Center for Biological Diversity v. Lee Zeldin

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued May 5, 2025 Decided March 27, 2026

No. 24-5101

CENTER FOR BIOLOGICAL DIVERSITY, ET AL.,

APPELLEES/CROSS-APPELLANTS

v.

LEE M. ZELDIN, IN HIS OFFICIAL CAPACITY AS ADMINISTRATOR

FOR THE U.S. ENVIRONMENTAL PROTECTION AGENCY, ET AL.,

APPELLANTS/CROSS-APPELLEES

STATE OF FLORIDA AND FLORIDA DEPARTMENT OF

ENVIRONMENTAL PROTECTION,

APPELLANTS/CROSS-APPELLEES

Consolidated with 24-5156, 24-5159

Appeals from the United States District Court

for the District of Columbia

(No. 1:21-cv-00119)

Rebecca Jaffe, Attorney, U.S. Department of Justice,

argued the cause for federal appellants/cross-appellees. With

her on the briefs were Adam R.F. Gustafson, Acting Assistant

Attorney General, Joan Pepin, Michael Eitel, and Andrew

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Coghlan, Attorneys, and Erica Zilioli, Attorney, U.S. Army

Corps of Engineers.

Aaron M. Streett argued the cause for appellants/cross-

appellees the State of Florida and Florida Department of

Environmental Protection. With him on the briefs were Jeffrey

DeSousa, Acting Solicitor General, Office of the Attorney

General for the State of Florida, Christopher J. Baum, Senior

Deputy Solicitor General, Anthony J. Lucisano, and Jeffrey H.

Wood. Christopher B. Carter entered an appearance.

Sean Reyes, Attorney General, Office of the Attorney

General for the State of Utah, and Stanford E. Purser, Solicitor

General, were on the brief for amici curiae the State of Utah,

et al. in support of appellants/cross-appellees.

Mohammad O. Jazil and Edward M. Wenger were on the

brief for amici curiae Florida Chamber of Commerce, et al. in

support of appellant/cross-appellee the State of Florida.

Christina I. Reichert argued the cause for plaintiff

appellees/cross-appellants. With her on the briefs were Tania

Galloni and Bonnie Malloy.

George Abney was on the brief for amicus curiae the

Miccosukee Tribe of Indians of Florida in support of

appellees/cross-appellants.

Before: HENDERSON, WILKINS, and PAN, Circuit Judges.

Opinion for the Court filed by Circuit Judge PAN.

Opinion concurring in part and concurring in the judgment

filed by Circuit Judge WILKINS.

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Opinion concurring in part and dissenting in part filed by

Circuit Judge HENDERSON.

PAN, Circuit Judge: Imagine that the owner of a trucking

company is required to register his trucks with the Department

of Motor Vehicles. To do so, each truck must pass a safety

inspection. The owner finds it burdensome to bring each

vehicle to the DMV for its own evaluation, so he meets with

the DMV manager and the vehicle inspector about a novel plan.

He says to the manager and inspector, “I don’t have all my

trucks here today. But I promise to do all the safety inspections

myself to make sure that the trucks are compliant with all the

regulations. I’ll consult with the vehicle inspector if I have any

questions. Could you please certify that all my trucks have

passed inspection and issue the registrations?” The vehicle

inspector agrees that the truck owner’s plan should be sufficient

and recommends that the manager approve it. The DMV

manager thinks about it and says to the inspector, “Well, if you

believe it’s good enough that he promises that the trucks will

comply with the safety regulations, and if he says that he’ll ask

you for help if he has any questions about it, then that’s all right

with me. Go ahead and certify that all his trucks have passed

inspection, I’ll issue the registrations, and let’s get those trucks

on the road!” The problem, of course, is that the truck owner

may or may not ensure that his trucks comply with the safety

regulations. And the vehicle inspector no longer has any

obligation to make sure that the trucks are safe.

That is similar to what happened in this case. Florida

asked the U.S. Environmental Protection Agency (EPA) to give

it authority to issue certain permits under the Clean Water Act

(CWA) that would allow permit holders to discharge pollutants

into waters in Florida. Florida promised that when it granted

those permits, it would make sure that any species that are

protected under the Endangered Species Act (ESA) would not

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be jeopardized. Florida also promised to monitor certain harms

to the protected species — called “incidental takings” — that

might occur under its permitting program and to ensure that

such incidental takings would comply with certain provisions

of the ESA. Furthermore, Florida promised to consult with the

U.S. Fish and Wildlife Service (FWS) about the effects of the

permits on protected species. The EPA and the FWS agreed to

support Florida’s proposal. The FWS found that Florida’s

permitting plan complied with the ESA, and the EPA then

relied on that finding to approve the permitting plan. As a

result, Florida and its permit recipients were essentially

excused from meeting additional ESA requirements.

Just like in the hypothetical situation at the DMV, the EPA

(like the “DMV manager”) and the FWS (like the “vehicle

inspector”) certified that Florida (the “owner”) complied with

the ESA. They did so without ensuring that Florida’s

permittees (the “trucks”) satisfied or ever would satisfy the

ESA’s “safety regulations” — either at the time of the

program’s approval, or at the time that individual permits

would be issued. The FWS thus abdicated its responsibility to

enforce the ESA: The agency essentially delegated that job to

Florida without ensuring that Florida would protect endangered

and threatened species in the manner specified by the ESA.

Meanwhile, the EPA relied on the FWS’s representations about

the program’s compliance with the ESA to approve Florida’s

permitting scheme. Thus, the EPA and the FWS enabled

Florida and the recipients of its permits to evade the ESA’s

exacting procedures for protecting listed species.

A coalition of environmental groups challenged Florida’s

permitting plan in the district court, arguing that the FWS and

the EPA violated the ESA and the Administrative Procedure

Act (APA) when they each approved Florida’s proposal. The

environmental groups argued that the FWS failed to comply

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with the ESA because it did not take necessary steps before

finding that Florida’s permitting program would not jeopardize

protected species and before concluding that Florida’s plan

would provide adequate protection against incidental takings.

They also argued that the EPA acted unlawfully by

(1) approving the permitting program in reliance on the FWS’s

inadequate conclusions, and (2) failing to consult with the

National Marine Fisheries Service (NMFS), as required by the

ESA.

The district court agreed. It vacated the Biological

Opinion (BiOp) and Incidental Take Statement (ITS) that FWS

had prepared to support its approval of Florida’s permitting

scheme, and it held that the EPA’s failure to consult with the

NMFS was arbitrary, capricious, and otherwise contrary to law.

The district court vacated the EPA’s approval of Florida’s

application to issue permits under the CWA because the EPA’s

approval was based on the flawed BiOp and ITS.

Florida and the Florida Department of Environmental

Protection (collectively, “Florida”), and the involved federal

agencies — the EPA, the FWS, the Army Corps of Engineers

(the “Corps”), and some of their leaders (collectively, the

“Federal Appellants”) — appeal the judgment of the district

court. They claim that the BiOp and the ITS relied upon by the

FWS complied with the requirements of the ESA and that the

EPA acted reasonably when it relied on the FWS’s conclusions

to approve Florida’s permitting program. Florida also argues

that the environmental groups lack standing to challenge the

agency actions at issue and that the EPA was not required to

consult with the NMFS.

We hold that (1) the environmental groups have standing

and their claims are ripe, see infra Part II; (2) the BiOp must be

set aside because it did not comply with the ESA and the EPA

violated the ESA by relying on the deficient BiOp, see infra

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Part III.B.1; see also Opinion of Wilkins, J., concurring in part

and concurring in the judgment; (3) the ITS must be set aside

because it did not comply with the ESA, see infra Part III.B.2,

and the EPA violated the ESA by relying on the deficient ITS,

id.; see also Opinion of Wilkins, J.; and (4) the EPA erred in

failing to engage in a mandatory, formal consultation with the

NMFS, see infra Part III.B.3. We further conclude that the

EPA’s approval of Florida’s permitting application must be

vacated at least because that approval relied on the problematic

ITS, which is fundamental to the permitting program, and

because the EPA approved the application without the benefit

of consultation with the NMFS. See infra Part IV; see also

Opinion of Wilkins, J. 1

I.

A. Statutory Background

1. The Clean Water Act

Congress enacted the CWA to “restore and maintain the

chemical, physical, and biological integrity of the Nation’s

waters.” 33 U.S.C. § 1251(a). To that end, Section 404 of the

CWA prohibits “the discharge of any pollutant” without a

permit into the “waters of the United States.” Id. §§ 1311(a),

1362(6), 1362(7), 1362(12). The Corps ordinarily issues

Section 404 permits and ensures that they comply with

regulations. See id. § 1344(a), (d); 40 C.F.R. § 230.10(b)(3).

But a state may apply to the EPA to assume the Corps’s

permitting authority for a subset of waters within the state. 33

1

Judge Henderson joins Parts II, III.B.2, and III.B.3 of this

opinion, other than the holding in Part III.B.3 that the EPA violated

the ESA by relying on the deficient ITS, and dissents from parts

III.B.1 and IV. Judge Wilkins joins Parts II, III.B.2, and III.B.3, and

concurs in the judgment as to Parts III.B.1 and IV.

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U.S.C. § 1344(g)(1). To do so, the applying state must develop

a permitting program that is consistent with the requirements

of the CWA and its implementing regulations. See 40 C.F.R.

§ 233.1(d)–(e). After soliciting public comments, the EPA

“shall approve” the state’s application if it determines that the

application complies with the CWA and its regulations. See 33

U.S.C. § 1344(g), (h)(1)(A)(i), (h)(2)(A); 40 C.F.R. § 233.15.

2. The Endangered Species Act

States, individuals, and federal agencies must ensure that

their actions comply with the Endangered Species Act.

Congress enacted the ESA to promote “the conservation of . . .

endangered species and threatened species,” and the

“ecosystems upon which [those] species depend.” 16

U.S.C. § 1531(b). The Act provides that a species can be

“listed” as either “endangered” or “threatened.” See id. § 1533.

An endangered species is “any species which is in danger of

extinction throughout all or a significant portion of its range.”

Id. § 1532(6). A threatened species is “any species which is

likely to become an endangered species within the foreseeable

future throughout all or a significant portion of its range.” Id.

§ 1532(20). Endangered species and threatened species

receive important protections under the ESA. See id.

§§ 1538(a)(1) (listing prohibited acts for endangered species),

1533(d) (authorizing protective regulations for threatened

species).

As relevant here, the ESA prohibits the “taking” of a listed

species by individuals, states, and federal agencies. 16 U.S.C.

§§ 1538(a)(1)(B), 1532(19), 1533(d). “Taking” has an

expansive meaning — it encompasses actions that “harass” or

“harm” a protected species. Id. § 1532(19). “Harm” includes

“significant habitat modification or degradation” that “actually

kills or injures wildlife by significantly impairing essential

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behavioral patterns” like “breeding, feeding, or sheltering.” 50

C.F.R. § 17.3. Violations of the prohibition against takings

may result in a range of civil and criminal penalties. 16 U.S.C.

§ 1540(a)(1)–(2), (b). But the ESA recognizes that some

takings are “incidental” to lawful activities — that is, they

“result from, but are not for the purpose of, carrying out an

otherwise lawful activity.” 50 C.F.R. § 402.02. Incidental

takings that do not jeopardize protected species or adversely

modify or destroy their critical habitat can be exempted from

the civil and criminal penalties that otherwise would apply

under the ESA. See 16 U.S.C. § 1539(a)(1)(B).

The ESA is administered by the FWS and the NMFS. 50

C.F.R § 402.01(b). The NMFS administers the ESA for

protected marine and anadromous species (ones that migrate

between freshwater and saltwater); and the FWS administers

the ESA with respect to all other protected species. See id. We

refer to the FWS and NMFS collectively as “the Services.”

a. Biological Opinion

Under the statute and implementing regulations, an agency

must determine “at the earliest possible time” whether any

contemplated agency action “may affect” listed species or

critical habitat; and if so, the agency must enter a “formal

consultation” with the Services under Section 7 of the ESA. 50

C.F.R. § 402.14(a), (c); see also 16 U.S.C. § 1536.

The first step of a Section 7 consultation requires the

Services to prepare a written BiOp that evaluates whether the

planned agency action is “not likely to jeopardize the continued

existence” of a protected species or result in the “destruction or

adverse modification” of its critical habitat. 16 U.S.C.

§ 1536(a)(2)–(4); Nat’l Ass’n of Home Builders v. Defs. of

Wildlife, 551 U.S. 644, 652 (2007). The process of preparing a

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BiOp is a rigorous endeavor. To prepare a BiOp, the Services

must:

(1) Review all relevant information provided

by the [action] agency or otherwise available.

Such review may include an on-site inspection

of the action area with representatives of the

[action] agency and the applicant.

(2) Evaluate the current status and

environmental baseline of the listed species or

critical habitat.

(3) Evaluate the effects of the action and

cumulative effects on the listed species or

critical habitat.

(4) Add the effects of the action and

cumulative effects to the environmental

baseline and in light of the status of the species

and critical habitat, formulate the Service’s

opinion as to whether the action is likely to

jeopardize the continued existence of listed

species or result in the destruction or adverse

modification of critical habitat.

50 C.F.R. § 402.14(g). The Services also must “[f]ormulate a

statement concerning incidental take, if such take is reasonably

certain to occur.” Id. § 402.14(g)(7).

We refer to the third BiOp requirement as the “effects

analysis.” See 50 C.F.R. § 402.14(g)(3). An effects analysis

encompasses two types of effects. First, the “effects of the

action” include “all consequences to listed species . . . that are

caused by the proposed action, including the consequences of

other activities that are caused by the proposed action.” Id.

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§ 402.02. “Effects of the action may occur later in time and

may include consequences occurring outside the immediate

area involved in the action.” Id. Second, the “cumulative

effects” on the listed species include “those effects of future

State or private activities, not involving Federal activities, that

are reasonably certain to occur within the action area of the

Federal action subject to consultation.” Id. (emphasis added).

Once the Services complete the effects analysis, the next

step — which culminates in the Services issuing a “jeopardy”

or “no jeopardy” determination — is mandatory. 50 C.F.R.

§ 402.14(g)(4), (h)(iv). The Services must “[add] the effects of

the action and cumulative effects to the environmental baseline

and in light of the status of the species and critical habitat,

formulate [its] opinion as to whether the action is likely to

jeopardize the continued existence of listed species.” Id.

§ 402.14(g)(4). In other words, the Services must determine

whether the planned action “reasonably would be expected,

directly or indirectly, to reduce appreciably the likelihood of

both the survival and recovery of a listed species in the wild by

reducing the reproduction, numbers, or distribution of that

species.” Id. § 402.02. The Services must summarize the

information on which their jeopardy determination is based and

“detail how the agency action affects the species or its critical

habitat.” 16 U.S.C. § 1536(b)(3)(A); see also 50 C.F.R.

§ 402.14(h).

In the event of a “jeopardy” determination, the consulting

agency “shall suggest those reasonable and prudent alternatives

which [it] believes would not violate [Section 7(a)(2)] and can

be taken by [the action agency].” 16 U.S.C. § 1536(b)(3)(A);

see also 50 C.F.R. § 402.14(h)(3), (g)(5). “Following the

issuance of a ‘jeopardy’ opinion, the [action] agency must

either terminate the action, implement the proposed alternative,

or seek an exemption from the Cabinet-level Endangered

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Species Committee pursuant to 16 U.S.C. § 1536(e).” Nat’l

Ass’n of Home Builders, 551 U.S. at 652. Importantly, in

“formulating its biological opinion, any reasonable and prudent

alternatives, and any reasonable and prudent measures,” the

Services are required to “use the best scientific and commercial

data available.” 50 C.F.R. § 402.14(g)(8); see also 16 U.S.C.

§ 1536(a)(2) (“In fulfilling the requirements of this paragraph

each agency shall use the best scientific and commercial data

available.”).

b. Incidental Take Statement

If a Service makes a no-jeopardy determination but

concludes that incidental take is nonetheless “reasonably

certain to occur,” 50 C.F.R. § 402.14(g)(7); id. § 402.02, it

proceeds to the second step of the Section 7 consultation

process: The Service must provide an ITS. Id.; see also id.

§ 402.14(i); 16 U.S.C. § 1536(b)(4).

An ITS must:

(i) specif[y] the impact of such incidental

taking on the species;

(ii) specif[y] those reasonable and prudent

measures that the Secretary considers

necessary or appropriate to minimize such

impact;

(iii) in the case of marine mammals, specif[y]

those measures that are necessary to comply

with [incidental-take procedures specific to

marine mammals]; and

(iv) set[] forth the terms and conditions

(including, but not limited to, reporting

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requirements) that must be complied with by

the Federal agency or applicant (if any), or

both, to implement the measures specified

under clauses (ii) and (iii).

16 U.S.C. § 1536(b)(4). The implementing regulation defines

“impact” to mean “the amount or extent of such incidental

taking on the species.” 50 C.F.R. § 402.14(i)(1)(i).

Further, the action agency or applicant must “monitor the

impacts of incidental take” and “report the progress of the

action and its impact on the species to the Service as specified

in the [ITS].” 50 C.F.R. § 402.14(i)(4). The action agency

“must reinitiate consultation immediately” if the “amount or

extent of incidental taking” specified in the ITS, as required by

the regulations, “is exceeded.” Id. § 402.14(i)(5) (emphasis

added); id. § 402.16(a). Additional consultation is required in

other situations, such as “if a new species is listed or critical

habitat designated that might be affected by the identified

action.” Id. § 402.16(a)(4).

Ultimately, if the Services provide a no-jeopardy

determination and issue an ITS, then the ITS offers a safe

harbor to those who participate in the planned agency action:

Parties that comply with the terms and conditions specified in

the ITS are exempted from civil and criminal liability under the

ESA for any incidental takings, and they need not seek any

other authorization or permit under the ESA. See 16 U.S.C.

§ 1536(o)(2) (“Any taking that is in compliance with the terms

and conditions specified in [the ITS] shall not be considered to

be a prohibited taking of the species concerned.”); 50 C.F.R.

§ 402.14(i)(6) (“Any taking that is subject to [an ITS] and that

is in compliance with the terms and conditions of that statement

is not a prohibited taking under the Act, and no other

authorization or permit under the Act is required.”).

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c. Programmatic Consultation

Section 7 consultation may focus on a single agency action

or on “an agency’s multiple actions on a program, region, or

other basis.” 50 C.F.R. § 402.02. The latter is known as a

“programmatic consultation,” which allows the Services to

consult on the effects of programmatic actions, such as

“[m]ultiple similar, frequently occurring, or routine actions,”

and proposed frameworks “for future proposed actions.” Id.

Regulations recognize that such “multiple actions” might not

be ready for full Section 7 consultation at the outset and may

need to defer the required Section 7 analysis until a later time.

See, e.g., id. § 402.14(i)(7). Accordingly, the regulations

provide that “any incidental take resulting from any action

subsequently authorized, funded, or carried out under the

program will be addressed in subsequent section 7

consultation, as appropriate.” Id. But importantly, neither the

statute nor any applicable regulation provides that

“programmatic” consultations allow the Services to avoid the

rigorous requirements of Section 7 consultation entirely. See

id.

d. Section 10 Consultation

Section 10 of the ESA establishes a different procedure for

private parties, states, and other nonfederal actors to deal with

the problem of incidental takings. See 16 U.S.C. § 1539(a); 50

C.F.R. § 402.14(i)(5). Under Section 10, a nonfederal actor

may obtain a permit from the Services that allows incidental

takings to occur without subjecting the actor to liability under

the ESA. 16 U.S.C. § 1539(a)(1)(B). To obtain such a permit,

the applicant must undergo a Section 10 consultation process.

The Section 10 applicant must submit a conservation plan that

describes the impacts of potential incidental takings, the steps

the applicant will take to minimize and mitigate those impacts,

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alternatives to the planned activity, why the applicant is not

taking those alternatives, and any other measures that the

Services “may require as being necessary or appropriate.” Id.

§ 1539(a)(2)(A). The Services must publish notice of the

Section 10 permit application in the Federal Register and

provide opportunity for public comment. Id. § 1539(c),

(a)(2)(B). And the Services must make certain findings before

they can issue a permit that allows incidental takings, including

that the takings “will not appreciably reduce the likelihood of

the survival and recovery of the species in the wild,” and that

“the applicant will, to the maximum extent practicable,

minimize and mitigate the impacts of such taking.” Id.

§ 1539(a)(2)(B).

B. Factual Background

Florida is home to hundreds of endangered and threatened

species, including the Florida panther, nesting sea turtles, the

West Indian manatee, the Audubon’s crested caracara, and the

bonneted bat. The presence of such species throughout the

state is a potential barrier to development because many

construction projects affect protected species and therefore

cannot proceed without meeting the rigorous requirements of

the ESA.

Florida sought to issue permits under Section 404 of the

Clean Water Act that would allow permittees associated with

building and mining projects to discharge dredged or fill

material into U.S. waters. The Section 404 permit recipients

normally would have to obtain an additional permit from the

FWS and NMFS under Section 10 of the ESA if they wished

to avoid liability for incidental takings resulting from the

planned discharges. Florida considered that extra step

“burdensome,” “time consuming[,] and resource-intensive,”

and therefore devised a plan to eliminate it. J.A. 2033 (Florida

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White Paper, Streamlined Approach to Address Endangered

Species Act Incidental Take Coverage). Specifically, Florida

proposed to “streamline” the ESA’s permitting process and to

obtain broad, up-front ESA liability protection for all its future

CWA permittees. Under the “streamlined” approach, the EPA

would engage in a “programmatic” Section 7 consultation with

the FWS concerning the EPA’s approval of Florida’s Section

404 permitting application. The one-time Section 7

consultation would produce a “programmatic” no-jeopardy

determination and a “programmatic” ITS that would provide

take-liability protection to all future state Section 404

permittees. J.A. 2034–35.

Florida envisioned that the “programmatic” BiOp and ITS

issued pursuant to the Section 7 consultation would defer

species-specific analyses and the formulation of take

limitations to a “technical assistance process.” J.A. 2043–47.

In other words, the Section 7 analysis would not occur when

the EPA reviewed Section 404 permitting applications but

instead would be deferred until Florida started approving

individual permits. At that point, the evaluation of individual

permit applications would be conducted by Florida — not the

FWS — pursuant to a “technical assistance process” that was

less rigorous than a Section 7 consultation but would

nonetheless “provide project applicants the needed liability

protection from claims arising under the ESA even though the

activity is authorized pursuant to a state permit.” J.A. 2509

(Florida White Paper, Potential Endangered Species Act

Compromise). By getting the EPA and the FWS to approve the

“technical assistance process” during a “programmatic”

Section 7 consultation at the outset, Florida could save its

Section 404 permittees the trouble of undergoing

individualized Section 10 scrutiny on each permit while still

guaranteeing them liability protection for incidental takings,

based on the Section 7 approval of the overall program. See

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Ctr. for Biological Diversity v. Regan (CBD v. Regan), 734 F.

Supp. 3d 1, 24 (D.D.C. 2024). Florida’s proposed plan was

modeled on a similar “programmatic consultation” that was

blessed by the Second Circuit’s decision in Cooling Water

Intake Structure Coalition v. EPA, 905 F.3d 49 (2d Cir. 2018).

Florida asserted that its plan was necessary because

without it, the permittees “must avoid entirely adverse impacts

to listed species or otherwise seek an incidental take permit

under ESA Section 10 separate and apart from the Section 404

permit process, which can take years to complete in contrast to

the [programmatic] Section 7 process and is more burdensome

for all involved.” J.A. 2033. According to Florida, “around

ten percent of the Section 404 permits . . . would require some

form of incidental take coverage, including for ‘many large real

estate, mining, agriculture, and utility industry projects with

significant economic benefits to the State.’” Id.

The EPA had previously determined that Section 7

consultation was inappropriate in the context of approving state

Section 404 applications. But the EPA considered Florida’s

proposal and agreed that Section 7 consultation would make

things easier for Florida. The EPA thus sought public comment

on whether Section 7 consultation was required for its approval

of state applications to assume Section 404 permitting

authority. In response to public comments, the EPA stated that,

in its view, Section 10 consultation by individual Section 404

permittees was not “realistically feasible for states with an

abundance of ESA listed species like Florida.” J.A. 2524. In

its final decision, the EPA further stated that the “streamlined

permitting process” that the BiOp and ITS contemplated

“would reduce costs and duplication of effort by state . . . and

federal authorities and facilitate more effective and efficient

state . . . CWA Section 404 programs.” J.A. 2504. The EPA

ultimately changed its prior position and decided that the

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Section 7 consultation process does apply to the EPA’s

consideration of a state’s Section 404 permitting application.

Id. 2

Before Florida submitted its Section 404 application to the

EPA, it collaborated with the FWS to design the “technical

assistance process” that would be incorporated into Florida’s

proposed permitting program. See CBD v. Regan, 734 F. Supp.

3d at 25–26 (citing ECF No. 112-5 at 170) (referring to FWS

employee’s memorialization of a February 2020 meeting that

occurred between the FWS, the EPA, and Florida, where

participants discussed features of the technical assistance

process). The FWS emphasized that the technical assistance

process would not involve additional Section 7 consultations

2

The EPA’s Section 7 consultation with the FWS was the key to

Florida’s plan to “streamline” environmental requirements. See J.A.

2033. Although the EPA decided that Section 7 applies to its

approval of Section 404 permitting applications, it is unclear whether

that conclusion was correct. Section 7 applies only when agencies

take discretionary action, see Nat’l Ass’n of Home Builders, 551 U.S.

at 663–64, but the approval of a state’s Section 404 application

arguably is not discretionary because the EPA “shall approve the

program” if it determines that the state has complied with the

relevant statutory and regulatory requirements. 33 U.S.C.

§ 1344(h)(2) (emphasis added). This issue is potentially dispositive,

but no party argues that the Section 7 consultation was improper. We

therefore assume without deciding that the EPA properly consulted

with the FWS about Florida’s Section 404 application. See

McFadden v. United States, 576 U.S. 186, 192 n.2 (2015) (“Because

we need not decide in this case whether that [statutory] interpretation

is correct, we assume for the sake of argument that it is.”); Nat’l

Ass’n of Realtors v. United States, 97 F.4th 951, 957 (D.C. Cir. 2024)

(noting that we generally “adopt the framing of the dispute that is

advanced by the parties because in our adversarial system of

adjudication, we follow the principle of party presentation” (cleaned

up)).

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when Florida issued the Section 404 permits. An FWS

employee advised Florida and the EPA to “be careful of using

words like consultation when you really mean coordination and

technical assistance.” Id. And in April 2020, an FWS

employee communicated to Florida:

After assumption [of Section 404 permitting

authority], FWS will not be issuing any project-

by-project incidental take statements [under

Section 7] for State 404 permits because the

State 404 BiOp will have a programmatic

incidental take statement that will cover any

incidental take for any state 404 permit. FWS

will merely be providing technical assistance on

the project by project reviews to [Florida]

and/or permit applicants and tracking on a

project-by-project basis any incidental take that

is anticipated to occur as the result of [Florida]

issuing any particular 404 permit.

J.A. 2546.

In August 2020, Florida formally applied to the EPA to

assume Section 404 permitting authority. See 33 U.S.C.

§ 1344(g)(1). Florida’s Section 404 application included a

draft Memorandum of Understanding (MOU), which explained

that “[u]pon assumption of the Section 404 Program,

coordination between the [FWS] and [Florida] related to the

proposed action’s effects on species will occur through the

technical assistance process, which is anticipated to be outlined

in the [FWS’s] biological opinion.” J.A. 1560. The MOU also

noted that the BiOp would be “based on information included

in the biological assessment” — a document that Florida

prepared for the EPA, which the EPA then sent to the FWS. Id.

19

In September 2020, the EPA submitted a request for a

formal consultation with the FWS under Section 7 concerning

the EPA’s consideration of Florida’s Section 404 application.

In November 2020, the FWS concluded its consultation and

published its Programmatic BiOp, comprising its BiOp and

ITS. Specifically, the FWS determined that the EPA’s

approval of Florida’s Section 404 permitting application would

not jeopardize protected species or harm critical habitats; and

it included a programmatic ITS that conferred on Florida’s

permittees liability protection for incidental takings.

In making its no-jeopardy determination, the FWS stated

that it was “not feasible, nor [was] it required, to conduct a

meaningful site-specific and species-specific effects analysis in

this BiOp.” J.A. 2655. Because of the “lack of information

and uncertainties surrounding the location, timing, frequency,

and intensity” of permit actions, the FWS based its “effects

analysis” on “a number of key assumptions.” J.A. 2656. Most

significant were its assumptions about the “technical assistance

process.” J.A. 2669.

Under the technical assistance process, Florida would have

the authority to approve the Section 404 permit applications.

Permit applicants would be required to include a description of

the proposed activity, the “specific areas” affected by the

activity, a description of protected species and habitats in the

area and ways in which they might be affected, analysis of any

cumulative effects, and other “relevant information,”

including, “[w]hen needed, proposed project designs and . . .

conservation measures that would avoid and minimize the

expected impacts to listed species and their habitats.” J.A.

2617. Based on that information, Florida (and not the FWS)

would decide whether protected species or habitats would be

adversely affected if the permit were granted.

20

The FWS would play a largely advisory role, with the

option of overriding Florida’s effects determination and

requiring the permittees to take additional protective measures.

The FWS would “[r]eceive” and “[r]eview” “all the 404 permit

applications,” which would be “sent by [Florida].” J.A. 2621.

The FWS could then participate in the approval process if it

chose to do so. If the FWS declined to make comments, its

silence would not indicate “concurr[ence] with any effect

determinations made by [Florida].” Id. But if the FWS decided

to weigh in and found that an application “may cause an

adverse effect to [a] species,” then that decision “would be

determinative,” and the project would be required to “include

additional protective measures or Florida [would] reject the

permit.” J.A. 2620, 2631. The EPA also could object to a

permit’s approval based on the FWS’s analysis, and the permit

could not be issued until Florida resolved the EPA’s objections.

See 40 C.F.R. § 233.50(f). 3 In addition, the FWS could, if it

wished, “provide [Florida] with technical information . . . and

recommended measures that would avoid or minimize effects.”

J.A. 2621; see also J.A. 2669 (explaining that the FWS would

“be provided an opportunity to review all State 404 permit

applications,” provide technical assistance “with respect to

avoiding and minimizing effects on ESA-listed species and

their critical habitats,” and make “monitoring and reporting

recommendations” (emphasis added)).

The FWS reasoned that the “assum[ed]” coordination

between the FWS and Florida in the technical assistance

3

The FWS also was tasked with determining whether each permit

application “ha[d] the required information needed to assess”

whether “issuing the permit is likely to jeopardize” protected species

or their habitats, and the FWS agreed to notify Florida if it believed

that information was missing. J.A. 2621. If the FWS “ha[d]

information that would disconfirm [Florida’s] effect determination,”

the FWS would provide it to Florida. Id.

21

program was “as protective as the section 7 interagency

consultation process.” J.A. 2657. Relying on that supposed

efficacy, the FWS concluded that the EPA’s approval of

Florida’s program was not “likely to jeopardize the continued

existence of [protected] species” or “destroy or adversely

modify designated critical habitat.” J.A. 2669. It concluded

that Florida’s program was “sufficiently structured” to avoid

jeopardy to ESA-listed species. J.A. 2655; see also J.A. 2656–

57 (“[S]ite-specific and species-specific information will

be . . . assessed through the technical assistance process.”).

The FWS then proceeded to determine whether incidental

takings were “reasonably certain” to occur due to the

permitting program. 50 C.F.R. § 402.14(g)(7). The FWS

concluded that some incidental take was “reasonably certain,”

and thus issued a “programmatic” ITS. J.A. 2670.

Although the implementing regulation requires the FWS

to estimate the take amount resulting from Florida’s permitting

program, 50 C.F.R. § 402.14(i), the FWS did not do so in its

ITS. According to the FWS, it could not make such an estimate

because it was “not possible for FWS to know what permits

would issue and where throughout the life of the program, let

alone specific amounts of take resulting from those permits.”

J.A. 2670–71. Instead, the FWS stated that Florida would

estimate incidental-take amounts on a permit-by-permit basis

and that the FWS would track anticipated take amounts of

listed species on a permit-by-permit basis.

Typically, the estimated take amount for the agency action

under review functions as a trigger for the action agency to

reinitiate a Section 7 consultation. 50 C.F.R. § 402.14(i)(5).

But the ITS provided that Florida (not the EPA) would

reinitiate consultation with the FWS if Florida found that its

own permit-level incidental-take estimates were exceeded.

22

The ITS also required Florida to take the initiative to reopen

permits and to “coordinate” with the FWS if new information,

such as the listing of a new protected species, showed that

impacts to listed species would be greater or different from

what Florida had anticipated at the time that an individual

permit issued. J.A. 2673. The ITS made clear that any renewed

consultations contemplated by the ITS would not be the same

as the reinitiated Section 7 consultations required under

applicable regulations. A reinitiated Section 7 consultation

would revisit whether the overall permitting program complied

with the ESA, but the ITS explained that Florida’s issuance of

Section 404 permits was not a federal action subject to Section

7 review. The ITS further provided that compliance with its

terms would confer ESA liability protection for incidental

takings of protected species that occurred as a result of Section

404 permitted activity. The ITS required Florida to participate

in the technical assistance program described above.

In sum, at the end of the Section 7 consultation, Florida

received (1) EPA approval of its application to issue permits to

discharge pollutants into certain waters in Florida under

Section 404 of the CWA; (2) a finding by the FWS that

Florida’s permitting program would not jeopardize listed

species or their habitats, as long as Florida engaged in the

“technical assistance process” for individual permits; and

(3) liability protection for individual permittees, conditioned

on compliance with the provisions of the ITS, which required

Florida to participate in the technical assistance program.

23

C. District Court Proceedings

In January 2021, a coalition of environmental groups filed

suit against the EPA, the Corps, the FWS, the NMFS, and

various federal officials. 4 The plaintiffs challenged the EPA’s

approval of Florida’s Section 404 permitting application and

the Programmatic BiOp, including the BiOp and ITS, prepared

by the FWS. In relevant part, the plaintiffs raised claims under

the ESA and the APA, arguing that the agencies violated the

statutory and regulatory requirements of the ESA. The district

court granted Florida’s unopposed motion to intervene to

defend the challenged federal actions.

The district court granted summary judgment to the

plaintiffs and concluded that the actions of the EPA and the

FWS were unlawful. The court held that the FWS’s BiOp and

ITS must be set aside because both the no-jeopardy conclusion

and the ITS failed to comply with applicable standards under

the ESA. The court also concluded that the EPA impermissibly

relied on the BiOp and the ITS in approving Florida’s Section

404 application.

The district court held that the FWS was not “free to

disregard” Section 7’s requirements by basing its no-jeopardy

conclusion on later analysis performed in a “technical

assistance” process that itself would not be subject to Section

7’s requirements. CBD v. Regan, 734 F. Supp. 3d at 49. The

district court also concluded that the FWS’s ITS was faulty,

because it omitted the “essential term” of a take limit and did

not provide a “clear standard for when the level of anticipated

take has been exceeded.” Id. at 52. The district court noted

4

These environmental organizations were the Center for

Biological Diversity, Defenders of Wildlife, Sierra Club,

Conservancy of Southwest Florida, Miami Waterkeeper, St. Johns

Riverkeeper, and Florida Wildlife Federation.

24

that the ITS unlawfully provided that federal agencies would

“not reinitiate formal consultation” even if the EPA’s approval

of Florida’s Section 404 program resulted in excess take or

otherwise jeopardized the continued existence of listed species.

Id. at 54 (emphasis in original). Moreover, the district court

rejected the FWS’s argument that it lacked sufficient

information to perform the required analyses under Section 7,

explaining that the statute does not create exceptions for

uncertainty or “require perfect foresight” of the FWS. Id. at

46. The district court noted that the ESA requires that wildlife

agencies use the best available data, 16 U.S.C. § 1536(a)(2),

and that the FWS had “reams of data from previous Section 7

consultations” in Florida. CBD v. Regan, 734 F. Supp. 3d at

46.

Additionally, the district court held that the EPA

impermissibly relied on the FWS’s actions to approve Florida’s

program, given that the FWS “entirely fail[ed] to address

essential questions.” CBD v. Regan, 734 F. Supp. 3d at 57.

The EPA also unlawfully concluded that it did not need to

formally consult with the NMFS under Section 7 regarding its

proposed approval of Florida’s permitting program.

Thus, the district court vacated the EPA’s approval of

Florida’s permitting program and the FWS’s BiOp and ITS.

The court held that vacatur was warranted because the

agencies’ ESA violations were serious and incapable of being

cured by additional explanation on remand. And although the

defendants complained that vacatur would result in a

“prolonged delay” in issuing Section 404 permits, the court

held that setting aside unlawful agency action almost always

results in some disruption and the type of disruption that the

defendants invoked was inherent in the Section 404 approval

process. CBD v. Regan, 734 F. Supp. 3d at 63.

25

The Federal Appellants and Florida appeal. We have

jurisdiction under 28 U.S.C. § 1291.

II.

Before turning to the merits, we consider two arguments

challenging justiciability: (1) Florida argues that Appellees

lack standing to challenge the FWS’s and the EPA’s actions in

approving its permitting program; and (2) the Federal

Appellants argue that Appellees’ challenge to the Incidental

Take Statement is not ripe. We disagree.

A. Standing

We begin with standing. The “irreducible constitutional

minimum of standing” requires that plaintiffs demonstrate, for

each claim, that they have (1) “suffered an injury in fact,”

(2) that is “fairly . . . trace[able] to the challenged action of the

defendant,” and (3) that it is “likely . . . that the injury will be

redressed by a favorable decision.” Lujan v. Defs. of Wildlife,

504 U.S. 555, 560–61 (1992) (cleaned up). An organization

may assert “associational standing” to sue on behalf of its

members. Hunt v. Wash. State Apple Advert. Comm’n, 432

U.S. 333, 343 (1977). Associational standing requires that:

(1) at least one member of the association

has standing to sue in her own right

(based on a showing of harm, causation,

and redressability), (2) the interests the

association seeks to protect by suing on its

members’ behalf are germane to its

purpose, and (3) neither the asserted claim

nor the relief requested requires

individual members to participate in the

litigation.

26

Ctr. for Biological Diversity v. EPA (CBD 2022), 56 F.4th 55,

66 (D.C. Cir. 2022) (citing Hunt, 432 U.S. at 343).

Florida contests only the first element of associational

standing: It contends that Appellees have not suffered an injury

in fact. 5 But Appellees establish that they have standing to sue

because the FWS and the EPA caused classic procedural

injuries to their members by failing to take steps required by

regulations. Appellees also demonstrate that those procedural

injuries caused their members substantive injuries, which can

be redressed by requiring the agencies to follow the steps that

they omitted.

An agency’s failure to meet its statutory consultation

requirement is the “archetypal procedural injury.” Ctr. for

Biological Diversity v. EPA (CBD 2017), 861 F.3d 174, 182

(D.C. Cir. 2017); see also CBD 2022, 56 F.4th at 67 (“A claim

of failure to fulfill the statutory consultation obligation under

the ESA is at least in significant part a claim of procedural

injury.” (citing Nat’l Ass’n of Home Builders, 551 U.S. at

667)). Here, Appellees allege that the FWS failed to comply

with procedural steps required in a Section 7 consultation and

that the EPA failed to consult with the NMFS.

When plaintiffs allege procedural injuries to support

standing, we also require an adequate “connection between the

alleged procedural injury and a substantive injury that would

otherwise confer Article III standing.” Nat’l Ass’n of Home

Builders v. EPA, 667 F.3d 6, 15 (D.C. Cir. 2011) (cleaned up).

5

We are satisfied that Appellees also meet the second and third

requirements of associational standing. Their missions “include the

protection of . . . diverse species and habitats, including listed species

in Florida,” and neither the claims asserted nor the relief sought

requires the participation of individual members. CBD 2022, 56

F.4th at 66.

27

To establish that connection, a plaintiff must show “[1] a causal

connection between the government action that supposedly

required the disregarded procedure and [2] some reasonably

increased risk of injury to its particularized interest.” Fla.

Audubon Soc. v. Bentsen, 94 F.3d 658, 664 (D.C. Cir. 1996).

And the plaintiff also must demonstrate that “a revisitation of

the [procedural requirement] would redress [the alleged] injury

because the [agency] could reach a different conclusion.” CBD

2017, 861 F.3d at 185 (emphasis added).

Appellees have satisfied all those requirements. They

demonstrate that their members had an aesthetic and

recreational interest in minimizing the loss of protected

species, including the Florida panther and nesting sea turtles.

And they connect the agencies’ alleged procedural failures to a

substantive injury to their interest: The FWS’s “bypassing of

its ESA obligations” and the EPA’s failure to consult with the

NMFS allegedly caused the EPA’s approval of Florida’s

permitting program, which authorized incidental takings of

listed species “without due attention to the risks posed to those

species.” J.A. 1328. The FWS conceded that the EPA’s

approval of Florida’s program was “‘reasonably certain’ to

result in some take of all 139 listed species in the State.” J.A.

2670 (quoting 16 U.S.C. § 1536(b)(4)). Moreover, were it not

for the alleged procedural violations, the FWS may not have

made its no-jeopardy determination and issued the

accompanying ITS, and the EPA may not have approved

Florida’s permitting program.

Florida’s arguments to the contrary are not persuasive.

First, Florida claims that Appellees cannot establish causation

because the EPA and the FWS will prevent any potential harm

through federal oversight. But in evaluating standing, we

“assume on the merits the [Appellees] would be successful in

their claims.” City of Waukesha v. EPA, 320 F.3d 228, 235

28

(D.C. Cir. 2003). We therefore must accept Appellees’

allegation that federal oversight will be insufficient because the

approved technical assistance process is less protective than the

procedures required by the ESA.

Florida also errs in suggesting that Appellees must wait

until Florida issues permits to projects and those projects

actually harm protected species before bringing their

complaint. We require plaintiffs to demonstrate only a

“substantial probability” that the government’s procedural

failures will cause injury to their concrete interest. CBD 2017,

861 F.3d at 184. Here, the alleged procedural failures create a

“substantial probability” of harm to endangered species and

habitats because they resulted in the approval of a permitting

program that relaxes the ESA’s statutory protections.

B. Ripeness

The Federal Appellants argue Appellees’ challenge to the

Incidental Take Statement is not ripe. They contend that

Appellees may challenge the ITS only after the FWS

unlawfully fails to reinitiate consultation as required by the

ITS, with respect to individual Florida permits. We disagree.

“The ripeness inquiry encompasses both the fitness of the

issues for judicial decision and the hardship to the parties of

withholding court consideration.” Bellion Spirits, LLC v.

United States, 7 F.4th 1201, 1209 (D.C. Cir. 2021). Whether a

challenge to agency action is “fit for judicial decision” depends

both upon whether it “involve[s] final agency action” and

whether “judicial intervention would . . . inappropriately

interfere with further administrative action.” Id. (cleaned up)

Here, the issuances of the BiOp and ITS, which together

constitute the Programmatic BiOp, are final agency actions.

Those issuances marked the completion of the Section 7

consultation, which led to the approval of Florida’s Section 404

29

application. No further agency action must occur to allow

Florida’s Section 404 permittees to avoid liability under the

ESA for incidental takings. Thus, the ITS “constitute[d] a

definitive statement of [the] agency’s position, has direct and

immediate effect on the complaining parties, and has the status

of law.” Clean Air Council v. Pruitt, 862 F.3d 1, 6 (D.C. Cir.

2017). And judicial review would not “inappropriately

interfere with future administrative action.” Bellion Spirits, 7

F.4th at 1209. The parties give us no reason to believe that we

are “prematurely meddling with an agency policy decision that

is currently undergoing change.” Great Lakes Gas

Transmission Ltd. P’ship v. FERC, 984 F.2d 426, 432 (D.C.

Cir. 1993). Further, withholding our consideration would

injure Appellees and their interests. The ITS creates legal

rights that make it easier for permittees to take protected

species that Appellees are interested in preserving.

III.

A. Standard of Review

The APA “sets forth the procedures by which federal

agencies are accountable to the public and their actions subject

to review by the courts.” Franklin v. Massachusetts, 505 U.S.

788, 796 (1992). We review a “Service’s ESA findings under

the APA” because the ESA does not specify a standard of

review. See Union Neighbors United, Inc. v. Jewell, 831 F.3d

564, 574 (D.C. Cir. 2016); see also Gerber v. Norton, 294 F.3d

173, 178 & n.4 (D.C. Cir. 2002).

Under the APA, a reviewing court must set aside agency

action that is “arbitrary, capricious, an abuse of discretion, or

otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A).

And a reviewing court must set aside agency action undertaken

“without observance of procedure required by law.” Id.

§ 706(2)(D). The question of whether agency action is

30

arbitrary and capricious is a legal one generally made on the

administrative record and resolved on summary judgment. See,

e.g., Nat’l Ass’n of Home Builders v. U.S. Army Corps of

Eng’rs, 417 F.3d 1272, 1277, 1282 (D.C. Cir. 2005). This

court reviews such a determination de novo. Child.’s Hosp.

Ass’n of Tex. v. Azar, 933 F.3d 764, 769 (D.C. Cir. 2019).

It is well settled that an agency must “adhere to its own

regulations,” Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d

533, 536 (D.C. Cir. 1986), and “an agency action may be set

aside as arbitrary and capricious if the agency fails to comply

with its own regulations,” Nat’l Env’t Dev. Ass’n’s Clean Air

Project v. EPA, 752 F.3d 999, 1009 (D.C. Cir. 2014) (cleaned

up). Moreover, an agency action that “violates [a statute] is

‘not in accordance with law’ within the meaning of [the APA].”

Chrysler Corp. v. Brown, 441 U.S. 281, 318 (1979).

B. Analysis

In this case, the state of Florida, the EPA, and the FWS

collaborated to develop and implement an innovative approach

to complying with certain mandatory requirements of the ESA

that are designed to protect endangered and threatened species.

With the explicit goal of “streamlining” the ESA’s procedures

and making them less “burdensome,” Florida proposed a state-

run permitting program under Section 404 of the CWA, under

which permit recipients could discharge pollutants into Florida

waters while also avoiding liability for incidental takings of

protected species under the ESA. Florida proposed that the

requirements of the ESA be deferred to a “technical assistance

process” that would be administered by Florida, with optional

input from the FWS. The key to Florida’s proposal was

securing ESA approval of the overall Section 404 permitting

program up front — through a “programmatic consultation”

under Section 7 of the ESA — which would obviate the need

31

for individual permittees to seek further approval under the

ESA for incidental takings associated with the activity

approved by their Section 404 permits.

The question before the court is whether the EPA and the

FWS’s Section 7 approval of Florida’s permitting

program — including the agencies’ reliance on the technical

assistance process and a programmatic ITS — comported with

the requirements of the ESA.

In Judge Pan’s view, the FWS’s BiOp, including its no-

jeopardy determination, was erroneous and must be set aside,

and the EPA violated the ESA by relying on the deficient BiOp

to approve Florida’s permitting program. See infra Part III.B.1.

Judge Wilkins agrees that the BiOp must be set aside, though

he reaches that conclusion for a different reason, and he agrees

that the EPA violated the ESA by relying on the deficient BiOp.

See Opinion of Wilkins, J. Judge Henderson dissents from

those conclusions. See Opinion of Henderson, J., concurring

in part and dissenting in part. The court unanimously holds that

the FWS violated Section 7 regulations when it issued a

programmatic ITS that weakened the protections of Section 7

while conferring protection from take liability on Florida and

its Section 404 permit recipients, see infra Part III.B.2; and a

divided court holds that the EPA violated the ESA by relying

on that ITS to approve Florida’s permitting program, see id.;

Opinion of Henderson, J. The court unanimously holds that the

EPA erred in failing to consult with the NMFS under Section

7. See infra Part III.B.3. The court further holds that the

agency’s errors require vacatur of the EPA’s approval of

Florida’s Section 404 application. See infra Part IV; Opinion

of Wilkins, J.

32

1. Biological Opinion

As previously explained, in a Section 7 consultation, the

Services are required to take several actions before making a

no-jeopardy determination. See 50 C.F.R. § 402.14(g). Among

those requirements, the Services “shall include” a “detailed

discussion of the effects of the action on listed species or

critical habitat” in the BiOp, id. § 402.14(h), and must “[a]dd

the effects of the action and cumulative effects to the

environmental baseline” to determine “whether the action is

likely to jeopardize the continued existence of listed species,”

id. § 402.14(g). Furthermore, the Services must “use the best

scientific and commercial data available” in making those

assessments. 16 U.S.C. § 1536(a)(2); see also 50 C.F.R.

§ 402.14(g)(8). Those actions did not happen here.

It is undisputed that the FWS did not evaluate how the

approval of Florida’s permitting program would affect listed

species or critical habitat. Instead, the FWS stated in the BiOp

that it was “not feasible, nor [was] it required, to conduct a

meaningful site-specific and species-specific effects analysis in

this BiOp,” because the consultation was “on a programmatic

action.” J.A. 2655. The BiOp reasoned that Florida’s program

was “sufficiently structured” to avoid jeopardy to ESA-listed

species, id., and opined that the “technical assistance process”

that was “built in[to]” the program would be “as protective” as

the requirements of Section 7 of the ESA, J.A. 2657; see also

J.A. 2656 (“[S]ite-specific and species-specific information

will be . . . assessed through the technical assistance process.”).

Based on those findings, the FWS concluded that Florida’s

permitting program was not “likely to jeopardize the continued

existence of [protected] species” or “destroy or adversely

modify designated critical habitat.” J.A. 2669.

33

But the FWS’s reasoning was demonstrably incorrect. The

technical assistance program was not “as protective” as the

Section 7 consultation process. In fact, the technical assistance

process was specifically designed to be “streamlined” and less

“burdensome,” and therefore omitted the precise analytical

steps that must be taken before a Service may issue a no-

jeopardy determination under Section 7. Those steps include

evaluating the program’s effects and then adding the effects to

the environmental baseline to assess whether any listed species

or critical habitat will be jeopardized. 50 C.F.R. § 402.14(g).

By contrast, the technical assistance process requires only that

Florida share permit applications with the FWS, which has the

option of weighing in to overturn Florida’s effects

determinations. The FWS also may, but is not required to,

“provide [Florida] with technical information . . . and

recommended measures that would avoid or minimize effects.”

J.A. 2621. And Florida and the FWS need not “use the best

scientific and commercial data available” in evaluating each

Section 404 permit, as the FWS would be required to do in

carrying out a proper Section 7 consultation. 16 U.S.C.

§ 1536(a)(2); see also 50 C.F.R. § 402.14(g)(8). The technical

assistance program is therefore far less demanding than what is

required under Section 7. 6

6

Appellees also contend that the FWS did not, as required,

analyze the environmental baseline of species because it did not

evaluate the conditions of individual protected species that live in

Florida at a sufficiently specific level of detail. See 50 C.F.R.

§ 402.14(g), (h)(ii) (requiring the BiOp to include a “detailed

discussion of the environmental baseline and critical habitat”). The

district court agreed, concluding that the FWS failed to undertake

“any species-specific analysis” in assessing the environmental

baseline. CBD v. Regan, 734 F. Supp. 3d at 42 (emphasis in

original). That may not be entirely accurate — in assessing the

34

To be clear, the Services may engage in “programmatic”

consultations. See, e.g., 50 C.F.R. § 402.14(i)(7). But

undertaking a programmatic consultation does not excuse the

Services from performing an effects analysis that is consistent

with Section 7’s requirements. See id. § 402.14(g); see also N.

Slope Borough v. Andrus, 642 F.2d 589, 608–09 (D.C. Cir.

1980) (holding that analysis under the Outer Continental Shelf

Lands Act could replace a “[m]andatory stage-by-stage

review” process under the ESA because that substitution

“ma[de] ESA requirements more likely to be satisfied both in

an ultimate and a proximate sense”). Indeed, ESA regulations

that govern “programmatic” consultations make clear that such

consultations may delay but may not avoid the requirements of

Section 7 regulations. See, e.g., 50 C.F.R. § 402.14(g) (creating

no exception to Service responsibilities for programmatic

consultations), (i)(7) (contemplating that “incidental take

statement[s]” for framework programmatic actions are not

required at the programmatic level because incidental takings

“will be addressed in subsequent section 7 consultation, as

appropriate” and requiring ITSs only for “those program

actions that are . . . not subject to further section 7

consultation”).

Appellants’ reliance on the Second Circuit’s decision in

Cooling Water Intake Structure Coalition, 905 F.3d at 49, to

reach a contrary conclusion is unpersuasive. Florida modeled

its permitting program on the one approved in Cooling Water,

environmental baseline, the FWS apparently adopted analysis from

the EPA that performed a species-level baseline analysis. But

because we conclude that the BiOp’s no-jeopardy conclusion fails to

perform the necessary effects analysis, we need not address the

environmental baseline evaluation. See Capitol Servs. Mgmt., Inc. v.

Vesta Corp., 933 F.3d 784, 793 (D.C. Cir. 2019) (“This court can

affirm a district court’s judgment on any basis supported by the

record.”).

35

and Appellants concede that Cooling Water “stands alone as the

only case concerning, much less approving, a programmatic

biological opinion and incidental take statement of this sort.”

CBD v. Regan, 734 F. Supp. 3d at 47. But Cooling Water does

not bind us, see Brink v. Continental Ins. Co., 787 F.3d 1120,

1125–26 (D.C. Cir. 2015) (“We [are] not . . . bound to follow

the decisions of other circuits.”); and its reasoning is at odds

with applicable regulations and our own precedents, see 50

C.F.R. § 402.14(g), (i)(7); N. Slope, 642 F.2d at 609. 7 A

technical assistance process that sets standards less protective

than those prescribed by the ESA cannot displace the ESA

itself.

Neither the ESA nor its implementing regulations permit

the FWS to dilute the requirements of Section 7, yet that is

precisely what the FWS sought to do. The BiOp’s no-jeopardy

determination was thus unlawful: It was arbitrary and

capricious because it violated applicable regulations, see Nat’l

Env’t Dev. Ass’n’s Clean Air Project, 752 F.3d at 1009, and it

was developed “without observance of procedure required by

law,” 5 U.S.C. § 706(2)(A), (D). The EPA’s reliance on the

7

The term “programmatic consultation” is undergirded by the

definition of “[f]ramework programmatic action,” which means “a

framework for the development of future action(s) that are . . . carried

out at a later time,” where “any take of a listed species [will] not

occur unless and until those future action(s) are . . . carried out and

subject to further section 7 consultation.” 50 C.F.R. § 402.02

(emphasis added); see also id. (“Mixed programmatic action means,

for purposes of an incidental take statement, a Federal action that

approves action(s) that [1] will not be subject to further section 7

consultation, and also approves [2] a framework for the development

of future action(s) [for which . . .] any take of a listed species [will

be . . . ] subject to further section 7 consultation.” (emphasis added)).

36

unlawful BiOp to approve Florida’s permitting application was

unlawful for the same consequential reasons. Id.

Our dissenting colleague would deem the BiOp consistent

with statutory and regulatory requirements. In her view, “the

parties’ dispute boils down to a simple question: can the FWS

rely on structural safeguards in Florida’s program to reach a no-

jeopardy determination without conducting an analysis of

potential harm to each individual species and habitat?”

Opinion of Henderson, J., at 14. In her view, the FWS “plainly

can.” Id. at 14. And here, she says, the technical assistance

process is sufficient because it “guarantees eventual site- and

species-specific assessments.” Id. at 16; see also id. at 32. But

even if structural safeguards in the form of deferred site- and

species-specific assessments might be sufficient in some

circumstances, that is not the case here. What the dissent fails

to acknowledge is that the deferred assessments contemplated

by the technical assistance process plainly will not meet

Section 7’s exacting requirements — indeed, the technical

assistance process was specifically designed to be

“streamlined” and less “burdensome” than Section 7. At

bottom, such a watered-down procedure does not comport with

agency regulations on programmatic approvals, which

expressly subject deferred actions to “further section 7

consultation.” 50 C.F.R. § 402.02.

2. Incidental Take Statement

Section 7 of the ESA and its implementing regulations

envision a multistep, iterative process for monitoring and

protecting against excessive incidental takings. When

evaluating a contemplated agency action, the Services are

directed to estimate the incidental-take amount that is deemed

acceptable and to include measures in the ITS to minimize the

effect of incidental take. See 50 C.F.R. § 402.14(i)(1)(i) (The

37

ITS must “[s]pecif[y] the impact of incidental taking as the

amount or extent of such taking.”); id. § 402.14(i)(1)(ii) (The

ITS must “[s]pecif[y] those reasonable and prudent measures

that the [FWS] considers necessary or appropriate to minimize

such impact of incidental taking on the species.”). The

Services normally monitor the levels of incidental take by

requiring the consulting agency to “report the progress of the

action and its impact on the species.” Id. § 402.14(i)(4). And

if the actual incidental takings exceed the estimated incidental-

take amount, the agency must reinitiate consultation with the

Services “immediately.” See id. §§ 402.14(i)(5), 402.16. Thus,

the initial estimate of “the amount or extent” of incidental take

is an important feature of any ITS because that take amount

triggers immediate reinitiation of consultation between the

Services and the action agency under Section 7. See Am. Rivers

v. FERC, 895 F.3d 32, 48–49 (D.C. Cir. 2018) (stressing the

need for a trigger to reinitiate formal consultation). The

Services also must engage in reinitiated agency consultations

when “a new species is listed or critical habitat designated that

may be affected by the action.” 50 C.F.R. § 402.16.

Here, the ITS violates several applicable regulations.

First, the ITS does not quantify “the amount or extent” of

incidental take of ESA-listed species, due to an asserted

“inability to anticipate the locations of future State 404 permit

applications,” which “did not allow the [FWS] to conduct site-

and species-specified analyses to estimate the number of

individuals that might be affected by the permitted activities.”

J.A. 2670. Instead, the ITS provides that “the amount and

extent of incidental take anticipated from the[] proposed

activities will be quantified and evaluated on a project-specific

basis through the technical assistance process conducted

between the [FWS] and [Florida].” Id.

38

Second, the ITS fails to identify specific “reasonable and

prudent measures” to minimize the impact of incidental take.

50 C.F.R. § 402.14(i)(1)(ii). Rather, it (1) generally instructs

the EPA, Florida, and other agencies to minimize impacts on

protected species, and (2) “assume[s] that through technical

assistance with the State, appropriate measures to minimize

incidental take and detrimental effects associated with

activities regulated by the State 404 program will be developed

by the [FWS], and that these measures will ensure that each

permit will minimize adverse effects and thereby avoid

jeopardy to ESA-listed species and avoid destruction or

adverse modification of critical habitat.” J.A. 2671 (emphasis

added).

Third, the ITS relieves the FWS of any mandatory duty to

participate in reinitiated Section 7 consultations. Applicable

regulations require the reinitiation of agency consultation if

expected take levels are exceeded, 50 C.F.R. § 402.14(i)(5), or

if a new species or habitat is deemed protected, id. § 402.16.

But the ITS addresses excessive-take levels through the

technical assistance process, which falls short of a renewed

Section 7 consultation. See J.A. 2671 (If incidental take occurs

after “implementation of recommended minimization

measures,” the FWS will “quantify” the amount or extent of the

take, and then “review reports and track the levels of the

estimated take through the technical assistance process.”).

Moreover, the ITS explicitly states that “the listing of a new

species or critical habitat shall not trigger reinitiation of

consultation on this action (approval of Florida’s assumption

of the CWA 404 program).” J.A. 2674 (emphasis added).

Indeed, the FWS contends it would have “no obligation” to

conduct further Section 7 consultations “because [Florida’s]

issuance of . . . a permit is not a Federal Action.” Id.

39

The FWS defends its failure to set an estimated incidental-

take amount, in violation of the applicable regulation, by

arguing only that it was unable to make that determination

because it did not know the geographic locations that would be

affected by Florida’s permits. But that assertion of

impossibility is dubious. The FWS surely could have

attempted to make the required estimate: The ESA mandates

only that the FWS use the “best available information.” 16

U.S.C. § 1536(a)(2); see also 50 C.F.R. § 402.14(g)(8). As the

district court pointed out, the FWS had “reams” of information

about protected Florida species at its disposal, gleaned from

numerous BiOps that it had previously prepared. CBD v.

Regan, 734 F. Supp. 3d at 54. Indeed, as the district court

suggested, “[i]f there are about 150 panthers left in Florida . . .

it is not difficult to imagine a cumulative take limit per year for

the entire State (or for particular regions of the State).” Id. at

52. Moreover, if the FWS faced difficulty estimating an

incidental-take amount when preparing the ITS, the FWS could

have deferred the required analysis to a subsequent Section 7

consultation. See 50 C.F.R. § 402.14(i)(7) (noting that an

“incidental take statement” may not be required at the

programmatic level when “any incidental take . . . will be

addressed in subsequent section 7 consultation”).

The FWS’s rationale for skirting mandatory reinitiation of

Section 7 consultations when expected take levels are

exceeded, 50 C.F.R. § 402.14(i)(5), and upon the listing of a

new species or the designation of a new critical habitat, id.

§ 402.16(a)(4), is equally unavailing. The FWS contends that

it has no obligation to engage in further Section 7

consultations — such as when expected take levels are

exceeded — because Florida’s subsequent permitting decisions

are not federal actions. That argument, though, does not justify

end-running Section 7 and instead suggests that programs like

this one are a poor fit for Section 7 consultation. See supra n.2.

40

Under the FWS’s reasoning, Florida would obtain the benefits

of a Section 7 consultation (i.e., a programmatic ITS that

provides permittees with incidental-take liability protection),

without the attendant costs (i.e., continued monitoring, with the

possibility of reinitiated Section 7 consultations, to protect

listed species or critical habitats).

Because the ITS openly violates applicable regulations

regarding take amounts and the reinitiation of consultation, it

is arbitrary and capricious. See Nat’l Env’t Dev. Ass’n’s Clean

Air Project, 752 F.3d at 1009. It also violates the APA because

the FWS developed the ITS “without observance of procedure

required by law.” 5 U.S.C. § 706(2)(D). And the EPA violated

the ESA and APA by relying on the deficient ITS to approve

Florida’s permitting-program application. Id.

3. Consultation with the NMFS

The EPA also erred by failing to formally consult with the

NMFS under Section 7. The EPA decided that it need not

consult with the NMFS because it believed Florida’s permitting

application would not affect protected species under the

NMFS’s jurisdiction. That decision was erroneous because the

EPA neglected to assess the downstream or indirect effects of

the permitting program in all areas to be affected directly or

indirectly by the program. See 50 C.F.R. § 402.02 (defining

“action area” and “effects of the action”).

As previously discussed, whenever an agency’s

discretionary action “may affect” a listed species in a

contemplated “action area,” the agency must consult with the

NMFS, the FWS, or both, if the affected species are within the

relevant Service’s jurisdiction. See 16 U.S.C. § 1536. The

agency must first coordinate with the Services to determine

whether the proposed agency action would have any impacts

on listed species, such that formal consultation under Section 7

41

is required. 50 C.F.R. § 402.14(b)(1). The agency may forgo

formal consultation with a Service if it determines, “with the

written concurrence of the [relevant Service], that the action is

not likely to adversely affect listed species or critical habitat”

under the Service’s jurisdiction. Id.; see also id. § 402.13(c).

The “action area” is defined as “all areas to be affected directly

or indirectly by Federal action and not merely the immediate

area involved in the action.” Id. § 402.02. Moreover, the

“effects of an action” are not temporally or geographically

limited, and “may occur later in time and may include

consequences occurring outside the immediate area involved in

the action.” Id.

Here, the NMFS provided an advisory letter to the EPA,

which stated that “[protected] species under NMFS’[s]

jurisdiction do not occur in waters that are assumable by

[Florida].” J.A. 2196. Based on the advisory letter, the EPA

informed the NMFS that it would “conclude consultation [with

the NMFS] on this action.” J.A. 2174. But importantly, neither

the NMFS nor the EPA recognized that the advisory letter was

insufficient in its scope: It focused on the “immediate area

involved in the action” instead of “all areas to be affected

directly or indirectly.” 50 C.F.R. § 402.02 (definition of

“action area”). In fact, the required effects analysis had to

encompass “all consequences to listed species or critical habitat

that are caused by the proposed action, including . . . effects

[that] may occur later in time and may include consequences

occurring outside the immediate area involved in the action.”

Id. (definition of effects of the action).

The EPA’s failure to consult with the NMFS was likely

significant. The record suggests that Florida’s program might

indirectly affect listed species under the NMFS’s jurisdiction.

For example, the BiOp notes that “freshwater eventually makes

its way to the nearly 2,000 miles of Florida coastline and

42

marine ecosystem,” suggesting that discharge into Florida’s

freshwaters might eventually affect marine species like the

Gulf sturgeon, Atlantic sturgeon, and shortnose sturgeon, all of

which are under the NMFS’s jurisdiction. J.A. 2643.

Consequently, the EPA’s determination that it need not

consult with the NMFS was arbitrary, capricious, and contrary

to law.

IV.

When an agency’s action is unlawful, “vacatur is the

normal remedy.” Allina Health Servs. v. Sebelius, 746 F.3d

1102, 1110 (D.C. Cir. 2014). That is because Congress has

directed us to “hold unlawful and set aside agency action” that

is “not in accordance with law[.]” 5 U.S.C. § 706(2)(A). Our

precedents “permit a court to remand without vacating the

agency’s action in limited circumstances,” but doing so is an

“exceptional remedy.” Am. Great Lakes Ports Ass’n v. Schultz,

962 F.3d 510, 518–19 (D.C. Cir. 2020) (citing Allina Health

Servs., 746 F.3d at 1110). To determine whether remand

without vacatur is warranted, we consider the factors set forth

in Allied-Signal, Inc. v. U.S. Nuclear Regulatory Commission,

namely: (1) the “the seriousness of the order’s deficiencies (and

thus the extent of doubt whether the agency chose correctly),”

and (2) the “disruptive consequences of an interim change that

may itself be changed.” 988 F.2d 146, 150–51 (D.C. Cir. 1993)

(cleaned up). The second factor “is weighty only insofar as the

agency may be able to rehabilitate its rationale.” Env’t Def.

Fund v. FERC, 2 F.4th 953, 976 (D.C. Cir. 2021) (citation

omitted).

As explained above, we hold that four agency actions

violate the ESA and the APA — i.e., the BiOp, the ITS, the

EPA’s failure to consult with the NMFS, and the EPA’s

approval of Florida’s permitting program. Each of those

43

unlawful agency actions requires the normal remedy of

vacatur.

First, the deficiencies of each action are serious and the

EPA cannot sufficiently explain its actions on remand. See

Standing Rock Sioux Tribe v. U.S. Army Corps of Eng’rs, 985

F.3d 1032, 1052 (D.C. Cir. 2021) (The inquiry is “whether the

agency could, with further explanation, justify” its procedural

failures.). The FWS based its BiOp’s no-jeopardy

determination on a flawed effects analysis and inaccurate

assumptions about the efficacy of the technical assistance

process. Moreover, the flawed ITS would allow Florida’s

Section 404 permittees to claim exemptions from take liability,

without requiring those permittees to meet applicable

requirements under either Section 7 or Section 10 of the ESA.

In addition, the EPA erroneously determined that consultation

with the NMFS was not required under Section 7. All of those

errors fatally undermine the EPA’s approval of the permitting

program, and that decision cannot be salvaged with additional

explanation. See N.J. Conservation Found. v. FERC, 111 F.4th

42, 64 (D.C. Cir. 2024) (vacatur appropriate where deficiencies

went to the core of an agency’s findings and were unlikely to

be cured with more explanation); Standing Rock, 985 F.3d at

1052 (vacatur appropriate where procedural violations “lead us

to doubt that the ultimate action will be approved”); Env’t Def.

Fund v. FERC, 2 F.4th 953, 976 (D.C. Cir. 2021) (vacatur

appropriate where agency action was informed by deficient

proceedings).

Second, vacatur would not likely cause undue “disruptive

consequences” from “an interim change that may itself be

changed.” Allied-Signal, 988 F.2d at 150–51. It is not at all

clear that Appellants will be able to reinstate the contemplated

permitting program consistent with the requirements of the

ESA. Moreover, it is not unduly disruptive for Section 404

44

permitting authority to revert to the Corps, which was

responsible for issuing such permits before Florida

implemented the program under review. And finally, our

vacatur of each agency action is prospective and should not call

into question previously issued Section 404 permits.

Our dissenting colleague would not vacate the EPA’s

approval of Florida’s permitting program because, in her view,

the BiOp permissibly defers FWS site- and species-specific

assessments and the ITS “had no bearing on the EPA’s transfer

decision.” See Opinion of Henderson, J., at 39. But even

assuming that she is correct about the BiOp, the concededly

deficient ITS independently requires vacatur because it was an

important aspect of the EPA’s approval process. See J.A. 2670;

see also 50 C.F.R. § 402.14(g), (i)(1) (ITS must be formulated

during the formal consultation process and “with the biological

opinion”). Without a valid procedure for dealing with

incidental takings, the EPA could not have approved Florida’s

permitting program consistent with the ESA and its

regulations. See, e.g., 16 U.S.C. § 1536(b)(4); 50 C.F.R.

§ 402.14. Moreover, the dissent’s remedy analysis overlooks

the EPA’s concededly erroneous failure to consult with the

NMFS. Because the mandated consultation did not occur,

there is no way to discern whether the NMFS would have

issued a BiOp with a “no jeopardy” determination that would

have allowed the EPA to approve Florida’s novel permitting

program. Those serious deficiencies cannot be addressed with

further explanation on remand, and it is unclear whether the

program’s approval can be rehabilitated. Thus, the normal

remedy of vacatur is warranted.

* * *

45

For the foregoing reasons, we affirm the judgment of the

district court. 8

So ordered.

8

Appellees conditionally cross-appealed the district court’s

dismissal of their CWA claims. Because the cross-appeal is

conditional and we need only reach it if we reverse the district court’s

judgment, we dismiss the cross-appeal as moot. See Sea-Land Serv.,

Inc. v. Dep’t of Transp., 137 F.3d 640, 649 (D.C. Cir. 1998).

WILKINS, Circuit Judge, concurring in part and concurring in

the judgment:

I concur in the judgment affirming the District Court. I

join Sections II, III.B.2, and III.B.3, and concur in the judgment

as to Sections III.B.1 and IV of the Majority Opinion.

Specifically, I agree that the Court should affirm the District

Court’s grant of summary judgment to Environmental

Appellees as to Counts 4 and 10–11 of the Complaint.

Counts 4 and 10 of the Amended Complaint alleged that

the Biological Opinion (“BiOp”) as a whole, including the

Incidental Take Statement (“ITS”), violated the Endangered

Species Act (“ESA”) and the Administrative Procedure Act

(“APA”) because, among other things, the ITS did not specify

the amount and extent of incidental take of listed species “and

fail[ed] to specify a take-based trigger for reinitiating

consultation[.]” J.A. 39, 155, 168. For the reasons stated in

Sections III.B.2 and III.B.3 of the Majority Opinion, and as

further explained below, the plaintiffs were entitled to

summary judgment on those counts.

Count 11 alleged that the Environmental Protection

Agency (“EPA”) arbitrarily and capriciously failed to consult

with the National Marine and Fisheries Service (“NMFS”)

because EPA failed to consider that Florida’s Section 404

program would have an indirect effect on species within

NMFS’s jurisdiction. J.A. 170–71. Since EPA has now

conceded that the District Court properly granted summary

judgment in favor of Environmental Appellees as to Count 11

because Florida’s 404 program may affect three ESA-listed

species in NMFS’s jurisdiction: the (1) Atlantic sturgeon, (2)

Shortnose sturgeon; and (3) Smalltooth sawfish, I would affirm

the District Court as to Count 11. See EPA Opening Br. 50.

I also agree that the Court should affirm the vacatur of the

Incidental Take Statement as deficient, which results in vacatur

2

of the Biological Opinion because its no jeopardy finding is

dependent upon the deficient ITS. I also agree that the Court

should affirm the vacatur of the EPA’s approval of Florida’s

Section 404 program, see 33 U.S.C. §§1344(g)–(h), because

such approval was dependent upon the now-vacated Biological

Opinion. To avoid undue disruption, I would not disturb any

of the permits that have already been granted under the

program.

I.

I write separately because my view of the statutory scheme

differs a bit from my colleagues.

A.

I begin with the framework that applies to our analysis of

the ESA challenge to this programmatic action, which is guided

by National Association of Home Builders. See Nat’l Ass'n of

Home Builders v. Defs. of Wildlife, 551 U.S. 644 (2007).

In National Association of Home Builders, the Court held

that the Clean Water Act (“CWA”) and the ESA must be

construed in manner that gives effect to both statutes’ specific

mandates if possible. 551 U.S. at 662–63. As the Court

explained, Section 7(a)(2) of the ESA can co-exist with Section

402 of the CWA and “[t]he transfer of permitting authority to

state authorities—who will exercise that authority under

continuing federal oversight to ensure compliance with

relevant mandates of the [ESA] and other federal

environmental protection statutes—was proper.” Id. at 649–

50, 673. Because implied repeals are disfavored, National

Association of Home Builders teaches that we have an

obligation to interpret Section 404 of CWA in the same

manner, so that we give effect to all provisions of the ESA and

3

Section 404, if at all possible. This perspective was explicitly

stated by Congress in the ESA. See 16 USC § 1531(c)(2) (“It

is further declared to be the policy of Congress that Federal

agencies shall cooperate with State and local agencies to

resolve water resource issues in concert with conservation of

endangered species.”). Thus, we have a duty to construe the

ESA harmoniously with Section 404 wherever we can do so

without nullifying any provision of the ESA.1

B.

Here, the way Florida and the federal agencies attempted

to implement Section 404 nullified two very clear and specific

requirements of the ESA.

First, the ESA requires that a BiOp includes an ITS when

the U.S. Fish and Wildlife Service (“FWS” or “Service”)

concludes that the action will result in take of such a protected

species. The ITS must “specif[y] the impact of such incidental

taking on the species,” 16 U.S.C. § 1536(b)(4)(i), and “the

amount or extent” of such taking. 50 C.F.R. § 402.14(i)(1)(i).

Second, ESA regulations mandate that the parties must monitor

the impact of the action on protected species, and if the amount

of take exceeds the limit set forth in the ITS, “the Federal

agency must reinitiate consultation immediately.” See 50

C.F.R. §§ 402.14(i)(4)–(5). The Florida/EPA Agreement does

not comply with either of these ESA requirements.

1

I do not think that the framing of the issues in Judge Pan’s opening

hypothetical is quite apt. See Majority Op. at 3. Because Florida

will not be the party applying for permits, it is not fair to equate the

sovereign’s role in a Section 404 program with that of a regulated

party, such as a truck owner seeking to pass inspection from the

Department of Motor Vehicles.

4

The ITS in the present case did not include any take limits

at all. Instead, the ITS stated “the amount and extent of

incidental take anticipated from these proposed activities will

be quantified and evaluated on a project-specific basis through

the technical assistance process conducted between the

USFWS and the State.” J.A. 2670. The ITS justified the

absence of any take limits because the “inability to anticipate

the locations of future state 404 permit applications did not

allow the Service to conduct site- and species-specific analyses

to estimate the number of individuals that might be affected by

the permitted activities.” Id. As the District Court found,

without a clear and enforceable incidental take limit, the ITS

violates the ESA. See Am. Rivers v. FERC, 895 F.3d 32, 48–

49 (D.C. Cir. 2018) (holding that the requirement to reinitiate

consultation if “the amount or extent of incidental take is

exceeded” did not provide enough guidance, rendering

biological opinion unlawful); see also Oregon Nat. Res.

Council v. Allen, 476 F.3d 1031, 1041 (9th Cir. 2007) (“The

salient point here, however, is that no matter what kind of

limitation on take the FWS chooses to place in the Incidental

Take Statement, it cannot be so indeterminate as to prevent the

Take Statement from contributing to the monitoring of

incidental take by eliminating its trigger function.”). Neither

the statute nor the regulations allow the action agency to state

that take limits will be determined at a later time, and then deem

Section 7 consultations finished.

To make matters worse, the ITS states that even if a later-

specified take limit is exceeded, the federal agencies were not

required to reinitiate consultation. See J.A. 2674.2 Thus, even

2

Indeed, the federal agencies effectively conceded this point,

Fed. Appellant Br. 47–48 & n.7, but they say in a footnote that

the issue is not ripe, id. The federal agencies cite no authority

5

though the ESA regulations mandate that when a take limit is

exceeded, “the Federal agency must reinitiate consultation

immediately,” see 50 C.F.R. §§ 402.14(i)(5), the EPA is not

required to do so here. Instead, Florida is required to re-open

the permit and coordinate further protective measures with the

FWS as part of the technical assistance process, but there is no

reinitiation of Section 7 consultation. This is wrong. The

Section 404 program cannot be implemented in a way that

impliedly repeals this bedrock requirement of the ESA. Rather,

the ITS was required to state, in some measurable manner, how

to determine when the program was allowing too much take

and to mandate the re-initiation of consultation if the take limit

were ever exceeded. This is critical, because the take immunity

expires when re-initiation of consultation begins, since the

BiOp is no longer valid. See Center for Biological Diversity v.

U.S. Bureau of Land Mgmt., 698 F.3d 1101, 1115 (9th Cir.

2012).

The federal agencies do not dispute that the absence of

concrete take limits in the ITS conflicts with ESA regulations,

but they assert that “the regulation does not speak to what the

agency must do when neither the amount of anticipated take

nor any surrogate is knowable at the time the statement must

issue[.]” See Fed. Appellant Br. 47. Not so. The ESA

regulations include a provision for issuing BiOps in

incremental steps, which requires further Section 7

consultation when an additional step is needed to determine an

incidental take limit. See 50 C.F.R. § 402.14(k). The

regulations also include an “expedited consultation” provision,

which can be used to quickly complete further consultation

needed to specify a take limit for a specific permit. See 50

in support of that proposition, and I do not find their one-

sentence conclusory argument persuasive.

6

C.F.R. § 402.14(l). See also U.S. Fish & Wildlife Service and

National Marine Fisheries Service, Endangered Species

Consultation Handbook, pp. 5-6 to 59 (1998) (describing

streamlined consultation procedures for programmatic actions

and incremental step consultations). The BiOp does not

explain why neither of these regulations could be employed

here. Neither do Florida or the federal agencies. For its part,

Florida argues that a rulemaking proceeding relating to

incidental take statements for programmatic actions

contemplated “other types” of programmatic actions that do not

fit within the definitions provided in the regulations. See Fla.

Appellant Br. 32–33 (citing 80 Fed. Reg. 26832, 26835 (May

11, 2015)). But that language does not help them, because the

rulemaking did not purport to exempt any such “other type” of

programmatic consultations from ESA regulations.

Florida and the federal agencies ask us to follow Cooling

Water Intake Structure Coalition v. EPA, 905 F.3d 49, 77 (2d

Cir. 2018), where the court rejected an ESA challenge to an

ITS that, like here, did not include take limits and instead relied

upon a subsequent “technical assistance” process to set them.

The Second Circuit held that the “justification for not

immediately qualifying take [wa]s adequate,” given the lack of

information at the programmatic consultation stage about

specific future sites and how particular species might be

affected. Id. I do not find this reasoning persuasive, given that

the court never addressed the conflict with the explicit mandate

in the ESA regulation that the ITS “will provide . . . a statement

concerning incidental take that . . .[s]pecifies the impact of

incidental taking as the amount or extent of such taking.” 50

C.F.R. § 402.14 (i)(1)(i) (emphasis added). The court cited

cases and legislative history for the proposition that Congress

anticipated that a numerical take limit would not always be

practicable, but those authorities merely support using a

surrogate (such as members of another species or a habitat

7

element like food, cover or water quality) to quantify take when

it is impracticable to quantify the protected species. See

Cooling Water, 905 F.3d at 77. None of those authorities

countenanced failing to set a take limit in the ITS at all. Indeed,

one of the cases relied upon by Cooling Water invalidated an

ITS because the FWS had removed the take limit in its revised

BiOp so that “no number of dead or vanished [protected

species] . . . will trigger re-consultation.” See Miccosukee

Tribe of Indians of Fla. v. U.S. Fish and Wildlife Service, 566

F.3d 1257, 1275 (11th Cir. 2009) (cited in Cooling Water, 905

F.3d at 77). Furthermore, Cooling Water’s reasoning cannot

be squared with longstanding agency procedure that “a

programmatic consultation will not substitute for an individual

project consultation, unless the programmatic analysis lays out

the species-specific standards within which all individual

activities will be conducted.” Endangered Species

Consultation Handbook, p. E-17.

In short, Florida and the federal agencies wanted to create

take immunity even though the ITS did not specify any clearly

identifiable take limits, conclude the required Section 7

consultation, and not bind themselves to reinitiate Section 7

consultation if any later-imposed take limits were exceeded.

That is not how the ESA statutory and regulatory scheme

works.

One other incongruity of the ITS results from the fact that,

if Florida’s position is correct, none of the federal agency

action occurring during the technical assistance process would

ever require Section 7 consultation because the permits are

issued by the state, rather than the federal government. See Fla.

Appellant Br. 34–35 (arguing that when Florida administers the

Section 404 permits, this is “not a ‘phase’ of the federal action

triggering additional Section 7 consultations[.]”). Recall that

the technical assistance process can involve a federal agency

8

deciding whether to object to a permit or to express a take limit

using a number or a surrogate, actions that appear to be

inherently discretionary. See Arkansas v. Oklahoma, 503 U.S.

91,99 (1992) (describing the EPA’s power to veto a state

permit as an act “in its discretion”); Nat. Res. Def. Council v.

Houston, 146 F.3d 1118, 1123, 1125–26 (9th Cir. 1998) (where

U.S. Bureau of Reclamation had authority to renew water

contracts on “mutually agreeable” terms, the federal agency

had discretion within the meaning of the ESA). Given that

Section 7 consultation “applies to every discretionary agency

action—regardless of the expense or burden its application

might impose,” see Nat’l Ass’n of Home Builders, 551 U.S. at

671 (emphasis removed) (citing TVA v. Hill, 437 U.S. 153

(1978)), I do not see how the entirety of the technical assistance

process falls outside of Section 7’s consultation requirements.

See id. at 672, n.11 (observing that following the transfer of

permitting authority to the state under Section 402 of the CWA,

“EPA will retain . . . the power to object to proposed permits,”

and “the fact that the EPA may exercise discretionary oversight

authority . . . may trigger Section 7(a)(2)’s consultation and no-

jeopardy obligations[.]”). This seems to be another way in

which this use of federal “technical assistance” to implement

Section 404 of the CWA impliedly repeals provisions of ESA

Section 7, which it cannot lawfully do.

Because these errors require vacatur of the BiOp, the ITS

and EPA’s approval of Florida’s Section 404 program, we can

affirm the District Court on this basis, and we have no need to

reach the remaining issues. For this reason, and because my

view of the remaining issues differs slightly from my

colleagues, I will leave it there.

KAREN LECRAFT HENDERSON, Circuit Judge, concurring

in part and dissenting in part: In 2020, after years of effort, the

Environmental Protection Agency (EPA) transferred Clean

Water Act (CWA) permitting authority from the Army Corps

of Engineers to the State of Florida. Despite a statutory

preference for state control of CWA permitting, this was only

the third successful federal-to-state handoff in the half-century

life of the permitting program. The reasons for states’

reluctance are many but at least one roadblock is arduous

environmental review. Even after a state clears the CWA’s

procedural hurdles, it must meet other federal laws and

regulations that can trip up even the most punctilious actor.

Nevertheless, Florida picked up the baton. For years, it built

an administrative apparatus, enacted legislation, promulgated

regulations, hired and trained personnel and worked hand-in-

hand with partner federal agencies to satisfy the environmental

laws. Its effort finally bore fruit when, in December 2020, the

EPA handed it control of the CWA program in Florida. But

“no sooner do agencies approve new [action] than they find

themselves under a tidal wave of litigation from environmental

groups.” Appalachian Voices v. FERC, 139 F.4th 903, 916–17

(D.C. Cir. 2025) (Henderson, J., concurring).

Within weeks of the EPA’s transfer, environmental groups

sued to stop Florida’s CWA assumption. On summary

judgment, the district court vacated the EPA’s transfer due to

alleged procedural violations of the Endangered Species Act

(ESA), violations that, on my reading, appear nowhere in the

statute. Nor can they be found in any agency regulation.

What follows is a technical, in-the-weeds discussion of

various overlapping environmental laws. But at a macro level,

the issue is remarkably simple. The ESA requires federal

agencies to assess the impact of any “final action” on

endangered species. Because the relevant “action” is Florida’s

ongoing assumption of CWA permitting, the relevant federal

agencies could not reliably predict or quantify the effects of the

2

transfer on endangered species. To comply with both laws, the

CWA and the ESA, the Government required Florida to consult

with it on each permit Florida plans to issue.1 These

consultations entailed built-in conditions to mitigate any

potential harm an individual permit might cause to a protected

species. Based on these structural safeguards, the Government

concluded that its action—CWA transfer to Florida—was

unlikely to jeopardize endangered species. The central

question is whether the Government can rely on future permit-

by-permit consultation to measure harm to endangered species

or whether, at the time of transfer, it has to divine the full

impact of permitting across the entire state of Florida for all

time.

Remarkably, the district court held the latter, breaking

from statutory text, context and the holding of a sister circuit.

As detailed infra, I believe the Congress has not required

federal agencies to make remote, perhaps improbable,

predictions in conducting their ESA review. And courts should

stop short of demanding that they try to do so. Accordingly, I

respectfully dissent in part.

I. BACKGROUND

A. Statutory and Regulatory Background

In the 1960s and 70s, a national push for greater

environmental protection led to a slew of environmental laws.

In 1966, the Congress enacted the Endangered Species

Preservation Act, which directed the Secretary of the Interior

to create a list of threatened and endangered species and to

1

I use “the Government” to refer collectively to the relevant

federal agencies: the EPA, the Services and the Army Corps of

Engineers. The remaining Appellants are officers of these agencies

respectively.

3

purchase land important for conservation. Pub. L. No. 89-669,

80 Stat. 926 (1966). A companion statute, the Endangered

Species Conservation Act, prohibited the import of most

endangered species. Pub. L. No. 91-135, 83 Stat. 275 (1969).

These measures proved inadequate and, in 1973, the Congress

enacted the Endangered Species Act, which made it the policy

of all federal agencies to conserve and protect endangered and

threatened species. Pub. L. No. 93-205, § 2, 87 Stat. 884

(1973), codified as amended at 16 U.S.C. § 1531(c). Like its

forebears, the ESA creates a list of “endangered” and

“threatened” species subject to legal protection.2 When a

species is listed, the Fish and Wildlife Service (FWS) and the

National Marine Fisheries Service (NMFS) (collectively, the

Services) must designate a critical habitat “to the maximum

extent prudent and determinable” and “develop and implement

plans . . . for the conservation and survival” of that species.3 16

U.S.C. § 1533(f); see 50 C.F.R. § 402.01(b) (tasking FWS and

NMFS with administering the Act).

Under § 7 of the ESA, every federal agency must consult

the Services if any action it authorizes, funds or carries out may

affect a listed species or critical habitat to ensure that the action

does not jeopardize the continued existence of the species or its

2

An endangered species is “any species which is in danger of

extinction throughout all or a significant portion of its range.” 16

U.S.C. § 1532(6). A threatened species is one “which is likely to

become an endangered species within the foreseeable future

throughout all or a significant portion of its range.” Id. § 1532(20).

3

The Secretary of Commerce is responsible for marine species

and administers the ESA through the NMFS. The Secretary of

Interior is responsible for terrestrial species and administers the ESA

through the FWS. 16 U.S.C. § 1532(15); 50 C.F.R. §§ 17.11,

402.01(b).

4

habitat. 16 U.S.C. § 1536(a)(2); 50 C.F.R. § 402.14(a).

Consultation requires the agency to prepare a Biological

Assessment, which identifies any protected species or habitats

likely to be affected by the proposed agency action. 16 U.S.C.

§ 1536(c).4 The Services then prepare a Biological Opinion

(BiOp) detailing how the species or critical habitat may be

affected. Id. § 1536(b)(3). If the Services determine that the

agency’s action is likely to jeopardize the continued existence

of a listed species or destroy or adversely modify a critical

habitat, the Services must propose reasonable and prudent

mitigation measures. Id. § 1536 (a)(2), (b)(3); see 50 C.F.R

§ 402.14(g)(4), (h)(3) (detailing the process). The agency, for

its part, must either terminate the action, adopt the Services’

proposal or seek an exemption. Weyerhaeuser Co. v. FWS, 586

U.S. 9, 15 (2018). The regulations implementing § 7 apply to

“all actions in which there is discretionary Federal involvement

or control.” 50 C.F.R. § 402.03.

Under § 9 of the ESA, no individual, private entity or

government may “take” a protected species, subject to civil and

criminal penalties. 16 U.S.C. §§ 1538(a)(1), 1540(a)–(b); see

also id. § 1532(13). To “take” a species is to “harass, harm,

pursue, hunt, shoot, wound, kill, trap, capture, or collect” it or

to attempt to do so. Id. § 1532(19). But if a taking is incidental

to an otherwise lawful activity, the Services may exempt the

activity, subject to a conservation plan. Id. § 1539(a)(2); 50

C.F.R. § 402.02. If the Services conclude that an action is not

likely to jeopardize a listed species or habitat but that

“incidental take” is reasonably likely to occur, they must

prepare an Incidental Take Statement (ITS), which authorizes

4

If the Biological Assessment leads the agency to conclude that

its proposed action is not likely to adversely affect a listed species or

habitat, it can avoid formal consultation with the Services. 50 C.F.R.

§ 402.14(b)(1).

5

the taking subject to applicable conditions. 16 U.S.C.

§ 1536(b)(4), (o)(2). Only federal agencies can obtain

exemption from ESA take requirements through § 7

consultations; states and private individuals must apply for an

individual permit under § 10, which authorizes “any taking

otherwise prohibited by” the ESA. Id. § 1539(a)(1)(B).

Around the time the ESA became law, the Congress also

enacted the Clean Water Act (CWA) to “restore and maintain

the chemical, physical, and biological integrity of the Nation’s

waters.” 33 U.S.C. § 1251(a). The CWA prohibits “the

discharge of any pollutant” into the waters of the United States

absent a permit. Id. §§ 1311(a), 1362(7). Section 404

authorizes the Army Corps of Engineers to issue permits “for

the discharge of dredged or fill material” into the waters of the

United States.5 Id. § 1344(a). If a permit affects a protected

species, the Corps must engage in a § 7 consultation under the

ESA.

The CWA codifies a congressional preference for “the

states . . . [to] implement the [CWA’s] permit programs.” Id.

§ 1251(b). To that end, states and tribal governments may

apply to the EPA to assume permitting authority over certain

waters—those not “presently used, or . . . susceptible to use . . .

as a means to transport interstate or foreign commerce

shoreward,” id. § 1344(g)(1), colloquially known as “assumed

waters.” Permitting for “interstate” waterways—also known

as “retained waters”—is retained by the federal agencies even

after a state assumes § 404 permitting authority. The

presumption is in favor of transferability. See id. § 1344(h)(3)

5

Dredging is the excavation of material from waters of the

United States and filling is the depositing of material into waters of

the United States. 33 C.F.R. § 323.2(c)–(f).

6

(deeming any application not acted on within 120 days

approved).

Before the EPA approves a transfer of authority, however,

it must conclude that a state can satisfy all § 404 requirements.

Id. § 1344(h)(1)–(2). One requirement prohibits any discharge

that “[j]eopardizes the continued existence of [ESA] species

. . . or results in likelihood of the destruction or adverse

modification of a [critical] habitat.” 40 C.F.R. § 230.10(b)(3).

Post-transfer, a state must continue to notify the EPA of any

permit it approves and the EPA may object to or require that

additional conditions attach to an assumed-waters permit. 33

U.S.C. § 1344(j).

To sum up, whenever a federal agency authorizes, funds

or carries out any action, it must assess whether that action may

affect endangered or threatened species or their habitats. To do

so, the agency consults with the Services—the Fish and

Wildlife Service and the National Marine Fisheries Service—

under § 7 of the Endangered Species Act. As part of the

consultation, the Services prepare a Biological Opinion that

details whether the agency action is likely to jeopardize the

continued existence of a protected species or habitat. If the

answer is no, the agency action may proceed; if the answer is

yes, it generally cannot absent an exemption. Even if the

Services make a no-jeopardy determination, they must

separately assess whether the proposed action will result in

incidental take, i.e., cause injury to a protected species or its

habitat. If so, the Services then prepare an Incidental Take

Statement under § 7(o)(2) that exempts the action from take

liability under § 9. Individuals and states must go through a

separate process under § 10 to obtain a take exemption.

Dredging or filling (removing or adding) materials into

waters of the United States also requires a § 404 CWA permit.

7

Permitting is managed by the Army Corps of Engineers but it

can authorize a state to manage permitting for non-interstate

waters of the United States. Before a state assumes § 404

permitting, it must demonstrate its own compliance with

several environmental laws and regulations. And, as described

below, the EPA has determined that a CWA § 404 transfer is a

federal action requiring ESA review.

B. Factual Background

In August 2020, Florida applied to the EPA to assume

CWA § 404 permitting authority. See Florida’s Request to

Assume Administration of a Clean Water Act Section 404

Program, 85 Fed. Reg. 57,853 (Sept. 16, 2020). But Florida

feared that once it assumed § 404 responsibilities, it and its

permittees would risk ESA liability for any incidental take of

an endangered or threatened species. Unlike a federal agency,

Florida could not consult the Services to obtain a § 7 ITS. To

avoid incidental take liability, it would be forced to obtain a

permit-by-permit exemption under § 10, a process that was

“burdensome” and could “take years.” J.A. 2033. So Florida

proposed a novel solution: the EPA could issue a “one-time

ESA Section 7 programmatic consultation in connection with

EPA’s initial review of a state application to assume the

Section 404 program.”6 Id. Florida’s plan works like this:

6

As defined by the Services, a programmatic consultation is:

A consultation addressing an agency’s multiple

actions on a program, region or other basis [about]

the effects of programmatic actions such as:

1. Multiple similar, frequently occurring, or

routine actions expected to be implemented in

particular geographic areas; and

8

Section 7 requires a federal agency to consult the Services to

determine if agency action is likely to jeopardize a listed

species or critical habitat. 16 U.S.C. § 1536(a)(4). The EPA’s

approval of Florida’s § 404 assumption constitutes agency

action that would affect listed species and therefore triggers § 7

consultation. 50 C.F.R. § 402.14(a). At the end of that

consultation, the Services could issue a “programmatic” BiOp

and ITS that pulls every subsequent Florida permit under the

§ 7(o)(2) liability exemption. Under this plan, an individual

permittee would not need to go through the cumbersome § 10

process to obtain a one-off exemption for incidental take.

Instead, the Services would preemptively exempt all future

permits from incidental take liability, subject to protections

prescribed by the Services.

Florida’s request faced an immediate roadblock: the

EPA’s then-prevailing view was that a § 404 transfer of

permitting authority did not require § 7 consultation. Section

402 of the CWA contains a similar permitting program subject

to state assumption once qualifying conditions are met.

Applying Chevron deference, the Supreme Court upheld the

EPA’s conclusion that a § 402 transfer does not require § 7

consultation. The Court explained that two features of § 402—

its “mandatory” command that the EPA “shall approve” a

transfer and its “exclusive” list of qualifying conditions to

approve a transfer—meant that approval is non-discretionary

and thus agency regulations could reasonably exempt § 402

approvals from § 7 ESA consultation. Nat’l Ass’n of Home

Builders (NAHB) v. Defs. of Wildlife, 551 U.S. 644, 661–64

(2007). Section 404 similarly requires that the EPA “shall

2. A proposed program, plan, policy, or

regulation providing a framework for future

proposed action

50 C.F.R. § 402.02.

9

approve” a transfer once a list of qualifying criteria is satisfied.

33 U.S.C. § 1344(h)(1)–(2). The EPA had therefore concluded

that its § 404 duties are likewise ministerial and not subject to

ESA § 7.7

Florida urged the EPA to revisit its position, arguing that

the text, legislative history and unique characteristics of § 404

made it discretionary in contradistinction to § 402. In May

2020, the EPA initiated a 45-day public-comment period on the

issue. See Request for Comment on Whether EPA’s Approval

of a Clean Water Act Section 404 Program Is Non-

Discretionary for Purposes of Endangered Species Act Section

7 Consultation, 85 Fed. Reg. 30,953 (May 21, 2020). After

reviewing the comments, the EPA concluded that “NAHB . . .

does not control . . . CWA Section 404” and, accordingly,

deemed § 404 a discretionary function. J.A. 2501. It then

approved Florida’s proposal that the Services issue a

programmatic BiOp and ITS.

In September 2020, the EPA submitted its Biological

Evaluation to FWS and requested ESA § 7 consultation. The

7

NAHB did not a fortiori control the EPA’s duties under § 404.

Not only is § 404 a separate—albeit similar—provision from the one

the Court construed in NAHB, but its holding also depended upon the

now-defunct Chevron framework. See Loper Bright Enters. v.

Raimondo, 603 U.S. 369, 412 (2024). In NAHB, the Court reviewed

the Services’ regulation harmonizing the ESA and the CWA by

rendering § 7 applicable only to those “actions in which there is

discretionary Federal involvement or control.” 50 C.F.R. § 402.03.

Four justices thought the regulation conflicted with the plain text of

§ 7. See NAHB, 551 U.S. at 673–74 (Stevens, J., dissenting). The

five-justice majority held that the regulation was a reasonable

interpretation of the ESA under Chevron and that, because § 402

transfers were not discretionary, the regulations permissibly

exempted transfers from § 7 of the ESA. Id. at 673.

10

EPA did not conduct consultations with NMFS because it

concluded that no species within NMFS’s jurisdiction lived in

assumed waters.8 In November 2020, FWS issued its BiOp,

which concluded that the EPA’s approval of Florida’s

permitting application was not likely to jeopardize any

protected species or critical habitat. Due to “substantial

uncertainty about the number, location, timing, frequency, and

intensity of regulated activity,” J.A. 2644, FWS could not

provide a “detailed analysis of potential effects.” J.A. 2658.

Instead, FWS summarized the types of activities that Florida

might permit and the areas where permits could be issued. It

then assessed the effect of these activities on “guilds” of

species, i.e., groups of species, including mammals and birds,

with similar traits and habitats.

FWS’s no-jeopardy determination rested on a myriad of

structural safeguards. Pursuant to a memorandum of

understanding (MOU) between FWS and Florida, FWS would

offer technical assistance to Florida to identify risks to listed

species and habitats and propose mitigation measures for those

risks. FWS would undertake that identify-and-mitigate process

for each permit Florida issued. After FWS’s review, Florida

would have two, and only two, choices: either incorporate

FWS’s proposed measures as terms and conditions of the

permit or deny the permit. Florida also amended its

administrative code to require coordination with FWS on a

permit-by-permit basis. See Fla. Admin. Code R. 62-331.051–

53.

8

The EPA subsequently revisited its position. In July 2023, it

requested consultation with NMFS after concluding that the indirect

effects of Florida’s assumption of authority could affect three NMFS

species. See ESA Biological Evaluation for CWA Section 404

Assumption by the State of Florida, § 8.3, p. 83–84 (July 2023)

[https://perma.cc/E9AX-662T].

11

Pursuant to regulation, the EPA retains the right to review

and submit objections to state CWA permits unless review is

waived. See 40 C.F.R. §§ 233.50(a)–(b), 233.51. The EPA’s

memorandum of agreement (MOA) with Florida waives

federal review except for eight categories, one of which

includes “[d]ischarges with reasonable potential for affecting

endangered or threatened species as determined by []FWS.”

J.A. 1573; see 40 C.F.R. § 230.10(b)(3) (prohibiting such

discharges). Like FWS, the EPA can compel Florida to

incorporate the EPA’s prophylactic measures as a condition of

issuing a permit. 40 C.F.R. § 233.50(f). With two federal

agencies superintending Florida’s CWA program for ESA

compliance, FWS concluded that Florida’s § 404 assumption

was not likely to jeopardize listed species or critical habitats.

FWS also issued an ITS that exempted the EPA, Florida

and future permittees from ESA liability for any incidental take

pursuant to a state-issued permit. Like the BiOp, the ITS

concluded that it was infeasible to measure anticipated future

take across the life of the permitting program; accordingly,

FWS indicated that it would track future take on a permit-by-

permit basis and Florida offered to reopen permits if actual

impact on affected species deviated from projections.

With the programmatic BiOp and ITS in hand, the EPA

approved Florida’s § 404 application on December 17, 2020,

effective five days later. See EPA’s Approval of Florida’s

CWA Section 404 Assumption Request, 85 Fed. Reg. 83,553

(Dec. 22, 2020). The EPA’s approval was only the third

approval of a state’s assumption of § 404 authority, following

Michigan in 1984 and New Jersey in 1994. See 40 C.F.R.

§ 233.70–71.

12

C. Procedural Background

Within weeks of the EPA’s decision, a collection of

environmental groups sued to challenge the EPA’s approval of

Florida’s application, FWS’s BiOp and ITS and the Corps’ list

of retained waters. On summary judgment, the district court

concluded that FWS’s BiOp and ITS “were facially and legally

flawed” and that the “EPA unreasonably relied on those

documents in approving Florida’s assumption application.”

Ctr. for Biological Diversity v. Regan, 734 F. Supp. 3d 1, 58

(D.D.C.), judgment entered, 729 F. Supp. 3d 37 (D.D.C. 2024).

As to the BiOp, the court fashioned a bespoke rule: that is,

a BiOp cannot assess species at the guild level. It reasoned that

the BiOp impermissibly deferred resolution of an essential

question—the impact on individual species—to the technical

assistance process, which “does not occur until after the federal

action [CWA transfer] is complete and . . . lacks a trigger for

reinitiating consultation.” Id. The court noted that a condition

precedent of § 7 consultation is a finding that agency action—

the EPA’s § 404 approval—is likely to adversely affect listed

species or critical habitats. Id. at 44. Having made that finding,

FWS could not then decide not to conduct a species-specific

analysis. Id.

As to the ITS, the court explained that it lacked a

“numerical take limit” or “clear standard for determining when

the level of anticipated take has been exceeded.” Id. at 52

(quoting 50 C.F.R. § 402.14(i)(1)(i)). As with the § 7

consultation, FWS could not issue an ITS unless it determined

“that incidental ‘take is reasonably certain to occur.’” Id. at 50

(quoting 50 C.F.R. § 402.14(g)(7)). Yet FWS specified no

species impact. Id. The coup de grâce for the EPA was its

failure to consult with NMFS. The court held that the EPA’s

failure was arbitrary and capricious because the EPA did not

13

consider indirect effects on listed species in contravention of

agency regulations. Id. at 59–60 (citing 50 C.F.R. § 402.02).

Based on these purported defects, the court vacated the BiOp,

the ITS and the EPA’s approval of Florida’s application. Id. at

63–64.

II. ANALYSIS

I believe appellees’ challenges to the Biological Opinion

are wrong in fact and law. Legally, the ESA violations they

identify are absent from the plain text of the Act. Factually, the

BiOp checks all the statutory and regulatory boxes and its

bottom-line conclusion is neither arbitrary nor capricious.9

As a roadmap to the reader, § II.A.1 walks through a

nearly identical BiOp and permitting scheme that was upheld

by the Second Circuit and that served as the template for FWS

and Florida here. Section II.A.2 explains why the granular

species-specific analysis insisted on by the district court—and

pressed by appellees—has no statutory hook. Section II.A.3

explains that the BiOp is not contrary to law and § II.A.4

endorses the BiOp’s bottom-line conclusion. Because I agree

with my colleagues that the ITS is defective, § II.B discusses

what, in my view, should be the appropriate remedy. Finally,

§ II.C underscores the dangers of judge-made, atextual rules

that, in my view, conflict with principles of federalism.

A. The Biological Opinion

Section 7 of the ESA requires federal agencies to consult

the Services to ensure that their action “is not likely to

9

I agree with the majority that the ITS does not comply with the

ESA and its implementing regulations and that the EPA, as it now

concedes, erred in failing to consult with NMFS. My dissent is

therefore limited to the BiOp and the EPA’s resulting § 404 transfer.

14

jeopardize the continued existence of any endangered species

or threatened species” or to destroy or adversely modify a

critical habitat. 16 U.S.C. § 1536(a)(2). Once an agency

concludes that its action “may adversely affect a listed species,

it must engage in a formal consultation.” Rancho Viejo, LLC

v. Norton, 323 F.3d 1062, 1064 (D.C. Cir. 2003) (citing 50

C.F.R. § 402.14). When consulted, the Services prepare a

BiOp that “detail[s] how the agency action affects the species

or its critical habitat.” 16 U.S.C. § 1536(b)(3)(A). As the name

implies, a Biological Opinion must give the Services’ bottom-

line opinion as to whether the proposed action is or is not likely

to jeopardize listed species or their critical habitat. Id.

The EPA asked FWS to render a programmatic § 7

consultation: one in which FWS assessed “multiple similar . . .

actions” and a “proposed program, plan, policy, or regulation

providing a framework for future proposed actions.” 50 C.F.R.

§ 402.02. FWS therefore properly focused its inquiry on

whether Florida’s “program, regulation, processes, and

procedures insure that EPA’s approval and [Florida’s]

subsequent assumption and implementation of the 404 program

is not likely to” jeopardize listed species and their habitats. J.A.

2608. The parties exchange endless volleys aimed at whether

FWS’s BiOp—and the EPA’s reliance thereon—was proper.

But at bottom, the parties’ dispute boils down to a simple

question: can FWS rely on structural safeguards in Florida’s

program to reach a no-jeopardy determination without

conducting an analysis of potential harm to each individual

species and habitat? In my view, it plainly can.

1. Cooling Water

Although ESA § 7 directs federal agencies to avoid

jeopardizing listed species and critical habitat, the statute is

silent on how agencies meet that obligation. See Gifford

15

Pinchot Task Force v. FWS, 378 F.3d 1059, 1067 (9th Cir.

2004) (“[T]he ESA does not prescribe how the jeopardy prong

is to be determined”). It is therefore “for the agencies to

determine how best to structure consultation to fulfill Section

7(a)(2)’s mandate.” Defs. of Wildlife v. Dep’t of the Navy, 733

F.3d 1106, 1121 (11th Cir. 2013). Given the rarity of state-

controlled § 404 permitting, Florida chose to model its program

on a comparable scheme upheld by the Second Circuit in

Cooling Water Intake Structure Coalition. v. EPA, 905 F.3d 49

(2d Cir. 2018).

Cooling Water involved a nearly identical CWA

permitting scheme under the previously-discussed neighboring

provision, § 402. There, the EPA promulgated a new

regulation governing the requirements for cooling water intake

structures. Id. at 58. The rule was to be implemented through

state-issued CWA permits. Because cooling water intake

structures can kill many aquatic species each year, the EPA

sought ESA § 7 consultation with the Services, which then

prepared a BiOp approving the rule change. Id. There, as here,

the Services relied on a programmatic approach because it was

infeasible to analyze the innumerable permits that a state might

issue in the future. Id. at 71. There, as here, the Services

reached a no-jeopardy determination based on a technical

assistance process that allowed the relevant federal agencies to

review individual state permit applications and supplement

them with necessary safeguards to shield at-risk species. Id. at

72, 74. And there, as here, environmental groups claimed that

the Services violated the ESA “by deferring analysis of the

[agency action’s] impact on jeopardy to the permit-specific

review stage.” Id. at 73.

The Second Circuit swept their challenge aside. As it

noted, the environmentalists’ claims were “really challenges to

the Services’ ‘programmatic’ approach to the biological

16

opinion,” an approach that it correctly deemed consistent with

the statute. Id. at 71. The court explained that nothing in the

ESA requires a BiOp to assess every future phase—i.e., future

permits—of an agency action on a site- or species-specific

basis. Id. at 73 (citing Defs. of Wildlife, 733 F.3d at 1121).

Instead, the Services were free to point to the procedural

safeguards that attach to future permits—the technical

assistance process that guarantees eventual site- and species-

specific assessments—as a basis for its no jeopardy finding. Id.

Appellees seek to distinguish Cooling Water on two grounds.

Neither suffices.

a. Cooling Water is Not Distinguishable

First, Appellees contend that there was “little, if any data

available [in Cooling Water] to inform species analysis at the

programmatic level” but, here, FWS has “ample data.” Red Br.

65; see also Regan, 734 F. Supp. 3d at 46 (asserting that FWS

possessed “reams of data from previous Section 7

consultations”). That contention misunderstands Cooling

Water. The salient question is not what data FWS possessed;

it is how FWS was required to use that data. In Appellees’

view, FWS should have used available data from federally

issued § 404 permits to conduct a species-by-species analysis.

In no uncertain terms, Cooling Water rejected that approach.

See Cooling Water, 905 F.3d at 75 (holding that FWS could

“defer[] evaluation of [the agency action]’s effects on the

species” rather than analyze then-available data).

Second, Appellees argue that, unlike in Cooling Water, the

technical assistance process here is “not codified” and therefore

not “legally binding.” Red. Br. 66; see also Regan, 734 F Supp.

3d at 47 (expressing a similar concern that the technical

assistance procedure appears in the BiOp, not in the Federal

Register). But how FWS and the EPA choose to memorialize

17

their technical assistance program is of no moment. FWS

signed a binding MOU with Florida memorializing the

“processes and procedures that [govern] . . . Florida’s

assumption of the CWA 404 program,” including the technical

assistance process. J.A. 1556. The EPA likewise entered an

MOA with Florida that fixed those procedures in contract. And

Florida amended its administrative code to codify both

agencies’ requirements. See Fla. Admin. Code R. 62-331.051–

.053.

The Government’s and Florida’s adherence to these

agreements is “entitled to the presumption of regularity.”

Citizens to Pres. Overton Park, Inc. v. Volpe, 401 U.S. 402,

415 (1971), abrogated on other grounds by Califano v.

Sanders, 430 U.S. 99 (1977); accord FDA v. Wages & White

Lion Invs., L.L.C., 145 S. Ct. 898, 922 (2025) (rejecting the

argument that an agency might secretly act contrary to its

public pronouncements, relying on the presumption of

regularity); El Puente v. Army Corps of Eng’rs, 100 F.4th 236,

255–56 (D.C. Cir. 2024) (relying on NMFS’s “promise” that it

would diligently act under a comparable monitoring plan to

uphold its determination that agency action was unlikely to

affect endangered species).

Indeed, Appellees’ (and the district court’s) concern was

squarely addressed and rejected by Cooling Water. There the

challengers similarly bemoaned that there was “no formal

assurance” that the Services would hew to the technical

assistance program. Cooling Water, 905 F.3d at 72 (citation

omitted). The Second Circuit disagreed. The court (i) cited a

Ninth Circuit decision treating comparable memoranda as

enforceable, (ii) quoted a Services ESA Handbook echoing that

implementation of such agreements is required and

(iii) explained that the procedures were mandatory because the

Services conditioned their no-jeopardy finding on compliance

18

and represented to the court their commitment to the

procedures. Id. In my view, the same result should obtain here.

b. Cooling Water was Correctly Decided

Notwithstanding the district court’s attempt to distinguish

Cooling Water, see Regan, 734 F Supp. 3d at 47, its conclusion

was that Cooling Water was wrongly decided, see id. at 48

(“Cooling Water is at odds with the statute, regulations, and

caselaw”). According to the district court, the “critical

misstep” in the Second Circuit’s reasoning was conflating two

distinct concepts. Id. Cooling Water explained—and the

district court accepted—that a BiOp “need not ‘assess every

future’ species-specific effect” at the outset. Id. (quoting

Cooling Water, 905 F.3d at 73). But, the district court

explained, “a phased approach to consultation” is permissible

only if “complete and adequate” § 7 consultation “occur[s] at

some point.” Id. (citation modified). That is, a programmatic

approach allows the Services either to conduct a species-

specific BiOp at the outset of the consultation or to conduct a

future § 7 consultation; nevertheless, the Services cannot rely

on a non-§ 7 process—like technical assistance—to satisfy the

species-specific analysis the court thought critical. Id.

Yet the district court committed the very mistake it

ascribed to Cooling Water: it disregarded the statute and its

regulations. No party disputes that the Services must comply

with § 7. The Government’s contention was and is that it did

comply and, having satisfied its § 7 obligations—in part based

on future implementation of procedural safeguards—it did not

need to reengage in § 7 consultations for each future action.

Neither regulation nor statute says otherwise.

First, the regulations. The district court construed the

Services’ “programmatic consultation” regulations to exclude

categorically future state involvement. Id. at 49. This was so,

19

the court explained, because the “phrase is defined in the

regulations” as “‘a consultation addressing an agency’s

multiple actions,’ 50 C.F.R. § 402.02—not a single agency

action followed by state-licensing decisions . . . that . . . do not

constitute federal action subject to Section 7 consultation.” Id.

That is wrong twice over. Factually, there are several agency

actions here: the EPA’s transfer of permitting authority and the

EPA’s and FWS’s subsequent reviews of individual state

permits. Legally, the court’s concerns were misguided. It

insisted that any follow-on technical assistance was deficient

because it would not be subject to another round of § 7

consultations. But the regulations expressly recognize that

programmatic actions sometimes involve scenarios in which

future “action(s) will not be subject to further section 7

consultation.” 50 C.F.R. § 402.02. If the Services reached a

proper programmatic determination on the front end, nothing

requires FWS to retrace a path to § 7 on the back end.

Next, the statute. The district court believed that a

programmatic consultation cannot “defer[] detailed, species-

specific analysis” to the technical assistance process. Regan,

734 F Supp. 3d at 49; see also id. at 42 (“[A]nalysis at the guild-

level fails the statutory and regulatory demand to assess the . . .

effects at the species-level”). Put another way, the court read

the ESA to mandate a detailed, species-specific analysis as part

of § 7 consultation. But nothing in the statute commands such

a granular assessment for § 7 consultations generally and so

none can be grafted onto a programmatic consultation. Cooling

Water’s holding flows naturally from the ESA’s text and

implementing regulations.

2. A Guild-Based Approach is Consistent with the ESA

To assess the environmental impact of the EPA’s transfer

of permitting authority, FWS’s BiOp used a guild-based

20

approach. A guild is “a group of organisms that use the same

ecological resources in the same way.” Guild (n.), additional

sense, Oxford Eng. Dictionary, https://doi.org/10.1093/

OED/7855507680 [https://perma.cc/4RGX-ZTK2]. But

Appellees’ argument—and the district court’s reasoning—is

that FWS must instead, on a species-by-species basis, detail the

effects of the EPA’s transfer. The ESA contains no such

mandate.

Start with the text. Section 7 requires a Biological Opinion

“detailing how the agency action affects the species or its

critical habitat.” 16 U.S.C. § 1536(b)(3)(A). Appellees latch

on to two statutory phrases—“detailing” and “the species or its

critical habitat”—that they claim bar analysis at the guild level.

From this textual pinhead, they attempt to poke a fatal hole in

FWS’s BiOp. Their attempt fails.

The statute does not otherwise define “detailing” so it

carries its “ordinary or natural meaning.” HollyFrontier

Cheyenne Ref., LLC v. Renewable Fuels Ass’n, 594 U.S. 382,

388 (2021). Dictionaries contemporaneous with the ESA’s

enactment define the phrase as (i) “to report minutely and

distinctly: specify,” Detail (vt), sense 1, Webster’s New

Collegiate Dictionary (1973), and (ii) “to relate in particulars”

or “enumerate, specify,” Detail (v), senses 1 & 2, Webster’s

Third New Int’l Dictionary of the Eng. Language Unabridged

(1976). As these definitions manifest here, “detailing” has a

dual meaning: both a description of the act of recording and the

specificity with which that record should be made. At a

minimum, then, BiOps must explain the Services’

understanding of how agency action will affect listed species

and habitats in a manner that is not “too vague, too general and

too conclusory.” Silva v. Lynn, 482 F.2d 1282, 1284 (1st Cir.

1973) (quoting Env’t Def. Fund, Inc. v. Froehlke, 473 F.2d 346,

348 (8th Cir. 1972)) (explaining the requirements of the

21

National Environmental Policy Act (NEPA)’s similarly

phrased “detailed statement” requirement). Put another way,

the BiOp must explain “its course of inquiry, its analysis, and

its reasoning” in a manner that “permits the court to ascertain

whether the agency has made a good faith effort” to comply

with the statute. Id. (quoting Ely v. Velde, 451 F.2d 1130, 1139

(4th Cir. 1971)).

Precisely “[h]ow much information is enough . . . . is not a

question to which” the ESA provides an answer. Alaska v.

Andrus, 580 F.2d 465, 473 (D.C. Cir. 1978) (describing

NEPA’s similar language), vacated in part on other grounds

sub nom. W. Oil & Gas Ass’n v. Alaska, 439 U.S. 922 (1978).

“Detail” is a word of degree lacking any checklist or bright-line

rule. And so, although “the meaning of ‘detailed’ is a question

of law . . . . what details need to be included in any given

[BiOp] . . . . involves primarily issues of fact” to which we owe

robust “judicial deference.” Seven Cnty. Infrastructure Coal.

v. Eagle Cnty., 145 S. Ct. 1497, 1512 (2025) (citation omitted).

Sometimes, a species-by-species analysis may prove necessary

to weigh the effects of the agency action. But in other

circumstances, a guild-based grouping is sufficient.10 The

question is not one of statutory interpretation so much as the

application of arbitrary and capricious review, according to

which we owe an “extreme degree of deference” to the

agency’s scientific expertise. City of Waukesha v. EPA, 320

F.3d 228, 247 (D.C. Cir. 2003) (citation omitted); see also Balt.

Gas & Elec. Co. v. Nat. Res. Def. Council, Inc., 462 U.S. 87,

103 (1983) (emphasizing that courts must be at their “most

deferential” when reviewing an agency’s “scientific

determination”).

10

For example, if a proposed agency action uniformly affects

similarly situated species or habitats, the Services can “detail” the

effects at the guild level.

22

The surrounding statutory context confirms as much. The

Services’ jeopardy determination is to be driven by “the best

scientific and commercial data available.” 16 U.S.C.

§ 1536(a)(2). The Congress thus understood that as available

inputs might fluctuate, so might the specificity of outputs. That

does not mean, as Appellees contend, that the meaning of

“detail” will “vary” to mean “different[] [things] at different

times.” Red Br. 52. The meaning of “detailing” is fixed—but

that fixed meaning is a standard whose application varies

depending on the facts. Nothing in the ordinary meaning of

“detailing” compels the level of analysis that Appellees seek to

impose. Instead, their “contentions boil down to questioning

the degree of detail rather than the lack of it.” Sierra Club v.

Morton, 510 F.2d 813, 825 (5th Cir. 1975).

Appellees find no more support in the remainder of the

text. They emphasize that § 7 speaks to “‘the species’ and ‘its

habitat,’” purportedly making plain that the Congress intended

individualized assessments. Red Br. 49–50. That conclusion

does not follow. A focus on harm to individualized species is

also consistent with an approach that groups species facing

similar risks. In other words, the agency must consider all

listed species and propose “reasonable and prudent

alternatives” if agency action jeopardizes the continued

existence of any listed species. 16 U.S.C. §§ 1536(a)(2),

(b)(3)(A). But in “detailing how the agency action affects”

listed species, id. § 1536(b)(3)(A), agencies can group together

species that are affected in a comparable manner.11

11

Indeed, the statute does not logically cohere under the

Appellees’ reading that “the species” and “its habitat” can mean only

the singular. A BiOp may describe how agency action affects

potentially hundreds of species or one species across multiple

habitats. These phrases must therefore sometimes carry a plural

23

Finally, Appellees tout—and the district court relied on—

a non-binding and out-of-circuit district court decision that,

they claim, rejected a guild-level analysis. See Red Br. 50–51

(citing Forest Serv. Emps. for Env’t Ethics v. Forest Serv., 726

F. Supp. 2d 1195 (D. Mont. 2010)); Regan, 734 F Supp. 3d at

46, 55 (similarly relying on Forest Service Employees). There,

FWS used a similar guild-level approach to a programmatic

BiOp. See Forest Serv. Emps., 726 F. Supp. 2d at 1202, 1204.

FWS argued that its approach was necessary based on the

number of affected species (387) and the scope of the affected

area (192 million acres). Id. at 1224. The court nevertheless

deemed the BiOp inadequate, explaining that convenience

could not excuse compliance. Id. From Forest Service

Employees, Appellees derive the mistaken proposition that

BiOps must include species-specific analyses. That misreads

the district court’s holding.

In Forest Service Employees, FWS applied a process it

termed a “coarse filter” to prepare its BiOp. The filter worked

like this: FWS grouped 387 species into guilds, then applied a

four-step risk profile to assess whether each species was likely

to be jeopardized by the Forest Service’s action. Id. at 1204.

FWS (i) assumed that well-distributed, population-dense

species were at low risk of jeopardy; (ii) considered the

likelihood that some species would be exposed to the agency

action; (iii) asked whether exposure was likely to result in take;

and (iv) assessed whether the amount of take would likely

jeopardize a species’ continued existence. Id. Coarse filtering

removed more than half of the species from FWS’s list. Id.

The remainder were then subject to more detailed analysis.

The failure in FWS’s approach was not its guild-level grouping

but its neglect of the effects on critical habitats. As the court

meaning—as the Dictionary Act sensibly commands. See 1 U.S.C.

§ 1 (instructing that singular words import the plural and vice versa).

24

noted, “[n]one of the four [coarse filter] prongs deals with the

value of critical habitat for recovery.” Id. at 1224. There were

several species for which critical habitat analysis was

“nonexistent.” Id. The failure to consider critical habitats—

not the guild-level approach of the BiOp—is what proved fatal.

Indeed, the court went on to reject precisely the argument

Appellees try to extract: “Defendants correctly point out that

the law does not impose an artificial obligation to include a

section expressly discussing recovery for every species.” Id. at

1225 (citation modified). In other words, Forest Service

Employees agreed that FWS could group like-species

together—it simply could not use that grouping to excuse a

failure to assess differences in critical habitats. Insofar as the

case can be read to stand for anything more, it offers no

controlling or persuasive reason to impose atextual species-

specific requirements on FWS.

The district court’s insistence that FWS tick off each and

every species with its own separate analysis is simply a judge-

made requirement that obfuscates the critical inquiry: whether

FWS assessed how the relevant action under review will affect

species and habitats and reached a bottom-line conclusion that

is neither arbitrary nor capricious.

3. The BiOp Satisfies ESA Procedures

FWS’s statutory obligation is remarkably succinct: it need

only “detail[] how” the EPA’s transfer of § 404 authority

“affects [listed] species or [their] critical habitat.” 16 U.S.C.

§ 1536(b)(3)(A). By regulation, the Biological Opinion must

include a (1) a “summary of the information on which the

opinion is based;” (2) a “detailed discussion of the

environmental baseline;” (3) a “detailed discussion of the

effects of the action on listed species or critical habitat;” and

(4) FWS’s opinion on whether the action is likely “to

25

jeopardize the continued existence of a listed species or result

in the destruction or adverse modification of critical habitat.”

50 C.F.R. § 402.14(h). No party disputes that the BiOp

includes the requisite first step summary; the remaining three

factors—and the failure of Appellees’ contrary to law

challenge—are discussed in turn.

a. The Environmental Baseline

A BiOp must discuss the environmental baseline in detail.

Id. The environmental baseline is the condition of the species

or habitat before the proposed action, including “the past and

present impacts of all Federal, State, or private actions . . . in

the action area.” Id. § 402.02. The district court did not pass

on the correctness of FWS’s baseline assessment, see Regan,

734 F. Supp. 3d at 43–44, but Appellees argue that the BiOp

gave short shrift to this step in the process.12

Appellees do not dispute that the BiOp adequately

documented past and present actions and the condition of

Florida’s habitats. Instead, they argue that FWS did not explain

how both affect listed species. The BiOp itself does not discuss

the condition of any species but that is because the BiOp

incorporates by reference the EPA’s Biological Evaluation.

The Biological Evaluation contains an eighty-page table of all

listed species in the affected area and their known

environmental stressors along with further information on the

critical habitats and their historic degradation.

Appellees complain that the baseline assessment does not

meticulously describe how past and present activities affect

each of the 235 documented species but they raise this point in

12

Appellees preserved the argument for review. They argued

below that the baseline was inadequate—the district court simply

declined to reach the issue given the other defects it identified.

26

a single sentence. See POM Wonderful, LLC v. FTC, 777 F.3d

478, 499 (D.C. Cir. 2015) (noting that arguments made “in

conclusory fashion and without visible support” may be

deemed forfeited) (citation omitted). Appellees’ primary

complaint is that FWS simply “copied [the EPA’s] Biological

Evaluation’s baseline section” and the EPA, in turn, lifted

significant portions of its assessment from “a Biological

Assessment Florida had prepared for EPA.” Red Br. 40.

FWS’s efficiency-based process should be lauded—not

lambasted.

Environmental review is arduous, often involving

hundreds if not thousands of pages of analysis. See

Appalachian Voices, 139 F.4th at 918 n.1, 922–23 (Henderson,

J., concurring). For that reason, agencies often incorporate by

reference the work of another agency. See, e.g., City of

Sausalito v. O’Neill, 386 F.3d 1186, 1214 (9th Cir. 2004)

(noting an environmental statement incorporated external data

by reference); Hughes River Watershed Conservancy v.

Glickman, 81 F.3d 437, 445 n.6 (4th Cir. 1996) (“A federal

agency may adopt an [environmental statement] prepared by

another federal agency”); Christian Broad. Network, Inc. v.

Copyright Royalty Tribunal, 720 F.2d 1295, 1306 (D.C. Cir.

1983) (“[A]n agency may explain itself by incorporating by

reference parts of the record”). The purpose of a BiOp “is not

to generate paperwork . . . but to foster excellent action.” Dep’t

of Transp. v. Pub. Citizen, 541 U.S. 752, 768–69 (2004). As

judges are acutely aware, excellent results can—and often

are—achieved by incorporating the work of others. See

generally today’s opinions; compare Alexander Hamilton,

Final Version of An Opinion on the Constitutionality of an Act

to Establish a Bank (Feb. 23, 1791), reprinted in 8 The Papers

of Alexander Hamilton, 97, 97–134 (Harold C. Syrett. ed.,

1965), with McCulloch v. Maryland, 17 U.S. (4 Wheat.) 316,

332–34 (1819) (parroting Hamilton’s reasoning).

27

Of course, incorporation cannot be used as a backdoor for

wholesale abdication of an agency’s statutory duties. But FWS

did not “delegate its responsibility” to reach an independent

opinion. Gerber v. Norton, 294 F.3d 173, 185 (D.C. Cir. 2002).

The environmental baseline is simply a factual compilation of

the status quo ante. FWS rendered an independent no-jeopardy

determination based on its assessed risks to species; it simply

relied, in part, on the data of the EPA (and Florida) to capture

baseline conditions. Nothing in the ESA requires FWS to

gather that information independently. See Sw. Ctr. for

Biological Diversity v. Babbitt, 215 F.3d 58, 60 (D.C. Cir.

2000). To the contrary, FWS must rely on the “the best . . .

data available” whatever the data’s origin. 16 U.S.C.

§ 1536(a)(2).

b. Effects of the Action

A BiOp must also include “[a] detailed discussion of the

effects of the action on listed species or critical habitat.” 50

C.F.R. § 402.14(h). The effects of the action are broadly

defined by regulation to include “the consequences of other

activities that are caused by the proposed action,” even if

“outside the immediate area involved in the action.” 50 C.F.R.

§ 402.02. Again, Appellees fault FWS for taking a guild-based

approach rather than conducting a species-specific analysis.

And again, their argument fails under the regulation for the

reasons it failed under the functionally identical statutory text:

the granularity Appellees demand is nowhere in law.

Appellees next fault FWS for assessing the effects of

dredge-and-fill activities on guilds “at the 30,000-foot level.”

Red Br. 41. Their altimeter might ring true but they use the

wrong sight line.

FWS was charged with measuring the effects of “the

action” on listed species and habitats. 50 C.F.R. § 402.14(h)

28

(emphasis added). The relevant action is not any individual

dredge or fill. Indeed, it is not any current action that may

affect a species or habitat. Instead, FWS must compare one

speculative future to another: a world in which the Army Corps

retains § 404 authority and a world in which Florida assumes

control. As it explained, “uncertainties surrounding the

location, timing, frequency, and intensity of State 404 permit

actions” necessarily rendered FWS’s task an exercise of

informed conjecture. J.A. 2656. Nevertheless, FWS gave a

more than adequate account of the discernible effects of the

EPA’s transfer. Based on the best available evidence, FWS

determined that transfer “is not expected to increase or

decrease the future number of CWA section 404 regulated

activities.” J.A. 2657. FWS further determined that the

technical assistance process it designed would be “as

protective” of listed species and critical habitat “as the section

7 interagency consultation processes that occur in the operation

of [the Corps’] 404 Program.” Id. Accordingly, FWS used

historic § 7 data to guide its approach.

FWS first identified 235 species that could be affected by

Florida’s assumption of § 404 permitting. It then explained the

types of activities that could lead to dredge or fill permits,

including agriculture, commercial development and mining,

among others. It delineated between the retained and assumed

waters of the United States and described the habitats contained

therein. It also categorized different types of effects on listed

species, which FWS termed “stressors.” It then discussed how

these stressors would affect guilds of species at the “macro”

level, explaining that the approach taken was “intentionally

broad” because “[i]mpact analysis on the species level” was

contained in a separate table. J.A. 2660–66; see J.A. 2426–76

(individualizing the species).

29

Appellees contend that FWS’s approach cloaked

meaningful differences within guilds. Their argument is belied

by the record. Take mammals. FWS divided the “mammals”

guild—consisting of just twenty-two animals—into seven

different subgroups based on their environment:

wetland/marsh, forest/grasslands/swamps, tropical hardwood

hammock/mangrove, caves, pine rockland, beach/scrub dune

and aquatic. It then assessed the anticipated effects of the

EPA’s transfer on each subgroup based on potential dredge and

fill activities in their shared habitats. FWS’s approach was

meticulous. It concluded that seventeen mammals were likely

to be adversely affected by the action but the remaining five

were not. Even within subgroups, FWS reached differing

outcomes for individual species. For example, FWS concluded

that the Red Wolf was not likely to be adversely affected but

the Florida Panther was, despite both occupying the

“forests/grasslands/swamps” subgroup. Similar fine-tuned

distinctions are found throughout the BiOp.13

As evidence to the contrary, Appellees highlight that

“FWS lumped together the threatened key largo woodrat with

the endangered Florida bonneted bat” when “[h]abitat loss is

the predominant threat to the woodrat, while the bonneted bat

is also affected by water quality changes.” Red Br. 41–42.

This is precisely the sort of “flyspeck[ing]” of an agency’s ESA

determinations that we have repeatedly rejected. El Puente,

100 F.4th at 246 (quoting Sierra Club v. DOE, 867 F.3d 189,

196 (D.C. Cir. 2017)); accord City of Waukesha v. EPA, 320

13

Although FWS analyzed individual species to assess whether

they were likely to be affected by the EPA’s action, its no-jeopardy

determination looked exclusively at species guilds because the

protections of the technical assistance process protected each species

in a similar manner. As explained supra II.A.2., an exclusively

guild-based assessment is consistent with the EPA if groups of

species will be similarly affected (or protected).

30

F.3d 228, 247 (D.C. Cir. 2003) (per curiam) (noting the

“extreme degree of deference” we accord to an agency

“evaluating scientific data within its technical expertise”)

(citation omitted). But even accepting Appellees’ proffered

evidence, they are hoist on their own petard. FWS identified

three listed mammals inhabiting the “tropical hardwood

hammock/mangrove” habitat. Two of these mammals—the

Florida Bonneted Bat and the Key Largo Woodrat—were both

listed as likely to be affected but for differing reasons. The

third—the Key Largo Cotton Mouse—was deemed unlikely to

be affected by the EPA’s transfer due to the species’ restricted

range. Appellees’ own evidence, apparently unintentionally,

manifests the fastidious approach FWS took in the Biological

Opinion.

c. FWS’s Opinion

Finally, FWS was required to include its opinion on

whether the EPA’s transfer of § 404 authority is likely “to

jeopardize the continued existence of a listed species or result

in the destruction or adverse modification of critical habitat.”

50 C.F.R. § 402.14(h). Appellees contend that FWS violated

that final step because it “did not analyze the baseline or

effects” and therefore lacked “a substantive basis to” reach its

no-jeopardy determination. Red Br. 42. As explained above,

FWS analyzed both the baseline and the effects. There is no

dispute that FWS offered an opinion; Appellees simply

disagree with it. That is an issue subject to arbitrary and

capricious review, which is addressed next.

4. The BiOp’s Substantive Determination is not

Arbitrary or Capricious

Appellees have a tough row to hoe. To prevail, they must

show that the BiOp “is not a product of reasoned

decisionmaking”—“a heavy burden, since State Farm entails a

31

very deferential scope of review that forbids a court from

substituting its judgment for that of the agency.” Van Hollen,

Jr. v. FEC, 811 F.3d 486, 495 (D.C. Cir. 2016) (citation

modified). That principle is no less true when an agency deals

with unavoidable uncertainty, as “[v]irtually every decision

must be made under some uncertainty; the question is whether

[FWS’s] response, given uncertainty, is supported by

substantial evidence and not arbitrary and capricious.” Dept of

Interior v. FERC, 952 F.2d 538, 546 (D.C. Cir. 1992). If data

is uncertain, the Court must “proceed with particular caution,

avoiding all temptation to direct the agency between rational

alternatives.” Am. Wildlands v. Kempthorne, 530 F.3d 991,

1000 (D.C. Cir. 2008) (citation omitted).

Appellees spill lots of ink explaining that programmatic

consultation cannot be used as an end-run around § 7. But no

one says it can. The question is whether FWS properly reached

a no-jeopardy determination in light of future structural

safeguards.

On the merits, FWS reasonably reached a no-jeopardy

determination. As FWS emphasized from the outset,

“substantial uncertainty” attached to any good-faith effort to

predict how Florida’s assumption of permitting authority

would affect individual listed species and habitats. J.A. 2644.

Rather than engage in rote speculation about future Floridian

permits—or simply assume away the problem wholesale—

FWS sensibly crafted a mechanism for follow-on review to

ensure ESA protections permit-by-permit. And based on that

permit-by-permit review, FWS reasonably concluded that it

was not “more likely than not” that the EPA’s transfer would

“jeopardize a species.” Me. Lobstermen’s Ass’n v. Nat’l

Marine Fisheries Serv., 70 F.4th 582, 595 (D.C. Cir. 2023).

32

Appellees insist that uncertainty does not authorize FWS

to defer to a later date a species-by-species assessment of the

harms emanating from transfer. They argue that FWS should

have given its best account of projected harms, “even if [the

data] is ‘quite inconclusive.’” Red Br. 46–47 (quoting Babbitt,

215 F.3d at 60). But Babbitt simply rejected the argument that

the Services are required to independently generate better data

if the data is inconclusive. Babbitt, 215 F.3d at 60–61. It did

not hold that agencies possessing only inconclusive data must

nevertheless project the consequences of their action ad

infinitum. To the contrary, if we required perfect foresight of

the “relevant environmental effects” “before action may be

taken, . . . it is doubtful that any project could ever be initiated.”

Andrus, 580 F.2d at 473 (quoting Jicarilla Apache Tribe of

Indians v. Morton, 471 F.2d 1275, 1280 (9th Cir. 1973)); see

also Me. Lobstermen’s Ass’n, 70 F.4th at 596 (“To say

uncertainty is a reason to veto a federal action is to say that

many valuable activities must cease, even if the risk of

jeopardy is not ‘likely’”); cf. Hamilton, supra (“If the abuses of

a beneficial thing are to determine its condemnation, there is

scarcely a source of public prosperity, which will not speedily

be closed”). There is sometimes “no substitute for reviewing

the actual results of a regulatory action.” Elec. Consumers Res.

Council v. FERC, 407 F.3d 1232, 1238 (D.C. Cir. 2005)

(citation omitted). That does not mean that FWS may forego

ESA assessment before the relevant agency action is complete.

It simply means that FWS’s conclusion must utilize the tools at

hand. Here, FWS properly accounted for post-action

safeguards built into Florida’s permitting scheme.

Our Court has repeatedly relied on an agency’s future

oversight as a basis for present-day approval. See Blumenthal

v. FERC, 552 F.3d 875, 882 (D.C. Cir. 2009) (“FERC

reasonably relied on its continuing oversight of the market”);

Elec. Consumers Res. Council, 407 F.3d at 1239 (“[T]he

33

deference the court affords the Commission is based on the

understanding that the Commission will monitor its experiment

and review it accordingly”). That principle applies with added

vigor in the environmental context. See, e.g.,

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