Bernalyn McGaughey, President / CEO of Compliance Services International (CSI) Pens Editorial titled, It’s Not About Glyphosate – Or Science, originally published in the Summer edition of the Aquatic Ecosystem Restoration Foundation (AERF) Newsletter, 2019.
It’s Not About Glyphosate – Or Science
Bernalyn McGaughey
The herbicide glyphosate is one of the most important, and safest, weed control tools in existence. The US Environmental Protection Agency, the European Commission and other health and environmental agencies have declared it safe as used, and it’s licensed in 130 countries. So far, only one institution – the quasi-governmental World Health Organization’s (WHO) International Agency for Research on Cancer (IARC) – has declared glyphosate a hazard as a “Class 2a carcinogen” (“probably carcinogenic to humans”), right alongside other 2A listed products such as DDT, Diazinon, Dieldrin, lead compounds, Malathion and – malaria. The 5 insecticides listed here have all been banned, and UNICEF reports that malaria kills one child every 30 seconds, which is about 3000 children a day. IARC’s labeling of glyphosate as a Class 2A carcinogen is extremely controversial, based on faulty application of data in the listing process, and out of line with every other global regulatory system’s conclusion.
However, now that the label is out there, the battle is on for manipulating public opinion, and heck with the science or validity of any conclusion other than what can be emotionally persuaded. Christopher Bossoi notes that “federal regulation in almost any area of national life is today’s governmental response to yesterday’s conditions . . . This observation applies particularly to any area of great scientific or technological complexity.” The general public, particularly those Twittering each other and getting their “science” from live feeds, has no clue as to which version of The Glyphosate Story is true. And to them, it doesn’t really matter anyway. For example, Judge Chhabria, the California judge handling the first bellwether glyphosate class action suits, instructed the jurors that they “must not defer to regulatory agencies” and should instead reach their own judgement based on the evidence presented at trial. Consequently, the complex, lengthy and repeated process of government scientific review of glyphosate and the weight of evidence supporting their conclusions, has no relevance. However, the juror most typically has neither the scientific specialization nor the investment of time to “weigh” one piece of evidence against another.
Accusations on glyphosate’s “hazard” are based largely on the misapplication of two groups of studies that can be found in published literature: those under conditions that are grossly out of line with how human exposure could actually occur, and those that are extrapolations from human population data (epidemiology studies). For example, studies that are conducted on unusual organisms – or through extreme exposure methods – or to tissues in vitro that are isolated from their normal metabolic processes – do not produce results in and of themselves that can be related to environmental levels of exposure. A valid scientific assessment that properly casts the weight-of-evidence of each study reviewed for the assessment in the analytical process would not find such information as damning or even relevant to a hazard conclusion in the absence of collaborating data generated through validated methods of testing.
For example, a Canadian scientist, Deborah Kurrasch, who’s main research is on bisphenol A, admits that the experiments she has run are in their “early days for this field of research,” which means that their repeatability and validity as a predictive tool for effects in humans or other non-target organisms is unproven. With regard to her findings of “hazard” related to glyphosate, one set of experiments involves soaking nematode worms, C. elegans, in Touchdown (a glyphosate formulation)—”in concentrations used by pesticide applicators—as a model to understand what effect the product could have on the nervous system of animals.”ii Unless you fill your hot tub with field-application-strength glyphosate spray mixture (and put your head underwater) and soak for some portion of your day or lifetime, your exposure to glyphosate levels in the environment are inconsequential when compared to a dose like that, setting aside other complicating factors like surface-active agents in the formulation and those hot tub chemicals that keep your water clear.
The second group of studies, those pooling large amounts of human population data and disease or death incidences, the same principle is true: without collaborating findings from studies using established methodologies and interpretation of those studies in a complex risk assessment process, there are many reasons why epidemiology studies cannot stand on their own to “predict” a hazard. A group of scientists working under a grant from NIEHS published one such “meta-analysis” on glyphosate.iii Their conclusion was that their “meta-analysis” of human epidemiological studies suggests a compelling link between exposures to glyphosate-based herbicides and increased risk for non-Hodgkin’s Lymphoma (NHL). However, the underlying variabilities in data, assumptions on exposure, and even the initial hypothesis of such an analysis hugely complicate the actual power of the “meta-analysis” to reliably point to an “increased risk” for a single given endpoint such as NHL.
Add to the uncertainty of the methods the uncertainty of the disease itself that is at issue, non-Hodgkin’s Lymphoma. According to the Mayo Clinic, “Non-Hodgkin’s lymphoma is more common than the other general type of lymphoma — Hodgkin lymphoma. Many different subtypes of non-Hodgkin’s lymphoma exist. . . In most cases, doctors don’t know what causes non-Hodgkin’s lymphoma. . . In most cases, people diagnosed with non-Hodgkin’s lymphoma don’t have any obvious risk factors. And many people who have risk factors for the disease never develop it.”iv There are six types of Hodgkin lymphoma, but to date at least 61 types of lymphomas have been described that have different characteristics from Hodgkin lymphoma. These were designated non-Hodgkin lymphomas and are divided further based on their development, spread and treatment options. Today, non-Hodgkin lymphoma represents the most common malignancy of the lymphatic system, and since the early 1970’s the incidence rates have nearly doubled.v Since medicine does not know what causes this cancer, and it is actually a disease of many different forms, and since no one form of this disease is connected to any specific set of risk factors, blaming glyphosate for an “increased risk” of is simply not possible.
As Roger Peng reports in the Royal Statistical Society’s magazine Significance, we have “a growing problem in science today: collecting data is becoming too much fun for everyone. Developing instruments, devices, and machines for generating data is fascinating, particularly in areas where little or no data previously existed. Our phones, watches, and eyeglasses all collect data. Because collecting data has become so cheap and easy, almost anyone can do it. . . Data follow us everywhere and analyzing them has become essential for all kinds of decision‐making. Yet, while our ability to generate data has grown dramatically, our ability to understand them has not developed at the same rate.”
The formula, then, is this: [A widely-used, largely innocuous-to-humans herbicide introduced in the 1970’s] + [A disease with no cause that has nearly doubled since 1970] x [(Social Media)x(Deluge of Data)] = Unprecedented Opportunity for Public Manipulation. In 1967, Frank Graham, writing for the National Audubon Society, noted “Conservationists have learned that it is not enough to complain to the world at large. Their most effective weapon against pollution is a well-substantiated case aimed at a specific target.”vi At that time the target was DDT. At that time, the newly formed Environmental Defense Fund, which was leading the litigation against DDT, noted that if they were successful in the effort of banning DDT, then nothing would stop them from successfully felling their next target.vii
Looking at a few clips of news items from the first 6 months of the year seems to demonstrate that The Glyphosate Story is no longer one of science:
Genetic Literacy Project: Science not Ideology
Examining the EU’s contradictory treatment of glyphosate and copper sulfate pesticides
Andrew Porterfield | December 19, 2018
“The politics of the European Union have often left observers baffled. But the decisions—and lack thereof—over how to regulate two popular pesticides have culminated in a series of contortions as member countries, courts and the European Parliament try to combine a strict precautionary principle, support of organic agriculture, and science. The last category usually has received the shortest shrift. For both the herbicide glyphosate and the fungicide copper sulfate, the EU granted a five-year license. But there the similarity of how Europe handled them ends.”
Agrow Agribusiness Intelligence
US Judge agrees to limit evidence in glyphosate cancer trials
J. R. Pegg | January 7, 2019
The issues of Monsanto’s alleged attempts to influence the EPA and other regulatory agencies and to manipulate public opinion are a “significant portion” of the plaintiffs’ case, according to the judge.
“These issues are relevant to punitive damages and some liability questions,” he explained. “But when it comes to whether glyphosate caused a plaintiff’s NHL [Non-Hodgkin’s Lymphoma], these issues are mostly a distraction, and a significant one at that. . . Judge Chhabria concluded that this “relatively minor concern” could be addressed by an instruction to the jurors that they “must not defer to regulatory agencies” and should instead reach their own judgement based on the evidence presented at trial.”
Agrow Daily News Alert
German BfR rejects report’s plagiarism charge in glyphosate assessment
17 Jan 2019
The German federal institute for risk assessment, the BfR, has rejected accusations of deliberate deception while defending itself against a report claiming “plagiarism and super-ordinated copy and paste” in its assessment of the herbicide, glyphosate. Germany was the EU rapporteur member state for the renewal of glyphosate’s approval and cleared the active ingredient in 2014 based on the recommendations of the BfR. The German draft re-assessment report (RAR) was forwarded to the European Food Safety Authority (EFSA), which concluded in 2015 that the ai was unlikely to be carcinogenic. In a new report, “experts” commissioned by the Greens/European Free Alliance parties discovered plagiarism “exclusively in the chapters dealing with the assessment of published studies on health risks related to glyphosate”. In these chapters, about half (50.1%) of the content was identified by them as plagiarism.
Agrow Daily News Alert
EU court overturns EFSA refusal to release glyphosate data
08 Mar 2019
An EU court has annulled two decisions by the European Food Safety Authority (EFSA) to refuse access to certain toxicity and carcinogenicity studies on the herbicide, glyphosate. The issue centered on whether the requested information was related to emissions to the environment, because public interest overrides confidentiality considerations for such information. The EFSA argued that the information requested was not related to emissions, but the General Court of the European Court of Justice (ECJ) disagrees and says that public interest must prevail.
CropLife Magazine
The War on Glyphosate Spreads
April 3, 2019
Although glyphosate has been in use in crop fields since 1974, debate over the safety and continued use of the herbicide has never been more intense than now. And the scope of these attacks is spreading.
Although this finding [the IARC report] has been contradicted by research from other regulatory agencies around the world in the intervening years, many glyphosate opponents have consistently cited the IARC report as “proof” that the herbicide is dangerous to human health and should be banned.
Following months of indecisive votes among the 28 EU member states, an agreement to re-approve glyphosate use in the block for five years was reached in September 2017 as 18 countries voted in favor of it. Despite this, one of the countries that voted against continuing the use of glyphosate, France, vowed to “take all necessary measures to ban the product as soon as an alternative was made available.”
Agrow Daily News Alert
Bayer Releases all of its Glyphosate Safety Studies
09 April 2019
Bayer’s Crop Science division has released all of the underlying safety study reports to the study summaries on the safety of legacy company Monsanto’s herbicide, glyphosate. The company released 300 study summaries on the herbicide in December last year that had been submitted for the review that led to the EU renewal decision. The EU approved the herbicide for just five years after several member states rejected reapproval, coming into force December 2017.
Agrow Daily News Alert
France confirms phase out of glyphosate use by 2020 end – update
13 May 2019
France’s Ministry of Agriculture has come up with an action plan to put an end to the main uses of the herbicide, glyphosate, “where alternatives exist”, by the end of 2020 and for all uses by 2022. The Ministry points out that farmers would not be left without solutions. the action plan also aims to reduce the use of agrochemicals by 25% by the end of 2020 and by 50% by 2025.
Agrow Daily News Alert
EU warns against MEPs’ bid to influence the EFSA
Jackie Bird | 03 Jun 2019
A recent successful bid by the European Parliament to increase its representation on the management board of the European Food Safety Authority (EFSA) “should not be considered as a precedent”, warns the European Commission. The public access proposals arose out of the controversial five-year renewal of the EU approval of the herbicide, glyphosate. During the discussions on glyphosate and the public access proposals, many MEPs continued to question the independence of the EFSA despite repeated presentations by the agency at parliamentary hearings and its release of numerous documents related to the case.
Agrow Daily News Alert
Bayer appeals $80 million award to US glyphosate cancer victim
06 Jun 2019
Bayer has appealed for legacy company Monsanto an $80 million jury award to a man who claims exposure to the company’s glyphosate-based herbicide caused his cancer. It argues that the decision runs counter to scientific evidence regarding the safety of the herbicide and conflicts with federal law.
Bayer says that either the verdict should be tossed out or that the company be granted a new trial. The company argues that US District Judge Vince Chhabria had failed to ensure a fair trial and allowed the jury to hear a “narrative … that painted a misleading and prejudicial picture” of Monsanto’s actions and the safety of glyphosate. “A number of procedural and evidentiary issues undermined the fairness and integrity of the trial,” Bayer states.
Agrow Daily News Alert
Bayer seeks glyphosate alternatives and sustainability
17 Jun 2019
Bayer is setting targets on increasing sustainability of agriculture products, improved transparency and developing alternatives to glyphosate herbicide. . . Bayer says that glyphosate will play a continuing “important” role in its portfolio, while the company seeks alternative weed controls by investing some €5 billion ($6 billion at the current rate) in research and development over the next decade. Bayer is facing various threats to its blockbuster herbicide. There are thousands of outstanding plaintiff cases claiming that glyphosate-based products resulted in third contracting cancer, and that legacy business Monsanto had failed to adequately warn users of the claimed risk. Early cases have resulted in large multimillion-dollar losses for the company. It has initiated appeals. Some countries are considering or, in some cases, promising bans on the herbicide.
* * * *
Science is losing. Agendas are winning. Banning DDT is one thing, but bringing down the world’s most important herbicide with the world’s best safety record? That is chilling. From its inception in 1992 at the United Nation’s Earth Summit, 50,000 delegates, heads of state, diplomats and Non-governmental organizations (NGOs) hailed Agenda 21 as the “comprehensive blueprint for the reorganization of human society.” To introduce the plan, the Earth Summit Chairman, Maurice Strong boldly proclaimed, “Current lifestyles and consumption patterns of the affluent middle class – involving meat intake, use of fossil fuels, appliances, air-conditioning, and suburban housing – are not sustainable.” In short, living the way we do is not sustainable. Raising crops conventionally and controlling pests that are disease vectors with insecticides is “not sustainable.” Sustainable farming practices, “limiting your footprint” and “going green” are buzzwords for curtailing your freedom to make choices about what you eat, where you go and how you get there.
i Christopher J. Bosso (1987). Pesticides and Politics: The Life Cycle of a Public Issue. University of Pittsburgh Press, Pittsburgh, PA.
ii Katarina Zimmer (2018). How Toxic is the World’s Most Popular Herbicide Roundup? The Scientist Magazine, February 7, 2018 as reported online (https://www.the-scientist.com/news-opinion/how-toxic-is-the-worlds-most-popular-herbicide-roundup-30308)
iii Louping Zhang, L. Rana, R. M. Shaffer, et al (2019). Exposure to glyphosate-based herbicides and risk for non-Hodgkin lymphoma: A meta-analysis and supporting evidence. Mutation Research/Reviews in Mutation Research 178: 186-206 (February 2019) (https://www.sciencedirect.com/science/article/pii/S1383574218300887#!)
iv Mayo Clinic (2019). Non-Hodgkin’s Lymphoma. Accessed on July 4, 2019 at https://www.mayoclinic.org/diseases-conditions/non-hodgkins-lymphoma/symptoms-causes/syc-20375680
v News Medical (2019). Non-Hodgkin Lymphoma History. Accessed on July 4, 2019 at https://www.news-medical.net/health/Non-Hodgkin-Lymphoma-History.aspx
vi Frank Graham (1967). Audubon 69(3): 30 (May 1967) vii Bosso Op. cit.
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