United States District Court, D. Oregon
Scott Jerger, Field Jerger LLP, and Michael Ray Harris,
Friends of Animals, Attorneys for Plaintiff.
Baynes, United States Department of Justice, Environment and
Natural Resources Division, Environmental Defense Section,
P.O. Box Of Attorneys for Defendants.
M. Engbloom, Lane Powell PC, Douglas A. Hastings, Morgan,
Lewis & Bockius, LLP, 1111 Pennsylvania Ave, NW,
Washington, DC 20004. Of Attorneys for Defendant-Intervenors.
OPINION AND ORDER
MICHAEL H. SIMON UNITED STATES DISTRICT JUDGE
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, 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.
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).
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).
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. §
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. §
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 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.
2009, The Humane Society of the United States
(“HSUS”) 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's waiver of the requirements to submit subchronic,
developmental, reproductive, genotoxicity, neurtoxicity, and
immunotoxicity studies based on “the lack of toxicity
to the target animal; history of safe use of the vaccine; the
mode of action and fate of the product'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.” Id. The
EPA also granted HSUS exemptions from all ...