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United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued May 14, 2010 Decided July 16, 2010
No. 09-1314
RECKITT BENCKISER INC.,
PETITIONER
v.
ENVIRONMENTAL PROTECTION AGENCY,
RESPONDENT
Consolidated with No. 09-5437
On Petition for Review of a Final Action
of the Environmental Protection Agency and
Appeal from the United States District Court
for the District of Columbia
(1:09-cv-00445)
Lisa S. Blatt argued the cause for petitioner/appellant. With
her on the briefs were Ronald A. Schechter, Lawrence E.
Culleen, and Michael R. Hartman.
2
Lynn L. Bergeson, Timothy D. Backstrom, and Steven
Schatzow were on the brief for amici curiae Liphatech, Inc. and
Woodstream Corporation in support of petitioner/appellant.
Sambhav N. Sankar, Attorney, U.S. Department of Justice,
argued the cause for respondent/appellee. With him on the brief
were Lisa E. Jones, Robert P. Stockman, and Stephanie J.
Talbert, Attorneys. R. Craig Lawrence, Assistant U.S. Attorney,
entered an appearance.
Before: ROGERS, TATEL and GRIFFITH, Circuit Judges .
Opinion for the Court by Circuit Judge ROGERS.
ROGERS, Circuit Judge: Reckitt Benckiser, Inc.
manufactures pesticides that are subject to regulation under the
Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”),
7 U.S.C. §§ 136–136y. On May 28, 2008, the Environmental
Protection Agency issued a Risk Mitigation Decision for Ten
Rodenticides (the “RMD,” revised June 24, 2008)1 and notified
the company in August 2008 that its registered products
containing these rodenticides would be considered misbranded
on June 14, 2011, unless certain product changes were made.
The company notified EPA that it did not intend to make the
changes and instead intended to challenge the RMD through the
registration cancellation procedures of FIFRA Section 6, 7
U.S.C. § 136d. When EPA did not expeditiously commence
cancellation proceedings, the company filed suit seeking
declaratory and injunctive relief on the ground EPA could not
bypass such proceedings and treat registered products as
1
The RMD is available at http://www.regulations.gov/search/
Regs/home.html#documentDetail?D=EPA-HQ-OPP-2006-0955-0764.
The revision of June 24, 2008, which included a revised timeline, is
also available at this website.
3
misbranded for failure to comply with the RMD. The district
court dismissed the complaint for lack of subject matter
jurisdiction. The company appeals, and we hold that there was
sufficiently final agency action ripe for review, see Ciba-Geigy
Corp. v. U.S. EPA, 801 F.2d 430 (D.C. Cir. 1986), and also that
the district court had jurisdiction pursuant to FIFRA Section
16(a), 7 U.S.C. § 136n(a). Accordingly, we reverse and remand.
I.
The statutory framework for EPA’s issuance of the RMD is
as follows. FIFRA provides that pesticides sold or distributed
in the United States must be registered with EPA. Id. § 136a(a).
A FIFRA registration is a product-specific license describing the
terms and conditions under which the product can be legally
distributed, sold, and used. See id. § 136a(a), (c)–(e). EPA can
only register a pesticide upon determining that “it will perform
its intended function without unreasonable adverse effects on the
environment” and that “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)(C), (D).
In 1978, Congress required EPA to “reregister” all
pesticides “in the most expeditious manner practicable” and to
give priority to food applications. Act of Sept. 30, 1978, Pub. L.
95-396, § 8, 92 Stat. 819, 827 (1978) (amending FIFRA).
Congress enacted FIFRA Section 4 in 1988, setting out the
detailed reregistration procedures for pesticides whose active
ingredients were first registered in a pesticide before November
1, 1984. See 7 U.S.C. 136a-1(a). Reregistration under Section
4 involves five phases, and in phase five EPA determines
whether a particular active ingredient is eligible for
reregistration. See id. § 136a-1(g)(2)(A). If EPA determines not
to reregister a pesticide, it “shall take appropriate regulatory
4
action . . . as expeditiously as possible.” Id. § 136a-1(g)(2)(D).
“Any failure of the Administrator to take any action required
by” Section 4 is subject to judicial review “under the procedures
prescribed by section 136n(b)” for review in a court of appeals.
Id. § 136a-1(m)2; see infra note 3.
A pesticide product remains registered until EPA or the
registrant cancels it pursuant to Section 6, 7 U.S.C. § 136d.
Under Section 6, when it appears to EPA that a registered
pesticide or its labeling does not comply with FIFRA or
“generally causes unreasonable adverse effects on the
environment,” EPA “may” bring cancellation proceedings, id.
§ 136d(b), in which the registrant has the right to demand a
hearing before an Administrative Law Judge (“ALJ”) and can
present evidence and argue for continued registration of its
product, id. § 136d(b), (d); see 40 C.F.R. § 164.80(b).
Registrants can seek review of a cancellation decision by filing
a petition for review in a court of appeals pursuant to Section 16,
2
Section 4(m) provides:
Any failure of the Administrator to take any action required
by this section shall be subject to judicial review under the
procedures prescribed by section 136n(b) of this title.
7 U.S.C. § 136a-1(m).
5
see 7 U.S.C. § 136n(b).3 Subject to certain exceptions, Section
3
Section 16 provides:
(a) District court review
Except as otherwise provided in this subchapter, the refusal of
the Administrator to cancel or suspend a registration or to
change a classification not following a hearing and other final
actions of the Administrator not committed to the discretion
of the Administrator by law are judicially reviewable by the
district courts of the United States.
(b) Review by court of appeals
In the case of actual controversy as to the validity of any order
issued by the Administrator following a public hearing, any
person who will be adversely affected by such order and who
had been a party to the proceedings may obtain judicial
review by filing in the United States court of appeals for the
circuit wherein such person resides or has a place of business,
within 60 days after the entry of such order, a petition praying
that the order be set aside in whole or in part. . . . The court
shall consider all evidence of record. The order of the
Administrator shall be sustained if it is supported by
substantial evidence when considered on the record as a
whole. . . . The commencement of proceedings under this
section shall not, unless specifically ordered by the court to
the contrary, operate as a stay of an order.
(c) Jurisdiction of district courts
The district courts of the United States are vested with
jurisdiction specifically to enforce, and to prevent and restrain
violations of, this subchapter.
7 U.S.C. § 136n.
6
16 provides that parties may obtain district court review of
EPA’s refusal to cancel a registration. See id. § 136n(a).
FIFRA Section 12 prohibits the sale or distribution of
registered but “misbranded” pesticides, id. § 136j(a)(1)(E),
defined to include registered pesticides whose packaging does
not adequately prevent against accidental ingestion, see id.
§ 136(q)(1)(B), or whose labels do not contain directions or
warnings “adequate to protect health and the environment,” id.
§ 136(q)(1)(F), (G). EPA has several options for addressing
pesticide products it concludes are misbranded: EPA can assess
civil administrative penalties against anyone who distributes a
misbranded pesticide, see id. § 136l(a); the charged party has a
right to hearing in which EPA must persuade an ALJ that the
person violated FIFRA, see id. § 136l(a)(3); 40 C.F.R. § 22.24.
EPA can pursue a criminal misbranding action, in which it bears
the burden to prove a violation beyond a reasonable doubt. See
id. § 136l(b). EPA also can issue, pursuant to FIFRA Section
13, “stop sale, use, or removal” orders and can commence court
proceedings to seize the pesticide. See id. § 136k(a), (b).4
EPA issued the RMD on May 28, 2010 (as revised June 24,
2008) as “the Agency’s final decision on the reregistration
eligibility of rodenticide products” that contained “one or more”
4
EPA has generally limited use of such stop sale orders
to “relatively serious” FIFRA violations. See EPA OFFICE OF
COMPLIANCE MONITORING, OFFICE OF PESTICIDES & TOXIC
SUBSTANCES, ENFORCEMENT RESPONSE POLICY FOR THE
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT
(FIFRA) 7 (1990), available at http://www.epa.gov/
compliance/resources/policies/civil/fifra/fifraerp.pdf.
7
of ten active ingredients,5 and also “the Agency’s final action in
response to the remand order” in West Harlem Environmental
Action v. EPA, 380 F. Supp. 2d 289, 296 (S.D.N.Y. 2005).
RMD at 1. In seeking to minimize children’s exposure to
rodenticide products containing the ingredients, the RMD
required such products to be marketed in bait stations, e.g., as
solid bait in tamper-resistant containers, rather than as loose
pellets or meal. See RMD at 1, 11. Seeking to minimize
wildlife exposure to and ecological risks from the ingredients,
the RMD prohibited marketing to general consumers for
residential use any rodenticide containing the second-generation
anticoagulants brodifacoum, bromadiolone, difenacoum, or
difethialone. See id. at 2, 16. The RMD also set restrictions on
the weight, labeling, and distribution of products containing one
of the ten rodenticides. See, e.g., id. at 17–19. The RMD stated
that affected products otherwise “would present unreasonable
risks inconsistent with FIFRA.” Id. at 25. The RMD warned
that EPA “may take regulatory action to address the risk
concerns from the use of the affected products” if a registrant
failed to comply with the RMD, and that while EPA “may
initiate cancellation actions” against products whose
manufacturers did not voluntarily comply with the RMD,
“[r]odenticide products that do not comply with this Risk
Mitigation Decision that a registrant releases for shipment after
June 4, 2011, would be considered misbranded.” Id. at 25–26
(emphasis added). In other words, EPA considered products
covered by the RMD misbranded as of the date of the RMD, but
provided a three-year “grace period” for compliance before
5
The ten rodenticide ingredients covered by the RMD were:
the “first-generation” anticoagulants warfarin (and its sodium salt),
chlorophacinone, and diphacinone (and its sodium salt); the “second-
generation” anticoagulants brodifacoum, bromadiolone, difenacoum,
and difethialone; and the non-anticoagulants bromethalin,
cholecalciferol, and zinc phosphide. RMD at 2.
8
registrants would be subject to misbranding actions. Oral Arg.
12:55–13:28; 25:35–52.
Reckitt Benckiser markets to consumers, under the brand
name d-CON®, registered rodenticide products that contain
ingredients prohibited by the RMD or contain ingredients
allowed by the RMD but in a pellet form prohibited by the
RMD. On June 18, 2008, by certified mail, EPA notified the
company of the RMD, described procedures for responding, and
repeated the RMD’s warnings that “[r]odenticide products that
do not comply . . . that a registrant releases for shipment after
June 4, 2011, would be considered misbranded” (emphasis
added) and that EPA “will initiate cancellation actions against
products for which it does not receive notification of the
registrant’s intent to comply.”6 The company responded that it
did not intend to comply with the RMD,7 and requested that
EPA “expeditiously commence” cancellation pursuant to
Section 6 for Reckitt Benckiser’s products affected by the
RMD.8 When EPA did not do so, the company filed suit on
March 3, 2009, for injunctive and declaratory relief, seeking an
order directing EPA to begin cancellation proceedings and
6
Letter from Steven Bradbury, Ph.D., Director of the Special
Review and Reregistration Division, EPA Office of Prevention,
Pesticides, and Toxic Substances, to Linda Jenkins, Reckitt Benckiser
Inc., at 2, 5 (June 18, 2008) (“2008 Letter”) (emphasis added).
7
Letter from Liane Jenkins, Senior Regulatory Specialist,
Reckitt Benckiser Inc., to Susan Lewis, Branch Chief, Special Review
& Reregistration Division, EPA Office of Pesticide Programs (Aug.
28, 2008).
8
Letter from Ronald A. Schechter and Lawrence E. Culleen,
Arnold & Porter LLP, to Susan Lewis, Branch Chief, Special Review
& Reregistration Division, EPA Office of Pesticide Programs (Jan. 9,
2009).
9
enjoining EPA from beginning misbranding proceedings prior
to their completion. The district court dismissed the complaint
for lack of subject matter jurisdiction, concluding that the
company’s claims arose under the reregistration provisions of
Section 4 and thus invoked the judicial review provisions of
Section 4(m), 7 U.S.C. § 136a-1(m), which provides for initial
review in the court of appeals.
The company appeals, and in the alternative filed a petition
in this court seeking review of EPA’s failure to act pursuant to
FIFRA; this court consolidated the cases. Our review of the
dismissal of the complaint is de novo. See Am. Fed’n of Gov’t
Employees, 475 F.3d 341, 347 (D.C. Cir. 2007).
II.
Reckitt Benckiser’s lawsuit challenges neither the substance
of the RMD nor EPA’s authority to bring certain misbranding
actions instead of or before Section 6 cancellation where a
product fails to bear a label consistent with the terms of that
product’s registration. See Appellant’s Br. 7, 8 & n.1. Instead
the company challenges EPA’s interpretation that under FIFRA
it has authority to commence enforcement proceedings for
misbranding against the company’s non–RMD-conforming
products without first cancelling their registrations pursuant to
Section 6, in effect canceling the registrations without following
the regulatory procedures provided in Section 6. EPA maintains
its misbranding threat is neither final agency action nor ripe for
review. We first address the threshold question of whether
EPA’s interpretation of its FIFRA misbranding enforcement
authority is ripe for judicial review. See Wyo. Outdoor Council
v. U.S. Forest Serv., 165 F.3d 43, 47–50 (D.C. Cir. 1999). We
conclude that our decision in Ciba-Geigy, 801 F.2d 430,
controls.
10
In Ciba-Geigy, much as here, the “principal issue” was
whether EPA’s interpretation of FIFRA as allowing misbranding
proceedings upon bypassing cancellation proceedings for failure
to comply with labeling changes was ripe for review. Id. at 435.
EPA had issued a “Registration Standard” for the registered
pesticide simazine and notified Ciba-Geigy and other simazine
registrants that EPA “intends to institute cancellation
proceedings” against products that did not comply with the
Registration Standard within nine months, and that non-
compliant products “will be considered misbranded” after the
deadline. Id. at 432 (emphasis added). Ciba-Geigy informed
EPA it did not intend to comply voluntarily with the Registration
Standard. Id. at 433. After the compliance deadline had passed,
EPA responded that “[i]t is the Agency’s position” that products
not complying with the Registration Standard “are misbranded”
under FIFRA, and that “the Agency does not agree with [Ciba-
Geigy’s] interpretation” of FIFRA that cancellation proceedings
were required before misbranding proceedings. Id. (first
alteration in Ciba-Geigy). Ciba-Geigy filed suit seeking a
declaration that EPA had failed to follow procedures required by
law when requiring labeling changes and use restrictions. The
district court dismissed the complaint for lack of subject matter
jurisdiction, concluding EPA had neither issued a final order nor
taken any other final action reviewable by a court. Reversing,
this court held that under Abbott Laboratories v. Gardner, 387
U.S. 136 (1967), abrogated on other grounds, Califano v.
Sanders, 430 U.S. 99 (1977), the challenge to EPA’s
interpretation of its FIFRA misbranding authority was ripe for
judicial review in the district court. Ciba-Geigy, 801 F.2d at
434–39.
Determining ripeness requires a court to evaluate “the
fitness of the issues for judicial decision and the hardship to the
parties of withholding court consideration.” Abbott Labs., 387
U.S. at 149. In addition to evaluating “whether delayed review
11
would cause hardship” to Reckitt Benckiser, this court must
consider “whether judicial intervention would inappropriately
interfere with further administrative action” and “whether the
courts would benefit from further factual development of the
issues presented.” Ohio Forestry Ass’n, Inc. v. Sierra Club, 523
U.S. 726, 733 (1998). Thus the fitness of an issue for review
depends on whether (1) “the issue presented is a purely legal
one,” (2) “consideration of that issue would benefit from a more
concrete setting,” and (3) “the agency’s action is sufficiently
final.” Ciba-Geigy, 801 F.2d at 435; see Abbott Labs., 387 U.S.
at 148; Nevada v. Dep’t of Energy, 457 F.3d 78, 85 (D.C. Cir.
2006). In Bennett v. Spear, 520 U.S. 154, 177–78 (1997), the
Supreme Court, in interpreting the Administrative Procedure Act
(“APA”), 5 U.S.C. § 704, held that the finality of an agency’s
action depends on whether it marks the “consummation of the
agency’s decisionmaking process” and is not “of a merely
tentative or interlocutory nature,” and determines “rights or
obligations” or is otherwise an action “from which legal
consequences will flow” (quotation marks omitted). Although
the court’s ripeness analysis in Ciba-Geigy predated Bennett v.
Spear, this court has treated the analysis of finality in relation to
ripeness in Ciba-Geigy as “complementary” to that of Bennett.
John Doe, Inc. v. DEA, 484 F.3d 561, 566 (D.C. Cir. 2007).
EPA’s interpretation of FIFRA as providing authority to
bypass Section 6 regulatory cancellation proceedings and
commence misbranding enforcement proceedings for failure to
comply with the RMD is fit for judicial review. First, EPA’s
interpretation raises “a pure legal question as to what procedures
EPA [i]s obliged to follow” under FIFRA when implementing
the RMD. Ciba-Geigy, 801 F.2d at 435. As counsel for EPA
explained at oral argument, “it is EPA’s view that we do not
need to bring a cancellation procedure before bringing a
misbranding action.” Oral Arg. 35:48–54. EPA “has not sought
to justify its interpretation of [FIFRA] on the basis of the specific
12
facts of the case,” Ciba-Geigy, 801 F.2d at 435, but has instead
adopted an interpretation of FIFRA that would apply in many
situations involving a labeling change to a registered pesticide.
Second, although EPA had identified the specific FIFRA
misbranding provisions it considered Ciba-Geigy products to be
violating, id. at 433, the lack of such factual development
regarding which specific FIFRA misbranding provisions EPA
might apply to Reckitt Benckiser’s products does not make
EPA’s interpretation unripe for review. Specification of the
misbranding provisions EPA considers a product to be violating
would not change EPA’s interpretation of FIFRA in the
reregistration RMD situation here. EPA has informed the
company of its interpretation and “steadfast[ly]” declined to
bring cancellation proceedings, as the company requested. Id. at
437. As in Ciba-Geigy, the court “has no reason to believe that
our consideration of the issue would be facilitated by further
factual developments.” Id. at 433.
Third, for similar reasons, EPA’s interpretation of its
misbranding authority under FIFRA is “sufficiently final”
agency action. Id. at 435. As in Ciba-Geigy, where EPA
unambiguously stated that the registrant was not entitled to a
cancellation proceeding before complying with proposed
pesticide labeling changes, id. at 437, EPA’s interpretation of its
authority here is definitive. EPA unequivocally informed Reckitt
Benckiser that its non–RMD-complying products “would be
considered misbranded” after June 4, 2011, see 2008 Letter at 2
(emphasis added), supra note 6, without regard to whether EPA
would have initiated or completed Section 6 proceedings to
cancel those products’ registrations. EPA suggests this statement
“assumes for now that the agency could bring a misbranding
action against the company’s products,” Appellee’s Br. 41, and
confirmed at oral argument that it had taken the position that “we
do not need to bring a cancellation procedure before bringing a
13
misbranding action,” Oral Arg. 35:48–54. As in Ciba-Geigy,
801 F.2d at 437, EPA’s statements “gave no indication that
[they] w[ere] subject to further agency consideration or possible
modification.” There is thus little chance that “judicial review
will disrupt the orderly process of administrative
decisionmaking” regarding EPA’s interpretation of its FIFRA
misbranding authority. Id. Furthermore, as the court explained
in Ciba-Geigy, 801 F.2d at 437, EPA, which is charged with
administering FIFRA, has made an authoritative interpretation of
its FIFRA misbranding authority that has practical and
significant legal effects.
With respect to hardship, EPA’s interpretation of its FIFRA
misbranding authority, as with the registrant in Ciba-Geigy, 801
F.2d at 438–39, has had a “direct effect” on Reckitt Benckiser’s
“day-to-day business.” Abbott Labs., 387 U.S. at 152.
According to sworn declarations by company officials, the
company has been forced to spend hundreds of thousands of
dollars on research and development of RMD-compliant
products and expects it will cost an additional one million dollars
to conclude development of these products by the June 4, 2011
deadline.9 The company also anticipates continued loss of sales
and sales opportunities as customers stop carrying its products
and it is forced to offer other products containing what the
company views as less effective active ingredients.10 See also
Envtl. Def. Fund v. Ruckelshaus, 439 F.2d 584, 591–92 (D.C.
Cir. 1971).
9
Pet. for Review Ex. 8, Decl. of David Long, Reckitt
Benckiser Inc., Vice President of Regional Regulatory and Medical
Affairs for North America, ¶ 7 (Dec. 17, 2009).
10
Long Decl. ¶ 11, supra note 9; Pet. for Review Ex. 9, Decl.
of Debra Eible, Reckitt Benckiser Inc., U.S. Multi-Surface and Pest
Control Marketing Director ¶¶ 7, 10 (Dec. 17, 2009).
14
The factual distinctions from Ciby-Geigy on which EPA
relies are immaterial. Here, unlike in Ciba-Geigy, the
compliance deadline has not passed. This distinction is
attributable to the shorter nine-month compliance deadline in
Ciba-Geigy, 801 F.2d at 432–33, while the RMD provided a
three-year grace period. Also here, unlike in Ciba-Geigy, EPA
has not decided whether to bring proceedings against Reckitt
Benckiser’s products, nor whether to bring misbranding
proceedings before or instead of Section 6 cancellation
proceedings. Even assuming Section 4 affords EPA discretion
upon deciding not to reregister a product to choose which
“appropriate regulatory action” to take “as expeditiously as
possible,” 7 U.S.C. § 136a-1(g)(2)(D), the issue raised by the
company is whether EPA has properly interpreted FIFRA to
allow enforcement proceedings for misbranding to bypass
cancellation proceedings as a means of implementing the RMD.
See Ciba-Geigy, 801 F.2d at 435. Regardless of whether
Congress broadened EPA’s enforcement discretion in Section 4,
because EPA has provided a definitive and sufficiently final
interpretation of its FIFRA misbranding authority, judicial
review of that interpretation would not interfere with EPA’s
administrative decisionmaking processes.
EPA’s view that its statement that non–RMD-complying
products “would be considered misbranded” after June 4, 2011
is not reviewable final agency action fails to address the finality
of EPA’s interpretation of FIFRA as allowing it to bypass
Section 6 cancellation proceedings in the implementation of the
RMD. The cases on which EPA relies address the finality of
EPA’s decision whether or not to bring enforcement proceedings
for misbranding rather than the finality of EPA’s interpretation
of its procedural FIFRA misbranding authority. EPA’s
interpretation is not less final because the court “do[es] not
know” whether, Reliable Automatic Sprinkler Co. v. Consumer
Prod. Safety Comm’n, 324 F.3d 726, 733 (2003), or “ha[s] no
15
idea whether or when,” Toilet Goods Ass’n v. Gardner, 387 U.S.
158, 163 (1967), EPA will bring enforcement proceedings for
misbranding bypassing regulatory cancellation proceedings.
Neither does EPA’s interpretation “merely express[] its view of
what the law requires of a party,” Indep. Equip. Dealers v. EPA,
372 F.3d 420, 427 (D.C. Cir. 2004) (quoting AT&T Co. v. EEOC,
270 F.3d 973, 975 (D.C. Cir. 2001)). Instead, EPA’s
interpretation had the “definitiveness and direct and immediate
effect” that the court in Ciba-Geigy, 801 F.2d at 436 (quotation
marks omitted), held was dispositive of finality. As the court
discussed in Ciba-Geigy, id. at 435, while the Supreme Court in
FTC v. Standard Oil Co. of California, 449 U.S. 232, 241–42
(1980), held that the issuance of a complaint was not reviewable
final agency action, the Court reiterated that Abbott Laboratories
holds that regulations that were “definitive” statements of the
agency’s position that had a “direct and immediate. . . effect on
the day-to-day business” of the parties were sufficiently final to
be judicially reviewable before enforcement, Standard Oil, 449
U.S. at 239 (quoting Abbott Labs., 387 U.S. at 152–53).
EPA’s other attempts to distinguish Ciby Geigy are also
unpersuasive. Reckitt Benckiser’s challenge to EPA’s
interpretation of its misbranding authority under FIFRA is not
untimely for failing to challenge EPA’s similar interpretation in
Ciba-Geigy, as EPA urges, because the company was not a party
in Ciba-Geigy, see Reply Br. 23–24. Although EPA claims its
interpretation of its FIFRA misbranding authority “left the world
just as it found it” by restating its interpretation from Ciba-Geigy
rather than “implementing, interpreting, or prescribing law or
policy,” EPA does not show its interpretation was sufficiently
“established” as a policy by or after Ciba-Geigy. Indep. Equip.
Dealers Ass’n, 372 F.3d at 428. As the company responds, EPA
has not cited one instance where it brought a misbranding action
to enforce compliance with a pronouncement such as the RMD
without first taking any of the steps to cancel a registration
16
pursuant to Section 6. And although EPA suggests that any
hardship the company suffers from EPA’s interpretation of its
misbranding authority for implementing the RMD does not meet
the hardship component in Abbott Laboratories, 387 U.S. at 149,
the company’s hardships are indistinguishable from those this
court found dispositive of ripeness when applying the Abbott
Laboratories test in Ciba-Geigy. Like Ciba-Geigy, as a result of
EPA’s interpretation of FIFRA, the company has stated it faces
a drop in sales and a choice between “costly compliance” and
“the risk of serious civil and criminal penalties for unlawful
distribution of ‘misbranded’ products.” Ciba-Geigy, 801 F.2d at
438–39; see Long Decl. ¶¶ 7–9, Eible Decl. ¶¶ 7–9, supra notes
8 & 9.
EPA’s reliance on Munsell v. Department of Agriculture,
509 F.3d 572, 586 (D.C. Cir. 2007), for the proposition that
“[m]ere uncertainty as to the validity of a legal rule” does not
qualify as hardship in a ripeness analysis, is misplaced. The
court was quoting the Supreme Court’s determination in
National Park Hospitality Association v. Department of the
Interior, 538 U.S. 803, 810–11 (2003), that where parties “suffer
no practical harm as a result” of an agency’s statement of policy
regarding a statute the agency was not charged with
administering, uncertainty regarding the legality of the policy
does not qualify as a hardship. EPA is charged with
administering FIFRA and its interpretation is having the
“practical effect” on Reckitt Benckiser as occurred in Ciba-
Geigy, 801 F.2d at 437. The hardship that makes Reckitt
Benckiser’s challenge ripe for review is not that it faces “the
prospect of having to defend itself in an administrative hearing
should the agency actually decide to pursue enforcement,”
Reliable Automatic Sprinkler, 324 F.2d at 732, but rather the
compliance “dilemma” it faces as a result of EPA’s interpretation
“purport[ing] to give an authoritative interpretation of a statutory
provision that has a direct effect on the [company’s] day-to-day
17
business,” Ciba-Geigy, 801 F.2d at 438 (quoting Abbott Labs.,
387 U.S. at 152)). In addition, unlike Standard Oil, 449 U.S. at
243, or Ticor Title Insurance Co. v. FTC, 814 F.2d 731, 742
(D.C. Cir. 1987) (opinion of Edwards, J.), the company is not
challenging the legality of a complaint EPA has issued.
Finally, under the two-prong analysis in Bennett, 520 U.S.
at 177–78, EPA’s interpretation of its misbranding authority
under FIFRA represents “final agency action” under the APA, 5
U.S.C. § 704. First, for the reasons discussed regarding the third
prong of the fitness analysis for purposes of ripeness, EPA’s
interpretation represents the “consummation of the agency’s
decision making process” regarding its legal authority. Bennett,
520 U.S. at 178 (quotation marks omitted). Second, EPA stated
in the RMD and the letter of June 18, 2008 to Reckitt Benckiser
obligations with which the company must comply or risk
misbranding enforcement proceedings. Having made a binding
procedural determination that, in the absence of compliance with
the RMD, the company is not entitled to a Section 6 cancellation
proceeding before being subject to a misbranding proceeding,
EPA has determined it has the discretion to deny the company a
right it claims to possess under FIFRA. See id.
III.
On the question of jurisdiction, EPA maintains that because
the RMD is a Section 4(g)(2)(A) determination of the
reregistration eligibility of active ingredients, any challenge to
EPA’s implementation of it necessarily arises under Section 4 as
well. However, EPA’s interpretation of its FIFRA misbranding
enforcement authority to implement the RMD cannot properly be
viewed as a form of “appropriate regulatory action” under
Section 4(g)(2)(D)(i), 7 U.S.C. § 136a-1(g)(2)(D)(i). An
agency’s exercise of its regulatory authority is related to but
distinct from an agency’s interpretation of a statute it
18
administers. Compare 5 U.S.C. § 706 with Chevron, 467 U.S. at
842–45; see Eagle Broad. Group, Ltd. v. FCC, 563 F.3d 543,
551 (D.C. Cir. 2009). Reckitt Benckiser has no remedy under
Section 4 to challenge EPA’s statutory interpretation. This court,
therefore, lacks jurisdiction pursuant to Section 4(m), 7 U.S.C.
§ 136a-1(m), supra note 2.
Neither does this court have jurisdiction under Section
16(b), 7 U.S.C. § 136n(b), supra note 3. EPA’s interpretation is
not an “order . . . following a public hearing” giving rise to court
of appeals rather than district court jurisdiction. 7 U.S.C.
§ 136n(b); cf. Humane Soc’y v. EPA, 790 F.2d 106, 110–11
(D.C. Cir. 1986); Envtl. Def. Fund v. Costle, 631 F.2d 922,
925–32 (D.C. Cir. 1980); see also United Farmworkers v. EPA,
592 F.3d 1080, 1082–83 (9th Cir. 2010).
However, the district court has jurisdiction over Reckitt
Benckiser’s challenge to EPA’s interpretation of its FIFRA
misbranding authority. EPA’s interpretation is an “other final
action[] of the Administrator not committed to the discretion of
the Administrator by law” and is judicially reviewable in the
district court under Section 16(a), 7 U.S.C. § 136n(a), supra note
3. Cf. Ciba-Geigy, 801 F.2d at 434, 437 n.8 (citing Heckler v.
Chaney, 470 U.S. 821, 834 (1984)). Because evaluating EPA’s
interpretation of its authority under FIFRA to implement the
RMD through enforcement proceedings for misbranding is a
prerequisite to evaluating Reckitt Benckiser’s contentions that
EPA improperly delayed or refused to initiate Section 6
cancellation proceedings, we do not reach the question of
whether these contentions provide additional bases of
jurisdiction. In view of our disposition, we also do not reach the
company’s contention that the district court has jurisdiction over
its claims under Section 16(c), 7 U.S.C. § 136n(c), supra note 3.
19
Accordingly, we reverse the dismissal of Reckitt
Benckiser’s complaint and remand the case to the district court
to address the company’s challenge to EPA’s interpretation of its
authority under FIFRA to bring enforcement proceedings for
misbranding before, or rather than, regulatory cancellation
proceedings under Section 6 against products not voluntarily
complying with a reregistration RMD. We, therefore, do not
reach the company’s contentions that EPA’s non-initiation of
Section 6 cancellation proceedings was arbitrary and capricious
or unreasonably delayed under the APA, 5 U.S.C. § 706. We
dismiss the petition for review for lack of jurisdiction.