Reckitt Benckiser Inc. v. Jackson
| Decision Date | 28 January 2011 |
| Docket Number | Civil Action No. 09–445 (ESH). |
| Citation | 762 F.Supp.2d 34 |
| Parties | RECKITT BENCKISER, INC., Plaintiff,v.Lisa P. JACKSON, Administrator, United States Environmental Protection Agency, et al., Defendants. |
| Court | U.S. District Court — District of Columbia |
OPINION TEXT STARTS HERE
Ronald A. Schechter, Lawrence E. Culleen, Arnold & Porter LLP, Washington, DC, for Plaintiff.Stephanie J. Talbert, U.S. Department of Justice, David M. Kerr, Morgan, Lewis & Bockius, LLP, Kenneth W. Weinstein, Claudia M. O'Brien, Latham & Watkins, Washington, DC, for Defendants.
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.
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 () (FIFRA § 4); § 136d (Administrative review; suspension) (FIFRA § 6); § 136j (Unlawful acts) (FIFRA § 12); 7 U.S.C. § 136k () (FIFRA § 13); and § 136 l (Penalties) (FIFRA § 14).
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)).
“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.
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, 136 l.4 A pesticide is
(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 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. 136 l (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. § 136 l (b).
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 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).
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 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 [ ] ¶ 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 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...
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