 Dow Agrosciences LLC; Makhteshim Agan of North America, Inc.; Cheminova, Inc. USA v. National Marine Fisheries Service; Eric C. Schwaab

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 Nie-
meyer wrote the opinion, in which Judge Shedd and Judge
Agee joined.

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COUNSEL
ARGUED: Christopher Landau, KIRKLAND & ELLIS,
LLP, Washington, D.C., for Appellants. Robert Parke Stock-
man, 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, Washing-
ton, D.C., for Appellants. Ignacia S. Moreno, Assistant Attor-
ney 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 "biologi-
cal 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 reregister-
ing 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 bio-
logical opinion. The district court dismissed the action, con-
cluding that the biological opinion is not reviewable under the
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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 Fish-
eries 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 opin-
ion 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 bio-
logical 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
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functions to "insure" that its actions are "not likely to jeopar-
dize the continued existence of any endangered species or
threatened species or result in the destruction or adverse mod-
ification of habitat" deemed critical to such species, id.
§ 1536(a)(2). The Act requires that the Secretary of the Inte-
rior publish a list of those species that the Secretary deter-
mines 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 Wild-
life Service as "the consulting agency," depending on the spe-
cies or habitat involved. 50 C.F.R. §§ 402.01, 402.14. The
consulting agency is then required to review all relevant infor-
mation, to make evaluations of the acting agency’s proposed
actions and the effects of its actions on the species or its habi-
tat, and to issue a "biological opinion" ("BiOp") as to whether
the agency’s proposed action "is likely to jeopardize the con-
tinued 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
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for any violation of the ESA, thus providing a "safe harbor."
16 U.S.C. § 1536(o)(2). The safe harbor also protects appli-
cants for registration of pesticides or holders of those registra-
tions. 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 war-
rant 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 environ-
ment; and
(D) when used in accordance with widespread and
commonly recognized practice it will not gen-
erally 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.
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To ensure that registrations are up to date, 1988 amend-
ments 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 rereg-
istration 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 review-
able 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, alleg-
ing 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
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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 con-
cluded 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 envi-
ronmental group filed suit in the Western District of Washing-
ton 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 com-
ment 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’ swim-
ming and olfactory senses. In short, the Fisheries Service’s
BiOp concluded that reregistration of the insecticides would
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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, how-
ever, 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 moni-
toring plan.
Upon the Fisheries Service’s issuance of the final BiOp, the
formal consultation between the EPA and the Fisheries Ser-
vice 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 Fish-
eries 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, diaz-
inon, and malathion (collectively, "Pesticide Manufacturers"),
commenced this action in the district court against the
National Marine Fisheries Service under § 704 of the APA to
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obtain judicial review of the Fisheries Service’s final BiOp
governing chlorpyrifos, diazinon, and malathion. In their
complaint, the Pesticide Manufacturers allege that the Fish-
eries 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 Fish-
eries 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 com-
ments 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 Agro-
Sciences 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 reg-
istrations, 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 juris-
diction 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 Pes-
ticide Manufacturers timely filed this appeal.
III
The Pesticide Manufacturers contend that the Fisheries Ser-
vice’s BiOp was a final agency action, as the term is used in
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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 "con-
summation of the [Fisheries Service’s] decisionmaking pro-
cess" and has "direct and appreciable legal consequences,"
Bennett v. Spear, 520 U.S. 154, 177-78 (1997) (internal quo-
tation 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 ‘consum-
mation’ of the agency’s decisionmaking process"—the Fish-
eries 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. (quot-
ing Port of Boston Marine Terminal Ass’n v. Rederiakiebola-
get 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
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Opinion of the sort rendered here alters the legal
regime to which the action agency is subject. . . .
[T]he Biological Opinion’s Incidental Take State-
ment constitutes a permit authorizing the action
agency to "take" the endangered or threatened spe-
cies 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 spe-
cies is subject to substantial civil and criminal penal-
ties, 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, autho-
rizing it to take the endangered species if (but only if) it com-
plies 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 pro-
vide 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 Admin-
istrator’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
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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 rereg-
istration of the three insecticides under FIFRA. There are sev-
eral reasons that support this conclusion.
First, the BiOp has immediate and independent legal con-
sequences 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 per-
form as claimed, their labeling, and their effect on the envi-
ronment. 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 Ser-
vice 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 insecti-
cides 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
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penalties. If, however, a person "takes" a protected species
while complying with the BiOp’s terms, that person is insu-
lated 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." Ben-
nett, 520 U.S. at 169. As the Court explained, the action
agency would "very rarely choose" to act contrary to the Fish-
eries 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 deter-
minative 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 Fish-
eries 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
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defined by the ESA. Only the BiOp protects persons from lia-
bility.
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 deter-
mine 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 conclu-
sions 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 capri-
cious, not whether the BiOp itself is somehow flawed"). As
the court in City of Tacoma explained, while the remedy flow-
ing 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 Pes-
ticide 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 reasonable-
ness of the EPA’s reliance on the BiOp. Even if a court were
to find that the EPA’s reliance was arbitrary and capricious
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because of an unreasonable or unsupportable BiOp, the rem-
edy would relate only to reregistration; the BiOp’s final find-
ings 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 provi-
sions does not contain "clear and convincing evidence" that
Congress intended FIFRA’s judicial review provisions to gov-
ern review of a BiOp issued by a different agency—the Fish-
eries 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 there-
fore 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 conse-
quences, 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 chal-
lenge 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
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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 agen-
cy’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 Fish-
eries 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 Fish-
eries 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 pro-
cess 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 preceden-
tial 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 judi-
cial review of a BiOp under the APA in other procedural cir-
cumstances.
The procedural posture in this case is different from that in
City of Tacoma, where reliance on the BiOp was challenged
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in connection with the acting agency’s final order. In the pro-
cedural 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 deci-
sion 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
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EPA is not required to adopt the reasonable and pru-
dent alternative provided in the BiOp, and EPA may
decide to take actions that are acceptable to the Reg-
istrants by either declining to modify the FIFRA reg-
istrations or adopting less stringent restrictions—in
which case the dispute may never materialize. Alter-
natively, if EPA decides to take a FIFRA action to
which the registrants object, FIFRA provides the
Registrants an opportunity to demand an administra-
tive 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 consult-
ing with the EPA "is terminated with the issuance of the bio-
logical opinion." 50 C.F.R. § 402.14(l). Accordingly, there is
no reason to conclude that the Fisheries Service would crys-
tallize 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 plain-
tiffs 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
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