F OR P UB LIC AT ION



### U N I TED STA TES C O U R T O F A PPEA LS F O R T H E N IN T H C IR C U IT

C EN T ER FOR F OOD S AF E TY ; S I ERRA C L UB ; T RASK F AMI L Y F AR MS ; G EE R TS ON S EE D F AR MS ; B EY OND P ES TI CI DES ; N A T I O N A L F A M I LY F AR M C OAL I TI ON ; THE C O R N U C O P IA I NS TI TU TE ; D AK OTA R ESOU RCE C O U N C IL ; W ES TER N O R GANI Z ATI ON O F R ES OURCE C O U N CI LS ; N OR TH E AS T O RGA N I C D A I RY P RO D U CE RS A LL I A N CE ; C A LIF O R N IA F A RM ER S U

NI ON , Plain tif fs- Ap pe lla nts ,

v.

T H O M A S J. V I LS A CK , Secre tary of Ag ri c ult ur e ; C I NDY S MI TH , Administrator of the Animal & Plant He a lthI ns pe c tio n Se rv ic e , U .S. Depa rtment of Ag riculture, Defendants-A

ppellees ,
F ORAGE G EN ET I CS I NTER NATI ONAL L L C; J OHN G ROVER ; D ANI EL M ED ER OS ; D AN S CHEPS ; C A RL S I MMONS ; M A RK W AT TE ; M ONS ANTO C OMPANY ; C A LIF O R N IA A L F AL F A AND F OR AGE A S S OC I ATI ON ; E UR EK A S EE DS , I NC .; No. 12-15052

D.C. No. 3:11-cv-01310- SC

OPI NI ONC EN T ER FOR F OOD S AF ETY V

. V I LS A CK

2

G AR DE NA A L F AL F A S EE D G ROW ERS A S S OC I ATI ON ; M I DW E S T F OR AGE A S S OC I ATI ON ,

In te rv e no r-

De fe nd an tsAppellee s

.

Appea l from the United States District Court fo r t he No rt he rn Di str ic t of

Ca lif or nia Samuel Conti, S enior District Judge, Pre siding

Argued and Submitted Oc tob e r 2 4, 20 12 —Sa

n F ra nc isc o, Ca lif

or nia

Filed Ma y 17, 2013

B e fo re : Ma

ry M. Sc hr oe de r, Sid

ne y R. T ho ma s, and N. Rand y Smith, Cir c uit

Judg e s. Opinion by

J udg e Schroe derC EN T ER FOR F OOD S AF ETY V

. V I LS A CK 3

T hi s s ummary cons t i t ut es n o part of t he op i ni on of

t he cour t

. I t ha s * b een p repa red b y co urt s t af f f o r t he co nveni ence o f

t he read er. SUMMAR

Y *

Envi ronm ental Law / P lant Pr otec tion Act The pa nel af firmed the district c ourt’s sum mary judgme nt in f avo r of fed e ra l of

fi c ia ls a nd int e rv e no r- de fe nd ants , comprised of corpor ate seed m anufa cture rs and indust ry trade g roups, in an action broug ht by environmenta l gr oups and far m er org anizations challeng ing the Record of Dec ision issued by t h e United States Depa rtment of Ag riculture’ s An ima l Pla

nt a nd He a lth I ns pe c tio n Se rv ic e un c on dit ion a lly de re g ulatin g Round

up Re a dy

Al fa lf a , a pla nt g e ne tic a lly
e n g i n e e r e d

o r m o d i f i e d b y t h e M o n s an t o C o mp an y.
Th e pa ne l hel d the Plant Pro te c tio n A c t do e s n ot r e g ulate the ty pe of ha rms that the plaintiffs com p lain of, and there fore the Animal Plant and Hea lth I nspec t ion Service
c or re c tly c on c lud e d th a t Ro un du

p Re a dy Al fa lf a was no t a “plant pest” under the Act. The panel he ld th at once the
a g e nc y c on c lud e d th a t Ro undu p Rea dy Al fa lf a wa s n ot a plant pest, it no long er ha d jurisdiction to continue regulating the pla nt, and thi s ob viate d the ne e d f or the a g e nc y

to c on su lt with the Fish and W i l d l i fe Service unde r the Enda ng ere d Species Ac t and to consider a lternatives to uncondit ional de re g ulatio n und e r t

he Natio na l E nv ir on me nta l Po lic y Ac t. The pan e l a lso he ld t

hat th e An ima l Pla

nt a nd He a lth I nspection S ervic e did not violate t he P lant Protection Act by not considering , sua sponte, whe ther Roundup R eady Alfalfa
was a nox ious weed.C EN T ER FOR F OOD S AF ETY V

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4

CO UN SEL

Geor g e A. Kimbre ll (argued), Cente r for Food Saf

ety , San Fr ancisc o, California; Paul H. Ac hitoff, Ear thjusti ce, Ho no lul u, Ha

wa ii, fo r P la int if

fs -A pp e lla nts

. Shaun A. Goho, Emmett Environmental L aw & Policy Clini c, Cambr idg e , M a ssa c hu se tts , f or amic i c ur ia e CRO PP Coo pe rativ e , e t a l.

Debor ah A. Sivas , Al icia E. The sing, L eah J. Russi n, and Mat th e w H

. A r

ms b y , E n v ir o n me n ta l L aw Cl in ic , St an f o rd, Ca lif or nia , f or ami ci c ur ia e Ce nte r f

or B iol og ic a l D ive rs ity
and Natur a l Re so ur c e s D e fe ns e Couns e l.

Stuart F. Deler

y , ActingAssistant Attorney Gene ral, Micha el J ay Singer and Da na Ka ersva

ng (argu ed), A

ppellate Staff

, Un i ted States Depa

rtment of Just ice, Civil Division, Washington, D.C.; I g nacia S. Moreno, Assis t an t Attorney Gene ral, Andr ew C. Me rg en and Robert J . Lundman, United States Depa

rtment o f J ustice, Environmenta l & Natural Resource s Division, W ashing t o n, D.C.; J ames A. B ooth, Carl y nne S. Co c kr

um, Sus an C. Go la

be k, and An dr e w R

. Var coe, Of Counsel, United States Depa rtment of Ag ri c ult ur e , f or De fe nd ants -A

pp e lle e s.
Richard P. B ress (argue d), Philip J . Perry , Dre w C. Ensign, and Andr ew D. Prins, L atham & Watkins L L P, W ashing ton, D. C., fo r I nte rv e no r-Defend ant -Ap pel lee Mo ns a nto C o mp a n y.C EN T ER FOR F OOD S AF ETY V

. V I LS A CK 5

B . A nd re w B ro wn , D or se y

& Whitne y

L L P, M inn eapo lis, Minne sota ; Ma

rt ha C. L ue me rs , D or se y

& Whitne y

L L P, P al o Al t o , C al i fo r n i a, fo r Int erv en o rs -A p p el l ee s Fo ra ge Gene tics I nternational, L L C, California Alfa lfa a nd For age As sociation, Eureka Seeds, I nc., M i d we s t Fo ra ge Association, and Ga

rdena Alfalfa Seed Growe rs Association.

Th oma s R. Lun dq

uis t and J. Mic ha el Kl ise , Cr ow e ll & Moring , L L P, W ashing ton, D.C., for amici c uriae Americ an Fa rm Bur eau F eder ation and B iotechnolog y Indust ry Org anization.

Gilbert S. Keteltas a

nd J ohn F. Br u ce, B aker & H ostetler, L L P, W ashington, D.C.; Christ opher H . Marr aro, Mc Kenna L ong & A ldridg e, L L P, W ashi n g ton, D.C., for amici c uriae Am e ri c an Su g arb e e t G ro we rs As so c iatio n, e t a l.

OP IN ION
SCHROEDER, Ci rcuit Judge:

OV ER VI EW This appea l repre sents another chapter in the United States Depa

rtment of Ag riculture’ s (“USDA” ) re g ulati on of Round up Re a dy Al fa lf a (“ RRA ” ). RRAis a

pla nt g e ne tic a lly “eng ineered ” o r “modified” by the Monsanto Company

and For ag e Ge netics International to be resistant to the her bicide gly ph os a te , w hic h M on santo se lls un de r t he tr a de name Roundup. Far

mers do not normally

apply an her bicide like Round up to a lf a lf a fi e lds be c a

us e the he rb ic ide kil ls n ot o nly the weeds, but a lso the a lf a lf a c ro p. RRA ’s tol e ra

nc e to R o u n d u p t h u s al l o ws fa rm er s t o co n t ro l we ed s th ro u ghC EN T ER FOR F OOD S AF ETY V

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6

he rb ic ide a

pp lic a tio n w ith out ha

rm ingthe al fa lf

a pla nt. Mo ns anto mar

ke ts RRAand

Round up tog e the r a s a

sin g le
cr o p sy stem. From the outse t, Monsanto and Forage Ge ne tic s’ s atte mpt s to i ntr od uc e RRAhave be e n me t w ith criticism and lawsuits from environmental g roups conc erne d ab o u t the adve rse e ffe cts that the plant may have on the
e nv ir on me nt a

nd the or g anic fo od ind

us tr y

. An e arl ie r p ha se of the litigation concern ed the scope of an injunction prohibiti n g t h e plantingof RRA pending completion of an Environmental Im p act Statement ( “EI S”) by the USDA’s Animal Plant and Hea lth I nspection S er v ice ( “APHI S”). Monsanto Co. v. Gee rtson Seed Farms , 130 S. C t

. 2743, 2761–62 (2010).

Her e, we consider the Re c o r d of De cision (“ROD” ) issued by APHI S, which unconditio n al l y dere g ulated RRA on the g round that RRA was not a “ plant pest ” wi thin the meaning of the te rm in t he Plant P ro te c tio n Act (“P P A” ), 7 U .S. C. §§ 7701–7772. The plaintiffs in this action seek revie w of APHI S’s dere g ulation of RRA. The plaintiffs ar e compr ised of environme ntal interest g roups and f arme r org anizations
conce rned a

bou t RRA’s potential harms. Their c oncer ns include the possibility that RRA will cross-pollinate with and
a lte r the g e ne tic str

uc tur e of c on ve nti on a l a lf

a lf a pla nts . T his phenomenon, r efe rre d to as transg enic c ontamination, contaminates c onventional alfa lfa plants with the g lyphosateresistant g ene. T he plaintiffs a nd amici supp o rting them contend that tra

nsg enic c ontamination wi ll harm the multi-bil lion dollar org anic f ood industry

. For

example, they argue that the thre at of tra nsg enic c ontamination wi ll force
ranc hers who r aise org anic meat to spend money testing the alfa lfa they

fee d their ani m al s to ensure that none of the alfa lfa is g enetic al l y modified. I f the ra ncher s cannot show th a t t h e ir an im a ls ar e f

e d n o n mo d if

ie d a lf a lf a , th e y c annotC EN T ER FOR F OOD S AF ETY V

. V I LS A CK 7

marke t their meat as org anic, whic h erode s the price premium they are able to cha

rg e. The plai ntiffs also fe ar that the contamination of co nventional alfa lfa plants with the g ly ph os a te -r e sis tant g e ne c ou ld c a us e oth e r c ountries to reduc e or stop their importation of U .S.-g rown a lfalfa

.
I n a dd iti on

to t ra ns g e nic c on tamin a tio n, the pla int if fs in thi s a c tio n a lso fe ar t

hat RRA ’s de re g ulatio n w ill le a d to g ly phosate-r esistant wee ds. The plaintiffs a lleg e that fa rmers will respond to the wee ds’ incre ased g ly phosate tolera

nce by applying e ven g reater amounts of gly phosate as well as using mixture s o f dif

fe re nt he rb ic ide s. Th is inc re a se d he rb ic ide us e c ou ld h arm

pla nts and anim a ls l iv in g ne ar a lf a lf a fi e lds , including spe cies listed as thre atene d or endang ere d under the Endang ere d Species Ac t (“ESA”)

. Concerne d about these environmental harms, the plaintiffs in this appea l argue that APHI S’s u n condit ional de re g ulatio n o f RRAwa s im pr op e r f or three re a so ns : F ir st, APHI S violated the PPA and the Administrative P ro ce dure Act (“ APA”) in concluding that RRA was not a plant pest and failing to cons i d er if RRA wa s a noxi ous wee d; second, b e c a u s e o f t h e s e e r r o r s i ns t a tu t o r y i n t e r

p r e t a t i o n , A P H IS violated t he ES A when it failed to consult with the Fish and Wil dlife Service (“F WS ”) a bou t RRA’s effe cts on endang ere d an d threatened spe cies, see16 U. S.C. § 1 53 6( a )( 2) ; 50 C.F .R. § 4 02 .14(a ); and thi rd , A PHI S a lso violated the National E nvironmental Policy Act (“NEPA”) by unconditional l y dere g ulating RRA without consideringthe option of partially

dere g ulating the cr o p, an ac tion that the
a g e nc y ha d in c lud e d in

the EI S.

After the plaintiffs filed this ac tion ag ainst the g ov e rnme nt i n th e dis tr ic t c ourt , Mon santo , Fo ra g e Ge ne tic s,C EN T ER FOR F OOD S AF ETY V

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8

the cor p o r a te s e e d

ma nu f a c tu r e r s an d in d u s tr y tr a d e g r o u

ps intervene d as def

endants. The district court u p h eld t he ag ency ’s dere g ulation decision in a published opinion. Ctr

. for Food Safety v. Vilsack , 8 44 F . Su

pp . 2 d 1 00 6 (N. D. Ca l. 2012). I t held that RRA i s n o t a “pla nt pest” within the meaning of the statute, and that the ag ency ’s der egulation of the pla nt the re fo re did no t viol a te the ESAor NE PA, be c a

us e the ag ency ’s jurisdiction did not extend to orga nisms that are not plant pests. Id. at 1015–16, 1020–22.

We affir m, beca use t he st atute does not regulate the ty pes o f h ar m s t h a tt h e p l a i n t i f

f s c o mp l a i no f

, an d t h e r e f o r e A P H IS
corr ectly conclude d that RRA was not a “plant pe st” under the PPA . O nce the a g e nc y c on c lud e d th a t RRAwa s n ot a plant pest, it no longe r had jurisdiction to continue re g ulating the plant. APHI S’s lack of jurisdiction over RRA obviated the nee d for the a g ency

to consult with the FWS under the ESA and to c onsider alternatives to u n co nditional de re g ulatio n und e r N EPA

. Se e Nat ’l As s’n o f H om e Bu ild

e rs v . D e fe nd e rs o f W ild lif e , 551 U.S. 644, 66 5 (2007). The dis tr ic t c ourt

thu s p ro pe rl y

e nte re d s umm ary ju dg me nt i n fa vo r o f t he de fe nd ants

. I. Regulator y Structure : the Coor din ated F ram ework for Regulation of

Biotechnology

Gene tically

modified p l ants like RRA are r egulated by various ag encie s pursuant to the Coordinated F rame work for Reg ulatio n of B iotechnolog y (“Coordinated Fr amewor k”). The Coordinate d Fr amewor k is a 1986 policy statement fr om the Off ice of Science and Tec hnology Policy that “desc ribes the co mpr e he ns ive re g ulator y po lic y fo r e ns ur ingthe sa fe ty of biotechnolog y

researc h and produc ts.” Coordinated Fr am ew o r k f

o r R egu l at i o no f B i o t ec h n o l o gy , 5 1 Fe d

. R eg.C EN T ER FOR F OOD S AF ETY V

. V I LS A CK 9

23,302, 23,302 (June 26, 1986). The g oal o f t his policy state me nt w a s to c on str

uc t a fr ame wo rk that wou ld not imp a ir the competivene ss or innovativeness of the United States ’s biotechnolog y

industry . Proposal for a Coordinated Fr am ew o rkfo r R egu l at i o no f B i o t ec h n o l o gy , 4 9 Fe d

. R eg. 50,856, 50,856 (propose d Dec. 31, 1984). Pursuant to the Coordinated F rame work, re g ulation of g enetica lly modified plants is divided among thr ee a g encie s: the Food a nd Drug Admin istration (“F DA”) , the Environmental Protec tion Ag ency (“EPA” ), and the USDA, throug h APHI S. None ar e requi re d to a dd

re ss t he e nv ir on me nta l or

e c on omi c ha

rm s wi th whic h the pla int if

fs are c on c e rn e d. We d e a l br ie fl y wi th the F DAand

EPA ’s re g ulatio n o f g e ne tic a lly mod if ie d p lants b e f o r e tu r n in g to th e s c o p e o f

A PH I S’ s r e g u lati o nun d e r the PPA.

A. F DA Re gulation of Genetic ally Modif ied P lants

Th e F DA ’s re g ulatio n o f g e ne tic a lly mod if ie d p lan ts is derive d from its authority to regulate food safety

under the Fe dera l Food, Dr

ug , and Cosmetic Act ( “F FDCA”), 21 U. S.C. §§ 30 1– 39 9. Th e F DA ’s a uth or ity is l im ite d to
r e m o v i n g a d

u l t e r a t e d f o o d f r o mt h e n a t i o n a l f

o o d s u p p l y, wh ic h c ou ld i nc lud e fo od fr om g e neti c a lly

mod if ie d p lants

. T h e F FDCA, how ever , does not contain a ny provisions that specifically

addre ss ge netically

modified plants. In October 20 03 , M on santo and

F or a g e Ge ne tic s p ro vid e d the F DAwi th a summary

of information that assessed the safe ty and nutr iti on a l qu a lit ie s o f RRA . A ft e r a sse ssi ngthi s information, the F DA conc luded in ear ly 2004 that RRA and foods der ived from it wer e saf e for consumption.C EN T ER FOR F OOD S AF ETY V

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B. EPARegulation of Ge netically Modifi ed P lants

Th e EPA ind ir e c tly re g ulate s g e ne tic a lly mod if ie d p lants throug h the Fe dera l I nsectici d e, F ung icide, and Rode nticide Act (“ FI FRA” ), 7 U.S.C. §§ 1 3 6 –136y . FI FRA g overns the use, sale, a

nd labeling of herbicides like g ly phosate. See Ba tes v. Dow A gr os c ie nc es LLC , 544 U.S. 431, 437 (2005). An he rb ic ide mus t f

ir st b e “ re g ist e re d” by

the EPAbe fo re it
c an be dis tr ibute d or so ld in the Un ite d State s. 7 U.S.C. §§ 13 6a (a ), 13 6j( a )( 2) (F ). Th e EPAre g istratio n p ro c e ss s tart s wi th the he rb ic ide manu fa c tur e r pr ov idi ng the EPA wi th info rm ation about the her bicide. Id. § 136a(c )(1) (C), (F ). The a g ency

then evaluates the ef

fec tiveness of the he rbicide and the a dver s e ef

fects it will have on huma ns and the environment. See id. § 1 36 a (c )( 5) ; Headwaters, Inc. v . Talent Irri ga ti on Di st. , 243 F.3d 526, 530 ( 9th Cir. 2001). On the ba sis o f th i s e v a l u a t i o n , t h e E P A t h e nd e t e r m i n e s i f i t wi ll permit the her

bicide’s use on a g iven plant, and, if s o , how much.

The E PA s e ts th e c o n d it io n s f o r th e h e r b ic id e ’ s u s e and pla c e s th e m in

la be lin g ins tr

uc tio ns tha

t a us e r m us t c omp ly with. See7 U.S.C. § 136j(a)(2) (G). The EPA re evaluates the herbic ide eve ry

fifteen y ear s, as par

t of a “ re- reg istration proce ss” i n which the ag ency deter mines if it should continue permitting the herbic ide’s use. Id. § 136a(g )(1) (A)( iv). The EPA orig inally

reg istered g ly

ph o s at e in 1974. I n 2004 and 20 05 , th e EPAa

pp ro ve d th e a

pp licatio n o f g ly

ph os a te to RRA after de termining that the her bicide would not cause any unre a so na

ble e nv ir on me nta l risk s so long a s it wa s a pp lie d in
acc ordanc e with its labeling instructions. These labe ling instructions contain, amongother thing s, prohibiti o n s on g ly phosate use near the habitats of threa tened or endang ere d specie s. The EPA is cu rr en tly in the proce ss ofC EN T ER FOR F OOD S AF ETY V

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“ re -r e g ist e ri ng ” g ly

ph os a te . T he a g e nc y is sc he du le d to complete the r e-r eg istration proce ss in 2015.

B e c a us e the EPA ’s F I F RAre g ulation d e a ls w ith chemica ls, the EPA exerci s es only limit ed jurisdiction over g e ne tic a lly

mod if ie d c ro ps . Su c h r e g ulatio n is lim it ed to plants that are modified to produce pesticides. See40 C.F .R. §§ 174.1, 174.3. The EPA there fore does not regulate RRA, beca use the plant itself doe s n o t p roduce or sec rete a pesticide.

C. AP HIS’ s Re gul at ion of P lan t P e st s a nd N ox iou s Weeds Under the P lant Pr otec tion Act

1. Regulation of

P lant Pe sts The PPA’s purpose is to pre vent t h e s p re ad of pa rasitic, dis e a se d, and

inv a siv e pla

nts and or g anis ms, and

it d oe s so throug h the re g ulation of “plant pe sts” and “noxious weeds.” See7 U.S. C

. § 7712. The PPA was ena cted in 2000 and combined APHI S’s prior re g ulation of plant pests and
no xious we e ds int o a

sin g le statut e. P re vio us ly , p lant p e sts and noxious wee ds wer e reg ulated by differ ent statutes: The Fe dera l Plant Pest Act of 1957 r egulated plant pests while the F e de ra l No xious Wee d Ac t of 19 74 re g ulate d n oxiou s w e e ds

. Th e PPA ma de fe w s ub stan ti ve c ha ng e s to the se statut e s. The PPA’s definition of “pla nt pest” is materia lly

the same a s the 19 57 F e de ra l Pla

nt P e st A c t’ s d e fi nit ion

of pla nt p e st. Com pa reFe dera l Plant P est Act, § 103(c ), 71 Sta t

. 3 1 , 32 (1957), with 7 U.S.C. § 7702(14).

Th is c a s e tu

r n s o nth e la

n g u a g e o f th e PP A th a t d e f

ines plant pests. APHI S has no jurisdiction to reg ulate a pla nt or animal u n l es s the org anism is a “plant pest” within theC EN T ER FOR F OOD S AF ETY V

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12

m ea n i n g of the statute. See7 U

. S

. C

. § 7 7 0 2 ( 1 4 ) ; 7 C

. F

. R. § 340.2 n.4 (“ An [ ] org anism belong ing to a ny taxa [ that 7 C.F.R. § 340.2 lists as a plant pest] is only considere d to be a plant pest if the org anism ‘ca n . . . injure, or c ause disea se, or damag e in a

ny plants or parts there of.

. . .’”)

. The pla int if fs ’ p ri nc ipa l c on te nti on

is that RRAis a

plan t pe st under the PPA. They

there fore contend that APHI S’s conclusion that RRA was not a plant pe st was ar bit ra ry and capr icious and violative of the PPA and APA.

The PPA defines a

plant pest to be:
[A] ny living st ag e of any of t he following th a tc and i r e c t l y

o r i n d i r e c t l y

i n j ur e , c a us e damag e to, or c ause disea se in an y p lant or pla nt p ro du c t: (A) A protozoan (B ) A nonhuman animal (C) A par asitic plant (D) A bac terium (E) A fungus (F ) A v ir

us or vir oid ( G ) Anin f

e c ti o u s a g e n t o r

o the r pathog en (H) Any

article simil ar to or a l lied with any of the a rticles spe cified in t he pr e c e din g su

bp ara g ra ph s. 7 U.S.C. § 7702(14).

Th e PPA state s th a t or g anis ms r e g ulate d a s “ pla nt p e sts ”
m u s t b e or gan i s m s t h at cau s e p h y s i ca l h armt o p l an t s t h ro u gh injury , damag e, or disea se. Ne ither the statute nor theC EN T ER FOR F OOD S AF ETY V

. V I LS A CK 13

r e g u la ti o n s in d ic a te th a t a

g e n e ti c a ll y

e n g in e e r e d

p la n t like RRA, which does not itself phy sically damag e plants, can be a plant p e s t. T h e r e g u lati o n s e c h o th e s tatute an d d e fine “plant pest” in 7 C.F.R. § 340.1 as “org anisms . . . which ca n direc tly or indirec tly

cause diseases or

damag e.”

APHI S regulations do not ignor e the introduc tion of
or g anis ms o r p ro du c ts a lte red or p ro du c e d thro ug h g e ne tic eng ineer ing, how ever

. See7 C. F.R

. § 3 40 .0 n. 1. Th is i s beca use g enetica lly

eng ineer ed plants ar e ofte n cre ated using an org anism that can itself be a plant pest unde r APHI S’s
re gu l at i o n s

. I n d ee d , R R A w as cr ea t ed b y i n s ert i n g a gl y p h osate-r esistant g ene into the g enetic struc ture of the conventional a lfalfa

plant using a plant pest. The g lyphosateresistant g ene w as transfe rre d to the conventional a lfalfa plant using a bacte rium—Ag robac te rium—that APHI S regulations classify as a pla

nt pest. See 7 C.F. R

. § 340.2. The regulations theref

ore pr ovide that a ge n etically modified org anism is re gu l at ed as a pla nt pest if it is create d using a n org anism that is its elf a

plant pest. Id. § 3 4 0

. 1 (d e f i n i n g a regulated ar

ticle under

APHI S’s plant pest regulations as “[ a] n y o rga n i s mwh i ch h as b ee nal t er edo r p ro d u ce d th ro u gh g enetic e ng ineer ing, if

th e donor or g anism . . . or vec tor or
v e c t o r a g e n t b e l o n g s t o an y g e n e r a o r t a xa d e s i g n a t e d in § 3 4 0

. 2 an d

m e e t s t h e d e f

i n i t i o no f p l an tp e s t ” )

. A P H IS
re g ulate s su c h a g e ne tic a lly e ng ine e re d o rg anis m, r e fe rr e d to by the parties as a “pre sumptive plant pest,” until the ag ency conclude s on the basis of scie ntific evidenc e that the modified plant is not a “plant pest.” See id. § 340.6.

To discontinue re g ulating a presumptive plant pe s t , the regulations spell out that any party may petition APHI S using the petitioning pr ocedur es d es cribed in 7 C.F.R § 340.6. When such a petiti on is filed, t he age ncy deter mines whetherC EN T ER FOR F OOD S AF ETY V

. V I LS A CK

14

a pre sumptive plant pest is an actua l p lant pest within the
mean in g o f

th e te r m i nth e PP A b y

e v a lu a ti n g d a ta

th a t the petitioning par

ty has included in its p et i t i on. Id. § 340.6(c)

. Such evidenc e is g eneral l y provided by

the company

that eng ineer ed the plant, f

or the re g ulations require information that is most easily

sup plied by

such a pa

rty . The re g ulation require s information about the pre sumptive plant pest’s biology and any experime n t s that wer e conduc ted on the plant. Id. Th e a g e nc y

a lso c on sid e rs data

fr om f ie ld t e sts in which APHI S permits introduction of the presumptive plant pe st i nto the e nv ir on me nt o n a lim ite d b a sis to s tud

y ho w i t aff ec t s o t h er plants. Id. § 340.6(c) (5). On the basis of the information submitted, APHI S ex amines whe ther the g enet ic a ll y

mo d if ie d p la n t p r e s e n ts a

g r e a te r r is k o f p lant harm than the nonmodified plant. See id. § 340.6(c) (4) (re quiring that a par

ty petitioning “[ d ]escribe known a nd po te nti a l di ff

e re nc e s f ro m the un mod if

ie d re c ipi e nt o rg anis m that w ou ld s ub sta

nti a te that the re g ulate d art ic le is unli ke ly to po se a g re a te r p lant p e st r isk

tha n th e unmod if

ie d o rg anis m from which it wa s derived” ). I f APHI S co n cl u d es that the pr e sumpt ive pla

nt p e st d oe s n ot e xhibi t any ri sk of pla nt p e st harm, APHI S must dere g ulate it since the a g ency d o es not have jur isdiction to reg ulate org ani s m s that are not plant pe sts

. 2. Re gul at ion of N ox iou s W e e ds

The PPA also authorizes APHI S to reg ulate noxious
wee ds. 7 U.S.C. § 7712(f). The a g enc y define s nox ious
wee ds as wee ds that are “likely to be ag g ressively

i n v asive, have sig nif

ic ant n e g ativ e imp a c ts, and are e xtre me ly

dif fi c ult to manag e or control once e stablished.” 76 F ed. Reg . 39,811, 39,811 (Jul y

7, 2011).C EN T ER FOR F OOD S AF ETY V

. V I LS A CK 15

APHI S regulates noxi ous wee ds and plant pests under differ ent re g ulatory

frameworks. Pl ant pests ar e re g ulated under 7 C.F .R. parts 3 3 0 an d 340, while noxi ous wee ds are
re g ulate d u

nd e r 7 C.F .R. par

t 36 0. Un lik e the pla

nt p e st frame w o r k , w h ic hp r e s u me s th a t s o me g e n e ti c a ll y mo d if ied plants are plant pests, the PPA’s nox ious weed r egulations do not presume that a

ny plant is a

nox ious weed. Thus, A PHI S’s classification of a plant as a pr esumptive plant pest does not trig g er a ny automatic requirement to eva luate it as a noxious
wee d. Rather, under the PPA’s nox ious weed r egulations, the ag ency can sua sponte assess the nox ious wee d proper ties of the plant. See7 C.F.R. § 360.200. I n addition, any party can petition APHI S to li st or delist a plant as a noxious weed usinga p r o c e s s th a t i s s im il ar

to th e p e ti ti o np r o c e s s for dere g ulating pla

nt pests. See id. §§ 360.500, 360.501.

APHI S has never

sua spont e evaluated RRA as a nox ious
wee d, and no par

ty has ever petitioned APHI S to li st RR A as
a no xious we e d. APH I S ha s th e re fo re ne ve r d e sig nate d RR A as a noxious weed.

II. F actual Background , Regulatory Histor y, and Prior Litigation

Grown on ove r twenty milli on acr es, alfalfa is the United State s’ s f ourt h mo st w ide ly

g ro wn c ro p a nd the thi rd mos t valuable. Alfalfa is ty

pically g rown as hay

and is one of the primary food sourc es for

rumin an t s l ike cattle, goats, and sheep. B eca

use many conventional he rbicides, like Roundup, k i l l co n v en t i o n al al fa l fa p l an t s , M o n s an t o an d F o r a ge Gene tics g enetica lly

engi n eer ed RRA in the 1990s to be
re sis tant t o g ly

ph os a te . RR

A’s im munity

to g ly ph os a te enable s far

mers to a pply signific antly g reater amounts of the he rb ic ide tha

n is fe a sible for c on ve nti on a l a lf a lf a . T hisC EN T ER FOR F OOD S AF ETY V

. V I LS A CK

16

al l o ws fa rm er s t o co n t ro l we ed s i nal fa l fafi el d s t h ro u gh g ly ph os a te a pp lic a tio n and to e xpand

a lf a lf a pr od uc tio n into
are as whe re weed infestations previously made c ultivation of the c ro p d if

fi c ult

. Monsant o a

n d F o r a g e G e n e ti cs marke t RRA and Roundup toge ther a s a si ng le cr op sy stem. Use of g ly phosate on a lfalfa fields is expected to in cre ase dr amatica lly with RRA’s introduction; APHI S predicted in its final EI S of R RA that
o n ce m ark et i n g o f R RA t ak es h o l d , an nu al gl y p h o s at e u s age on alfa lfa fields will incr ease from less than hal f a m illion po un ds to m or e tha

n 2 4 mi lli on

po un ds

. Monsanto and F orag e Ge netics cr eate d RRA by transfe rringa g ene f

rom Ag robac terium, a natur ally occur ring bacte rium, into the ge netic s tructure of conve ntional alfalfa

. APH I S r e g ulatio ns lis t A g ro ba c te ri um as a pl ant p e st. 7 C.F.R. § 340.2. The inser tion of t h i s gene c hang es the g e ne tic str

uc tur e of the a lf a lf a pla nt a nd make s it

re sis tant t o g ly phosate. Be cause APHI S’s regulations provide that Ag ro ba c te ri um c an b e a

“ pla nt p e st, ” APH I S r e g ulate d RR A as a presumptive plant pest. See70 Fe d. Reg . 36,917, 36,919 (June 27, 2005) (desc ribing APHI S’s initi al regulation of RRA as a plan t p es t ). So long as RRA wa s a pre sumptive plant pest and within APHI S’s sco p e o f re g ulation, farme rs could plant the cr op only with the ag ency ’s co n s en t. See 7 C.F.R. § 340.0(a) (2) a

nd n.1.

Se e kin g to e nd

APH I S’ s r e g ulatio n o f RRAa s a “pre sumptive plant pest,” Monsanto and F orag e Ge netics invoked the proc edure s provided in 7 C.F.R. § 34 0.6 and petitioned the ag ency

in April 2004 for a d etermination that RR A wa s n o t a plant pest. See7 0 F e d

. R e g

. 3 6 , 9 1 7

. In
re sp on se to t

he pe tit io n, APH I S a sse sse d w he the r RRAC EN T ER FOR F OOD S AF ETY V

. V I LS A CK 17

cause d any

plant pest harms. APHI S considered inf ormation
su bmi tte d b y Mo ns anto and F or a g e Ge ne tic s, inc lud ingdata fr om RRA fi e ld t e sts , as wel l as p ub lic c omm e nts . A PHI S, in J une 2005, conc luded t h at RRA was not a plant pest and there fore should not be re g ulated. Id. a t3 6 , 9 1 8

- 1 9

. A P H IS found that RRA prese nted n o gre ater plant pest harms than conventional a lfalfa

. Id. at 36,918. The ag ency further found that th e pla

nt pest pr op e rt ie s o f t

he Ag ro ba c te ri um u se d to eng in ee r RRA were “disarme d” and c ould not injure or damag e other

plants. Id. APHI S state d that the R R A p l ant would not damage other plants, wa s not a plant pathog en, sh ou ld n ot l imi t a

fa rm e r’ s a bil ity to c ontrol pla

nt p e sts in alfa lfa a nd other c rops, and woul d n o t harm thre atene d or endang ere d specie s that wer e benef icial to ag riculture. Id. at 36, 918–19.
Pursuant to NEPA, APHI S also conduc ted an “Environmenta l Assessment.” Id. NEPA r egulations provide that an a g e nc y

sh a ll c on du c t an E nv ir on me nta l As se ssm e nt t o deter mine if an a g ency

action will signi fi cantly aff ect the environment. 40 C.F.R § 1501.4. I f t h i s initi al assessment finds that the ag ency ’s ac tion ma y signific antly

aff ect the environment, the ag ency

must then prepar e an E I S. Id. I f the ag ency conclude s that its action will not signific antly impact the e n v ir o n me n t, th e a g e n c y is s u e s a

“ F in d in g o f

No Sig ni fi c a nt Impa c t,” and

the a g e nc y

c an p ro c e e d w ithits proposed a ction wi t h o u t prepa ring an EI S. Id. In it s N EPA Environmental Assessment, APHI S issued a “F inding of No S i g n i f i c an tImp a c t

. ” 7 0 F e d

. R e g

. a t3 6 , 9 1 9

. A P H IS t h e r e f o r e d i d n o tp r e p ar e anE IS

. O nJ u n e 1 4 , 2 0 0 5 , A P H IS unconditionally

dere g ulated RRA.C EN T ER FOR F OOD S AF ETY V

. V I LS A CK

18

A. T h e Gee rtson Litigation a nd R e la t e d A g e nc y Ac ti ons

I n ear ly 2006, s o m e of the same far mers and environmenta l gr oups who are plaintiffs in this sui t responded to APHI S’s J une 2005 der egulation of RRA by s u i n g the ag ency in the United S t ates District Court for the Norther n District of California. T h ey contende d that APHI S’s J une 20 05 de re g ulatio n v iol a te d th e PPA , ESA , and NE PA. With reg ard to the pla int iffs’ NE PA claim, the district court rule d in a Fe bruar

y 2007 unpublished decision that AP HIS had vio late d N EPAby

fa ili ngto p re pa

re an EI S be fo re it d er egulated RRA. Gee rtson Seed Farms v . Johanns , No. C06-01075, 2007 WL 518624, at *10-12 (N.D. Cal. Fe b. 13, 2007). The district co u rt held that an EI S should have
a dd res se d th e e nv ir on me nta l e ff e c ts o f t rans g e nic contamination and g ly

phosate-r esistant weeds. Id. at *12. Th e dis tr ic t c ourt no te d that tr ans g e nic c on tamin a tio n could
a dv e rs e ly a ff e c t th e we lf

are of or g anic fa

rm e rs wh o r a ise conventional a lfalfa

. Id. Acc ording ly , t he district cour t issued order s vacating APHI S’s dere g u la ti o n o f RRA pending completion of an EI S that addresse d those harms, e njoining APHI S from dere g ulating R RA in any manner while the ag ency prepa red the EI S, and enjoi n i n g further planting of RRA. Gee rtson Seed Farms v . Johanns , 2007 WL 776146,
a t *2 -3 (N .D . Ca l. M ar. 12 , 2 00 7) ; Gee rtson See d Farms v. Johanns , 2007 WL 1302981, at *9 (N.D

. Cal. May 3, 2007). The district c ourt did not rea ch the plaintiffs’ clai m s u n d er the PPA or the ESA.

This court af

firmed the district c ourt’s orde r. Ge er t s on S ee d Farms v. J

ohanns , 5 7 0 F

. 3 d

1 1 3 0 , 1 1 3 3

– 3 4 ( 9 th

Cir. 2009). The S upreme Court gr anted c ertiora ri, howeve r, and
rema nded. Monsanto Co. v. Gee rtson Seed Farms , 1 30 S. Ct

.C EN T ER FOR F OOD S AF ETY V

. V I LS A CK 19

2743, 2761–62 (2010). The Court held that an injunction that prohibited APHI S f

rom partially

dere g ulating RRA while the agenc y prepa red a n EI S was overbr oad. Id. at 2 7 5 9

– 6 0

. It state d th a t the re we re sit

uatio ns wh e re APH I S c ou ld p art ia lly de re g ulate RRAwi tho ut causingthe pla int if fs ir re pa ra ble injury

. Id. T h e C o u rt n o t e d t h a t t h e a g e n c y c o u l d mit ig a te the dang ers of

transg enic c ontaminati o n b y limit ing the g eog raphic are a whe re f

arme rs could g row RRA or imposing isolation dist ance s betwee n fields of RRA and c on v en tional alfa lfa. Id. at 2760. For the same r easons, the Court he ld that the injunction enjoining a ll RR A planting was ove rbroa d. Id. at 2761.

The district c ourt’s orig inal decision in Gee rtson , in 2007, had vac ated APHI S’s der egulation of RRA and that ruling was not challeng ed in the appellate courts. Id. at 2756. The Supreme Court noted that “ we a ssume without deciding that the District Court [i n Gee rtson ] acted lawf ul l y in vacating [AP HI S’s] d er egulation decision.” Id. The Gee rtson appellate litigation involved only the scope of the injunction that the district court iss ued pendingAPHI S’s prepa ration of an EI S under NEPA. Se e id .; Gee rtson Seed Farms , 570 F.3d at 1133–34.

APH I S r e le a s e d

it s f in a l E I S i nD e c e mb e r

2 0 1 0

. T he final EI S lis ted par

tial dere g ulation as one of two “pr efe rre d” alternatives. The other “pre fer red” alternative was a

n action that unconditionally

dere g ulat ed R RA. The ag ency was re qu ir e d to cho os e amon g the se tw o a lte rn a tiv e s w hil e sti ll actingwithin its jurisdiction under the PPA to reg ulate plant pests. APHI S concluded that unc onditionally dere gu lating RRA was the alter

native consistent with the ag ency ’s limited statutory mandate. T his conclusion necessar ily followedC EN T ER FOR F OOD S AF ETY V

. V I LS A CK

20

from APHI S’s e arlier conclusion in J une 2005 that RRA was not a plant pest. See70 Fe d. Reg . at 36,919.

Wh il e A PH I S w a s p r e p ar in g th e 2 0 1 0 f in a l E I S, the district court ’s orde r in Gee rtson , vacating APHI S’s dere g ulation of RRA, remained in e ffe ct. Afte r compl et i ng the fi na l E I S inDe c e mbe r 2 01 0, the or de r e xpir e d b e c a us e APHI S had fulfilled its obligations under NEPA by prepa ring the EI S.

APHI S then issued, in J anuar y 2011, the ROD, unconditionally

dere g ulating RRA. The R OD relied on APH I S ’s June 20 05 a sse ssm e nt o f RRA ’s pla nt p e st p ro p er t i es co n d

u c t edi nre s p o n s e t o M o n s an t o an d Fo ra ge Gene tics’s 2004 dere g ulation petit ion in which the ag ency had conc luded that RRA wa s not a plant pest. The 2011 ROD noted that althoug h RRA wa s cre ated using a plant pest (the Ag robac terium), the g enetica lly modified plant did not prese nt any

direc t or indirect plant pe st risks and th er ef o re should be g rante d “nonre g ulated status.” The ROD stated that be c a us e RRAwi ll n ot d ama g e or in ju re oth e r p lants , it does not prese nt a g reater plant p est risk than conve ntional alfa lfa.

APHI S noted in the ROD that its final EI S had rec og nized that con tin

ue d r e g ulatio n o f RRAwa s th e e nv ir on me nta lly pref err ed option, but APHI S con cluded that, as a matter of law, ne ithe r t

he PPA no r t

he re g ulatio ns pe rm itt e d it to continue re g ulating RRA once it concluded that RRA was not a plant pest within the re g ulatory scop e o f t he statute. The ag ency stated t hat “it would be inconsist ent with the PPA, the regulation codified at 7 C.F. R

. p ar t 340, and the biotechnology

regulatory

policies in the Coordinated Fr amewor

k, to preve nt the commerc ial rele ase of [R RA].”C EN T ER FOR F OOD S AF ETY V

. V I LS A CK 21

B. Thi s Litigation

Almost im mediately

afte r the issuanc e of APHI S’s 2011 ROD dere g ulating RRA, the plaintiffs filed this action in the distric t c o u rt. T h e d is tr ic t c o u rt h e ld th a t th e d an g e r s of transg enic contamination and increase d g ly phosate usag e ar e not plant pest harms under the PPA. Ctr

. for Fo od Sa fe ty , 84 4 F . Su pp . at 10 17 . It a lso ru le d th a t t he PPA ’s se pa ra te
re g ulator y fr ame wo rk s fo r pla

nt pe sts and

no xious we e ds did not r e qu ir e A PH I S t o e v a lu a te w h e th e r RR A w a s a n o xious
we e d at th e tim e the a g e nc y c on sid e re d w he the r RRAwa s a plant pest. Id. at 1015. The district c o u rt als o noted that APHI S’s dere g ulation of RRA was not inconsistent with the Supreme Court’s decision in Mo ns an to , id. at 1018, in which the Supreme Court e x pressly stated that it was not deci d ing if APHI S acted law fully when it dere g ulated RRA, see Mo ns an to , 130 S. Ct . at 2756.

The district cour

t rejec ted the plaintiffs’ other theorie s as w e l l

. C i t i n g National

Association of Home Builders v. De fe nd e rs o f W ild lif e , 551 U.S. 644 (2007), it he ld that once APHI S corre ctly

conclude d that it no longer had jurisdiction to r e g ulate RRA , th e dere gulatio n o f RRAwa s a no n d i s c r e t i o n ar

y a c t t h a t d i d n o t o b l i g a t e th e a g e n c y to
con sult with t he F WS under the ESA conce rning further action. Ctr . fo r F

oo d S afe ty , 8 4 4 F. Supp. 2d at 1020–21. The district cour

t further held t hat APHI S’s EI S satisfied NEPA’s procedura l require ments. Id. a t 1 0 2 4

. A c c o r d i n g l y, the district court e ntere d summary judgme nt in favor of

the defe ndants on all claims. Id. at 1024–25.

I n this appeal, the pla intiffs argue that t he district cour t mis int e rp re te d th e PPA in m ult ipl e way s whe n it

up he ld APHI S’s decisi o n t o dere g ulate RRA. They contendC EN T ER FOR F OOD S AF ETY V

. V I LS A CK

22

fundame ntally that the district c ourt err ed in conc luding that tr ans g e nic c on tamin a tio n a nd the ha rm s ass oc iate d w ith incre ased herbic ide use are not pla nt pe st ha

rms under the PPA , a nd that RRAwa s th e re fo re no t a “ pla nt p e st” wi thi n the ag ency ’s re g ulatory

jurisdiction.

T h i s a p p e a l t h u s tu r

n s o nw h e t h e r

t h e a g e n c y

p r o p e r ly d e t e r m i n e d t h a tR RA i s n o ta “ p l an t p e s t ” un d e r th e P P A

. If RRA is not a “pla

nt pest,” the age n cy

was without jurisdiction to regulate the plant, and was require d to order d e r e g u lati o n , th

u s o b v iati n g th e n e e d to c o n s u lt w it h th e F WS
or co n s i der othe r options involving continued r egulation of RRA.

DI SCU SSIO N

I. Whe th e r RR

A i s a “P lan t P e st ” and Thus W it hin t he Scope of APHIS’s Regulatory A uthority

T h e p r i m ar

y i s s u e w e m u s td e t e r

m i n e i s w h e th e r

A P H IS has interpr eted the me aningof “pla nt p es t ” in the PPA too
narr owly . The plaintiffs maintai n that it has, and that the te rm inc lud e s a ll g e ne tic a lly e ng ine e re d pla nts and or g anis ms that ha ve an e nv ir on me nta lly a dv e rs e e ff e c t on pla nts

. Acc ording to the plainti ff s , AP HI S has discretion under the PPA to reg ulate RRA, which, if c orre ct, would re q uire the ag ency , pursuant to t he ES A, t o consult with the FWS about the c ro p’ s e ff

e c ts o n e nd ang e red plant and anim a l sp e c ie s. 16 U. S.C. § 1 53 6( a )( 2) ; see Karuk Tri b e of C al. v. U.S. Forest Serv. , 681 F.3d 1006, 1020 (9th Cir. 2012) (e n banc)

. The pa rties all ag ree that under the PPA, APHI S regulates org anisms that are “plant pests.” T he PPA defines a “plant pest” a s any

“living sta g e” of

a li s t o f o rganisms , or ar ticlesC EN T ER FOR F OOD S AF ETY V

. V I LS A CK 23

“similar to or all i ed with” org anisms, “that ca n direc tly or indirectly injure, ca

use dama g e to, or ca

use disease in any plant or plant produc t.” 7 U.S.C. § 7702(14). Whil e neither the statute nor the r egulations further de fine the ty p e of

“ inj ur y ,” “ dama g e ,” or “ dis e a se ” a pla nt p e st mus t c a

us e , a ll of the or g anis ms that APH I S lis ts a s pla nt pe sts c an cause wi de sp re a d p hy sic a l da

ma g e or de str uc tio n o f p lants

. Wit h respe ct to g enetica lly eng ineer ed plants, t he regulations specifica lly

define the t erm “ regulated ar ticle” a s a g enetica lly

eng ineer ed org anism that is creat ed u sing a n org anism that is its elf a

plant pest. 7 C

. F. R

. § 3 40.1. The regulations g o on to spe cify that, as such, t h e “ regulated
arti c le ” mu s t i n

ju r e p la n ts

. 7 C.F.R

. § 3 4 0

. 2 n

. 4 ( “ A n [] org anism belong ing to a

ny taxa [t hat 7 C.F.R. § 340.1 lists as a plant pest] is only

considere d to be a pl an t p es t if the org anism ‘ca

n . . . injure, or c ause disea se, or damag e in any plants or par

ts thereof . . . .’”)

. The plaintiffs’ concern i s with two ty pes of ha

rm g e ne tic a lly

mod if ie d R RA can caus e : tr a ns g e nic contamination of c onventional alf a lf a a nd incre ased he rbicide use. These alleg ed harms may well be adve rse e nvironmental and economic eff

ects. APHI S c ontends, howeve r, they do not constitute plant disease, injury , o r damag e, which a re the harms that the statute require s. The ag enc y t here fore conclude s that RRA is not a “pla nt pest.”

I n s up po rt

of its po sit ion , A PHI S po ints o ut t hat, a s a matter of historica l prac tice, it has p reviously assessed the plant pest proper

ties of g enetica lly

modified crops suc h as
c ott on , c or

n, and so y be ans . In c on du c tin g the se pla nt p e st
as s essments, APHI S does not consider whe ther the g enetica lly

modified plant could cr o s s
- p o ll inate with and a lterC EN T ER FOR F OOD S AF ETY V

. V I LS A CK

24 the g enetic struc ture of othe r plants. This policy is consistent wi th A PHI S’ s c la ssi fi c a tio n o f oth e r p lants that c ou ld c ro sspollina t e and de stroy

the cr op value in the pr ocess ( such as canola with other ty

pes of rapese ed, and f

ield with sweet corn) . The a g ency

has never cla ssified a plant a s a “pla nt p e s t ” b a s e d

o ns u c hc r o s s
- p o l l i n a t i o ne f f e c t s

. A P H IS
e xpla ins thi s is be c a

us e it doe s not c on sid e r s uc h a lte ratio n to be a pla nt pest harm within the meaningof t h e st atute. The
a g e nc y ha s si mil arl y

ne ve r c on sid e re d th e po ssi ble conseque nces a ssociated wit h incre ased he rbicide use , including c reation of herbicide resistant we eds, t o be “pla nt pe st” inj ur ie s. APH I S e xpla ins su c h h arm s do no t c on sti tut e phy sical dama g e or injury to other plants. APHI S’s consistent interpre tation, which is a lso the best interpre tation of thi s p art ic ula

r s tatut or y language, must b e take n into
acc ount. See Sk

idmore v. Swif

t & Co. , 323 U.S. 134, 140 (1944) ( “consistenc y ” of ag ency interpre tations with “ear lier and later pronounce ments” is a fac tor to consider in dec iding wh e the r t o d e fe r t o a g e nc y int e rp re tatio n) ; Uni t ed S tates v. Mead Corp. , 533 U.S. 218, 219 (2001).

T h e p la inti f

f s n e v e rth e le s s ar g u e th a t A PH I S’s interpre tation of the mea ning of pl an t p es t is too narrow. Th e y c on te nd tha t w e sh ou ld h old

that RRAis a

pla nt p e st be c a us e the RRApla

nt r e su lts fr om t

he tr ans fe r o f g e ne tic
mate ri a l f

ro m th e Ag ro ba c te ri um. Sin c e the st atut e in 7 U.S.C

. § 7 7 0 2(14)( H) de fines a pla nt pest to be “[a]ny article simil ar to or allied with any of the a rticles spec ified,” the plaintiffs asse rt that the RRA plant is “ al l i ed with” the Ag ro ba c te ri um. Thus , th e pla int if fs ’ t he or y is that tr ans g e nic contamination and incr ease d g ly phosate use are harms ca

used by the Ag ro ba c te ri um, and the re fo re mus t a lso be “ pla nt p e st” harms under

the PPA.C EN T ER FOR F OOD S AF ETY V

. V I LS A CK 25

The plaintiffs’ logic is a stretch beca u s e i t fails to deal with the langu age of the statute def ining plant pe st harm as inj ur y , d ise a se , o r d ama ge t o oth e r p lants

. See 7 U .S. C. § 7702(14). Althoug h the re g ulations classify Ag robac terium itse lf a s a pla nt p e st, the Ag ro ba c te ri um’ s p lant p e st proper ties are “disarme d” and c an no long er injure other pla nts on c e the bacte ri um’ s g e ne tic mate ri a l is ins e rt e d into the g enetic structure of conventional alfa lfa. 70 Fe d. Reg . at 36,91 8 (“APHI S determined that the ve ctors and othe r e le me nts [of the Ag ro ba c te ri um] w e re dis arm e d [in the RRA p l an t ]

. . . . ”)

. R RA i s t h u s n o m o re l i k el y t o i n j ure o r d am age other plants than is conve ntional, nonmodified alfalf a. Id. We do not sug g est that the g enetic eng ineer ing is without possible economic c onsequenc es. AP HI S’s final EI S noted that transg enic c ontaminati on could ec onomically hurt far mers who raise conventional alfa lfa and marke t the ir crop
a s o rg anic . T he c on tamin a tio n o f c on ve nti on al alf a lf a wi th the g ly ph os a te -r e sis tant g e ne c ou ld c los e fo re ign marke ts t o U.S.-g rown a lfalfa . I t could also fo rc e farmers of conventional a lfalfa

to incur additio nal costs testing and
cer tifying that their alfa lfa is not co ntaminated with the g ly phosate-r esistant g ene. These c oncer ns, howeve r, ar e not the resu lt o f p la n t p e s t h ar

ms a s d e f

in e d un d e r th e PPA. APH I S thus ha s n o p ow e r t o r e g ulate the a dv e rs e e c on omi c eff ects that c ould follow RRA’s deregulation.

Th e pla intiff

s als o ma int a in t

hat be c a us e RRAre su lts in more use of

the her bicide g ly phosate, the ha

rms associate d with increa sed g ly

phosate usa ge are plant pest har ms under the PPA . We re c og nize , o f c ours e , th a t de re g ulatin g RRAis exp ec t ed to re sult in i ncre ased use of her bicides. Indeed, RRA wa s de ve lop e d so fa rm e rs c ou ld a

pp ly signif ic antl y g reater a mounts of herbicide s to alfa lfa fields. The incr ease dC EN T ER FOR F OOD S AF ETY V

. V I LS A CK

26

use of he rbicides c an b e potentially damag ing to the environment. But the PPA addr esses only the harms ca used by pla nt p e sts to o ther p lants and APH I S c an r e g ulate RRA only if it causes pla

nt pest harms. See 7 U.S.C. § 7702(14). Th e e nv ir on me nta l ha

rm s the pla int if

fs c ite are no t pl ant p e st harms. More over, the RRA plant itself does not ca use the harm produc ed by h erbicides. I t is the application of he rb ic ide s to fie lds of RRA , not the RRA pla nt, tha t r e su lts in
su c h h arm

. APHI S stresses it has no author i t y to regulate the use of h e r b ic id e s li k e g ly

p h o s a te

. T h e Co o r d in a te d F r ame w ork tasks the EPA, under F I FRA, with re g ulating her b i cide use, and it does so throug h labelinginstructions that the herbicide user must comply

with. See R u ckelshaus v. Monsanto Co. , 46 7 U .S. 98 6, 99 1– 92 (1 98 4) (no tin g that ame ndme nts to F I F RA in 1 97 2 “ tr ans fo rm e d F I F RA fr om a la be lin g law i nto
a compre hensive re g ulatory statute . . . [that] regulated the use, as we l l as the sale and labe ling, of pesticides” ( citation omitted)); Coordinated F rame work, 51 F ed . Reg . at 23,302. The PPA was ena cted to prote ct pl ants, but not to control the burg eoninguse of c hemicals in cr op production.

For these rea sons, we cannot interpre t the languag e of the PPA, which Congr ess has not materially amende d since 1957, to addre ss the alleg ed har ms that may

result from the mod if ic a tio n of a pla

nt’ s g e no me

. Th e job of

up datin g Ti tle 7 o f t he Un ite d St a te s Co de to a dd re ss t he po te nti a l ha

rm s c a us e d b y g e ne tic mod if

ic a tio n ( inc lud ingtr ans g e nic contamination and incr ease d herbic ide use) is a job for Congr ess, not this co u rt , to undertake . Pursuant to the lang uag e of the statute, we must rule that RRA is not a plant pest under the meaning of the ter m in the PP A and the
re g ulatio ns

.C EN T ER FOR F OOD S AF ETY V

. V I LS A CK 27

II. AP HIS’s Uncond iti o na l D e r e g ul a t io n o f R R A V io lated Neitherthe ESA nor NEPA

. Th e pla int if

fs argue that be fo re APH I S de c ided to dere g ulate RRA, the ag ency should have c onsulted with the F ish and Wild lif

e Se rv ic e (“ F WS” ) a

bo ut t he a dv e rs e environmenta l effe cts that RRA’s dere g ulation may have on endang ere d and thre aten ed plants and animals. The Endang ere d Species Ac t (“ESA”) imposes a duty on an ag ency to consult with the FWS or the National Oce anic a nd Atmospheric Administration F i s herie s Service when an
a g e nc y a c tio n ma

y a dv e rs e ly

a ff e c t a lis te d s peci es or it s c r i t i c a l h a

b i t a t

. 1 6 U

. S

. C

. § 1 5 3 6 ( a ) ( 2 ) ; 5 0 C

. F .R. § 4 02 .1 4( a ); see Karuk, 681 F.3d at 1011.

Th e ESA ’s c on su ltatio n duty is tri g g e re d, ho we ve r, on ly wh e n th e a g e nc y

ha s a uth or ity to t ake a c tio n a

nd dis c re tio n to de c ide wh a t a c tio n to take

. Th e re is n o p oint in c on su lti ngif the ag ency

has no choic es. The Supre me C o u rt rec og nized the principle in National Association o

f Ho me Builders v. De fe nd e rs of W ild lif e , 551 U. S. 644 , 655 (2 00 7) , w he n it sa id that “ the ESA ’s re qu ir e me nts wo uld c ome int o p lay

on ly when an action re sults from an exercise of ag ency discretion.” See Karuk, 6 81 F .3 d at 10 21 (r e c og nizi ngthat Ho meBu ild e rs “har moniz es the ES A consultation requir ement with other statu to ry mand a te s th a t le ave an a g e nc y no dis c re tio n to consider the protec tion of l isted specie s” (citation omit ted)). I n Ho meBu ild

e rs , th e Sup re me Court

he ld t hat on c e the EPA ha d d e te rm ine d th a t A ri zon a met th e statut or

y re qu ir e me nts under the Clean W ater Act for the transf

er of regulatory
au t h o ri t y o v er t h e s t at e’ s Na t i o n al P o l l u t i o nD i s ch ar ge El imi natio n Sy ste m pe rm itt ingpr og ra m, t he EPA ha d n o d

uty to c on su lt b e c a

us e the tr ans fe r w a s a

no nd isc re tio na

ry a c t. Ho meBu ild

e rs , 551 U.S. at 655.C EN T ER FOR F OOD S AF ETY V

. V I LS A CK

28

Her e, once APHI S c oncluded that RRA wa s not a pl ant pest bec ause it did not cause plant pest injury to plants, the ag ency had no jurisdiction to cont inue re g ulating the crop. Th e a g e nc y ’s de re g ula tio n o f R RA wa s th us a no nd isc re tio na

ry a c t th a t did no t tr ig g e r the a g e nc y ’s duty to consult under the E SA. Accor din gl y , t he district cour t
corr ec tly ruled that APHI S’s dere g ulation of RRA did not violate the ESA.

Nor d i d the district court e rr in ente ring summary jud g me nt i n f

avo r o f the de fe nd ants on the pla int if fs ’ N EPA
c l a i m

. T h at cl ai mre s t edo nt h e c o n t en t i o nth at AP H IS should have c onsidered pa rtial dere g ulation as an alter native to full deregulation. NEPA require s that an age n cy take a “har d look” at the environmenta l e ffe cts of a pr oposed ac tion that could signific antly

aff ect the e nvironment by

evaluating all rea sonable a lternatives to the proposed ac tion. See 40 C.F.R. § 1502.14(a) ; Ea rth Is lan d In st

. v. U .S . F or est Serv. , 442 F.3d 1147, 1159 (9th Cir. 2006) (interna l quotation marks omitted), abrogated on other grounds by W i n t er v. Nat’l Res. Def. Council, Inc. , 555 U.S

. 7 , 21 (2008). He re, the re we re no re a so na

ble a lte rn a tiv e s to de re g ulatio n b e c a us e the ag ency

lacks jurisdiction to regulate R R A. APHI S was not r equire d to look at alternatives to the unconditional de re g ulatio n o f RRA a

bs e nt a ny juri sdic tio n to a do pt t

he m. See S. Coast Air Quality Mgmt. Dist. v. FERC , 621 F.3d 1085, 1092 (9th Cir. 2010) ( “[ NEPA] does not ex pand the jur isd ic tio n o f a

n a g e nc y be y on d th a t se t f

orth inits or g anic statute .

. . .”) (internal quotation marks omi tted) (a lterations in orig inal).C EN T ER FOR F OOD S AF ETY V

. V I LS A CK 29

III

. Co nsis te nc y wit h M o n s a n t o v . G e e rt s o n F a r ms The plaintiffs ne verthe less contend that the d is tric t court’s decision upholding APHI S’s unconditional dere g ulat i on of RRA c on fl ic ts with the Sup re me Court ’s Monsanto decision, wher e the Court looked at alternatives to deregulati o n

. The t w o d ec i s i o n s , h o we v er , co n ce rn d i ff er en ti s s u es

. In Mo ns an to , the Court’s decision we nt only to the scope of

the inj un c tio n e njo ini ngthe planti ng and de re g ulatio n o f RRA pendingprepa ra t i o n of the EI S. Mo ns an to , 130 S. Ct . at 2756. The Court assumed, without deciding , that APHI S had jurisdiction to reg ulate RRA. Id

. I n thi s a pp e a l, t he iss ue is whether APHI S corre ctly

deter mined that RRA is not a plant pest, there by compelling unconditional dere g ulation of RRA. The S upreme Court in Monsanto expressly noted that it was not a ddressing that issue. Id. (“[ W] e assume w ithout decidingthat the District Court [i n Gee rtson ] ac te d la wf ull y in vacating [APHI S’s] dere g ulation decision.”). Monsanto is there fore not on point, and thus the district court’s dec ision befor e us is not inconsistent with Mo ns an to

. IV

. No xio us W e e d Ri sk The plaintiffs c ontend that APHI S violated the PPA by not evaluatingwhether

RRA was a “ nox ious weed” under 7 U.S.C. § 7712(f). Ac cordingto the plai n t i ff s , when Monsanto and F orag e Ge netics petitioned APHI S for a de te rm inatio n th a t RRAwa s n ot a “pl ant p e st, ” the statut e compelled t h e ag ency

to evaluate whether

RRA should be regulated as a

nox ious weed. The plaintiffs’ theor y is that RRAis a

no xious we e d und er th e PPAbe c a us e it w ill “indirec tly

injure . . . ag ricultural inter es t s ” by cre ating g ly phosat e-resistant wee ds. See 7 U.S.C. § 7702(10) (def ining a “noxious wee d” as “ any plant or plant produc t thatC EN T ER FOR F OOD S AF ETY V

. V I LS A CK

30

can dir ectly

or indirec tly

injure or cause damag e to c rops

. . . or other inter ests of ag riculture” ).

Neither the PPA nor APHI S’s regulations, ho we v er, re qu ir e APH I S to c on du c t a se pa rate no xious we e d a

na ly sis in response to a

party ’s p et i t ion to deregulate a pla nt under 7 C.F.R. § 340.6. Plant pests and n o x i o u s wee ds are regulated under

separ ate regulatory fra

meworks. Regulations for plant pe s t s are contained in 7 C.F .R. parts 330 and 340 while the re g ulations gove rning nox ious weeds a re c ontained in 7 C.F.R. pa

rt 360. The proce dures under 7 C.F .R. § 340.6 pr ovid e fo r d e re g ulatin g a pr e sumpt ive pla

nt p e st. A p art

y seekingto list or delist a plant as a nox ious weed must invoke proce dures se t forth in 7 C.F.R. § 3 6 0

. 500 and § 360.501. The sepa rate regulat o ry fra

meworks f

or plant pests and
no xious we e ds are c on sis te nt w ithsta nd ards of the statut e treating plant pe sts and nox ious weeds se paratel y . I ndeed, the PPA kept in plac e the se parate re g ulatory frameworks f

or pla nt p e sts and

no xious we e ds that w ere or ig ina lly promulg ated unde r the Fede ral P lant Pest Act and the Fe dera l No x i ous Weed Act. See7 U

. S. C. § 7 7 5 8 ( c ) ( “ Re g u lations issued under the authority of [t he Fe dera l Plant P est Act a nd Fe dera l Nox ious W eed A ct] shall remain in eff ect . . . .” ).

Whil e APH I S ha s p ro po se d ame nd ingits re g ulatio ns to consider noxious weed ha rms and plant pest harms tog ether , it has not y et adopted those regulations. SeeProposed Rule, 73 Fe d. Reg . 60 , 008, 60,011 (Oc t. 9, 2008). Ther efor e, the
re g ulatio ns have no e ff

e c t on APHI S’ s ana ly sis of RRA . T his is be cause proposed regulations ha ve no leg al ef

fec t. He nr

y 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).C EN T ER FOR F OOD S AF ETY V

. V I LS A CK 31

B e c a us e no pa

rt y pe tit ion e d A PHI S to lis t RRAa s a nox ious weed, t h e agenc y did not violate the PPA by not
e va luati ng RRA ’s no xious we e d p ro pe rt ie s w he n it dere g ulated RRA. The district court thus c orre ctly ruled that APHI S did not vi olate the PPA by n o t co n s idering , sua sponte, whethe r RRA was a noxious weed.

CO NC LU SION

Th e dis tr ic t c ourt ’s jud g me nt in f avo r o f t he Ap pe lle e s is AF F IRM ED

.