NATURAL RESOURCES DEFENSE COUNCIL; PESTICIDE ACTION NETWORK NORTH AMERICA, Petitioners, v. U.S. ENVIRONMENTAL PROTECTION AGENCY, Respondent, NATIONAL ASSOCIATION OF WHEAT GROWERS; NATIONAL COTTON COUNCIL OF AMERICA; AMERICAN FARM BUREAU FEDERATION; NATIONAL CORN GROWERS ASSOCIATION; AMERICAN SOYBEAN ASSOCIATION; NATIONAL SORGHUM PRODUCERS; AGRICULTURAL RETAILERS ASSOCIATION; NATIONAL ASSOCIATION OF LANDSCAPE PROFESSIONALS; MONSANTO COMPANY; GOLF COURSE SUPERINTENDENTS ASSOCIATION OF AMERICA; AMERICAN SUGARBEET GROWERS ASSOCIATION, Intervenors.
No. 20-70787
EPA No. EPA-HQ-OPP-2009-0361
UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT
Filed June 17, 2022
FOR PUBLICATION
RURAL COALITION; ORGANIZACION EN CALIFORNIA DE LIDERES CAMPESINAS; FARMWORKER ASSOCIATION OF FLORIDA; BEYOND PESTICIDES; CENTER FOR FOOD SAFETY, Petitioners, v. U.S. ENVIRONMENTAL PROTECTION AGENCY; MICHAEL REGAN, in his official capacity as Administrator, Respondents, NATIONAL ASSOCIATION OF WHEAT GROWERS; NATIONAL CORN GROWERS ASSOCIATION; NATIONAL COTTON COUNCIL; AMERICAN SOYBEAN ASSOCIATION; AMERICAN SUGARBEET GROWERS ASSOCIATION; NATIONAL SORGHUM PRODUCERS; AMERICAN FARM BUREAU FEDERATION; AGRICULTURAL RETAILERS ASSOCIATION; NATIONAL ASSOCIATION OF LANDSCAPE PROFESSIONALS; GOLF COURSE SUPERINTENDENTS ASSOCIATION OF AMERICA; MONSANTO COMPANY, Intervenors.
No. 20-70801
EPA No. EPA-HQ-OPP-2009-0361
On Petition for Review of an Order of the Environmental Protection Agency
Argued and Submitted January 10, 2022 Pasadena, California
Filed June 17, 2022
Before: J. Clifford Wallace, Danny J. Boggs,* and Michelle T.
Opinion by Judge Friedland
SUMMARY**
Pesticides
The panel (1) granted in part and denied in part a petition for review challenging the U.S Environmental Protection Agency‘s decision determining that glyphosate, the active ingredient in the weedkiller Roundup, does not pose “any unreasonable risk to man or the environment“; and (2) remanded to the agency for further consideration.
The Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA“) requires the U.S Environmental Protection Agency (“EPA“) to regulate pesticides, which are defined to include herbicides. A pesticide product may not be distributed or sold in the United States until EPA has issued a registration pursuant to FIFRA. A registration functions as a license setting forth the conditions under which the pesticide may be sold, distributed, and used. The EPA may not issue a registration for a pesticide that causes “unreasonable adverse effects on the environment.” In 2007, Congress added a new process called “registration review” to the FIFRA scheme governing pesticides, instructing EPA to periodically review pesticide registrations every fifteen years. For pesticides registered before 2007, such as glyphosate, EPA must complete the first registration review by October 1, 2022.
EPA began its registration review of glyphosate in 2009 and completed a preliminary ecological risk assessment of the pesticide in 2015. That assessment concluded that glyphosate may pose certain risks to mammals and birds and may adversely affect terrestrial and aquatic plants, primarily from spray drift. The EPA also released a draft human-health risk assessment and a paper about glyphosate‘s carcinogenic potential, entitled the Revised Glyphosate Issue Paper: Evaluation of Carcinogenic Potential (“Cancer Paper“), which concluded that glyphosate posed no serious human-health risks and should be classified as “not likely to be carcinogenic to humans.”
In January 2020, EPA issued an Interim Registration Review Decision for glyphosate (“Interim Decision“), which: (1) announced that its earlier draft human-health and ecological risk assessments were final; (2) contained a brief cost-benefit analysis concluding that the benefits outweighed the potential ecological risks when glyphosate is used according to label directions; and (3) laid out various mitigation measures, in the form of label changes for glyphosate products, to reduce the potential ecological risks. According to the Interim Decision, EPA still planned, among other things, to complete an assessment of glyphosate‘s effect on endangered and threatened species, pursuant to the Endangered Species Act (“ESA“).
Two groups of petitioners filed petitions for review of the Interim Decision: one led by Rural Coalition and the other led by Natural Resources Defense Council (“NRDC“). Rural Coalition‘s petition made two attacks on the Interim Decision. It challenged EPA‘s conclusions on human health and insisted that EPA should have followed the ESA‘s procedural requirements before issuing the Interim Decision. NRDC‘s petition primarily challenges EPA‘s ecological risk assessment, cost-benefit analysis, and risk-mitigation requirements.
The panel first considered Rural Coalition‘s challenge to EPA‘s conclusion that glyphosate poses “no risks to human health.” 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.
The panel next addressed Rural Coalition‘s claim alleging that EPA impermissibly failed to follow the ESA consultation procedures before issuing the Interim Decision. The ESA protects endangered and threatened species, in part, by requiring federal agencies to consult with the U.S. Fish and Wildlife Service or the National Marine Fisheries Service. The consultation procedures begin with an agency reviewing its actions at the earliest possible time to determine whether any action may affect listed species or critical habitat, resulting in an effects determination.
The panel determined that Rural Coalition had standing to bring an ESA claim. Rural Coalition‘s members submitted declarations stating that they regularly engaged in educational and recreational activities involving a variety of endangered species and that glyphosate was threatening their interests by exposing those species to toxic runoff and residues on vegetation. Members therefore had cognizable interests for purposes of standing. Rural Coalition also established causation by showing that EPA might have required more mitigation efforts had the agency completed the ESA‘s procedures before issuing the Interim Decision and redressability by showing that, at the time the petition was filed, court-ordered relief was possible. The panel rejected intervenor Monsanto‘s argument that EPA‘s recent consultation efforts mooted the case.
Turning to the merits of the ESA claim, the panel held that EPA‘s registration review decision under FIFRA was an “action” that triggered the ESA‘s consultation requirement; EPA actively exercised its regulatory power, completing an assessment of glyphosate‘s risks under FIFRA and delineating what constituted acceptable glyphosate use under the statute‘s safety standard. EPA therefore had to comply with the ESA by making an effects determination before issuing the decision. It was undisputed that EPA did not do so. Accordingly, EPA violated the ESA. Nevertheless, the panel declined to order relief for the ESA violation, noting that, according to the timeline imposed by Congress, EPA must complete its final registration review decision—including formal consultation—by October 2022. Given that the FIFRA deadline was fast approaching, shortening EPA‘s time to consult would be only moderately beneficial to Rural Coalition but potentially very disruptive to the agency. The panel declined to vacate the Interim Decision, other than to the extent specified regarding the human-health portion, because it was not clear that vacatur would be beneficial; the Interim Decision included certain mitigation efforts designed to limit the ecological impact of glyphosate use, and vacatur would eliminate those mitigation requirements.
The remaining issue involved petitioners’ challenges to the Interim Decision‘s ecological risk assessment, determination of glyphosate‘s costs, cost-benefit analysis, and mitigation requirements (collectively, the “ecological portion“), and EPA‘s responsive motion for remand. The panel granted EPA‘s motion to remand without vacatur as to the ecological portion of the decision but required EPA to issue a new ecological portion by the October 2022 FIFRA deadline. Because the panel granted EPA‘s motion, it did not reach the parts of NRDC‘s and Rural Coalition‘s petitions that challenged the remanded portion of the Interim Decision.
COUNSEL
Amy van Saun (argued), George A. Kimbrell, and Ryan D. Talbott, Center for Food Safety, Portland, Oregon, for Petitioners Rural Coalition, Organización en California de Líderes Campesinas, Farmworker Association of Florida; Beyond Pesticides, and Center for Food Safety.
Lucas Rhoads (argued), Aaron Colangelo, and Tom Zimpleman, Natural Resources Defense Council, Washington, D.C., for Petitioners Natural Resources Defense Council and Pesticide Action Network North America.
Philip R. Dupre (argued), Attorney; Robert Williams, Senior Trial Attorney; Benjamin Carlisle, Senior Attorney; Bruce S. Gelber, Deputy Assistant Attorney General; Jean E. Williams, Acting Assistant Attorney General; Environment and Natural Resources Division, United States Department of Justice, Washington, D.C.; Devi Chandrasekaran and Forrest Pittman, Attorney Advisors, Office of General Counsel, United States Environmental Protection Agency, Washington, D.C.; for Respondent.
Richard P. Bress (argued), Philip J. Perry, Stacey L. VanBelleghem, and Andrew D. Prins, Latham & Watkins LLP, Washington, D.C., for Intervenors.
Shannen W. Coffin, Sara Beth Watson, and Mark C. Savignac, Steptoe & Johnson LLP, Washington, D.C., for Amicus Curiae CropLife America.
OPINION
FRIEDLAND, Circuit Judge:
Glyphosate, the active ingredient in Roundup, is the nation‘s most heavily used weedkiller. The Environmental Protection Agency (“EPA“) recently assessed whether glyphosate poses “any unreasonable risk to man or the environment” and answered, for the most part, “no.” A group of petitioners challenged EPA‘s decision, arguing, among other things, that EPA did not adequately consider whether glyphosate causes cancer and shirked its duties under the Endangered Species Act (“ESA“). We agree and remand to the agency for further consideration.
I.
A.
The Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA“) requires EPA to regulate pesticides, which are defined to include herbicides.1 See
EPA may not issue a registration for a pesticide that causes “unreasonable adverse effects on the environment.”
In 2007, Congress added a new process called “registration review” to the FIFRA scheme governing pesticides, instructing EPA to “periodically review[]” pesticide registrations every fifteen years.
EPA has promulgated regulations delineating an elaborate process for registration review.
B.
Glyphosate is a chemical that kills a broad range of plants by inhibiting an important enzyme. EPA registered the first glyphosate product in 1974, when Monsanto, an agrochemical and agricultural biotechnology company, sought to sell the now-well-known weedkiller Roundup. During its first two decades on the market, Roundup had limited utility to farmers because it killed all vegetation in an application area. But in the mid-1990s, Monsanto developed a “Roundup Ready” crop system, selling Roundup along with seeds genetically modified to tolerate glyphosate. The system allowed farmers to apply glyphosate over genetically modified crops, killing weeds but leaving the crops unharmed. As a result, glyphosate use skyrocketed. The nationwide acreage across which glyphosate is currently used is roughly equivalent to three times the size of California.
Glyphosate is generally applied by being sprayed from planes, ground equipment, or handheld devices. Workers and residential users are exposed to glyphosate when, for example, they handle the chemical during application or enter areas where it was recently sprayed. People are also exposed to glyphosate when they eat food from crops treated with it.
Whether these exposures create health risks has become a hotly debated and litigated issue. 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. IARC‘s conclusion stemmed in part from scientific studies that found an association between glyphosate exposure and non-Hodgkin‘s lymphoma (“NHL“), a type of cancer that affects white blood cells. The IARC classification spurred a wave of lawsuits against Monsanto. Since 2015, tens of thousands of individuals with NHL have sued Monsanto in state and federal court, alleging that Roundup caused their illnesses. See, e.g., In re Roundup Prods. Liab. Litig., 544 F. Supp. 3d 950, 953 (N.D. Cal. 2021). Monsanto lost the first three lawsuits to go to trial, and the plaintiffs were awarded tens of millions of dollars. Id. at 955–57.
C.
EPA began its registration review of glyphosate in 2009.2 In September 2015, the agency completed a preliminary ecological risk assessment of the pesticide. The assessment considered glyphosate‘s effects on all “non-target organisms“—that is, animals and plants not intended to be killed by the pesticide. EPA concluded that glyphosate may pose certain risks to mammals and birds. EPA also determined that glyphosate may adversely affect terrestrial and aquatic plants, primarily from spray drift.
Meanwhile, EPA was working on a human-health risk assessment and, in particular, an analysis of glyphosate‘s carcinogenic potential. EPA‘s pesticide unit made
ORD‘s criticisms did not change EPA‘s overall “not likely” determination, and, in September 2016, EPA defended that determination in a draft paper entitled Glyphosate Issue Paper: Evaluation of Carcinogenic Potential. The agency requested feedback on that draft from an EPA-commissioned Scientific Advisory Panel (“SAP“).
The SAP published a report in response. Many of the SAP‘s comments were similar to ORD‘s, but the SAP focused on EPA‘s treatment of laboratory studies that examined whether glyphosate causes tumors in rodents, rather than on the epidemiological studies of human health that ORD had emphasized. The SAP “concluded that the EPA evaluation does not appear to follow the [Cancer Guidelines] in several ways.” The SAP also criticized the criteria EPA used to discount tumor results in rodent studies, opining that EPA‘s approach was not “a conservative approach for public health protection” and was “not advisable” because it was “not consistent with ... standard ways in which ... results are typically interpreted.”
Ultimately, the SAP was divided as to whether EPA‘s “not likely” determination was appropriate. According to the report, “[m]any Panel members believe[d] that the EPA did not provide convincing evidence of a lack of carcinogenic effects.” These panelists thought that the rodent studies alone provided suggestive evidence of carcinogenic potential. Some panelists, however, argued that results from those studies “are consistent with what would be expected by chance and not reflective of [glyphosate]-induced effects,” emphasizing the “wealth of [rodent] studies with insufficiently consistent findings” and an inability to “definitively link[]” the “positive [epidemiological] results ... to glyphosate-exposure.”
One year after receiving the SAP‘s feedback, EPA released a draft human-health risk assessment for glyphosate and an updated and final paper about glyphosate‘s carcinogenic potential, now entitled the Revised Glyphosate Issue Paper: Evaluation of Carcinogenic Potential (“Cancer Paper“). In the draft risk assessment, EPA concluded that glyphosate poses no serious human-health risks, stating, for instance, that “[g]lyphosate exhibits low toxicity across species, durations, life stages, and routes of exposure.” EPA also concluded that “glyphosate should be classified as ‘not likely to be carcinogenic to humans‘” and explained that conclusion in the Cancer Paper. Separately, EPA responded to the SAP‘s criticisms, revealing that those criticisms had prompted very
In January 2020, EPA issued an Interim Registration Review Decision for glyphosate (“Interim Decision“). The Interim Decision had three main components. First, the Interim Decision announced that the earlier draft human-health and ecological risk assessments were now final—with no changes from those drafts. In summarizing the human-health risk assessment, the Interim Decision explained that the agency “determined that there are no risks to human health from the current registered uses of glyphosate and that glyphosate is not likely to be carcinogenic to humans.” The Interim Decision directed readers to the human-health risk assessment and to the Cancer Paper for additional information. According to EPA, there were “[n]o additional human health data needs” for glyphosate‘s registration review. The Interim Decision then reaffirmed the ecological risk assessment, confirming that “potential risks of concern were identified for mammals and birds” as well as for “terrestrial and aquatic plants.”
Second, the Interim Decision contained a brief cost-benefit analysis. EPA reiterated that glyphosate poses potential risks to mammals, birds, and plants. It also summarized glyphosate‘s various benefits, such as its ability to provide a broad spectrum of weed control across agricultural and non-agricultural sites and its low cost. EPA concluded that “the benefits outweigh the potential ecological risks when glyphosate is used according to label directions.”
Third, the Interim Decision laid out various mitigation measures, in the form of label changes for glyphosate products, to reduce the potential ecological risks. One label change involves application restrictions to reduce spray drift. Another label change alerts users that glyphosate has the potential to harm non-target organisms. A final label change warns of the risk that glyphosate use can cause herbicide resistance.
According to the Interim Decision, only three steps remained before EPA would conclude registration review. First, EPA planned to complete an assessment of glyphosate‘s effect on endangered and threatened species, pursuant to the ESA. As necessary based on that assessment, EPA would then consult with the U.S. Fish and Wildlife Service or the National Marine Fisheries Service to mitigate any adverse effects on those species.3 Second, EPA planned to address a petition that had been filed under the Federal Food, Drug, and Cosmetic Act (“FFDCA“), requesting that EPA restrict glyphosate‘s use on oats to reduce dietary exposure to the herbicide. And third, EPA planned to conduct
D.
In March 2020, two groups of petitioners filed petitions for review of the Interim Decision: one led by Rural Coalition and the other led by Natural Resources Defense Council (“NRDC“). Rural Coalition‘s petition makes two attacks on the Interim Decision. It challenges EPA‘s conclusions on human health and insists that EPA should have followed the ESA‘s procedural requirements before issuing the Interim Decision. NRDC‘s petition primarily challenges EPA‘s ecological risk assessment, cost-benefit analysis, and risk-mitigation requirements, though NRDC also asserts that EPA failed to address NRDC‘s comments on human-health risks made during the public-comment period. We consolidated the petitions and granted a motion to intervene by Monsanto and various agricultural and landscaping groups (collectively, “Monsanto“).
In May 2021, EPA filed its answering brief, which addresses only its human-health findings, along with a motion for voluntary partial remand without vacatur. EPA seeks partial remand of the portions of the Interim Decision related to glyphosate‘s ecological risks as well as the agency‘s cost-benefit analysis. EPA‘s answering brief and Monsanto‘s brief do not substantively address those issues but do offer defenses to Petitioners’ challenges to EPA‘s human-health analysis and the alleged failure to comply with the ESA. NRDC agreed that the remand requested by EPA would be appropriate, but Rural Coalition opposed any remand.
We heard oral argument in January 2022.
II.
Under FIFRA, we review EPA‘s Interim Decision for “substantial evidence when considered on the record as a whole.” NRDC v. EPA, 857 F.3d 1030, 1035–36 (9th Cir. 2017) (quoting
The Administrative Procedure Act (“APA“) governs judicial review of administrative decisions involving the ESA. See Nat‘l Fam. Farm Coal. v. EPA, 966 F.3d 893, 923 (9th Cir. 2020). Under the APA, courts “shall ... hold unlawful and set aside agency action, findings, and conclusions” that are “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law” or “without observance of procedure required by law.”
III.
We first consider Rural Coalition‘s challenge to EPA‘s conclusion that glyphosate poses “no risks to human health.” That conclusion rests in important part on EPA‘s determination, explained in its Cancer Paper, “that glyphosate is not likely to be carcinogenic to humans.” Rural Coalition contests the Cancer Paper‘s reasoning, primarily arguing that EPA contravened the Cancer Guidelines it purported to follow. We agree.
EPA‘s Cancer Guidelines lay out four steps for conducting risk assessments of chemicals’ carcinogenic potential. The first step—and the one most relevant here—is hazard identification, which asks whether a chemical can “present a carcinogenic hazard to humans and, if so, under what circumstances.” The second step considers the “dose response” to a chemical—in other words, the levels of exposure at which adverse effects might occur. The third step assesses “the conditions of human exposure.” The fourth and final step evaluates “the character of the risk,” including “[h]ow well ... data support conclusions about the nature and extent of the risk from various exposures.”
For the first step, hazard identification, the Guidelines lay out strategies for reviewing and evaluating data from human and animal studies. For example, the Guidelines
include criteria for identifying reliable epidemiological studies as well as factors to consider when determining whether observed effects in such studies are causal. The Guidelines also provide methods for analyzing tumor data from animal laboratory studies, including tests for determining whether results are statistically significant. In addition, the Guidelines identify potential observations, such as cellular metastases or tumors detected in multiple species, whose presence or absence should add to or detract from the weight of studies findings.
The culmination of the hazard-identification step is a “weight of evidence narrative.” According to the Cancer Guidelines, that narrative should explain the available evidence and summarize how the evidence supports a conclusion about human carcinogenic potential. The Guidelines lay out five standard hazard descriptors for expressing such a conclusion, with criteria for when each applies: “Carcinogenic to Humans,” “Likely to Be Carcinogenic to Humans,” “Suggestive Evidence of Carcinogenic Potential,” “Inadequate Information to Assess Carcinogenic Potential,” and “Not Likely to Be Carcinogenic to Humans.” Although the choice of a descriptor is holistic and does not automatically compel an ultimate FIFRA conclusion, EPA‘s choice among those descriptors generally has practical consequences. As the parties explained at oral argument, hazard descriptors indicating higher levels of risk usually prompt more mitigation efforts—for example, labeling requirements intended to protect human health.
EPA ties itself to the Cancer Guidelines in its Interim Decision. The Interim Decision relies on the Cancer Paper to explain its conclusions about human health. And, in that Cancer Paper, EPA explicitly states that it is completing an “Evaluation of Cancer Classification per the 2005 EPA Guidelines for Carcinogen Risk Assessment [i.e., the Cancer Guidelines].” The Cancer Paper directly quotes the Cancer Guidelines language about the five hazard descriptors.
In the Cancer Paper, the agency ultimately concludes that “[t]he strongest support is for [the hazard descriptor] “not likely to be carcinogenic to humans.“”
A.
EPA‘s choice of the “not likely” descriptor conflicts with a determination EPA made earlier in the Cancer Paper. Earlier, EPA explained that “a conclusion regarding the association between glyphosate exposure and risk of NHL cannot be determined based on the available evidence.”
In coming to that determination, the Cancer Paper discussed human epidemiological studies showing what could be considered suggestive evidence that glyphosate exposure causes NHL. For example, the Cancer Paper stated that “reported effect estimates across case-control studies and the associated meta-analyses [were] greater than 1,” meaning that most studies EPA examined indicated that human exposure to glyphosate is associated with an at least somewhat increased risk of developing NHL.6 The Cancer Paper also acknowledged that some epidemiological studies provide evidence of an exposure-response relationship between glyphosate and NHL. One study, for instance, indicated that there was an increased risk of NHL for those with more than ten years of glyphosate exposure. In addition, that same study as well as another indicated that those who are exposed to relatively more glyphosate in a year face a higher risk of NHL.
But EPA discounted epidemiological studies showing increased NHL risk by concluding that “chance and/or bias” could be “an explanation for observed associations in the database.” EPA stated that some of the study results showing increased NHL risk were not statistically significant, which raises the concern that those results were due to chance. EPA raised the possibility that confounders, such as exposure to other pesticides, animals, or diesel fumes, were driving the NHL results. EPA also emphasized what it deemed “contradictory results“—that a few studies did not detect a positive association between glyphosate exposure and NHL or an exposure-response relationship. EPA opined that such inconsistencies and limitations precluded it from coming to any firm determination on glyphosate‘s potential to cause NHL.
As Rural Coalition correctly argues, EPA‘s own conclusion from that epidemiological evidence is inconsistent with its ultimate selection of the “not likely” hazard descriptor. According to EPA‘s Cancer Guidelines, that hazard descriptor is appropriate when the agency determines that “available data are considered robust for deciding that there is no basis for human hazard concern.” EPA therefore cannot
We made a similar point in Pollinator Stewardship Council v. EPA, 806 F.3d 520 (9th Cir. 2015), in rejecting an argument by EPA “that since the studies are inconclusive as to the risks of sulfoxaflor for bees, the studies affirmatively prove that sulfoxaflor does not cause unreasonable adverse effects on bees.” Id. at 531. We explained that “[n]either logic nor precedent can sustain this position. We have previously held that an agency cannot rely on ambiguous studies as evidence of a conclusion that the studies do not support.” Id.; see also League of United Latin Am. Citizens v. Regan, 996 F.3d 673, 701 (9th Cir. 2021) (“[Because] EPA represents that there are “uncertainties concerning the impact of chlorpyrifos on children” ... EPA has not determined, and on this record reasonably could not determine to a “reasonable certainty” that aggregate chlorpyrifos exposures under the current tolerances pose no risk of harm.“).
B.
The analysis underpinning EPA‘s “not likely” descriptor is also flawed in various other ways. EPA relies on two main propositions to support its chosen hazard descriptor, but neither withstands scrutiny under the agency‘s own framework.
1.
EPA‘s first proposition is that “the agency did not consider any of the tumors observed in the animal carcinogenicity studies to be treatment-related” (i.e., caused by glyphosate). According to EPA, “none of the tumors evaluated in individual rat and mouse carcinogenicity studies are treatment-related due to lack of pairwise statistical significance, lack of a monotonic dose response, absence of preneoplastic or related non-neoplastic lesions, no evidence of tumor progression, and/or historical control information (when available).” But EPA‘s reliance on at least two of these indicia to infer a lack of treatment-related effects—historical-control data and pairwise statistical significance—conflicts with the Guidelines that the agency contends it is following.7
EPA‘s Cancer Paper uses historical-control data selectively and in a manner that is inconsistent with the Cancer Guidelines. Historical-control data show the natural frequency of different types of tumors in an animal strain. As the Cancer Paper acknowledges, the Cancer Guidelines instruct that historical-control data can “add to the analysis, particularly by enabling identification of uncommon tumor types or high spontaneous incidence of a tumor in a given animal strain.” For example, according to the Guidelines, historical-control data that show a particular type of tumor is very rare in an animal strain could indicate that, when tumors of that type do occur in a study using that strain, “the result is in fact unlikely to be due to chance.” By contrast, the Guidelines explain that historical-control data showing “common tumors” in an animal strain could reduce the importance of “results that are barely statistically significant or in which incidence rates in concurrent controls are unusually low in comparison with historical controls.”
EPA‘s reliance on a second indicium, “lack of pairwise statistical significance,” is also inconsistent with the Cancer Guidelines. Pairwise comparison and trend tests are two different tests for assessing statistical significance, which is an indication that a particular result is unlikely due to chance. A pairwise comparison test asks whether tumor incidence in a treatment group was higher than in the control group, while a trend test asks whether tumor incidences in all treatment groups increased as the glyphosate dose increased. EPA acknowledges in its Cancer Paper that, according to the Cancer Guidelines, “[s]ignificance in either kind of test is sufficient to reject the hypothesis that chance accounts for the result.” (emphasis added). But as both ORD8 and the SAP pointed out, in analyzing various rodent studies, EPA discounts tumor incidences because those incidences were not statistically significant in pairwise comparison tests—when those same tumor incidences were apparently statistically significant using trend tests. Criticizing EPA‘s approach, “the [SAP] noted that requiring a significant pairwise comparison in addition to a significant trend is neither consistent with the [Cancer Guidelines] nor a conservative approach for public health protection.” (emphasis in original).9
Responding to that criticism, EPA asserts that, although its Cancer Guidelines correctly convey that satisfaction of either a trend test or a pairwise test is sufficient for statistical significance, they do “not imply that statistical significance alone in an individual test is sufficient to determine that observed tumors are treatment-related.”
2.
EPA‘s second proposition in support of its selection of the “not likely” descriptor is that concerning results only occurred at high doses. In the Cancer Paper, EPA invokes the Cancer Guidelines’ criterion that a chemical can be considered “not likely to be carcinogenic” when there is “convincing evidence that carcinogenic effects are not likely below a defined dose range.” EPA states that, even if the tumors were treatment-related as “some believe,” those tumors occurred only at very high glyphosate dosages. According to EPA, increased tumor incidences generally occurred at “the highest doses tested“—“approximately equal to or greater than the limit dose (1000 mg/kg/day).” EPA also mentions that positive results in genotoxicity studies occurred only at “high doses.” Importantly, for both the rodent studies and genotoxicity studies, “[t]hese high doses [were] not considered relevant to human health risk assessment based on the currently registered use pattern for glyphosate” because “[m]aximum potential glyphosate exposure [had] been estimated at ... 7 mg/kg/day ... which [is] well-below the doses necessary to elicit the effects seen in these animal carcinogenicity and genotoxicity studies.”
But EPA‘s disregard of tumor results occurring at high dosages conflicts with the guidelines EPA purports to follow. The “not likely” descriptor can, in fact, be applied when there is “convincing evidence that carcinogenic effects are not likely below a defined dose range,” as EPA states. But the Cancer Guidelines indicate that this use of the “not likely” descriptor is appropriate “when the mode of action is sufficiently understood to conclude that a key event in tumor development would not occur below a certain dose range“—to avoid discounting potentially concerning animal results from laboratory settings unless there is a compelling reason to believe that those results are irrelevant to humans.10
Indeed, when that mode of action is sufficiently understood, the Cancer Guidelines contemplate that the chemical would merit “multiple descriptors“: it “could be described as likely to be carcinogenic above a certain dose range but not likely to be carcinogenic below that range.” Despite these instructions, the Cancer Paper provides no explanation of any “mode of action” indicating that tumors are not likely to occur below a certain glyphosate dosage range, nor does it offer two different hazard descriptors for dosages above
But the Cancer Guidelines do not support disregarding results simply because they are based on exposures that exceed typical human-exposure levels. More specifically, no part of the hazard assessment Guidelines encourages disregarding results occurring at high dosage ranges for any reason other than when there is evidence of excessive toxicity. Excessive toxicity occurs when a dose is so high that the sheer amount of the chemical induces abnormal responses in laboratory animals. Excessive toxicity is rare, so, according to the Cancer Guidelines, “[i]n general ... effects seen at the highest dose tested are assumed to be appropriate for assessment.” That highest dose “is generally selected to provide the maximum ability to detect treatment-related carcinogenic effects while not compromising the outcome of the study through excessive toxicity.” (emphasis added). The Cancer Guidelines further provide that results “may be regarded as not appropriate to include in assessment of the potential for human carcinogenicity of the agent” only “[i]f adequate data demonstrate that the effects are solely the result of excessive toxicity rather than carcinogenicity of the tested agent per se.” Despite EPA‘s various invocations of its Guidelines, the agency provides no evidence of excessive toxicity yet nonetheless disregards high-dosage results.
Indeed, disregarding results occurring at high dosage ranges seems contrary to the “purpose” of a hazard assessment. According to the Cancer Guidelines, the “purpose” of a hazard assessment “is to construct a total analysis examining what the biological data reveal as a whole about carcinogenic effects and mode of action of the agent, and their implications for human hazard and dose-response evaluation.” Consistent with this understanding, subsequent steps in the Cancer Guidelines’ risk assessment—ones that follow only once EPA has determined that there is, in fact, a hazard—integrate human-exposure patterns into the risk assessment through a variety of complex methods. In fact, as explained above, choosing a hazard descriptor is presented in the Guidelines as part of the hazard-identification step, and a subsequent step focuses entirely on characterizing “the conditions of human exposure.”12
The SAP expressly stated the concern that EPA improperly discounted study results involving dosages at or above 1,000 mg/kg/day: “Disregarding responses at any dose above a pre-selected “limit dose,” even though the dose did not exceed the maximum tolerated dose“—that is, the maximum dose before excessive toxicity kicks in—“is not in keeping with the way rodent bioassays are normally interpreted.... Thus selecting 1,000 mg/kg/day a priori as the limit dose appears to be an ad hoc decision that is not well-justified, and is not justified on the basis of the [Cancer Guidelines].” Despite the SAP‘s criticism, EPA declined to change its approach or to meaningfully respond.
C.
For these reasons, EPA‘s choice of a hazard descriptor is not supported by substantial evidence. Despite EPA‘s repeated invocation of its Cancer Guidelines, the Interim Decision fails to abide by those Guidelines. Inconsistent reasoning “is, absent explanation, “the hallmark of arbitrary action.“” Nat‘l Parks Conservation Ass‘n v. EPA, 788 F.3d 1134, 1145 (9th Cir. 2015) (quoting Sierra Club v. EPA, 719 F.2d 436, 459 (D.C. Cir. 1983)). It cannot survive substantial-evidence review. NRDC v. EPA, 31 F.4th 1203, 1210 (9th Cir. 2022) (considering internal “inconsistencies” and “EPA‘s decision to abandon its own guidance ... without a discernable rationale” in holding that a decision was not supported by substantial evidence).
Vacatur is the traditional remedy for erroneous administrative decisions. See Pollinator Stewardship Council, 806 F.3d at 532. To determine whether vacatur is appropriate, we consider at least three factors. First, “we weigh the seriousness of the agency‘s errors against the disruptive consequences of an interim change that may itself be changed.” Nat‘l Fam. Farm Coal. v. EPA, 960 F.3d 1120, 1144 (9th Cir. 2020) (quoting Pollinator Stewardship Council, 806 F.3d at 532). Second, we consider “the extent to which either vacating
Based on these considerations, we vacate the human-health portion of EPA‘s Interim Decision and remand for further analysis and explanation. The first factor clearly weighs in favor of vacatur. EPA‘s errors in assessing human-health risk are serious. Moreover, no disruptive consequences will result from vacating the human-health portion of the Interim Decision because that portion simply maintained the status quo—the Interim Decision imposed no new mitigation measures associated with human health. For similar reasons, vacating the human-health portion is unlikely to risk environmental harm, and thus the second factor also weighs in favor of vacatur. The last factor is more uncertain. It is possible that EPA could come to the same human-health conclusion on remand, but the agency‘s explanation would need to be so different that we cannot make a confident prediction on this factor. With two factors weighing in favor of vacatur, uncertainty with respect to this last one does not tip the scale in the other direction.13
In light of this holding, we need not reach Rural Coalition‘s arguments about other alleged errors pertaining to human health. See Pollinator Stewardship Council, 806 F.3d at 532 (“The matter must be remanded to the agency. We need not reach the other claims of error raised by petitioners.“). Similarly, our vacatur makes it unnecessary to address NRDC‘s objection that EPA did not comply with its procedural obligation to respond to NRDC‘s comments about human health—because further proceedings, including a new public-comment process, will be needed on remand.14
IV.
We next address Rural Coalition‘s Endangered Species Act claim. Congress enacted the
The
Rural Coalition argues that EPA failed to comply with these obligations before issuing the Interim Decision. At the threshold, Intervenor Monsanto argues that we should not decide the merits of this claim because Rural Coalition lacks standing, the claim is moot, and/or the claim was not adequately preserved. To help explain our analysis of these arguments, we first describe the aspects of the Interim Decision relevant to the
A.
The Interim Decision contains the critical pieces of EPA‘s registration review of glyphosate. It “finalizes” the human and ecological risk assessments and announces that “[n]o additional data are required.” As to human health, it “determine[s] that there are no risks to human health from the current registered uses of glyphosate” and imposes no health-related mitigation requirements. As to ecological risk, it finds potential risks to animals and plants and “require[s]” mitigation in light of those risks, laying out specific language for glyphosate product labels. Crucially, the Interim Decision “concludes that the benefits outweigh the potential ecological risks” when glyphosate is used according to the restrictions imposed by the Interim Decision. That conclusion is the critical determination that the pesticide complies with FIFRA‘s safety standard. See Nat‘l Fam. Farm Coal. v. EPA, 960 F.3d 1120, 1133 (9th Cir. 2020) (“FIFRA uses a cost-benefit analysis to ensure that there is no unreasonable risk created for people or the environment from a pesticide.” (quoting Pollinator Stewardship Council v. EPA, 806 F.3d 520, 522-23 (9th Cir. 2015))).15
1.
We turn to the first threshold question: whether Rural Coalition lacks standing to bring an
“To satisfy the injury-in-fact requirement of the Article III inquiry, “a plaintiff asserting a procedural injury must show that the procedures in question are designed to protect some threatened concrete interest of his that is the ultimate basis of his standing.“” Salmon Spawning & Recovery All. v. Gutierrez, 545 F.3d 1220, 1225 (9th Cir. 2008) (quoting Citizens for Better Forestry v. U.S. Dep‘t of Agric., 341 F.3d 961, 969 (9th Cir. 2003)). Rural Coalition‘s members have submitted declarations stating that they regularly engage in educational and recreational activities involving a variety of endangered species, including the Indiana bat, whooping crane, and least tern. These members also allege that glyphosate is threatening their interests by exposing those species to toxic runoff and residues on vegetation. The interests identified in the Rural Coalition declarations are “undeniably ... cognizable interest[s] for [the] purpose of standing.” See Lujan, 504 U.S. at 562-63. In addition, the consultation procedures that Rural Coalition claims were required but not completed are intended to protect these types of interests. See Salmon Spawning, 545 F.3d at 1226 (“These procedures are designed to advance the ESA‘s overall goal of species preservation, and thus the [members‘] specific goals as to ... preservation, by ensuring agency compliance with the ESA‘s substantive provisions.“). Accordingly, the injury-in-fact requirement is met.
Rural Coalition has also established causation. We have held that an alleged violation of the consultation requirement constitutes a “procedural injury” for standing purposes. Citizens for Better Forestry, 341 F.3d at 971. When a procedural injury is asserted, “[t]he causation requirement is satisfied by showing a “reasonable probability of the challenged action‘s threat to [the petitioner‘s] concrete interest.“” Nat‘l Fam. Farm Coal. v. EPA, 966 F.3d 893, 910 (9th Cir. 2020) (quoting Hall v. Norton, 266 F.3d 969, 977 (9th Cir. 2001)). Here, EPA reconsidered the conditions under which the most heavily used herbicide in the nation may be used, acknowledging in the Interim Decision that glyphosate poses “potential risks of concern” for mammals, birds, and plants. Yet the agency imposed few limitations on glyphosate use. Thus, there is a reasonable probability that the requested
EPA‘s recent analysis of glyphosate‘s impact on listed species—that is, its
affect” all ESA-listed species that experience glyphosate exposure—that is, 1,795 species—and is likely to adversely affect 93% of those species. EPA has begun formal consultation about how to mitigate these adverse effects.
Monsanto argues unconvincingly that the causation requirement is not satisfied. According to Monsanto, the Interim Decision did not grant or extend glyphosate‘s registration, and EPA could not cancel that registration through such a decision. Instead, if the agency intends to cancel a pesticide‘s registration, it must initiate cancellation through an elaborate statutory process. See
When petitioners allege a procedural violation, the redressability prong is satisfied by showing that the agency decision “could be influenced” by the procedures at issue. Hall, 266 F.3d at 977; see also Nat‘l Fam. Farm Coal., 966 F.3d at 911 (explaining that the redressability requirement is satisfied when relief “may influence the agency‘s ultimate decision of whether to take or refrain from taking a certain action” (quoting Salmon Spawning, 545 F.3d at 1226-27)). Broadly speaking, Rural Coalition requests that the agency complete the consultation procedures found in the ESA. As explained above, it is apparent that EPA might have required more mitigation efforts had the agency completed an effects determination and consulted before issuing the Interim Decision.
Monsanto also argues that any alleged injury is not redressable because EPA began following the ESA consultation procedures before Rural Coalition filed its petition for review of the Interim Decision. By the time Rural Coalition filed its opening brief, the agency had released a draft BE in preparation for its final registration review decision. Since then, EPA has released a final BE and has begun formally consulting. Monsanto argues that an order to complete consultation procedures would not prompt EPA to do anything more than it is already doing, and that any injury is therefore not redressable. See Massachusetts v. EPA, 549 U.S. 497, 518 (2007) (requiring “some possibility that the requested relief will prompt the injury-causing party to reconsider the decision that allegedly harmed the litigant” (emphasis added)).
We disagree. “When evaluating whether [the standing] elements are present, we must look at the facts as they exist[ed] at the time the complaint was filed.” Slayman v. FedEx Ground Package Sys., Inc., 765 F.3d 1033, 1047 (9th Cir. 2014) (alteration in original) (quoting ACLU of Nev. v. Lomax, 471 F.3d 1010, 1015 (9th Cir. 2006)). At the time Rural Coalition filed its petition, court-ordered relief was possible. EPA had not even completed a draft BE, and it was unclear when the agency would do so. Thus, we could have, for example, remanded the Interim Decision, directed the agency to comply with the ESA, and even imposed a deadline for completing the effects determination required by the statute—that is, ordered EPA to finalize a BE and to initiate any required consultation by a certain date. See, e.g., League of United Latin Am. Citizens v. Regan, 996 F.3d 673, 703 (9th Cir. 2021); see also Nat‘l Wildlife Fed‘n v. Nat‘l Marine Fisheries Serv., 524 F.3d 917, 936-38 (9th Cir. 2008); Alaska Ctr. For Env‘t v. Browner, 20 F.3d 981, 986-87 (9th Cir. 1994). An aggressive deadline—and any court oversight that might accompany such a deadline—presumably would have spurred EPA to act at least somewhat faster than it otherwise would have, redressing Rural Coalition‘s injury. That is enough for Rural Coalition to have standing.
2.
Monsanto alternatively argues that EPA‘s recent consultation efforts moot this case. “If an event occurs that prevents the court from granting effective relief, the claim is moot and must be dismissed.” Am. Rivers v. Nat‘l Marine Fisheries Serv., 126 F.3d 1118, 1123 (9th Cir. 1997); see Church of Scientology of Cal. v. United States, 506 U.S. 9, 12 (1992). On Monsanto‘s
But Monsanto‘s understanding of the relief available here is too narrow. Broadly speaking, the allegedly unlawful behavior targeted by the petition is a failure to complete procedures required by the ESA before formally concluding whether and how glyphosate may be used consistent with FIFRA‘s safety standard, and that behavior still has not been rectified. The allegedly unlawful behavior could be remedied by our imposition of an aggressive deadline for the completion of consultation, an order for EPA to complete the parts of consultation within its control with the utmost speed, or an order for EPA to file status reports with our court on consultation‘s progress.18 Such relief could meaningfully
hasten ESA compliance, especially because EPA appears inclined to delay consultation given that it has already pushed the entire consultation process until the final year of registration review. Thus, Rural Coalition‘s claim is not moot.19
3.
Monsanto additionally argues that Rural Coalition‘s ESA claim was not preserved during the public-comment period. This argument is unconvincing. A Rural Coalition petitioner, Center for Biological Diversity, discussed ESA consultation in its comments on the proposed Interim Decision. The Center argued that “EPA must consult with the Services on its continuing and ongoing authority over this pesticide to satisfy its duty to [en]sure that its use will not jeopardize or adversely modify protected species or their critical habitat
C.
We now turn to the merits of Rural Coalition‘s ESA argument. As explained above, the consultation procedures begin with an agency “review[ing] its actions at the earliest possible time to determine whether any action may affect listed species or critical habitat,”
We have held that “agency action” under the ESA has only two requirements. There is “agency action” whenever an agency makes a decision that is (1) affirmative and (2) discretionary about whether, or under what conditions, to allow private activity to proceed. Karuk Tribe, 681 F.3d at 1011. That the second requirement is satisfied is not disputed here—EPA clearly has the power to restrict pesticide use by private parties through mitigation measures to protect listed species.
We agree with Rural Coalition that the first requirement is also satisfied, because the Interim Decision is an affirmative act. An agency must adhere to the consultation requirement when it makes an “affirmative” act or authorization. Cal. Sportfishing Prot. All. v. FERC, 472 F.3d 593, 595 (9th Cir. 2006). But “[w]here private activity is proceeding pursuant to a vested right or to a previously issued license, an agency has no duty . . . under Section 7 if it takes no further affirmative action regarding the activity.” Karuk Tribe, 681 F.3d at 1021; W. Watersheds Project v. Matejko, 468 F.3d 1099, 1108 (9th Cir. 2006) (“‘[I]naction’ is not ‘action’ for section 7(a)(2) purposes.“). Here, EPA actively exercised its regulatory power, completing an assessment of glyphosate‘s risks under FIFRA and delineating what constituted acceptable glyphosate use under the statute‘s safety standard. See Karuk Tribe, 681 F.3d at 1024 (finding affirmative action when “the Forest Service formulated precise criteria for the protection of coho salmon, communicated those criteria to prospective miners, and approved the miners’ activities under a [Notice of Intent] only if they strictly conformed their mining to the specified criteria“).
EPA and Monsanto‘s primary argument is that Rural Coalition is objecting to inaction, not action, when it complains that EPA would have instituted more mitigation efforts if EPA had engaged in ESA consultation. That argument fails. EPA
Because EPA‘s registration review decision under FIFRA is the “action” that triggers the consultation requirement, it is irrelevant—despite EPA and Monsanto‘s suggestion to the contrary—that Rural Coalition takes the view that the Interim Decision does very little to protect listed species and should have contained more mitigation measures. Indeed, the notion that challenging an absence of mitigation efforts is merely an objection to inaction is inconsistent with the purpose of the ESA. Arguing that protection for endangered and threatened species is insufficient is precisely the point of an ESA claim. When aggrieved parties file a lawsuit asserting that the government should not have authorized a certain activity, such as the diversion of water from a river, the core grievance is often that the activity threatens—or, put differently, does not sufficiently protect—listed species. See, e.g., NRDC v. Houston, 146 F.3d 1118 (9th Cir. 1998). Many clearly cognizable ESA claims, then, could easily be framed as a complaint about the failure to institute more mitigation efforts. That framing does not mean that the claim merely challenges inaction.
D.
Because the Interim Decision was an affirmative, discretionary action, EPA had to comply with the ESA by making an effects determination before issuing the decision. It is undisputed that EPA did not do so. Accordingly, EPA violated the ESA.
Nevertheless, because of the odd confluence of circumstances here, we decline to order relief for the ESA violation. Although relief such as a consultation deadline could hasten EPA‘s compliance with the ESA (and thus we have held that the ESA claim is not moot), we believe that the FIFRA deadline to complete glyphosate‘s registration review by October 2022 is a sufficient backstop. According to the timeline imposed by Congress, EPA already must complete its final registration review decision—including formal consultation—by that October 2022 deadline. Given that the FIFRA deadline is fast approaching, shortening EPA‘s time to consult would be only moderately beneficial to Rural Coalition but potentially very disruptive to the agency.
Rural Coalition urges vacatur of the Interim Decision for failure to comply with the ESA. But it is not clear that
V.
The remaining issue involves Petitioners’ challenges to the Interim Decision‘s ecological risk assessment, determination of glyphosate‘s costs, cost-benefit analysis, and mitigation requirements (collectively, the “ecological portion“), and EPA‘s responsive motion for remand. We grant EPA‘s motion to remand without vacatur as to the ecological portion of the decision, but we impose a time limit on the remand.
NRDC argues that EPA failed to consider major environmental and economic costs of glyphosate use, including the costs of creating glyphosate-resistant weeds, harm to soil health caused by glyphosate, and the decimation of milkweed in agricultural fields. In addition, NRDC argues that EPA failed to provide any explanation as to how it weighed the purported benefits and risks of glyphosate use, pointing out that EPA simply concluded in a single sentence that the purported benefits outweigh the risks without any sort of reasoned analysis. Finally, NRDC argues that EPA‘s decision rests on unsubstantiated assumptions that the mitigation measures will, in fact, reduce the acknowledged ecological risks posed by glyphosate use—without any evidence that the mitigation measures imposed will ensure that glyphosate use satisfies FIFRA‘s safety standard. Rural Coalition echoes many of these concerns, adding that EPA failed to consider the cost of glyphosate drift as well as the costs to pollinators and to monarch butterflies.
EPA does not respond to the attack on the ecological portion of the Interim Decision. Instead of answering these parts of the petitions, EPA asks us to remand the ecological portion for further consideration without vacatur and thereby asks us not to reach the corresponding claims in NRDC‘s and Rural Coalition‘s petitions.
Courts generally grant an agency‘s request for voluntary remand unless the request is frivolous or made in bad faith. Cal. Cmtys. Against Toxics v. EPA, 688 F.3d 989, 992 (9th Cir. 2012); see also Ethyl Corp. v. Browner, 989 F.2d 522, 524 (D.C. Cir. 1993) (“We commonly grant [agency remand] motions, preferring to allow agencies to cure their own mistakes rather than wasting the courts’ and the parties’ resources reviewing a record that both sides acknowledge to be incorrect or incomplete.“). Normally, when remand is requested and granted, “the agency intends to take further action with respect to the original agency decision on review.” Util. Solid Waste Activities Grp. v. EPA, 901 F.3d 414, 436 (D.C. Cir. 2018) (quoting Limnia, Inc. v. U.S. Dep‘t of Energy, 857 F.3d 379, 386 (D.C. Cir. 2017)). “[I]ntervening events outside of the agency‘s control, for example, a new legal decision or the passage of new legislation,” counsel in favor of granting such a remand request. SKF USA Inc. v. United States, 254 F.3d 1022, 1028 (Fed. Cir. 2001). That said, we have “broad discretion” in deciding whether to do so. Util. Solid Waste, 901 F.3d at 436.
Here, EPA has neither conceded error nor given any clear indication of how it will proceed on remand. Instead, EPA has vaguely asserted that “intervening decisions
Rural Coalition opposes the remand motion, arguing that EPA‘s actions are a bad-faith attempt to avoid judicial review. According to Rural Coalition, “EPA seeks remand of part of its action at the eleventh hour to avoid an adverse court ruling with little or no binding commitment to . . . actually change its decision.” Rural Coalition further argues that EPA does not have a properly cognizable rationale for its request. Rural Coalition dismisses the BE because it was within EPA‘s control and dismisses the intervening court decisions that EPA raises because they established no new law and simply required compliance with FIFRA‘s core mandate.
NRDC, on the other hand, does not oppose EPA‘s motion but responds to it by urging a 90-day deadline for completing the reconsideration of the ecological portion of the Interim Decision on remand. According to NRDC, EPA is unlikely to issue a final registration review decision by the October 2022 statutory deadline because the agency only recently initiated formal consultation under the ESA, which NRDC predicts will take years. NRDC additionally details how “EPA‘s pesticide approval process has been beset by consistent delays,” arguing that “[t]his history of delay means that a deadline for remand is appropriate.” NRDC thus asks that the Interim Decision be re-issued within 90 days.
Although Rural Coalition‘s arguments have force, we decide to grant EPA‘s motion to remand largely for practical reasons. As stated above, the challenges to the ecological portion are properly raised in Petitioners’ briefs, but EPA chose not to respond to those challenges in this action, instead filing a motion to remand on the deadline for filing its answering brief. Monsanto also did not substantively respond to those challenges. If we were to evaluate the merits of NRDC‘s challenges, we first would want to request responsive briefs and to have oral argument on the ecological issues, raising the possibility that the FIFRA October 2022 deadline would arrive before we could complete our review. Thus, while we hesitate to reward what some might consider sloth or indolence, we also recognize that fully litigating the issues could result in an outcome nobody wants: more, and probably unnecessary, delay. Because of these unusual circumstances, we GRANT EPA‘s motion to remand.
We are sympathetic, however, to Petitioners’ concerns about delay and gamesmanship. That said, we do not believe that NRDC‘s proposed 90-day deadline is warranted or that EPA must issue another interim decision before its final decision. Instead, we require EPA to issue a new ecological portion by the October 2022 FIFRA deadline.20 See Wis. v. EPA, 964 F.3d 1145, 1176 (D.C. Cir. 2020) (“EPA offers no reason, nor can we think of one, why it should be permitted to evade the Clean Air Act‘s statutory deadline through a voluntary remand.“).
VI.
EPA‘s motion to remand the ecological portion of the Interim Decision without vacatur of that portion is GRANTED subject to the deadline described above. Because we grant EPA‘s motion, we do not reach the parts of NRDC‘s and Rural Coalition‘s petitions that challenge the remanded portion of the Interim Decision.
The remainder of Rural Coalition‘s petition for review is GRANTED in part and DENIED in part. We VACATE the human health portion of the Interim Decision and REMAND for further consideration. Given that vacatur, we do not reach the remainder of NRDC‘s petition challenging the public-comment process that informed the human health portion of the Interim Decision. And although we agree with Rural Coalition that an ESA violation has occurred, we decline Rural Coalition‘s request for relief for the reasons stated above.
REMANDED.