor dated Jul 6, 1982: Roundup herbicide: Addendum to pathology report for a three-­generation reproduction study in rats with glyphosate. (Unpublished study received Jul 7, 1982 under 524-308; submitted by Monsanto Co., Washington, DC; CDL:247793-A) MRID 00105995

4. Structure - Activity Relationships. (No studies submitted)

5. Acute, subchronic and chronic feeding / oncogenicity data. P.17. (studies extracted from US EPA RED 1993 p. 10 & 13)

Birch, M.D. (1970) Toxicological Investigation of CP 67573-3: Project No. Y-70-90. (Unpublished study received Jan 30, 1973 under 524-308; prepared by Younger Laboratories, Inc., submitted by Monsanto Co., Washington, D.C.; CDL:008460-C) MRID 00067039

Reyna, M. (1985) Twelve Month Study of Glyphosate Administered by Gelatin Capsule to Beagle Dogs: Project No. ML-83-137: Study No. 830116. Unpublished study prepared by Monsanto Company Environmental Health. 317 p. MRID 00153374

END OF STUDIES in Second Peer Review Paper.

G. Classification p. 19 (Second Peer Review)

Considering criteria contained in the EPA Guidelines (FR 51:33992-34003, 1986) for classifying a carcinogen, the Committee concluded that Glyphosate should be classified as a Group E (evidence of Non-carcinogenicity to humans), based on lack of convincing carcinogenicity evidence in adequate studies in two animal species.

It should be emphasised, however, that designation of an agent in Group E is based on the available evidence at the time of evaluation and should not be interpreted as a definitive conclusion that the agent will not be a carcinogen under any circumstances.

End discussion Second Peer Review Paper.

26 March 1998

Information retreived from:  EPA Memorandum date 17 August 2000 : Glyphosate in/on Alfalfa hay and forage; Field corn forage; Stover and straw of the cereal grains crop group; numerous minor crops; and flax in Northern Dakota. HED Risk Assessment. P. 6/7

Section:  Dose Response Assessment

On 26 March 1998 the HED Hazard Identification Assessment Review Committee (HIARC) evaluated the toxicology database, selected doses and endpoints for chronic dietary risk assessment, considered the carcinogenic potential and addressed the sensitivity of infants and children from exposure to glyphosate as required by the Food Quality Protection Act (FQPA) of 1996 (HED Doc. No. 12586, W. Dykstra and J. Rowland, 20-APR-1998).


The FQPA Safety Factor Committee (SFC) met on April 6, 1998 and addressed the potential of enhanced sensitivity to infants and children as required by FQPA (HED Doc. 012584 B. Tarplee and J. Rowland  17-APR-1998). The Committee recommended the 10X FQPA Safety Factor be reduced to 1X in assessing the risk posed by this chemical because: 1) the toxicology data base is complete; 2) there is no indication of susceptibility of rats to in utero and/or postnatal exposure to glyphosate (in the prenatal development study in rats, effects in the offspring were observed only at or above the treatment levels which resulted in the evidence of appreciable maternal toxicity), and 3) the use of generally high quality data, conservative models and/or assumptions in the exposure assessment provides adequate protection of infants and children.


An acute dose and endpoint were not selected for any population subgroups because no effects could be attributed to a single exposure (dose) were observed in oral toxicity studies including the development toxicity studies in rats and rabbits.  Therefore a dose and endpoint were not identified for acute dietary risk assessment.


Memorandum Page 6. I believe the studies this was based on are as follows:


CRfD 2.0mg/kg/day based on rabbit developmental study with NOAEL 175 mg/kg/day:
Rodwell DE; Tasker EJ; Blair M; et al. (1980) : Teratology Study in Rabbits. Unpublished. Pre GLP. Monsanto Company. 1980b. Report no. IR-79_018. MRID No. 00046363. IRDC No. 401-056. International Research and Development Corp


4 month mouse carcinogenicity study (NOAEL 750 mg/kg/day):
2 McConnel, R. (1985) A Chronic Feeding Study of Glyphosate (Roundup Technical in Mice): Pathology Report on Additional Kidney Sections: Addendum to Final Report Dated July 21, 1983: Project No. 77-2061A. Unpublished study prepared by Bio/dynamics Inc. 59 p. MRID 00150564  Bio/dynamics studies are almost always Monsanto submitted


1 yr dog study (NOAEL 500 mg/kg/day)
Reyna, M. (1985) Twelve Month Study of Glyphosate Administered by Gelatin Capsule to Beagle Dogs: Project No. ML-83-137: Study No. 830116. Unpublished study prepared by Monsanto Company Environmental Health. 317 p. MRID 00153374


2 year chronic/onco rat study (NOAEL 400 mg/kg/day):
tout, L.; Ruecker, F. (1990) Chronic Study of Glyphosate Administered in Feed to Albino Rats: Lab Project Number: MSL- 10495: R.D. 1014. Unpublished study prepared by Monsanto Agricultural Co. 2175 p.    MRID 41643801

2 generation rat reproduction study (NOAEL 500 mg/kg/day):
Reyna, M. (1990): Two Generation Reproduction Feeding Study with Glysophate in Sprague-Dawley Rats: Lab Project No: MSL-10387. MRID 41621501 Unpublished study prepared by Monsanto Agricultural Co.  1158


Rat development toxicity study (NOAEL 1000 mg/kg/day):
Rodwell, D.E.; Tasker, E.J.; Blair, A.M.; et al. (1980): Teratology Study in Rats: IRDC No. 401-054. MRID 00046362 (Unpublished study including IRDC no. 999-021; received May 23, 1980 under 524-308; prepared by International Research and Development Corp., submitted by Monsanto Co., Washington, D.C.; CDL:242516-A)


An uncertainty factor (UF) of 100 was applied to account for interspecies extrapolation (10X) and intraspecies variation (10X).  The chronic population adjusted dose (cPAD) is equal to the cRfD divided by the FQPA Safety Factor. Because the 10X safety factor was reduced to 1X, the cPAD is equivalent to the cRfD of 2.0 mg/kg/day.
Because of the lack of evidence of carcinogenicity in mice and rats at doses that were judged to be adequate to assess the carcinogenic potential, glyphosate was classified as a ‘Group E’ chemical.

Further reading and link to study outlines released to public.  EPA Memorandum date 17 August 2000

 WHO: studies behind the WHO 2004 carcinogenicity evaluation.

PLEASE ADVISE ME IF THERE HAS BEEN A CARCINOGENICITY REVIEW SINCE 1998. I DO NOT BELIEVE THIS HAS OCCURRED.

PLEASE ALSO ADVISE ME IF YOU SEE INCORRECT CONTENT. THIS HAS BEEN CARRIED OUT TO THE BEST OF MY ABILITY AND THERE IS NO INTENTION TO DECEIVE. 

References:

EPA 1993 Glyphosate Reregistration Eligibilty Decision (RED) PDF (EPA has removed this from public access during 2014/2015)

Information for the 1985 & 1991 evaluations has been extracted from an EPA Memorandum date 17 August 2000 for a HED risk assessment for glyphosate.  pp. 5/6

Cornell Paper: Proposed Pesticide Tolerance Glyphosate 5/93.

Information regarding the 1998 evaluations extracted from an EPA Memorandum dated March 13 2002  from an occupational exposure risk assessment. Page 6.

30 October 1991 - US EPA Second Peer Review of Glyphosate. Memorandum 1071-83-6. From William Dykstra and George Z Ghali.  http://www.epa.gov/opp00001/chem_search/cleared_reviews/csr_PC-103601_30-Oct-91_265.pdf