FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

CENTER FOR FOOD SAFETY; SIERRA

CLUB; TRASK FAMILY FARMS;

GEERTSON SEED FARMS; BEYOND

PESTICIDES; NATIONAL FAMILY

FARM COALITION; THE CORNUCOPIA

INSTITUTE; DAKOTA RESOURCE

COUNCIL; WESTERN ORGANIZATION

OF RESOURCE COUNCILS;

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.;

No. 12-15052

D.C. No.

3:11-cv-01310-

SC

OPINION
2 CENTER FOR FOOD SAFETY V. VILSACK

GARDENA ALFALFA SEED GROWERS

ASSOCIATION; MIDWEST FORAGE

ASSOCIATION,

Intervenor-DefendantsAppellees.

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

 This summary constitutes no part of the opinion of the court. It has

*

been prepared by court staff for the convenience of the reader.

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. 
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 glyphosateresistant 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 PolicyAct (“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’sregulation 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 organismsthat 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 glyphosateresistant 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 maywell 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 crosspollinate 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

explainsthis 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 EPAhad 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.