The Glyphosate Files: Smoke & Mirrors in the Pesticide Approvals Process

Helmut Burtscher-Schaden

The Glyphosate Files

Smoke & mirrors in the pesticide approvals process

For Laurin and Livia

www.kremayr-scheriau.at

eISBN 978-3-218-01100-6

2017 by Verlag Kremayr & Scheriau GmbH & Co. KG, Wien

All rights reserved

Image Part II Chapter 1: courtesy of Andreas Rummel

Image Part II Chapter 4: courtesy of GLOBAL 2000

Translation: Patricia Lorenz and Joanna Scudamore-Trezek

Project management & copy-editing: Sonja Franzke, vielseitig.co.at

Cover design & letterpress: Silvia Wahrstätter, buchgestaltung.at

Table of contents

Prologue: The wrong WHO

Part One USA 1973 to 1991

Chapter 1: Suspected fraud

Chapter 2: Cancer alarm

Chapter 3: Miraculously exonerated

Chapter 4: A licence to kill

Part Two Europe 2012 to 2017

Chapter 1: System failure

Chapter 2: Mobilisation

Chapter 3: Smoke and mirrors

Chapter 4: Entanglements

Chapter 5: Cracks in the system

Epilogue The future

Appendix

Glossary

Endnotes

Thanks

Prologue

The wrong WHO

16 May 2016. My instructions were to refrain from working, just for once. Simply to spend a stress-free afternoon with my daughter at the playground. Nothing unusual for a public holiday in spring, but it wasn’t to turn out like that. While my daughter clambered over the climbing frame on this particular Whit Monday, I typed the term glyphosate into Google News on my mobile phone.

The force of habit.

For I work as a biochemist for the Austrian environmental organisation GLOBAL 2000. The main focus of my work is problematic commonplace chemicals and how to protect people from the dangers and risks they present. Over the past year I had been working with a group of environmental activists, consumer protectionists and scientists from various European countries towards our shared goal of preventing the European Union from renewing its approval of a carcinogenic pesticide. In only two days‘ time, in Brussels, the 28 EU Member States would vote on the issue which had kept my European colleagues and myself busy for months. Would glyphosate receive renewed approval in the European Union despite the WHO classifying it as probably carcinogenic for humans?

What Google News returned in response to my query from the playground was unexpected bad news; I read the words: WHO gives thumbs up for glyphosate. Germany’s daily newspaper FAZ wrote: New evaluation of risk: WHO does not believe glyphosate causes cancer¹. Even Die Zeit carried the headline: WHO scientists classify glyphosate as not carcinogenic.²

I was shocked. At a stroke this volte-face would make all our work of the recent months obsolete. How could this be? And above all, why should the WHO’s cancer research agency (IARC) have suddenly revised their assessment?

Then came the revelation – someone else was behind the retraction: the joint FAO/WHO meeting on Pesticide Residues (JMPR). This scarcely pronounceable name describes an international pesticide advisory panel of rather dubious repute. However, at this moment the retraction of the JMPR threatened to tip the scales at the forthcoming EU vote: in just two days‘ time glyphosate could be given renewed approval. The champagne would then be flowing at Monsanto! What was little known, however, was that the JMPR had already once given a highly dubious all-clear to Monsanto’s glyphosate back in the 1980s. Even then the JMPR contradicted another expert panel which the previous year had classified glyphosate as possibly carcinogenic in humans.

Back in the 1980s it was the American environmental protection agency, the U.S. EPA; today it is the WHO’s cancer research agency IARC. But who or what is this JMPR?

While the WHO’s cancer research agency IARC exclusively uses studies which are open to public examination when classifying cancer, the JMPR primarily relies on studies which are carried out by the pesticide manufacturers themselves and kept under wraps. Where the IARC strives for independence and transparency in its decision-making, many see the JMPR as dominated by industry and opaque in its dealings. While the IARC assesses whether a chemical by its very nature is carcinogenic, irrespective of dosage and method of intake, the JMPR examines only the risk posed by pesticide residues in foodstuffs.

One of the first to welcome the JMPR’s positive assessment on Twitter was the Executive Vice President and CTO of Monsanto, Robb Fraley. Only a year earlier Fraley had ranted and raved against the IARC. Now he happily tweeted: WHO/FAO refutes WHO/IARC; glyphosate safety re-affirmed! But there was another tweet on the same topic: French journalist Stéphane Foucart of Le Monde revealed an interrelationship which throws a different light on the JMPR’s judgement: Alan Boobis and Angelo Moretto (ILSI associates) were not only members of the JMPR WG on glyphosate, they were its chair and co-chair. Someone had done some careful research, because Alan Boobis and Angelo Moretto are two scientists whose names regularly crop up whenever there are attempts to turn industry-friendly recommendations into regulations. Both have important roles at the International Life Science Institute (ILSI), a global science institute largely financed by major food and chemical corporations including Monsanto, Bayer, Nestle, BASF, and many others.³

Despite this, however, many newspapers appeared the next day falsely proclaiming that the WHO gives the all-clear for glyphosate. And the timing of this purported exoneration of the pesticide, just one day before the decisive vote, was naturally devastating, both for us and all those wanting to block glyphosate.

The trip to the playground was abruptly ended by this news. My confidence that our work would bear fruit in terms of the EU decision was seriously dented. Now it was essential to rectify the basic facts with a statement to the press. Firstly, that the WHO had not made a retraction. Secondly, that there are still unresolved conflicts of interest within the JMPR. And thirdly, that the JMPR is exclusively concerned with pesticide residues in foodstuffs. Too many topics to squeeze into a 1-page press release. For in the end this was only the latest development in a story which had started in the USA in the 1970s. To explain all this would fill a book. This book.

PART ONE

USA 1973 to 1991

Chapter 1

Suspected fraud

Too good to be true

On 4 April 1983, the US Federal Court of Chicago opened a trial that was to become one of the most extensive trials in the history of Illinois. By the time the sentence was pronounced in October 1983, its records filled more than 16,000 pages.¹ The legal authorities had been investigating the case for six years. Newspaper commentaries had called it the biggest case of scientific fraud in the history of the USA, maybe even in the history of the world. The fraud was suspected to have been committed by Industrial Bio-Test Laboratories (IBT Laboratories), formerly the largest private testing institute for industrial chemicals in the United States. In the dock were Joseph C. Calandra, the founder and former owner of IBT Laboratories, as well as three of his former leading scientists. They were charged with routinely falsifying test reports on substances in drugs, personal care products and pesticides and thus to have wilfully deceived the US-American regulators.

The fraud had already been uncovered back in 1976. Adrian Gross, an attentive investigator at the US Food and Drug Administration (FDA), the authority responsible for the authorisation of drugs and food additives, had become suspicious when examining a study on a painkiller carried out by IBT Laboratories. The test data seemed too good to be true.² None of the rats had developed tumours, Adrian Gross explained later, although every pathologist knows that rats and mice in long-time studies also develop spontaneous tumours, and show a certain degree of mortality. However, according to the IBT study, all of the animals were clean.

During a more precise examination of the data of this Naproxen study, Gross discovered oddities in the data tables: rats which had been listed as dead in one section of the study suddenly reappeared in another section of the study. We do not really believe in animals coming back to life after death, Adrian Gross noted in his report. Due to the appalling sanitary and hygienic conditions in the animals’ housings, IBT Laboratories indeed struggled with a mortality rate among the laboratory animals that, in many cases, prevented them from doing tests in accordance with the regulations. In order to hush up this fact, IBT technicians were ordered to replace perished animals with healthy ones. When the advanced decay of the dead animals made an autopsy impossible, this was documented internally with the abbreviation TBD / TDA, too badly decomposed/technician destroyed animal. ³ This probably explained the riddle of the lack of tumours.

The Naproxen painkiller study was only one of 22,000 studies that the IBT had carried out for manufacturers and authorities during their three decades of existence. Hundreds of chemicals that had since become part of thousands of daily products had been classified as safe because of the test results. One of these chemicals was to receive particular attention in the forthcoming trial: Monsanto’s antibacterial agent triclocarban (TCC). What the interrogation of witnesses was to unearth about the safety testing on TCC and the role that Monsanto played in this is suggestive of how far the company was ready to go to push through its interests.

TCC, an anti-bacterial additive for soaps, had attracted the attention of the FDA at the beginning of the 1970s. There had been indications that TCC had caused deformities in the testicles of rats fed with the anti-bacterial agent. This presented Monsanto with a problem: at around the same time, the chemical company had requested an increase in the permitted levels of TCC in bar and liquid soaps. Monsanto therefore asked the private IBT Laboratories to do a feeding study on rats. The study was supposed to convince the authorities that TCC was safe. Interestingly, at about the same time, Monsanto toxicologist Paul Wright left his job at Monsanto to take up a position at IBT Laboratories. There, as section head for rat toxicology, he supervised the very study that was to prove the safety of TCC. However, as early as half way through the 24 month feeding study, it became apparent that the laboratory rats resisted this (putative) plan. In June 1972, pathologist Donovan L. Gordon discovered testicular lesions in the male animals. He noted his observations in an interim report, which caused unexpected reactions.

The numerous attempts that Gordon’s superiors and Monsanto representatives made between 1972 and 1976 to convince the pathologist that the damages he identified were not caused by TCC, but had to be due to other reasons, were given a lot of space in the trial. In a report that is as readable as it is disturbing, US-American journalist Keith Schneider outlines the details. It was published in the Spring Edition 1983 of the Amicus Journal by the environmental organisation Natural Resources Defense Council, and taken up in numerous US-American media. Here is an overview of the most important events as they relate to Monsanto’s TCC:⁴

•On 11 October 1972, before the interim presentation of the study to an FDA panel, two Monsanto scientists impress upon Gordon how important it is to present TCC in a good light. Seemingly with success, for the minutes do not mention testicular lesions. However, Gordon continues to think that the testicular lesions are caused by TCC.

•6 October 1973: three months after the end of the feeding study, Paul Wright, who by then has quit IBT and is again working for Monsanto, meets the head of IBT, Joseph C. Calandra. He is concerned that Gordon’s interim report continues to describe testicular lesions that have occurred with large and small doses of TCC. He pushes Calandra to convince Gordon to change his conclusions, because factors such as stress, gender, age and nutrition could also be responsible for the animals’ lesions.

•On 22 January and 21 February 1975, Gordon’s findings in the TCC study are criticised at two further meetings at IBT.

•25 August 1975: Gordon, who sticks to his conclusion, has to re-examine and discuss the tissue samples with Dr William Ribelin, a pathologist hired by Monsanto. Gordon is able to convince Monsanto pathologist Ribelin that his observations indeed prove a treatment-related effect in all three dose groups⁵. Later, he will testify in court that Ribelin also gave him a handwritten copy of his report, in which Monsanto was informed that Ribelin had also arrived at the conclusion that TCC caused testicular lesions in all three dose groups.

•In January 1976, a last unsuccessful attempt is made to persuade Gordon to change his findings. Then Calandra asks an unexpected question: had there been any significant decomposition in the rats he studied? Gordon confirms that this was the case in some rats but not with others. Calandra then informs Donovan L. Gordon that he will remove his findings from the report and replace them with the wording that decomposition precluded meaningful evaluation of the testicular tissues.

•11 May 1976: Monsanto delivers the final TCC report, in which rats in the low dose group no longer show testicular lesions, to the FDA. The latter sees its concerns about testicular atrophy due to TCC dispelled, and recommends an increase of the admissible levels of TCC in bar and liquid soaps.

•April to July 1976: IBT is suspected of fraud. The TCC study is one of the first to come to the attention of the investigators. Monsanto has to repeat the study and commissions the private Bio/dynamics testing laboratory to do this. IBT, meanwhile, shreds hundreds of letters between IBT and its clients that, investigators presume, could have proven that large chemical companies had known about the IBT fraud.

•June 1982: a Monsanto spokesman explains to the magazine Mother Jones⁶ that the hopelessly flawed IBT study had been replaced by a study by Bio/dynamics Laboratories. According to the spokesman, that study shows that a human would have to eat 26 bars of soap a day for a normal lifetime in order to consume the amount of TCC that caused significant toxic effects in the test animals. Monsanto’s bacterial killer TCC is considered vindicated.

•21 October 1983: Paul Wright and two of his co-accused are found guilty by the jury of key charges (IBT founder Joseph C. Calandra was able to evade the trial because of health problems). Wright is jailed for six months and loses his job at Monsanto.

The man who had uncovered the scandal, Adrian Gross, had been asked one year before the start of the trial why corporations would allow their products to be subjected to phony or inadequate testing. Did the companies not want to know if their product causes cancer, reduces fertility or damages the DNA? And did they not risk being sued and financially destroyed by marketing dangerous products? Gross answered with a counter question: How are you going to prove that one pesticide caused cancer in somebody? First of all… a person, unlike a rat, is exposed to hundreds if not thousands of them. Chemical companies, Mother Jones stated, know that they are fairly safe from individual product liability lawsuits. In the rare event that they lose a case, damage awards tend to be relatively small when weighed against the profits generated by the product."⁷

The further course of the history of TCC proves him right: Monsanto escapes further investigations. This is not changed by the fact that, according to Mother Jones, the new contracting laboratory of Monsanto, which in the end vindicated TCC, also came to the attention of a U.S. EPA/FDA inspection shortly afterwards because of inadmissible practices and deficits. TCC successfully survived on the US market. According to a study by the U.S. EPA, more than 80% of deodorant soaps in the USA contained TCC at the turn of the millennium. In 2008, however, a team of researchers at the University of California found that TCC is an endocrine disrupting substance (see box on page 22) and causes changes in male sexual organs in tests with rats.⁸

A worrying result for, in 2014, a study sponsored by the National Institute of Health showed that 80% of the pregnant women examined excreted TCC in their urine and a fifth of the newborns had the bacterial killer in their blood at the moment of their birth.⁹ The authors of this study expressed their concerns about the endocrine-disrupting potential of TCC. On 6 September 2016, the FDA finally decided to ban the use of TCC in bar and liquid soaps, with the exception of medical purposes. More than four decades after the pathologist Donovan L. Gordon noted the first clear indications of this in his study report, the FDA thus stated that TCC could pose health risks, such as (…) hormonal effects¹⁰.

Endocrine Disrupting Chemicals, EDC

The WHO links endocrine-disrupting chemicals to a worldwide increase in fertility disorders, such as a decrease in the quality of sperm or deformities of male sexual organs, an increase in hormone-related forms of cancer, such as breast, prostate or testicular cancer, as well as a series of other diseases of modern civilisation, such as diabetes, cardiovascular diseases, etc. Their damaging effect is due to the fact that, because of their (coincidental) structural similarity to hormones, they can disrupt sensitive hormonal control processes in the organism. Like hormones, they can sometimes take effect in very low doses. The organism is most sensitive to the interference of endocrine-disrupting chemicals during so-called critical developmental windows, which is why foetuses, infants and adolescents are particularly sensitive to these substances. Decades can pass between the exposure to endocrine-disrupting chemicals and the manifestation of an illness due to this exposure.¹¹

We are the lab rats!

In the US media, the IBT fraud case caused some venomous and strong reactions. In its edition of 4 July 1982, the Tallahassee Democrat asked:

Feel safe? … and then adds: Don’t. They’re testing products on you.¹²

One of the most comprehensive, radical and simultaneously unerring analyses was offered by the monthly Mother Jones magazine¹³ in its June and the following July edition of 1982. In part 1 of its analysis¹⁴ the editors preceded their report with a letter that said:

A year-long team investigation has found that our entire regulatory structure is so corporate-dominated, so riddled with incompetence and corruption that it almost completely fails to protect the American people.

The paper bluntly uncovered the inherent conflicts of interest that contracting laboratories, such as IBT, face:

Private testing laboratories live and die by the positive results generated on products they test for safety. Your future as a laboratory owner or administrator is in serious jeopardy if you find too many products unsafe.

The magazine however, was hardest on regulatory authorities:

The illusion of safety is not always created by corrupt testing laboratories or deceptive corporations. Too often, regulatory agencies look the other way or blindly accept the conclusions of obviously self-interested research.

The total failure of the regulatory system was closely linked to the concern for health. The authors of Mother Jones presented concrete figures on the incidence of deformities in newborns and of annual cancers, and linked them to the disastrous failure of safety checks by authorities.

More than 800,000 new cases of cancer are expected this year, and, according to the Center for Disease Control, nearly three out of every 100 children born in 1982 will have serious birth defects. Some of this carnage is inevitable. It is caused by combinations of human error, bad luck and acts of God. But far too much of it is caused by products we place our trust in because they are labelled safe.

Suddenly, a question that nobody had been interested in for years was being debated in the national papers: is it smart to leave the examination of sensitive chemicals to those who produce and sell these chemicals? And why are the test reports kept a secret?

Lessons learned…

Will those responsible now draw the evident and necessary conclusions from the scandal? Will the registration system be fundamentally reformed? Unfortunately, the answer is no. The essence of the registration system remains untouched, although a lack of transparency, inherent conflicts of