On June 17, 2022, the Ninth Circuit Court of Appeals issued a decision ordering the Environment Protection Agency (“EPA”) to reexamine its conclusion that glyphosate is “not likely” to cause cancer in humans. EPA reached this determination in a paper examining the carcinogenicity of glyphosate that supported the agency’s 2020 Interim Registration Review Decision (“Interim Decision”). According to the Ninth Circuit, EPA’s conclusion that glyphosate is “not likely” to cause cancer was inconsistent with other statements the agency made in the paper. Due to these inconsistencies, the court vacated the human-health portion of the Interim Decision that was based on the “not likely” conclusion and remanded that part of the decision to EPA for further review.
Background
Glyphosate, the active ingredient in Roundup, is one of the most widely-used pesticides in the United States. It was first registered for use under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) in 1974. In order for a pesticide to be registered under FIFRA, EPA must make a finding that the pesticide will not cause “any unreasonable adverse risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.” 7 U.S.C. § 136(bb).
In 2007, Congress amended FIFRA to implement a new process called “registration review” which requires EPA to review pesticide registrations every fifteen years to ensure that they continue to meet FIFRA’s registration standard. 7 U.S.C. § 136a(g)(1)(A)(iii)(II). For those pesticides like glyphosate which were registered before 2007, Congress mandated that registration review be completed by October 1, 2022. 7 U.S.C. § 136a(g)(1)(A)(iii)(I). The registration review process is both complex and time-consuming. According to regulations adopted by EPA, during registration review the agency must review all available data, including any new data that may be needed to adequately conduct a safety review. 40 C.F.R. § 155.40. Before issuing a final registration review decision, EPA may choose to issue an interim registration review decision. An interim decision may, among other things, allow EPA to require new risk mitigation measures to be added to the pesticide’s label, and identify data needed to complete registration review. 40 C.F.R. § 155.56.
EPA began its registration review of glyphosate in 2009. As part of that review, EPA completed both a “preliminary ecological risk assessment” and a “draft human-health risk assessment” in 2015 concluding that glyphosate may pose risks to mammals and birds, but is “not likely to be carcinogenic to humans.” In 2017, EPA issued a paper entitled the Revised Glyphosate Issue Paper: Evaluation of Carcinogenic Potential (“2017 Cancer Paper”), in which the agency officially concluded that glyphosate was “not likely” to cause cancer in humans. The 2017 Cancer Paper was drafted according to the Guidelines for Carcinogen Risk Assessment which EPA adopted in 2005 specifically for assessing the health risks posed by possible carcinogens. Under those Guidelines, a “not likely” conclusion can only be reached when there is “robust” data to show that there is “no basis for human hazard concern.”
In 2020, EPA issued its Interim Decision for glyphosate. Along with announcing several new mitigation measures that would be added to the glyphosate label, the Interim Decision affirmed that the findings in the 2015 ecological risk assessment and human-health risk assessment were now final. The Interim Decision relied on the 2017 Cancer Paper to support EPA’s finding in the human-health risk assessment that exposure to glyphosate was “not likely to be carcinogenic to humans.”
Following the release of the 2020 Interim Decision, several environmental groups filed suit. According to the plaintiffs in Natural Res. Def. Council v. U.S. Envtl. Prot. Agency, No. 20-70787 (9th Cir. 2022), EPA improperly concluded that glyphosate was “not likely” to cause cancer in humans, and had failed to comply with the Endangered Species Act’s (“ESA”) consultation requirements when it published the Interim Decision. The Ninth Circuit ruled in favor of the plaintiffs on both counts.
The Court’s Decision
The plaintiffs in Natural Res. Def. Council v. U.S. Envtl. Prot. Agency raised two main claims before the Ninth Circuit. First, the plaintiffs claimed that EPA violated FIFRA by failing to support its finding that glyphosate is “not likely to be carcinogenic to humans” with substantial evidence. Second, the plaintiffs claimed that EPA violated the ESA by failing to satisfy the consultation requirements when it issued the glyphosate Interim Decision. Ultimately, the court found in favor of the plaintiffs and vacated the human-health risk assessment portion of the Interim Decision.
FIFRA Claim
According to the plaintiffs, EPA violated by FIFRA by failing to support the glyphosate Interim Decision with substantial evidence. Under FIFRA, whenever a court reviews an action taken by EPA, the action may only be sustained “if it is supported by substantial evidence[.]” 7 U.S.C. § 136n(b). The court notes that the “substantial evidence” standard is met when the evidence presented is enough for a reasonable person to reach the same conclusion as EPA, even if other conclusions are possible. Additionally, EPA’s reasoning must be both “coherent and internally consistent” to meet the substantial evidence standard. Because human health-risk assessment portion of the Interim Decision was based on the 2017 Cancer Paper, the Ninth Circuit reviewed that paper to determine whether the substantial evidence standard had been met.
The official conclusion of the 2017 Cancer Paper was that glyphosate is “not likely” to be carcinogenic for humans. To reach that decision, EPA reviewed various studies and data related to the possible carcinogenicity of glyphosate. In the 2017 Cancer Paper, EPA made a statement explaining that based on the contradictory results of some of the studies, the agency was unable to reach a conclusion regarding the association between glyphosate exposure and risk of non-Hodgkin’s lymphoma. According to the Ninth Circuit, this statement directly contradicts the “not likely” finding. Because the substantial evidence standard can only be met when EPA’s reasoning is consistent, the court found that the 2017 Cancer Paper was not based on substantial evidence. Accordingly, the court found that the Interim Decision violated FIFRA, and ordered the human health portion of the Decision that was based on the 2017 Cancer Paper to be vacated and sent back to EPA for further review.
ESA Claim
Next, the plaintiffs claimed that EPA violated the ESA when it issued the Interim Decision without conducting an ESA consultation. Under the ESA, any time a federal agency carries out an “agency action,” it is required to determine whether the action “may affect” any species listed under the ESA. 50 C.F.R. § 402.14. If the agency does find that its action “may affect” listed species, then it is required to engage in consultation with either Fish and Wildlife Service or the National Marine Fisheries Service to determine whether any mitigation measures are needed to avoid harm to protected species. 50 C.F.R. § 402.01. Importantly, this consultation requirement is only triggered if a federal agency is carrying out an “agency action,” which the ESA describes as any action “authorized, funded, or carried out” by an agency. 7 U.S.C. § (a)(2). The Ninth Circuit explained that along with the ESA definition of “agency action,” the court will find an “agency action” to exist whenever an agency makes decision that is both “(1) affirmative and (2) discretionary about whether, or under what conditions, to allow private activity to proceed.”
The Ninth Circuit concluded that the Interim Decision was an agency action because it was an affirmative action that affected the conduct of private parties. According to the court, the Interim Decision is an affirmative action because it is an exercise of EPA’s regulatory power. Additionally, the Interim Decision impacts private parties because it added new mitigation measures to the glyphosate label that affect how private parties use glyphosate. Therefore, the Ninth Circuit determined that the Interim Decision was an agency action, and that by failing to initiate consultation, EPA had violated the ESA.
Although the court found that EPA had failed to conduct ESA consultation, it declined to order relief. The Ninth Circuit stated that in this instance, vacating the Interim Decision and remanding it back to EPA for ESA consultation would not be beneficial for two reasons. First, although EPA did not engage in consultation for the Interim Decision, it is currently involved in consultation for the for its final registration review of glyphosate. Second, Congress has required that the final registration review be completed by October 1, 2022, a deadline that is fast-approaching. Because EPA would be unlikely to complete a satisfactory ESA consultation before October 2022, and the agency is already consulting over the final registration review for glyphosate, the Ninth Circuit refused to grant relief for the ESA violation.
Going Forward
Importantly, the Ninth Circuit’s ruling is not about whether EPA’s conclusion that glyphosate is “not likely to be carcinogenic in humans” is incorrect. The decision to vacate the human-health risk assessment portion of the 2020 Interim Decision is based on inconsistencies in the 2017 Cancer Paper that EPA relied on to support its “not likely” finding. According to the court, it is “possible that EPA could come to the same human-health conclusion on remand[.]” EPA could make the same “not likely” finding, however it must provide an explanation for that finding which would satisfy the substantial evidence standard. With the October 2022 deadline approaching, it is unclear at the moment if EPA will redo the human-health risk assessment in the Interim Decision, or if it will instead seek to resolve the inconsistencies when it publishes the final registration review for glyphosate.
Additionally, while the Ninth Circuit’s ruling on the ESA challenge is not likely to affect the on-going registration review for glyphosate, it is unclear how it will affect other pesticide registration reviews going forward. As part of the registration review process, EPA conducts an ESA analysis and begins consultation if necessary. Generally, EPA does this once during the registration review process to ensure that the final registration review decision complies with the ESA. Going forward, EPA may have to comply with the ESA consultation provisions both when it issues an interim registration review decision and when it issues the final registration review decision. It is currently unknown how EPA will respond to the Ninth Circuit’s ruling on this issue.
To read the Ninth Circuit’s decision in Natural Res. Def. Council v. U.S. Envtl. Prot. Agency, click here.
To read the 2020 Interim Decision for glyphosate, click here.
To read the 2017 Cancer Paper, click here.
To read the text of FIFRA, click here.
To read the text of the ESA, click here.
For more National Agricultural Law Center resources on pesticides, click here.