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Daily News Blog

09
Jun

EU and U.S. Pesticide Regulators Ignore Developmental Neurotoxicity of Pesticides, Industry Hides Data

(Beyond Pesticides, June 9, 2023) Glyphosate, usually marketed as the herbicide Roundup, has long been the poster child for shoddy regulation by both the U.S. Environmental Protection Agency (EPA) and the European Food Safety Authority (EFSA). In a study published June 1, 2023 in Environmental Health by Axel Mie and Christina Rudén, PhD, of Stockholm University and the Centre for Organic Food and Farming in Uppsala, the authors followed up on earlier work that documented deficiencies in information provided to European Union (EU) regulators by manufacturers. They identified nine studies on developmental neurotoxicity (DNT) that had been submitted to the U.S. Environmental Protection Agency (EPA) but were not disclosed to EU authorities. According to the research, seven of these studies would have “actual or potential regulatory impact.”

According to the authors: “Of the nine undisclosed DNT studies, three were sponsored by Bayer and performed in their own laboratory. Three studies were sponsored by Syngenta and performed in their Central Toxicology Laboratory. One study each was sponsored by Nissan Chemicals and Ishihara Sangyo Kaisha (ISK), and these were performed at Huntingdon Life Sciences. For the remaining study, the sponsor and laboratory are unknown to us.”

This study is a new example of regulatory capture, following up on the authors’ 2022 research that identified an unreported study performed more than two decades ago on glyphosate trimethylsulfonium salt, also known as “glyphosate trimesium,” which showed developmental neurotoxicity in rats. This study from 2001—prior to EFSA’s overall approval of glyphosate—was never reported to the agency; in fact, EFSA knew nothing about it until the Swedish team notified the agency of its existence.

A further extension of approval for glyphosate is currently being evaluated by EFSA, according to Mr. Mie and Dr. Rudén. But the researchers stress that EFSA is still not following EU law because it has not contemplated any developmental neurotoxicity studies for glyphosate, and the 2001 study at minimum identifies the need to commission further studies because other forms of the chemical than trimesium may also produce such neurotoxicity.

Beyond Pesticides, along with many investigative journalists such as Sharon Lerner, Carey Gillam, and the late Elizabeth Grossman, has delineated numerous instances of regulatory malfeasance in the entire system of registering chemicals, including the checkered history of glyphosate.

In both the U.S. and the E.U., companies registering pesticides must provide evidence from toxicological studies to support their marketing plans. But in both countries there is a built-in conflict of interest in the way the science is used to justify commercial ends, and the fox should not be the party rationalizing its presence in the henhouse.

There is certainly evidence of it in that early trimesium study. In the two highest-dose groups, the testing company observed decreased motor activity in pups up to 72% at two weeks after birth. This was despite the highest doses having no effect on their mothers. However, the testing company dismissed those results as incidental. Curiously, EPA did evaluate the study in 2005 and concluded that trimesium does cause behavioral effects in offspring from exposed mother rats. It then set “no adverse effect” and “adverse effect” thresholds for the U.S. at the second and third exposure levels, respectively. These were lower than the EU acceptable daily intake levels of glyphosate. However, EPA has dismissed studies reporting glyphosate’s developmental neurotoxicity.

The Swedish researchers note that EU law requires companies to report all results of all toxicological screenings and notify regulators as soon as any adverse effect is observed. They add that there is “no systematic way of knowing what information the applicants have access to but did not include in the dossier. The regulatory system therefore relies on trust that companies abide by the rules and submit all relevant information that is available to them. Therefore, this case has impact beyond glyphosate: It reduces our confidence that the pesticide industry submits all data on risks and hazards of their products.”

This lacuna is a form of willful ignorance on the part of regulators and industry, which is compounded by the refusal of regulators to consider scientific evidence outside the very narrow strictures of regulatory toxicology. In 2022 French academics analyzed two European expert panels and concluded that “processes of producing ignorance have been structurally embedded in the evaluation and regulation procedures of the tens of thousands of hazardous chemicals present on the market…the routine functioning of regulatory science tends to favor industry-sponsored studies, while obscuring other knowledge that could have been useful for regulation.” The internal conflicts within the EPA during glyphosate’s first round of registration as far back as 1974 are emblematic of how evaluations by agency experts are easily papered over by higher-ups with political preferences in order to produce official ignorance.

None of this is really a surprise. Beyond Pesticides has repeatedly called for reform of pesticides regulation, but much of the scaffolding is still occupied by industry influencers. The notorious “revolving door” between government jobs and lucrative consultancies for the chemical industry remains intact. For example, Beyond Pesticides reported in 2017 on the Trump Administration’s nomination of Michael L. Dourson, PhD, to be EPA’s Assistant Administrator for Chemical Safety. He worked at the EPA in the 1980s and formed the private consultancy Toxicology Excellence for Risk Assessment (TERA) in 1995. More than half of TERA’s clients are industry groups; TERA tends to see low risks from chemical exposures to its clients’ products, such as in a study for Burger King and Frito-Lay finding little risk from acrylamide in fast-food wrappers. Other clients range from the Koch Brothers to Dow Chemical.  Congress refused to confirm Dourson for the EPA post but he remains active in attempts to downplay chemical health effects.

The problem of industry influence on pesticide regulation extends deep into the scientific literature. In the early 2000s, the groundbreaking work of Tyrone Hayes, PhD, on endocrine-disrupting effects of atrazine triggered heavy resistance from the manufacturer, Syngenta. Dr. Hayes subsequently investigated the effect of funding source on study conclusions, reporting in 2004 that “financial sponsorship was a very strong predictor” of finding no chemical effects, and “100 percent of the negative studies [on atrazine] were funded by Syngenta.”

Beyond Pesticides has noted that “[n]ecessary change will not and has not come with campaigns and lawsuits against individual chemicals. Rather, the representative industry and resulting agency corruption must be purged in order to address a systemic problem. The transformation requires a focus on eliminating toxics in favor of ecosystem-compatible practices and products that are now available, but undermined by weak statutes, regulations, and ongoing corruption.”

There is mounting evidence that scientists and regulators themselves want to see reform. A 2022 survey of agricultural scientists found that many—especially university researchers—believe that EPA underestimates risk significantly, and they support regulation of inert ingredients as well as active pesticide ingredients, along with better labeling. As reported by Sharon Lerner in The Intercept, Public Employees for Environmental Responsibility has supported several whistleblowers inside the agency who disclosed pressure from political appointees in the Office of Pesticide Protection’s New Chemicals Division to remove language about toxic effects of pesticides and otherwise interfere with scientific evaluations.

But the pesticide industry is nothing if not wily, and it has no qualms about inventing new forms of disinformation. Last year, a team of Syngenta authors actually tried to make the case that climate change, biodiversity crashes, economic failures, and other disasters make it necessary to continue using pesticides, and assured that, “The current U.S. EPA’s pesticide regulatory framework is comprehensive, science-based, rigorous, continuously improving, transparent and is unlikely to underestimate risk to ensure the protection of human health.”

Advocates say this is patently untrue and call for urgent action by policymakers.

What can you do?

And beware of claims that climate change, wildfires, economic crunches, and biodiversity crises require the use of pesticides. They do not. Just the opposite: as we reported this week, melting permafrost will release hundreds of chemicals trapped in the ice, including DDT and chlorpyrifos. Refusing to acknowledge reality–willful ignorance—is not powerful and will not solve our pressing biological problems.

All unattributed positions and opinions in this piece are those of Beyond Pesticides.

Source: “Non-disclosure of developmental neurotoxicity studies obstructs the safety assessment of pesticides in the European Union,” and “What you don’t know can still hurt you – underreporting in EU pesticide regulation.”

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