21
Dec
Review Shows that Monsanto/Bayer Claims of Glyphosate Safety Not Supported by Credible Science
(Beyond Pesticides, December 21, 2021) A research team undertaking a review of industry-conducted glyphosate safety studies submitted to EU (European Union) regulators shows that most of the research fails to meet current international standards for scientific validity. The researchers find that of the 11 reviewed studies, which were submitted to regulators by Bayer AG (now owner of the Monsanto “Roundup” brand of glyphosate herbicide) and several other chemical companies, only two are scientifically “reliable”; six others are deemed “partly reliable,” and the remaining three, “not reliable.” These results go, in part, to the age of some of the studies (see below); but they also underscore the point Beyond Pesticides has made for years. Regulators, whether in the UK, the U.S., or anywhere else, ought not be relying solely and without adequate auditing on industry-generated and -funded safety research in making safety determinations that underlie regulations impacting the well-being of millions of people (and other organisms), never mind the environment writ large.
The report, from a team working out of the Institute of Cancer Research (ICR) at the Medical University of Vienna, is timely: the European Food Safety Authority (EFSA) and European Chemicals Agency (ECHA) are currently considering whether or not to renew EU approval of glyphosate when the existing license expires in December 2022. In 2017, glyphosate was granted, by a narrow vote margin, a five-year renewal following the European Parliament’s vote against renewal. According to The Guardian, “The analysis comes at a critical time as Bayer and a contingent of companies calling themselves the Glyphosate Renewal Group are again asking European regulators to reauthorize glyphosate ahead of the expiration of approval next year, and as the industry battles to preserve glyphosate use globally.”
The Guardian reported, “In August, authorities from France, Hungary, the Netherlands and Sweden weighed in on the renewal question with a draft report concluding that glyphosate is not carcinogenic.” EFSA and ECHA allowed other parties to comment, up until November 22, 2021, on the issue of glyphosate’s potential re-licensing in 2022. Lead author of the ICR report, Siegfried Knasmueller, issued an earlier report on glyphosate studies in July, titled “Corporate studies asserting herbicide safety show many flaws, new analysis finds.” This study, which reviewed 53 corporate studies submitted to regulators, was requested by the SumOfUs nonprofit organization, and was submitted in response to the November deadline. A spokesperson for EFSA indicated that the body would “develop its opinion” on the matter by June 2022.
The industry research studies reviewed by the ICR team focused on the genotoxicity (ability to cause DNA damage) of glyphosate. This issue is a huge and concerning one because damage to DNA is a well-recognized contributor to the development of cancers. The studies reviewed through the Austrian team’s project maintain that glyphosate is not genotoxic. Yet the IARC (International Agency for Research on Cancer) in 2015 declared not only that glyphosate is a “likely human carcinogen,” but also, that it causes DNA and chromosomal damage in human cells. As Beyond Pesticides noted then, “Epidemiologic studies have found that exposure to glyphosate is significantly associated with an increased risk of non-Hodgkin’s Lymphoma (NHL).”
In addition, multiple studies have found that glyphosate can induce genetic changes, including statistically significant increases in fatty liver disease and liver cell death. Certainly, the juries in several high-profile glyphosate trials in the U.S. have understood the relationship between glyphosate exposure and development of cancer — and of NHL, in particular.
Professor Siegfried Knasmueller, PhD, the ICR team’s principal investigator — who is an expert in genetic toxicology, a researcher at the Medical University of Vienna’s Cancer Research Institute, and editor-in-chief of two scientific journals, including Mutation Research/Genetic Toxicology and Environmental Mutagenesis — has commented on the team’s review. He told The Guardian, “Not only are most of the studies lacking in quality, but . . . the industry research does not include new and ‘probably better tests for the detection of genotoxic carcinogens.’ He said there is evidence in published research that glyphosate may cause DNA damage in human-derived liver cells. . . . [And] that while several industry studies were ‘correct from a methodological point of view at the time when they were conducted,’ they are not in agreement with the current strategy.’”
The team’s findings about reliability constellate in part on the currency of analytical methodologies; the two studies deemed “reliable” were relatively recent (2016 and 2020), while the “not reliable” ones were conducted one or more decades ago. The findings of the July report identify a specific problem: many of the industry studies focused on “testing for chromosome damage in early stages in red blood cells of the bone marrow in laboratory mice and rats. These tests routinely detect only 50–60% of carcinogens, according to Knasmueller. ‘So many carcinogens are not detected with this method,’ he said.” Professor Knasmueller indicated that a kind of test called a ‘comet assay’ can detect and quantify DNA damage in the individual cells of a range of organs — and thus, is more valuable in identifying carcinogens. This comet assay is commonly used to evaluate genotoxicity, but was not used in the glyphosate studies submitted to EFSA and ECHA.
The Guardian reported on these aspects from the July paper: “Researchers from the Institute of Cancer Research at the Medical University of Vienna in Austria said a thorough review of 53 safety studies submitted to regulators by large chemical companies showed that most do not comply with modern international standards for scientific rigor, and lack the types of tests most able to detect cancer risks. The quality of these studies, not of all, but of many of these studies is very poor. The health authorities . . . accepted some of these very poor studies as informative and acceptable, which is not justified from a scientific point of view.’” The Guardian added, “If Knasmueller’s observations are accurate, the new finding of flaws in industry studies means regulatory assurances about glyphosate safety in Europe and the United States have been based, at least in part, on shoddy science.”
In response to that July report, the former director of the U.S. National Institute for Environmental Health Sciences (NIEHS), Linda Birnbaum, PhD, indicated that the problem of regulators accepting industry studies “at industry’s word” and simultaneously “ignoring red flags raised in non–industry funded research” is ongoing, according to The Guardian. The paper also wrote that EPA confirmed that no comet assay testing is required (to ferret out genotoxic potential) for industry studies used by the agency. An EPA spokesperson issued a statement at the time, saying that the agency “strives to use high-quality studies” and “a broad set of data” in its evaluations of pesticides, and “independently evaluates required studies for scientific acceptability.”
The EPA website brandishes this text: “EPA’s pesticide program is committed to using current state-of-the-science methods to enable a more effective and efficient testing and assessment paradigm for chemical risk management. . . . Also, we encourage the incorporation of genotoxicity endpoints into routine toxicology studies where scientifically feasible. Certain genotoxicity studies, including the micronucleus and comet assays, can effectively be incorporated into routine toxicology studies.” Beyond Pesticides notes that “encouraging” use of such assays in industry-conducted research — on which EPA relies — is a far cry from requiring use of such methodologies that can more effectively identify genotoxic properties of pesticides, and therefore, shape more-protective risk assessment and regulation.
The track records of both the U.S. Environmental Protection Agency (EPA) and ECHA have been riddled with less-than-protective actions. On the European front, for example: (1) EFSA ignored a study linking Monsanto’s Roundup herbicide to cancer — after consulting with an EPA official linked to Monsanto; and (2) documents showed that text in an EU report declaring glyphosate safe was copied and pasted from a Monsanto study.
Across the pond in the U.S., Beyond Pesticides has covered both the EPA’s reliance on industry research in its evaluation of pesticides, and industry influence on, and corruption within, EPA that have made its pesticide regulation so often misguided and ineffectual. Investigative journalist Carey Gillam, in a speech to Beyond Pesticides’ 2018 National Pesticide Forum on the so-called “Monsanto Papers” — chronicling a litany of company malfeasance related to glyphosate, and the EPA Office of Pesticide Programs’ (OPP’s) preposterous alignment with industry’s wishes. Just one example was that of Jess Rowland, a Deputy Division Director of the Office of Pesticide Programs, who moved heaven and Earth to protect the ability of Monsanto to continue to sell Roundup, unencumbered by pesky warnings of carcinogenicity. Read more on EPA dysfunction here, here, and here.
EPA’s sketchy relationship with scientific integrity may be one of the worst-kept secrets in Washington, DC. In December 2016, when EPA consulted with a scientific advisory panel, The Guardian notes, members of the panel griped that the agency was failing to follow “proper scientific guidelines for how to asses research about glyphosate health impacts.” Nina Holland, a researcher with Corporate Europe Observatory, commenting to The Guardian on the same phenomenon in the EU, said: “This puts once more a finger on a sore spot: that national regulators do not seem to pay close scrutiny when looking at the quality of industry’s studies. This is shocking as it is their job to protect people’s health and the environment, not to serve the interests of the pesticide industry.” Her critique holds up when applied to EPA, according to Beyond Pesticides, which has written extensively (and recently) about such failings of the agency tasked with protecting public health and the environment.
Stay current with developments in the world of glyphosate (and all pesticides) with the Daily News Blog, with opportunities to take action via the Action of the Week, and via wider and deeper dives in Beyond Pesticides’ journal, Pesticides and You
Sources: https://www.theguardian.com/environment/2021/nov/26/glyphosate-eu-regulators-studies-roundup-weedkiller and https://www.theguardian.com/business/2021/jul/02/glyphosate-herbicide-roundup-corporate-safety-studies
All unattributed positions and opinions in this piece are those of Beyond Pesticides.
