throbber
FOR PUBLICATION
`
`UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`
`NATURAL RESOURCES DEFENSE
`COUNCIL; PESTICIDE ACTION
`NETWORK NORTH AMERICA,
`Petitioners,
`
` No. 20-70787
`
`EPA No.
`EPA-HQ-OPP-
`2009-0361
`
`
`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. 20-70801
`
`EPA No.
`EPA-HQ-OPP-
`2009-0361
`
`
`OPINION
`
`2
`
`
`NRDC V. USEPA
`
`RURAL COALITION; ORGANIZACION
`EN CALIFORNIA DE LÍDERES
`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.
`
`
`
`
`
`

`

`
`
`
`
`
`NRDC V. USEPA
`
`3
`
`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. Friedland, Circuit Judges.
`
`Opinion by Judge Friedland
`
`
`
`* The Honorable Danny J. Boggs, United States Circuit Judge for
`the U.S. Court of Appeals for the Sixth Circuit, sitting by designation.
`
`

`

`NRDC V. USEPA
`
`SUMMARY**
`
`Pesticides
`
`4
`
`
`
`
`
`
` 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
`
`** This summary constitutes no part of the opinion of the court. It
`has been prepared by court staff for the convenience of the reader.
`
`

`

`5
`
`NRDC V. USEPA
`
`
`
`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.
`
`
`
`

`

`NRDC V. USEPA
`
`6
`
`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
`
`

`

`NRDC V. USEPA
`
`
`
`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.
`
`7
`
`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
`
`

`

`NRDC V. USEPA
`
`8
`
`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
`
`Interim Decision’s ecological
`risk assessment,
`the
`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.
`
`
`
`
`
`
`

`

`NRDC V. USEPA
`
`9
`
`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.
`
`
`
`
`
`

`

`10
`
`
`NRDC V. USEPA
`
`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 7 U.S.C. §§ 136 et seq.
`FIFRA’s primary
`regulatory mechanism
`is called
`“registration.” Id. § 136a(a). A pesticide product may not
`be distributed or sold in the United States until EPA has
`issued a registration, which functions as a license setting
`forth the conditions under which the pesticide may be sold,
`distributed, and used. See id. § 136a. Those conditions
`
`
`1 Under FIFRA, a “pesticide” includes both “any substance or
`mixture of substances intended for preventing, destroying, repelling, or
`mitigating any pest” as well as “any substance or mixture of substances
`intended for use as a plant regulator, defoliant, or desiccant.” 7 U.S.C.
`§ 136(u).
`
`

`

`NRDC V. USEPA
`
`
`
`include labeling requirements with directions for proper use.
`Id. § 136a(c); see 40 C.F.R. § 156.10.
`
`11
`
`EPA may not issue a registration for a pesticide that
`causes “unreasonable adverse effects on the environment.”
`7 U.S.C. § 136a(c)(5)(C); see also 40 C.F.R. § 152.112(e).
`“[U]nreasonable adverse effects on the environment”
`include “any unreasonable 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). This is commonly referred to as the FIFRA safety
`standard.
`
`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.
`
`Id.
`§ 136a(g)(1)(A). For pesticides registered before 2007, such
`as glyphosate, EPA must complete the first registration
`review by October 1, 2022. Id.
`
`EPA has promulgated regulations delineating an
`elaborate process for registration review. 40 C.F.R.
`§§ 155.23–155.58. The regulations require EPA to assess
`any new information regarding risks to human health and the
`environment that has emerged since EPA last issued a
`registration decision for a pesticide to verify that the
`pesticide continues to satisfy the FIFRA safety standard.
`See, e.g., id §§ 155.40, 155.53(a). The process concludes
`with a registration review decision, which conveys “the
`Agency’s determination whether a pesticide meets, or does
`not meet,” the FIFRA safety standard. Id. § 155.57. The
`regulations also permit, but do not require, EPA to issue an
`“interim
`registration
`review decision” prior
`to
`the
`registration review decision. Id. § 155.56. “[T]he interim
`registration review decision may require new risk mitigation
`
`

`

`NRDC V. USEPA
`
`12
`
`measures, impose interim risk mitigation measures, identify
`data or information required to complete the review, and
`include schedules for . . . completing the registration
`review.” Id.
`
`If EPA finds that a pesticide does not satisfy the FIFRA
`safety standard, EPA may initiate cancellation proceedings
`to
`rescind
`a
`pesticide’s
`registration,
`7 U.S.C.
`§§ 136a(g)(1)(A)(v), 136d(b); 40 C.F.R. § 155.40(a)(2), or
`may require mitigation measures to reduce risk to acceptable
`levels, see 40 C.F.R. § 155.58.
`
`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
` The nationwide acreage across which
`skyrocketed.
`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
`
`

`

`NRDC V. USEPA
`
`
`
`exposed to glyphosate when they eat food from crops treated
`with it.
`
`13
`
`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
`
`2 For registration review, EPA may evaluate a “pesticide case . . .
`composed of 1 or more active ingredients and the products associated
`with the active ingredients” or may evaluate each pesticide product
`registration individually. 7 U.S.C. § 136a(g)(1)(A)(iii). Here, EPA
`decided to conduct registration review on glyphosate, an active
`ingredient.
`
`

`

`NRDC V. USEPA
`
`14
`
`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 a
`preliminary determination that glyphosate was not likely to
`be carcinogenic and shared that determination with the
`agency’s Office of Research and Development (“ORD”). In
`December 2015, ORD offered comments in response,
`including criticisms of the pesticide unit’s approach to
`reviewing epidemiological studies—specifically, studies of
`human populations
`investigating whether glyphosate
`exposure causes cancer. ORD commented that the pesticide
`unit seemed to “dichotomize” such studies as “either ‘causal’
`or ‘not causal’” rather than recognize “gradations of
`causality.” According to ORD, that approach contravened
`the
`“[f]rameworks
`for data
`analysis
`and
`causal
`determinations” employed by “the
`risk assessment
`community” and “by EPA” in its 2005 Guidelines for
`Carcinogen Risk Assessment (“Cancer Guidelines” or
`“Guidelines”). The Cancer Guidelines are intended to guide
`EPA in classifying chemicals according to their carcinogenic
`potential. After stating its methodological concerns, ORD
`expressed disagreement with
`the pesticide unit’s
`determination that glyphosate was “not likely to be
`carcinogenic.”
`
`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”).
`
`

`

`15
`
`NRDC V. USEPA
`
`
`
`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
`
`

`

`NRDC V. USEPA
`
`16
`
`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 few changes between the earlier draft and the
`finalized Cancer Paper.
`
`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
`
`

`

`NRDC V. USEPA
`
`
`
`ecological risks when glyphosate is used according to label
`directions.”
`
`17
`
`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
`
`
`3 Since the Interim Decision issued, EPA began following the ESA’s
`procedures. The first step is to determine whether an agency action “may
`affect” an endangered or threatened species or critical habitat. In
`November 2020, EPA completed a preliminary effects determination,
`publishing a draft Biological Evaluation that assessed potential effects
`from all registered uses of glyphosate on ESA-listed species. It found
`that glyphosate “may affect” all listed species experiencing glyphosate
`exposure—that is 1,795 endangered or threatened species. In November
`2021, EPA issued a final Biological Evaluation with similar conclusions.
`Under the ESA, a “may affect” determination triggers a requirement that
`the agency consult with the relevant wildlife agencies to prevent adverse
`effects. See Nat’l Fam. Farm Coal. v. EPA, 966 F.3d 893, 922 (9th Cir.
`2020). Thus, EPA is now consulting with those agencies. To the extent
`the draft Biological Evaluation and final Biological Evaluation are not
`part of the record before us, we take judicial notice of them. See Dine
`
`
`

`

`NRDC V. USEPA
`
`18
`
`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 an endocrine analysis of glyphosate pursuant to the
`FFDCA.4
`
`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
`
`Citizens Against Ruining Our Env’t v. Bureau of Indian Affs., 932 F.3d
`843, 848 n.1 (9th Cir. 2019).
`
`4 An endocrine analysis strives to determine whether a substance is
`an endocrine disruptor—for example, whether it has effects in humans
`or wildlife similar to those of naturally occurring estrogen.
`
`

`

`19
`
`NRDC V. USEPA
`
`
`
`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 7 U.S.C. § 136n(b)). This standard requires
`the administrative record to show “such relevant evidence as
`a reasonable mind might accept as adequate to support a
`conclusion even if it is possible to draw two inconsistent
`conclusions from the evidence.” Id. at 1036 (quoting NRDC
`v. EPA, 735 F.3d 873, 877 (9th Cir. 2013)). The agency’s
`reasoning must also be coherent and internally consistent.
`See NRDC v. EPA, 31 F.4th 1203, 1210 (9th Cir. 2022)
`(relying on internal “inconsistencies” in holding that a
`decision was not supported by substantial evidence); Lott v.
`Colvin, 772 F.3d 546, 551 (8th Cir. 2014) (holding that a
`decision marked by “internal inconsistencies” was not
`supported by substantial evidence); Linear Tech. Corp. v.
`Int’l Trade Comm’n, 566 F.3d 1049, 1065 (Fed. Cir. 2009)
`(holding that a decision based on “[i]nconsistent[]” rulings
`and “contradictory statement[s]” was not supported by
`substantial evidence).
`
`The Administrative Procedure Act (“APA”) governs
`judicial review of administrative decisions involving the
`
`

`

`NRDC V. USEPA
`
`20
`
`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.” 5
`U.S.C. § 706; see NRDC v. Houston, 146 F.3d 1118, 1125
`(9th Cir. 1998).
`
`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
`
`

`

`21
`
`NRDC V. USEPA
`
`
`
`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 Huma

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