By Carey Gillam

As agrochemical giant Monsanto Co. faces a growing wave of U.S. lawsuits over its top-selling Roundup herbicide line, among its key defense arguments is that the U.S. Environmental Protection Agency (EPA) has long backed the safety of the weed-killing products.

And indeed, the EPA has been a stalwart supporter of Monsanto Co.'s claims of safety, assuring the public that there is nothing to fear from the company's cocktail of chemicals. But internal agency documents, released in response to a Freedom of Information Act (FOIA) lawsuit, indicate that as recently as last year, the agency had holes in its data files when it comes to the actual Roundup formulations used by consumers, farmers and others around the world. The documents also raise questions about how and why regulators for years have failed to require robust testing on what is the world's most widely used weed killer.

The EPA documents show that only a little more than a year ago, in March and April of 2016, EPA officials were scrambling to gather data on ingredients Monsanto has commonly used to formulate its herbicide products. Glyphosate is the active ingredient in Roundup brands as well as hundreds of other herbicides, and the agency has a deep database of studies submitted by Monsanto regarding that specific chemical. But in the EPA records from 2016, the agency is seen urgently asking Monsanto for any studies it could provide analyzing the safety of its fully formulated products and seeking to understand the make-up of formulations used for decades. Even though Monsanto has been selling Roundup herbicides for more than 40 years, the internal agency documents indicate the agency had only sparse information about those formulations.

The EPA's interest in scrutinizing formulations came after the agency was poised to issue an updated favorable risk assessment of glyphosate in 2015. The agency only delayed finalizing that assessment after the International Agency for Research on Cancer (IARC) reported in 2015 that there was enough peer-reviewed, published research to classify glyphosate as a probable human carcinogen. IARC also noted in its report that there was research showing risks with formulations.

The EPA appeared to be playing catch-up in March of last year when agency officials requested information from Monsanto on the inert ingredients in popular U.S. and European formulations of glyphosate used in "the present day and also dating back to the 80s." EPA was particularly interested in "information on how glyphosate formulations have changed over time in the last 20-30 years."



The EPA records also show a certain level of double-talk about that lack of data. Even as the agency was working to gather details on the Roundup formulations, the agency was at the same time assuring the public that there was no reason for concern because the EPA had the information needed to gauge the safety of those formulations.

Consider this statement from the agency:

"Often, glyphosate products contain water, dyes, and/or surfactants that help facilitate movement of glyphosate into the plant…" EPA Chemical Review Manager Khue Nguyen wrote in January 2016 to an 83-year-old homeowner who had read about Roundup concerns and written to the agency seeking answers. "While manufacturers of pesticide products do not always disclose all 'other ingredients' on their labels ... they are required to disclose those ingredients to EPA. Inert ingredients in a product such as Roundup are not of concern for the consumer when pesticide products are used according to the label."

Contrast those public assurances about the EPA's knowledge of Roundup ingredients with an internal discussion documented by Nguyen three months later. In an email dated April 6, 2016, Nguyen reminded five Monsanto executives that the EPA had a "time sensitive" information request—it needed data, and the notes attached to the email show a particular need for data on glyphosate formulations:

"In an effort to resolve questions about the potential toxicity of glyphosate, glyphosate formulations, and any co-formulants (inert ingredients and surfactants), EPA was interested in any data or information Monsanto may have on how the formulations may differ from data on the active ingredient and surfactants independently of one another," the notes attached to Nguyen's email state. The notes go on to ask for information about changes in Monsanto's Roundup formulation "over the years."

The notes state "Monsanto indicated that up until 2000, nearly all glyphosate products on the market were its Roundup formulation which used some form of tallow amine as a surfactant. Afterwards, the properties of surfactants used and the ratio of surfactant to active ingredient were changed in most formulations… EPA suggested that Monsanto provide in writing any information that documents the changes of glyphosate formulations over time and across the globe."

Subsequent to that meeting, Monsanto did send over some data, and in a follow-up email dated April 18, 2016, an EPA scientist sought clarification about what to look for. "Just to be clear on our strategy here, we want to see which of these we have or don't have, and we also want to see if there are any formulation studies that will help our analysis. Does that sound right?"

It is heartening that EPA is starting to pay attention to questions about the safety of Roundup formulations, but such evaluations are long overdue and the agency's public assurances of safety despite the lack of data is "such hypocrisy," said Michael Hansen, senior staff scientist with the Consumers Union. "And it's an admission that this is a big problem."

These mixtures, or formulations, have raised concerns with certain independent scientists who say laboratory studies show the combinations of glyphosate with other substances used in Roundup are more toxic that glyphosate alone, and can possibly cause cancer or other health problems. Some research has indicated the formulations can be endocrine disruptors, meaning they have the potential to trigger serious diseases such as cancers, reproductive and developmental problems, and birth defects.

The EPA's knowledge—or lack thereof—about formulated Roundup products is also potentially important to litigation pending against Monsanto. Thousands of people around the United States are suing the chemical company, alleging that not only did Roundup exposure cause them or their loved ones to get cancer, but that Monsanto knew the Roundup formulations could be harmful but covered up the evidence. They also allege that certain EPA officials colluded with Monsanto in the handling of safety assessments, and the EPA's Office of Inspector General (OIG) has confirmed it is probing those concerns.

One ingredient traditionally used in Roundup has been the focus of particular scrutiny as some research has shown that this added ingredient, polyethoxylated tallow amine (POEA), can be extremely damaging to human cells. POEA is a surfactant that helps glyphosate adhere to the leaves of plants. European regulators became so concerned with POEA that in 2016 they agreed to ban it from use as a co-formulant in glyphosate-based herbicides after the European Food Safety Authority (EFSA), in a 2015 report, said there was insufficient data available to perform a risk assessment on POEA. EFSA stated: "Its genotoxicity, long term toxicity/carcinogenicity, reproductive/developmental toxicity and endocrine disrupting potential should be further clarified."

In part of the April 18, 2016 email string with the EPA, a Monsanto executive confirmed the widespread use of POEA in its products, telling the EPA "the surfactant system used almost exclusively in Roundup agricultural herbicide formulations globally throughout these two decades (the 1980s and 1990s) contained a polyethoxylated tallow amine surfactant…"

Monsanto says on its website that tallowamine-based products "do not pose an imminent risk for human health when used according to instructions" and points out that in 2009 the EPA exempted the surfactant from legal limitations on residues in food, because there "is a reasonable certainty that no harm will result to the general population…"

Still, the company itself has admitted a lack of extensive safety tests on its formulated products. In an internal Monsanto email from December 2010, a Monsanto chemistry regulatory affairs manager noted that "with regards to the carcinogenicity of our formulations we don't have such testing on them directly…" The manager went on to explain that the company has "extensive testing" on glyphosate and "some extensive tox testing" on the surfactant and should be able to address questions about the safety of its formulations "in a confident manner." That email and hundreds of others were obtained by plaintiffs as part of discovery in the lawsuits against Monsanto.

In a 2002 email also obtained as part of discovery in the court case, a Monsanto scientist writes to a colleague, "we are in pretty good shape with glyphosate but vulnerable with surfactants. What I've been hearing from you is that this continues to be the case with these studies - Glyphosate is OK but the formulated product (and thus the surfactant) does the damage." In another 2002 email between the same Monsanto colleagues, the scientist writes, "Even though no testing requirements have been implemented for several years now, this damn endocrine crap just doesn't go away, does it."

And in a 2003 email, a Monsanto toxicologist writes, "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 on the formulations are not anywhere near the level of the active ingredient. We can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer."

An EPA spokesman confirmed that the agency does not "routinely require long-term toxicity studies for pesticide product formulations" as it does for active ingredients like glyphosate. He added, however, that all inert ingredients in pesticide products, must be approved for use by EPA and "each component of an inert mixture must be supported by a battery of toxicity data and must be approved for use by EPA."

Further, the EPA spokesman said, "If there are data to indicate risk for a formulated mixture, EPA evaluates the potential effects in our risk assessments. The human health risk assessment process is conservative… thus ensuring that when a pesticide is used according to the label, people are well protected."

The EPA's recent interest in pursuing questions about formulated glyphosate products was also seen in September 2016, when the agency stated that it was collaborating with the National Toxicology Program (NTP) Division of the National Institute of Environmental Health Sciences to develop a research plan that would evaluate "the role of glyphosate in product formulations and the differences in formulation toxicity." The agency acknowledged that "currently, the publicly available information regarding non-cancer endpoints for glyphosate and glyphosate formulations is limited."

The status of EPA's involvement in that collaboration is unknown but the NTP confirms on its website that it is "undertaking additional research to investigate the potential genetic and mechanistic toxicity of glyphosate and glyphosate formulations."

Still, CropLife America, the lobbying group for Monsanto and other agrochemical industry players, have made it clear such an inquiry is not welcomed. In a letter dated October 2016, CropLife questioned "why EPA would collaborate and develop a research program with the National Toxicology Program (NTP) without input from the registrant." That registrant, Monsanto, "would be the appropriate source" for data EPA might need, CropLife wrote.