Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-09-01314/USCOURTS-caDC-09-01314-0/pdf.json

Parties Involved:
Environmental Protection Agency
Respondent
Liphatech, Inc.
Amicus Curiae for Petitioner
Reckitt Benckiser Inc.
Petitioner
Woodstream Corporation
Amicus Curiae for Petitioner

Document Text:

Notice: This opinion is subject to formal revision before publication in the

Federal Reporter or U.S.App.D.C. Reports. Users are requested to notify the

Clerk of any formal errors in order that corrections may be made before the

bound volumes go to press.

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. 

USCA Case #09-1314 Document #1255606 Filed: 07/16/2010 Page 1 of 19
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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.

USCA Case #09-1314 Document #1255606 Filed: 07/16/2010 Page 2 of 19
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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

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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).

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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.

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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.

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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 “secondgeneration” anticoagulants brodifacoum, bromadiolone, difenacoum,

and difethialone; and the non-anticoagulants bromethalin,

cholecalciferol, and zinc phosphide. RMD at 2.

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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). 

USCA Case #09-1314 Document #1255606 Filed: 07/16/2010 Page 8 of 19
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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.

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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 noncompliant 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 [CibaGeigy’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

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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

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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

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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). 

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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

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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

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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 CibaGeigy, 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

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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

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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.

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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.

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