United States District Court, N.D. California
ORDER GRANTING IN PART AND DENYING IN PART
DEFENDANTS' MOTION FOR JUDGMENT ON THE PLEADINGS; DENYING
PLAINTIFFS' MOTION FOR SUMMARY JUDGMENT RE: DKT. NOS.
145, 198
VINCE
CHHABRIA UNITED STATES DISTRICT JUDGE.
The
Food and Drug Administration has concluded that its authority
to regulate drugs includes the authority to regulate the
material used to modify an animal's genetic makeup.
Pursuant to that asserted authority, the FDA approved a
company's application to create, through genetic
manipulation, a type of salmon that grows to mature size more
quickly than normal. As a condition of approval, the FDA
imposed restrictions on how and where the salmon are grown,
to reduce the risk that the engineered salmon will mix with
normal salmon.
The
FDA's approval of the salmon has drawn a lawsuit by a
coalition of environmental and industry groups. The lawsuit
is both a broadside attack on the FDA's authority to
regulate the genetic engineering of animals and a targeted
attack on the particular process by which the agency approved
the salmon. Presently, the Court has been asked to address
the broadside attack. For the most part, the parties have
left for a later date the adjudication of specific claims
relating to the salmon approval.
The
plaintiffs' broadside attack has a head-scratching
element to it. Although they insist the FDA lacks the
authority to regulate the genetic engineering of animals, the
plaintiffs have not explained how this conduct can otherwise
be regulated under current law. It thus appears that their
argument, if successful, would create a regulatory void in
which companies would be free to genetically engineer animals
without meaningful regulatory oversight (at least unless
Congress were able to agree on legislation restricting
genetic engineering of animals). But even without considering
these consequences, the FDA's assertion of authority is
valid. Under the plain language of the Food, Drug, and
Cosmetic Act, the FDA has the authority to require companies
to seek its approval before creating and breeding genetically
engineered animals. Perhaps the genetic material used to
modify an animal does not seem like a “drug” in
the colloquial sense, but it is the statutory definition that
matters. The statutory definition of “drug” is
far broader than the ordinary meaning of that word, and the
modification of an animal's genetic makeup falls squarely
within the statutory definition.
Because
the FDA possesses the authority to regulate this conduct, and
for the additional reasons set forth in this ruling, the
government largely prevails in this round of the litigation.
A hearing will take place in May 2020 on the second round,
which involves the question whether the agency's approval
of the genetically engineered salmon was faulty, even if its
general assertion of jurisdiction over genetic engineering is
lawful.
I
To
genetically engineer an animal, a scientist first derives a
sequence of recombinant DNA, known in this field as an rDNA
construct. This construct can encode and represent a specific
trait. Next, the rDNA construct is integrated into the genome
of an animal. In essence, the presence of the construct will
cause the animal to express the sought-after trait. And the
rDNA construct can be heritable, meaning that the animal will
pass the trait to its progeny. Take the following real-world
example: If a scientist wants to engineer a fish that glows
under certain kinds of light, they would first derive an rDNA
construct that represents the trait of glowing under those
kinds of light, and then they would integrate the construct
into the genome of a fish. Now the scientist has a glowing
fish, as well as the ability to breed a whole line of glowing
fish.
The FDA
regulates certain rDNA constructs on the theory that they are
“drugs” under the Food, Drug, and Cosmetic Act
(FDCA). The FDA first signed off on the use of an rDNA
construct to genetically engineer an animal in 2009. That
construct, when integrated into a goat's genome, causes
the goat to produce an anticoagulant in its milk, which in
turn is used to produce a medication that prevents certain
people from getting blood clots. 21 C.F.R. § 528.1070.
The FDA next approved an application for an rDNA construct
intended to produce chickens whose egg whites contain a
protein that treats a rare enzyme disorder. § 528.2010.
And just this year, the FDA greenlit an rDNA construct that
causes rabbits to produce milk capable of treating
hemophilia. § 528.1080. The FDA has also declined, in an
exercise of its enforcement discretion, to regulate the
genetic engineering of some animals, including the glow fish
mentioned above. See International Center for Technology
Assessment v. Thompson, 421 F.Supp.2d 1, 5 (D.D.C.
2006).
AquaBounty
Technologies, Inc. employed a similar technique to create
salmon with an abnormally high growth rate. To create its
rDNA construct, AquaBounty derived genetic material from a
Pacific Chinook salmon and from an ocean pout (which is
another type of fish). AquaBounty integrated that rDNA
construct into the genome of an Atlantic salmon to produce a
line of fish that apparently grow to full size in roughly
half the standard time. The commercial moniker for
AquaBounty's genetically engineered fish is the
AquAdvantage salmon.
In
November 2015, the FDA granted AquaBounty's application
for approval of this rDNA construct as a new animal drug. In
technical terms, the FDA approved the use of “[a]
single copy of the α-form of the opAFP-GHc2 recombinant
deoxyribonucleic acid (rDNA) construct at the α-locus
in the EO-1 α lineage of triploid, hemizygous,
all-female Atlantic salmon (Salmo salar).” 21 C.F.R.
§ 528.1092(a). The regulation memorializing the
FDA's approval limits the production of these fish to
“physically-contained, freshwater culture facilities
specified in an FDA-approved application.” §
528.1092(d).
From a
regulatory standpoint, the AquAdvantage salmon present
somewhat different issues from the goats, chickens, and
rabbits mentioned above. Those other animals are engineered
to produce something that becomes an ingredient in a drug to
be taken by human beings. The FDA's drug authority is
exercised at the front end (when the rDNA construct is used
on the animal) and the back end (when the animal's
byproduct is turned into a drug for people). The salmon, on
the other hand, merely become food to be consumed by people.
AquaBounty's application represents the FDA's first
approval of the use of an rDNA construct to develop
genetically engineered animals destined for the kitchen
table.
In its
initial approval, the FDA mandated a production process
whereby AquaBounty produced eggs in Canada on Prince Edward
Island and grew the eggs into mature fish inside freshwater
tanks in Panama. Application AR 23116. The FDA also imposed
various conditions of use (including agency inspections) to
ensure that the AquAdvantage salmon are sterile and cannot
escape into the wild. Application AR 23117-19. At present,
with the FDA's permission, AquaBounty is raising the
salmon in landlocked, freshwater tanks in Indiana.
See Statement of FDA Commissioner Scott Gottlieb,
Continued Efforts to Advance Safe Biotechnology
Innovations, and the Deactivation of an Import Alert on
Genetically Engineered Salmon (Apr. 8, 2019),
https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-continued-efforts-advance-safe-biotechnology.
The Department of Agriculture recently finalized labeling
standards for the AquAdvantage salmon that carry an
implementation date of January 1, 2020. National
Bioengineered Food Disclosure Standard, 83 Fed. Reg. 65, 814
(Dec. 21, 2018); see 7 C.F.R. §§ 66.6,
66.13. The first harvest of AquAdvantage salmon is planned
for late 2020, so filets of these genetically engineered
salmon could be sold for consumption in the United States not
long after.
A
coalition of environmental and industry groups, believing the
FDA's approval of AquAdvantage salmon to be unlawful,
brought this lawsuit against the FDA and its Commissioner, as
well as the Secretary of Health and Human Services and the
Fish and Wildlife Service.[1] At a ten-thousand-foot level, the
plaintiffs contend that: (i) the FDA lacks the authority to
regulate rDNA constructs as drugs; and (ii) the agency has
not adequately evaluated the environmental risks posed by
genetically engineered animals in general, or by the
AquAdvantage salmon in particular. AquaBounty intervened as a
defendant to protect its interests in the litigation.
This
lawsuit has been divided into two stages. In the current
stage, the Court has been asked to adjudicate four claims.
Two of those claims challenge a document in which the FDA
explained its authority to regulate genetically engineered
animals. As explained in Section II, however, the document
does not reflect “final agency action” and
therefore is not subject to judicial review. Another claim
seeks to set aside approval of the AquAdvantage salmon on the
ground that the FDA lacks statutory authority to regulate
genetically engineered animals. As explained in Section III,
the government prevails on this claim, because the plain
language of the FDCA authorizes the FDA to require approval
of genetically engineered animals and impose conditions on
their use. Finally, the plaintiffs contend that the
genetically engineered salmon are dangerous to the
environment, and that the FDCA precludes the FDA from
approving drugs that are not environmentally safe. As
discussed in Section IV, adjudication of this claim will be
deferred to the next stage of the case. This claim raises
several questions that the parties have not adequately
addressed, and in any event these arguments are better
considered in the context of the plaintiffs' other
targeted challenges to the AquAdvantage salmon approval.
II
To
explain the basis for its prior assertions of regulatory
authority over the creation of genetically engineered
animals, the FDA issued a guidance document. This document,
which is called “Guidance for Industry 187, ”
announces and outlines the FDA's understanding of how the
FDCA and its implementing regulations apply to the process of
genetically engineering animals. Claim 8 of the
plaintiffs' lawsuit alleges that the FDA should have
prepared, in connection with the guidance document, a
programmatic environmental impact statement pursuant to the
National Environmental Policy Act (NEPA). See 40
C.F.R. § 1502.4. Claim 13 targets the FDA's decision
not to make the guidance document available in accordance
with the notice-and-comment procedures of the Administrative
Procedure Act (APA). See 5 U.S.C. § 553.
Through
the FDA Modernization Act of 1997, Congress authorized the
FDA to issue guidance documents. Pub. L. No. 105-115, §
405, 111 Stat. 2296, 2368-69 (codified as amended at 21
U.S.C. § 371(h)). That Act empowers the FDA to
“develop guidance documents with public participation,
” subject to the limitation that such guidance
documents “shall not create or confer any rights for or
on any person.” 21 U.S.C. § 371(h)(1)(A).
Consistent with the public-participation requirement, the FDA
posted notice of a draft version of the guidance document
relating to genetically engineered animals, and the agency
finalized the document only after the period for public
comment had passed. 73 Fed. Reg. 54, 407 (Sept. 19, 2008); 74
Fed. Reg. 3, 057 (Jan. 16, 2009).[2]
In the
guidance document, the FDA defines genetically engineered
animals as “those animals modified by rDNA techniques,
including the entire lineage of animals that contain the
modification.” AR 569.[3] The FDCA provides multiple
definitions of the term “drug, ” but the foothold
for the FDA's assertion of authority is the phrase
“articles (other than food) intended to affect the
structure or any function of the body of man or other
animals.” 21 U.S.C. § 321(g)(1)(C). According to
the guidance document, an “rDNA construct in a GE
animal that is intended to affect the structure or function
of the body of a GE animal” qualifies as a drug under
this provision. AR 572.
The
guidance document then addresses the steps an applicant must
take to secure FDA approval of an rDNA construct. AR 578-91.
To that end, the document canvasses the existing statutory
and regulatory requirements for new animal drugs.
See 21 U.S.C. § 360b; 21 C.F.R. § 514.1.
In the document, the FDA acknowledged that the
“application of some of the statutory and regulatory
requirements for new animal drug applications to GE animals
may not be obvious, ” but the FDA nonetheless concluded
that these generally applicable provisions can sensibly be
used in this context. AR 579. The same day it adopted the
guidance document, the FDA denied a citizen petition
requesting rulemaking tailored to genetically engineered
animals on the ground “that it already has a
comprehensive regulatory framework in place.” Citizen
Petition AR 806 (internal quotation marks omitted).
Judicial
review under the APA extends to “[a]gency action made
reviewable by statute and final agency action for which there
is no other adequate remedy in a court.” 5 U.S.C.
§ 704. Section 704 reflects a congressional policy
against premature judicial intervention into the
administrative process, and in favor of courts resolving only
disputes with concrete legal stakes. In Bennett v.
Spear, 520 U.S. 154 (1997), the Supreme Court identified
the two hallmarks of final agency action: “First, the
action must mark the consummation of the agency's
decisionmaking process-it must not be of a merely tentative
or interlocutory nature. And second, the action must be one
by which rights or obligations have been determined, or from
which legal consequences will flow.” Id. at
177-78 (internal quotation marks and citation omitted). An
action that “carries no direct consequences” and
serves “more like a tentative recommendation than a
final and binding determination” is not reviewable
under the APA. Franklin v. Massachusetts, 505 U.S.
788, 798 (1992).
The
guidance document contains two primary parts: (i) the
FDA's interpretation of the term “drug” as
including the use of an rDNA construct to create a
genetically engineered animal; and (ii) recommendations to
applicants regarding the approval process for new animal
drugs. The two-step test for finality applies on an
issue-by-issue basis. See Navajo Nation v. U.S.
Department of Interior, 819 F.3d 1084, 1091 (9th Cir.
2016). In theory, then, both parts, one part, or neither part
of the guidance document could be final agency action
reviewable under the APA.
As the
D.C. Circuit recently noted, when a guidance document is
challenged under the APA, “the finality inquiry is
often framed as the question of whether the challenged action
is best understood as a non-binding action, like a policy
statement or interpretive rule, or a binding legislative
rule.” Association of Flight Attendants-CWA,
AFL-CIO v. Huerta, 785 F.3d 710, 716 (D.C. Cir. 2015).
The plaintiffs argue that the guidance document is a
legislative rule; on that basis (and only on that basis),
they contend that the guidance document is final agency
action. The Ninth Circuit holds that “a rule has the
‘force of law' and is therefore legislative: (1)
when, in the absence of the rule, there would not be an
adequate legislative basis for enforcement action; (2) when
the agency has explicitly invoked its general legislative
authority; or (3) when the rule effectively amends a prior
legislative rule.” Wilson v. Lynch, 835 F.3d
1083, 1099 (9th Cir. 2016) (internal quotation marks
omitted).
The
guidance document fits none of the three categories of
legislative rules, so it cannot be considered final agency
action based on the argument put forth by the plaintiffs.
First, as will be explained in Section III, the statutory
drug definition furnishes an adequate legislative basis to
consider new-animal-drug applications related to genetically
engineered animals. Cf. Hemp Industries Association v.
DEA, 33 F.3d 1082, 1090 (9th Cir. 2003).[4] Second, the FDA
disavowed resort to its legislative authority to issue the
guidance document. AR 571. And third, the guidance
document's recommendations to applicants don't
effectively amend any legislative rules. The only supposed
amendment identified by the plaintiffs is the FDA's
suggestion that applicants place “animal care and
safety information (e.g., husbandry or containment), ”
when relevant, on the drug's label. ...