Legal Filing Accuses EPA of Unfairly Protecting Monsanto
March 01, 2017
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By Dr. Mercola
Glyphosate — the active ingredient in Monsanto's wide-spectrum herbicide Roundup and other pesticides — is the most widely used agricultural chemical in the world, and has been detected in a wide array of samples, including blood, urine, breast milk and drinking water.
A German study1 published in 2012 showed that even those with no direct agricultural contact have significant concentrations of glyphosate in their urine — concentrations ranging from five to 20 times the permissible limit for glyphosate in German drinking water.
Similarly, tests conducted by the University of San Francisco, published in May last year, showed that 93 percent of Americans have detectable levels of glyphosate in their urine.2
If you believe Monsanto's PR department, this is no cause for concern, as — in their estimation — glyphosate is harmless. However, independent studies suggest otherwise.
In March, 2015, the International Agency for Research on Cancer (IARC), a research arm of the World Health Organization (WHO) and the "gold standard" in carcinogenicity research, reclassified glyphosate as a "probable human carcinogen" (Class 2A).3,4
Additionally, research scientist and consultant Anthony Samsel reports that he has uncovered evidence showing Monsanto has known glyphosate promotes cancer since 1981.
Monsanto attempted to overturn the OEHHA's decision, but Fresno County Superior Court Judge Kristi Kapetan ruled against it5,6,7 — an action seen as a boon to the 60 or more plaintiffs suing Monsanto, claiming Roundup caused or contributed to their non-Hodgkin lymphoma.
In its defense, Monsanto has relied heavily on the U.S. Environmental Protection Agency's (EPA) determination that the chemical is "not likely to be carcinogenic" to humans — a decision issued on September 12, 2016.8 But just how objective was the EPA in its evaluation of the available science?
According to some of the experts on the scientific advisory panel convened to evaluate the strength of the EPA's decision, the EPA appears to have violated its own guidelines by discounting and downplaying data from studies linking glyphosate to cancer.9
According to a recent court filing requesting the deposition of Jess Rowland, former associate director of the EPA's Pesticide Health Effects Division,10 the EPA's favorable ruling on glyphosate was reached to protect Monsanto's interests. As reported by The Huffington Post:11
According to the featured article,13 " … [T]he communication, if authentic, could be an explosive development in the snowballing multi-district litigation … accusing Monsanto of covering up evidence that Roundup herbicide could cause cancer."
Plaintiff lawyers are also requesting documents detailing Rowland's interactions with Monsanto to be unsealed. While Monsanto turned the documentation over during discovery, they were all marked confidential, which means they cannot be used as exhibits in court filings or be made public.
Monsanto has also filed a court brief arguing the IARC classification of glyphosate as a probable human carcinogen should be disregarded as irrelevant in these cases. According to Monsanto, the IARC's approach is "less rigorous" than the EPA's, and its conclusions are "scientifically unreliable."
Moreover, Monsanto claims "neither the views of IARC or EPA are necessarily relevant to the general causation issue of the litigation because plaintiffs will need to present admissible expert testimony showing the company's products in fact caused their cancers," The Huffington Post writes.
According to Joanne Doroshow, executive director of the Center for Justice and Democracy: "The bill is designed to ensure that no class action could ever be brought or litigated for anyone. It would obliterate civil rights, antitrust, consumer, essentially every class action in America."
For example, the bill would require counsel for a plaintiff to submit sufficient verification of the allegations within 45 days of filing the civil action.
Verification of allegations include "evidentiary support (including but not limited to medical records) for the factual contentions in plaintiff's complaint regarding the alleged injury, the exposure to the risk that allegedly caused the injury and the alleged cause of the injury."
This deadline cannot be extended, and if the judge decides the evidentiary support is insufficient, the civil action is to be dismissed without prejudice. The class action must also prove that each class member "suffered the same type and scope of injury as the named class representative or representatives."
Ironically, the bill would also require all class members to prove they have no conflicts of interest in the case.
Initial toxicity testing by the industry itself suggested these formulations posed low risks to non-target species, mammals and human health. As a result, high acceptable exposure limits were set worldwide. Limits were raised even higher to accommodate increased usage on genetically engineered (GE), herbicide-tolerant crops.
Since 1974, 1.8 million tons of glyphosate have been applied to U.S. fields; two-thirds of that volume has been sprayed in the last 10 years.17 Between 1974 and 2014, 9.4 million tons of glyphosate were used worldwide.
However, the scientific evidence that has emerged over the past decade "point to the need for a fresh look at glyphosate toxicity."
Based on "current published literature describing GBH uses, mechanisms of action, toxicity in laboratory animals, and epidemiological studies," the authors present seven conclusions, starting with the facts that GBHs are the most widely applied herbicides in the world, and that glyphosate is a commonly found contaminant in drinking water, rain and air. In addition to that, the scientific evidence suggests that:
For example, in one recent animal study,18 Roundup was found to cause fatty liver disease at 0.1 parts per billion (ppb) in drinking water, which is 14,000 times lower than the concentration permitted in U.S. drinking water (700 ppb). At this dose, the daily intake level of glyphosate amounted to 4 nanograms per kilogram of bodyweight per day, which is 437,500 times below the permitted intake level in the U.S.
This is said to be the first study to present a causative link between dietary exposure to Roundup and serious disease, and endocrine disruption is one of the proposed mechanisms. Disturbingly, previous tests showing glyphosate levels in urine suggest Americans have a daily intake of glyphosate that is about 1,000-fold higher than the level found to cause fatty liver disease in rats.
Another recent study found Roundup adversely affects the development of female rats' uteruses, increasing the risk for both infertility and uterine cancer.19 So why is no action taken to protect human health? It really boils down to the fact that without Roundup and other GBHs the GE seed business would collapse, and chemical technology companies, with their vast resources and revolving doors into government regulatory agencies, have managed to deceive people into thinking there's no problem.
This task force warns that the health effects of hormone-disrupting chemicals is such that everyone needs to take proactive steps to avoid them — especially those seeking to get pregnant, pregnant women and young children, as even extremely low-level pesticide exposures have been found to considerably increase the risk of certain diseases.
For example, evidence25 suggests endocrine disrupting chemicals (EDCs) play a role in obesity, diabetes-related non-alcoholic fatty liver disease, reduced fertility, hormone-sensitive cancers, thyroid diseases and neurodevelopmental diseases. According to GM Watch:26
Glyphosate — the active ingredient in Monsanto's wide-spectrum herbicide Roundup and other pesticides — is the most widely used agricultural chemical in the world, and has been detected in a wide array of samples, including blood, urine, breast milk and drinking water.
A German study1 published in 2012 showed that even those with no direct agricultural contact have significant concentrations of glyphosate in their urine — concentrations ranging from five to 20 times the permissible limit for glyphosate in German drinking water.
Similarly, tests conducted by the University of San Francisco, published in May last year, showed that 93 percent of Americans have detectable levels of glyphosate in their urine.2
If you believe Monsanto's PR department, this is no cause for concern, as — in their estimation — glyphosate is harmless. However, independent studies suggest otherwise.
In March, 2015, the International Agency for Research on Cancer (IARC), a research arm of the World Health Organization (WHO) and the "gold standard" in carcinogenicity research, reclassified glyphosate as a "probable human carcinogen" (Class 2A).3,4
Additionally, research scientist and consultant Anthony Samsel reports that he has uncovered evidence showing Monsanto has known glyphosate promotes cancer since 1981.
Environmental Protection Agency Accused of Colluding With Monsanto
Based on the IARC's determination, the California agency of environmental hazards (OEHHA) declared glyphosate a carcinogen under Proposition 65, and will require all glyphosate-containing products to carry a cancer warning.Monsanto attempted to overturn the OEHHA's decision, but Fresno County Superior Court Judge Kristi Kapetan ruled against it5,6,7 — an action seen as a boon to the 60 or more plaintiffs suing Monsanto, claiming Roundup caused or contributed to their non-Hodgkin lymphoma.
In its defense, Monsanto has relied heavily on the U.S. Environmental Protection Agency's (EPA) determination that the chemical is "not likely to be carcinogenic" to humans — a decision issued on September 12, 2016.8 But just how objective was the EPA in its evaluation of the available science?
According to some of the experts on the scientific advisory panel convened to evaluate the strength of the EPA's decision, the EPA appears to have violated its own guidelines by discounting and downplaying data from studies linking glyphosate to cancer.9
According to a recent court filing requesting the deposition of Jess Rowland, former associate director of the EPA's Pesticide Health Effects Division,10 the EPA's favorable ruling on glyphosate was reached to protect Monsanto's interests. As reported by The Huffington Post:11
"The filing,12 made [February 27, 2017] by plaintiff's attorneys, includes what the attorneys represent to be correspondence from a 30-year career EPA scientist accusing top-ranking EPA official Jess Rowland of playing 'your political conniving games with the science' to favor pesticide manufacturers such as Monsanto.
Rowland oversaw the EPA's cancer assessment for glyphosate … and was a key author of a report finding glyphosate was not likely to be carcinogenic.
But in the correspondence, longtime EPA toxicologist Marion Copley cites evidence from animal studies and writes: 'It is essentially certain that glyphosate causes cancer.'"
Legal Wrangling in the Works
In her correspondence, dated March 4, 2013, the since-deceased Copley accuses Rowland of intimidating EPA staff to alter reports to favor the chemical industry.According to the featured article,13 " … [T]he communication, if authentic, could be an explosive development in the snowballing multi-district litigation … accusing Monsanto of covering up evidence that Roundup herbicide could cause cancer."
Plaintiff lawyers are also requesting documents detailing Rowland's interactions with Monsanto to be unsealed. While Monsanto turned the documentation over during discovery, they were all marked confidential, which means they cannot be used as exhibits in court filings or be made public.
Monsanto has also filed a court brief arguing the IARC classification of glyphosate as a probable human carcinogen should be disregarded as irrelevant in these cases. According to Monsanto, the IARC's approach is "less rigorous" than the EPA's, and its conclusions are "scientifically unreliable."
Moreover, Monsanto claims "neither the views of IARC or EPA are necessarily relevant to the general causation issue of the litigation because plaintiffs will need to present admissible expert testimony showing the company's products in fact caused their cancers," The Huffington Post writes.
House Bill Aims to Cement Industry Protection Against Litigation
The EPA is not alone in aiding and abetting the chemical technology industry. On February 9, House Judiciary Chairman Bob Goodlatte (R-VA) introduced the "Fairness in Class Action Litigation Act of 2017" (H.R. 985),14 which opponents warn would make it nearly impossible for the average person to challenge a company in court.According to Joanne Doroshow, executive director of the Center for Justice and Democracy: "The bill is designed to ensure that no class action could ever be brought or litigated for anyone. It would obliterate civil rights, antitrust, consumer, essentially every class action in America."
For example, the bill would require counsel for a plaintiff to submit sufficient verification of the allegations within 45 days of filing the civil action.
Verification of allegations include "evidentiary support (including but not limited to medical records) for the factual contentions in plaintiff's complaint regarding the alleged injury, the exposure to the risk that allegedly caused the injury and the alleged cause of the injury."
This deadline cannot be extended, and if the judge decides the evidentiary support is insufficient, the civil action is to be dismissed without prejudice. The class action must also prove that each class member "suffered the same type and scope of injury as the named class representative or representatives."
Ironically, the bill would also require all class members to prove they have no conflicts of interest in the case.
Scientific Consensus Statement on Glyphosate
In February, 2016, a group of researchers published a consensus statement15,16 on glyphosate-based herbicides (GBH). As noted in this paper, GBHs "were developed to replace or reduce reliance on herbicides causing well-documented problems associated with drift and crop damage, slipping efficacy and human health risks."Initial toxicity testing by the industry itself suggested these formulations posed low risks to non-target species, mammals and human health. As a result, high acceptable exposure limits were set worldwide. Limits were raised even higher to accommodate increased usage on genetically engineered (GE), herbicide-tolerant crops.
Since 1974, 1.8 million tons of glyphosate have been applied to U.S. fields; two-thirds of that volume has been sprayed in the last 10 years.17 Between 1974 and 2014, 9.4 million tons of glyphosate were used worldwide.
However, the scientific evidence that has emerged over the past decade "point to the need for a fresh look at glyphosate toxicity."
Based on "current published literature describing GBH uses, mechanisms of action, toxicity in laboratory animals, and epidemiological studies," the authors present seven conclusions, starting with the facts that GBHs are the most widely applied herbicides in the world, and that glyphosate is a commonly found contaminant in drinking water, rain and air. In addition to that, the scientific evidence suggests that:
- The half-life of glyphosate in water and soil is longer than previously recognized
- Glyphosate and its metabolites are widely present in the global soybean supply
- Human exposures to GBHs are rising
- Glyphosate is now authoritatively classified as a probable human carcinogen
- Regulatory estimates of tolerable daily intakes for glyphosate in the United States and European Union are based on outdated science
Causative Link Found Between Glyphosate and Fatty Liver Disease
The paper recommends investing in more studies "that draw on the principles of endocrinology to determine whether the effects of GBHs are due to endocrine disrupting activities." This recommendation arose from findings that glyphosate displays hormone-disrupting effects in some experiments, and many endocrine disrupting (ED) chemicals are known to affect human health even at minute levels.For example, in one recent animal study,18 Roundup was found to cause fatty liver disease at 0.1 parts per billion (ppb) in drinking water, which is 14,000 times lower than the concentration permitted in U.S. drinking water (700 ppb). At this dose, the daily intake level of glyphosate amounted to 4 nanograms per kilogram of bodyweight per day, which is 437,500 times below the permitted intake level in the U.S.
This is said to be the first study to present a causative link between dietary exposure to Roundup and serious disease, and endocrine disruption is one of the proposed mechanisms. Disturbingly, previous tests showing glyphosate levels in urine suggest Americans have a daily intake of glyphosate that is about 1,000-fold higher than the level found to cause fatty liver disease in rats.
Another recent study found Roundup adversely affects the development of female rats' uteruses, increasing the risk for both infertility and uterine cancer.19 So why is no action taken to protect human health? It really boils down to the fact that without Roundup and other GBHs the GE seed business would collapse, and chemical technology companies, with their vast resources and revolving doors into government regulatory agencies, have managed to deceive people into thinking there's no problem.
Many Organizations Warn Endocrine Disrupting Chemical Exposures Are Affecting Human Health
According to a report20,21 by the International Federation of Gynecology and Obstetrics,22 which represents OB-GYNs in 125 countries, chemical exposures, including pesticides, represent a major threat to human health and reproduction. Pesticides are also included in a recent scientific statement on endocrine-disrupting chemicals by the Endocrine Society task force.23,24This task force warns that the health effects of hormone-disrupting chemicals is such that everyone needs to take proactive steps to avoid them — especially those seeking to get pregnant, pregnant women and young children, as even extremely low-level pesticide exposures have been found to considerably increase the risk of certain diseases.
For example, evidence25 suggests endocrine disrupting chemicals (EDCs) play a role in obesity, diabetes-related non-alcoholic fatty liver disease, reduced fertility, hormone-sensitive cancers, thyroid diseases and neurodevelopmental diseases. According to GM Watch:26
"Scientists have calculated that in the U.S. alone, pesticide EDs cause some 7,500 annual serious disability cases and generate annual medical and lost work costs of about $45 billion. A study (covering some … EDC-associated diseases within the [EU] puts annual costs to health services within this region at €150 billion per annum and some $340 billion in the U.S."The author of that GM Watch article, Ramon Seidler, Ph.D., a retired senior research scientist and team leader of the Genetically Engineered Organism biosafety program at the EPA, concludes:
"It is long past time for the U.S. Congress to change the rules that now require industry to study and report risk evaluations to regulators prior to sale of new chemicals. Realities dictate that the opposite should be the case; i.e., regulators and government or academic scientists should conduct and study chemical safety parameters and report the independent results to industry. Funding for such determinations could come from an industry registration tax for each chemical being registered ...
Today we need to know why the U.S. EPA and other regulators around the world continue to make what many scientists and members of the public feel are decisions that lack common sense. In the U.S., I believe that we need publicly visible, politically courageous investigations within regulatory agencies, perhaps conducted by the Office of Inspector General, to attempt resolution of these crucial matters …"
Potential Health Effects of Glyphosate Exposure
Glyphosate is most heavily applied on GE corn, soybeans and sugar beets, but it's also commonly used to desiccate conventional (non-GMO but non-organic) wheat and protect other conventional crops from weeds. Glyphosate and Roundup may be even worse than DDT, having been linked to an ever-growing array of health effects, including:27,28| Nutritional deficiencies, especially minerals, as glyphosate immobilizes certain nutrients and alters the nutritional composition of the treated crop | Disruption of the biosynthesis of aromatic amino acids (these are essential amino acids not produced in your body that must be supplied via your diet) |
| Increased toxin exposure (this includes high levels of glyphosate and formaldehyde in the food itself) | Impairment of sulfate transport and sulfur metabolism; sulfate deficiency |
| Systemic toxicity — a side effect of extreme disruption of microbial function throughout your body; beneficial microbes in particular, allowing for overgrowth of pathogens | Gut dysbiosis (imbalances in gut bacteria, inflammation, leaky gut and food allergies such as gluten intolerance) |
| Enhancement of damaging effects of other food-borne chemical residues and environmental toxins as a result of glyphosate shutting down the function of detoxifying enzymes | Creation of ammonia (a byproduct created when certain microbes break down glyphosate), which can lead to brain inflammation associated with autism and Alzheimer's disease |
| Increased antibiotic resistance | Increased cancer risk29,30,31,32 |
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