As Bayer faces ongoing litigation and public scrutiny over its herbicide Roundup, a new report from Friends of the Earth raises fresh concerns about the safety of the company’s reformulated product. According to the report, the new chemical composition is 45 times more toxic to human health compared to the previous glyphosate version. At least 28 countries have banned glyphosate for the potential harm it causes to human health.

The new Roundup formulation for residential consumers contains four active ingredients that have replaced glyphosate. Diquat Dibromide is one of these chemicals that is in the new Roundup, but the herbicide was banned in the European Union in 2019. According to the report, Diquat Dibromide is “twenty-seven times more acutely toxic and two hundred times more chronically toxic to humans than glyphosate.” The authors of the report say “The U.S. Food and Drug Administration does not allow Bayer or other drug companies to replace the aspirin in a brand-name pain reliever with oxycontin or fentanyl, and for good reason.”

The EPA states, “Diquat dibromide exhibits low acute toxicity via the oral and inhalation routes of exposure but exhibits moderate to severe acute toxicity via the dermal route of exposure. Diquat dibromide is not an acute skin irritant, nor a dermal sensitizer, but it is considered a moderate to severe eye irritant.”

The National Oceanic and Atmospheric Administration says, “Diquat causes severe skin and eye irritation and is toxic or fatal if absorbed through the skin, inhaled or swallowed.” The other chemicals included in the new formulation are fluazifop-P-butyl, triclopyr, and imazapic. Friends of the Earth concluded that all of the chemicals are individually more chronically toxic than glyphosate.

The HighWire reached out to Bayer with questions about the report. A representative responded with this prepared media statement. “A recent, deeply flawed report contains false claims about the active ingredients in Roundup Lawn & Garden products. The active ingredients in all Roundup Lawn & Garden products have been thoroughly studied, reviewed and approved by independent experts at the Environmental Protection Agency (EPA) and used safely and effectively in many different weed-control products from a variety of companies for decades. The report reaches its misleading conclusion through a methodology that is entirely inconsistent with how leading regulatory and health experts measure risk in how people use these products in the real world and in accordance with the label. Simply put, consumers can feel confident safely using Roundup products.”

The HighWire reported last week about the pressure EPA toxicologists feel to quickly complete chemical evaluations within 90 days. The report refers to toxicologists who were retaliated against for requiring more information from companies before completing the chemical evaluation. The HighWire has also reported about the EPA’s “secret backchannel” to chemical companies, an alleged cover-up in East Palestine, and the reaction to the chlorine fire in Conyers, Georgia. The EPA recently lost the seven-year court case defending community water fluoridation as the judge ruled the practice to be an “unreasonable risk.”

Monsanto and Bayer have relied on the EPA’s evaluation of chemicals to support their assertion that Roundup is safe.

The Friends of the Earth report explains the methodology by calculating the toxicity of each chemical in the new Roundup formulation. They determined the average acute and chronic toxicity based on the chemical concentration and then applied two key measures: LD-50 and cRfD. LD-50 represents the dose that kills half of the test animals exposed, while cRfD (chronic reference dose) estimates how much exposure is considered safe over a lifetime. The EPA uses these measures to assess non-cancer health risks.

Bayer’s statement calls the report “flawed,” but doesn’t outright say that the methodology is flawed. Instead, Bayer said the methodology is “inconsistent” with how “leading regulatory and health experts measure risk in how people use these products in the real world and in accordance with the label.”

Friends of the Earth states in the report that there are limitations to this methodology because the EPA’s cRfD is “based on one specific adverse effect observed in an animal toxicology study.” The researchers also said that users of the product will be exposed to the whole formulation rather than just the active ingredients that are listed on the label. This includes surfactants and adjuvants that the EPA considers “inert,” but FotE contends that these ingredients make the product “more toxic and/or change the physical and chemical properties of the formulated product in ways that increase human or environmental risk.”

FotE also says that the chronic reference dose does not include data regarding DNA damage or a potential increased risk of cancer.

The four chemicals in the new formulation of Roundup potentially cause a variety of side effects. This includes reproductive effects, developmental and birth defects, kidney/liver damage, neurotoxicity, and others. The authors state that “endocrine disruption, metabolic effects, and disruption of the gut microbiome” have not been adequately studied. The authors imply that there may be more detrimental health effects from exposure to the chemicals in Roundup that haven’t been evaluated. They state that the absence of a health effect from the chart is not “conclusive evidence” that it is not a potential concern for individuals who have been exposed.

The analysis claims that Bayer has not properly rebranded or informed consumers about the chemical change in Roundup as required by the EPA. The authors found glyphosate to be present in seven Roundup products despite Bayer’s public commitment to remove the chemical from all products by 2023.

Casey and Calley Means are siblings talking about the connection between pesticides, food, and pharmaceutical products with chronic health issues in the United States. Calley Means appeared on The HighWire last month. Casey Means said 99% of farmland is sprayed with toxic pesticides, which equates to a billion pounds per year. She said these pesticides are linked with “autism, ADHD, sex hormone disruption, thyroid disease, sperm dysfunction, Alzheimer’s, dementia, birth defects, cancer, obesity, liver dysfunction, female infertility and more.”

The HighWire has also reported Bayer’s attempt to obtain liability protections for pesticides and herbicides while contending with hundreds of thousands of lawsuits, including attempts to add specific language to the national farm bill as well as lobbying state governments.