OEHHA

Baum Hedlund Submits Public Comment to OEHHA on Glyphosate Warning

October 8, 2021, Los Angeles, California - - The national law firm of Baum Hedlund Aristei & Goldman submitted a public comment to the California Office of Environmental Health Hazard Assessment (OEHHA) yesterday regarding proposed rulemaking for glyphosate exposure warnings. Glyphosate, the active ingredient in Roundup weed killer, is a chemical known to cause cancer under California's Safe Drinking Water and Toxic Enforcement Act (known more simply as Proposition 65).

Consumer attorney Pedram Esfandiary submitted the public comment on the firm’s behalf. Mr. Esfandiary served on the trial teams in the first three Monsanto Roundup trials involving claimants who alleged exposure to Roundup (and its glyphosate active ingredient) caused them to develop non-Hodgkin’s lymphoma. In 2017, Mr. Esfandiary spoke before OEHHA during a hearing on glyphosate and submitted a public comment on the firm’s behalf regarding a proposed No Significant Risk Level (NSRL) for the agrichemical.

In the public comment, Mr. Esfandiary and the firm make it clear that Californians should have a clear and fair warning “that comports with the facts, an utmost concern for public health, and basic honesty” when it comes to the dangers that glyphosate poses to human health.

This is Baum Hedlund’s public comment:

October 7, 2021

Re: Warnings for Exposures to Glyphosate from Consumer Products New Sections 25607.48 and 25607.49

Dear OEHHA,

We write with regard to the “Notice of Proposed Rulemaking, Warnings for Exposures to Glyphosate from Consumer Products New Sections 25607.48 and 25607.49.” A warning for exposure to glyphosate from consumer products is wholly consistent with the available scientific evidence (demonstrating that exposure to glyphosate-based products (“GBPs”) may be carcinogenic to humans), and conforms to governing regulations and laws, principles of public health, and sound policy. Indeed, several years of personal injury litigation involving exposure to GBPs and the development of cancer—which our firm spearheaded through three trials that returned unanimous, substantial jury verdicts (all affirmed on appeal) on behalf of individuals harmed by GBPs—underscore the need for adequate warning language before Californians are exposed to potentially carcinogenic products. See Johnson v. Monsanto Company (2020) 52 Cal.App.5th 434; Pilliod v. Monsanto Company (2021) 67 Cal.App.5th 591; Hardeman v. Monsanto Company (9th Cir. 2021) 997 F.3d 941. We applaud and welcome OEHHA’s continued efforts to fulfill the right-to-know mandate of Prop 65 (the “Act”).

However, the instant Notice of Proposed Rulemaking (“NPR”), while generally a step in the right direction, contains a significant factual error which undermines the spirit, purpose and mandate of the Act to communicate clear, reasonable, unambiguous and, most importantly, accurate information regarding exposure to a potential toxin. Specifically, the proposed warning contains the following language: “Other authorities, including USEPA, have determined that glyphosate is unlikely to cause cancer, or that the evidence is inconclusive.” This sentence is inaccurate and risks misleading the public. Contrary to the impression conveyed by the clause, the USEPA (referred to herein as “EPA”) has not “determined that glyphosate is unlikely to cause cancer”. In fact, as recent investigative efforts and litigation have revealed, EPA’s conclusion has historically beenconsistent with the three unanimous jury verdicts cited above that all found glyphosate to be carcinogenic to humans.1

In the summer of 2016, the EPA’s Office of Research and Development (“ORD”) analyzed seven epidemiological studies on the association between glyphosate and the blood cancer non-Hodgkin lymphoma (“NHL”). See generally 2016 Internal EPA Rpt.2 To be clear, these studies consisted of human data evaluating real-world exposure to glyphosate and the risk of developing NHL in exposed populations, and were also relied upon by IARC in rendering its 2015 classification of glyphosate as a “probable human carcinogen”. The internal “confidential” report concluded that four of the highest-quality studies “all reported elevated risks of NHL associated with exposure to glyphosate even after controlling for other pesticide exposures.” Id. at (8). Following review of the seven studies, the report observed that “the results of seven epidemiologic studies reporting on the association between exposure to glyphosate and risk of NHL were consistent in reporting elevated risks of NHL associated with exposure to glyphosate.” Id. at (2). Significantly, the report proceeded to conclude that the “available epidemiologic studies provide suggestive evidence of carcinogenic potential between glyphosate exposure and increased risk of non-Hodgkin lymphoma.” Id. at (9) (emphasis added). This is clearly a far-cry from the assertion that EPA has “determined that glyphosate is unlikely to cause cancer”, or even that the evidence is “inconclusive”.

However, notwithstanding its own conclusion based on sound human data, the internal report from the summer of 2016 never saw the light of day. Instead, as investigative journalist, Sharon Lerner, recently noted, “[EPA] released reports in 2016 and 2017 that clearly drew on the earlier document—several sections have identical wording—but reached the opposite conclusion: that glyphosate is ‘not a probable carcinogen.’”3 The EPA’s 180 degree turn in the later published 2016 and 2017 reports was not due to newly discovered data that was unavailable at the time of the mid-2016 internal report. Indeed, as Lerner observed, the published 2016 and 2017 reports that reached the opposite conclusion were based on the same human data and contained verbatim sections lifted from the unpublished 2016 report. The real reason for the disconnect between the data and the agency’s conclusion in the later reports is, to be frank, insidious. In her 2021 report, Lerner interviewed more than a dozen former EPA Office of Pesticide Programs (“OPP”) employees—the very office within the EPA responsible for regulating glyphosate—who described the agency as “unable to stand up to the intense pressures from powerful agrochemical companies, which spend tens of millions of dollars on lobbying each year and employ many former EPA scientists once they leave the agency.”4

Lerner’s disturbing revelations of regulatory capture—and willingness by the EPA to interpret scientific data in a light most favorable to perpetuating the federal registration of glyphosate—are further supported by the substantial evidence presented throughout the three glyphosate cancer trials. During the second trial, Pilliod v. Monsanto Company, the trial court held the following with respect to evidence of Monsanto actively pressuring and influencing the EPA vis-à-vis the agency’s determination of glyphosate carcinogenicity:

There was clear and convincing evidence that (1) Monsanto internally made little to no effort to follow up on indications that glyphosate and/or Roundup might be carcinogenic, (2) Monsanto externally made a substantial effort to influence scientists to state that glyphosate and/or Roundup were not carcinogenic, (3) Monsanto externally made a substantial effort to influence the EPA to find that glyphosate and/or Roundup were not carcinogenic.

Exh 1. Order Denying Motion for JNOV at 3-4 (emphasis added).5 The Pilliod trial court’s order echoed that of the court in the earlier 2018 trial of Johnson v. Monsanto Company, which likewise found overwhelming evidence of Monsanto’s efforts to dictate the EPA’s glyphosate classification and a strategy to “influence the scientific literature to prevent its internal concerns from reaching the public sphere and to bolster its defenses in products liability actions.” Id. at 4) Indeed, such evidence presented during both the Johnson and Pilliod trials was later affirmed by the California Court of Appeal, with the Johnson appellate court specifically noting that “Monsanto’s actions in attempting to influence regulatory agencies evinced an indifference to public safety… Shortly after the IARC announced that glyphosate was probably carcinogenic, representatives of Monsanto met with staff from the EPA…the jury could have inferred that these meetings were intended primarily to protect Monsanto’s bottom line.” Johnson, 52 Cal.App.5th at 458; see also Pilliod, 67 Cal.App.5th at 643-646 (noting that there was sufficient evidence for the jury to infer that the EPA’s later glyphosate evaluations were tainted by Monsanto’s influence and that “this evidence supports an inference that Monsanto acted to manipulate the scientific discourse with conscious disregard for public safety.”). The documentary evidence underlying the damning trial and appellate court opinions is publicly available for OEHHA to consult.6

The facts are unequivocal. The EPA concluded internally in 2016 that the existing human data provides “suggestive” evidence of an association between exposure to glyphosate and cancer—the very same scientific evidence tried and held to pass muster in three trial courts and three appellate courts, and upon which IARC relied in its 2015 glyphosate classification. Monsanto’s sustained efforts to align the agency’s determination with its corporate agenda—as repeatedly affirmed by independent juries and judges based on the company’s own internal documents—were instrumental in ensuring that the EPA’s published glyphosate analyses departed from the agency’s 2016 internal finding. Based upon this record, it is nothing short of misleading for a proposed warning to convey the impression that the EPA has held that glyphosate is “unlikely” to cause cancer or that the agency deemed the data “inconclusive”. The EPA concluded in no uncertain terms in 2016 that the “available epidemiologic studies provide suggestive evidence of carcinogenic potential between glyphosate exposure and increased risk of non-Hodgkin lymphoma.” 2016 Internal EPA Rpt. at 9.7 Monsanto’s lobbying ensured that an opposite conclusion—based on the same data—was published, the same tainted conclusion that now serves as the basis of the warning language proposed by the instant NPR.

We urge OEHHA to provide Californians with the opportunity to exercise informed consent based on facts, not the orchestrated fraud for which Monsanto has been held liable in courts throughout our State. As such, the proposed warning language should omit any reference to the EPA’s published classification of glyphosate. Whether viewed through the prism of the 2016 internal report, or Monsanto’s tireless campaign to influence the agency’s public position, the EPA’s glyphosate classification is simply not reliable; it should certainly not serve as the basis for public health decisions made under the ambit of an Act intended to provide a “clear and reasonable” warning to Californians before they expose themselves to a carcinogenic product.

To be sure, OEHHA may still strike a balance between complying with the requirements of the Act as well as the order issued in the pending National Association of Wheat Growers action (currently on appeal before the 9th Circuit Court of Appeals). For example, the proposed warning language may inform consumers of the IARC glyphosate classification while generally referencing the conclusions of other agencies without identifying the EPA for the reasons stated above. California deserves a warning that comports with the facts, an utmost concern for public health, and basic honesty. We are confident that OEHHA can fulfill this imperative task. Please do not hesitate to contact us should we be of further assistance with this matter.

Sincerely,

BAUM HEDLUND, ARISTEI, & GOLDMAN, P.C.

Pedram Esfandiary, Esq.

Footnotes:

1Lerner, S., The Department of Yes: How Pesticide Companies Corrupted the EPA and Poisoned America (The Intercept, June 30, 2021), available at: https://theintercept.com/2021/06/30/epa-pesticides-exposure-opp/

2Available at: https://www.documentcloud.org/documents/20786671-%20doc101719

3Lerner, supra, available at https://theintercept.com/2021/06/30/epapesticides-exposure-opp/

4Lerner, supra, available at https://theintercept.com/2021/06/30/epapesticides-exposure-opp/

5Although the “tentative” order is cited here, the court later entered the tentative order as the “final” order of the court.

6Tellingly, in the pending case of National Association of Wheat Growers et al. v. Becerra et al., (E.D. Cal., Case No. 20-16758), the EPA submitted statements to the federal court regarding the carcinogenicity of glyphosate that were inconsistent with the agency’s mid-2016 internal report. And, in 2019, just days before the jury in Pilliod v. Monsanto Company was slated to begin deliberations, an EPA preliminary report on glyphosate—overseen by an EPA official (Mr. Billy Smith) with no relevant scientific background— again declared that glyphosate is not a probable carcinogen. The timing and substance of the EPA’s submission to the federal court in the National Association of Wheat Growers case and the introduction of a slap-dash preliminary report at the tail end of the Pilliod matter (which was excluded by the trial court for being unreliable) further evince the iron hand that Monsanto and industry exercise over the agency, to such an extent that the EPA is willing to contradict its own internal scientific conclusions to bolster litigation outcomes in favor of industry. Indeed, such conduct by the EPA, driven by the will of industry, is one of the reasons that IARC classifications—impartial and authoritative—are sufficient to trigger a Prop 65 warning.

7Available at: https://www.documentcloud.org/documents/20786671-%20doc101719

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