Attorneys Urge the CA EPA to Require a Roundup Warning Label

Roundup cancer attorneys at Baum Hedlund Aristei & Goldman submitted a public comment to the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA), urging the agency to require agrochemical giant Monsanto to have a Roundup warning label that marks its weed killer as a possible carcinogen.

Read Baum Hedlund’s Glyphosate Safe Harbor Comment to CA EPA/OEHHA

OEHHA proposed a No Significant Risk Level (NSRL) of 1,100 micrograms per kilogram of body weight per day as a safe exposure level for glyphosate, the active chemical in Roundup®. Products resulting in glyphosate exposure amounts below the NSRL would be provided a ‘Safe Harbor’ and thus not required to have a carcinogenicity warning.

In Baum Hedlund’s public comment to OEHHA, the firm respectfully requested that the agency carefully consider the following issues before imposing a potentially unsafe Safe Harbor NSRL that would allow Monsanto to avoid implementing a Roundup warning label for cancer:

Issues with Proposed Glyphosate No Significant Risk Level

OEHHA stated in its Initial Statement of Reasons (the basis for the proposed NSRL) that it calculated the glyphosate NSRL by using a single rodent diet exposure study. Per Baum Hedlund’s Comment, OEHHA ought to have considered additional animal studies, accounting for variable exposure doses used in studies that observed tumor incidence and the growth of lymphomas at significantly lower doses than the single rodent diet exposure study OEHHA relied upon.

According to Baum Hedlund attorneys:

“OEHHA reviewed a two-year rodent carcinogenicity study where 50 male CD-1 mice were fed a diet containing glyphosate at concentrations intended to achieve dose rates of 0, 100, 300, or 1000 milligrams of glyphosate per kilogram of body weight per day. Tumor incidence was observed in the 1000 milligrams per day dose group. However, other rodent studies examining exposure to both mice and rats have found the development of tumors at much lower doses … A lower NSRL would thus be reached using data from such studies which found carcinogenesis and lymphomagenesis at lower doses than the bioassay considered by OEHHA in determining the Safe Harbor.”

These other rodent studies that found incidences of tumor development include:

  1. Wood et al. found Lymphoid hyperplasia at low and mid doses in male mice at 71.4 and 234.2 mg/kg-bw/day in a study where malignant lymphomas were significantly induced at 810 mg/kg-bw/day.*
  2. Lankas in a 1981 study where Lymphocytic hyperplasia was observed at 11 mg/kg-bw/day in Sprague-Dawley rats.**
  3. Lankas observed Testicular interstitial tumors in male Sprague-Dawley rats which demonstrated a significant trend and a significant pairwise comparison between control and the high dose of 31.49 mg/kgbw/ day.**
  4. Stout and Ruecker observed Pancreatic islet cell adenoma in male Sprague-Dawley rats demonstrating a significant pairwise comparison relative to controls at the low dose, 89 mg/kg-bw/day in 1990.***

EPA Glyphosate Issue Paper 2016 page 81
**EPA Glyphosate Issue Paper page 74
***EPA Glyphosate Issue Paper page 75

In addition to the above studies, Baum Hedlund urged OEHHA to consider the recent disclosure of eight additional tumor sites found in previously unavailable data in several of the key animal studies related to glyphosate carcinogenicity. Data regarding these sites was recently released to IARC members and was the subject of a May 28, 2017 letter Dr. Christopher Portier sent to EU Commissioner Jean Claude Juncker.

“These additional tumor sites’ data were not available to IARC when IARC issued its glyphosate probable carcinogen findings in 2015,” Baum Hedlund’s public comment states. “They further bolster IARC’s original carcinogenicity findings. We, therefore, urge OEHHA to conduct an exhaustive review of the eight studies which concluded significant (p<0.05) tumor increases due to glyphosate exposure.”

Dennis Kucinich, a former U.S. Representative of Ohio and two-time presidential candidate, shared the same concern regarding the lack of attention paid to other animal studies in his own public comment to OEHHA. According to Kucinich, “the establishment of an NSRL level of 1100 micrograms per kilogram of body weight is inconsistent with sound regulatory practice, in that it does not look at all animal studies which question whether any level of exposure to glyphosate and its surfactants is safe.

Human Epidemiology Data on Glyphosate Cancer Risk

The California Code of Regulations Section 25703(a)(2) requires that a quantitative risk assessment appraise the “quality and suitability of available epidemiologic data…”

According to Baum Hedlund attorneys, OEHHA has not thoroughly complied with the statute by utilizing the abundant epidemiological literature on glyphosate carcinogenicity.

For example, a number of epidemiological studies demonstrate a significantly elevated risk of non-Hodgkin lymphoma (NHL) among farmers. These studies include:

  • Orsi, L., et al., Occupational exposure to pesticides and lymphoid neoplasms among men: results of a French case-control study, Occupational and environmental medicine 2009, 66: 291-298
  • Morton LM et al., Heterogeneity among non- Hodgkin lymphoma subtypes: The Inter Lymph non-Hodgkin lymphoma subtypes project. J. Natl. Cancer Inst 2014, 48: 130-144
  • Hardell, L., et al., Exposure to pesticides as a risk factor for non- Hodgkin’s lymphoma and hairy cell leukemia: a pooled analysis of two Swedish case-control studies. Leuk Lymphoma. 2002 May; 43(5):1043-1049

Other epidemiological studies link glyphosate exposure to an elevated risk of NHL, including:

  • De Roos et al. (2003) reported that the use of glyphosate was associated with an increased incidence of NHL.
  • Eriksson et al. (2008) reported that exposure to glyphosate was associated with increased odds for lymphoma subtypes and elevated odds of B-cell lymphoma and the subcategory of small lymphocytic lymphoma/chronic lymphocytic leukemia. The study also found that handling glyphosate for more than 10 years was associated with a significantly increased risk of NHL.
  • Pahwa et al. (2016) reported an elevated risk of all NHL types with any glyphosate use and a dose-response effect was observed with greater use. The study also found that handling glyphosate for more than two days per year was associated with a significantly increased risk of NHL.
  • An analysis of Schinasi et al. (2014) reported increases in NHL risk with any glyphosate exposure.
  • Chang and Delzel, (2016) reported “marginally significant positive meta-RRs for the association between glyphosate use and risk of NHL.”

The proposed glyphosate Safe Harbor NSRL does not include an epidemiological appraisal, thus undercutting its correlation to safe use levels for glyphosate. Baum Hedlund’s public comment emphasizes this point:

“Epidemiological data (including a review of the available meta-analyses) would thus provide a robust and comprehensive evaluation of a chemical that most users absorb via cutaneous and respirational contact and which has been positively associated with cancers such as Non-Hodgkin’s Lymphoma. OEHHA should reconsider the proposed NSRL of 1100μg after a thorough review of the epidemiological data in accordance with the requirements of Section 25703 and the principles of sound science.

Prioritizing animal studies over epidemiological data when assessing the carcinogenic potential of glyphosate overlooks the risk to glyphosate applicators, including farmers, agricultural workers, gardeners, landscapers, government workers, and a host of other individuals.

The need for a Roundup warning label is even more important when you consider that glyphosate applied in agriculture or domestically is mixed with several toxic surfactants and humectants, which not only increase the absorption of glyphosate through the skin but also work synergistically with glyphosate to increase genotoxicity. A more comprehensive analysis should account not just for dietary ingestion, but also exposure via inhalation and absorption through the skin.

Effects of Glyphosate on Human Microbiota

Glyphosate kills weeds by interfering with the “shikimate pathway,” a metabolic sequence that synthesizes vital amino acids. Glyphosate disrupts the shikimate pathway by interfering with 5-enolpyruvylshikimate-3-phosphate (EPSP), an enzyme that governs aromatic amino acid formation in higher plants, bacteria, and fungi.

While Monsanto’s current Roundup® label says glyphosate targets “an enzyme found in plants but not in people or pets,” EPSP is, in fact, present in many beneficial bacteria that inhabit the human mucous membranes, skin and gut. The current Roundup label, in effect, disregards the millions of bacteria, fungi, and other microorganisms in or on human mucous membranes, skin and the gut that rely upon the shikimate pathway, which glyphosate interrupts. Health risks follow when glyphosate disrupts the microbiota cells that regulate numerous biological processes such as the immune system and digestion.

Glyphosate Exposure Risks and the Need for a Roundup Warning Label

There is a subtle but imperative difference between glyphosate exposure and Roundup exposure. Roundup contains glyphosate and a host of “inert” ingredients, adjuvants (added substances that alter the physical properties or improve the performance of the spray mixture) and surfactants (compounds that lower surface tension or interfacial tension between a liquid and a solid or between two liquids).

All of the added ingredients in Roundup carry potential health risks, according to Baum Hedlund’s public comment.

“Indeed, the surfactant POEA has been banned in several countries and certain co-formulants like the harmful humectant, ethylene glycol, is toxic to children as found in a 70 cc of Roundup containing 5 percent ethylene glycol. 1, 4 dioxane, one of the impurities of POEA, has been listed by OEHHA under Proposition 65 as known to the State of California to cause cancer. Monsanto itself is well aware of the dangers of 1, 4 dioxane, but still chose to increase the amount of 1, 4 dioxane in the formulated Roundup product … Another chemical, N-Nitroso-Glyphosate (“NNG”), is found in glyphosate-based formulations such as Roundup, but not necessarily in glyphosate evaluated in animal bioassays. The public will not find any reference to NNG on the Roundup® label. NNG is part of a family of carcinogenic chemicals known as ‘nitroso compounds’. Nitroso compounds have consistently been identified as carcinogenic following analysis. NNG forms whenever glyphosate interacts with nitrites, whether outside or inside the body. Monsanto is aware of this problem with NNG and has attempted to downplay the issue.”

By not considering epidemiology, multiple exposure routes and glyphosate’s effect on human microorganisms, OEHHA’s proposed NSRL for glyphosate may establish a Safe Harbor that is anything but safe for Californians. The firm believes that a Roundup warning label is necessary for consumers to make an informed choice on a product that studies have linked to cancer:

“The known dangers of glyphosate warrant extensive investigation before Californians are exposed to any amount. There are numerous explicit health concerns associated with glyphosate that render it inappropriate for a consumer to be deprived of the opportunity to exercise informed choice when contemplating purchasing and using this product, or a product containing glyphosate. A label warning would thus ensure the presence of a modest protective moat before the gates of public health. A Safe Harbor with an unsafe NSRL circumvents that protection. Please continue to protect the health and welfare of Californians and all those who emulate California as a standard bearer.”

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