PUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

DOW AGROSCIENCES LLC; 

MAKHTESHIM AGAN OF NORTH

AMERICA, INC.; CHEMINOVA, INC.

USA,

Plaintiffs-Appellants,  No. 09-1968

v.

NATIONAL MARINE FISHERIES

SERVICE; ERIC C. SCHWAAB,

Defendants-Appellees. 

Appeal from the United States District Court

for the District of Maryland, at Greenbelt.

Alexander Williams, Jr., District Judge.

(8:09-cv-00824-AW)

Argued: October 27, 2010

Decided: March 2, 2011

Before NIEMEYER, SHEDD, and AGEE, Circuit Judges.

Reversed and remanded by published opinion. Judge Niemeyer wrote the opinion, in which Judge Shedd and Judge

Agee joined.
COUNSEL

ARGUED: Christopher Landau, KIRKLAND & ELLIS,

LLP, Washington, D.C., for Appellants. Robert Parke Stockman, UNITED STATES DEPARTMENT OF JUSTICE,

Washington, D.C., for Appellees. ON BRIEF: David B.

Weinberg, Eric Andreas, WILEY REIN LLP, Washington,

D.C.; David Menotti, Warren U. Lehrenbaum, PILLSBURY

WINTHROP SHAW PITTMAN LLP, Washington, D.C.;

Michael D. Shumsky, KIRKLAND & ELLIS, LLP, Washington, D.C., for Appellants. Ignacia S. Moreno, Assistant Attorney General, Andrew C. Mergen, Michael T. Gray, Meredith

L. Flax, Pamela B. Lawrence, Environmental & Natural

Resources Division, UNITED STATES DEPARTMENT OF

JUSTICE, Washington, D.C., for Appellees.

OPINION

NIEMEYER, Circuit Judge:

The question presented by this appeal is whether a "biological opinion" issued by the National Marine Fisheries Service

to the Environmental Protection Agency (EPA) pursuant to

the Fisheries Service’s consulting role under the Endangered

Species Act is subject to judicial review in the district court

under the Administrative Procedure Act (APA), 5 U.S.C.

§ 704. The Fisheries Service, which provided the biological

opinion to the EPA as part of the EPA’s process of reregistering for sale and use the insecticides chlorpyrifos, diazinon,

and malathion, concluded that the insecticides will destroy or

harm Pacific salmonids and their habitat.

Pesticide manufacturers who hold the registrations for

those insecticides commenced this action to challenge the biological opinion. The district court dismissed the action, concluding that the biological opinion is not reviewable under the

2 DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES
APA because the EPA has not yet acted on the biological

opinion and when it does issue a final order on whether to

reregister the insecticides, the order, including the biological

opinion, will be subject to judicial review in a court of

appeals, as authorized in the Federal Insecticide, Fungicide,

and Pesticide Act (FIFRA), 7 U.S.C. § 136n.

In this appeal from the district court’s dismissal order, we

conclude that, under Bennett v. Spear, 520 U.S. 154 (1997),

the Fisheries Service’s biological opinion is a final agency

action and that deferring judicial review of the biological

opinion until the EPA acts on reregistration of the insecticides

would not provide the manufacturers adequate review of the

biological opinion. Accordingly, we conclude that the Fisheries Service’s biological opinion is judicially reviewable

under § 704 of the APA. We reverse and remand for further

proceedings in the district court.

I

The issue whether the Fisheries Service’s biological opinion is reviewable in court under § 704 of the APA or is only

reviewable in a court of appeals after the EPA issues an order

on the reregistration of the three insecticides at issue, as

authorized by FIFRA, 7 U.S.C. § 136n, can better be resolved

with an understanding of the interaction of two statutory

schemes—the Endangered Species Act of 1973 (ESA) and

FIFRA. If FIFRA provides adequate judicial review of a biological opinion issued by the Fisheries Service to the EPA,

then judicial review under the APA is unavailable. See 5

U.S.C. § 704 (authorizing judicial review if there is "no other

adequate remedy in a court").

A

Congress enacted the ESA "to conserve endangered species

and threatened species," 16 U.S.C. § 1531(c)(1), and to that

end the ESA requires each federal agency in carrying out its

DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES 3
functions to "insure" that its actions are "not likely to jeopardize the continued existence of any endangered species or

threatened species or result in the destruction or adverse modification of habitat" deemed critical to such species, id.

§ 1536(a)(2). The Act requires that the Secretary of the Interior publish a list of those species that the Secretary determines to be endangered or threatened. Id. § 1533(c)(1). The

Act also makes it unlawful for any person to "take" any

endangered species, meaning to "harass, harm, pursue, hunt,

shoot, wound, kill, trap, capture, or collect" the species. Id.

§ 1538(a)(1)(B); id. § 1532(19).

When a federal agency’s action is likely to jeopardize the

existence of any endangered species, the agency is required to

consult or confer with the Secretary of the Interior to engage

in a process under which the Secretary provides an opinion

evaluating the agency’s actions under the ESA. Id. § 1536(a).

Consultation and conferral with the Secretary require that the

agency, called the "acting agency," interact with either the

National Marine Fisheries Service or the U.S. Fish and Wildlife Service as "the consulting agency," depending on the species or habitat involved. 50 C.F.R. §§ 402.01, 402.14. The

consulting agency is then required to review all relevant information, to make evaluations of the acting agency’s proposed

actions and the effects of its actions on the species or its habitat, and to issue a "biological opinion" ("BiOp") as to whether

the agency’s proposed 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)(4), (h). The consulting agency’s issuance of a

BiOp terminates the formal consultation between the acting

agency and the consulting agency. 50 C.F.R. § 402.14(l).

The acting agency may then take under advisement the

consulting agency’s recommendations, as stated in the BiOp,

and decide how to proceed. If the acting agency chooses to

comply with the terms and conditions of the BiOp, the acting

agency and its employees become exempt from prosecution

4 DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES
for any violation of the ESA, thus providing a "safe harbor."

16 U.S.C. § 1536(o)(2). The safe harbor also protects applicants for registration of pesticides or holders of those registrations. The acting agency may also choose not to comply with

the BiOp. But in any event, the acting agency is not free to

alter either the BiOp, which is the final decision of another

agency, or the safe harbor created by the BiOp. See Bennett,

520 U.S. at 169-70.

B

The acting agency in this case is the EPA in its capacity as

the Administrator of FIFRA.

FIFRA provides that "no person in any State may distribute

or sell to any person any pesticide that is not registered [with

the EPA] under this subchapter." 7 U.S.C. § 136a(a). The

EPA is required to register a pesticide if it determines that

(A) [the pesticide’s] composition is such as to warrant the proposed claims for it;

(B) its labeling and other material required to be

submitted comply with the requirements of this

subchapter;

(C) it will perform its intended function without

unreasonable adverse effects on the environment; and

(D) when used in accordance with widespread and

commonly recognized practice it will not generally cause unreasonable adverse effects on

the environment.

Id. § 136a(c)(5). And FIFRA prohibits manufacturers from

selling or distributing a registered pesticide in a manner

inconsistent with the registration. Id. § 136j.

DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES 5
To ensure that registrations are up to date, 1988 amendments to FIFRA require the EPA to reregister any pesticide

that was first registered before November 1, 1984. 7 U.S.C.

§ 136a-1(a). In the reregistration process, the EPA examines

data to determine whether registered pesticides still meet

FIFRA’s requirements, including the requirements that the

pesticide perform without "unreasonable adverse effects" on

the environment. If a registrant fails to conform to the reregistration process or no longer meets the requisite criteria, the

EPA may deny reregistration and cancel the registration. Id.

§§ 136a-1, 136d. Thus, whenever the EPA determines that a

pesticide or its labeling does not comply with the provisions

of FIFRA or "when used in accordance with widespread and

commonly recognized practice, [the pesticide] generally

causes unreasonable adverse effects on the environment," the

EPA can cancel the pesticide’s registration. Id. § 136d(b).

FIFRA provides for judicial review of the EPA’s pesticide

registration decisions. 7 U.S.C. § 136n. If the EPA issues an

order following a public hearing, its order is reviewable

exclusively in the courts of appeals. If, however, the EPA has

not issued an order following a hearing, its inaction is reviewable in the United States district courts. Id.

II

Chlorpyrifos was first registered in 1965; diazinon, in

1956; and malathion, in 1956. Accordingly, under FIFRA’s

1988 amendments requiring the reregistration of pesticides

registered before November 1, 1984, these insecticides

became subject to reregistration by the EPA.

In January 2001, several environmental groups filed a suit

against the EPA in the Western District of Washington, alleging that the EPA was violating the ESA by failing to consult

with the Secretary of the Interior with respect to the EPA’s

reregistration and continuing approval of 54 active ingredients

in pesticides, including the three insecticides involved in this

6 DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES
case. The district court agreed with the plaintiffs and ordered

the EPA to initiate consultation with the National Marine

Fisheries Service in connection with the pesticide ingredients.

Wash. Toxics Coalition v. EPA, Civ. No. 01-132, 2002 WL

34213031 (W.D. Wash. July 2, 2002). Accordingly, in

December 2004, the EPA initiated formal consultation with

the Fisheries Service on 37 active pesticide ingredients,

including chlorpyrifos, diazinon, and malathion, having concluded that they "may affect" listed Pacific salmonid species

and their habitats. 

When the Fisheries Service failed for several years to issue

its BiOps pursuant to the EPA’s formal consultation, an environmental group filed suit in the Western District of Washington to require the Fisheries Service to issue its BiOps, as

required by the ESA. See Northwest Coalition for Alternatives

to Pesticides v. Nat’l Marine Fisheries Serv., Civ. No. 07-

1791 (W.D. Wash. filed Nov. 5, 2007). The Fisheries Service

settled the suit on July 30, 2008, by agreeing to issue its first

BiOp within 90 days. One day after the settlement agreement,

the Fisheries Service issued a draft of its first BiOp, which

addressed the effects of chlorpyrifos, diazinon, and malathion.

The draft concluded that these insecticides would jeopardize

critical habitat and prey for "evolutionarily significant units"

of 28 Pacific salmonid species that are listed as endangered or

threatened. Shortly after issuing the draft BiOp, the Fisheries

Service opened an online docket to enable persons to comment on the draft until September 15, 2008. On November 18,

2008, it issued its final BiOp on the three insecticides.

The final BiOp concluded that chlorpyrifos, diazinon, and

malathion would jeopardize numerous salmonid species and

adversely affect critical habitat for them. Specifically, it found

that the exposure to these pesticides will kill salmonids and,

even at low exposure levels, will reduce salmonid growth,

reduce the availability of prey, and impair salmonids’ swimming and olfactory senses. In short, the Fisheries Service’s

BiOp concluded that reregistration of the insecticides would

DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES 7
jeopardize the survival of 27 of 28 listed salmonid species and

adversely affect the critical habitat of 25 of the 26 species for

which critical habitat had been designated. The BiOp, however, recommended a "reasonable and prudent alternative" to

the current registrations by (1) requiring setbacks for the

application of insecticides that would be 500 feet away from

salmonid habitats for ground applications and 1,000 feet for

aerial application; (2) limiting application in high wind; (3)

requiring a 20-foot strip of vegetation near surface waters

connected to salmonid habitats; (4) requiring regular reports

concerning fish mortality; and (5) limiting application when

soil moisture is, or is likely to become, high. The BiOp also

issued an "Incidental Take Statement" requiring that the EPA

implement a Fisheries Service approved effectiveness monitoring plan.

Upon the Fisheries Service’s issuance of the final BiOp, the

formal consultation between the EPA and the Fisheries Service ended. See 50 C.F.R. § 402.14(l).

The EPA has yet to release its decision on the reregistration

of chlorpyrifos, diazinon, and malathion. But it has advised

the Fisheries Service by letter that it intends to implement

only some of the Fisheries Service’s proposed label changes

and to adopt its own buffer requirements, which the EPA

stated would accomplish the Fisheries Service’s goals. See

Letter from Richard P. Keigwin, Jr., Director, Special Review

and Reregistration Division, U.S. EPA, to James H. Lecky,

Director, Office of Protected Resources, Nat’l Marine Fisheries Service (Sept. 10, 2009), available at

http://www.epa.gov/oppfead1/endanger/litstatus/wtc/.

Dow AgroSciences LLC, Makhteshim Agan of North

America, Inc., and Cheminova, Inc. USA, manufacturers of

pesticides and holders of registrations for chlorpyrifos, diazinon, and malathion (collectively, "Pesticide Manufacturers"),

commenced this action in the district court against the

National Marine Fisheries Service under § 704 of the APA to

8 DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES
obtain judicial review of the Fisheries Service’s final BiOp

governing chlorpyrifos, diazinon, and malathion. In their

complaint, the Pesticide Manufacturers allege that the Fisheries Service did not comply with the ESA’s mandate that its

BiOp be based on the "best scientific and commercial data

available," 16 U.S.C. § 1536(a)(2). They allege that the Fisheries Service ignored superior scientific studies submitted by

them and supported by the EPA. Additionally, they allege that

the Fisheries Service accelerated the timeline for issuing the

final BiOp, causing the agency not to address material comments submitted in response to the draft BiOp.

On the motion of the Fisheries Service, the district court

dismissed the action for lack of jurisdiction. Dow AgroSciences LLC v. National Marine Fisheries Service, 638 F.

Supp. 2d 508 (D. Md. 2009). The court concluded

In the case before this Court the Biological Opinion

was prepared during an EPA licensing proceeding

under FIFRA. If the EPA relies on the Biological

Opinion and seeks to cancel Plaintiffs’ pesticide registrations, EPA will have to issue an order under

FIFRA. Any such order could only be challenged in

a federal court of appeals.

* * *

As the federal courts of appeals have exclusive jurisdiction over FIFRA orders, the Court finds that it

does not have jurisdiction over matters that could

directly affect the exclusive jurisdiction.

Id. at 513. From the entry of that July 29, 2009 order, the Pesticide Manufacturers timely filed this appeal.

III

The Pesticide Manufacturers contend that the Fisheries Service’s BiOp was a final agency action, as the term is used in

DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES 9
the APA, that is subject to judicial review in the district court.

See 5 U.S.C. § 704. They argue that the BiOp was the "consummation of the [Fisheries Service’s] decisionmaking process" and has "direct and appreciable legal consequences,"

Bennett v. Spear, 520 U.S. 154, 177-78 (1997) (internal quotation marks omitted).

The National Marines Fisheries Service contends that even

if the BiOp is a final agency action, it would be reviewable

in a district court under the APA only if there were "no other

adequate remedy in a court." 5 U.S.C. § 704. The Fisheries

Service claims that in this case "there will be adequate review

of the BiOp by the court of appeals on review of any decision

by the EPA to cancel or alter the registrations as provided by

FIFRA’s special statutory jurisdictional provision," 7 U.S.C.

§ 136n. It maintains, accordingly, that judicial review now in

the district court is not authorized by the APA.

Section 704 of the APA provides that "final agency action

for which there is no other adequate remedy in a court [is]

subject to judicial review." 5 U.S.C. § 704 (emphasis added).

Thus we must determine (1) whether a BiOp is a final agency

action, and (2) whether there is another adequate remedy in

a court for review of the BiOp.

On the first question, the Supreme Court has held that a

BiOp is a final agency action. First, it "mark[s] the ‘consummation’ of the agency’s decisionmaking process"—the Fisheries Service’s work as a consulting, specialist agency.

Bennett, 520 U.S. at 178 (quoting Chicago & Southern Air

Lines, Inc. v. Waterman S.S. Corp., 333 U.S. 103, 113

(1948)). Second, it determines "rights or obligations" or is an

action from which "legal consequences will flow." Id. (quoting Port of Boston Marine Terminal Ass’n v. Rederiakiebolaget Transatlantic, 400 U.S. 62, 71 (1970)). Specifically

addressing the legal consequences of a BiOp, the Court stated:

[The action agency] runs a substantial risk if its

(inexpert) reasons turn out to be wrong. A Biological

10 DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES
Opinion of the sort rendered here alters the legal

regime to which the action agency is subject. . . .

[T]he Biological Opinion’s Incidental Take Statement constitutes a permit authorizing the action

agency to "take" the endangered or threatened species so long as it respects the Service’s "terms and

conditions." The action agency is technically free to

disregard the Biological Opinion and proceed with

its proposed action, but it does so at its own peril

(and that of its employees) for "any person" who

knowingly "takes" an endangered or threatened species is subject to substantial civil and criminal penalties, including imprisonment.

520 U.S. at 169-70; see also id. at 178 ("[T]he Biological

Opinion and accompanying Incidental Take Statement alter

the legal regime to which the action agency is subject, authorizing it to take the endangered species if (but only if) it complies with the prescribed conditions"). Applying Bennett, we

conclude that the Fisheries Service’s BiOp was a final agency

action.

On the second question, whether there is another adequate

remedy in a court for review of the BiOp, FIFRA does provide for judicial review in the court of appeals of "any order

issued by the Administrator [the EPA] following a public

hearing." 7 U.S.C. § 136n(b) (emphasis added). But because

a BiOp is not an "order issued by the Administrator [the

EPA]," the plain language does not provide statutory support

for an argument that a BiOp issued by the Fisheries Service

can be subject to judicial review as part of the FIFRA Administrator’s decision.

Nonetheless, an exclusive judicial review provision applies

to "all issues inhering in the controversy." City of Tacoma v.

Taxpayers of Tacoma, 357 U.S. 320, 336 (1958). Thus, if a

challenge to the BiOp inheres in the challenge to a final EPA

order under FIFRA, it would be reviewable under FIFRA’s

DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES 11
judicial review provisions. We conclude, however, that a

challenge to the adequacy of the Fisheries Service’s BiOp is

not an issue inherent in the EPA’s eventual order on the reregistration of the three insecticides under FIFRA. There are several reasons that support this conclusion.

First, the BiOp has immediate and independent legal consequences that cannot be changed on later review of the

EPA’s action on reregistration, even if the EPA relies on the

BiOp. The EPA’s reregistration of pesticides involves a broad

array of different issues relating to whether the pesticides perform as claimed, their labeling, and their effect on the environment. See 7 U.S.C. § 136a(c)(5). Even though the EPA

must also consider a BiOp, it cannot change it or modify it.

See Bennett, 520 U.S. at 169-70. The BiOp is the final action

of the Fisheries Service that determines whether the use of

certain pesticides will jeopardize an endangered or threatened

species or adversely affect their habitats. To issue a BiOp, the

Fisheries Service develops its own record and makes its own

findings.

In this case, the Fisheries Service concluded that the use of

chlorpyrifos, diazinon, and malathion "is likely to jeopardize

the continued existence" of Pacific salmonids and "is likely to

destroy or adversely modify" their habitats. The Fisheries Service conditioned any further use of chlorpyrifos, diazinon, and

malathion on modifications in their use that were significant.

The conditions require that the insecticides not be applied in

specified areas near salmonid habitats and that they not be

applied anywhere when certain weather factors exist. The

conditions also require that any person applying the insecticides report "all incidents of fish mortality that occur within

four days of application."

Most importantly, the BiOp creates a safe harbor for all

persons. See 16 U.S.C. § 1536(o)(2). If a person, including a

government employee, knowingly "takes" an endangered or

threatened species, that person is subject to civil and criminal

12 DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES
penalties. If, however, a person "takes" a protected species

while complying with the BiOp’s terms, that person is insulated from liability. Thus, as the Supreme Court has noted,

while a BiOp does not create a legally binding prohibition,

"[i]n reality [the BiOp] has a powerful coercive effect." Bennett, 520 U.S. at 169. As the Court explained, the action

agency would "very rarely choose" to act contrary to the Fisheries Service’s recommendation, and if it did so, it would do

so "at its own peril (and that of its employees)," because in

doing so it would lose statutory immunity and expose itself to

the civil and criminal penalties, including imprisonment. Id.

at 170. As the Court pointed out, "The [Fisheries] Service

itself is, to put it mildly, keenly aware of the virtually determinative affect of its biological opinions." Id.

In this way, therefore, any continued use of chlorpyrifos,

diazinon, and malathion is subject to the Fisheries Service’s

BiOp, which "alters the legal regime to which the action

agency [and the Pesticide Manufacturers] is subject," Bennett,

520 U.S. at 169, and the safe harbor from liability under the

ESA is finally and exclusively defined by the BiOp, not by

the EPA’s final reregistration decision under FIFRA.

Second, if the EPA were to choose not to rely on the Fisheries Service’s BiOp, then the BiOp would not be subject to

any review in a judicial proceeding challenging the FIFRA

reregistration order. Yet, the BiOp would still exist, having

significant legal consequences, as we have noted, because it

makes final findings and defines the safe harbor from civil

and criminal liability. Thus, after the EPA’s reregistration

decision, the Pesticide Manufacturers would still be governed

in part by the BiOp. If the Pesticide Manufacturers took an

action that complied with the EPA’s reregistration decision,

but did not comply with all of the terms of the BiOp, they

would not be protected by the BiOp’s safe harbor. In such a

situation, the Pesticide Manufacturers would still be subject to

the legal consequences for "taking" a protected species as

DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES 13
defined by the ESA. Only the BiOp protects persons from liability.

Third, when a court of appeals reviews the EPA’s reliance

on a BiOp issued by the Fisheries Service, the court’s review

would not be the same as if the district court were to review

the BiOp itself directly under the APA. When a court of

appeals reviews the EPA’s reliance on a BiOp, it would determine only whether the EPA’s reliance was arbitrary and

capricious. But only by direct judicial review by the district

court under the APA could the BiOp’s findings and conclusions themselves be challenged. See City of Tacoma v. FERC,

460 F.3d 53, 75 (D.C. Cir. 2006) ("[W]hen we are reviewing

the decision of an action agency to rely on a BiOp, the focus

of our review is quite different than when we are reviewing

a BiOp directly. In the former case, the critical question is

whether the action agency’s reliance was arbitrary and capricious, not whether the BiOp itself is somehow flawed"). As

the court in City of Tacoma explained, while the remedy flowing from the EPA’s inappropriate reliance could result in

reversal of the EPA’s reregistration, because the EPA had no

authority or requirement to address the adequacy of the BiOp

itself, there could never be a basis for the reviewing court to

vacate the BiOp. The BiOp would remain as the final action

of the Fisheries Service which would persist in shaping the

legal regime under which both the action agency and the Pesticide Manufacturers thereafter function. As the Supreme

Court observed, the Fisheries Service’s BiOp would remain

"virtually determinative." See Bennett, 520 U.S. at 170.

Fourth, if the EPA were to choose to follow the Fisheries

Service’s BiOp, any challenge to the EPA’s reliance on the

BiOp on judicial review could not itself cause the EPA to

alter the BiOp. The EPA does not have that authority, and the

Fisheries Service would not be a party to the proceeding. The

only issue that could be reviewed would be the reasonableness of the EPA’s reliance on the BiOp. Even if a court were

to find that the EPA’s reliance was arbitrary and capricious

14 DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES
because of an unreasonable or unsupportable BiOp, the remedy would relate only to reregistration; the BiOp’s final findings and definition of the safe harbor would continue to be in

effect as final agency action, see 50 C.F.R. § 401.14(1), and

its legal consequences could still not be altered, regardless of

the EPA’s reregistration order. See Bennett, 520 U.S. at 169-

70.

Fifth, the plain language of FIFRA’s judicial review provisions does not contain "clear and convincing evidence" that

Congress intended FIFRA’s judicial review provisions to govern review of a BiOp issued by a different agency—the Fisheries Service, which is within the Department of Commerce.

See Abbott Labs. v. Gardner, 387 U.S. 136, 141 (1967)

(requiring "clear and convincing evidence" that Congress

intended to restrict judicial review). Because there is a strong

presumption that Congress intends to allow for judicial review

of final agency actions, see Bowen v. Michigan Academy of

Family Physicians, 476 U.S. 667, 670 (1986), BiOps therefore should be subject to judicial review under the APA. Not

only does FIFRA’s language not provide clearly for judicial

review of BiOps, but also any review under FIFRA would be

restricted to the EPA’s reliance on the BiOps and then only

to those portions on which the EPA relies.

In sum, the BiOp in this case was the final agency action

of the Fisheries Service, which has ongoing legal consequences, and it could not be altered, modified, or changed by

the EPA during its registration process under FIFRA. In some

circumstances, the BiOp might not even be considered by the

EPA, leaving review under the APA as the only avenue for

judicial review. And if the EPA followed the BiOp, only the

EPA’s action in relying on the BiOp, not the adequacy of the

BiOp itself, could be reviewed. In these circumstances, a challenge to an EPA order on registration does not provide an

adequate judicial review of the BiOp.

The circumstances of this case and the statutory roles of the

agencies involved distinguish this case from those in which

DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES 15
agency actions have been found to inhere in final agency

actions. For example, in Telecommunications Research &

Action Ctr. v. FCC, 750 F.2d 70, 75 (D.C. Cir. 1984), the

D.C. Circuit held that resolution of or challenge to an agency’s unreasonable delay in making a decision inhered in that

agency’s final action because the nonfinal nature of the delay

indicated that the process in reaching a decision was a part of

decisionmaking and could not be reviewed independently. See

also Taxpayers of Tacoma, 357 U.S. at 336 (characterizing

"all objections to the order, to the license it directs to be

issued, and to the legal competence of the licensee to execute

its terms" as issues inhering in an order). By contrast, a Fisheries Service’s BiOp and the EPA’s final order under FIFRA

are two distinct final agency actions. While the BiOp might

become part of the EPA’s ruling, the EPA proceeding could

not reopen and modify the BiOp, especially when the Fisheries Service would not be a party to the proceeding.

The Fisheries Service relies on City of Tacoma v. FERC,

460 F.3d 53 (D.C. Cir. 2006), to argue that a BiOp is subject

to exclusive judicial review under the provision provided for

EPA orders in administering FIFRA. In City of Tacoma, the

D.C. Circuit reviewed a challenge to a FERC licensing process in which the plaintiff alleged that FERC relied on flawed

BiOps in its decisionmaking. The D.C. Circuit allowed review

of the BiOps in the course of review of FERC’s action, even

though the proceeding was challenging only FERC’s final

action in relying on the BiOps. Id. at 76. While we do not

determine here whether to follow this decision, any precedential value it might provide is limited to a discussion of

whether a court of appeals could expand the permissive scope

of review when reviewing an acting agency’s action to

include review of the BiOp itself. But a ruling providing for

such an expansion of judicial review does not preclude judicial review of a BiOp under the APA in other procedural circumstances.

The procedural posture in this case is different from that in

City of Tacoma, where reliance on the BiOp was challenged

16 DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES
in connection with the acting agency’s final order. In the procedural posture presented here, where judicial review of a

BiOp itself is sought prior to the acting agency’s final action,

courts have allowed for judicial review of the BiOp, as we do

here. See Miccosukee Tribe v. United States, 566 F.3d 1257,

1264 (11th Cir. 2009); Ctr. for Biological Diversity v. U.S.

Fish & Wildlife Serv., 450 F.3d 930, 940-41 (9th Cir. 2006).

Indeed, even the D.C. Circuit has recognized judicial review

under the circumstances presented here. See Rancho Viejo,

LLC v. Norton, 323 F.3d 1062, 1066 n.1 (D.C. Cir. 2003).

For all of the foregoing reasons, we hold the district court

had jurisdiction over the Pesticide Manufacturer’s complaint

and it therefore erred in dismissing this action for lack of

jurisdiction.

IV

The National Marine Fisheries Service also contends that

plaintiffs’ claims are not ripe for decision because resolution

of them may prove unnecessary once the plaintiffs have

exhausted their administrative remedies before the EPA under

FIFRA.

In resolving the Fisheries Service’s ripeness argument, we

assess two factors: (1) the fitness of the issue for judicial decision and (2) the hardship to the parties of withholding court

consideration. Abbott Labs., 387 U.S. at 149. In determining

whether an issue is fit for judicial decision, we consider the

agency’s interest in "crystallizing its policy before that policy

is subject to review" and the court’s interest in "avoiding

unnecessary adjudication and in deciding issues in a concrete

setting." Reg’l Mgmt. Corp. v. Legal Servs. Corp., 186 F.3d

457, 465 (4th Cir. 1999).

The Fisheries Service’s argument here is based on its view

that the BiOp could become insignificant. As it argues in its

brief, the

DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES 17
EPA is not required to adopt the reasonable and prudent alternative provided in the BiOp, and EPA may

decide to take actions that are acceptable to the Registrants by either declining to modify the FIFRA registrations or adopting less stringent restrictions—in

which case the dispute may never materialize. Alternatively, if EPA decides to take a FIFRA action to

which the registrants object, FIFRA provides the

Registrants an opportunity to demand an administrative hearing. The result of the FIFRA administrative

hearing may satisfy the Registrants without the need

for court intervention.

As we have noted, the Fisheries Service’s BiOp represents

the culmination of its decisionmaking process. Under the

agency’s regulations, the Fisheries Service’s role in consulting with the EPA "is terminated with the issuance of the biological opinion." 50 C.F.R. § 402.14(l). Accordingly, there is

no reason to conclude that the Fisheries Service would crystallize its policy at some later time. See Reg’l Mgmt. Corp.,

186 F.3d at 465. Moreover, because the BiOp will stand as

final agency action even after the EPA’s registration decision

is issued, its effect will never be insignificant. As the Supreme

Court noted in Bennett, a BiOp alters the legal landscape by

allowing persons to comply with the BiOp and avoid ESA

sanctions. Bennett, 520 U.S. at 169-70. Thus, it cannot be said

that the BiOp could become insignificant depending on how

the EPA rules. Indeed, the Pesticide Manufacturers may suffer

hardship simply by delay of judicial review. The BiOp creates

a safe harbor, which, if set incorrectly, can burden the plaintiffs by narrowing the scope of behavior protected from ESA

prosecution.

Accordingly, we conclude that a challenge to the BiOp is

ripe for judicial review at this time.

For the reasons given, we reverse the district court’s order

dismissing this case and remand for further proceedings.

REVERSED AND REMANDED

18 DOW AGROSCIENCES v. NATIONAL MARINE FISHERIES