Center for Food Safety v. Thomas Vilsack

FOR PUBLICATION

UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT

CENTER FOR FOOD SAFETY ; SIERRA No. 12-15052
CLUB; TRASK FAMILY FARMS;
GEERTSON SEED FARMS; BEYOND D.C. No.
PESTICIDES; NATIONAL FAMILY 3:11-cv-01310-
FARM COALITION ; THE CORNUCOPIA SC
INSTITUTE; DAKOTA RESOURCE
COUNCIL; WESTERN ORGANIZATION
OF RESOURCE COUNCILS; OPINION
NORTHEAST ORGANIC DAIRY
PRODUCERS ALLIANCE ; CALIFORNIA
FARMERS UNION ,
Plaintiffs-Appellants,

v.

THOMAS J. VILSACK, Secretary of
Agriculture; CINDY SMITH ,
Administrator of the Animal & Plant
Health Inspection Service, U.S.
Department of Agriculture,
Defendants-Appellees,

FORAGE GENETICS INTERNATIONAL
LLC; JOHN GROVER; DANIEL
MEDEROS; DAN SCHEPS; CARL
SIMMONS; MARK WATTE;
MONSANTO COMPANY ; CALIFORNIA
ALFALFA AND FORAGE
ASSOCIATION ; EUREKA SEEDS, INC.;
2 CENTER FOR FOOD SAFETY V . VILSACK

GARDENA ALFALFA SEED GROWERS
ASSOCIATION ; MIDWEST FORAGE
ASSOCIATION ,
Intervenor-Defendants-
Appellees.

Appeal from the United States District Court
for the Northern District of California
Samuel Conti, Senior District Judge, Presiding

Argued and Submitted
October 24, 2012—San Francisco, California

Filed May 17, 2013

Before: Mary M. Schroeder, Sidney R. Thomas,
and N. Randy Smith, Circuit Judges.

Opinion by Judge Schroeder
 CENTER FOR FOOD SAFETY V . VILSACK 3

SUMMARY*

Environmental Law / Plant Protection Act

The panel affirmed the district court’s summary judgment
in favor of federal officials and intervenor-defendants,
comprised of corporate seed manufacturers and industry trade
groups, in an action brought by environmental groups and
farmer organizations challenging the Record of Decision
issued by the United States Department of Agriculture’s
Animal Plant and Health Inspection Service unconditionally
deregulating Roundup Ready Alfalfa, a plant genetically
engineered or modified by the Monsanto Company.

The panel held the Plant Protection Act does not regulate
the type of harms that the plaintiffs complain of, and
therefore the Animal Plant and Health Inspection Service
correctly concluded that Roundup Ready Alfalfa was not a
“plant pest” under the Act. The panel held that once the
agency concluded that Roundup Ready Alfalfa was not a
plant pest, it no longer had jurisdiction to continue regulating
the plant, and this obviated the need for the agency to consult
with the Fish and Wildlife Service under the Endangered
Species Act and to consider alternatives to unconditional
deregulation under the National Environmental Policy Act.
The panel also held that the Animal Plant and Health
Inspection Service did not violate the Plant Protection Act by
not considering, sua sponte, whether Roundup Ready Alfalfa
was a noxious weed.

*
This summary constitutes no part of the opinion of the court. It has
been prepared by court staff for the convenience of the reader.
4 CENTER FOR FOOD SAFETY V . VILSACK

COUNSEL

George A. Kimbrell (argued), Center for Food Safety, San
Francisco, California; Paul H. Achitoff, Earthjustice,
Honolulu, Hawaii, for Plaintiffs-Appellants.

Shaun A. Goho, Emmett Environmental Law & Policy Clinic,
Cambridge, Massachusetts, for amici curiae CROPP
Cooperative, et al.

Deborah A. Sivas, Alicia E. Thesing, Leah J. Russin, and
Matthew H. Armsby, Environmental Law Clinic, Stanford,
California, for amici curiae Center for Biological Diversity
and Natural Resources Defense Counsel.

Stuart F. Delery, Acting Assistant Attorney General, Michael
Jay Singer and Dana Kaersvang (argued), Appellate Staff,
United States Department of Justice, Civil Division,
Washington, D.C.; Ignacia S. Moreno, Assistant Attorney
General, Andrew C. Mergen and Robert J. Lundman, United
States Department of Justice, Environmental & Natural
Resources Division, Washington, D.C.; James A. Booth,
Carlynne S. Cockrum, Susan C. Golabek, and Andrew R.
Varcoe, Of Counsel, United States Department of
Agriculture, for Defendants-Appellees.

Richard P. Bress (argued), Philip J. Perry, Drew C. Ensign,
and Andrew D. Prins, Latham & Watkins LLP, Washington,
D.C., for Intervenor-Defendant-Appellee Monsanto
Company.
 CENTER FOR FOOD SAFETY V . VILSACK 5

B. Andrew Brown, Dorsey & Whitney LLP, Minneapolis,
Minnesota; Martha C. Luemers, Dorsey & Whitney LLP,
Palo Alto, California, for Intervenors-Appellees Forage
Genetics International, LLC, California Alfalfa and Forage
Association, Eureka Seeds, Inc., Midwest Forage
Association, and Gardena Alfalfa Seed Growers Association.

Thomas R. Lundquist and J. Michael Klise, Crowell &
Moring, LLP, Washington, D.C., for amici curiae American
Farm Bureau Federation and Biotechnology Industry
Organization.

Gilbert S. Keteltas and John F. Bruce, Baker & Hostetler,
LLP, Washington, D.C.; Christopher H. Marraro, McKenna
Long & Aldridge, LLP, Washington, D.C., for amici curiae
American Sugarbeet Growers Association, et al.

OPINION

SCHROEDER, Circuit Judge:

OVERVIEW

This appeal represents another chapter in the United
States Department of Agriculture’s (“USDA”) regulation of
Roundup Ready Alfalfa (“RRA”). RRA is a plant genetically
“engineered” or “modified” by the Monsanto Company and
Forage Genetics International to be resistant to the herbicide
glyphosate, which Monsanto sells under the trade name
Roundup. Farmers do not normally apply an herbicide like
Roundup to alfalfa fields because the herbicide kills not only
the weeds, but also the alfalfa crop. RRA’s tolerance to
Roundup thus allows farmers to control weeds through
6 CENTER FOR FOOD SAFETY V . VILSACK

herbicide application without harming the alfalfa plant.
Monsanto markets RRA and Roundup together as a single
crop system. From the outset, Monsanto and Forage
Genetics’s attempts to introduce RRA have been met with
criticism and lawsuits from environmental groups concerned
about the adverse effects that the plant may have on the
environment and the organic food industry. An earlier phase
of the litigation concerned the scope of an injunction
prohibiting the planting of RRA pending completion of an
Environmental Impact Statement (“EIS”) by the USDA’s
Animal Plant and Health Inspection Service (“APHIS”).
Monsanto Co. v. Geertson Seed Farms, 130 S. Ct. 2743,
2761–62 (2010).

Here, we consider the Record of Decision (“ROD”) issued
by APHIS, which unconditionally deregulated RRA on the
ground that RRA was not a “plant pest” within the meaning
of the term in the Plant Protection Act (“PPA”), 7 U.S.C.
§§ 7701–7772. The plaintiffs in this action seek review of
APHIS’s deregulation of RRA. The plaintiffs are comprised
of environmental interest groups and farmer organizations
concerned about RRA’s potential harms. Their concerns
include the possibility that RRA will cross-pollinate with and
alter the genetic structure of conventional alfalfa plants. This
phenomenon, referred to as transgenic contamination,
contaminates conventional alfalfa plants with the glyphosate-
resistant gene. The plaintiffs and amici supporting them
contend that transgenic contamination will harm the
multi-billion dollar organic food industry. For example, they
argue that the threat of transgenic contamination will force
ranchers who raise organic meat to spend money testing the
alfalfa they feed their animals to ensure that none of the
alfalfa is genetically modified. If the ranchers cannot show
that their animals are fed nonmodified alfalfa, they cannot
 CENTER FOR FOOD SAFETY V . VILSACK 7

market their meat as organic, which erodes the price premium
they are able to charge. The plaintiffs also fear that the
contamination of conventional alfalfa plants with the
glyphosate-resistant gene could cause other countries to
reduce or stop their importation of U.S.-grown alfalfa.

In addition to transgenic contamination, the plaintiffs in
this action also fear that RRA’s deregulation will lead to
glyphosate-resistant weeds. The plaintiffs allege that farmers
will respond to the weeds’ increased glyphosate tolerance by
applying even greater amounts of glyphosate as well as using
mixtures of different herbicides. This increased herbicide use
could harm plants and animals living near alfalfa fields,
including species listed as threatened or endangered under the
Endangered Species Act (“ESA”).

Concerned about these environmental harms, the
plaintiffs in this appeal argue that APHIS’s unconditional
deregulation of RRA was improper for three reasons: First,
APHIS violated the PPA and the Administrative Procedure
Act (“APA”) in concluding that RRA was not a plant pest and
failing to consider if RRA was a noxious weed; second,
because of these errors in statutory interpretation, APHIS
violated the ESA when it failed to consult with the Fish and
Wildlife Service (“FWS”) about RRA’s effects on
endangered and threatened species, see 16 U.S.C.
§ 1536(a)(2); 50 C.F.R. § 402.14(a); and third, APHIS also
violated the National Environmental Policy Act (“NEPA”) by
unconditionally deregulating RRA without considering the
option of partially deregulating the crop, an action that the
agency had included in the EIS.

After the plaintiffs filed this action against the
government in the district court, Monsanto, Forage Genetics,
8 CENTER FOR FOOD SAFETY V . VILSACK

the corporate seed manufacturers and industry trade groups
intervened as defendants. The district court upheld the
agency’s deregulation decision in a published opinion. Ctr.
for Food Safety v. Vilsack, 844 F. Supp. 2d 1006 (N.D. Cal.
2012). It held that RRA is not a “plant pest” within the
meaning of the statute, and that the agency’s deregulation of
the plant therefore did not violate the ESA or NEPA, because
the agency’s jurisdiction did not extend to organisms that are
not plant pests. Id. at 1015–16, 1020–22.

We affirm, because the statute does not regulate the types
of harms that the plaintiffs complain of, and therefore APHIS
correctly concluded that RRA was not a “plant pest” under
the PPA. Once the agency concluded that RRA was not a
plant pest, it no longer had jurisdiction to continue regulating
the plant. APHIS’s lack of jurisdiction over RRA obviated
the need for the agency to consult with the FWS under the
ESA and to consider alternatives to unconditional
deregulation under NEPA. See Nat’l Ass’n of Home Builders
v. Defenders of Wildlife, 551 U.S. 644, 665 (2007). The
district court thus properly entered summary judgment in
favor of the defendants.

I. Regulatory Structure: the Coordinated Framework
for Regulation of Biotechnology

Genetically modified plants like RRA are regulated by
various agencies pursuant to the Coordinated Framework for
Regulation of Biotechnology (“Coordinated Framework”).
The Coordinated Framework is a 1986 policy statement from
the Office of Science and Technology Policy that “describes
the comprehensive regulatory policy for ensuring the safety
of biotechnology research and products.” Coordinated
Framework for Regulation of Biotechnology, 51 Fed. Reg.
 CENTER FOR FOOD SAFETY V . VILSACK 9

23,302, 23,302 (June 26, 1986). The goal of this policy
statement was to construct a framework that would not impair
the competiveness or innovativeness of the United States’s
biotechnology industry. Proposal for a Coordinated
Framework for Regulation of Biotechnology, 49 Fed. Reg.
50,856, 50,856 (proposed Dec. 31, 1984). Pursuant to the
Coordinated Framework, regulation of genetically modified
plants is divided among three agencies: the Food and Drug
Administration (“FDA”), the Environmental Protection
Agency (“EPA”), and the USDA, through APHIS. None are
required to address the environmental or economic harms
with which the plaintiffs are concerned. We deal briefly with
the FDA and EPA’s regulation of genetically modified plants
before turning to the scope of APHIS’s regulation under the
PPA.

A. FDA Regulation of Genetically Modified Plants

The FDA’s regulation of genetically modified plants is
derived from its authority to regulate food safety under the
Federal Food, Drug, and Cosmetic Act (“FFDCA”),
21 U.S.C. §§ 301–399. The FDA’s authority is limited to
removing adulterated food from the national food supply,
which could include food from genetically modified plants.
The FFDCA, however, does not contain any provisions that
specifically address genetically modified plants. In October
2003, Monsanto and Forage Genetics provided the FDA with
a summary of information that assessed the safety and
nutritional qualities of RRA. After assessing this
information, the FDA concluded in early 2004 that RRA and
foods derived from it were safe for consumption.
10 CENTER FOR FOOD SAFETY V . VILSACK

B. EPA Regulation of Genetically Modified Plants

The EPA indirectly regulates genetically modified plants
through the Federal Insecticide, Fungicide, and Rodenticide
Act (“FIFRA”), 7 U.S.C. §§ 136–136y. FIFRA governs the
use, sale, and labeling of herbicides like glyphosate. See
Bates v. Dow Agrosciences LLC, 544 U.S. 431, 437 (2005).
An herbicide must first be “registered” by the EPA before it
can be distributed or sold in the United States. 7 U.S.C.
§§ 136a(a),136j(a)(2)(F). The EPA registration process starts
with the herbicide manufacturer providing the EPA with
information about the herbicide. Id. § 136a(c)(1)(C), (F).
The agency then evaluates the effectiveness of the herbicide
and the adverse effects it will have on humans and the
environment. See id. § 136a(c)(5); Headwaters, Inc. v. Talent
Irrigation Dist., 243 F.3d 526, 530 (9th Cir. 2001). On the
basis of this evaluation, the EPA then determines if it will
permit the herbicide’s use on a given plant, and, if so, how
much.

The EPA sets the conditions for the herbicide’s use and
places them in labeling instructions that a user must comply
with. See 7 U.S.C. § 136j(a)(2)(G). The EPA reevaluates the
herbicide every fifteen years, as part of a “re-registration
process” in which the agency determines if it should continue
permitting the herbicide’s use. Id. § 136a(g)(1)(A)(iv). The
EPA originally registered glyphosate in 1974. In 2004 and
2005, the EPA approved the application of glyphosate to
RRA after determining that the herbicide would not cause any
unreasonable environmental risks so long as it was applied in
accordance with its labeling instructions. These labeling
instructions contain, among other things, prohibitions on
glyphosate use near the habitats of threatened or endangered
species. The EPA is currently in the process of
 CENTER FOR FOOD SAFETY V . VILSACK 11

“re-registering” glyphosate. The agency is scheduled to
complete the re-registration process in 2015.

Because the EPA’s FIFRA regulation deals with
chemicals, the EPA exercises only limited jurisdiction over
genetically modified crops. Such regulation is limited to
plants that are modified to produce pesticides. See 40 C.F.R.
§§ 174.1, 174.3. The EPA therefore does not regulate RRA,
because the plant itself does not produce or secrete a
pesticide.

C. APHIS’s Regulation of Plant Pests and Noxious
Weeds Under the Plant Protection Act

1. Regulation of Plant Pests

The PPA’s purpose is to prevent the spread of parasitic,
diseased, and invasive plants and organisms, and it does so
through the regulation of “plant pests” and “noxious weeds.”
See 7 U.S.C. § 7712. The PPA was enacted in 2000 and
combined APHIS’s prior regulation of plant pests and
noxious weeds into a single statute. Previously, plant pests
and noxious weeds were regulated by different statutes: The
Federal Plant Pest Act of 1957 regulated plant pests while the
Federal Noxious Weed Act of 1974 regulated noxious weeds.
The PPA made few substantive changes to these statutes.
The PPA’s definition of “plant pest” is materially the same as
the 1957 Federal Plant Pest Act’s definition of plant pest.
Compare Federal Plant Pest Act, § 103(c), 71 Stat. 31, 32
(1957), with 7 U.S.C. § 7702(14).

This case turns on the language of the PPA that defines
plant pests. APHIS has no jurisdiction to regulate a plant or
animal unless the organism is a “plant pest” within the
12 CENTER FOR FOOD SAFETY V . VILSACK

meaning of the statute. See 7 U.S.C. § 7702(14); 7 C.F.R.
§ 340.2 n.4 (“An[] organism belonging to any taxa [that
7 C.F.R. § 340.2 lists as a plant pest] is only considered to be
a plant pest if the organism ‘can . . . injure, or cause disease,
or damage in any plants or parts thereof. . . .’”). The
plaintiffs’ principal contention is that RRA is a plant pest
under the PPA. They therefore contend that APHIS’s
conclusion that RRA was not a plant pest was arbitrary and
capricious and violative of the PPA and APA.

The PPA defines a plant pest to be:

[A]ny living stage of any of the following
that can directly or indirectly injure, cause
damage to, or cause disease in any plant or
plant product:

(A) A protozoan
(B) A nonhuman animal
(C) A parasitic plant
(D) A bacterium
(E) A fungus
(F) A virus or viroid
(G) An infectious agent or other
pathogen
(H) Any article similar to or allied
with any of the articles specified
in the preceding subparagraphs.

7 U.S.C. § 7702(14).

The PPA states that organisms regulated as “plant pests”
must be organisms that cause physical harm to plants through
injury, damage, or disease. Neither the statute nor the
 CENTER FOR FOOD SAFETY V . VILSACK 13

regulations indicate that a genetically engineered plant like
RRA, which does not itself physically damage plants, can be
a plant pest. The regulations echo the statute and define
“plant pest” in 7 C.F.R. § 340.1 as “organisms . . . which can
directly or indirectly cause diseases or damage.”

APHIS regulations do not ignore the introduction of
organisms or products altered or produced through genetic
engineering, however. See 7 C.F.R. § 340.0 n.1. This is
because genetically engineered plants are often created using
an organism that can itself be a plant pest under APHIS’s
regulations. Indeed, RRA was created by inserting a
glyphosate-resistant gene into the genetic structure of the
conventional alfalfa plant using a plant pest. The glyphosate-
resistant gene was transferred to the conventional alfalfa plant
using a bacterium—Agrobacterium—that APHIS regulations
classify as a plant pest. See 7 C.F.R. § 340.2. The
regulations therefore provide that a genetically modified
organism is regulated as a plant pest if it is created using an
organism that is itself a plant pest. Id. § 340.1 (defining a
regulated article under APHIS’s plant pest regulations as
“[a]ny organism which has been altered or produced through
genetic engineering, if the donor organism . . . or vector or
vector agent belongs to any genera or taxa designated in
§ 340.2 and meets the definition of plant pest”). APHIS
regulates such a genetically engineered organism, referred to
by the parties as a “presumptive plant pest,” until the agency
concludes on the basis of scientific evidence that the modified
plant is not a “plant pest.” See id. § 340.6.

To discontinue regulating a presumptive plant pest, the
regulations spell out that any party may petition APHIS using
the petitioning procedures described in 7 C.F.R § 340.6.
When such a petition is filed, the agency determines whether
14 CENTER FOR FOOD SAFETY V . VILSACK

a presumptive plant pest is an actual plant pest within the
meaning of the term in the PPA by evaluating data that the
petitioning party has included in its petition. Id. § 340.6(c).
Such evidence is generally provided by the company that
engineered the plant, for the regulations require information
that is most easily supplied by such a party. The regulation
requires information about the presumptive plant pest’s
biology and any experiments that were conducted on the
plant. Id. The agency also considers data from field tests in
which APHIS permits introduction of the presumptive plant
pest into the environment on a limited basis to study how it
affects other plants. Id. § 340.6(c)(5). On the basis of the
information submitted, APHIS examines whether the
genetically modified plant presents a greater risk of plant
harm than the nonmodified plant. See id. § 340.6(c)(4)
(requiring that a party petitioning “[d]escribe known and
potential differences from the unmodified recipient organism
that would substantiate that the regulated article is unlikely to
pose a greater plant pest risk than the unmodified organism
from which it was derived”). If APHIS concludes that the
presumptive plant pest does not exhibit any risk of plant pest
harm, APHIS must deregulate it since the agency does not
have jurisdiction to regulate organisms that are not plant
pests.

2. Regulation of Noxious Weeds

The PPA also authorizes APHIS to regulate noxious
weeds. 7 U.S.C. § 7712(f). The agency defines noxious
weeds as weeds that are “likely to be aggressively invasive,
have significant negative impacts, and are extremely difficult
to manage or control once established.” 76 Fed. Reg. 39,811,
39,811 (July 7, 2011).
 CENTER FOR FOOD SAFETY V . VILSACK 15

APHIS regulates noxious weeds and plant pests under
different regulatory frameworks. Plant pests are regulated
under 7 C.F.R. parts 330 and 340, while noxious weeds are
regulated under 7 C.F.R. part 360. Unlike the plant pest
framework, which presumes that some genetically modified
plants are plant pests, the PPA’s noxious weed regulations do
not presume that any plant is a noxious weed. Thus, APHIS’s
classification of a plant as a presumptive plant pest does not
trigger any automatic requirement to evaluate it as a noxious
weed. Rather, under the PPA’s noxious weed regulations, the
agency can sua sponte assess the noxious weed properties of
the plant. See 7 C.F.R. § 360.200. In addition, any party can
petition APHIS to list or delist a plant as a noxious weed
using a process that is similar to the petition process for
deregulating plant pests. See id. §§ 360.500, 360.501.

APHIS has never sua sponte evaluated RRA as a noxious
weed, and no party has ever petitioned APHIS to list RRA as
a noxious weed. APHIS has therefore never designated RRA
as a noxious weed.

II. Factual Background, Regulatory History, and Prior
Litigation

Grown on over twenty million acres, alfalfa is the United
States’s fourth most widely grown crop and the third most
valuable. Alfalfa is typically grown as hay and is one of the
primary food sources for ruminants like cattle, goats, and
sheep. Because many conventional herbicides, like Roundup,
kill conventional alfalfa plants, Monsanto and Forage
Genetics genetically engineered RRA in the 1990s to be
resistant to glyphosate. RRA’s immunity to glyphosate
enables farmers to apply significantly greater amounts of the
herbicide than is feasible for conventional alfalfa. This
16 CENTER FOR FOOD SAFETY V . VILSACK

allows farmers to control weeds in alfalfa fields through
glyphosate application and to expand alfalfa production into
areas where weed infestations previously made cultivation of
the crop difficult.

Monsanto and Forage Genetics market RRA and Roundup
together as a single crop system. Use of glyphosate on alfalfa
fields is expected to increase dramatically with RRA’s
introduction; APHIS predicted in its final EIS of RRA that
once marketing of RRA takes hold, annual glyphosate usage
on alfalfa fields will increase from less than half a million
pounds to more than 24 million pounds.

Monsanto and Forage Genetics created RRA by
transferring a gene from Agrobacterium, a naturally occurring
bacterium, into the genetic structure of conventional alfalfa.
APHIS regulations list Agrobacterium as a plant pest.
7 C.F.R. § 340.2. The insertion of this gene changes the
genetic structure of the alfalfa plant and makes it resistant to
glyphosate. Because APHIS’s regulations provide that
Agrobacterium can be a “plant pest,” APHIS regulated RRA
as a presumptive plant pest. See 70 Fed. Reg. 36,917, 36,919
(June 27, 2005) (describing APHIS’s initial regulation of
RRA as a plant pest). So long as RRA was a presumptive
plant pest and within APHIS’s scope of regulation, farmers
could plant the crop only with the agency’s consent. See
7 C.F.R. § 340.0(a)(2) and n.1.

Seeking to end APHIS’s regulation of RRA as a
“presumptive plant pest,” Monsanto and Forage Genetics
invoked the procedures provided in 7 C.F.R. § 340.6 and
petitioned the agency in April 2004 for a determination that
RRA was not a plant pest. See 70 Fed. Reg. 36,917. In
response to the petition, APHIS assessed whether RRA
 CENTER FOR FOOD SAFETY V . VILSACK 17

caused any plant pest harms. APHIS considered information
submitted by Monsanto and Forage Genetics, including data
from RRA field tests, as well as public comments. APHIS,
in June 2005, concluded that RRA was not a plant pest and
therefore should not be regulated. Id. at 36,918-19. APHIS
found that RRA presented no greater plant pest harms than
conventional alfalfa. Id. at 36,918. The agency further found
that the plant pest properties of the Agrobacterium used to
engineer RRA were “disarmed” and could not injure or
damage other plants. Id. APHIS stated that the RRA plant
would not damage other plants, was not a plant pathogen,
should not limit a farmer’s ability to control plant pests in
alfalfa and other crops, and would not harm threatened or
endangered species that were beneficial to agriculture. Id. at
36, 918–19.

Pursuant to NEPA, APHIS also conducted an
“Environmental Assessment.” Id. NEPA regulations provide
that an agency shall conduct an Environmental Assessment to
determine if an agency action will significantly affect the
environment. 40 C.F.R § 1501.4. If this initial assessment
finds that the agency’s action may significantly affect the
environment, the agency must then prepare an EIS. Id. If the
agency concludes that its action will not significantly impact
the environment, the agency issues a “Finding of No
Significant Impact,” and the agency can proceed with its
proposed action without preparing an EIS. Id. In its NEPA
Environmental Assessment, APHIS issued a “Finding of No
Significant Impact.” 70 Fed. Reg. at 36,919. APHIS
therefore did not prepare an EIS. On June 14, 2005, APHIS
unconditionally deregulated RRA.
18 CENTER FOR FOOD SAFETY V . VILSACK

A. The Geertson Litigation and Related Agency
Actions

In early 2006, some of the same farmers and
environmental groups who are plaintiffs in this suit responded
to APHIS’s June 2005 deregulation of RRA by suing the
agency in the United States District Court for the Northern
District of California. They contended that APHIS’s June
2005 deregulation violated the PPA, ESA, and NEPA. With
regard to the plaintiffs’ NEPA claim, the district court ruled
in a February 2007 unpublished decision that APHIS had
violated NEPA by failing to prepare an EIS before it
deregulated RRA. Geertson Seed Farms v. Johanns, No.
C06-01075, 2007 WL 518624, at *10-12 (N.D. Cal. Feb. 13,
2007). The district court held that an EIS should have
addressed the environmental effects of transgenic
contamination and glyphosate-resistant weeds. Id. at *12.
The district court noted that transgenic contamination could
adversely affect the welfare of organic farmers who raise
conventional alfalfa. Id. Accordingly, the district court
issued orders vacating APHIS’s deregulation of RRA pending
completion of an EIS that addressed those harms, enjoining
APHIS from deregulating RRA in any manner while the
agency prepared the EIS, and enjoining further planting of
RRA. Geertson Seed Farms v. Johanns, 2007 WL 776146,
at *2-3 (N.D. Cal. Mar. 12, 2007); Geertson Seed Farms v.
Johanns, 2007 WL 1302981, at *9 (N.D. Cal. May 3, 2007).
The district court did not reach the plaintiffs’ claims under
the PPA or the ESA.

This court affirmed the district court’s order. Geertson
Seed Farms v. Johanns, 570 F.3d 1130, 1133–34 (9th Cir.
2009). The Supreme Court granted certiorari, however, and
remanded. Monsanto Co. v. Geertson Seed Farms, 130 S. Ct.
 CENTER FOR FOOD SAFETY V . VILSACK 19

2743, 2761–62 (2010). The Court held that an injunction that
prohibited APHIS from partially deregulating RRA while the
agency prepared an EIS was overbroad. Id. at 2759–60. It
stated that there were situations where APHIS could partially
deregulate RRA without causing the plaintiffs irreparable
injury. Id. The Court noted that the agency could mitigate
the dangers of transgenic contamination by limiting the
geographic area where farmers could grow RRA or imposing
isolation distances between fields of RRA and conventional
alfalfa. Id. at 2760. For the same reasons, the Court held that
the injunction enjoining all RRA planting was overbroad. Id.
at 2761.

The district court’s original decision in Geertson, in 2007,
had vacated APHIS’s deregulation of RRA and that ruling
was not challenged in the appellate courts. Id. at 2756. The
Supreme Court noted that “we assume without deciding that
the District Court [in Geertson] acted lawfully in vacating
[APHIS’s] deregulation decision.” Id. The Geertson
appellate litigation involved only the scope of the injunction
that the district court issued pending APHIS’s preparation of
an EIS under NEPA. See id.; Geertson Seed Farms, 570 F.3d
at 1133–34.

APHIS released its final EIS in December 2010. The
final EIS listed partial deregulation as one of two “preferred”
alternatives. The other “preferred” alternative was an action
that unconditionally deregulated RRA. The agency was
required to choose among these two alternatives while still
acting within its jurisdiction under the PPA to regulate plant
pests. APHIS concluded that unconditionally deregulating
RRA was the alternative consistent with the agency’s limited
statutory mandate. This conclusion necessarily followed
20 CENTER FOR FOOD SAFETY V . VILSACK

from APHIS’s earlier conclusion in June 2005 that RRA was
not a plant pest. See 70 Fed. Reg. at 36,919.

While APHIS was preparing the 2010 final EIS, the
district court’s order in Geertson, vacating APHIS’s
deregulation of RRA, remained in effect. After completing
the final EIS in December 2010, the order expired because
APHIS had fulfilled its obligations under NEPA by preparing
the EIS.

APHIS then issued, in January 2011, the ROD,
unconditionally deregulating RRA. The ROD relied on
APHIS’s June 2005 assessment of RRA’s plant pest
properties conducted in response to Monsanto and Forage
Genetics’s 2004 deregulation petition in which the agency
had concluded that RRA was not a plant pest. The 2011 ROD
noted that although RRA was created using a plant pest (the
Agrobacterium), the genetically modified plant did not
present any direct or indirect plant pest risks and therefore
should be granted “nonregulated status.” The ROD stated
that because RRA will not damage or injure other plants, it
does not present a greater plant pest risk than conventional
alfalfa.

APHIS noted in the ROD that its final EIS had recognized
that continued regulation of RRA was the environmentally
preferred option, but APHIS concluded that, as a matter of
law, neither the PPA nor the regulations permitted it to
continue regulating RRA once it concluded that RRA was not
a plant pest within the regulatory scope of the statute. The
agency stated that “it would be inconsistent with the PPA, the
regulation codified at 7 C.F.R. part 340, and the
biotechnology regulatory policies in the Coordinated
Framework, to prevent the commercial release of [RRA].”
 CENTER FOR FOOD SAFETY V . VILSACK 21

B. This Litigation

Almost immediately after the issuance of APHIS’s 2011
ROD deregulating RRA, the plaintiffs filed this action in the
district court. The district court held that the dangers of
transgenic contamination and increased glyphosate usage are
not plant pest harms under the PPA. Ctr. for Food Safety,
844 F. Supp. at 1017. It also ruled that the PPA’s separate
regulatory frameworks for plant pests and noxious weeds did
not require APHIS to evaluate whether RRA was a noxious
weed at the time the agency considered whether RRA was a
plant pest. Id. at 1015. The district court also noted that
APHIS’s deregulation of RRA was not inconsistent with the
Supreme Court’s decision in Monsanto, id. at 1018, in which
the Supreme Court expressly stated that it was not deciding
if APHIS acted lawfully when it deregulated RRA, see
Monsanto, 130 S. Ct. at 2756.

The district court rejected the plaintiffs’ other theories as
well. Citing National Association of Home Builders v.
Defenders of Wildlife, 551 U.S. 644 (2007), it held that once
APHIS correctly concluded that it no longer had jurisdiction
to regulate RRA, the deregulation of RRA was a
nondiscretionary act that did not obligate the agency to
consult with the FWS under the ESA concerning further
action. Ctr. for Food Safety, 844 F. Supp. 2d at 1020–21.
The district court further held that APHIS’s EIS satisfied
NEPA’s procedural requirements. Id. at 1024. Accordingly,
the district court entered summary judgment in favor of the
defendants on all claims. Id. at 1024–25.

In this appeal, the plaintiffs argue that the district court
misinterpreted the PPA in multiple ways when it upheld
APHIS’s decision to deregulate RRA. They contend
22 CENTER FOR FOOD SAFETY V . VILSACK

fundamentally that the district court erred in concluding that
transgenic contamination and the harms associated with
increased herbicide use are not plant pest harms under the
PPA, and that RRA was therefore not a “plant pest” within
the agency’s regulatory jurisdiction.

This appeal thus turns on whether the agency properly
determined that RRA is not a “plant pest” under the PPA. If
RRA is not a “plant pest,” the agency was without
jurisdiction to regulate the plant, and was required to order
deregulation, thus obviating the need to consult with the FWS
or consider other options involving continued regulation of
RRA.

DISCUSSION

I. Whether RRA is a “Plant Pest” and Thus Within the
Scope of APHIS’s Regulatory Authority

The primary issue we must determine is whether APHIS
has interpreted the meaning of “plant pest” in the PPA too
narrowly. The plaintiffs maintain that it has, and that the
term includes all genetically engineered plants and organisms
that have an environmentally adverse effect on plants.
According to the plaintiffs, APHIS has discretion under the
PPA to regulate RRA, which, if correct, would require the
agency, pursuant to the ESA, to consult with the FWS about
the crop’s effects on endangered plant and animal species.
16 U.S.C. § 1536(a)(2); see Karuk Tribe of Cal. v. U.S.
Forest Serv., 681 F.3d 1006, 1020 (9th Cir. 2012) (en banc).

The parties all agree that under the PPA, APHIS regulates
organisms that are “plant pests.” The PPA defines a “plant
pest” as any “living stage” of a list of organisms, or articles
 CENTER FOR FOOD SAFETY V . VILSACK 23

“similar to or allied with” organisms, “that can directly or
indirectly injure, cause damage to, or cause disease in any
plant or plant product.” 7 U.S.C. § 7702(14). While neither
the statute nor the regulations further define the type of
“injury,” “damage,” or “disease” a plant pest must cause, all
of the organisms that APHIS lists as plant pests can cause
widespread physical damage or destruction of plants.

With respect to genetically engineered plants, the
regulations specifically define the term “regulated article” as
a genetically engineered organism that is created using an
organism that is itself a plant pest. 7 C.F.R. § 340.1. The
regulations go on to specify that, as such, the “regulated
article” must injure plants. 7 C.F.R. § 340.2 n.4 (“An[]
organism belonging to any taxa [that 7 C.F.R. § 340.1 lists as
a plant pest] is only considered to be a plant pest if the
organism ‘can . . . injure, or cause disease, or damage in any
plants or parts thereof. . . .’”).

The plaintiffs’ concern is with two types of harm
genetically modified RRA can cause: transgenic
contamination of conventional alfalfa and increased herbicide
use. These alleged harms may well be adverse environmental
and economic effects. APHIS contends, however, they do not
constitute plant disease, injury, or damage, which are the
harms that the statute requires. The agency therefore
concludes that RRA is not a “plant pest.”

In support of its position, APHIS points out that, as a
matter of historical practice, it has previously assessed the
plant pest properties of genetically modified crops such as
cotton, corn, and soybeans. In conducting these plant pest
assessments, APHIS does not consider whether the
genetically modified plant could cross-pollinate with and alter
24 CENTER FOR FOOD SAFETY V . VILSACK

the genetic structure of other plants. This policy is consistent
with APHIS’s classification of other plants that could cross-
pollinate and destroy the crop value in the process (such as
canola with other types of rapeseed, and field with sweet
corn). The agency has never classified a plant as a “plant
pest” based on such cross-pollination effects. APHIS
explains this is because it does not consider such alteration to
be a plant pest harm within the meaning of the statute. The
agency has similarly never considered the possible
consequences associated with increased herbicide use,
including creation of herbicide resistant weeds, to be “plant
pest” injuries. APHIS explains such harms do not constitute
physical damage or injury to other plants. APHIS’s
consistent interpretation, which is also the best interpretation
of this particular statutory language, must be taken into
account. See Skidmore v. Swift & Co., 323 U.S. 134, 140
(1944) (“consistency” of agency interpretations with “earlier
and later pronouncements” is a factor to consider in deciding
whether to defer to agency interpretation); United States v.
Mead Corp., 533 U.S. 218, 219 (2001).

The plaintiffs nevertheless argue that APHIS’s
interpretation of the meaning of plant pest is too narrow.
They contend that we should hold that RRA is a plant pest
because the RRA plant results from the transfer of genetic
material from the Agrobacterium. Since the statute in
7 U.S.C. § 7702(14)(H) defines a plant pest to be “[a]ny
article similar to or allied with any of the articles specified,”
the plaintiffs assert that the RRA plant is “allied with” the
Agrobacterium. Thus, the plaintiffs’ theory is that transgenic
contamination and increased glyphosate use are harms caused
by the Agrobacterium, and therefore must also be “plant pest”
harms under the PPA.
 CENTER FOR FOOD SAFETY V . VILSACK 25

The plaintiffs’ logic is a stretch because it fails to deal
with the language of the statute defining plant pest harm as
injury, disease, or damage to other plants. See 7 U.S.C.
§ 7702(14). Although the regulations classify Agrobacterium
itself as a plant pest, the Agrobacterium’s plant pest
properties are “disarmed” and can no longer injure other
plants once the bacterium’s genetic material is inserted into
the genetic structure of conventional alfalfa. 70 Fed. Reg. at
36,918 (“APHIS determined that the vectors and other
elements [of the Agrobacterium] were disarmed [in the RRA
plant] . . . .”). RRA is thus no more likely to injure or damage
other plants than is conventional, nonmodified alfalfa. Id.

We do not suggest that the genetic engineering is without
possible economic consequences. APHIS’s final EIS noted
that transgenic contamination could economically hurt
farmers who raise conventional alfalfa and market their crop
as organic. The contamination of conventional alfalfa with
the glyphosate-resistant gene could close foreign markets to
U.S.-grown alfalfa. It could also force farmers of
conventional alfalfa to incur additional costs testing and
certifying that their alfalfa is not contaminated with the
glyphosate-resistant gene. These concerns, however, are not
the result of plant pest harms as defined under the PPA.
APHIS thus has no power to regulate the adverse economic
effects that could follow RRA’s deregulation.

The plaintiffs also maintain that because RRA results in
more use of the herbicide glyphosate, the harms associated
with increased glyphosate usage are plant pest harms under
the PPA. We recognize, of course, that deregulating RRA is
expected to result in increased use of herbicides. Indeed,
RRA was developed so farmers could apply significantly
greater amounts of herbicides to alfalfa fields. The increased
26 CENTER FOR FOOD SAFETY V . VILSACK

use of herbicides can be potentially damaging to the
environment. But the PPA addresses only the harms caused
by plant pests to other plants and APHIS can regulate RRA
only if it causes plant pest harms. See 7 U.S.C. § 7702(14).
The environmental harms the plaintiffs cite are not plant pest
harms. Moreover, the RRA plant itself does not cause the
harm produced by herbicides. It is the application of
herbicides to fields of RRA, not the RRA plant, that results in
such harm.

APHIS stresses it has no authority to regulate the use of
herbicides like glyphosate. The Coordinated Framework
tasks the EPA, under FIFRA, with regulating herbicide use,
and it does so through labeling instructions that the herbicide
user must comply with. See Ruckelshaus v. Monsanto Co.,
467 U.S. 986, 991–92 (1984) (noting that amendments to
FIFRA in 1972 “transformed FIFRA from a labeling law into
a comprehensive regulatory statute . . . [that] regulated the
use, as well as the sale and labeling, of pesticides” (citation
omitted)); Coordinated Framework, 51 Fed. Reg. at 23,302.
The PPA was enacted to protect plants, but not to control the
burgeoning use of chemicals in crop production.

For these reasons, we cannot interpret the language of the
PPA, which Congress has not materially amended since 1957,
to address the alleged harms that may result from the
modification of a plant’s genome. The job of updating Title
7 of the United States Code to address the potential harms
caused by genetic modification (including transgenic
contamination and increased herbicide use) is a job for
Congress, not this court, to undertake. Pursuant to the
language of the statute, we must rule that RRA is not a plant
pest under the meaning of the term in the PPA and the
regulations.
 CENTER FOR FOOD SAFETY V . VILSACK 27

II. APHIS’s Unconditional Deregulation of RRA Violated
Neither the ESA nor NEPA.

The plaintiffs argue that before APHIS decided to
deregulate RRA, the agency should have consulted with the
Fish and Wildlife Service (“FWS”) about the adverse
environmental effects that RRA’s deregulation may have on
endangered and threatened plants and animals. The
Endangered Species Act (“ESA”) imposes a duty on an
agency to consult with the FWS or the National Oceanic and
Atmospheric Administration Fisheries Service when an
agency action may adversely affect a listed species or its
critical habitat. 16 U.S.C. § 1536(a)(2); 50 C.F.R.
§ 402.14(a); see Karuk, 681 F.3d at 1011.

The ESA’s consultation duty is triggered, however, only
when the agency has authority to take action and discretion to
decide what action to take. There is no point in consulting if
the agency has no choices. The Supreme Court recognized
the principle in National Association of Home Builders v.
Defenders of Wildlife, 551 U.S. 644, 655 (2007), when it said
that “the ESA’s requirements would come into play only
when an action results from an exercise of agency discretion.”
See Karuk, 681 F.3d at 1021 (recognizing that Home Builders
“harmonizes the ESA consultation requirement with other
statutory mandates that leave an agency no discretion to
consider the protection of listed species” (citation omitted)).
In Home Builders, the Supreme Court held that once the EPA
had determined that Arizona met the statutory requirements
under the Clean Water Act for the transfer of regulatory
authority over the state’s National Pollution Discharge
Elimination System permitting program, the EPA had no duty
to consult because the transfer was a nondiscretionary act.
Home Builders, 551 U.S. at 655.
28 CENTER FOR FOOD SAFETY V . VILSACK

Here, once APHIS concluded that RRA was not a plant
pest because it did not cause plant pest injury to plants, the
agency had no jurisdiction to continue regulating the crop.
The agency’s deregulation of RRA was thus a
nondiscretionary act that did not trigger the agency’s duty to
consult under the ESA. Accordingly, the district court
correctly ruled that APHIS’s deregulation of RRA did not
violate the ESA.

Nor did the district court err in entering summary
judgment in favor of the defendants on the plaintiffs’ NEPA
claim. That claim rested on the contention that APHIS
should have considered partial deregulation as an alternative
to full deregulation. NEPA requires that an agency take a
“hard look” at the environmental effects of a proposed action
that could significantly affect the environment by evaluating
all reasonable alternatives to the proposed action. See
40 C.F.R. § 1502.14(a); Earth Island Inst. v. U.S. Forest
Serv., 442 F.3d 1147, 1159 (9th Cir. 2006) (internal quotation
marks omitted), abrogated on other grounds by Winter v.
Nat’l Res. Def. Council, Inc., 555 U.S. 7, 21 (2008). Here,
there were no reasonable alternatives to deregulation because
the agency lacks jurisdiction to regulate RRA. APHIS was
not required to look at alternatives to the unconditional
deregulation of RRA absent any jurisdiction to adopt them.
See S. Coast Air Quality Mgmt. Dist. v. FERC, 621 F.3d
1085, 1092 (9th Cir. 2010) (“[NEPA] does not expand the
jurisdiction of an agency beyond that set forth in its organic
statute . . . .”) (internal quotation marks omitted) (alterations
in original).
 CENTER FOR FOOD SAFETY V . VILSACK 29

III. Consistency with Monsanto v. Geertson Farms

The plaintiffs nevertheless contend that the district court’s
decision upholding APHIS’s unconditional deregulation of
RRA conflicts with the Supreme Court’s Monsanto decision,
where the Court looked at alternatives to deregulation. The
two decisions, however, concern different issues. In
Monsanto, the Court’s decision went only to the scope of the
injunction enjoining the planting and deregulation of RRA
pending preparation of the EIS. Monsanto, 130 S. Ct. at
2756. The Court assumed, without deciding, that APHIS had
jurisdiction to regulate RRA. Id. In this appeal, the issue is
whether APHIS correctly determined that RRA is not a plant
pest, thereby compelling unconditional deregulation of RRA.
The Supreme Court in Monsanto expressly noted that it was
not addressing that issue. Id. (“[W]e assume without
deciding that the District Court [in Geertson] acted lawfully
in vacating [APHIS’s] deregulation decision.”). Monsanto is
therefore not on point, and thus the district court’s decision
before us is not inconsistent with Monsanto.

IV. Noxious Weed Risk

The plaintiffs contend that APHIS violated the PPA by
not evaluating whether RRA was a “noxious weed” under
7 U.S.C. § 7712(f). According to the plaintiffs, when
Monsanto and Forage Genetics petitioned APHIS for a
determination that RRA was not a “plant pest,” the statute
compelled the agency to evaluate whether RRA should be
regulated as a noxious weed. The plaintiffs’ theory is that
RRA is a noxious weed under the PPA because it will
“indirectly injure . . . agricultural interests” by creating
glyphosate-resistant weeds. See 7 U.S.C. § 7702(10)
(defining a “noxious weed” as “any plant or plant product that
30 CENTER FOR FOOD SAFETY V . VILSACK

can directly or indirectly injure or cause damage to crops . . .
or other interests of agriculture”).

Neither the PPA nor APHIS’s regulations, however,
require APHIS to conduct a separate noxious weed analysis
in response to a party’s petition to deregulate a plant under
7 C.F.R. § 340.6. Plant pests and noxious weeds are
regulated under separate regulatory frameworks. Regulations
for plant pests are contained in 7 C.F.R. parts 330 and 340
while the regulations governing noxious weeds are contained
in 7 C.F.R. part 360. The procedures under 7 C.F.R. § 340.6
provide for deregulating a presumptive plant pest. A party
seeking to list or delist a plant as a noxious weed must invoke
procedures set forth in 7 C.F.R. § 360.500 and § 360.501.
The separate regulatory frameworks for plant pests and
noxious weeds are consistent with standards of the statute
treating plant pests and noxious weeds separately. Indeed,
the PPA kept in place the separate regulatory frameworks for
plant pests and noxious weeds that were originally
promulgated under the Federal Plant Pest Act and the Federal
Noxious Weed Act. See 7 U.S.C. § 7758(c) (“Regulations
issued under the authority of [the Federal Plant Pest Act and
Federal Noxious Weed Act] shall remain in effect . . . .”).

While APHIS has proposed amending its regulations to
consider noxious weed harms and plant pest harms together,
it has not yet adopted those regulations. See Proposed Rule,
73 Fed. Reg. 60,008, 60,011 (Oct. 9, 2008). Therefore, the
regulations have no effect on APHIS’s analysis of RRA. This
is because proposed regulations have no legal effect. Henry
v. Champlain Enters., Inc., 445 F.3d 610, 619 (2d Cir. 2006);
see also Commodity Futures Trading Comm’n v. Schor,
478 U.S. 883, 845 (1986).
 CENTER FOR FOOD SAFETY V . VILSACK 31

Because no party petitioned APHIS to list RRA as a
noxious weed, the agency did not violate the PPA by not
evaluating RRA’s noxious weed properties when it
deregulated RRA. The district court thus correctly ruled that
APHIS did not violate the PPA by not considering, sua
sponte, whether RRA was a noxious weed.

CONCLUSION

The district court’s judgment in favor of the Appellees is
AFFIRMED.