United States District Court, D. Colorado
ORDER
PHILIP
A. BRIMMER CHIEF UNITED STATES DISTRICT JUDGE
This
matter is before the Court on Federal Defendants' Motion
to Dismiss [Docket No. 64], [1] State Defendants' Motion to
Dismiss Plaintiff's Complaint Under Fed.R.Civ.P. 12(b)(1)
and 12(b)(6) [Docket No. 63],[2] and Defendant Association of
American Feed Control Officials' Motion to Dismiss
[Docket No. 65]. Plaintiff raises claims under the
Administrative Procedure Act (“APA”), 5 U.S.C.
§ 704, and contends that the Court has subject matter
jurisdiction under 28 U.S.C. §§ 1331 and 1367.
Docket No. 1 at 12.
I.
BACKGROUND
Plaintiff
is a pet food manufacturer that produces and sells raw pet
food. Docket No. 1 at 18, ¶ 60. Due to its manufacturing
process, plaintiff's products naturally contain certain
microorganisms at scientifically detectable levels that
plaintiff claims are not harmful to humans. Id.,
¶ 61; id. at 19, ¶ 64. One type of
microorganism that may be present in plaintiff's pet food
products is Salmonella. Id. at 18, ¶
61.
In July
2013, the Food and Drug Administration (“FDA”)
issued a final version of its Compliance Policy Guide
(“CPG”) § 690.800,
“Salmonella in Food for Animals.”
See U.S. Food & Drug Ass'n, Guidance for FDA
Staff: Compliance Policy Guide Sec. 690.800 Salmonella
in Food for Animals (2013),
https://www.fda.gov/media/86247/download; see
also Docket No. 64-1. The CPG states that the “FDA
considers an animal feed or pet food that may be injurious to
health because it is contaminated with Salmonella to
be adulterated under section 402(a)(1) of the [Food, Drug,
and Cosmetic Act (“FDCA”)] (21 U.S.C.
342(a)(1)).” Docket No. 64-1 at 6. A food is
“adulterated” under the FDCA if it “bears
or contains any poisonous or deleterious substance which may
render it injurious to health, ” but is not considered
adulterated if the substance is not an added substance and
“if the quantity of such substance in such food does
not ordinarily render it injurious to health.” 21
U.S.C. § 342(a)(1). In the CPG, the FDA recommends that
its staff members should consider the following risk-based
criteria in deciding whether to recommend seizure or import
refusal of a pet food, animal feed, or their ingredients on
the basis that it is adulterated:
1. Salmonella is present in one or more subsamples
of the pet food or pet food ingredient; and
2. The pet food or pet food ingredient will not be, or
information is not available to determine whether the pet
food or pet food ingredient will be, further processed with a
heat treatment or other method during the commercial
manufacturing or processing to eliminate the
Salmonella.
3. The Salmonella is of any serotype.
Docket No. 64-1 at 7. The CDA has adopted a definition of
“adulteration” that mirrors the FDA's CPG.
Docket No. 1 at 14, ¶ 41. The Model Bill and Regulations
of the Association of American Feed Control
Officials[3] (“AAFCO”) provide a similar
definition. Id., ¶ 43. Plaintiff contends that
the CPG, and the similar state definitions, is at odds with
21 U.S.C. § 342 and its provision that a naturally
occurring substance will not render a product adulterated if
the substance is in such quantity as to not render it
injurious to health. Docket No. 1 at 29-30, ¶¶
107-116.
On
April 11, 2018, a CDA inspector collected a sample of
plaintiff's pet food from a pet store in Littleton,
Colorado. Id. at 26, ¶ 93. The sample allegedly
contained Salmonella and Listeria
monocytogenes in an unspecified quantity. Id.
at 27, ¶ 94. The CDA is “currently
prosecuting” plaintiff in the Colorado Office of
Administrative Courts (“COAC”) based on this
sample. Id. at 12 n. 21. Plaintiff attributes such
prosecution to the FDA, asserting that “[t]he FDA,
through the CDA, has chosen to prosecute Plaintiff for
alleged violations of the [CPG].” Id. at 15,
¶ 47. Specifically, plaintiff contends that the CDA
acted “pursuant to interagency agreement(s) between
Colorado and the FDA and the FDA's call to the states for
sampling of raw products.” Id. at 26, ¶
93.
On
January 9, 2019, the FDA issued a Public Warning Notice for
plaintiff's A ANSWERS™ Straight Beef Formula for
Dogs on the basis that the product represented a serious
threat to human and animal health. Id. at 25, ¶
90. The FDA issued the warning after plaintiff refused to
conduct a voluntary recall of its product. Id. The
public warning stated that “[f]ederal law requires all
pet food to be free of pathogens, including
Salmonella.” Id. at 26, ¶ 90.
The FDA recommended that pet owners throw the product away
and clean the areas in which the product was stored, as well
as all items that may have come into contact with the
product. Id., ¶ 91.
Plaintiff
sued the FDA, the AAFCO, the CDA, three CDA employees, and
the United States Department of Health and Human Services on
July 5, 2019. See generally Id. Plaintiff seeks a
declaratory judgment that plaintiff was denied its due
process rights and seeks an injunction (a) preventing the FDA
and the AAFCO from applying or enforcing the CPG and (b)
requiring them to suspend any pending related enforcement
actions specific to the CPG. Id. at 34. Plaintiff
also seeks to enjoin defendants from reintroducing similar
compliance policy guides, from circumventing the APA, and
from “creating artificial, false, and misleading
appearances with respect to raw pet food products, safety,
security, commodity, and currency (including removal of such
from existing federal government websites and other means of
publications).” Id.
In
addition, plaintiff requests that all claims and references
of plaintiff distributing an adulterated product, and any
other federal report or record related to the § 690.800
enforcement, “be expunged from all federal and state
records.” Id.
The
federal defendants move to dismiss plaintiff's action on
the basis that, among other reasons, the Court lacks subject
matter jurisdiction over plaintiff's lawsuit. Docket No.
64 at 5, 9. The state defendants also argue that the Court
lacks subject matter jurisdiction over this case. Docket No.
63 at 5. Finally, the AAFCO moves to dismiss the claims
against it on the basis that the Court lacks personal
jurisdiction over the association. Docket No. 65 at 3.
II.
LEGAL STANDARD - SUBJECT MATTER JURISDICTION
Dismissal
pursuant to Federal Rule of Civil Procedure 12(b)(1) is
appropriate if the Court lacks subject matter jurisdiction
over claims for relief asserted in the complaint. Merrill
Lynch Bus. Fin. Servs., Inc. v. Nudell, 363 F.3d 1072,
1074 (10th Cir. 2004). Rule 12(b)(1) challenges are generally
presented in one of two forms: “[t]he moving party may
(1) facially attack the complaint's allegations as to the
existence of subject matter jurisdiction, or (2) go beyond
allegations contained in the complaint by presenting evidence
to challenge the factual basis upon which subject matter
jurisdiction rests.” Id. (quoting Maestas
v. Lujan, 351 F.3d 1001, 1013 (10th Cir. 2003)).
“In reviewing a facial attack on the complaint, a
district court must accept the allegations in the complaint
as true.” Holt v. United States, 46 F.3d 1000,
1002 (10th Cir. 1995). However, “[w]hen reviewing a
factual attack on subject matter jurisdiction, a district
court may not presume the truthfulness of the complaint's
factual allegations.” Id. at 1003. “The
substantive distinction between a facial attack and a factual
attack is that in a facial attack the defendant contests the
sufficiency of the complaint, while a factual attack
challenges the existence in fact of federal subject matter
jurisdiction.” LaLoup v. United States, 29
F.Supp.3d 530, 536 (E.D. Pa. 2014). “Because the
jurisdiction of federal courts is limited, there is a
presumption against our jurisdiction, and the party invoking
federal jurisdiction bears the burden of proof.”
Merida Delgado v. Gonzales, 428 F.3d 916, 919 (10th
Cir. 2005) (citation omitted).
III.
ANALYSIS
A.
Federal Defendants
The
federal defendants argue that the Court lacks subject matter
jurisdiction over plaintiff's claims because plaintiff
seeks pre-enforcement review of an FDA enforcement action.
Docket No. 64 at 5-6. “It has long been established
that courts lack jurisdiction to enjoin FDA from initiating
enforcement proceedings under the FDCA.” Cody
Labs., Inc. v. Sebelius, 2010 WL 3119279, at *8 (D. Wyo.
July 26, 2010) (citation omitted).
The
APA, on which plaintiff bases subject matter jurisdiction,
provides that “[a]gency action[s] made reviewable by
statute and final agency action[s] for which there is no
other adequate remedy in a court are subject to judicial
review.” 5 U.S.C. § 704. “A preliminary,
procedural, or intermediate agency action or ruling not
directly reviewable is subject to review on the review of the
final agency action.” Id. Plaintiff
“[has] the burden of identifying specific federal
conduct and explaining how it is ‘final agency
action.'” Colo. Farm Bureau Fed'n v. U.S.
Forest Serv., 220 F.3d 1171, 1173 (10th Cir. 2000)
(quotation omitted).
In
arguing that the Court lacks subject matter jurisdiction over
this case, the federal defendants rely upon Ewing v.
Mytinger & Casselberry, Inc., 339 U.S. 594 (1950).
In Ewing, a distributor of nutritional supplements
challenged the seizure by the FDA of its product under 21
U.S.C. § 334(a), which permitted seizures of misbranded
articles where there was probable cause to believe that the
misbranded article was dangerous to public health or that the
labeling of the article was fraudulent. Id. at 595,
597.[4]
The statute permitted such seizures “when the
Administrator has probable cause to believe from facts found,
without hearing, by him or any officer or employee of the
Agency that the misbranded article is dangerous to health, or
that the labeling of the misbranded article is fraudulent, or
would be in a material respect misleading to the injury or
damage of the purchaser or customer.” Id. at
595-96 (quoting 21 U.S.C. § 334(a)). The Supreme Court
held that the district court “had no jurisdiction to
review the administrative determination of probable
cause.” Id. at 600. Specifically, the Supreme
Court stated that “[j]udicial review of this
preliminary phase of the administrative procedure does not
fit the statutory scheme nor serve the policy of the
[FDCA].” Id. The Ewing Court noted
that “Congress made numerous administrative
determinations under the [FDCA] reviewable by the courts,
” but the administrative finding of probable cause was
not one of them. Id.
In
arguing that it seeks not pre-enforcement review, but review
of a final agency action, plaintiff relies upon Abbott
Laboratories v. Gardner, 387 U.S. 136 (1967),
abrogated on other grounds by Califano v. Sanders,
430 U.S. 99 (1977). In Abbott, the Supreme Court
noted that, while Ewing was “quite clearly
correct, ” it did not govern the case before it - a
declaratory judgment action challenging an administrative
regulation that had already been promulgated. Id. at
147. Specifically, the Supreme Court found that
Ewing “bears no analogy to the promulgation,
after formal procedures, of a rule that must be followed by
an entire industry” and that to find otherwise
“would immunize nearly all agency rulemaking activities
from the coverage of the Administrative Procedure Act.”
Id. “[O]nly upon a showing of clear and
convincing evidence of a contrary legislative intent should
the courts restrict access to judicial review.”
Id. at 141 (quotations omitted). Plaintiff argues
that its lawsuit is a challenge to a final FDA rule and, for
this reason, Ewing does not apply. Docket No. 78 at
3.
The
Supreme Court has stated that, for an agency action to be
considered “final, ” two conditions must be
satisfied: “[f]irst, the action must mark the
‘consummation' of the agency's decision making
process, ” and “second, the action must be one by
which ‘rights or obligations have been determined, or
from which legal consequences will flow.'”
Bennett, 520 U.S. at 178 (quoting Chicago &
S. Air Lines, Inc. v. Waterman S.S. Corp., 333 U.S. 103,
113 (1948) and Port of Boston Marine Terminal Ass'n
v. Rederiaktiebolaget Transatlantic, 400 U.S. 62, 71
(1970)). A final agency action must “determine rights
or obligations, or produce legal consequences.”
Ass'n of Flight Attendants-CWA v. Huerta, 785
F.3d 710, 714 (D.C. Cir. 2015). “In litigation over
guidance documents, the finality inquiry is often framed as
the question of whether the challenged agency action is best
understood as a non-binding action, like a policy statement
or interpretive rule, or a binding legislative rule.”
Id. at 716. A policy statement “explains how
the agency will enforce a statute or regulation - in other
words, how it will exercise its broad enforcement discretion
. . . under some extant statute or rule, ” id.
(internal quotation marks omitted), while an interpretive
rule is “issued by an agency to advise the public of
the agency's construction of the statutes and rules which
it administers.” Id. (quoting Perez v.
Mortg. Bankers Ass'n, 575 U.S. 92, 97 (2015)). A
legislative rule “‘modifies or adds to a legal
norm based on the agency's own authority' flowing
from a congressional delegation to engage in supplementary
lawmaking.” Id. at 717 (emphasis omitted)
(quoting Syncor Int'l Corp. v. Shalala, 127 F.3d
90, 95 (D.C. Cir. 1997)). “The most important factor in
differentiating between binding and nonbinding actions is
‘the actual legal effect (or lack thereof) of the
agency action in question.'” Id. (quoting
Nat'l Min. Ass'n v. McCarthy, 758 F.3d 243,
252 (D.C. Cir. 2014)).
Plaintiff
alleges that “the FDA has taken final agency action by
promulgating [the CPG] and is enforcing that rule through a
shadow regulation scheme to disguise their role in the
actions taken against the Plaintiff.” Docket No. 78 at
3. Specifically, it argues that the FDA's action marks
the consummation of its decision-making process because (1)
the FDA took a definitive legal position regarding its
statutory authority; (2) the CPG concerns a legal question of
statutory interpretation; and (3) the CPG “burdens the
Plaintiff directly because of ...