Monsanto : requête du cabinet Hollingsworth à l

Monsanto : requête du cabinet Hollingsworth à l'EPA

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Avi S. Garbow, Esq. September 15, 2016 Page 2 federal courts and some in state courts). These lawsuits expressly cite in support of their allegations, the July 2015 monograph of a Working Group of the International Agency for Research on Cancer (“IARC”) regarding glyphosate, as well as allegations regarding the evaluation and process that led to the IARC monograph.The monograph’s List of Participants includes the following individuals who were EPA employees at the time:Matthew Martin, Peter Egeghy, Catherine Eiden, and Jesudosh Rowland.EPA and other regulatory authorities have stated in the past that “glyphosate does not pose a cancer risk to humans.”2013 Federal Register Notice (FR 25396, Vol. 78, No. 84, May 1, 2013);see, e.g., German Federal Institute for Risk Assessment,Glyphosate Renewal Assessment Report, Germany as Rapporteur Member State for the European Renewal of Approval for Glyphosate(2015) (“In epidemiological studies in humans, there was no evidence of carcinogenicity and there were no effects on fertility, reproduction and development of neurotoxicity that might be attributed to glyphosate.”). Securing information regarding what transpired during the IARC’s deliberations about glyphosate and what led to the conclusions of this monograph may assist the parties and the courts in the above captioned litigation in evaluating the plaintiffs’ claims.Accordingly, we request pursuant to 40 C.F.R.

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Avi S. Garbow, Esq. September 15, 2016 Page 2 federal courts and some in state courts).These lawsuits expressly cite in support of their allegations, the July 2015 monograph of a Working Group of the International Agency for Research on Cancer (“IARC”) regarding glyphosate, as well as allegations regarding the evaluation and process that led to the IARC monograph. The monograph’s List of Participants includes the following individuals who were EPA employees at the time: Matthew Martin, Peter Egeghy, Catherine Eiden, and Jesudosh Rowland. EPA and other regulatory authorities have stated in the past that “glyphosate does not pose a cancer risk to humans.” 2013 Federal Register Notice (FR 25396, Vol. 78, No. 84, May 1, 2013);see, e.g., German Federal Institute for Risk Assessment,Glyphosate Renewal Assessment Report, Germany as Rapporteur Member State for the European Renewal of Approval for Glyphosate(2015) (“In epidemiological studies in humans, there was no evidence of carcinogenicity and there were no effects on fertility, reproduction and development of neurotoxicity that might be attributed to glyphosate.”).
Securing information regarding what transpired during the IARC’s deliberations about glyphosate and what led to the conclusions of this monograph may assist the parties and the courts in the above captioned litigation in evaluating the plaintiffs’ claims. Accordingly, we request pursuant to 40 C.F.R. Part 2, Subpart C that you produce certified copies of:all emails with any attachments and all other documents created by, sent by, received by, copied to, or maintained by one or more of the following EPA employees: Matthew Martin, Peter Egeghy, Catherine Eiden, and Jesudosh Rowland, relating or referring to:
The International Agency for Research on Cancer (“IARC”);
The IARC Working Group 112 and/or its carcinogenicity conclusions;
Any other cancer assessments of glyphosate, including, but not limited to, assessments of glyphosate by non-U.S. based entities;
Any communications to or from IARC invited specialist Christian Portier, either with the same four EPA employees identified above or with any other employees of the EPA who work in the Office of Research and Development in Washington DC;
Any communications to or from anyone on the staff of IARC, including but not limited to, Kurt Straif, Kathryn Guyton, and Dana Loomis, either with the same four EPA employees identified above or with any other employees of the EPA who work in the Office of Research and Development in Washington DC;
Any communications to or from Aaron Blair, Gloria D. Jahnke, Charles W. Jameson, Matthew K. Ross, Ivan I. Rusyn, Patrice Sutton, and Lauren Zeise either with the same four EPA employees identified above or with any other employees of the EPA who work in the Office of Research and Development in Washington DC,
Avi S. Garbow, Esq. September 15, 2016 Page 3 whether these documents are located in agency or personal computers or e-mail accounts or in hard-copy documents or files. This request is limited to the last five years.
For purposes of this letter, the term “documents” is used broadly, and encompasses all tangible things and recorded information possessed by you, including but not limited to, handwritten, typed, or printed papers, handwritten notations, letters, cards, memoranda, diaries, electronic mail, drawings, photographs, audio, DVD and videotape recordings, statements, manuals, calendars, notes of telephone conversations, reports, receipts, correspondence, notes, computer print outs, tapes, disks, CD-ROM, and other forms of electronically or magnetically maintained information.
A.
Background
In the four representative cases identified in the subject line of this letter, a variety of claimed users of glyphosate-containing products allege that exposure to the products caused their cancer:
Four farmers from Nebraska, Larry E. Domina, Frank Pollard, Robert L. Dickey, and Royce D. Janzen filed their products liability lawsuit against Monsanto in the U.S. District Court ® for the District of Nebraska. All four plaintiffs allege that exposure to Monsanto’s Roundup caused their non-Hodgkin’s lymphoma. As alleged support for their causation claims, they all rely expressly on the IARC monograph on glyphosate. Discovery is expected to begin shortly in this case.
A turf installer, Emanuel Giglio, filed his products liability lawsuit against Monsanto in the U.S. District Court for the Southern District of California on October 9, 2015. Mr. Giglio ® alleges that he developed non-Hodgkin’s lymphoma from exposure to Monsanto’s Roundup . As alleged support for his causation claim, he relies expressly on the IARC monograph on glyphosate. Discovery is expected to begin shortly.
® Edward Hardeman, who claims that he used Monsanto’s Roundup on his own property to control weeds, filed his products liability lawsuit against Monsanto in the U.S. District Court for the Northern District of California on February 1, 2016. Mr. Hardeman alleges that he ® developed non-Hodgkin’s lymphoma from exposure to Roundup . As alleged support for the causation claim, he also relies expressly on the IARC monograph on glyphosate. TheHardeman case is now in active discovery.
Phyllis Kennedy filed her products liability lawsuit against Monsanto in the Circuit Court of Camden County, Missouri on December 31, 2015. Ms. Kennedy alleges that her deceased spouse, Van Kennedy, developed non-Hodgkin’s lymphoma from exposure to Monsanto’s ® Roundup used on the family’s lawn and garden. As alleged support for the causation claim, she also relies expressly on the IARC monograph on glyphosate. TheKennedycase is now in active discovery; in addition to seeking millions of pages of records from Monsanto, the plaintiff’s
Avi S. Garbow, Esq. September 15, 2016 Page 4 counsel have served numerous subpoenas to third-parties, including advertising agencies that assisted Monsanto in its marketing and sales activities.
As noted above, Monsanto is now facing an additional 40 similar complaints involving 151 plaintiffs at this time in 28 different jurisdictions, and the number of cases and plaintiffs is expected to increase.
1 Glyphosate is “the most important herbicide” developed in the post-World War II era. Glyphosate-based herbicides first became commercially available in 1974 when, after four years ® of testing by its research scientists, Monsanto introduced Roundup , a mixture of glyphosate and surfactants. Glyphosate is non-selective, meaning that it is intended to and will eradicate any ® exposed plant. Farmers apply Roundup before crops are planted or, where glyphosate resistant seed is used, during the growing process. Glyphosate works by inhibiting a growth-stimulating enzyme that is specific to plants. As documented in numerous scientific analyses, glyphosate is 2 not toxic to human or animals. EPA, which has broad authority to regulate all herbicides under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), has for decades found 3 glyphosate to be “one of the most safely-used pesticides in the U.S.,” and repeatedly has concluded that glyphosate exposure does not cause cancer.
We understand that EPA employees Matthew Martin, Peter Egeghy, Catherine Eiden, and Jesudosh Rowland were asked to serve as members and/or agency representatives of IARC Working Group 112, which reviewed the carcinogenic potential of glyphosate and several other substances.Seehttp://monographs.iarc.fr/ENG/Meetings/vol112-participants.pdf. Although Peter Egeghy and Catherine Eiden were ultimately unable to attend the meeting of the Working Group, they likely were included in correspondence leading up to the meeting of the Working Group, which took place in Lyon, France, in March 2015. The Working Group thereafter classified glyphosate “asprobably carcinogenic to humans(Group 2A).” 1 Stephen O. Duke & Stephen B. Powles,Glyphosate: A Once-In-A-Century Herbicide, 64 Pest Mgmt. Sci. 319 (2008).2 SeeKeith R. Solomon et al.,Human Health and Environmental Risks from the Use of Glyphosate Formulations to Control the Production of Coca in Colombia: Overview and Conclusions, 72 J. Toxicology & Envtl. Health 914, 919 (2009); Keith R. Solomon et al.,Coca and Poppy Eradication in Colombia:Environmental and Human Health Assessment of Aerially Applied Glyphosate,190 Revs. Envtl. Contamination & Toxicology 43, 106 (2007); Gary M. Williams et al.,Safety Evaluation and Risk Assessment of the Herbicide Roundup and Its Active Ingredient, Glyphosate, for Humans, 31 Reg. Toxicology & Pharmacology 117, 129 (2000) (reviewing over 188 documents either in published scientific literature or submitted to regulatory agencies assessing the safety of glyphosate, and concluding that glyphosate “is considered to be practically nontoxic by all these routes of exposure”). 3 Letter from EPA Assistant Administrator Stephen L. Johnson to Secretary of State Colin L. Powell at 1 (Aug. 19, 2002).
Avi S. Garbow, Esq. September 15, 2016 Page 5 The plaintiffs identified above have filed complaints alleging that exposure to Monsanto’s glyphosate-containing products caused them to develop cancer, relying in their complaints on allegations regarding the evaluation conducted by the IARC working group. More similar complaints are expected.
B.
Justification for Document Production
Monsanto serves this request for voluntary production so that service of subpoenas on EPA for this material may hopefully be avoided. Monsanto believes it is in the interest of EPA and the courts in these cases to permit evaluation of the inconsistency between the IARC working group’s monograph and the conclusions reached by EPA and other regulatory authorities. Because the IARC monograph has been released, disclosure of the underlying data and materials bearing on the monograph’s reliability or lack thereof is appropriate discovery material in related litigation. Courts in similar situations have granted discovery into raw data underlying a scientific study that was important to the scientific issues in a case.See Deitchman v. E.R. Squibb & Sons, Inc., 740 F.2d 556 (7th Cir. 1984) (ordering third-party scientist to produce documents relating to his scientific research into the drug DES, which was central to plaintiffs’ experts’ causation testimony);Cipollone v. Liggett Grp. Inc., Nos. 86-1198, 86-1223, 1987 WL 36515, at *1 (4th Cir. Feb. 13, 1987) (ordering U.S. Department of Health and Human Services to produce subpoenaed documents relating to scientific research central to plaintiff’s personal injury claims);Wolpin v. Philip Morris Inc., 189 F.R.D. 418 (C.D. Cal. 1999) (ordering University of Southern California to produce raw data relating to epidemiological study about the effects of second hand smoke at issue in personal injury litigation).
C.
Compliance with EPA Rule 40 C.F.R. Part 2, Subpart C
Considerations often factored in by EPA in determining whether to grant or deny a request under 40 C.F.R. Part 2, Subpart C are whether the request can be fulfilled without unduly imposing on “the employees’ official time,” whether the request can be granted while “maintain[ing] the impartiality of EPA among private litigants,” whether granting the request would require expending “public funds . . . for private purposes,” and whether “production of documents . . . [is] clearly in the interests of EPA.” 40 C.F.R. § 2.401(c). At the same time, the statute pursuant to which these regulations were promulgated, provides that “[t]his section does not authorize withholding information from the public or limiting the availability of records to the public.” 5 U.S.C. § 301.
Complying with Monsanto’s request is clearly in the interests of EPA, as the regulation provides. First, EPA has an interest in transparency and open government, as discussed on its “Open Initiative Homepage.”Seeaccordance with Presidenthttp://www2.epa.gov/open. In Obama’s directive, EPA affirms that it is committed to “fostering a culture of transparency, participation, and collaboration through the government.”Id. EPA of course has a strong interest in complying with Presidential directives regarding the Executive Branch’s open government policy. In addition, EPA, Monsanto, and the public at large have a clear interest in
Avi S. Garbow, Esq. September 15, 2016 Page 6 understanding how an international working group reached conclusions regarding registered pesticides that contradict EPA’s own conclusions. EPA also has an interest in ensuring that litigation surrounding glyphosate (the most widely used herbicide in the United States) is based on sound science. Part of the reason glyphosate is so popular is its “low toxicity in humans” and “nontoxic” properties in animals.Seehttp://www2.epa.gov/ingredients-used-pesticide-products/glyphosate. Monsanto seeks information that will be useful to evaluating the reliability of the conclusions in the IARC monograph.
Finally, complying with Monsanto’s request clearly would promote IARC’s stated interest in transparency and open decision making. For example, a recently published article by IARC monograph working group members repeatedly asserts that IARC’s proceedings are transparent: “Science moves forward on careful evaluations of data and a rigorous review of findings, interpretations and conclusions. An important aspect of this process is transparency and the ability to question or debate the findings of others.” Portier CJ,et al., Differences in the carcinogenic evaluation of glyphosate between the International Agency for Research on Cancer (IARC) and the European Food Safety Authority (EFSA), J. Epidemiol. & Community Health (Mar. 3, 2016). Monsanto seeks information that will be useful to evaluating the reliability of the conclusions in the IARC monograph.
Because this request is for documents only, as opposed to testimony, Monsanto’s request will impose minimal burden on the identified EPA employees. We recognize that EPA will incur some administrative time in collecting and processing the requested documents for production, but we are willing to reimburse EPA for those costs at EPA’s customary rates. Moreover, we and our client Monsanto are willing and anxious to work with EPA to minimize any interference to its work and mission in producing these documents.
We appreciate your prompt attention to this request. Please feel free to contact me regarding any questions or concerns.
Very truly yours,
Joe G. Hollingsworth Counsel for Defendant Monsanto Company