A new report by the European Chemical Agency’s Committee for Risk Assessment (RAC) has concluded that current scientific evidence does not meet the criteria to classify glyphosate, the active ingredient in Roundup, as a carcinogen, as a mutagen or as toxic for reproduction. The finding is at odds with a new EPA Scientific Advisory Panel on glyphosate which offers there is “suggestive evidence of carcinogenic potential.”
The Scientific Advisory Panel report concluded that the pesticides office at the Environmental Protection Agency failed to follow its own guidelines when it found last year that glyphosate — the active ingredient in Monsanto’s flagship pesticide Roundup — is not likely to be carcinogenic to humans.
The panel — an independent group of scientists commissioned by the EPA to review the agency’s work — remained split on whether the pesticide program’s non-carcinogenic conclusion was justified.
Panel members agreed that there is no reliable evidence of an association between glyphosate exposure and any solid tumor, or between glyphosate exposure and leukemia or Hodgkin’s lymphoma. However, some Panel members also noted that the epidemiologic data are still limited, and, and for some cancer types (e.g., lung, colorectal, breast cancers, etc.), there was only one study available.
Remarkably, none of the studies involved glyphosate manufacturing workers or others who may be relatively highly exposed. This was felt to be a critical data-gap.
Panel members were surprised when EPA scientists revealed that they did not search for nor did they find studies of workers involved in the manufacture of glyphosate for the review. Historically, for other chemical and physical agents, studies of manufacturing workers have contributed predominantly in scientific evaluations of the potential carcinogenicity of chemicals.
Some Panelists also noted that while the majority of the individual studies are not statistically significant, combining the results using meta-analysis shows a scientifically important and statistically significant elevated non-Hodgkin lymphoma (NHL) risk that is relevant for understanding carcinogenic potential. Panel members believed that there is limited but suggestive evidence of a positive association between glyphosate exposure and risk of NHL.
“Based on the weight-of-evidence from epidemiological studies and meta-analyses, the Agency cannot exclude the possibility that observed positive associations between glyphosate exposure and risk of NHL suggest human carcinogenic potential of glyphosate, even though study limitations and concerns about potential biases remain.”
The EPA reviewed and analyzed the results of 15 rodent bioassays and concluded that the results as a whole do not indicate carcinogenicity of glyphosate. Some Panel members interpreted the totality of the tumor data as supporting the hypothesis that glyphosate may cause the promotion or progression of common spontaneous lesions. These Panel members argued that there is sufficient evidence to conclude that glyphosate is a rodent carcinogen and/or tumor promoter.
The Scientific Advisory Panel had been delayed after industry representatives complained about the objectivity of some of the members. The trade association CropLife America, which represents Monsanto and other pesticide-makers, wrote to the EPA to object about the inclusion of epidemiologist Dr. Peter Infante because of his, “radical, anti-pesticide position.” The industry pressure led to his removal.
“Even with Monsanto’s undue influence on the makeup of this panel, there was still considerable concern about the safety of this pesticide,” said Nathan Donley, a senior scientist at the Center for Biological Diversity. “When the pesticide office doesn’t even follow its own guidelines in determining the safety of glyphosate, how can we trust its conclusions?”
“Monsanto’s troubling influence and coordination with the pesticide office, combined with its utter disregard for established guidelines, completely discredits the pesticide office’s conclusion that glyphosate does not cause cancer,” said Donley. “The 2015 finding of the World Health Organization’s cancer arm that glyphosate is a probable carcinogen remains the most credible and scientifically supported finding on the carcinogenicity of glyphosate. This latest science panel report really just confirms that the pesticide approval process in this country needs to be fundamentally changed to protect public health.”
Regarding the European Chemicals Agency and their impartiality, Dr. Rosemary Mason wrote an open letter in November to the agency: “The current EU legislation was originally set up to protect the pesticides industry. Monsanto and other agrochemical corporations helped the EU to design the regulatory systems for their own products and chose which country should be appointed as Rapporteur Member State. Regulation 1107/2009, Article 63 specified that: “All confidential data …shall be deleted or redacted.” Much of the industry data submitted to the German RMS was redacted.”
She quoted German toxicologist Dr Peter Clausing who accused the German Federal Institute for Risk Assessment (BfR) and the European Food Safety Authority (EFSA) of committing scientific fraud by twisting scientific facts and distorting the truth, with the aim of concluding that glyphosate is not a carcinogen.
“Ample evidence has been provided showing that European Authorities twisted or ignored scientific facts and distorted the truth to enable the conclusion that glyphosate is not to be considered a carcinogen.”
While the EFSA claimed, “No evidence of carcinogenicity was observed in rats and mice,” Clausing reported that males in five mouse carcinogenicity studies showed a statistically significant increase in the incidence of one or several tumour types.
Glyphosate is the most heavily used herbicide in the United States, with about 220 million pounds used in 2015 alone.