The documents 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.
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 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.”