In re Roundup Products Liability Litigation

Exhibit 1

Northern District of California, cand-3:2016-md-02741

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44 EXHIBIT 1 44 44 EXPERT REPORT OF CHARLES M. BENBROOK, PhD TABLE OF CONTENTS I. Summary of Opinions --------------------------------------------------------------------------------- 3 II. Science Judgements Impacting the Use of Glyphosate ---------------------------------------- 14 III. Expert Background and Qualifications----------------------------------------------------------- 31 IV. The EPA Pesticide Regulatory Decision Process -------------------------------------------- 40 A. Three Major OPP/EPA Actions and Decisions -------------------------------------------------- 40 B. Applications to Register a New Pesticide -------------------------------------------------------- 42 C. Actions Impacting the Future Use of an Already-Registered Pesticide ---------------------- 43 D. Impacts of OPP Cancer Determinations on Tolerance Setting ------------------------------- 44 V. Early EPA Actions on Glyphosate Herbicide --------------------------------------------------- 49 A. Initial Uses and Tolerance Actions ---------------------------------------------------------------- 49 B. Studies on Glyphosate Conducted by Industrial BioTest --------------------------------------- 52 C. Contaminants, Adjuvants, and Surfactants ------------------------------------------------------- 54 D. Sources of Pesticide Product Risk ----------------------------------------------------------------- 56 1. Impurities in Glyphosate Active Ingredient --------------------------------------------------- 57 2. Adjuvants and Surfactants in Roundup End Use Products ---------------------------------- 57 3. Heightened Toxicity Caused by the Surfactants in Formulated Roundup ---------------- 57 VI. Bio/dynamics Mouse Oncogenicity Study Triggers "Possible Oncogen" Classification 64 A. Results of Bio/dynamics Mouse Oncogenicity Study -------------------------------------------- 64 B. Review of the Bio/dynamics Mouse Study -------------------------------------------------------- 65 C. OPP Dismisses Monsanto's Historical Control Data Argument ----------------------------- 71 D. Monsanto Takes Its Case to the Director of the OPP Registration Division ---------------- 72 E. Monsanto Hires Another Pathologist to Re-read the Kidney Slides -------------------------- 73 F. Re-sectioning of the Bio/dynamic Mouse Kidney Slides---------------------------------------- 74 G. The 1986 SAP Review of the Mouse Oncogenicity Study -------------------------------------- 78 VII. Monsanto Does Not Add New Worker Safety Language on Roundup Warning Labels ---------------------------------------------------------------------------------------------------------- 87 VIII. Monsanto Terminates TNO Study, Which Showed Elevated Rates of Dermal Absorption ---------------------------------------------------------------------------------------------------- 96 1 44 IX. Monsanto's Relationships with "Friendly" Scientists and Officials in EPA ------------ 100 A. Jess Rowland --------------------------------------------------------------------------------------- 100 B. Jack Housenger ------------------------------------------------------------------------------------ 103 X. Monsanto Asks Dr. Parry to Assess Glyphosate Genotoxicity and Then Does Not Disclose His Findings to Regulators or Conduct the Studies He Recommends ------------- 106 XI. Corporate Ghost-Authorship/Writing ---------------------------------------------------------- 111 A. Gary Williams et al 2000 Paper ----------------------------------------------------------------- 112 B. Williams et al 2012 -------------------------------------------------------------------------------- 117 C. Kier and Kirkland 2013 Paper ------------------------------------------------------------------- 119 D. Critical Reviews of Toxicology Special Issue on Glyphosate Risks ------------------------ 121 E. Other Forms of Ghost-Writing ------------------------------------------------------------------- 125 XII. Responses to Scientists Raising Concerns over Glyphosate Safety -------------------- 128 A. IARC Working Group Members ----------------------------------------------------------------- 128 B. Seralini Team --------------------------------------------------------------------------------------- 128 C. The IARC Classification -------------------------------------------------------------------------- 134 D. Political and Other Activities Post-IARC------------------------------------------------------- 151 E. Blocking the ATSDR Review of Glyphosate ---------------------------------------------------- 153 XIII. Downplaying Glyphosate Risks---------------------------------------------------------------- 155 A. Freedom to Operate (FTO) ----------------------------------------------------------------------- 156 1. Section 6(a)(2) of FIFRA ---------------------------------------------------------------------- 157 2. Responding to FQPA Challenges ------------------------------------------------------------- 157 B. Understating Risks --------------------------------------------------------------------------------- 159 1. The IARC Review Process -------------------------------------------------------------------- 159 2. Advertising --------------------------------------------------------------------------------------- 165 2 44 I. Summary of Opinions 1. I have been asked by the Plaintiffs' attorneys to review materials relating to the composition, use, testing, stewardship, risk assessment, and regulation of glyphosate and Roundup®-brand herbicides ("Roundup"). My review of public documents, the discovery record, and my work over decades on glyphosate risks, regulation, and the use of Roundup herbicides have shaped the opinions expressed herein. 2. All of my opinions were reached to a reasonable degree of scientific certainty. 3. I include opinions in this summary section most responsive to the key issues I have been asked to address. These opinions cover many different areas, but they relate to my core expertise of examining whether Monsanto's conduct as a pesticide manufacturer and registrant, comport with its obligations and stewardship responsibilities. 4. Throughout this report, additional opinions, and more complete explanations of my opinions are presented, along with my discussion of the various Monsanto actions, inactions, documents, and initiatives leading to my opinions. 5. I reserve the right to augment or revise this report to fix typos, add MONGLY document references, or incorporate new studies or data I become aware of that alter or reinforce findings and opinions expressed in this report. 6. The likelihood that exposures to Roundup can trigger or contribute to the progression of non-Hodgkin lymphoma is central to this case. Extensive scientific and regulatory resources have been invested over decades in pursuit of clarity on this core question. Has Monsanto done everything it could have, and should have done to resolve uncertainty in the scientific data relied upon to answer this core question? a. In my opinion, no, they have not. 3 44 b. The first valid chronic oncogenicity study on glyphosate was submitted to EPA in 1983 (the Bio/dynamic mouse study). It showed an increase in renal tubular adenomas in the male mice that Monsanto claimed was not treatment related. EPA disagreed, and classified glyphosate as a "possible human oncogen" in 1985. c. Monsanto challenged EPA's determination through multiple avenues, for years, leading to an EPA request for Monsanto to do a new and better study. A Scientific Advisory Panel convened by EPA to provide guidance in resolving the controversy over the 1983 Bio/dynamic study called for a repeat study. The EPA adopted the SAP's advice and required a repeat mouse study in its 1986 Registration Standard document on glyphosate. Monsanto refused to conduct it and has not done so to this day. d. Monsanto has refused since the mid-1980s to conduct the studies needed to resolve uncertainty over the oncogenicity of Roundup, including studies specifically requested by the EPA. In my opinion, the failure of Monsanto to invest in new and better science, such as the more powerful mouse cancer replacement study requested by EPA in 1986, has perpetuated scientific uncertainty and undermined EPA's ability to understand and quantify Roundup cancer risks. e. I also conclude that, as a result, the EPA has been unable to determine whether Roundup-associated cancer risks fall below or exceed the agency's "level of concern." Because no one has ever sprayed or been exposed to pure glyphosate, Monsanto's assertions and EPA's conclusion 4 44 that glyphosate does not pose significant cancer risk to the general public, based on current and typical levels of exposure, is not reassuring nor particularly useful in understanding and managing cancer risks arising from exposures to formulated Roundup and other GBHs. f. Dr. Donna Farmer, a senior Monsanto scientists wrote to a Monsanto communications professional "You cannot say that Roundup is not a carcinogen…we have not done the necessary testing on the formulation to make that statement. The testing of the formulations are not anywhere near the level of the [testing on] the active ingredient." (MONGLY00922457- 8). 7. For decades, there have been multiple studies showing that formulated Roundup is more toxic than pure, 100% technical glyphosate. Most of the surfactants in Roundup-brand herbicides are more toxic, ounce for ounce, than glyphosate. Plus, pure glyphosate does not move readily through the skin or into cells, whereas Roundup and other GBHs does. a. The surfactants in Roundup products are added to formulations to speed up the movement of glyphosate through weed leaf surfaces, and then into the cells of weeds. Roundup surfactants act roughly the same way when Roundup comes into contact with human skin. This is one of the primary reasons why Roundup is markedly more toxic to exposed humans than glyphosate. b. Despite knowledge of the differences in toxicity and risks arising from exposures to formulated Roundup in contrast to pure glyphosate, Monsanto has not carried out critical, long-term cancer feeding studies 5 44 with Roundup. Nor has anyone else. c. In my opinion, Monsanto's refusal to carry out long-term cancer feeding studies in both mice and rats using a common Roundup formulation has perpetuated scientific uncertainty and delayed the regulatory consequences of such studies, in the event one or both studies report evidence of a treatment-related oncogenic response. 8. Monsanto has refused to conduct state-of-the-art genotoxicity assays in mammals and in human populations exposed to formulated Roundup. When the EPA reviewed this area of science, my systematic review of the studies cited and available to the EPA reveals that those studies originated by industry, and for the most part conducted by Monsanto, generally show no genotoxic effect, whereas independent studies, utilizing more advanced state-of-the-art systems, do show genotoxic effect. This discrepancy indicates that the EPA's review of genotoxicity has been skewed by industry studies that are less sensitive. a. In its September 2016 evaluation of glyphosate oncogenicity, EPA reviews about 50 registrant-commissioned genotoxicity studies carried out mostly by Monsanto on pure, glyphosate technical. Only one of these ~50 registrant studies reported evidence of a genotoxic response. b. Another approximate 45 registrant-commissioned studies were carried out on formulated Roundup and other GBHs. Of the ~45 registrant studies on GBH genotoxicity, none reported evidence of a genotoxic response. c. Accordingly, out of nearly 100 registrant-commissioned studies cited in EPA's September 2016 report on glyphosate genotoxicity, only one reported a positive genotoxic response. 6 44 d. About another 55 studies on pure glyphosate have been published in peer- reviewed science journals (hereafter referred to as "public literature"), and another 70 have been published on formulated GB