New analysis of glyphosate industry studies finds them outdated, flawed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The resulting analysis was released July 2, 2021 and concluded that the bulk of the industry studies were outdated and did not meet current guidelines.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

What Killed Jack McCall? A Farmer Dies; A Case Against Monsanto Takes Root

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By Carey Gillam

CAMBRIA, Calif.- Standing on the ridge overlooking her central California farm, new widow Teri McCall sees her husband Jack nearly everywhere. There, atop the highest hill, is where the couple married in 1975- two self-described “hippies’ who knew more about how to surf than farm. And over there, surrounded by the lemon, avocado and orange trees Jjack mccall copyack planted, sits the 800-square-foot house the young Vietnam veteran built for his bride and a family that grew to include two sons and a daughter. Solar panels Jack set up in a sun-drenched stretch of grass power the farm’s irrigation system.

And down there, clasped in the cusp of the velvet green valley sits the century-old farmhouse Jack and Teri eventually made their permanent home. Jack installed a stained glass window featuring a heart and flowers over the front door.

“Literally hundreds of times a day, something reminds me of him,” McCall says, as she and a visitor strolled through the orchards on a recent sunny spring morning. “That’s part of why it’s so hard to believe… I can never see him again.”

Anthony ‘Jack’ McCall, 69, died Dec. 26 after a painful and perplexing battle with non-Hodgkin lymphoma. The loss is certain, fixed forever into his family’s heartbreak. But questions about why and how he was stricken – a man who never smoked, stayed fit and had no history of cancer in his family – are part of what some legal experts see as a potential landmark legal claim against one of the world’s largest agrichemical companies, Monsanto Co.

McCall shunned pesticide use on his farm, except for the herbicide called Roundup – marketed by Monsanto as having extremely low toxicity. He used Roundup regularly, spraying it himself around the farm to drive back worrisome weeds. He even recommended Roundup to friends, telling them it was supposed to be much safer than alternatives on the market, and touting its effectiveness.

But now in his death, McCall is one of several plaintiffs in more than a dozen lawsuits that claim the active ingredient in Roundup – a chemical called glyphosate – gave them cancer, and that Monsanto has long known glyphosate poses “significant risks to human health, including a risk of causing cancer.”

The lawsuits, brought by plaintiffs in California, Florida, MissouriDelaware, Hawaii,and elsewhere over the last several months, claim Monsanto has hidden evidence, and manipulated regulators and the public into believing in the safety of glyphosate, which annually brings in about $5 billion, or a third of total sales, for the agribusiness giant. Like McCall, many farmed, or worked in agricultural jobs in which they regularly were using or exposed to glyphosate.

The claims come at a critical time for Monsanto and its signature product as regulators in the United States and other countries evaluate whether or not to continue to allow glyphosate herbicides. Last year the World Health Organization’s cancer experts classified glyphosate as a probable human carcinogen. That team, the International Agency for Research on Cancer (IARC), said glyphosate shows a “positive association” for non-Hodgkin lymphoma. 

The outcomes of the legal battle and the regulatory reviews could have broad implications. Glyphosate is the most widely used herbicide on the planet, sprayed on fields for row crops like corn, soybeans and wheat, as well as a variety of fruits, nuts and vegetable crops such as almonds, apples, cherries and oranges.

That ubiquitous role played by glyphosate means the litigation, plaintiffs’ lawyers say, marks the beginning of a potential wave of legal actions against Monsanto. Teams of attorneys have been criss-crossing the country lining up potential plaintiffs who they say will likely number in the hundreds and possibly thousands. It’s a time-tested practice by plaintiffs’ attorneys who have brought similar mass actions in the past against tobacco, pharmaceutical and chemical industries.

“Monsanto has deliberately concealed or suppressed information about the dangers of its product,” said environmental and chemical pollution attorney Robert F. Kennedy Jr., who is assisting in litigating glyphosate cases. “This is big. It’s on every farm in the world.”

Kennedy predicts glyphosate liability litigation will become as widespread as has been decades of litigation over asbestos, which is seen in legal circles as the longest-running mass tort action in U.S. history. Asbestos was used for years as a safe and effective flame retardant in the construction industry but has been tied to lung diseases and cancers, and spawned hundreds of millions of dollars in legal claims.

The glyphosate litigation partly mirrors courtroom battles Monsanto has been fighting for years involving the polychlorinated biphenyls, or PCBs it once manufactured. Plaintiffs in those cases also claim PCBs caused them to fall ill while Monsanto hid the risks. Monsanto claims plaintiffs cannot definitively link illnesses to PCB exposure.

AMONG THE SAFEST OPTIONS
Patented by Monsanto and commercialized in 1974, glyphosate herbicide has long been considered among the safest pesticide options on the market. The weed-killer came off patent in 2000 and is now used in more than 700 products around the world, beloved by farmers, homeowners, and groundskeepers. The chemical is the world’s most widely used herbicide with an estimated 1.8 billion pounds applied in 2014, up 12-fold from 1994, according to recently published research.

But as use has grown, concerns about safety have also mounted. Residues have been documented by public and private researchers in waterways, air, food and in human bodily fluids. Several scientific studies tied the chemical to cancers and other health problems before the March 2015 classification by IARC.

Lawyers for plaintiffs in the glyphosate cases say that among the evidence that glyphosate’s toxicity has long been known is an EPA memo detailing how glyphosate was classified by agency scientists as a possible human carcinogen in 1985 before classified in 1991 as a having “evidence of non-carcinogenicity” for humans. The classification was changed despite the fact that some peer review members did not concur. The lawsuits also cite evidence of fraud at laboratories used by Monsanto to perform toxicology studies of glyphosate, and point to fraud convictions of executives at those labs.

St. Louis-based Monsanto, a global agrichemical and seed powerhouse, cites its own evidence to counter both the validity of the allegations in the lawsuits, as well as the IARC findings. Last year, the company hired a team of experts to review the safety of glyphosate, and said that team found no cancer links. 

“Comprehensive long-term toxicological studies repeated over the last 30 years have time and again demonstrated that glyphosate is unlikely to pose a cancer risk in humans,” Monsanto states on its website. ‘Regulatory authorities and independent experts around the world have reviewed numerous long-term/carcinogenicity and genotoxicity studies and agree that there is no evidence that glyphosate… causes cancer, even at very high doses.”

Monsanto attorneys have been seeking to dismiss and/or delay several cases thus far filed, asserting that federal law and approvals by the Environmental Protection Agency for labels on Roundup herbicide products protect Monsanto from the claims in the lawsuits. In recent arguments in U.S. District Court in Northern California, for example, lawyers for Monsanto argued that “EPA repeatedly has concluded that glyphosate is not a carcinogen.” But in April a federal judge in California ruled that Monsanto was not protected from liability by the EPA registration and approved labels.

In a Missouri case that Monsanto also was unable to get dismissed, discovery is starting, and plaintiffs’ lawyers are eagerly awaiting what they hope will be a treasure trove of evidence for their clients.

The legal claims come at the same time that European and U.S. regulators are conducting their own assessments of the safety of glyphosate and considering restrictions, processes that have become fraught with infighting and accusations of bias from both fans and foes of glyphosate. The European Food Safety Authority (EFSA) said in November that evidence shows glyphosate is unlikely to be carcinogenic. But the European Parliament has said the herbicide use should be reined in with a ban on non-professional use and around parks and playgrounds because of the health worries.

The EPA was due to release a fresh risk assessment on glyphosate nearly a year ago, but has stalled the process amid the uproar. And in an odd twist to the saga, on April 29, the agency posted an internal document to its website, showing that the EPA’s cancer assessment experts have determined that glyphosate is “Not Likely to be Carcinogenic to Humans.”

On May 2, EPA withdrew the memo from its website and said it was not supposed to have been released because the cancer assessment is ongoing. But Monsanto heralded the release of the document as proof of what it has been saying about glyphosate’s safety.

Wall Street is keeping a wary eye on the litigation. But generally market watchers care less about Monsanto’s risk from potential liability payouts and more about any potential long-term revenue hit if regulators were to restrict or ban glyphosate, said Piper Jaffray analyst Brett Wong, who tracks Monsanto’s business strategies and financial health. The courtroom battles could influence regulators, he said.

“There are obviously a lot of lawsuits,” Wong said. “They aren’t intrinsic to impacting their business but there is always some sentiment pressure on investors. If it were to impact the regulatory structure and glyphosate was banned… that could obviously have an impact.”

Legal experts with experience defending the chemical industry are watching the cases with interest, and many say given a lack of regulatory support for the cancer linkage, plaintiffs’ attorneys have an uphill climb to make such claims stick.

“The evidence to support the claims isn’t there, said one prominent lawyer, declining to be quoted by name. “It’s not mothers’ milk by any means. I wouldn’t mix it in my drink, but it’s one of the safest chemicals out there,” he said.

Attorney Brent Wisner, who is representing the McCall family, said he is confident in the strength of the evidence against Monsanto. “It’s going to be a fairly large litigation when it’s all said and done. We’re confident we’ll be able to show that Monsanto controlled research and suppressed science,” he said.

Back in Cambria, Jack McCall’s son Paul McCall is running the farm in his father’s place. His eyes tear quickly when asked about his father’s diagnosis in September 2015 and death only three months later, the day after Christmas. He doesn’t want to talk about the lawsuit, other than to say he has no use for glyphosate now, and wants to warn others away from it.

“This is a battle that has to be fought,” he said.

How big and how bloody the litigation becomes is still an open question. The shouting from both sides of the issues is getting louder with each passing day. But the deep questions about the safety of this herbicide deserve serious and scientific review as the answers hold implications for our food production, our environment and the health of our families well into the future.

This article originally appeared in Huffington Post

Carey Gillam is a veteran former Reuters journalist, current freelance writer/editor and research director for U.S. Right to Know, a food industry research group