17 October, 2016
Dr.
Jane Philpott
Canadian Minister of Health
Health Canada
Ottawa, Canada
Dr. Richard Aucoin
Executive Director
Pesticides Management Regulatory Agency (PMRA)
Ottawa, Canada
cc:
Justin Trudeau
Prime Minister of Canada
Ottawa, Canada
Rona Ambrose
Official Opposition Leader
(Former Canadian Minister of Health)
Ottawa, Canada
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:
Excerpts:
" 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."
Source:
http://www.hc-sc.gc.ca/…/…/_prvd2015-01/prvd2015-01-eng.php…
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
Source:
http://www.reuters.com/…/us-health-who-glyphosate-idUSKCN0Y…
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.
Source:
http://detoxproject.org/glyphosate/hormone-hacking/
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).
Excerpts:
" 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:
http://www.endocrinedisruption.org/…/tedx-l…/chemicalsearch…
Moreover, a peer reviewed
Scientific Consensus Statement recently
published by a number of prominent and eminent scientists states:
Abstract:
" 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:
http://ehjournal.biomedcentral.com/…/10.1…/s12940-016-0117-0
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:
http://www.healthandenvironment.org/partnership_calls/18015
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!
http://beyondpesticides.org/…/glyphosate-residues-found-in…/
Roundup is alarmingly ubiquitous in our daily food supply, as the
following recent investigative articles and reports alarmingly reveal:
https://usrtk.org/…/CFIA_ACIA-9123346-v1-FSSD-FSSS-Glyphosa…
http://www.cbc.ca/n…/health/cfia-report-glyphosate-1.4070275
http://www.truth-out.org/…/35919-not-just-for-corn-and-soy-…
http://www.huffingtonpost.com/…/fda-tests-confirm-oatmeal_b…
https://s3.amazonaws.com/…/FDN_Glyphosate_FoodTesting_Repor…
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.”
Source:
https://usrtk.org/…/Monsanto-application-guide-for-preharve…
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".
Source:
http://www.reuters.com/…/us-food-agriculture-glyphosate-idU…
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.
Conclusion
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,
Arya Vrilya
