UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
__________________________________________
)
RECKITT BENCKISER, INC. )
)
Plaintiff, )
)
v. ) Civil Action No. 09-445 (ESH)
)
LISA P. JACKSON, )
ADMINISTRATOR, UNITED STATES )
ENVIRONMENTAL PROTECTION )
AGENCY, ET AL., )
)
Defendants. )
__________________________________________)
MEMORANDUM OPINION
Following a remand from the Court of Appeals, see Reckitt Benckiser, Inc. v. EPA, 613
F.3d 1131, 1133 (D.C. Cir. 2010), the parties have filed cross-motions for summary judgment on
the following issue of statutory interpretation: whether the United States Environmental
Protection Agency (“EPA”) has authority under the Federal Insecticide, Fungicide and
Rodenticide Act (“FIFRA”), 7 U.S.C. §§ 136-136y, to bring a misbranding action in lieu of a
cancellation proceeding against plaintiff Reckitt Benckiser’s registered rodenticide products
based solely on those products’ non-compliance with the EPA’s May 28, 2008 “Risk Mitigation
Decision for Ten Rodenticide Products” (“RMD”). For the reasons stated herein, the Court will
grant plaintiff’s motion, deny defendant’s motion, and enjoin EPA from bringing an enforcement
action against plaintiff or any of its products based upon a failure to satisfy the requirements of
the RMD until defendants have completed the administrative cancellation procedures required
by FIFRA Section 6, 7 U.S.C. § 136d.
BACKGROUND
I. STATUTORY FRAMEWORK
The following sections of FIFRA, 7 U.S.C. §§ 136-136y, are relevant to the question of
statutory interpretation that is before the Court: § 136 (Definitions) (FIFRA § 2); § 136a
(Registration of Pesticides) (FIFRA § 3); § 136a-1 (Reregistration of registered pesticides)
(FIFRA § 4); § 136d (Administrative review; suspension) (FIFRA § 6); § 136j (Unlawful acts)
(FIFRA § 12); 7 U.S.C. § 136k (Stop sale, use, removal, and seizure) (FIFRA § 13); and § 136l
(Penalties) (FIFRA § 14).
A. Registration (7 U.S.C. § 136a)
FIFRA requires that all pesticide products sold or distributed in the United States be
registered with EPA. 7 U.S.C. § 136a(a). EPA is directed to approve the registration of a
pesticide if “(A) its composition is such as to warrant the proposed claims for it; (B) its labeling
and other material required to be submitted comply with the requirements of this subchapter; (C)
it will perform its intended function without unreasonable adverse effects on the environment;
and (D) when used in accordance with widespread and commonly recognized practice it will not
generally cause unreasonable adverse effects on the environment.”1 7 U.S.C. § 136a(c)(5)
(hereinafter “Registration Standard”). “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 Reckitt, 613 F.3d at 1133 (citing 7 U.S.C. § 136a(a), (c)-(e)).
1
“Unreasonable adverse effects” in relevant part means “any unreasonable risk to
man or the environment, taking into account the economic, social, and environmental costs and
benefits of the use of any pesticide.” 7 U.S.C. § 136(bb).
2
B. Cancellation of a Registered Pesticide (7 U.S.C. § 136d)
“A pesticide product remains registered until EPA or the registrant cancels it pursuant to
FIFRA Section 6, 7 U.S.C. § 136d.”2 Reckitt, 613 F.3d at 1134. EPA may commence
cancellation proceedings “[i]f it appears to the [EPA] Administrator that a pesticide or its
labeling or other material required to be submitted does not comply with the provisions of this
subchapter or, when used in accordance with widespread and commonly recognized practice,
generally causes unreasonable adverse effects on the environment.” 7 U.S.C. § 136d(b)3
(hereinafter “Cancellation Standard”). The statute gives EPA the option of either issuing a
notice of intent to cancel or issuing a notice of intent to hold a hearing to determine whether or
not a registration should be canceled. Id. If the first option is chosen, the registrant may demand
a hearing. Id. § 136d(b), (d); 40 C.F.R. § 164.20. Once a final decision to cancel has been made,
the registrant may seek judicial review of that decision by filing a petition for review in a court
of appeals. 7 U.S.C. § 136n.
C. Misbranding / Unlawful Acts / Enforcement / Penalties
(7 U.S.C. §§ 136, 136j, 136k, 136l)
Under FIFRA, EPA has the authority to bring enforcement actions for “unlawful acts,”
one of which is distributing or selling a pesticide which is “misbranded.” 7 U.S.C. § 136j, 136k,
2
“The term ‘registrant’ means a person who has registered any pesticide pursuant to the
provisions of this subchapter.” 7 U.S.C. § 136(y).
3
Before issuing any notice, EPA has to provide the Department of Agriculture with notice
and the opportunity to provide input on the determination, consult with the Secretary of Health
and Human Services, “when a public health use is affected,” and present its case to an
independent Science Advisory Panel. 7 U.S.C. §§ 136d(b) & (d); id. § 136w(d).
3
136l.4 A pesticide is “misbranded” under FIFRA if5
(A) its labeling bears any statement, design, or graphic representation relative
thereto or to its ingredients which is false or misleading in any particular;
(B) it is contained in a package or other container or wrapping which does not
conform to . . . section 136w(c)(3) of this title [Child-Resistant Packaging
requirements];
...
(F) the labeling accompanying it does not contain directions for use which are
necessary for effecting the purpose for which the product is intended and if
complied with, together with any requirements imposed under section 136a(d) of
this title, are adequate to protect health and the environment;
(G) the label does not contain a warning or caution statement which may be
necessary and if complied with, together with any requirements imposed under
section 136a(d) of this title, is adequate to protect health and the environment.
7 U.S.C. § 136(q)(1) (emphasis added). The terms “protect health and the environment” and
“protection of health and the environment” are further defined in section 136(x) to mean
“protection against any unreasonable adverse effects on the environment,” 7 U.S.C. § 136(x), the
same language used in the Registration and Cancellation Standards. 7 U.S.C. §§ 136a, 136d.
When EPA concludes that a pesticide is “misbranded” in violation of FIFRA, it “may
issue a written or printed ‘stop sale, use, or removal’ order to any person who owns, controls, or
4
Other “unlawful acts” include, but are not limited to, distributing or selling “(A) any
pesticide that is not registered under section 136a of this title or whose registration has been
canceled or suspended . . . ; (B) any registered pesticide if any claims made for it as a part of its
distribution or sale substantially differ from any claims made for it as a part of the statement
required in connection with its registration under section 136a of this title; [or] (C) any registered
pesticide the composition of which differs at the time of its distribution or sale from its
composition as described in the statement required in connection with its registration under
section 136a of this title.” 7 U.S.C. § 136j(a)(1).
5
According to EPA, these are the four types of misbranding that are “most pertinent to the
issue in the pending matter.” (Defs.’ Mem. at 6.)
4
has custody of such pesticide,” 7 U.S.C. § 136k(a)6; it may commence an in rem seizure action
against the pesticide product “in any district court in the district where it is found” 7 U.S.C. §
136k(b)(1)(a); it may seek civil penalties against “[a]ny registrant, commercial applicator,
wholesaler, dealer, retailer, or other distributor who violates any provision of this subchapter,” 7
U.S.C. 136l(a); and it may seek criminal penalties against “[a]ny registrant, applicant for a
registration, or producer who knowingly violates any provision of this subchapter. 7 U.S.C. §
136l(b).
D. Reregistration of Registered Pesticides (7 U.S.C. § 136a-1)
In 1988, Congress enacted FIFRA Section 4, which established procedures for the
reregistration of pesticides whose active ingredients were first registered in a pesticide before
November 1, 1984. See 7 U.S.C. § 136a-1(a). The process involved five phases, 7 U.S.C. §
136a-1(b),7 culminating in a determination by EPA “whether to reregister a pesticide by
6
In its entirety, § 136k(a) provides:
Whenever any pesticide or device is found by the Administrator in any State and
there is reason to believe on the basis of inspection or tests that such pesticide or
device is in violation of any of the provisions of this subchapter, or that such
pesticide or device has been or is intended to be distributed or sold in violation of
any such provisions, or when the registration of the pesticide has been canceled
by a final order or has been suspended, the Administrator may issue a written or
printed “stop sale, use, or removal” order to any person who owns, controls, or
has custody of such pesticide or device, and after receipt of such order no person
shall sell, use, or remove the pesticide or device described in the order except in
accordance with the provisions of the order.
7 U.S.C. § 136k(a).
7
Subsection (b) summarizes the five reregistration phases:
(1) The first phase shall include the listing under subsection (c) of this section of
the active ingredients of the pesticides that will be reregistered.
5
determining whether such pesticide meets the requirements of [the Registration Standard].” 7
U.S.C. § 136a-1(g)(2)(C). If EPA determines that a pesticide “should not be reregistered,”
FIFRA provides that it “shall take appropriate regulatory action” and that such action “shall be
completed as expeditiously as possible.” Id. § 136a-1(g)(2)(D).
II. FACTS
Plaintiff manufactures pesticides that are subject to regulation under FIFRA. On May 28,
2008, as part of FIFRA Section 4's “reregistration” process, 7 U.S.C. § 136a-1, EPA issued a
“Risk Mitigation Decision for Ten Rodenticides” (“RMD”). (Pl.’s Mem. in Support of Mot. for
Summ. J. [“Pl.’s Mem.”], Ex. 1, Sept. 24, 2010; Pl’s Statement of Material Facts [“Pl.’s SOMF”]
¶ 1.)8 The RMD set forth EPA’s “final decision on the reregistration eligibility of rodenticide
(2) The second phase shall include the submission to the Administrator under
subsection (d) of this section of notices by registrants respecting their intention to
seek reregistration, identification by registrants of missing and inadequate data for
such pesticides, and commitments by registrants to replace such missing or
inadequate data within the applicable time period.
(3) The third phase shall include submission to the Administrator by registrants of
the information required under subsection (e) of this section.
(4) The fourth phase shall include an independent, initial review by the
Administrator under subsection (f) of this section of submissions under phases
two and three, identification of outstanding data requirements, and the issuance,
as necessary, of requests for additional data.
(5) The fifth phase shall include the review by the Administrator under subsection
(g) of this section of data submitted for reregistration and appropriate regulatory
action by the Administrator.
7 U.S.C. § 136a-1(b).
8
In a June 24, 2008 letter from EPA to “registrants,” EPA revised the RMD. (Pl.’s Mem.,
Ex. 1, at 3-4.) The revised RMD and the June 24, 2008 letter together comprise Exhibit 1 to
6
products containing brodifacoum; bromadiolone; bromethalin; chlorophacinine; cholecalciferol;
difethialone; diphacinone (and its sodium salt); warfarin (and its sodium salt); and zinc
phosphide.” (RMD at 1; Pl.’s SOMF ¶ 2; Defendant’s Statement of Material Facts [“Defs.’
SOMF”] ¶ 2.) EPA concluded was that “these products, unless labeled and used as specified in
this document, would present unreasonable risks inconsistent with FIFRA” and, thus, were not
eligible for reregistration unless the registrant implemented certain “risk mitigation measures.”
(RMD at 25.)
The RMD directed “[p]ersons [including plaintiff] holding a manufacturing-use or end-
use registration for a rodenticide product containing one of the active ingredients covered by this
risk mitigation decision” to “provide a letter to the Agency on or before September 2, 2008,
declaring an intent to comply or not comply with the risk mitigation measures described in this
document.” (Id.) Specifically, registrants were directed that “this 90-day response letter must
indicate, for each of the registrants’ registered rodenticide products, whether the registrant
intends to amend the registration to conform to the risk mitigation decision.” (Id..) The RMD
further provided that “[f]or each registered product for which a registrant declares its intent not
to comply (i.e., not to amend labeling and/or packaging and not to develop a replacement bait
station product), the company needs to include a request to cancel that product.” (Id.)
The RMD stated that “should a registrant fail to implement any of the risk mitigation
measures identified in this document, the Agency may take regulatory action to address the risk
concerns from the use of the affected products.” (Id.) It also provided that “June 4, 2011 would
plaintiff’s motion. For ease of reference, any citation to the revised RMD uses the page numbers
that appear in the document itself.
7
be the last day for registrants to ‘release for shipment’ (sell or distribute) rodenticide products
not complying with the Risk Mitigation Decision” and that “”[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 26.) However, according to the EPA, the RMD
“does not represent individual product reregistration decisions under FIFRA Section 4(g)(2)(C)
or (D)” and that it “imposes no legally binding requirements on any regulatee, either upon
issuance of the RMD or as of June 4, 2011.” (Defs.’ SOMF ¶¶ 2, 21.)
On June 18, 2008, EPA sent letters directly to registrants, advising them of the RMD’s
conclusions and implementation timetable. (Pl.’s Mem., Ex. 2, at 1.) Registrants were advised
that to comply with the RMD, “[s]ome currently registered rodenticide products may be brought
into compliance with the risk mitigation decision through amendment,” but others “will require
cancellation.” (Id. at 3.) Thus, registrants were told, “[f]or each registered product that is
covered by the risk mitigation decision and which will not be amended to comply, registrants
must submit a request to voluntarily cancel that product under FIFRA § 6(f)(1) [7 U.S.C. §
136d].” (Id. at 4.) The 90-day response form that EPA sent out with the June 18, 2008 letter,
gave registrants the option of either (1) selecting an the “intended method for complying,” one of
which was voluntary cancellation; or (2) selecting the option “I do not intend to voluntarily bring
this product into compliance with the requirements of the May 2008 risk mitigation decision. I
understand that EPA may pursue additional regulatory action, including cancellation.” (Id. at 6.)
Plaintiff timely filed its 90-day response for its thirteen affected products,9 indicating for
9
Plaintiff’s affected products have the following EPA Product Registration Numbers:
3282-3, 3282-4, 3282-9, 3282-15, 3282-32, 3282-65, 3282-66, 3282-74, 3282-81, 3282-85,
3282-86, 3282-87, 3282-88. (Pl.’s Mem., Ex. 4, at 2-4.)
8
each its “intent not to comply with the Risk Mitigation Decision” because it would “remove the
most effective and affordable rodent control products from consumers’ hands, without any
significant countervailing benefit.” (Pl.’s Mem., Ex. 4, at 1 [Aug. 28, 2008 Letter from Plaintiff
to EPA].) In subsequent oral and written communications, plaintiff requested that EPA
commence the administrative process by issuing a Notice of Intent to Cancel the registrations for
plaintiff’s affected rodenticide products under FIFRA Section 6, 7 U.S.C. § 136d. (Pl.’s SOMF
¶¶ 14-17; Defs.’ SOMF ¶¶ 14-17; Pl.’s Mem., Ex. 5, at 1 [Nov. 11, 2008 Letter from Plaintiff’s
Counsel to EPA]; Pl.’s Mem., Ex. 6, at 1 [Jan. 9, 2009 Letter from Plaintiff’s Counsel to EPA].)
On February 3, February 26, and March 5, 2009, the Agency verbally confirmed that EPA had
no plans to initiate cancellation proceedings. (Pl.’s SOMF ¶ 17; Defs.’ SOMF ¶ 17.)
III. PROCEDURAL HISTORY
On March 5, 2009, plaintiff filed its Verified Complaint in this matter, seeking
declaratory and injunctive relief preventing EPA from initiating misbranding or other
enforcement actions against plaintiff’s affected products until the procedures of FIFRA § 6 had
been initiated and completed. (Pl.’s SOMF ¶ 18; Defs.’ SOMF ¶ 18.) Plaintiff asked the Court
to “declare EPA’s failure to initiate cancellation proceedings in the face of EPA’s threat of
enforcement action [to be] arbitrary, capricious, an abuse of discretion and otherwise not in
accordance with law,” and to issue “an injunction prohibiting EPA from taking enforcement
action against the [plaintiff’s] products until such time as EPA has initiated and fully completed
the administrative processes provided for under FIFRA § 6 . . ., and ordering EPA to initiate the
Section 6 Procedures in which [plaintiff] can challenge the merits of the RMD.” (Pl.’s Opp’n to
Defs.’ Mot. to Dismiss at 2, June 22, 2009). EPA moved to dismiss on a number of grounds,
9
including lack of subject matter jurisdiction. On October 30, 2009, this Court granted the motion
to dismiss, concluding that jurisdiction lay with the Court of Appeals because plaintiff was
asking the Court to enforce the reregistration requirement that EPA take “appropriate regulatory
action” as “expeditiously as possible.” Reckitt, 666 F. Supp. 2d 131, 138 (D.D.C. 2009) (citing
7 U.S.C. 136a-1(m) (“Any failure of the Administrator to take any action required by this section
shall be subject to judicial review . . . in a court of appeals.”)), rev’d, Reckitt, 613 F.3d 1131. On
December 4, 2009, plaintiff submitted additional correspondence to EPA reiterating its intention
not to voluntarily modify its rodenticide product registrations to comply with the RMD and again
requesting that EPA initiate the administrative procedures called for by the RMD and FIFRA §
6. (Pl.’s SOMF ¶ 19; Defs.’ SOMF ¶ 19; Pl’s Mem., Ex. 7.)
Plaintiff appealed this Court’s decision and also filed a direct petition for review in the
Court of Appeals. The Court of Appeals held that the first question that had to be addressed was
“EPA’s interpretation of its misbranding authority under FIFRA” – that is, whether EPA had
authority under FIFRA to bring a misbranding action based on noncompliance with the RMD
rather than commencing cancellation proceedings. See Reckitt, 613 F.3d at 1141 (“evaluating
EPA’s interpretation of its authority under FIFRA to implement the RMD through enforcement
proceedings for misbranding is a prerequisite to evaluating [plaintiff’s] contentions that EPA
improperly delayed or refused to initiate Section 6 cancellation proceedings”). The Court of
Appeals concluded that EPA’s assertion of that authority in the RMD was a “binding procedural
determination” that constituted “‘final agency action’ under the APA [Administrative Procedure
Act], 5 U.S.C. § 704”; the issue was “ripe for review”; and the district court had jurisdiction
because EPA’s legal interpretation of its authority was “other final action of the Administrator”
10
under FIFRA Section 16(a), 7 U.S.C. § 136n. Reckitt, 613 F.3d at 1141.10 Thus, the Court of
Appeals remanded for this Court to decide whether EPA has the “authority under FIFRA to bring
enforcement proceedings for misbranding before, or rather than, regulatory cancellation
proceedings under [FIFRA] Section 6 against products not voluntarily complying with a
reregistration RMD.” Id. As explained herein, the Court’s answer to his question is that the
statute does not permit the agency to proceed by use of a misbranding proceeding to effectuate a
cancellation.
DISCUSSION
Plaintiff argues that EPA’s legal interpretation of its authority is arbitrary, capricious, an
abuse of discretion and not in accordance with law because it “would utterly defeat Congress’
intent in enacting the registration and cancellation process.” (Pl.’s Mem. in Support of Mot. for
Summ. J. at 10, Sept. 24, 2010 [“Pl’s Mem.”].) Plaintiff’s view is that “EPA may not bring an
enforcement action against [plaintiff’s] properly registered products for allegedly failing to
conform to the [Registration Standard],” but rather “must actually comply with the Act’s
provisions for cancelling a registration.” (Id. at 10.) EPA argues that its interpretation is entitled
10
As explained by the Court of Appeals:
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 administers. Compare 5 U.S.C. § 706 with
Chevron, 467 U.S. at 842-45, 104 S.Ct. 2778; 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.
Reckitt, 613 F.2d at 1141.
11
to deference under Chevron and, therefore, must be accepted because it is “reasonable.” (Defs.’
Mem. in Support of Defs.’ Cross-Mot. for Summ. J. at 13, Oct. 12, 2010 [“Defs.’ Mem.”].) Even
if no deference is due, EPA argues that its interpretation is “compelled” by the “plain language
of FIFRA and its history.” (Id.)
I. STANDARD OF REVIEW
The scope of review of a challenge to the EPA’s actions under FIFRA is governed by the
Administrative Procedure Act (“APA”). See Defenders of Wildlife v. E.P.A., 882 F.2d 1294,
1303 (8th Cir. 1989). Agency action reviewed under the APA may not be overturned unless it is
“arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C.
§ 706(2)(A). As the Court is reviewing an agency’s interpretation of a law it administers, it must
apply the principles of Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S.
837 (1984). Se. Ala. Med. Ctr. v. Sebelius, 572 F.3d 912, 916 (D.C. Cir. 2009); National Ass’n
of Clean Air Agencies v. E.P.A., 489 F.3d 1221, 1228 (D.C. Cir. 2007).
Under Chevron, the first step is “examine the statute de novo, employing ‘traditional
tools of statutory construction.’” Nat’l Ass’n of Clean Air Agencies, 489 F.3d at 1228 (quoting
Chevron, 467 U.S. at 843)); see Mount Royal Joint Venture v. Kempthorne, 477 F.3d 745, 754
(D.C. Cir. 2007) (court begins by “applying customary rules of statutory interpretation”).
Because the judiciary functions as the final authority on issues of statutory construction, ‘[a]n
agency is given no deference at all on the question whether a statute is ambiguous.’” Wells
Fargo Bank N.A. v. FDIC, 310 F.3d 202, 206 (D.C. Cir. 2002) (quoting Cajun Elec. Power
Coop., Inc. v. FERC, 924 F.2d 1132, 1136 (D.C. Cir. 1991)). “If the intent of Congress is clear,
that is the end of the matter; for the court, as well as the agency, must give effect to the
12
unambiguously expressed intent of Congress.” Chevron, 467 U.S. at 842-4; see Eagle
Broadcasting Group, Ltd. v. FCC, 563 F.3d 543, 552 (D.C. Cir. 2009) (if the “search for the
plain meaning of the statute . . . yields a clear result, then Congress has expressed its intention as
to the question, and deference is not appropriate.” (internal quotations omitted)); Arkansas Dairy
Co-op Ass’n, Inc. v. U.S. Dept. of Agr., 573 F.3d 815, 829 (D.C. Cir. 2009) (no deference due
where agency’s construction is “contrary to clear congressional intent”). Only if “the statute is
silent or ambiguous with respect to the specific issue,” Chevron, 467 U. at 843, does the analysis
proceed to the next step, which is to “determine the deference, if any, [the court] owe[s] the
agency’s interpretation of the statute.” Mount Royal Joint Venture, 477 F.3d at 754. As the
Court ultimately concludes that the statute is not ambiguous with respect to the issue at hand, it
is immaterial what level of deference EPA’s interpretation would be entitled to under the second
step of Chevron.11 See, e.g., Martini v. Federal Nat. Mortg. Ass’n, 178 F.3d 1336 (D.C. Cir.
1999).
II. STATUTORY CONSTRUCTION
Under the first step of Chevron, the Court must use the “customary statutory
interpretation tools of ‘text, structure, purpose, and legislative history’” to determine whether
11
Under the second step of Chevron, “[i]f Congress has explicitly left a gap for the
agency to fill, there is an express delegation of authority to the agency to elucidate a specific
provision of the statute by regulation. Such legislative regulations are given controlling weight
unless they are . . . manifestly contrary to the statute.” Chevron, 467 U.S. at 843-44. “Where a
legislative delegation to an agency on a particular question is implicit rather than explicit, [the
court] must uphold any reasonable interpretation made by the administrator’ of that agency.”
National Ass’n of Clean Air Agencies, 489 F.3d at 1228 (internal quotations and citations
omitted); Chevron, 467 U.S. at 844. “On the other hand, if the agency enunciates its
interpretation through informal action that lacks the force of law, we accept the agency’s
interpretation only if it is persuasive.” Mount Royal Joint Venture, 477 F.3d at 754 (D.C. Cir.
2007) (citing United States v. Mead Corp., 533 U.S. 218, 235 (2001)).
13
Congress’s intent as to the precise question at issue is clear. California Metro Mobile
Communications, Inc. v. FCC, 365 F.3d 38, 44-45 (D.C. Cir. 2004) (quoting Consumer
Electronics Ass’n v. FCC, 347 F.3d 291, 297 (D.C. Cir. 2003)). Even if there are “textual
ambiguities,” “a statute may foreclose an agency’s preferred interpretation . . . if its structure,
legislative history, or purpose makes clear what its text leaves opaque.” Catawba Cty. v. EPA,
571 F.3d 20, 36 (D.C. Cir. 2009); see also Ass’n of Civilian Technicians, Inc. v. U.S., 603 F.3d
989, 992 (D.C. Cir. 2010) (in looking at the text of a statute, “words are to be read in the context
in which they are used and in the broader context of the statutory scheme” (internal quotations
omitted)). Using these tools, the Court concludes that FIFRA does not give EPA the authority to
pursue a misbranding enforcement action in lieu of a cancellation proceeding based on a
registrant’s failure to comply with the RMD.
A. Text and Structure
Plaintiff argues that EPA’s interpretation of FIFRA renders the Section 6 cancellation
procedures meaningless, in violation of the “cardinal principle of statutory construction that a
statute ought, upon the whole, to be so construed that, if it can be prevented, no clause, sentence,
or word shall be superfluous, void, or insignificant.” TRW Inc. v. Andrews, 534 U.S. 19, 31
(2001). EPA counters that plaintiff’s interpretation of FIFRA suffers from similar infirmities.
1. 7 U.S.C. § 136d (FIFRA Section 6)
Plaintiff argues that only its interpretation is consistent with the existence and content of
Section 6, 7 U.S.C. § 136d. The Court agrees. Section 6 is the “cancellation” section within
FIFRA. It establishes a detailed, multi-step process that EPA must follow when it wants to
cancel or suspend a registration. Reckitt, 613 F.3d at 1134 (“A pesticide product remains
14
registered until EPA or the registrant cancels it pursuant to Section 6.”).12 The process imposes
certain obligations on EPA before it may issue a notice of intent to cancel or a notice of intent to
hold a hearing on cancellation, and it entitles the registrant to notice, a hearing and other
procedural protections before EPA can make a final decision on cancellation. 7 U.S.C. § 136d;
40 C.F.R. §§ 164.20-164.111.
It is undisputed that plaintiff holds valid registrations for products that EPA believes
must be cancelled because they do not comply with the RMD. Yet, if EPA also has the authority
to bring misbranding enforcement actions after June 4, 2011, against these registered products
based on non-compliance with the RMD, it will be able to “bypass[] cancellation proceedings”
and “effect[ively] cancel[] the registrations without following the regulatory procedures provided
in Section 6.” See Reckitt, 613 F.3d at 1136. To interpret FIFRA to give EPA that authority not
only renders Section 6 superfluous; it also allows EPA to avoid the rigorous cancellation process
Congress provided for in the statute. In addition, as plaintiff points out, under EPA’s
interpretation applicants whose registrations are denied are guaranteed access to the procedural
protections of Section 6, see 7 U.S.C. § 136a(c)(6),13 while a product that has already been
12
EPA concedes that it can only cancel a registration by commencing the cancellation
process established in FIFRA Section 6. (Defs.’ Reply in Support of Defs.’ Cross-Mot. for
Summ. J. at 1, Nov. 8, 2010 [“Defs.’ Reply”].)
13
§ 136a(c)(6) provides:
Whenever the Administrator refuses to register a pesticide, the Administrator
shall notify the applicant of the Administrator’s decision and of the
Administrator’s reasons (including the factual basis) therefor. The Administrator
shall promptly publish in the Federal Register notice of such denial of registration
and the reasons therefor. Upon such notification, the applicant for registration or
other interested person with the concurrence of the applicant shall have the same
remedies as provided for in section 136d of this title.
15
registered and is in compliance with the terms of its registration would be deprived of those
protections. Such an interpretation is simply illogical.
EPA’s only response to plaintiff’s Section 6 argument is that because there is no “express
provision” in FIFRA linking EPA’s authority to pursue misbranding action under FIFRA
Sections 12, 13, and 14 to its cancellation authority in FIFRA Section 6, it follows that “it may
bring a misbranding action under FIFRA Sections 12, 13, and 14, at the end of the reregistration
process or at any other time, when it believes a product is misbranded, without first cancelling
that product’s registration under FIFRA Section 6.” (Defs.’ Mem. at 22) In EPA’s view “[i]f
Congress had intended to require EPA to cancel a registered pesticide before pursuing
misbranding action, it could easily have put language to that effect into FIFRA.” (Id.) However,
given Congress’s establishment of a detailed process for cancellation (or suspension in the event
of an “imminent hazard”), it is reasonable (and more likely) that Congress did not expressly
prohibit EPA from proceeding with a misbranding action, instead of a cancellation proceeding,
because it never contemplated that EPA would try to use such an enforcement action (or threat of
such an action) as a substitute for a cancellation proceeding once it had concluded that a
product’s registration should be cancelled.
Accordingly, the Court concludes that the existence and content of Section 6 is strong
evidence that Congress intended EPA to use Section 6, not the threat of a misbranding
enforcement action, to remove a product from the market if it determines that the product is no
longer eligible for registration.
7 U.S.C. § 136a(c)(6) (emphasis added).
16
2. 7 U.S.C. § 136a-1(g)(2)(D) (FIFRA Section 4(g)(2)(D))
EPA argues that only its interpretation gives effect to FIFRA Section 4(g)(2)(D), the
provision which directs EPA to take “appropriate regulatory action” once it determines that a
pesticide is not eligible for reregistration. Id. § 136a-l(g)(2)(D). However, this argument is not
persuasive. The only issue in the present case is whether EPA has the option of pursuing a
misbranding enforcement action rather than a cancellation proceeding once it has determined as
part of a reregistration eligibility decision that a product is “not eligible for reregistration,” and,
therefore, it must be cancelled. To adopt plaintiff’s view would not read Section 4(g) out of the
statute, but would simply reject EPA’s contention that “appropriate regulatory action” under the
specific factual circumstances presented here includes a misbranding enforcement action in
favor of plaintiff’s position that the “appropriate regulatory action” is limited to a cancellation
proceeding.14 FIFRA Section 4(g) does not give EPA authority to take any regulatory action; it
gives it authority – indeed it requires it – to take “appropriate” regulatory action. Thus, rejecting
EPA’s interpretation does not render this provision superfluous, it merely provides a legal
interpretation as to what is an “appropriate regulatory action” under the circumstances presented
here.
EPA also argues that because it is possible that misbranding might be “discovered”
during the reregistration review process, “appropriate regulatory action” must include the power
14
Whether EPA could succeed in a misbranding action is not before the Court. Indeed,
the record is limited to EPA’s assertion that plaintiff’s products “would be misbranded” and its
identification of four aspects of the definition of misbranding as the “most pertinent.” See supra
n.5; see also Reckitt, 613 F.3d at 1138 (“the lack of such factual development regarding which
specific FIFRA misbranding provisions EPA might apply to [plaintiff’s] products does not make
EPA’s interpretation unripe for review”).
17
to bring a misbranding action. EPA’s argument is circular: if a “misbranding” enforcement
action is authorized by the statute, EPA may bring it, irrespective of Section 4(g) or when and
how it determined that a registered product is misbranded. But if a misbranding enforcement
action is not authorized under certain circumstances – the issue before the Court – then it is not
“appropriate” action.
Finally, EPA argues that because FIFRA does not expressly define what constitutes
“regulatory action,” nor does it specify any limits on what regulatory actions are appropriate in
the context of Section 4(g)(2)(D), its interpretation must be correct. In making this argument,
however, EPA completely ignores that the legislative history posits that “appropriate regulatory
action” following a reregistration eligibility decision would include actions “such as canceling,
suspending, or restricting the pesticide, or imposing label changes . . . ,” H.R. Rep. No. 100-939,
at 30 (1988), reprinted in 1988 U.S.C.C.A.N. 3474, 3479 (1988) (emphases added), but makes
no mention of a misbranding enforcement action as an option.
3. 7 U.S.C. § 136(q)(1)(F) & (G)
EPA next text-based argument is that only its interpretation gives effect to 7 U.S.C. §
136(q)(1)(F) and (G). Subsection (F) provides that a pesticide is misbranded if “the label
accompanying it does not contain directions for use which . . . are adequate to protect health and
the environment.” 7 U.S.C. § 136(q)(1)(F) (emphasis added). Subsection (G) provides that a
pesticide is misbranded if “the label does not contain a warning or caution statement which . . . is
adequate to protect health and the environment . . . .” 7 U.S.C. § 136(q)(1)(G) (emphasis added).
As other provisions already allow EPA to bring a misbranding action against an unregistered
product or a product whose labeling fails to conform with the label approved by EPA, see id. §
18
136j(a)(1)(A) (prohibiting distribution or sale of an unregistered pesticide), § 136(q)(2)(E)
(defining “misbranded” as any product that does not bear its approved labeling), EPA contends
that the only use for these provisions is to “allow EPA to pursue misbranding action if a
pesticide bears either directions for use or warning or caution statements that are not adequate to
protect health and the environment, regardless of whether those directions for use and warning or
caution statements were once deemed adequate for the product’s registration.” (Defs.’ Mem. at
19.) In making this argument, EPA again ignores the contours of the issue before the Court.
Rejecting EPA’s interpretation does not render either (F) or (G) superfluous, it merely limits
their application to situations where EPA has not already determined that the product itself
requires cancellation.
4. 7 U.S.C. § 136a(f)(2) (FIFRA Section 3)
EPA’s final textual argument is based on FIFRA’s provision that “[i]n no event shall
registration of an article be construed as a defense for the commission of any offense under this
subchapter.” 7 U.S.C. § 136a(f)(2) (emphasis added). Rather, “[a]s long as no cancellation
proceedings are in effect registration of a pesticide shall be prima facie evidence that the
pesticide, its labeling and packaging comply with the registration provisions of the subchapter.”
7 US.C. § 136a(f)(2). Based on this language, EPA argues that
this provision expressly authorizes EPA to use enforcement actions to ensure
compliance with the registration requirements of FIFRA where EPA has
sufficient evidence to rebut the presumption of compliance that the registration
provides. Thus, FIFRA authorizes EPA to bring misbranding action against a
registered pesticide at any time, including at the conclusion of the reregistration
process if EPA determines that there is evidence sufficient to demonstrate that the
product’s labeling or packaging do not meet the FIFRA Section 3(c)(5) standard.
(Defs.’ Mem. at 20.) EPA’s conclusion goes far beyond what the text requires. A FIFRA
19
registration is essentially a license to sell and distribute pesticide products in accordance with the
terms of the registration and the statute. Thus, the Court agrees with plaintiff that “Section
3(f)(2) stands for the unremarkable proposition that a registration is not a defense against an
allegation that a product violates the terms of that registration, just as a valid driver’s license is
not a defense against a speeding ticket.” (Pl.’s Mem. at 17.)
B. Legislative History
Both plaintiff and defendant claim that the FIFRA’s legislative history supports their
interpretation. When FIFRA was first enacted in 1947,15 it prohibited interstate commerce in
pesticides unless they were registered with the Secretary of Agriculture, properly labeled, and
not adulterated or misbranded. FIFRA §§ 3(a), 4(a), ch. 125, 61 Stat. 163, 166-68 (1947). If the
Secretary of Agriculture believed that a pesticide did not satisfy FIFRA’s requirements, the
applicant could insist that the pesticide be registered “under protest” and proceed to sell its
product. The pesticide then could be removed from the market only through an enforcement
action where the government bore the burden of proving that it was misbranded or otherwise did
not comply with FIFRA. FIFRA was substantially amended in 1964, 1972, and 1988 to create
the system of registration and cancellation that exists today and the reregistration process that led
to the RMD. EPA views the legislative history as evidence that Congress intended to
continually expand, rather than diminish, EPA’s regulatory authority through amendments to
FIFRA. Plaintiff believes the history confirms that Congress intended EPA to use the Section 6
cancellation process to remove registered products from the market for failing to meet the
FIFRA’s registration standard. The Court agrees with plaintiff.
15
FIFRA replaced the Insecticide Act of 1910.
20
1. 1964 Amendments
In 1964, Congress amended FIFRA to “eliminate registration under protest.” Pub. L.
88-305,78 Stat. 190, and replace it with “various appeal procedures where registration is refused
or canceled.” S. Rep. 88-573, at 1 (1963) (Br. of Amicus Curiae, Attachment 2, Sept. 30, 2010)
(“purpose” of the amendments was both “to end the practice of protest registration whereby the
manufacturer of a pesticide can market a product despite Department of Agriculture doubts as to
its effectiveness or safety,” and replace it with “a complete appeal system whereby the applicant
for registration can appeal the decision” to refuse or cancel a registration); H.R. Rep. No. 88-
1125, at 1 (1964), reprinted in 1964 U.S.C.C.A.N. 2166 (same).
The legislative history establishes that the amendments were aimed at several distinct
problems caused by the existing system. First, Congress believed there was a “need for the
legislation” because:
[A]t present, the Secretary can be required to register a product even though he is
convinced that it is ineffective and dangerous to human life. He can proceed
against it in such case only after it has moved to interstate commerce, and he then
has the burden of proving that it violates the law. The bill would correct this
situation and afford greater protection to the public by repealing the authority for
registration under protest.
Id. at 2, reprinted in 1964 U.S.C.C.A.N. at 2167. A second “need for the legislation” existed
because under the protest registration system, if a product had been registered under protest, the
registrant was “protected from the effects of failure to register, but not from penalties and seizure
if the product is actually misbranded or otherwise out of compliance with the act.” Id. As
explained by Senator Ellender:
[R]egistration under protest provides a means by which an applicant for
registration may appeal from a decision of the Secretary with which he disagrees.
However, in order to take this appeal, he must take actions which subject him to
21
penalties, the product to seizure, and the public to possible danger if the
Secretary’s determination should prove to be correct.
109 Cong. Rec. 20,079 (Oct. 22, 1963) (statement of Sen. Ellender) (prior to 1964, “if a
registrant disagreed with the Agency’s determination as to the safety of its product, its only
recourse was to market the product and face the risk of a prosecution and penalties in an
enforcement action”). By providing that “applicants dissatisfied with the Secretary’s action in
refusing or canceling registration may have recourse to advisory committee proceedings, public
hearings, and eventually judicial review,” the amendments were designed to both “afford[]
adequate protection to the public,” and “protect[] applicants for registration from arbitrary or
ill-advised action by the Department.” H.R. Rep. No. 88-1125, at 2, reprinted in 1964
U.S.C.C.A.N. at 2167 (emphasis added); see also S. Rep. 88-573, at 2; 109 Cong. Rec. 20079
(statement of Sen. Ellender) (“[i]n lieu of the existing “unsatisfactory type of appeal,” “[t]he bill
. . . provides better procedures to protect the applicant or registrant from any arbitrary
determination”).)
The only plausible reading of the legislative history relating to the 1964 amendments is
that Congress intended to eliminate the system of protest registration and to create an
administrative cancellation process to take its place, see Environmental Defense Fund v.
Ruckelshaus, 439 F.2d 589, 593 (D.C. Cir. 1971) (1964 amendments “eliminate[d] the system of
protest registration and substitute[d] the present administrative mechanism for cancelling
registrations”), because it was concerned both with the risks of having unsafe products on the
market and it wanted to eliminate the system whereby registrants had to risk prosecution if they
disagreed with the agency’s determination as to registration eligibility. To accept EPA’s
interpretation in the present case would recreate precisely the same problem Congress intended
22
to eliminate in 1964: forcing plaintiff to accede to EPA’s demand that it change its products to
conform to reregistration standards of the RMD or face the severe sanctions of enforcement
proceedings. The Court agrees with plaintiff that “If . . . Congress meant to allow EPA to
continue to use its enforcement authority to remove already registered products from the market,
there was little point to creating the registration and cancellation provisions at all.” (Pl.’s Opp’n
to Defs.’ Mot. for Summ. J. & Reply in Support of Pl’s Mot. for Summ. J. at 20, Oct. 29, 2010
[“Pl’s Opp’n & Reply”].) Indeed, as plaintiff points out, “under EPA’s view of its misbranding
authority, an applicant is entitled to a Section 6 hearing if it is denied an initial registration under
Section 3, but EPA is free to bypass Section 6 and proceed directly to enforcement if the Agency
changes its mind about a registered product and concludes that it no longer meets FIFRA’s
registration criteria.” (Pl.’s Opp’n & Reply at 20.) To afford greater procedural protections to
an applicant whose registration is denied than to a registrant selling a registered product in
compliance with the terms of its registration is both illogical, see supra p.13, and in direct
conflict with Congress’s clear goal of eliminating the system of protest registration and
replacing it with a process for cancellation.
2. 1972 Amendments
In 1972, the Federal Environmental Pesticide Control Act of 1972 rewrote FIFRA, both
to amend it and to reflect the transfer of implementation authority from the Department of
Agriculture to EPA. Pub. L. 92-516, 86 Stat. 973.16 EPA directs the Court’s attention to two
16
As revised, FIFRA for the first time provided “for direct controls over pesticide use, for
classification of selected pesticides into a restricted use category, for registration of
manufacturing plants, and for a national monitoring program for pesticide residues. In addition,
it added environmental effects to the risks to be weighted in the pesticide registration process.”
H.R. Rep. No. 100-939, at 2 (1988), reprinted in 1988 U.S.C.C.A.N. 3474, 3476. “The 1972
23
specific changes made by the 1972 amendments. Prior to 1972, the precursor to Sections
2(q)(1)(F) and 2(q)(1)(G) in the current statute defined a product as misbranded if its “label” did
not contain “directions for use adequate for the protection of the public” or “a warning or
caution statement adequate to prevent injury to living man and other vertebrate animals,
vegetation, and useful invertebrate animals.” See 7 U.S.C. §135(z)(2)(c), (d) (1970). In 1972,
that language was altered to provide that a pesticide is misbranded if “the label accompanying it
does not contain directions for use which . . .are adequate to protect health and the environment,”
7 U.S.C. § 136(q)(1)(F), or “the label does not contain a warning or caution statement which . . .
is adequate to protect health and the environment . . . .” 7 U.S.C. § 136(q)(1)(G). Section 2(x)
defines “adequate to protect health and the environment “ as “protection against any
unreasonable adverse effects on the environment,” id § 136(x), the same language that appears in
the registration and cancellation sections of FIFRA. 7 U.S.C. § 136a(c)(5); 7 U.S.C. § 136d(b).
EPA argues that these changes show that Congress intended to “significantly expand[]
the definition of misbranding” and make “misbranding and cancellation . . . parallel, albeit
independent, regulatory tools.” (Defs.’ Mem. at 24-25.) Thus, EPA argues, “Congress provided
EPA parallel misbranding regulatory authority to ensure that EPA would apply the same
standard whether it chose to proceed through misbranding action or cancellation – that pesticide
products do not present unreasonable adverse effects.” (Id. at 25.) But EPA’s interpretation
ignores the fact that even though the “unreasonable adverse effects on the environment” standard
FIFRA amendments made pesticide registrations renewable on a five-year basis, and required
review of all then-registered products to reassess and to ensure their safe use. This general
reregistration requirement was originally ordered to be completed by 1975, but after a brief
extension, the deadline was dropped in 1978.” Id. at 4, reprinted in 1988 U.S.C.C.A.N. at 3477.
24
is now part of the definition of misbranding under subsections (F) and (G), both those
subsections are concerned only with a product’s “label.” In contrast, in both the registration and
cancellation context, the standard is used more broadly to address the use of the product, not
merely its label. See 7 U.S.C. § 136a(c)(5) (product is eligible for registration if “it will perform
its intended function without unreasonable adverse effects on the environment” and “when used
in accordance with widespread and commonly recognized practice it will not generally cause
unreasonable adverse effects on the environment”); 7 U.S.C. § 136d(b) (product is subject to
cancellation if “when used in accordance with widespread and commonly recognized practice,
[it] generally causes unreasonable adverse effects on the environment”). Thus, the Court does
not agree with EPA that the textual changes to §§ 136(q)(1)(F) and (G) compel the conclusion
that misbranding and cancellation are “parallel, albeit independent, regulatory tools.” (Defs.’
Mem. at 25).
There is nothing else in the legislative history of the 1972 amendments to support EPA’s
interpretation. Indeed, an earlier version of the bill included a provision that a pesticide would
be misbranded if “when used in accordance with the requirements of the Act or commonly
recognized practice it causes unreasonable adverse effects on the environment,” language almost
identical to the standard for cancellation, but that language was eliminated in conference because
[t]he conferees do not believe that a manufacturer should be subjected to criminal
penalties for a “misbranding” which is beyond his control. The conference
substitute shifts this language to section 3 [registration] and section 6
[cancellation]. Thus, although no criminal penalties are applicable, the
Administrator will have the authority to deny registration or cancel where there is
a widespread and commonly recognized practice of using a pesticide which
generally causes unreasonable adverse effects on the environment.
H.R. Conf. Rep. 92-1540, at 2, reprinted in 1972 U.S.C.C.A.N. 4130, 4131.
25
3. 1988 Amendments
The 1988 amendments created the reregistration process that ultimately led to the RMD.
In terms of their relevance to the issue of statutory interpretation before the Court, EPA makes
three points. First, EPA argues that it is significant that the 1988 amendments did not take away
any preexisting enforcement power because
Congress presumably was aware of the Agency’s assertion of authority to bring
misbranding actions against registered pesticides, and the 1986 Ciba-Geigy
decision, 801 F.2d 430 (D.C. Cir. 1986), which reviewed whether such an
interpretation was ripe for review, when it added the reregistration process. Thus,
it contends, it is significant that Congress could have, but did not, exclude the
misbranding tool from among EPA’s choices of regulatory actions at that time,
just like Congress could have, but did not, make misbranding action contingent on
cancellation elsewhere in the statute.
(Defs.’ Mem. at 25.) This argument is problematic, however, because Ciba-Geigy was the first
time (and only time prior to the pending matter) EPA had ever asserted that it had the authority
to effectively cancel a registration through use of a misbranding action, and, significantly, the
case settled prior to any decision on the merits of EPA’s position. Nor is there any indication in
the legislative history that Congress was even aware of Ciba-Geigy, much less that it was
approving EPA’s novel position in that litigation.
More generally, EPA argues that the 1988 amendments, along with the 1964 and 1972
amendments, “establish that Congress steadily expanded EPA’s regulatory authority.” (Defs.’
Mem. at 24.) Even if that is true, that general proposition does not suffice to answer a specific
question of statutory construction, especially where, as here, the text, structure, purpose and
legislative history point to a different conclusion.
CONCLUSION
Having considered the text, structure, purpose and legislative history of FIFRA, the Court
26
concludes that Congress clearly did not intend to give EPA the authority it asserted in the RMD
to bring a misbranding action in lieu of a cancellation proceeding against a product that failed to
comply with the RMD and, therefore, in EPA’s view, no longer meets the Section 3(c)(5) criteria
– the standard for registration, reregistration and cancellation. As the statute is not ambiguous, it
is unnecessary to decide what level of deference EPA’s interpretation would be entitled to under
the second step of Chevron. See, e.g., Martini v. Federal Nat. Mortg. Ass’n, 178 F.3d 1336
(D.C. Cir. 1999). Accordingly, the Court grants plaintiff’s motion for summary judgment and
denies defendants’ cross-motion. A separate Order accompanies this Memorandum Opinion.
/s/
ELLEN SEGAL HUVELLE
United States District Judge
Date: January 28, 2011
27