Source: http://or.findacase.com/research/wfrmDocViewer.aspx/xq/fac.20190423_0000561.DOR.htm/qx
Timestamp: 2020-07-14 16:50:39
Document Index: 644513393

Matched Legal Cases: ['§ 136', '§ 136', '§ 136', '§ 136', '§ 136', '§ 154', '§ 136', '§ 136', '§ 154', '§ 154', '§ 154', '§ 136', '§ 136', '§ 136', '§ 136', '§ 136']

FindACase™ | Friends of Animals v. United States Environmental Protection Agency
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, and ANDREW WHEELER, in his official capacity as Acting Administrator of the U.S. Environmental Protection Agency, Defendants, and THE HUMANE SOCIETY OF THE UNITED STATES Defendant-Intervenor.
R. Scott Jerger, Field Jerger LLP, and Michael Ray Harris, Friends of Animals, Attorneys for Plaintiff.
Sheila Baynes, United States Department of Justice, Environment and Natural Resources Division, Environmental Defense Section, P.O. Box Of Attorneys for Defendants.
Julie M. Engbloom, Lane Powell PC, Douglas A. Hastings, Morgan, Lewis & Bockius, LLP, 1111 Pennsylvania Ave, NW, Washington, DC 20004. Of Attorneys for Defendant-Intervenors.
Plaintiff, Friends of Animals, seeks judicial review of the EPA's denial of its request to initiate a Special Review of a pesticide registered with the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”). After hearing from the parties on cross-motions for summary judgment, United States Magistrate Judge Patricia Sullivan issued her Findings and Recommendation (“F&R”). Judge Sullivan concluded that the EPA's decision not to initiate a Special Review was not subject to judicial review and dismissed the case for want of jurisdiction. After de novo review[1], the Court rejects the F&R and concludes that the Court does have jurisdiction over Plaintiff's case. The Court remands the case to Judge Sullivan for a recommendation on the merits of the cross-motions for summary judgment.
A. FIFRA
FIFRA sets out detailed procedures governing the sale, use, and distribution of pesticides and requires that all pesticides must be registered with the EPA. 7 U.S.C. § 136a(a). Before a pesticide can be properly registered with the EPA, the Administrator must determine that the pesticide does “not generally cause unreasonable adverse effects on the environment.” Id. § 136(a)(c)(5)(D). FIFRA defines an “unreasonable adverse effect on the environment” as one that poses “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.” Id. § 136(bb).
After a pesticide is registered with the EPA, FIFRA provides certain review procedures for the EPA to continually reevaluate a pesticide's risks and benefits. If the EPA finds that a registered pesticide, “when used in accordance with widespread and commonly recognized practice, generally causes unreasonable adverse effects on the environment, ” the EPA may institute proceedings either to “cancel its registration or change its classification, ” or to “determine whether or not its registration should be cancelled or its classification changed.” See 7 U.S.C. § 136d(b)(1)-(2). The EPA also has the authority to suspend the registration of the pesticide immediately “[i]f the [EPA] determines that action is necessary to prevent an imminent hazard during the time required for cancellation or change in classification proceedings.” 7 U.S.C. § 136d(c)(1).
The EPA may conduct a public interim administrative review, called a Special Review, see 40 C.F.R. § 154.1(a); 50 Fed. Reg. 12200, to determine whether a pesticide should be cancelled or reclassified, see 7 U.S.C. § 136d(b). “[A] decision to initiate a Special Review must be ‘based on a validated test or other significant evidence raising prudent concerns of unreasonable adverse risks to man or to the environment.'” 50 Fed. Reg. 49006 (quoting 7 U.S.C. § 136a(c)(8)). The regulations promulgated under FIFRA identify six criteria for the EPA Administrator to consider in determining whether “based on a validated test or other significant evidence . . . the use of the pesticide” poses unreasonable risks to humans and the environment such that the EPA should initiate a Special Review. 40 C.F.R. § 154.7(a) (identifying six criteria for EPA Administrator to consider). If the Administrator finds that at least one of those six criteria is met, she “shall consider available evidence concerning both the adverse effect of the pesticide and the magnitude and scope of exposure to humans and nontarget organisms.” Id. § 154.7(b). The EPA may initiate Special Review of a pesticide either on its own initiative or “at the suggestion of any interested party” who submits a “petition[] to begin the Special Review process.” See Id. § 154.10.
Any final orders of the Administrator made specifically under 7 U.S.C. § 136d are subject to judicial review under 7 U.S.C. § 136n(a). See 7 U.S.C. § 136d(h). District courts have jurisdiction to review “the refusal of the [EPA] to cancel or suspend a registration or change a classification not following a hearing and other final actions of the [EPA] not committed to the discretion of the [EPA] by law.” See Id. § 136n(a). Appellate courts have jurisdiction to review the validity of orders made after a public hearing. Id. § 136n(b).
B. ZonaStat-H
At issue in this case is the continued registration under FIFRA of the pesticide ZonaStat-H, a contraceptive for wild horses and burros that contains the active ingredient porcine zona pellucida (“PZP”). PZP is a naturally-occurring animal glycoprotein harvested from the ovaries of pigs. EPA000044. The pesticide ZonaStat-H is made up of PZP and two adjuvants[2] which, when combined and injected into mares, blocks the attachment of sperm to egg, thereby preventing fertilization. Id.; EPA000038. ZonaStat-H is used to manage wild horse and burro populations.
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;In 2009, The Humane Society of the United States (&ldquo;HSUS&rdquo;) submitted an application to register ZonaStat-H under FIFRA for the specific use of limiting populations of wild and feral horses and burros. HSUS submitted information in support of its application for registration, including published journal articles and peer-reviewed studies on the use of PZP. EPA granted HSUS&#39;s waiver of the requirements to submit subchronic, developmental, reproductive, genotoxicity, neurtoxicity, and immunotoxicity studies based on &ldquo;the lack of toxicity to the target animal; history of safe use of the vaccine; the mode of action and fate of the product&#39;s metabolites; the limited opportunity of exposure to non-target animals, applicators, and the public; and the lack of immunotoxicity as shown in the published literature.&rdquo; Id. The EPA also granted HSUS exemptions from all ...