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New Evidence Shows Monsanto’s Manipulation of Science to Hide Herbicide Risks

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

Dear Friends and Colleagues

New Evidence Shows Monsanto’s Manipulation of Science to Hide Herbicide Risks

Four months after the publication of a batch of internal Monsanto documents stirred international controversy over whether or not the agricultural chemical giant suppressed information about the potential dangers of its Roundup herbicide and relied on U.S. regulators for help, a new trove of company records was released early this August.

More than 75 documents, including text messages and discussions about payments to scientists, were posted for public viewing by attorneys who are suing Monsanto on behalf of thousands of plaintiffs in the US alleging Roundup caused them or their family members to become ill with non-Hodgkin lymphoma, a type of blood cancer (Item 1). The documents were obtained through court order. The documents allegedly show a lack of robust testing of formulated Roundup products; Monsanto executives colluding with EPA officials to manipulate and bury scientific data to kill studies when preliminary data threatened Monsanto’s business; bribing scientists and ghostwriting their publications; and purchasing peer review to conceal information about Roundup’s carcinogenicity, toxicity, rapid absorption by the human body, and severe risks to public health and the environment.

Glyphosate is the active ingredient in Roundup brands as well as hundreds of other herbicides. It is the most widely used herbicide globally, and is used in conjunction with GM crops engineered to be resistant to the herbicide. There have been studies to suggest that formulations of glyphosate with other substances used in Roundup are more toxic that glyphosate alone, and can possibly cause cancer, endocrine disruption, and other health problems.

Internal documents of theU.S. Environmental Protection Agency (EPA), released in response to a Freedom of Information Act (FOIA) lawsuit, indicate that in March and April of 2016, EPA officials were scrambling to gather data on ingredients Monsanto commonly used to formulate its herbicide products (Item 2). The scramble for data came after the agency was poised to issue an updated favorable risk assessment of glyphosate in 2015 following the International Agency for Research on Cancer’s (IARC) classification of glyphosate as a probable human carcinogen. Even as the EPA was working to gather details on the Roundup formulations, it was at the same time apparently assuring the public that there was no reason for concern because the EPA had the information needed to gauge the safety of such formulations.

 

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Item 1

JUST-RELEASED DOCS SHOW MONSANTO ‘EXECUTIVES COLLUDING WITH CORRUPTED EPA OFFICIALS TO MANIPULATE SCIENTIFIC DATA’

Carey Gillam
U.S. Right to Know
3 August 2017
http://www.alternet.org/environment/just-released-docs-show-monsanto-executives-colluding-corrupted-epa-officials-manipulate

The damning documents were released by plaintiffs suing Monsanto in a claim that Roundup caused them to become ill with non-Hodgkin lymphoma.

Four months after the publication of a batch of internal Monsanto Co. documents stirred international controversy, a new trove of company records was released early Tuesday, providing fresh fuel for a heated global debate over whether or not the agricultural chemical giant suppressed information about the potential dangers of its Roundup herbicide and relied on U.S. regulators for help.

More than 75 documents, including intriguing text messages and discussions about payments to scientists, were posted for public viewing early Tuesday morning by attorneys who are suing Monsanto on behalf of people alleging Roundup caused them or their family members to become ill with non-Hodgkin lymphoma, a type of blood cancer. The attorneys posted the documents, which total more than 700 pages, on the website for the law firm Baum, Hedlund, Aristei & Goldman, one of many firms representing thousands of plaintiffs who are pursuing claims against Monsanto. More than 100 of those lawsuits have been consolidated in multidistrict litigation in federal court in San Francisco, while other similar lawsuits are pending in state courts in Missouri, Delaware, Arizona and elsewhere. The documents, which were obtained through court-ordered discovery in the litigation, are also available as part of a long list of Roundup court case documents compiled by the consumer group I work for, U.S. Right to Know.

It was important to release the documents now because they not only pertain to the ongoing litigation, but also to larger issues of public health and safety, while shedding light on corporate influence over regulatory bodies, according to Baum Hedlund attorneys Brent Wisner and Pedram Esfandiary.

"This is a look behind the curtain," said Wisner. "These show that Monsanto has deliberately been stopping studies that look bad for them, ghostwriting literature and engaging in a whole host of corporate malfeasance. They [Monsanto] have been telling everybody that these products are safe because regulators have said they are safe, but it turns out that Monsanto has been in bed with U.S. regulators while misleading European regulators."

Esfandiary said public dissemination of the documents is important because regulatory agencies cannot properly protect public and environmental health without having accurate, comprehensive and impartial scientific data, and the documents show that has not been the case with Monsanto’s Roundup herbicide and the active ingredient glyphosate.

When reached for comment, Robert F. Kennedy, Jr., one of the plaintiffs’ lawyers said, "This trove marks a turning point in Monsanto’s corporate life. They show Monsanto executives colluding with corrupted EPA officials to manipulate and bury scientific data to kill studies when preliminary data threatened Monsanto’s commercial ambitions, bribing scientists and ghostwriting their publications, and purchasing peer review to conceal information about Roundup’s carcinogenicity, its toxicity, its rapid absorption by the human body, and its horrendous risks to public health and the environment."

"We can now prove that all Monsanto’s claims about glyphosate’s safety were myths concocted by amoral propaganda and lobbying teams," Kennedy continued. "Monsanto has been spinning its lethal yarn to everybody for years and suborning various perjuries from regulators and scientists who have all been lying in concert to American farmers, landscapers and consumers. It’s shocking no matter how jaded you are! These new revelations are commiserate with the documents that brought down big tobacco."

Several of the documents discuss a lack of robust testing of formulated Roundup products. In one email, Monsanto scientist Donna Farmer writes "you cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement. The testing on the formulations are not anywhere near the level of the active ingredient."

The release of the documents Tuesday came without the blessing of Judge Vince Chhabria, who is overseeing the multidistrict litigation moving its way through the U.S. District Court for the Northern District of California. In March, Chhabria did agree to unseal several other discovery documents—over Monsanto’s objections—and those documents prompted a wave of outrage for what they revealed: questionable research practices by Monsanto, cozy ties to a top official within the U.S. Environmental Protection Agency (EPA), and indications that Monsanto may have engaged in "ghostwriting," of research studies that appeared to be independent of the company.

The revelations within those documents prompted an investigation by the EPA’s Office of Inspector General into possible Monsanto-EPA collusion, and roiled Europe where regulators now are trying to decide whether or not to reauthorize glyphosate, which is the most widely used herbicide in the world and is found in numerous products in addition to Roundup.

The lawyers said they are sending copies of the documents to European authorities, to the EPA’s OIG and to the California Office of Environmental Health Hazard Assessment (OEHHA), which has been sued by Monsanto for moving to list glyphosate as a known carcinogen

Monsanto has fought to keep most of the documents it turned over in discovery sealed, complaining to Judge Chhabria that in several court filings plaintiffs’ attorneys presented discovery materials out of context and tried to exploit the information to influence public opinion. Chhabria has both chided Monsanto for trying to improperly seal certain documents and warned plaintiffs’ attorneys against unfairly publicizing certain documents. It is unclear how Judge Chhabria will react, if at all, to the law firm’s release of these more than 75 documents.

Baum Hedlund attorneys said they notified Monsanto on June 30 of their intent to unveil the 75+ documents and gave Monsanto the legally required 30-day window to formally object. That period expired Monday, clearing the way for them to make the release early Tuesday, said Wisner.

Concerns about the safety of glyphosate and Roundup have been growing for years amid mounting research showing links to cancer or other diseases. But the lawsuits only began to accumulate after the International Agency for Research on Cancer (IARC) in 2015 classified glyphosate as a probable human carcinogen. The plaintiffs in the lawsuits allege that the combination of glyphosate with certain surfactants used in Monsanto-branded Roundup products is even more toxic than glyphosate alone, and Monsanto has sought to cover up that information.

Monsanto has publicly denied that there are cancer connections to glyphosate or Roundup and said 40 years of research and scrutiny by regulatory agencies around the world confirm its safety.

Monsanto has made billions of dollars a year for decades from its glyphosate-based herbicides, and they are the linchpin to billions of dollars more it makes each year from the genetically engineered glyphosate-tolerant crops it markets. The company is currently moving toward a planned merger with Bayer AG.

Item 2

INTERNAL EPA DOCUMENTS SHOW SCRAMBLE FOR DATA ON MONSANTO’S ROUNDUP

Carey Gillam
7 August 2017
https://www.ecowatch.com/epa-monsanto-roundup-2470250508.html

As agrochemical giant Monsanto Co. faces a growing wave of U.S. lawsuits over its top-selling Roundupherbicide line, among its key defense arguments is that the U.S. Environmental Protection Agency (EPA) has long backed the safety of the weed-killing products.

And indeed, the EPA has been a stalwart supporter of Monsanto Co.’s claims of safety, assuring the public that there is nothing to fear from the company’s cocktail of chemicals. But internal agency documents, released in response to a Freedom of Information Act (FOIA) lawsuit, indicate that as recently as last year, the agency had holes in its data files when it comes to the actual Roundup formulations used by consumers, farmers and others around the world. The documents also raise questions about how and why regulators for years have failed to require robust testing on what is the world’s most widely used weed killer.

The EPA documents show that only a little more than a year ago, in March and April of 2016, EPA officials were scrambling to gather data on ingredients Monsanto has commonly used to formulate its herbicide products. Glyphosate is the active ingredient in Roundup brands as well as hundreds of other herbicides, and the agency has a deep database of studies submitted by Monsanto regarding that specific chemical. But in the EPA records from 2016, the agency is seen urgently asking Monsanto for any studies it could provide analyzing the safety of its fully formulated products and seeking to understand the make-up of formulations used for decades. Even though Monsanto has been selling Roundup herbicides for more than 40 years, the internal agency documents indicate the agency had only sparse information about those formulations.

The EPA’s interest in scrutinizing formulations came after the agency was poised to issue an updated favorable risk assessment of glyphosate in 2015. The agency only delayed finalizing that assessment after the International Agency for Research on Cancer (IARC) reported in 2015 that there was enough peer-reviewed, published research to classify glyphosate as a probable human carcinogen. IARC also noted in its report that there was research showing risks with formulations.

The EPA appeared to be playing catch-up in March of last year when agency officials requested information from Monsanto on the inert ingredients in popular U.S. and European formulations of glyphosate used in "the present day and also dating back to the 80s." EPA was particularly interested in "information on how glyphosate formulations have changed over time in the last 20-30 years."

The EPA records also show a certain level of double-talk about that lack of data. Even as the agency was working to gather details on the Roundup formulations, the agency was at the same time assuring the public that there was no reason for concern because the EPA had the information needed to gauge the safety of those formulations.

Consider this statement from the agency:

"Often, glyphosate products contain water, dyes, and/or surfactants that help facilitate movement of glyphosate into the plant…" EPA Chemical Review Manager Khue Nguyen wrote in January 2016 to an 83-year-old homeowner who had read about Roundup concerns and written to the agency seeking answers. "While manufacturers of pesticide products do not always disclose all ‘other ingredients’ on their labels … they are required to disclose those ingredients to EPA. Inert ingredients in a product such as Roundup are not of concern for the consumer when pesticide products are used according to the label."

Contrast those public assurances about the EPA’s knowledge of Roundup ingredients with an internal discussion documented by Nguyen three months later. In an email dated April 6, 2016, Nguyen reminded five Monsanto executives that the EPA had a "time sensitive" information request—it needed data, and the notes attached to the email show a particular need for data on glyphosate formulations:

"In an effort to resolve questions about the potential toxicity of glyphosate, glyphosate formulations, and any co-formulants (inert ingredients and surfactants), EPA was interested in any data or information Monsanto may have on how the formulations may differ from data on the active ingredient and surfactants independently of one another," the notes attached to Nguyen’s email state. The notes go on to ask for information about changes in Monsanto’s Roundup formulation "over the years."

The notes state "Monsanto indicated that up until 2000, nearly all glyphosate products on the market were its Roundup formulation which used some form of tallow amine as a surfactant. Afterwards, the properties of surfactants used and the ratio of surfactant to active ingredient were changed in most formulations… EPA suggested that Monsanto provide in writing any information that documents the changes of glyphosate formulations over time and across the globe."

Subsequent to that meeting, Monsanto did send over some data, and in a follow-up email dated April 18, 2016, an EPA scientist sought clarification about what to look for. "Just to be clear on our strategy here, we want to see which of these we have or don’t have, and we also want to see if there are any formulation studies that will help our analysis. Does that sound right?"

It is heartening that EPA is starting to pay attention to questions about the safety of Roundup formulations, but such evaluations are long overdue and the agency’s public assurances of safety despite the lack of data is "such hypocrisy," said Michael Hansen, senior staff scientist with the Consumers Union. "And it’s an admission that this is a big problem."

These mixtures, or formulations, have raised concerns with certain independent scientists who say laboratory studies show the combinations of glyphosate with other substances used in Roundup are more toxic that glyphosate alone, and can possibly cause cancer or other health problems. Some research has indicated the formulations can be endocrine disruptors, meaning they have the potential to trigger serious diseases such as cancers, reproductive and developmental problems, and birth defects.

The EPA’s knowledge—or lack thereof—about formulated Roundup products is also potentially important to litigation pending against Monsanto. Thousands of people around the United States are suing the chemical company, alleging that not only did Roundup exposure cause them or their loved ones to get cancer, but that Monsanto knew the Roundup formulations could be harmful but covered up the evidence. They also allege that certain EPA officials colluded with Monsanto in the handling of safety assessments, and the EPA’s Office of Inspector General (OIG) has confirmed it is probing those concerns.

One ingredient traditionally used in Roundup has been the focus of particular scrutiny as some research has shown that this added ingredient, polyethoxylated tallow amine (POEA), can be extremely damaging to human cells. POEA is a surfactant that helps glyphosate adhere to the leaves of plants. European regulators became so concerned with POEA that in 2016 they agreed to ban it from use as a co-formulant in glyphosate-based herbicides after the European Food Safety Authority (EFSA), in a 2015 report, said there was insufficient data available to perform a risk assessment on POEA. EFSA stated: "Its genotoxicity, long term toxicity/carcinogenicity, reproductive/developmental toxicity and endocrine disrupting potential should be further clarified."

In part of the April 18, 2016 email string with the EPA, a Monsanto executive confirmed the widespread use of POEA in its products, telling the EPA "the surfactant system used almost exclusively in Roundup agricultural herbicide formulations globally throughout these two decades (the 1980s and 1990s) contained a polyethoxylated tallow amine surfactant…"

Monsanto says on its website that tallowamine-based products "do not pose an imminent risk for human health when used according to instructions" and points out that in 2009 the EPA exempted the surfactant from legal limitations on residues in food, because there "is a reasonable certainty that no harm will result to the general population…"

Still, the company itself has admitted a lack of extensive safety tests on its formulated products. In an internal Monsanto email from December 2010, a Monsanto chemistry regulatory affairs manager noted that "with regards to the carcinogenicity of our formulations we don’t have such testing on them directly…" The manager went on to explain that the company has "extensive testing" on glyphosate and "some extensive tox testing" on the surfactant and should be able to address questions about the safety of its formulations "in a confident manner." That email and hundreds of others were obtained by plaintiffs as part of discovery in the lawsuits against Monsanto.

In a 2002 email also obtained as part of discovery in the court case, a Monsanto scientist writes to a colleague, "we are in pretty good shape with glyphosate but vulnerable with surfactants. What I’ve been hearing from you is that this continues to be the case with these studies – Glyphosate is OK but the formulated product (and thus the surfactant) does the damage." In another 2002 email between the same Monsanto colleagues, the scientist writes, "Even though no testing requirements have been implemented for several years now, this damn endocrine crap just doesn’t go away, does it."

And in a 2003 email, a Monsanto toxicologist writes, "you cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement. The testing on the formulations are not anywhere near the level of the active ingredient. We can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer."

An EPA spokesman confirmed that the agency does not "routinely require long-term toxicity studies for pesticide product formulations" as it does for active ingredients like glyphosate. He added, however, that all inert ingredients in pesticide products, must be approved for use by EPA and "each component of an inert mixture must be supported by a battery of toxicity data and must be approved for use by EPA."

Further, the EPA spokesman said, "If there are data to indicate risk for a formulated mixture, EPA evaluates the potential effects in our risk assessments. The human health risk assessment process is conservative… thus ensuring that when a pesticide is used according to the label, people are well protected."

The EPA’s recent interest in pursuing questions about formulated glyphosate products was also seen in September 2016, when the agency stated that it was collaborating with the National Toxicology Program(NTP) Division of the National Institute of Environmental Health Sciences to develop a research plan that would evaluate "the role of glyphosate in product formulations and the differences in formulation toxicity." The agency acknowledged that "currently, the publicly available information regarding non-cancer endpoints for glyphosate and glyphosate formulations is limited."

The status of EPA’s involvement in that collaboration is unknown but the NTP confirms on its website that it is "undertaking additional research to investigate the potential genetic and mechanistic toxicity of glyphosate and glyphosate formulations."

Still, CropLife America, the lobbying group for Monsanto and other agrochemical industry players, have made it clear such an inquiry is not welcomed. In a letter dated October 2016, CropLife questioned "why EPA would collaborate and develop a research program with the National Toxicology Program (NTP) without input from the registrant." That registrant, Monsanto, "would be the appropriate source" for data EPA might need, CropLife wrote.

September 5th, 2017 | Category: Science Policy
«  
  »

New Evidence Shows Monsanto’s Manipulation of Science to Hide Herbicide Risks

Item 1

JUST-RELEASED DOCS SHOW MONSANTO ‘EXECUTIVES COLLUDING WITH CORRUPTED EPA OFFICIALS TO MANIPULATE SCIENTIFIC DATA’

Carey Gillam
U.S. Right to Know
3 August 2017
http://www.alternet.org/environment/just-released-docs-show-monsanto-executives-colluding-corrupted-epa-officials-manipulate

The damning documents were released by plaintiffs suing Monsanto in a claim that Roundup caused them to become ill with non-Hodgkin lymphoma.

Four months after the publication of a batch of internal Monsanto Co. documents stirred international controversy, a new trove of company records was released early Tuesday, providing fresh fuel for a heated global debate over whether or not the agricultural chemical giant suppressed information about the potential dangers of its Roundup herbicide and relied on U.S. regulators for help.

More than 75 documents, including intriguing text messages and discussions about payments to scientists, were posted for public viewing early Tuesday morning by attorneys who are suing Monsanto on behalf of people alleging Roundup caused them or their family members to become ill with non-Hodgkin lymphoma, a type of blood cancer. The attorneys posted the documents, which total more than 700 pages, on the website for the law firm Baum, Hedlund, Aristei & Goldman, one of many firms representing thousands of plaintiffs who are pursuing claims against Monsanto. More than 100 of those lawsuits have been consolidated in multidistrict litigation in federal court in San Francisco, while other similar lawsuits are pending in state courts in Missouri, Delaware, Arizona and elsewhere. The documents, which were obtained through court-ordered discovery in the litigation, are also available as part of a long list of Roundup court case documents compiled by the consumer group I work for, U.S. Right to Know.

It was important to release the documents now because they not only pertain to the ongoing litigation, but also to larger issues of public health and safety, while shedding light on corporate influence over regulatory bodies, according to Baum Hedlund attorneys Brent Wisner and Pedram Esfandiary.

"This is a look behind the curtain," said Wisner. "These show that Monsanto has deliberately been stopping studies that look bad for them, ghostwriting literature and engaging in a whole host of corporate malfeasance. They [Monsanto] have been telling everybody that these products are safe because regulators have said they are safe, but it turns out that Monsanto has been in bed with U.S. regulators while misleading European regulators."

Esfandiary said public dissemination of the documents is important because regulatory agencies cannot properly protect public and environmental health without having accurate, comprehensive and impartial scientific data, and the documents show that has not been the case with Monsanto’s Roundup herbicide and the active ingredient glyphosate.

When reached for comment, Robert F. Kennedy, Jr., one of the plaintiffs’ lawyers said, "This trove marks a turning point in Monsanto’s corporate life. They show Monsanto executives colluding with corrupted EPA officials to manipulate and bury scientific data to kill studies when preliminary data threatened Monsanto’s commercial ambitions, bribing scientists and ghostwriting their publications, and purchasing peer review to conceal information about Roundup’s carcinogenicity, its toxicity, its rapid absorption by the human body, and its horrendous risks to public health and the environment."

"We can now prove that all Monsanto’s claims about glyphosate’s safety were myths concocted by amoral propaganda and lobbying teams," Kennedy continued. "Monsanto has been spinning its lethal yarn to everybody for years and suborning various perjuries from regulators and scientists who have all been lying in concert to American farmers, landscapers and consumers. It’s shocking no matter how jaded you are! These new revelations are commiserate with the documents that brought down big tobacco."

Several of the documents discuss a lack of robust testing of formulated Roundup products. In one email, Monsanto scientist Donna Farmer writes "you cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement. The testing on the formulations are not anywhere near the level of the active ingredient."

The release of the documents Tuesday came without the blessing of Judge Vince Chhabria, who is overseeing the multidistrict litigation moving its way through the U.S. District Court for the Northern District of California. In March, Chhabria did agree to unseal several other discovery documents—over Monsanto’s objections—and those documents prompted a wave of outrage for what they revealed: questionable research practices by Monsanto, cozy ties to a top official within the U.S. Environmental Protection Agency (EPA), and indications that Monsanto may have engaged in "ghostwriting," of research studies that appeared to be independent of the company.

The revelations within those documents prompted an investigation by the EPA’s Office of Inspector General into possible Monsanto-EPA collusion, and roiled Europe where regulators now are trying to decide whether or not to reauthorize glyphosate, which is the most widely used herbicide in the world and is found in numerous products in addition to Roundup.

The lawyers said they are sending copies of the documents to European authorities, to the EPA’s OIG and to the California Office of Environmental Health Hazard Assessment (OEHHA), which has been sued by Monsanto for moving to list glyphosate as a known carcinogen

Monsanto has fought to keep most of the documents it turned over in discovery sealed, complaining to Judge Chhabria that in several court filings plaintiffs’ attorneys presented discovery materials out of context and tried to exploit the information to influence public opinion. Chhabria has both chided Monsanto for trying to improperly seal certain documents and warned plaintiffs’ attorneys against unfairly publicizing certain documents. It is unclear how Judge Chhabria will react, if at all, to the law firm’s release of these more than 75 documents.

Baum Hedlund attorneys said they notified Monsanto on June 30 of their intent to unveil the 75+ documents and gave Monsanto the legally required 30-day window to formally object. That period expired Monday, clearing the way for them to make the release early Tuesday, said Wisner.

Concerns about the safety of glyphosate and Roundup have been growing for years amid mounting research showing links to cancer or other diseases. But the lawsuits only began to accumulate after the International Agency for Research on Cancer (IARC) in 2015 classified glyphosate as a probable human carcinogen. The plaintiffs in the lawsuits allege that the combination of glyphosate with certain surfactants used in Monsanto-branded Roundup products is even more toxic than glyphosate alone, and Monsanto has sought to cover up that information.

Monsanto has publicly denied that there are cancer connections to glyphosate or Roundup and said 40 years of research and scrutiny by regulatory agencies around the world confirm its safety.

Monsanto has made billions of dollars a year for decades from its glyphosate-based herbicides, and they are the linchpin to billions of dollars more it makes each year from the genetically engineered glyphosate-tolerant crops it markets. The company is currently moving toward a planned merger with Bayer AG.

Item 2

INTERNAL EPA DOCUMENTS SHOW SCRAMBLE FOR DATA ON MONSANTO’S ROUNDUP

Carey Gillam
7 August 2017
https://www.ecowatch.com/epa-monsanto-roundup-2470250508.html

As agrochemical giant Monsanto Co. faces a growing wave of U.S. lawsuits over its top-selling Roundupherbicide line, among its key defense arguments is that the U.S. Environmental Protection Agency (EPA) has long backed the safety of the weed-killing products.

And indeed, the EPA has been a stalwart supporter of Monsanto Co.’s claims of safety, assuring the public that there is nothing to fear from the company’s cocktail of chemicals. But internal agency documents, released in response to a Freedom of Information Act (FOIA) lawsuit, indicate that as recently as last year, the agency had holes in its data files when it comes to the actual Roundup formulations used by consumers, farmers and others around the world. The documents also raise questions about how and why regulators for years have failed to require robust testing on what is the world’s most widely used weed killer.

The EPA documents show that only a little more than a year ago, in March and April of 2016, EPA officials were scrambling to gather data on ingredients Monsanto has commonly used to formulate its herbicide products. Glyphosate is the active ingredient in Roundup brands as well as hundreds of other herbicides, and the agency has a deep database of studies submitted by Monsanto regarding that specific chemical. But in the EPA records from 2016, the agency is seen urgently asking Monsanto for any studies it could provide analyzing the safety of its fully formulated products and seeking to understand the make-up of formulations used for decades. Even though Monsanto has been selling Roundup herbicides for more than 40 years, the internal agency documents indicate the agency had only sparse information about those formulations.

The EPA’s interest in scrutinizing formulations came after the agency was poised to issue an updated favorable risk assessment of glyphosate in 2015. The agency only delayed finalizing that assessment after the International Agency for Research on Cancer (IARC) reported in 2015 that there was enough peer-reviewed, published research to classify glyphosate as a probable human carcinogen. IARC also noted in its report that there was research showing risks with formulations.

The EPA appeared to be playing catch-up in March of last year when agency officials requested information from Monsanto on the inert ingredients in popular U.S. and European formulations of glyphosate used in "the present day and also dating back to the 80s." EPA was particularly interested in "information on how glyphosate formulations have changed over time in the last 20-30 years."

The EPA records also show a certain level of double-talk about that lack of data. Even as the agency was working to gather details on the Roundup formulations, the agency was at the same time assuring the public that there was no reason for concern because the EPA had the information needed to gauge the safety of those formulations.

Consider this statement from the agency:

"Often, glyphosate products contain water, dyes, and/or surfactants that help facilitate movement of glyphosate into the plant…" EPA Chemical Review Manager Khue Nguyen wrote in January 2016 to an 83-year-old homeowner who had read about Roundup concerns and written to the agency seeking answers. "While manufacturers of pesticide products do not always disclose all ‘other ingredients’ on their labels … they are required to disclose those ingredients to EPA. Inert ingredients in a product such as Roundup are not of concern for the consumer when pesticide products are used according to the label."

Contrast those public assurances about the EPA’s knowledge of Roundup ingredients with an internal discussion documented by Nguyen three months later. In an email dated April 6, 2016, Nguyen reminded five Monsanto executives that the EPA had a "time sensitive" information request—it needed data, and the notes attached to the email show a particular need for data on glyphosate formulations:

"In an effort to resolve questions about the potential toxicity of glyphosate, glyphosate formulations, and any co-formulants (inert ingredients and surfactants), EPA was interested in any data or information Monsanto may have on how the formulations may differ from data on the active ingredient and surfactants independently of one another," the notes attached to Nguyen’s email state. The notes go on to ask for information about changes in Monsanto’s Roundup formulation "over the years."

The notes state "Monsanto indicated that up until 2000, nearly all glyphosate products on the market were its Roundup formulation which used some form of tallow amine as a surfactant. Afterwards, the properties of surfactants used and the ratio of surfactant to active ingredient were changed in most formulations… EPA suggested that Monsanto provide in writing any information that documents the changes of glyphosate formulations over time and across the globe."

Subsequent to that meeting, Monsanto did send over some data, and in a follow-up email dated April 18, 2016, an EPA scientist sought clarification about what to look for. "Just to be clear on our strategy here, we want to see which of these we have or don’t have, and we also want to see if there are any formulation studies that will help our analysis. Does that sound right?"

It is heartening that EPA is starting to pay attention to questions about the safety of Roundup formulations, but such evaluations are long overdue and the agency’s public assurances of safety despite the lack of data is "such hypocrisy," said Michael Hansen, senior staff scientist with the Consumers Union. "And it’s an admission that this is a big problem."

These mixtures, or formulations, have raised concerns with certain independent scientists who say laboratory studies show the combinations of glyphosate with other substances used in Roundup are more toxic that glyphosate alone, and can possibly cause cancer or other health problems. Some research has indicated the formulations can be endocrine disruptors, meaning they have the potential to trigger serious diseases such as cancers, reproductive and developmental problems, and birth defects.

The EPA’s knowledge—or lack thereof—about formulated Roundup products is also potentially important to litigation pending against Monsanto. Thousands of people around the United States are suing the chemical company, alleging that not only did Roundup exposure cause them or their loved ones to get cancer, but that Monsanto knew the Roundup formulations could be harmful but covered up the evidence. They also allege that certain EPA officials colluded with Monsanto in the handling of safety assessments, and the EPA’s Office of Inspector General (OIG) has confirmed it is probing those concerns.

One ingredient traditionally used in Roundup has been the focus of particular scrutiny as some research has shown that this added ingredient, polyethoxylated tallow amine (POEA), can be extremely damaging to human cells. POEA is a surfactant that helps glyphosate adhere to the leaves of plants. European regulators became so concerned with POEA that in 2016 they agreed to ban it from use as a co-formulant in glyphosate-based herbicides after the European Food Safety Authority (EFSA), in a 2015 report, said there was insufficient data available to perform a risk assessment on POEA. EFSA stated: "Its genotoxicity, long term toxicity/carcinogenicity, reproductive/developmental toxicity and endocrine disrupting potential should be further clarified."

In part of the April 18, 2016 email string with the EPA, a Monsanto executive confirmed the widespread use of POEA in its products, telling the EPA "the surfactant system used almost exclusively in Roundup agricultural herbicide formulations globally throughout these two decades (the 1980s and 1990s) contained a polyethoxylated tallow amine surfactant…"

Monsanto says on its website that tallowamine-based products "do not pose an imminent risk for human health when used according to instructions" and points out that in 2009 the EPA exempted the surfactant from legal limitations on residues in food, because there "is a reasonable certainty that no harm will result to the general population…"

Still, the company itself has admitted a lack of extensive safety tests on its formulated products. In an internal Monsanto email from December 2010, a Monsanto chemistry regulatory affairs manager noted that "with regards to the carcinogenicity of our formulations we don’t have such testing on them directly…" The manager went on to explain that the company has "extensive testing" on glyphosate and "some extensive tox testing" on the surfactant and should be able to address questions about the safety of its formulations "in a confident manner." That email and hundreds of others were obtained by plaintiffs as part of discovery in the lawsuits against Monsanto.

In a 2002 email also obtained as part of discovery in the court case, a Monsanto scientist writes to a colleague, "we are in pretty good shape with glyphosate but vulnerable with surfactants. What I’ve been hearing from you is that this continues to be the case with these studies – Glyphosate is OK but the formulated product (and thus the surfactant) does the damage." In another 2002 email between the same Monsanto colleagues, the scientist writes, "Even though no testing requirements have been implemented for several years now, this damn endocrine crap just doesn’t go away, does it."

And in a 2003 email, a Monsanto toxicologist writes, "you cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement. The testing on the formulations are not anywhere near the level of the active ingredient. We can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer."

An EPA spokesman confirmed that the agency does not "routinely require long-term toxicity studies for pesticide product formulations" as it does for active ingredients like glyphosate. He added, however, that all inert ingredients in pesticide products, must be approved for use by EPA and "each component of an inert mixture must be supported by a battery of toxicity data and must be approved for use by EPA."

Further, the EPA spokesman said, "If there are data to indicate risk for a formulated mixture, EPA evaluates the potential effects in our risk assessments. The human health risk assessment process is conservative… thus ensuring that when a pesticide is used according to the label, people are well protected."

The EPA’s recent interest in pursuing questions about formulated glyphosate products was also seen in September 2016, when the agency stated that it was collaborating with the National Toxicology Program(NTP) Division of the National Institute of Environmental Health Sciences to develop a research plan that would evaluate "the role of glyphosate in product formulations and the differences in formulation toxicity." The agency acknowledged that "currently, the publicly available information regarding non-cancer endpoints for glyphosate and glyphosate formulations is limited."

The status of EPA’s involvement in that collaboration is unknown but the NTP confirms on its website that it is "undertaking additional research to investigate the potential genetic and mechanistic toxicity of glyphosate and glyphosate formulations."

Still, CropLife America, the lobbying group for Monsanto and other agrochemical industry players, have made it clear such an inquiry is not welcomed. In a letter dated October 2016, CropLife questioned "why EPA would collaborate and develop a research program with the National Toxicology Program (NTP) without input from the registrant." That registrant, Monsanto, "would be the appropriate source" for data EPA might need, CropLife wrote.

September 5th, 2017 | Category: Biosafety Science
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