us-appeals-court-says-epas-interim-registration-of-glyphosate-is-unlawful-will-now-require-further-research-from-the-agency

US Appeals Court Says EPA’s Interim Registration of Glyphosate Is Unlawful, Will Now Require Further Research from the Agency


The U.S. Court of Appeals for the Ninth Circuit has ruled that the Environmental Protection Agency (EPA) has unlawfully registered glyphosate (most notoriously used in the weedkiller, Roundup), and will now require the federal agency to redo an ecological toxicity assessment, as well as a new cost analysis of impacts to farmers from pesticide harms.


In what the Center for Food Safety (CFS)—a non-profit advocacy organization based in Washington, D.C.—is touting as “a historic victory for farmworkers and the environment,” the U.S. Court of Appeals for the Ninth Circuit has ruled the Environmental Protection Agency’s (EPA) 2020 interim registration (in effect, approval) of glyphosate is unlawful. According to the judge’s ruling, the EPA’s registration of the herbicide—most notoriously used as the active ingredient in Monsanto-Bayer’s flagship Roundup weedkiller—to be unlawful because the agency “did not adequately consider whether glyphosate causes cancer and shirked its duties under the Endangered Species Act (ESA).”

CFS—representing farmworker and conservation clients—and its “allies” originally filed the lawsuit in 2020, “incorporating volumes of evidence showing how EPA ignored glyphosate’s health risks, including cancer risks, to farmworkers and farmers exposed during spraying.” Petitioners challenged the EPA’s interim glyphosate registration as well, “based on risks to the environment and imperiled species, such as the Monarch butterfly.”

Most importantly, CFS notes that “EPA failed to test any of the glyphosate product formulations, which contain ingredients beyond just the active ingredient (glyphosate) and can increase the harmful effects of pesticide exposure.”

“Whether [glyphosate] exposures create health risks has become a hotly debated and litigated issue,” Judge Michelle T. Friedland wrote in an opinion on behalf of herself the two other judges on the panel. “Health concerns proliferated when the International Agency for Research on Cancer (‘IARC’), a subdivision of the World Health Organization, classified glyphosate as “probably carcinogenic to humans in 2015,” Judge Friedland added, going on to note that “IARC’s conclusion stemmed in part from scientific studies that found an associated between glyphosate exposure and nonHodgkin’s lymphoma (‘NHL’), a type of cancer that affects white blood cells.”

Indeed, as the World Health Organization (WHO) explicitly noted in a Q&A on glyphosate posted March 1, 2016, IARC—a sub-organization of the WHO—determined glyphosate is “probably carcinogenic to humans… based on ‘limited’ evidence of cancer in humans (from real-world exposures that actually occurred) and ‘sufficient’ evidence of cancer in experimental animals (from studies of ‘pure’ glyphosate).”

The WHO went on to explicitly note that “To reach these conclusions, IARC reviewed about 1000 studies. Some of the studies looked at people exposed through their jobs, such as farmers. Others were experimental studies on cancer and cancer-related effects in experimental systems.”

“Today’s decision gives voice to those who suffer from glyphosate’s cancer, non-Hodgkin’s lymphoma,” Amy van Saun, senior attorney with Center for Food Safety and lead counsel in the case said in a CFS news release“EPA’s ‘no cancer’ risk conclusion did not stand up to scrutiny. Today is a major victory for farmworkers and others exposed to glyphosate.”

The summary of the judges’ decision puts things succinctly, noting that:

“The panel first considered Rural Coalition’s challenge to EPA’s conclusion that glyphosate poses “no risks to human health.” [Rural Coalition was one of CFS’ petitioners.] That conclusion rested in important part on EPA’s determination, explained in its Cancer Paper, that glyphosate was not likely to be carcinogenic to humans. The panel held that EPA’s conclusion was in tension with parts of the agency’s own analysis and with the 2005 Guidelines for Carcinogen Risk Assessment (‘Cancer Guidelines’), which EPA purported to follow. The panel noted that earlier in the Cancer Paper, EPA had explained that a conclusion regarding the association between glyphosate exposure and risk of Non-Hodgkin’s lymphoma (“NHL”) could not be determined based on the available evidence. The panel stated that EPA could not reasonably treat its inability to reach a conclusion about NHL risk as consistent with a conclusion that glyphosate is not likely to cause cancer within the meaning of the Cancer Guidelines. Because inconsistent reasoning cannot survive substantial-evidence review, the panel concluded that EPA’s determination that glyphosate was not likely to be carcinogenic was not supported by substantial evidence. The panel therefore vacated the human-health portion of the EPA’s Interim Decision and remanded for further analysis and explanation. Given that vacatur, the panel did not reach Rural Coalition’s arguments of other errors pertaining to human health or NRDC’s petition challenging the public comment process that informed the human health portion of the Interim Decision.”

Now that the court has “vacated the [EPA’s] human health assessment” of glyphosate, it has required the agency to “redo and/or finish all remaining glyphosate determinations by an October 2022 deadline, or within four months.” CFS notes this process will include “a redone ecological toxicity assessment, a redone cost analysis of impacts to farmers from pesticide harms, as well as all Endangered Species analysis and mitigation.”

As of this writing, the EPA retains on its website that “Residues of glyphosate on any food or feed item are safe for consumers if they comply with the established tolerances.” In direct contradiction to the IARC’s findings, the EPA say it has “also found that glyphosate is unlikely to be a human carcinogen.” 

In a 2019 study in the peer-reviewed Scandinavian Journal of Work, Environment & Health, the authors looked at the association between glyphosate use and NHL incidence overall compared to overall NHL rates in a control cohort not exposed to the herbicide and found that “Subjects who ever used glyphosate had an excess of NHL overall… .” The authors concluded that “There was some limited evidence of an association between glyphosate use and NHL in this pooled analysis.” They added that “Suggestive associations” for SLL (small lymphocytic lymphoma) deserve “additional attention.”

CFS notes that in July 2021 pharmaceutical giant Bayer announced the corporation would end sales of its glyphosate-based herbicides in the U.S. residential garden and lawn market in 2023 in order to “manage litigation risk and not because of any safety concerns.” The non-profit adds that “Last year, courts affirmed a judgment against Monsanto for cancer from Roundup in Hardeman v. Monsanto—one of the first in a series of high-profile consumer lawsuits filed against Monsanto-Bayer—and in the third appeal of such a claim in Pilliod v. Monsanto.”


Feature image: Boasiedu

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