New analysis of glyphosate industry studies finds them outdated, flawed

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See Carey Gillam’s article in The Guardian, Corporate studies asserting herbicide safety show many flaws, new analysis finds (July 2, 2021). In this post we provide links to the 53 once-secret studies and related materials. 

Questions about the safety of glyphosate-based herbicides (GBHs) have persisted for years, as scientific research has split over whether or not the widely used weed killing chemical introduced by Monsanto in the 1970s causes cancer or other human health problems.

A number of independent studies show links between glyphosate herbicides and cancer and other health problems, leading the International Agency for Research on Cancer in 2015 to classify glyphosate as a probable human carcinogen.

But Monsanto, purchased by Bayer AG in 2018, has maintained glyphosate is not carcinogenic, nor does it cause other health problems when used as directed. Other large chemical companies that sell glyphosate or related products echo Monsanto’s safety assurances.

Regulators in Europe and the United States, Canada and elsewhere have affirmed the corporate assertions of glyphosate safety. They point to decades of tests conducted by or for the companies that have not been published but which regulators have reviewed, as well as published studies in the scientific literature.

The corporate studies have long been kept secret, even by regulators. But in Europe, litigation by a group of European Parliament lawmakers led to the release of dozens of such studies.

A consumer advocacy group, SumOfUs, provided more than 50 studies to two independent scientists for review – Armen Nersesyan and Siegfried Knasmueller, both from the Institute of Cancer Research, Department of Medicine at the Medical University of Vienna.

Knasmueller, the lead author, is an expert in genetic toxicology and along with his work at the cancer institute is editor-in-chief of two prominent scientific journals, including Mutation Research – Genetic Toxicology and Environmental Mutagenesis.

The goal of the evaluation was to determine if the industry studies examined comply with current international guidelines for chemical testing. The studies are those concerning the genotoxic properties of glyphosate.

The resulting analysis was released July 2, 2021 and concluded that the bulk of the industry studies were outdated and did not meet current guidelines. An array of shortcomings and flaws were found in the studies, rendering most of them unreliable, according to the analysis.

In fact, of the 53 studies submitted to regulators by the companies, only two were acceptable under current internationally recognized scientific standards, said Knasmueller.

Knasmueller said there are more reliable methods for detecting carcinogens but those were not used in the industry tests. Read the evaluation here. 

Regulatory renewal sought

The analysis of the older studies comes as the companies that sell glyphosate products are seeking reauthorization in Europe and trying to fight against calls for restrictions and bans on glyphosate across the globe.

In June 2021, the European Union’s (EU) Assessment Group on Glyphosate (AGG) issued an 11,000-page draft report concluding that glyphosate is safe when used as directed and does not cause cancer. The finding is based in part on a dossier of roughly 1,500 studies submitted to European regulators by the “Glyphosate Renewal Group (GRG),” a collection of companies that includes Bayer.

Bayer confirmed that the older studies were included in the new dossier given to European regulators, but said the GRG was “required to submit all genotoxicity studies that have been conducted, including those submitted in past registration review cycles.” The company said the dossier also includes “new genotoxicity studies conducted since the previous re-approval of glyphosate and a vast review of thousands of published scientific publications regarding glyphosate.”

The companies are seeking the renewal of the EU authorization of glyphosate. Current authorization in Europe expires in December 2022. The companies say they also gave regulators a “literature review” of around 12,000 published scientific articles on glyphosate.

 The European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) are organizing public consultations to start in September.

The Knasmueller analysis drew both criticism and support from a mix of scientists who reviewed the work. Here are two comments:

Paul Demers,  director of the Occupational Cancer Research Centre, Ontario Health, in Canada:

The classification of the carcinogenicity of glyphosate has been particularly contentious with international bodies disagreeing not only on areas of interpretation but even on which studies to consider. The critical evaluation, using the latest OECD criteria, of 53 studies submitted to Bundesinstitut für Risikobewertung and European Food Safety Authority is a valuable contribution to the ongoing debate on the carcinogenicity of glyphosate. The observation by the authors that few of these studies met the OECD criteria should be considered by regulatory authorities tasked with protecting workers and the public. Personally, I agree with the approaches for evaluation taken by the International Agency for Research on Cancer, which were used for glyphosate. That said, I also believe that there needs to room for scientific debate and disagreements on issues of interpretation, criteria for evaluation, and even what studies to include. However, there should not be a debate on transparency when it comes to the evidence considered by public bodies in determining the safety of chemicals.  Studies of health effects, with sufficient details regarding the methods used and the results, need to be accessible and open to the critical eyes of the scientific community and other concerned parties.” 

Raymond Tice, retired scientist, U.S. National Institute of Environmental Health Sciences, former  President of the U.S. Environmental Mutagen Society: “An analysis of the experimental data supporting the safety of any chemical should be conducted using systematic review methodology… which takes into account not only the completeness of the information but also categorizes the risk of bias, whether positive or negative.  Clearly, this was not conducted by EFSA or by Dr. Knasmueller.  In general, it is not appropriate to disregard all studies that do not meet current standards, but rather to consider the results in terms of their limitations. Overall, It seems to me that Knasmueller is selective (i.e., exhibits bias) in what he presents and does not present. At the same time, I would fault EFSA for not doing due diligence in what they considered…  Also, I agree that there is a suggestion that (glyphosate) is linked to the induction of oxidative stress which can result in DNA damage (i.e., oxidative stress is one of the key characteristics of carcinogens) but would be expected to have a threshold below which damage is not likely to result in an adverse effect.”

Once-secret studies

See the full analysis, authors’ comments, industry summaries, a list of studies submitted for the current European Union re-authorization, and links to 53 previously secret corporate glyphosate studies below:

Reference-List-of-Glyphosate-Studies-submitted-for-the-Renewal-of-Approval-AIR5-of-Glyphosate-in-2020-EN

European Assessment Group on Glyphosate report on glyphosate renewal

Evaluation of the scientific quality of industry studies of genotoxic properties of glyphosate

Comments concerning the mutagenic/genotoxic properties of glyphosate

Toxicological and Metabolism Studies summary by industry

Albaugh 2014 glyphosate reverse mutation assay Switzerland

Syngenta 2012 glyphosate technical micronucleus assay in bone marrow cells of the mouse

Dow Chemical 2012 Micronucleus test of glyphosate TGAI in mice

Industrias Afrasa 2012 reverse mutation with glyphosate

Helm 2010 Reverse Mutation Assay glyphosate using bacteria

Helm 2010 reverse mutation assay 

Helm 2010 mutagenicity of glyphosate testing

Helm 2009 mutagenicity study of glyphosate Germany

Helm 2009 Micronucleus test of glyphosate in bone marrow cells of rat

Syngenta 2009 glyphosate reverse mutation

Jingma Chemicals China 2008 evaluation of the mutagenic potential of glyphosate by reverse mutation assay 

Jingma 2008 evaluation of mutagenic potential of glyphosate by micronucleus assay in mice

Syngenta 2008 glyphosate micronucleus assay in bone marrow cells of the mouse

Helm 2007 Mammalian erythrocyte micronucleus test for glyphosate

Helm Do Brasil 2007 Bacterial reverse mutation test glyphosate

Nufarm 2007 reverse mutation glyphosate technical 05068

Nufarm 2007 1061403 reverse mutation glyphosate technical 05067

Nufarm 2007 1061402 reverse mutation glyphosate technical 05070 

Nufarm 2005 glyphosate technical micronucleus test in the mouse

Monsanto 1998 Mouse micronucleus screening assay of MON-0818

Zeneca Glyphosate 1998 acid Invitro 

Cheminova 1996 reverse mutation glyphosate Brazil

Cheminova 1996 A micronucleus study in mice for the product GILFOS

Zeneca 1996 glyphosate mutagenicity potential

Zeneca 1996 Glyphosate acid mouse bone marrow micronucleus test

Zeneca 1996 glyphosate acid mouse lymphoma gene mutation assay

Sanko 1995 glyphosate in vitro cytogenetics

Sanko 1995 glyphosate DNA Repair Test

Sankyo 1995 reverse mutation study 

Mastra and Maruzen Kako 1995 Technical glyphosate

Mastra and Maruzen Kako 1995 reverse mutation assay glyphosate

Agrichem 1995 Evaluation of ability of glyphosate to induce chromosome aberrations

Feinchemie Schwebda 1994 DNA repair test with primary rat hepatocytes

Feinchemie Schwebda 1994 in vivo mammalian bone marrow cytogenetic test

Feinchemie Schwebda 1993 Mutagenicity-micronucleus glyphosate test in swiss albino mice

Feinchemie Schwebda 1992 Dominant lethal test in Wistar rats

Monsanto 1992 Mouse micronucleus study of Roundup

Monsanto 1992 glyphosate mutagenicity assay on Roundup

Monsanto 1992 Mouse micronucleus study of RODEO glyphosate formulation

Monsanto 1992 glyphosate mutagenicity assay on RODEO herbicide

Monsanto 1992 mouse micronucleus study of DIRECT formulation

Monsanto 1992 glyphosate mutagenicity potential DIRECT brand

Hoechst Dodigen 4022 1992 study of mutagenic potential in strains of salmonella and E Coli

Hoechst Dodigen 4022 1992 Chromosome aberrations in vitro in V79 Chinese hamster cells

Cheminova 1991 #12323 glyphosate mutagenicity test

Cheminova 1991 #12324 Mutagenicity test micronucleus glyphosate

Cheminova 1991 #12325 glyphosate mutagenicity test in vitro mammalian cell gene mutation test

Monsanto 1990 Ames Salmonella mutagenicity assay of MON 0818

Monsanto 1983 In vivo bone marrow cytogenetics study of glyphosate in Sprague-Dawley rats

Monsanto 1983 glyphosate gene mutation assay

Monsanto 1981 Ames salmonella mutagenicity assay of MON 8080

Monsanto 1980 Dominant lethal mutagenicity assay with technical glyphosate in mice

Institute of Environmental Toxicology 1978 Glyphosate report of mutagenic study with bacteria

Monsanto Weed Killer: Scientific Manipulation Revealed

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Also see: MDL Monsanto Glyphosate Cancer Case Key Documents and Analysis
and US Right to Know Sues EPA for Release of Glyphosate Documents

By Carey Gillam 

The puzzle pieces are starting to fall into place, but so far it’s not a pretty picture.

A series of internal Monsanto Co. documents revealed this week via a court order show that the company’s long-standing claims about the safety of its top-selling Roundup herbicide do not necessarily rely on sound science as the company asserts, but on efforts to manipulate the science.

Congressman Ted Lieu of California has called for an investigation by Congress and the Department of Justice to look into the matter, and he is advising consumers to “immediately” stop using Roundup.

“We need to find out if Monsanto or the Environmental Protection Agency misled the public,” Lieu said in a statement.”

Hundreds of pages of emails and other records became part of a public court file this week over Monsanto objections after a federal judge in San Francisco ordered they would no longer be kept sealed despite potential “embarrassment” to Monsanto. U.S. District Judge Vince Chhabria is overseeing more than 55 lawsuits brought by individuals filed by people from around the United States who allege that exposure to Monsanto’s Roundup herbicide caused them or their loved ones to develop non-Hodgkin lymphoma. In addition to those cases, which are moving forward jointly in what is known as “multdistrict litigation (MDL), hundreds of other cases making similar claims are pending in state courts.

Questions about the key ingredient in Roundup, a chemical called glyphosate, have been circulating for years amid mounting research showing links to cancer or other diseases. The International Agency for Research on Cancer in 2015 classified glyphosate as a probable human carcinogen and many international scientists have reported research that shows the chemical can have a range of harmful impacts on people.

The plaintiffs in the lawsuit 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 denied that there are cancer connections to glyphosate or Roundup and says 40 years of research and scrutiny by regulatory agencies around the world confirm its safety. On Wednesday a European Chemicals Agency’s committee said its review found glyphosate is not a carcinogen.

Documents seem to show a company less interested in exploring mounting concerns about its products than in protecting the billions of dollars in revenue it makes each year from the herbicides.

But a look at the documents obtained by plaintiffs from Monsanto as part of court-ordered discovery seem to show a company less interested in exploring mounting concerns about its products than in protecting the billions of dollars in revenue it makes each year from the herbicides. The documents show discussions by Monsanto officials about many troubling practices, including ghostwriting a glyphosate manuscript that would appear to be authored by a highly regarded, independent scientist who Monsanto and other chemical industry players would pay for participation. One such scientist would need “less than 10 days” to do the work needed but would require payment of more than $21,000, the records show.

In a 2015 email, Monsanto executive William Heydens suggested that Monsanto employees could ghostwrite a research paper as he said had been done in the past: “We would be keeping the cost down by us doing the writing and they would just edit & sign their names so to speak,” Heydens wrote.

The internal communications also show company executives expressing dissatisfaction with a scientist who had concerns about glyphosate, and an unwillingness to do the studies he suggested needed to be done. Monsanto officials discussed a need to “find/develop someone who is comfortable with the genetox profile of glyphosate/Roundup and who can be influential with regulators… when genetox issues arise.”

Other records show an internal discussion of how glyphosate and surfactants it is formulated with work together in penetrating human skin upon exposure; documents that discuss a need to “protect” formulations that use tallow amine as a surfactant despite formulations, despite concerns about enhanced toxicity when glyphosate and tallow amine are combined.

And perhaps most damning – the internal records indicate that a senior EPA official in the agency’s pesticide division worked collaboratively with Monsanto to protect glyphosate’s safety record. Jess Rowland, who headed an EPA Cancer Assessment Review Committee (CARC) report that backed the safety of glyphosate, told Monsanto he would try to block a planned U.S. Department of Health and Human Services’ review of glyphosate’s safety, saying: “If I can kill this I should get a medal,” according to a 2015 internal Monsanto email.

Rowland “could be useful as we move forward with ongoing glyphosate defense,” Dan Jenkins, Monsanto’s chief regulatory liaison, wrote in a 2015 email. Rowland left the agency shortly after the CARC report was leaked to the public, posted to an agency website in late April 2016 before it was deleted a few days later. Plaintiffs’ attorneys hope to depose Rowland within the next few weeks, though the EPA has opposed the deposition.

The documents released this week provide only a snapshot of the internal workings of Monsanto when it comes to glyphosate, and the company has argued that the emails and other communications are being taken out of context by plaintiffs’ attorneys and media. The company’s work is built on “sound science,” and “governed by the highest principles of integrity and transparency,” Monsanto states.

The EPA has also consistently defended the safety of glyphosate, issuing a report in September that concluded that glyphosate was “not likely carcinogenic to humans.”

But in a report released Thursday, a special advisory panel to the EPA said they could not fully agree with that determination. Some of the panel members who reviewed the research said studies on glyphosate “suggest a potential for glyphosate to affect cancer incidence.” The group said the EPA was improperly discounting the findings of some studies, and “many of the arguments put forth” by the EPA as supporting glyphosate safety “are not persuasive.”

Real answers about the real impacts of Roundup on human health are long overdue, considering the fact that glyphosate is the most widely used herbicide in the world, and is commonly found in food and water and human urine samples.

“The importance of this issue of whether Roundup causes cancer is immense,” the plaintiffs’ attorneys stated in a recent court filing. “Unfortunately, Monsanto is not forthcoming with sharing information on Roundup with the public.”

This story originally appeared in Huffington Post. Sign up to receives breaking news and updates from US Right to Know: https://usrtk.org/sign-up/