Dr. Jane Philpott
Canadian Minister of Health
Dr. Richard Aucoin
Pesticides Management Regulatory Agency (PMRA)
Prime Minister of Canada
Official Opposition Leader
(Former Canadian Minister of Health)
RE: Proposed Re-evaluation Decision PRVD2015-01, Glyphosate:
Dear Dr. Jane Philpott and Dr. Richard Aucoin,
I am writing to you regarding the ongoing risk assessment and re-evaluation of glyphosate by Health Canada/PMRA (Proposed Re-evaluation Decision PRVD2015-01)
I hereby wish to share with you some recently published peer reviewed scientific literature, data and evidence on the toxicity of Glyphosate Based Herbicides (GBH) residues in our food and water.
Monsanto, the industry and regulatory agencies in the US (EPA), EU (EFSA) and in Canada (Health Canada) have (erroneously) discredited and dismissed the recent WHO/International Agency for Research on Cancer (IARC) credible and alarming classification of glyphosate as a "probable human carcinogen” by arguing that a health hazard is not a health risk because - they erroneously argue - a health risk is based on the level of human exposure to glyphosate/Roundup.
As Health Canada writes in its own risk assessment and proposed re-evaluation decision of glyphosate:
" 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.
Only uses for which exposure is well below levels that cause no effects in animal testing are considered acceptable for registration. Toxicology studies in laboratory animals describe potential health effects from varying levels of exposure to a chemical and identify the dose at which no effects are observed. The risk assessment approach ensures that the level of exposure to humans is well below the lowest dose at which these effects occurred in animal tests."
GBH residues in our food and water
Health Canada further writes:
" Dietary risks from food and water are not of concern."
" Reference doses define levels to which an individual can be exposed over a single day (acute) or lifetime (chronic) and expect no adverse health effects. Generally, dietary exposure from food and water is acceptable if it is less than 100% of the acute reference dose or chronic reference dose (acceptable daily intake). An acceptable daily intake is an estimate of the level of daily exposure to a pesticide residue that, over a lifetime, is believed to have no significant harmful effects.
The chronic dietary exposure estimate for the general population represents 30% of the acceptable daily intake (ADI). Exposure estimates for population subgroups range from 20% of the ADI (for adults aged 50 years or older) to 70% of the ADI (for children 1-2 years old). Thus, acute and chronic dietary risks are not of concern. Food containing a pesticide residue that does not exceed the established MRL does not pose a health risk concern."
Moreover, the recently held joint WHO-FAO Meeting on Pesticide Residues (JMPR) - the arm of the WHO that determines and sets the so-called "safe" level of pesticide residues allowed in our food and water - has also (erroneously) declared that glyphosate is unlikely to cause cancer through pesticide residues in our food. The summary report from the JMPR is available at this link: http://www.who.int/foodsafety/jmprsummary2016.pdf?ua=1
GLYPHOSATE/ROUNDUP/GBH: ENDOCRINE DISRUPTING CHEMICALS (EDC) TOXIC AT LOW/MINUTE DOSES:
What both Health Canada/PMRA and the joint WHO-FAO/JMPR omit to indicate and take into account in their risk assessment and in setting the ADI for GBHs, is that both glyphosate (Active Principle), Roundup (formulation) and each one of its so-called “inert” and "secret" co-formulants have alarmingly been found to be endocrine disrupting chemicals (EDCs) which are extremely toxic to human health at low/minute doses.
As the following paper explains:
" The endocrine disrupting effect of glyphosate and its commercial formulations (i.e. Roundup) is their most insidious and worrying toxic effect. This is because EDC's do not function like normal poisons, where a higher dose gives greater toxicity. Often, endocrine disruptive effects are seen at lower doses but not at higher doses. The studies conducted by industry for regulatory purposes use relatively high doses and are not able to detect these effects. Endocrine disruption in humans is thought to contribute to some cancers, birth defects, reproductive problems such as infertility, and developmental problems in foetuses, babies, and children.
Governments recognize the threat posed by endocrine disruption, which are believed to be implicated in serious diseases, such as cancer, reproductive and developmental problems, and birth defects. These effects are thought to result from very low doses over a long period of exposure or from exposures in critical windows of development, such as foetal development in the womb.
Alarmingly, professor Gilles-Éric Séralini and his team of prominent and eminent scientific researchers have recently found both glyphosate, Roundup as well as each one of its so-called “inert” and “secret” co-formulants to be endocrine disrupting chemicals (EDC).
" A new study shows that the Acceptable Daily Intake (ADI), the supposedly safe level for glyphosate is unreliable in terms of assessing the risks of the complete commercial formulations that we are actually exposed to. The co-formulants were shown in the new study to have a far more powerful endocrine-disrupting effect at lower doses than the isolated active ingredient i.e. glyphosate. The complete formulations (i.e. Roundup) were also found to have much greater endocrine disrupting effects at lower doses than glyphosate alone. The research shows that the ADI should be calculated from toxicity tests on the commercial formulations as sold and used. The new study is the first ever demonstration that the endocrine disrupting effects of glyphosate based herbicides (GBH) are not only attributable to glyphosate, the declared active ingredient, but above all to the co-formulants."
Link to the study: http://www.gmoseralini.org/new-research-shows-regulatory-s…/
As the following paper further explains:
" The so-called safe levels of glyphosate exposure have never been tested directly to determine if indeed they are really safe to consume over the long term. Instead the “safe” levels are extrapolated from higher doses tested in industry studies. Industry toxicity study protocols are out of date. All toxicity tests conducted by industry for regulatory purposes are based on the old adage: “The dose makes the poison” – that is, the higher the dose, the greater the degree of toxicity. However, in some cases, low doses corresponding to human exposures can be more toxic than the higher doses tested in laboratory animals in industry studies. This is especially true for chemicals that disrupt the hormonal system (endocrine disruptors). Safe levels of these chemicals cannot be extrapolated from effects at higher doses. Evidence from in vitro and animal experiments shows that glyphosate may be an endocrine disruptor at levels permitted in tap water in the EU.
Findings that glyphosate and its commercial formulations may be endocrine disruptors imply that the standard industry long-term animal studies are inadequate. These studies are conducted on adult animals, and fail to test the effects of exposure during important windows of development, such as foetal development. Yet hormones are vital regulators of development. A subtle hormonal effect during early life can modify organ morphology and function for the rest of the life, as well as potentially leading to chronic diseases such as cancer and reproductive dysfunction in adults.
The complete glyphosate herbicide formulations as sold and used contain additives (adjuvants), which are toxic in their own right and/or increase the toxicity of glyphosate. Safety limits are set for the isolated ingredient glyphosate, but the whole formulations, which are generally more toxic, are never tested to determine long-term toxic effects. This limitation of the regulatory process applies to all pesticides in all countries worldwide. Studies in rats confirm that the complete glyphosate herbicide formulations are toxic at levels deemed safe by regulators for the isolated ingredient glyphosate. Other feeding studies in pigs and rats directly comparing the toxicity of formulations with glyphosate alone found that the formulations were far more toxic.
Even glyphosate alone may not be as safe as claimed. Industry tests on glyphosate alone revealed toxic effects, notably birth defects, below the levels that regulators claimed showed no toxic effect – but these results were ignored or dismissed by regulators in setting the supposedly safe ADI. Independent studies have found toxic effects of glyphosate and its commercial formulations at environmentally realistic levels, which have never been tested by regulators. Effects include oxidative stress on liver and kidneys and endocrine disrupting effects. These findings, taken as a whole, suggest that the levels of Roundup we are exposed to may not be safe over the long term."
Link to the article with references: http://detoxproject.org/…/how-safe-are-safe-levels-of-roun…/
The following independent peer reviewed published studies have also found both glyphosate and Roundup to be EDCs:
Moreover, a peer reviewed Scientific Consensus Statement recently published by a number of prominent and eminent scientists states:
" Our Statement of Concern considers current published literature describing glyphosate based herbicides (GBH) uses, mechanisms of action, toxicity in laboratory animals, and epidemiological studies. It also examines the derivation of current human safety standards.
We conclude that: (1) GBHs are the most heavily applied herbicide in the world and usage continues to rise; (2) Worldwide, GBHs often contaminate drinking water sources, precipitation, and air, especially in agricultural regions; (3) The half-life of glyphosate in water and soil is longer than previously recognized; (4) Glyphosate and its metabolites are widely present in the global soybean supply; (5) Human exposures to GBHs are rising; (6) Glyphosate is now authoritatively classified as a probable human carcinogen; (7) Regulatory estimates of tolerable daily intakes for glyphosate in the United States and European Union are based on outdated science." (emphasis is mine.)
" We offer a series of recommendations related to the need for new investments in epidemiological studies, biomonitoring, and toxicology studies that draw on the principles of endocrinology to determine whether the effects of GBHs are due to endocrine disrupting activities.
We suggest that common commercial formulations of GBHs should be prioritized for inclusion in government-led toxicology testing programs such as the U.S. National Toxicology Program, as well as for biomonitoring as conducted by the U.S. Centers for Disease Control and Prevention."
Link to the complete Scientific Consensus Statement:
The Endocrine Society has also recently published an alarming (2nd) Scientific Statement on the toxicity of EDC's:
" This Executive Summary to the Endocrine Society's second Scientific Statement on environmental endocrine-disrupting chemicals (EDCs) provides a synthesis of the key points of the complete statement. The full Scientific Statement represents a comprehensive review of the literature (1300 studies) on seven topics for which there is strong mechanistic, experimental, animal, and epidemiological evidence for endocrine disruption, namely: obesity and diabetes, female reproduction, male reproduction, hormone-sensitive cancers in females, prostate cancer, thyroid, and neurodevelopment and neuroendocrine systems."
"Scientific advances over the past 5 years (encompassing 1300 studies) reveal numerous EDC effects on obesity, diabetes, male and female reproduction (including cancer), the prostate and thyroid glands, and neurodevelopment. The past 5 years represent a leap forward in our understanding of EDC actions on endocrine health and disease."
Link to the complete Scientific Statement:
Glyphosate Risk Assessment: Health Hazards vs Health Risks
Furthermore, the risk assessment of GBHs carried out by Health Canada/PMRA and all regulatory agencies is scientifically flawed and outdated for the reasons briefly explained below.
1) “The dose makes the poison”
The health hazards vs health risks assessment carried out by Health Canada/PMRA and by all regulatory agencies is scientifically flawed and outdated because regulators erroneously believe the five century old adage that the “dose makes the poison.” However, recent toxicology peer-reviewed and published scientific research has shown that this outdated dogma is in many cases inaccurate and quite often the opposite is true (i.e. linear vs nonmonotonic dose-response curves) Study link:http://www.ncbi.nlm.nih.gov/pubmed/22419778
2) Active Principle (glyphosate) vs Formulation/product (Roundup)
Regulatory agencies only review the toxicity of the Active Principle alone (i.e. glyphosate) and not the whole product formulation (i.e Roundup) which contains other highly toxic and synergistic “secret” adjuvants. However, a recent landmark peer-reviewed and published study has alarmingly found Monsanto's Roundup and other pesticide formulations to be 125-1000 times more toxic than their declared Active Principle.
The authors of the study alarmingly found and write:
“We tested the toxicity of 9 pesticides, comparing active principles and their formulations, on three human cell lines[...] Despite its relatively benign reputation, Roundup was among the most toxic herbicides and insecticides tested. Most importantly, 8 formulations out of 9 were up to one thousand times more toxic than their active principles. Our results challenge the relevance of the acceptable daily intake for pesticides because this norm is calculated from the toxicity of the active principle alone. Chronic tests on pesticides may not reflect relevant environmental exposures if only one ingredient of these mixtures is tested alone.”
Study Link: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3955666/
EPA and EFSA recognize the toxicity of GBH formulations
Both the US Environmental Protection Agency (EPA) and the European Food Safety Authority (EFSA) have publicly recognized the toxicity of glyphosate based herbicides (GBH) formulations.
In its own risk assessment of glyphosate, the EPA publicly admits and states that it evaluated only the "human carcinogenic potential for the active ingredient," not that of "glyphosate-based pesticide formulations." The EPA acknowledges that the formulations may be more toxic than glyphosate and expresses the need to evaluate the toxicity of the entire formulation i.e. Roundup. The EPA is developing a “research plan” with the National Institute of Environmental Health Sciences to “evaluate the role of glyphosate in product formulations and the differences in formulation toxicity.”
Similarly, EFSA's risk assessment of glyphosate was based exclusively on the toxicity of glyphosate alone, not on the complete formulation; although EFSA acknowledged that one common ingredient in glyphosate based herbicides - POE-tallowamine - is more toxic than glyphosate itself, EFSA publicly admits and writes that the carcinogenic potential of GBH formulations "should be further considered and addressed."
3) Acceptable Daily Intake (ADI)
Health Canada/PMRA and regulatory agencies worldwide determine and set the Acceptable Daily Intake (ADI) of glyphosate/Roundup based exclusively on the Active Principle alone (AP) (i.e. glyphosate) and not on the complete product formulation (i.e. Roundup). However, the actual product that is approved by regulatory agencies and copiously sprayed in our food, soil, water, air and environment is not only glyphosate (AP) but the whole product formulation (i.e. Roundup). This constitutes a flagrant and dangerous flaw in the risk assessment of GBHs and a serious health risk to public health
ROUNDUP (GBH) RESIDUES IN OUR FOOD AND WATER
Roundup residues have alarmingly been found in various common food items i.e. flour, bread, cereals, lentils, peas, beans, potatoes, dairy, eggs, fruits, vegetables, wine, beers, etc., as well as in human urine, blood and breastmilk!
Roundup is alarmingly ubiquitous in our daily food supply, as the following recent investigative articles and reports alarmingly reveal:
In fact, Roundup is not only used on GMO crops; it is also widely used as a dessicant to dry and kill non-GMO grain crops such as wheat, oats, barley, flax, etc. a few weeks before harvest; it is also copiously sprayed on nuts, lentils, peas, beans, potatoes, fruits and vegetables.
In its “pre-harvest staging guide” Monsanto states: “A preharvest weed control application is an excellent management strategy to not only control perennial weeds, but to facilitate harvest management and get a head start on next year’s crop.”
Roundup is also present in our daily drinking water supply. The following recently published study also found ultra-low dose exposure to Roundup in drinking water to adverse impacts on rat livers and kidneys: http://ehjournal.biomedcentral.com/…/10.1…/s12940-015-0056-1
Monsanto and the industry of course deny that glyphosate/Roundup residues in our food and water supply are dangerous to human health. "According to physicians and other food safety experts, the mere presence of a chemical itself is not a human health hazard. It is the amount, or dose, that matters," Monsanto senior toxicologist Kimberly Hodge-Bell said in the Monsanto blog; "trace amounts are not unsafe".
However, this misleading and false public statement by Kimberly Hodge-Bell and Monsanto is not supported by the peer reviewed published scientific literature, evidence and data and is contradicted by the science of toxicology and endocrinology, as I have argued and demonstrated in this paper.
To summarize and to conclude, Monsanto, Health Canada, regulatory agencies and the Joint WHO-FAO JMPR claim and argue that glyphosate/Roundup residues in our food and water are safe for human consumption and pose no human health risks; they erroneously believe in the five century old and outdated dogma that “the dose makes the poison.” However, recent toxicology research has shown that this belief is in many cases inaccurate and quite often the opposite is true i.e. linear vs nonmonotonic dose-response curves.
Furthermore, glyphosate, Roundup and each one of its so-called “inert” and “secret” co-formulants have been found to be endocrine disrupting chemicals (EDC) which are extremely toxic to human health at low/minute doses. Endocrine disruptive effects are seen at lower doses but not at higher doses. The studies conducted by industry for regulatory purpose and approval use relatively high doses and are not able to detect these effects.
EDCs in humans are believed to contribute to some cancers, birth defects, reproductive problems such as infertility, and developmental problems in foetuses, babies, and children. These effects are thought to result from very low doses over a long period of exposure or from exposures in critical windows of development, such as foetal development in the womb.
Furthermore, Health Canada/PMRA and all regulatory agencies only review industry-funded and supplied studies on the toxicity of the Active Principle (AP) alone (i.e. glyphosate), not on the whole product formulation (i.e. Roundup) which contains other highly toxic and synergistic “secret” adjuvants. However, a recent landmark peer-reviewed published study has alarmingly found Roundup and other pesticide formulations to be 125-1000 times more toxic than their declared Active Principle.
Health Canada/PMRA sets the Acceptable Daily Intake (ADI) of pesticide residues in our food and water based exclusively on the toxicity of glyphosate alone and not on the entire formulation i.e. Roundup. However, the actual product that is approved by Health Canada/PMRA and copiously sprayed in our food, water, soil, air and environment is not only glyphosate (AP), but the complete pesticide formulation i.e. Roundup. This constitutes a major flaw in the risk assessment of glyphosate/Roundup and all GBH formulations and a serious danger and risk to public health.
Therefore, it is fair to conclude that both the risk assessment of glyphosate/Roundup and all GBH formulations as well as the ADI set by Health Canada/PMRA are scientifically flawed and outdated and extremely toxic to human health since they expose us to extremely high doses of glyphosate based herbicides (GBHs) and endocrine disrupting chemicals (EDCs) residues in our food and water.
I hereby ask you both Dr. Jane Philpott and Dr. Richard Aucoin to urgently and carefully read, study and take into account the above published peer reviewed scientific literature, data and evidence on the toxicity of Monsanto's Roundup and all GBHs in your ongoing risk assessment and final re-evaluation decision of glyphosate/Roundup/GBHs and to BAN all ongoing and future usage of GBHs in our food, water and environment to protect our health, our lives and our environment.
Both you Dr. Jane Philpott as Canadian Health Minister and Dr. Richard Aucoin have a public mandate and a legal obligation and responsibilty to make sure that the food we eat and the water we drink is safe for human consumption and to protect the health and the lives of all Canadians.
HEALTH CANADA FINAL RE-EVALUATION DECISION ON GLYPHOSATE
Tragically but unsurprisingly, Health Canada and Health Minister Jane Philpott have re-approved the unrestricted use of glyphosate/GBH/Roundup in Canada for another 15 years! Health Canada writes: " Following a rigorous science-based assessment, Health Canada has determined that when used according to the label, products containing glyphosate are not a concern to human health and the environment."
Link to the Final Re-Evaluation Decision: https://www.canada.ca/en/health-canada/news/2017/04/statement_from_healthcanadafinalre-evaluationdecisiononglyphosat.html?wbdisable=true
With grave concern,