N O T FO R PUB L ICAT IO N UNITED STATES C OUR T OF APPEALS FOR THE NINTH C IR C UIT
C ENTER FOR FOOD SAFETY; C ENTER FOR B IOLOGIC A L DIVER SITY; SIERR

AC LUB ; HUM ANE SOC IETY OF THE UNITED STATES; ANIM AL LEGAL DEFENSE FUND; UNITED FAR

M W O RKER S OF AM E R IC A, Pla i ntiffs-Appe lla nts,
v. M AR GARET A. HAM B UR G, C om m issione r, Unite d State s Food a nd Drug Adm inistra

tion; U.S. FOOD & DR UG ADM INISTR

A TION, De fe nda n ts-Appe lle e s, ELANC O US INC .,

Inte rve nor-De fe nda

ntAppe lle e . No. 15-17510 D.C . Nos. 4:14-c v-04932-YGR

4:14-c v-04933-YGR
M EM O R ANDUM *

Appe a l from

the Unite d

Stat e s Distric t C ourt for the Northe rn Distric t of C a lifornia Yvonne Gonz a le z R oge rs, Distric t Judge , Pre siding 

# F IL ED
AUG 22 2017 M OLLY C. DW Y ER, CLERK U

. S. CO URT O F APPEALS

* This disposition is not a ppropria te for public at ion a

nd is not pre c e de nt e xc e pt a s provide d

by Ninth C irc uit R

ule 36-3.Argue d a nd Subm itte d April 17, 2017 San Fran c isc o , C a lifornia B e fore : SC HR OEDER

and R AW LINSON, C irc uit Judge s, a nd DR A IN, * * Distric t Judge
. Appe lla

nt C e nte r for Food Sa fe ty (C FS) a ppe a ls the distric t c ourt’ s dism issa l of its c om pla i nt a lle ging tha

t the Food a

nd Drug Administra

tion (FDA) a

pprova l of the u se of a

nim a l drugs viola

t e d the Nationa l Environm e nta l Polic y Ac t. C FS
c onte nds tha

t the distric t c ourt e rre d in dismissing its c om pla int ba se d on C FS’ s fa ilure to sa

tisfy the Adm inistra

tive Proc e dure Ac t’ s e xha u stion re quire m e nts. The distric t c ourt prope rly he ld tha t, unde r the fa c ts of this c a se , the FDA should bea fforde d a

n opportunity

to a pply its e xpe rtise to a s se ss C FS’ s c la im s in the first insta

nc e “ prior to possible

judic ia l inte rve ntion.” C tr. for Food Safe ty

v . Hamburg , 142 F. Supp. 3d 898, 907 (N.D. C a l. 2015). R e quiring C FS to file a
c itiz e n pe tition “

pre ve nts[s] pre m ature inte rfe re nc e with a ge nc y proc e sse s so tha

t the a ge nc y m ay

func t ion e ffic ie ntly

and so tha

t it m ay hav e an opportunity

to
c orre c t its own e rrors, to a fford the pa rtie s a nd the c o urts the be ne fit of its
e xpe rie nc e and e xpe rtise , a nd to c om pile a re c ord whic h is a de quate for judic ia l

* * The Honora

ble Ge rshwin A. Dra in, Unite d Stat e s Distric t Judge for the E a s te rn Distric t of M ic higa n , sitting by

de signa t ion. 2re vie w.” Tamosaitis v . URS Inc

. , 781 F.3d 468, 478 (9th C ir. 2015), as ame nde d

(c ita tion omitte d). The distric t c ourt c o ge n t ly propose d to sta

y the proc e e dings to allow C FS to file a c itiz e n pe tition. S

e e C tr. for Food Safe ty , 142 F. Supp. 3d a t 910. Howe ve r, the p artie s re que ste d tha

t the distric t c ourt e nte r a fina l orde r dism issing C FS’ s
c om pla i nt, like ly

in orde r to e nsure a

ppe lla te re vie w. The distric t c ourt’ s inc l ination to sta

y the a c t ion wa s spot on. Se e 21 C .F.R . § 10.25(a); se e also 21 C .F.R . § 10.45(b) (providing tha t “ [a ] re que st tha

t the C om m issione r take or
re fra in from

ta king a ny form of a dm inistra

tive a c tion m

ust first be the subje c t of a fina l a d m inistra tive de c i sion ba se d on a

pe tition subm

itte d unde r § 10.25(a ) . . . be fore any

le g a l a c tion is file d in a

c o urt c om

pla ining of thea c tion or fa ilure to
a c t” ). Ac c ordingly , the distric t c ourt is dire c te d to sta y furthe r proc e e dings to
a llow C FS to c om

ply with theFDA’ s c i tiz e n pe tition re quire m e nt. The distric t
c ourt re ta ins a

uthority to “ c om pe l a ge nc y

a c tion unla

wfully withhe ld or
unre a s ona

bly de la y e d” pursua

nt to 5 U.S.C . § 706(1) following c o m ple tion of the
a dm inistra

tive proc e e dings. V ACAT E D and RE M ANDE D w ith dir e c tions.

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