Internal EPA Documents Show Scramble for Data on Monsanto’s Roundup
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.
'Secret Docs' Show Monsanto's Attempt to Influence Writers, Bribe Scientists https://t.co/0AqIfexG1R— Mark Ruffalo (@Mark Ruffalo)1501774205.0
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.
By Dana M Bergstrom, Euan Ritchie, Lesley Hughes and Michael Depledge
In 1992, 1,700 scientists warned that human beings and the natural world were "on a collision course." Seventeen years later, scientists described planetary boundaries within which humans and other life could have a "safe space to operate." These are environmental thresholds, such as the amount of carbon dioxide in the atmosphere and changes in land use.
The Good and Bad News<p><span>Ecosystems consist of living and non-living components, and their interactions. They work like a super-complex engine: when some components are removed or stop working, knock-on consequences can lead to system failure.</span></p><p>Our study is based on measured data and observations, not modeling or predictions for the future. Encouragingly, not all ecosystems we examined have collapsed across their entire range. We still have, for instance, some intact reefs on the Great Barrier Reef, especially in deeper waters. And northern Australia has some of the most intact and least-modified stretches of savanna woodlands on Earth.</p><p><span>Still, collapses are happening, including in regions critical for growing food. This includes the </span><a href="https://www.mdba.gov.au/importance-murray-darling-basin/where-basin" target="_blank" rel="noopener noreferrer">Murray-Darling Basin</a><span>, which covers around 14% of Australia's landmass. Its rivers and other freshwater systems support more than </span><a href="https://www.abs.gov.au/ausstats/[email protected]/latestproducts/94F2007584736094CA2574A50014B1B6?opendocument" target="_blank" rel="noopener noreferrer">30% of Australia's food</a><span> production.</span></p><p><span></span><span>The effects of floods, fires, heatwaves and storms do not stop at farm gates; they're felt equally in agricultural areas and natural ecosystems. We shouldn't forget how towns ran out of </span><a href="https://www.mdba.gov.au/issues-murray-darling-basin/drought#effects" target="_blank" rel="noopener noreferrer">drinking water</a><span> during the recent drought.</span></p><p><span></span><span>Drinking water is also at risk when ecosystems collapse in our water catchments. In Victoria, for example, the degradation of giant </span><a href="https://theconversation.com/logging-must-stop-in-melbournes-biggest-water-supply-catchment-106922" target="_blank" rel="noopener noreferrer">Mountain Ash forests</a><span> greatly reduces the amount of water flowing through the Thompson catchment, threatening nearly five million people's drinking water in Melbourne.</span></p><p>This is a dire <em data-redactor-tag="em">wake-up</em> call — not just a <em data-redactor-tag="em">warning</em>. Put bluntly, current changes across the continent, and their potential outcomes, pose an existential threat to our survival, and other life we share environments with.</p><p><span>In investigating patterns of collapse, we found most ecosystems experience multiple, concurrent pressures from both global climate change and regional human impacts (such as land clearing). Pressures are often </span><a href="https://besjournals.onlinelibrary.wiley.com/doi/abs/10.1111/1365-2664.13427" target="_blank" rel="noopener noreferrer">additive and extreme</a><span>.</span></p><p>Take the last 11 years in Western Australia as an example.</p><p>In the summer of 2010 and 2011, a <a href="https://theconversation.com/marine-heatwaves-are-getting-hotter-lasting-longer-and-doing-more-damage-95637" target="_blank" rel="noopener noreferrer">heatwave</a> spanning more than 300,000 square kilometers ravaged both marine and land ecosystems. The extreme heat devastated forests and woodlands, kelp forests, seagrass meadows and coral reefs. This catastrophe was followed by two cyclones.</p><p>A record-breaking, marine heatwave in late 2019 dealt a further blow. And another marine heatwave is predicted for <a href="https://www.theguardian.com/environment/2020/dec/24/wa-coastline-facing-marine-heatwave-in-early-2021-csiro-predicts" target="_blank" rel="noopener noreferrer">this April</a>.</p>
What to Do About It?<p><span>Our brains trust comprises 38 experts from 21 universities, CSIRO and the federal Department of Agriculture Water and Environment. Beyond quantifying and reporting more doom and gloom, we asked the question: what can be done?</span></p><p>We devised a simple but tractable scheme called the 3As:</p><ul><li>Awareness of what is important</li><li>Anticipation of what is coming down the line</li><li>Action to stop the pressures or deal with impacts.</li></ul><p>In our paper, we identify positive actions to help protect or restore ecosystems. Many are already happening. In some cases, ecosystems might be better left to recover by themselves, such as coral after a cyclone.</p><p>In other cases, active human intervention will be required – for example, placing artificial nesting boxes for Carnaby's black cockatoos in areas where old trees have been <a href="https://www.environment.gov.au/biodiversity/threatened/publications/factsheet-carnabys-black-cockatoo-calyptorhynchus-latirostris" target="_blank" rel="noopener noreferrer">removed</a>.</p><p><span>"Future-ready" actions are also vital. This includes reinstating </span><a href="https://www.abc.net.au/gardening/factsheets/a-burning-question-fire/12395700" target="_blank" rel="noopener noreferrer">cultural burning practices</a><span>, which have </span><a href="https://theconversation.com/australia-you-have-unfinished-business-its-time-to-let-our-fire-people-care-for-this-land-135196" target="_blank" rel="noopener noreferrer">multiple values and benefits for Aboriginal communities</a><span> and can help minimize the risk and strength of bushfires.</span></p><p>It might also include replanting banks along the Murray River with species better suited to <a href="https://www.abc.net.au/gardening/factsheets/my-garden-path---matt-hansen/12322978" target="_blank" rel="noopener noreferrer">warmer conditions</a>.</p><p>Some actions may be small and localized, but have substantial positive benefits.</p><p>For example, billions of migrating Bogong moths, the main summer food for critically endangered mountain pygmy possums, have not arrived in their typical numbers in Australian alpine regions in recent years. This was further exacerbated by the <a href="https://theconversation.com/six-million-hectares-of-threatened-species-habitat-up-in-smoke-129438" target="_blank" rel="noopener noreferrer">2019-20</a> fires. Brilliantly, <a href="https://www.zoo.org.au/" target="_blank" rel="noopener noreferrer">Zoos Victoria</a> anticipated this pressure and developed supplementary food — <a href="https://theconversation.com/looks-like-an-anzac-biscuit-tastes-like-a-protein-bar-bogong-bikkies-help-mountain-pygmy-possums-after-fire-131045" target="_blank" rel="noopener noreferrer">Bogong bikkies</a>.</p><p><span>Other more challenging, global or large-scale actions must address the </span><a href="https://www.youtube.com/watch?v=iICpI9H0GkU&t=34s" target="_blank" rel="noopener noreferrer">root cause of environmental threats</a><span>, such as </span><a href="https://www.nature.com/articles/s41559-018-0504-8" target="_blank" rel="noopener noreferrer">human population growth and per-capita consumption</a><span> of environmental resources.</span><br></p><p>We must rapidly reduce greenhouse gas emissions to net-zero, remove or suppress invasive species such as <a href="https://onlinelibrary.wiley.com/doi/abs/10.1111/mam.12080" target="_blank" rel="noopener noreferrer">feral cats</a> and <a href="https://theconversation.com/the-buffel-kerfuffle-how-one-species-quietly-destroys-native-wildlife-and-cultural-sites-in-arid-australia-149456" target="_blank" rel="noopener noreferrer">buffel grass</a>, and stop widespread <a href="https://theconversation.com/to-reduce-fire-risk-and-meet-climate-targets-over-300-scientists-call-for-stronger-land-clearing-laws-113172" target="_blank" rel="noopener noreferrer">land clearing</a> and other forms of habitat destruction.</p>
Our Lives Depend On It<p>The multiple ecosystem collapses we have documented in Australia are a harbinger for <a href="https://www.iucn.org/news/protected-areas/202102/natures-future-our-future-world-speaks" target="_blank">environments globally</a>.</p><p>The simplicity of the 3As is to show people <em>can</em> do something positive, either at the local level of a landcare group, or at the level of government departments and conservation agencies.</p><p>Our lives and those of our <a href="https://theconversation.com/children-are-our-future-and-the-planets-heres-how-you-can-teach-them-to-take-care-of-it-113759" target="_blank">children</a>, as well as our <a href="https://theconversation.com/taking-care-of-business-the-private-sector-is-waking-up-to-natures-value-153786" target="_blank" rel="noopener noreferrer">economies</a>, societies and <a href="https://theconversation.com/to-address-the-ecological-crisis-aboriginal-peoples-must-be-restored-as-custodians-of-country-108594" target="_blank" rel="noopener noreferrer">cultures</a>, depend on it.</p><p>We simply cannot afford any further delay.</p><p><em><a rel="noopener noreferrer" href="https://theconversation.com/profiles/dana-m-bergstrom-1008495" target="_blank" style="">Dana M Bergstrom</a> is a principal research scientist at the University of Wollongong. <a rel="noopener noreferrer" href="https://theconversation.com/profiles/euan-ritchie-735" target="_blank" style="">Euan Ritchie</a> is a professor in Wildlife Ecology and Conservation, Centre for Integrative Ecology, School of Life & Environmental Sciences at Deakin University. <a rel="noopener noreferrer" href="https://theconversation.com/profiles/lesley-hughes-5823" target="_blank">Lesley Hughes</a> is a professor at the Department of Biological Sciences at Macquarie University. <a rel="noopener noreferrer" href="https://theconversation.com/profiles/michael-depledge-114659" target="_blank">Michael Depledge</a> is a professor and chair, Environment and Human Health, at the University of Exeter. </em></p><p><em>Disclosure statements: Dana Bergstrom works for the Australian Antarctic Division and is a Visiting Fellow at the University of Wollongong. Her research including fieldwork on Macquarie Island and in Antarctica was supported by the Australian Antarctic Division.</em></p><p><em>Euan Ritchie receives funding from the Australian Research Council, The Australia and Pacific Science Foundation, Australian Geographic, Parks Victoria, Department of Environment, Land, Water and Planning, and the Bushfire and Natural Hazards CRC. Euan Ritchie is a Director (Media Working Group) of the Ecological Society of Australia, and a member of the Australian Mammal Society.</em></p><p><em>Lesley Hughes receives funding from the Australian Research Council. She is a Councillor with the Climate Council of Australia, a member of the Wentworth Group of Concerned Scientists and a Director of WWF-Australia.</em></p><p><em>Michael Depledge does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</em></p><p><em>Reposted with permission from <a href="https://theconversation.com/existential-threat-to-our-survival-see-the-19-australian-ecosystems-already-collapsing-154077" target="_blank" style="">The Conversation</a>. </em></p>
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