The beginning of December saw a few updates regarding glyphosate.
Here’s Why Glyphosate Has Been in the News
Currently, Bayer is the only domestic producer of glyphosate in the U.S. The company mines elemental phosphorus in Soda Springs, Idaho, formulates glyphosate production in Muscatine, Iowa, and finishes the formulation and production in Luling, La.
To date, Bayer has paid more than $10 billion to plaintiffs in litigation claiming Roundup as the cause of their cancer.
Bill Anderson became CEO in 2023, and one of his commitments was to get the glyphosate litigation “under control” by the end of 2026. In total, there have been about 180,000 lawsuits brought forward, with about 60,000 cases open now. The company has budgeted more than $17 billion toward the glyphosate litigation.
Bayer continues to advance a multipronged strategy, which includes court case management, state law advocacy and a call to the U.S. Supreme Court to review the FIFRA’s preemption provision.
The company has said it could withdraw from the market if they aren’t successful with the goal of containing the litigation next year.
Supreme Court Update
On Dec. 1, the Solicitor General filed of a brief with the U.S. Supreme Court supporting Bayer’s petition seeking review of the Durnell case.
“The support of the U.S. government is an important step and good news for U.S. farmers, who need regulatory clarity,” says CEO Bill Anderson in a company statement. “The stakes could not be higher as the misapplication of federal law jeopardizes the availability of innovative tools for farmers and investments in the broader U.S. economy.”
There has been a split among federal circuit courts in Roundup personal injury litigation, which brought it to the Supreme Court. The company says this raises the cross-cutting question of whether federal law preempts state claims based on failure-to-warn theories. And tens of thousands of Roundup cases in litigation now are based on claims grounded in failure-to-warn theories.
Bayer points out there’s established preemption language to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that could be similarly applied here and is already used in federal statutes regulating medical devices, poultry products, meat and motor vehicles.
Academic Paper in Question
Also in the first week of December, a paper originally published in April 2000 was retracted by the publisher. Titled “Safety Evaluation and Risk Assessment of the Herbicide Roundup and Its Active Ingredient, Glyphosate, for Humans” and appearing in the journal Regulatory Toxicology and Pharmacology (RTP), the paper is commonly referenced as the “Williams paper.”
In a statement from Bayer’s indirect subsidiary Monsanto, the company said: “Monsanto’s involvement with the Williams et al paper did not rise to the level of authorship and was appropriately disclosed in the acknowledgments. The listed authors had full control over and approved the study’s manuscript. Two prior inquiries into the study previously found that the paper was appropriate, including the European Food Safety Authority (EFSA), and Williams’ former employer.”
The article in question was a review of other studies and did not provide new scientific research.
The editor of the journal states: “I emphasize that this retraction does not imply a stance on the ongoing debate regarding the carcinogenicity of glyphosate or Roundup, but originates from directly following the COPE guidelines.”
Regulatory implications appear to be limited after this retraction.
“The retraction of this publication has no impact on EPA’s glyphosate assessment, which has historically reviewed more than 6,000 individual studies across all disciplines, including human and environmental health,” the EPA states.
The European Union did not rely on the Williams paper for its most recent assessment; its agencies only look back and consider the past 15 years of published research.
In the statement from Monsanto, the company reaffirms: “Glyphosate is the most extensively studied herbicide over the past 50 years. Thousands of studies have been conducted on the safety of glyphosate products, and the vast majority of published studies had no Monsanto involvement. The consensus among leading regulatory bodies worldwide is that glyphosate can be used safely as directed and is not carcinogenic. Because the Williams et al paper is 25 years old, the EU did not rely on this paper in its recent assessment and approval process. Furthermore, the Williams paper is a review article of properly-conducted studies which were separately provided to regulators for their review and contains no original data.”
