The opinion of the court was delivered by: Ellen Segal Huvelle United States District Judge
The Defenders of Wildlife and Audubon of Kansas (collectively, "Defenders") and the Natural Resources Defense Council ("NRDC") have sued Lisa Jackson in her official capacity as the Administrator of the Environmental Protection Agency ("Agency"), alleging that the Agency violated the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"), the Administrative Procedure Act ("APA"), and the Endangered Species Act ("ESA") by registering the rodenticide Rozol. (Defenders Compl. ¶ ¶ 50-57, 61-62.) The Defenders also allege that the Agency violated the Bald and Golden Eagle Protection Act ("Eagle Act"), the Migratory Bird Treaty Act ("Migratory Bird Act"), and Executive Order No. 13186.*fn1 (Id. ¶ ¶ 63-64.) LiphaTech, Inc., the manufacturer of Rozol, has intervened as a defendant. (Dkt. No. 7.) Plaintiffs filed a joint motion for summary judgment, while the Agency and LiphaTech filed separate cross-motions for dismissal or, in the alternative, for summary judgment. (Dkt. Nos. 29, 33, 35.) For the reasons stated herein, the motions of all parties will be granted in part and denied in part.
A. Endangered Species Act
The ESA, 16 U.S.C. § 1531 et seq., has been called the "most comprehensive legislation for the preservation of endangered species ever enacted by any nation." Babbitt v. Sweet Home Chapter of Cmties. for a Great Or., 515 U.S. 687, 698 (1995) (internal quotation marks omitted). Section 7(a)(2) of the ESA requires agencies to consult with the Fish and Wildlife Service ("FWS") to "insure that any action authorized, funded, or carried out" is "not likely to jeopardize the continued existence of an endangered species or threatened species or result in the destruction or adverse modification" of a listed species' critical habitat. 16 U.S.C. § 1536(a)(2). Agency regulations define "action" as "all activities or programs of any kind authorized, funded, or carried out, in whole or in part, by Federal agencies in the United States." 50 C.F.R. § 402.02. "[J]eopardize the continued existence" means to "reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of that species." Id. The Agency must review actions "at the earliest possible time." Id. § 402.14(a). If it determines that action will affect a listed species or critical habitat, it must engage in formal consultation with the FWS, unless one of several exceptions applies. Id. The FWS is required to produce a "biological opinion" that states whether the action will "jeopardize the continued existence of listed species or result in the destruction or adverse modification of critical habitat" and "[f]ormulate discretionary conservation recommendations" and a "statement concerning incidental take." 50 C.F.R. § 402.14(g).
Agency regulations also provide for an alternative "optional formal consultation procedure." Id. § 402.46. This provides an "additional" way for the Agency to "satisfy the requirements of section 7(a)(2) . . . for certain regulatory actions under FIFRA." Id. § 402.41. The Agency begins the consulting process by providing the FWS with a "written request," accompanied by an "effects determination," that lists information required under 50 C.F.R. § 402.14(c) and details the impact of the proposed action on the listed species or critical habitat. Id. § § 402.40(b), 402.46. The Agency may include its own conclusions and "incidental take statement," which the FWS can adopt or reject. Id. § 402.46; see also Wash. Toxics Coal. v. Dep't of Interior, Fish & Wildlife Serv., 457 F. Supp. 2d 1158, 1180 (W.D. Wash. 2006). If the FWS accepts these conclusions, the Agency's proposal is converted into the required "biological opinion and incidental take statement." Wash. Toxics Coal., 457 F. Supp. 2d at 1180.
Consultation is "designed as an integral check on federal agency action, ensuring that such action does not go forward without full consideration of its effects on listed species." Lujan v. Defenders of Wildlife, 504 U.S. 555, 603 (1992) (Blackmun, J., dissenting). Moreover, once consultation has begun under § 7(d), the "[f]ederal agency and the permit or license applicant shall not make any irreversible or irretrievable commitment of resources with respect to the agency action which has the effect of foreclosing the formulation or implementation of any reasonable and prudent alternative measures which would not" jeopardize an endangered or threatened species or destroy its habitat. 16 U.S.C. § 1536(d). This "prohibition is in force" until the "requirements of section 7(a)(2) are satisfied." 50 C.F.R. § 402.09.
Private parties may enforce the ESA via a "citizen suit" provision that allows for "any person" to bring a civil suit to "enjoin any person, including . . . any other governmental instrumentality or agency . . . alleged to be in violation of any provision of this chapter . . . ." 16 U.S.C. § 1540(g)(1)(A). The Court has jurisdiction "to enforce any such provision or regulation." Id. § 1540(g)(1). However, no action "may be commenced" under § (g)(1)(A) "prior to sixty days after written notice of the violation has been given . . . ." Id. § 1540(g)(2)(A).
FIFRA, 7 U.S.C. § § 136-136y, requires pesticide manufacturers to register their products with the Agency before selling or distributing them. Registration under FIFRA is "product-specific" and defines the "terms and conditions under which the product can be legally distributed, sold, and used." Reckitt Benckiser, Inc. v. EPA, 613 F.3d 1131, 1133 (D.C. Cir. 2010). The Agency "shall register" a pesticide if it determines
(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.
7 U.S.C. § 136a(c)(5). The Agency must publish notice of applications for registration "promptly" if the pesticide "contains any new active ingredient or if it would entail a changed use pattern." 7 U.S.C. § 136a(c)(4). The Agency must also publish "notice of receipt" in the Federal Register and must publish notice and respond to public comments when an application proposes a "new use." 40 C.F.R. § 152.102. A new use is one that would "result in a significant increase in the level of exposure, or a change in the route of exposure, to the active ingredient of man or other organisms." 40 C.F.R. § 152.3.
FIFRA also has a "conditional registration provision," which allows the Agency to "conditionally register or amend the registration of a pesticide if" it determines that the pesticide and proposed use are (i) . . . substantially similar to any currently registered pesticide . . . or differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment, and (ii) approving the registration . . . would not significantly increase the risk of any unreasonable adverse effect on the environment.
7 U.S.C. § 136a(c)(7)(A).*fn2 Thus, the Agency may register a product even if the applicant is missing data that would otherwise be "required to obtain registration of a similar pesticide," so long as the applicants submit the data "not later than the time such data are required to be submitted with respect to similar pesticides already registered under this subchapter." Id.
FIFRA also allows states to register "additional uses" of "federally registered pesticides" to meet "special local needs," so long as registration for that use has "not previously been denied, disapproved, or canceled" by the Agency. 7 U.S.C. § 136v(c)(1). Though registration under this provision is "deemed registration under 136a," it only applies within the state issuing the registration. Id. The Agency may disapprove of a "local registration," and thereby render it ineffective, but must give the state advance warning and provide an opportunity to respond, unless it determines that the pesticide poses an "imminent hazard." Id. § § 136v(c)(2)-(3).
A pesticide's registration must be "periodically reviewed," id. § 136a(g), and may be cancelled at any time by the Agency under § 136d(b) or by the registrant under § 136d(f)(1). Reckitt Benckiser Inc., 613 F.3d at 1134. The Agency "may" issue a notice of intent to cancel a product's registration or to hold a hearing on cancellation when it "appears" that the pesticide or its labeling does not comply with FIFRA or "generally causes unreasonable adverse effects on the environment." See id. (citing 7 U.S.C. § 136d(b)). If the Agency refuses to cancel a registration, a party may obtain review of the decision in a district court. Id. (quoting 7 U.S.C. § 136n(a)). If the Agency simply issues notice of an intent to cancel and does not issue a notice of a hearing, the registrant may "demand" a hearing before an Administrative Law Judge, at which it may present testimonial and documentary evidence. 7 U.S.C. § § 136d(b)(1), (d). Agency regulations also allow "any person adversely affected by a notice of the Administrator of his refusal to register or of his intent to cancel the registration or to change the classification of a pesticide" to request a hearing. 40 C.F.R. § 164.20(a). The same hearing is available when the Agency refuses to grant an application to register a pesticide. 7 U.S.C. § 136a(c)(6).
At a cancellation hearing, the "proponent of cancellation or change in classification" must present an "affirmative case for the cancellation or change in the classification of the registration." 40 C.F.R. § 164.80(a). At an application hearing, the "applicant shall have the burden of going forward." Id. However, "on all issues arising in connection with the hearing," whether related to cancellation or application, "the ultimate burden of persuasion shall rest with the proponent of the registration." Id. § 164.80(b); see also Envtl. Def. Fund, Inc. v. EPA, 510 F.2d 1292, 1302 (D.C. Cir. 1975) ("[t]he responsibility to demonstrate that the benefits outweigh the risks is upon the proponents of continued registration").
If a pesticide presents an "imminent hazard" and the Agency determines that "action is necessary . . . during the time required for cancellation or change in classification proceedings," the Agency may "suspend the registration of the pesticide immediately." 7 U.S.C. § 136d(c)(1). The Agency must generally issue a "notice of intention" to act before issuing a suspension order, and must include "findings pertaining to the question of 'imminent hazard'," to which the registrant may respond at an "expedited hearing." Id.
FIFRA channels cases into two separate pools for the purposes of
judicial review. District courts have jurisdiction over "the refusal
of [the EPA] to cancel or suspend a registration or to change a
classification not following a hearing and other final actions of [the
EPA] not committed to the discretion of [the EPA] by law." 7 U.S.C. § 136n(a).
Courts of appeals have "exclusive jurisdiction" over challenges to the
"validity of any order issued by the Administrator following a public
hearing" made by "any person who will be adversely affected by such
order and who had been a party to the proceedings."*fn3
Id. § 136n(b).
C. Migratory Bird Act And Eagle Act
The Migratory Bird Act, 16 U.S.C. § 703 et seq., makes it "unlawful"
to "pursue, hunt, take, capture, kill, attempt to take, capture, or
kill" one of an enumerated list of birds protected under the Act. Id.
§ 703(a). The Eagle Act imposes criminal and civil penalties against
anyone who takes bald and golden eagles without permission. 16 U.S.C.
§ § 668a-b. The Eagle Act defines "take," in part, as "poison, wound,
[or] kill." Id. § 668c. Neither Act provides a framework for judicial
review of agency actions.
D. The Administrative Procedure Act
The APA gives a court jurisdiction over "[a]gency action made reviewable by statute and final agency action for which there is no other adequate remedy in a court." Nat'l Ass'n of Home Builders v. Norton, 415 F.3d 8, 13 (D.C. Cir. 2005) (quoting 5 U.S.C. § 704)) (emphasis altered) (brackets in original). The APA defines agency action as "the whole or a part of an agency rule, order, license, sanction, relief, or the equivalent or denial thereof, or failure to act."
5 U.S.C. § 551(13). A court must "hold unlawful and set aside agency actions, findings, and conclusions" that are arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law. 5 U.S.C. § 706(2).
The product at issue is Rozol, a rodenticide used on prairie dogs, and its active ingredient, chlorophacinone. In 1978, Congress passed a law requiring the Agency to "'reregister' all pesticides 'in the most expeditious manner practicable.'" Reckitt Benckiser Inc., 613 F.3d at 1133 (quoting Act of Sept. 30, 1978, Pub. L. 95-396, § 8, 92 Stat. 819, 827 (1978)). In 1988, Congress enacted Section 4 of FIFRA, which details reregistration procedures for pesticides with active ingredients first registered before November 1, 1984. 7 U.S.C. § 136a-1(a). Chlorophacinone is one of these active ingredients. (See Administrative Record ["AR"] 81B at 2 (reregistration decision letter).)
In 1991, the Agency requested formal consultation with the FWS regarding a variety of previously registered chemicals, including chlorophacinone. (AR 81C at I-1.) Chlorophacinone, an "anticoagulant," progressively disrupts the body's blood-clotting ability over "an extended period of time." (AR 9 at 2.) The progressive worsening of symptoms causes affected animals to "exhibit weakness, disorientation," and other signs of illness. (Id.) In 1993, the FWS issued a Biological Opinion noting that some birds and mammals were "highly sensitive" to the chemical. (AR 81C at II-29.) The Agency determined that chlorophacinone was eligible for reregistration on September 30, 1997. (AR 81B, Letter from Lois A. Rossi.) At the time, twenty states had already locally registered the chemical for use against small ground mammals. (Id. at 6.) The Agency noted that it "presume[d] high risk to any small mammals that feed on chlorophacinone baits" and that rodents that had been poisoned with the chemical "pose[d] a risk to coyotes and presumably other species." (Id. at 89.) It added that "[a]additional consultation with the Fish and Wildlife Service . . . may be necessary to determine if steps need to be taken to protect newly listed species . . . from proposed new uses of" chlorophacinone. (Id. at 109.) The Agency noted that further studies of the effects of "[s]econdary [p]oisoning"*fn4 in mammals and birds were required. (Id. at 111.)
On April 1, 2004,*fn5 the State of Kansas registered Rozol under FIFRA's special local need provision, with the stated purpose of controlling the prairie dog population. (AR 3 at 1.) Prairie dogs are "considered a public health pest" by the Agency because they can host fleas "that may vector plague." (AR 7 at 2.) Though Rozol was (and is) limited to use inside prairie dog burrows (AR 86 at 4), the disorientation and weakness caused by exposure can lead to poisoned animals "dying aboveground and being scavenged by other animals." (AR 9 at 2.) Moreover, animals exposed to the chemical take at least one week to die and sometimes survive more than two weeks. (AR 82 at 4.) There is also evidence that the chemical stays active within animals' bodies for twenty days or more. (Id. at 7.)
The Agency approved this registration on July 30, 2004, although it required several changes to the product label to provide more precise instructions for use. (AR 6 at 1.) Nebraska and Wyoming approved Rozol for local use on black-tailed prairie dogs effective February 14 (AR 16 at 1) and May 23, 2006 (AR 29 at 1), respectively. The FWS repeatedly expressed concerns about Rozol's effect on endangered and threatened species (see AR 9, AR 15, AR 30) and sent a letter to the Nebraska Department of Agriculture asking it not to "issue the 24(c) SLN registration for Rozol to control [prairie dogs] in Nebraska." (AR 9 at 8.) After Nebraska approved the registration, the FWS wrote to the Agency expressing "concerns regarding the use of Rozol" and "recommend[ing] that EPA disapprove the Rozol special local needs registration for Nebraska until important data gaps can be addressed." (AR 15 at 1.) The Agency approved Nebraska's and Wyoming's registrations on November 16, 2006. (AR 17; AR 29 at 1.) Colorado approved Rozol for a special local need on ...