# P l a nt P e st R i s k A s s e ss me n t f o r H C E M 4 8 5 C o r n

A P H I S’ a utho r i t y to re g u l a te g e n e ti ca l l y e n g i n ee re d (GE ) o r g a nisms und e r t he Pl a nt P r ot ec tion

Ac t ( PP A ) ( 7 U .S.C. S e c 7701 e t s e q .) is limit e d to those G E o r g a nisms th a t ar e pl a nt p e sts a s

d ef in e d und e r S ec tion 4 0 3 ( 14) of the PPA ( 7 U

. S C. 7702 ( 14 ) 1 )

. A P H I S re gul a tions a t 7 C F R p ar t

340, w hi c h we r e p r omu l g a t e d in 1987 und e r the a utho r it y of the F e d era l Pl a nt P e st Ac t a nd Pl a nt

Q u ara ntine A c t, p r ovid e d A P H I S w ith the m e c h a n ism to re g ul a te ar ti c l e s a l t ere d or p r od u ce d

th

r ou g h g e n e tic e n g in e er i ng a s pl a nt p e sts a nd th a t the A dminist e r c onsid e r s a pl a nt p e st b a s e d

upon the d ef inition of a r e g u l a t e d ar ti c l e ( 7 C F R p ar t 340.1 )

. I n 1993, 7 CFR p ar t 340 wa s

re vis e d to in c lude a p r o c e ss w h e r e b y a p e r son m a y p e tition the a g e n c y to m a ke a d e t er min a tion

th a t a r e g ul a t e d ar ti c le s h ould not be r e g ul a t e d ( 7 C F R p ar t 340.6 ) . R e qui r e d d a ta a nd

in f o r m a tion (a s p e r 7 C FR p ar t 340.6 (c ) ) is submitt e d to the a g e n c y to d e m onst ra te th a t the

ar

ti c le th a t is the subj ec t of the p e tition do e s not pose a g r e a t e r pl a nt p e st r isk th a n the o r g a nism

fr om w hi c h it wa s d e r iv e d a nd th a t it should no l o n g e r be subj e c t to the r e gul a tions of 7 C F R p ar t

340. I f A P H I S d e t er min e s th a t a G E o r g a nism is unlik e l y to pose a pl a nt p e st r isk, A P H I S th e n

h a s no r e g ul a to r y a utho r it y und e r 7 C F R P ar t 340 or the pl a nt p e st p r ovisions of the Pl a nt

P r ot ec tion Ac t to c ontinue to r e g ul a te th a t o r g a ni s m. A ddition a l l y , un d e r 7 C F R p ar t 340.6 ( e ) , a

p er son m a y r e qu e st th a t A P H I S e x t e nd a d e t er min a tion of nonr e g ul a t e d s t a tus, b a s e d on

simil ar it y o f a re g ul a t e d ar ti c le to a n a n t ece d e nt o r g a nism w hi c h h a s p r e vious l y b e e n d e t er min e d

to be unlik e l y to pose a p l a nt p e st r isk a nd is no lon g e r subj ec t to the pl a nt p e st p r ovisions of the

Pl a nt P r ot ec tion Ac t a nd 7 C F R p ar t 340.

Stine S ee d F ar m, I n c

. ( h e reaf t e r r ef e rre d to a s Sti n e S ee d ) , h a s submitt e d to A P H I S a n e x t e nsion

re qu e st f or a d e t e r min a tion of non r e g ul a t e d st a tus of G E c o r n ( Z e a m a y s ) e v e nt H C E M485,

b a s e d on simil ar i t y to the c o r n e v e nt G A 21 f or w h i c h a p e tition ( 97

- 099

- 0 1 p) f or non re g ul a t e d

st a tus wa s a pp r ov e d in 1 997 ( 62 F R 64350 )

. T he Stine S ee d e x t e nsion re qu e st f or H C E M485

c o r n wa s o r i g i n a l l y r e c e iv e d on M arc h 4, 2009. A re vis e d v e r sion ( 09

- 0 6 3

- 01p_ a 3) r ece i v ed on

A

p r il 1, 2011 ( Stin e , 2011 ) wa s d e e m e d t ec hn i ca l l y c ompl e t e a nd is the v er sion of the p e tition

ref e re n c e d in this do c um e nt. B oth H C E M485 c o r n a nd GA 21 c o r n a r e simil ar l y g e n e ti ca l l y

e n g i n ee r e d f or re sist a n c e to the h er bi c ide g l y pho s a t e

. T his pl a nt p e st r isk a ss e ssm e nt wa s

c ondu c t e d to d e t e r mine w h e th er

, a s w ith the a nt e ce d e nt GA 21 c o r n, e v e nt H C E M485 c o r n is

unlik e l y to pose a g rea t e r pl a nt p e st r isk th a n the unmodi f i e d o r g a nism fr o m w hi c h it wa s

d er iv e d. I f t h e submitt e d e x t e nsion re qu e st p r ovid e s e vid e n c e of su f f

i c i e nt simil ar it y to the

a nt ece d e nt GA 21, a llo w i ng A P H I S to m a ke a d e t e r min a tion th a t H C E M485 is unlik e l y to po s e a

1 The t erm “ p l ant p e s t” is d e f ined in t he PP A as any li v ing s ta g e of a n y o f the f o llo w ing that c a n

dire c tly or indire c tly injure, c a u s e d a ma g e to, or c a u s e di s ea s e in a ny plant or plant p rodu c t:

(A) proto z oan.

(B) A nonhum a n an i m a l.

(C) A para s i tic pl a nt.

(D) bac t eri u m.

(E) A f un g u s

. (F) v irus or v iroid.

(G) A n in f ectious a g ent or other p atho g en

(H) A n y artic l e s i m ilar to or al l ied w ith a ny o f the arti c les s pe c i f ied in the p re c eding s ubpara g raph s

.

1pl a nt p e st r isk, H C E M485 a nd its p rog eny w i l l n o lo n g er be co nsi d e r ed r e gul ated a r ti cl es u n d er

r e g u l ati o ns at 7 C FR pa r t 340

.

Pot e nti a l imp ac ts to be a dd re ss e d in this r isk a ss e ssm e nt ar e those th a t p e r t a in to the use of

H C E M485 c o r n a nd its p r og e n y in the a bs e n c e of c on f in e m e nt

. A P H I S e x a min e d in f o r m a tion

submitt e d b y the p e tition e r ( Stin e , 2011 ) a s we ll a s i n f o r m a tion c ont a in e d in our d e t er min a tion

of n onr e g ul a t e d st a tus a nd t h e suppo r ting d o c um e nts f or the a nt e c e d e nt o r g a nism GA 21 (a s p e r 7

C F R p ar t 340.6 ( c )( 4 ) ) r e l a t e d to pl a nt p e st r isk c h arac t er isti c s, in c luding dis ea s e a nd p e s t

sus ce ptibiliti e s, e x p re s s ion of the g e ne p r od u c t, n e w e n z y m e s or c h a n g e s to pl a nt m e t a bo l ism,

wee di n e ss ( in c luding c ont r ol options) of the r e g ul a t e d ar t i c le

, a nd a n y imp a c ts on the wee din e ss

o f any oth e r pl a nt with which it can interbreed

, eff e c ts of the re g ul a t e d ar ti c le on non

- t a r g et

b e n ef i c i a l o r g a nisms, changes to agricultural and cultivation practices that might impact plant

pest control measures, a n d pot e nti a l f or pl a nt p e st eff e c ts fr om ho r i z ont a l g e ne t ra ns f er

. A P H I S

a lso e x a min e d in f o r m a tion submitt e d b y t h e p e tition e r (a s p e r 7 C F R p a r t 3 4 0.6 (e)( 2 ) ) r e l a t e d to

the simil ar i t y of the re g ul a t e d ar ti c le to the a nt e c e d e nt o r g a nism GA 21. O t h e r issu e s re l a t e d to

a g r i c ultu ra l or c ultiv a tion p rac ti ce s ( in c luding but not limit e d to those re l a t e d to c h a n g e s in

h er bi c id e s us e d to c on t r o l wee ds in c o r n ) a nd oth e r imp ac ts to the e nvi r o n m e nt ar e e x a min e d in

the s e p a r a t e l y d r a f t e d E n vi r onm e nt a l A ss e ssm e nt f or H C E M485 c o r n.

A P H I S m a y a lso c onsid e r in f o r m a tion re l e v a nt to re vi ew s c ond u c t e d b y o t h e r a g e n c i e s th a t a r e

p ar t of the ‘ Coo r din a t e d F ra m e w o r k f o r the R e g u l a tion of B iot ec hnol og y ’ ( 51 F R 23302, J une

26, 1986 )

. U nd e r the C o o r din a t e d F ra m ew o r k, the ov er s i g ht of biot ec hno l o g y

- d er iv e d pl a nts

re sts w ith the A P H I S, the F ood a nd D r u g A dminist ra tion ( F D A )

, a nd the O ff i c e of P e sti c i d e

P r o g r a ms of the U .S. E n vi r onm e nt a l P r ot ec tion A g e n c y (E P A)

. De p e ndi n g on its c h a rac t er isti c s,

cer t a in biot ec hnol og y

- d e r iv e d p r odu c ts a r e subj e c t e d to re vi e w b y one o r mo r e of th e se a g e n c i e s.

T he E PA und e r the F e d e r a l I n s ec ti c id e

, F u n g i c ide a nd Rod e nti c ide Ac t ( F I F R A)

, re g ul a t e s the

dist r ibution, s a l e , use a nd t e sting of p e sti c id a l sub s t a n ce s p r od u ce d in pl a nts a nd mi cr ob e s,

in c luding those p e sti c id e s th a t ar e p r od u ce d b y a n o r g a nism th r ou g h t e c hn i qu e s of mod er n

biot ec hnolo g y

. T h e E PA a lso s e ts tol era n c e limits f or re sidu e s o f p e sti c id e s , in c luding

h er bi c id e s, on a nd in f o o d a nd a nim a l f e e d, or e s t a blish e s a n e x e mption fr om the re qui re m e nt f o r

a tol era n c e

, und e r the F e d era l F o o d, Dr u g a nd C o sm e tic Ac t ( F F D C A)

. H C EM 485 , as w e l l as

t h e ante c e d ent org ani s m GA21

, a r e not e n g in ee re d to e x p re ss p e sti c id a l subst a n ce s, ho we v e r

tol era n c e l e v e ls f or re si d u e s of g l y pho s a te h a v e a l rea d y b e e n e st a blish e d f o r GA 21 c o r n.

Suppl e m e nt a l l a b e ls ar e r e qui re d to a llow ov e r

- th e

- top a ppli ca tions of g l y p hos a te h er bi c i d e on

cr ops g e n e ti c a l l y modi f i e d f or g l y pho s a te r e sist a n c e a nd h a ve a l r ea d y b ee n a pp r ov e d f o r GA 21

c o r n. T he F D A un d e r the FF D CA is r e sponsible f or e nsu r i n g the s a fe t y a n d p r op e r l a b e ling of a ll

pl a nt

- d er iv e d f oods a nd f ee ds, in c luding tho s e d e v e lop e d th r o u g h mod er n b iot ec hnolo g y

. T o

h e lp sponso r s of f oods a n d fee ds d e r iv e d f r om g e n e ti ca l l y e n g in e e re d c r ops c omp l y w ith th e ir

obli g a tions, the F D A e n c ou r a g e s th e m to p ar ti c i p a te in its volunt a r y c onsul t a tion p r o ce ss ( 57 F R

22984 ) . Stine S ee d h a s s ubmitt e d a f ood a nd f e e d s afe t y a nd nut r ition a l a s s e ssm e nt f or e v e nts

H C E M485 on Dec . 27, 2 010, a nd received a completed consultation letter from the FDA in July

2012 ( B N F 106 ). Likewise,

, a c onsult a tion p r o ce ss h a s b e e n c ompl e t e d f or GA 21 ( B F N 51) a nd

both letters are a v a il a ble f o r public re vi e w v i a the F D A C o mpl e t e d Consult a tions on

B io e n g in e e re d F oods p a ge a t w w w

. f d a

. g ov/bi o c oninv e nto r y

.



### H i s t o r y o f D e v e l o p m e n t o f H C E M 4 8 5 G l y p h os a te He r b i c i d e

- R e s is t a nt Co rn

H C E M485 c o r n is a G E c o r n line th a t h a s b e e n p r ovid e d re sist a n c e to t r ea t m e nt w ith the

h er bi c ide g l y phos a t e

. T h e p ar ti c ul a r g e n e tic e l e m e nt c on f e rr i n g this t ra it is a n a lt ere d s e qu e n ce

of DN A d e r iv e d fr om the g e no m e of c o r n. Sp ec i f i ca l l y , Stine S ee d re mov e d a 6 kilob a se ( sixthous a nd nu c l e otid e s ) s e c tion of DN A fr om a n inb r e d c o r n lin e , modi f i e d t h e 5

-

e nol p y r u v y lshikim a t e

- 3

- phosph a te s y nt h a se ( e ps p s ) g e ne c on t a in e d w ithin th a t DN A s ec tion,

a nd th e n re int r od u ce d the DN A into c o r n. T he m o di f i e d g e n e tic s e q u e n c e o f the e psps g e n e

e n c od e s a do u ble mut a t e d 2m E PS P S e n z y me p r o du c t id e nti ca l to th a t p r o du ce d in the non

r e g ul a t e d G E c o r n lin e

, GA 21, th a t is a lso re sist a nt to g l y pho s a te ( F unke e t a l. 2009 )

, a lthou g h

the r e g ul a to r y s e q u e n c e s c ont r olling e x p re ssion of the g e ne do di f f e r b e t we e n H C E M485 a nd

GA 21 ( s e e “De s cr iption of the I ns er t e d Ge n e tic M a t er i a l

... ” b e lo w)

.

A p e tition re qu e st f or a d e t er min a tion of nonr e g u l a t e d st a tus of the f i r st c o r n line c ont a ining a

g l y phos a te re sist a n c e t ra i t p r odu ce d th r o u g h the u s e of biot ec hnol og y wa s a pp r ov e d b y A P H I S in

1995, a nd sin c e th a t time s e v e r a l oth e r c o r n lin e s c ont a ining g l y pho s a te re sist a n c e h a ve a lso b ee n

d e t e r min e d b y A P H I S to be no lo n g e r subj e c t to the re g u l a to r y re qu i r e m e nts of 7 C F R p ar t 340

or the pl a nt p e st p r o visions of the Pl a nt P r ot ec tion Ac t. I n 2011, a pp r o x im a t e l y 72% o f c o r n

pl a nt e d in the U nit e d St a t e s poss e ss e d re sist a n c e t o a n h er bi c ide t h a t wa s c on fer r e d th r o u g h

biot ec hnolo g y ( U S DA

- E RS, 2011 )

. T he p r im a r y h er bi c ide r e sist a n c e t r a it in use is g l y phos a te

re sist a n ce

, a nd the a dopt i on of this t ra it in oth e r m a jor cr ops, su c h a s c otton a nd s o y b ea n, is e v e n

hi g h er

. We e d re sist a n c e t o h er bi c id e s is a c o n c e r n in a g r i c ultu ra l p r odu c tio n

, a nd the w id e

sp rea d a doption of h er bi c ide re sist a nt cr ops, e s p ec i a l l y G E

- d er iv e d g l y pho s a t e

- r e sist a nt cr ops,

h a s d ra m a ti c a l l y c h a n g e d the a pp r o a c h th a t f a r m e r s t a ke to a void y i e ld loss e s fr om w e e ds

( Ve n c ill e t a l., 2012 )

.

G l y phos a t e

- re sist a nt c r o ps h a ve b ec o m e w id e l y a dopt e d sin c e th e ir int r o d u c tion in the mid

- l a te

1990s f or s e v e ra l r e a son s

. G l y phos a t e w o r ks non

- s e l ec tiv e l y on a w i d e ra n ge of pl a nt sp ec i e s, is

a re l a tiv e l y lo w

- c ost h er b i c id e

, fac ilit a t e s ‘ n o

- till’ far mi n g p r a c ti ce s, a nd h a s minim a l a nim a l

to x i c olo g i ca l a nd e nvi r o n m e nt a l imp ac t ( G i a n e ssi, 2008 ; D uke a nd Po w l e s, 2009 )

Stine S ee d c ondu c t e d c o n f in e d f i e ld t e sts of H C E M485 c o r n in the U nit e d St a t e s b e g inni n g in

2005 und e r re q u e st e d no t i f i ca tions ac kno w l e d g e d b y A P H I S ( Stine 2011, p a ge 50 a nd A p p e ndix

2 )

, a nd h a s p r ovi d e d d a ta in the p e tition fr om s e v e ra l of those c o n f in e d f i e l d t r i a ls.

I f a d e t er min a tion of no n r e g ul a t e d st a tus is e x t e nd e d to H C E M485, this c ultiv a r is e x p ec t e d to

a dd to the options th a t g r o wer s h a v e w h e n d ec idi n g on a g l y pho s a t e

- r e sist a nt c o r n lin e

. I t is not

e x p ec t e d th a t the a v a il a b i lit y o f H C E M485 w ill si g ni f i c a nt l y imp a c t the a d option ra te of

g l y phos a te re sist a nt c o r n cr ops

, nor w ill it g r ea t l y i mp ac t c u r r e nt or f utu r e t r e nds of g l y pho s a te

re sist a n c e a mong wee d s p ec i e s. T h e s e sp ec i f i c issu e s ar e dis c us s e d in g r e a t e r d e t a il in the

E nvi r onm e nt a l A ss e ssm e nt th a t is wr itt e n f or H C E M485.



### D e s c r i p t i o n o f the I n s e r ted Ge n e t i c Ma te r i a l i n H C E M 4 8 5 a nd t he A ntece d e nt

T he simil ar i t y of the t r a n s f o r m a tion p r o ce ss a nd ins er t e d g e n e tic e l e m e nts a nd g e ne p r o d u c ts

e x p re ss e d in H C E M485 c o r n c omp a re d to the a n t ece d e nt ar e summ a r i z e d h er e a nd i n f o r m the

pl a nt p e st r isk a ss e ssm e n t.

H C E M485 c o r n wa s p r o du ce d usi n g a n a er osol b ea m inj ec tor ( He ld, 200 4 ) to int r odu c e a 6.0

kilob a se c o r n g e nomic f r a g m e nt, o r i g i n a l l y isol a t e d fr om a b a c t er i a l a r ti f i c i a l c h r omosome

( B A C) c o r n D N A lib ra r y

. T he m e thod of di r e c t D N A int r odu c tion is a simil a r m e thod to the

p ar ti c le bomb ar d m e nt, or “ biolisti c s ”

, a pp r o ac h u s e d to g e n e r a te the a n t ec e d e nt e v e nt GA 21.

T he o r i g in a l DN A fr om the B A C lib r a r y wa s mo d i f i e d to in c o r po ra te t h e d e si re d c h a n g e to

E PSPS f un c tion a lit y

, h o we v e r a ll g e n e tic m a t e r i a l ins er t e d b y aer osol b e a m inj ec tion was

oth erw ise e nti re l y d er iv e d fr om c o r n D NA

. A ll p r omot er , int r on, a nd t er m in a tor s e qu e n c e s th atins er t e d into H C E M485 ar e the s a me a s those a l r e a d y a sso c i a t e d w ith the n a tive E PSPS

e n c odi n g g e ne in c o r n. N o DN A fr om pl a nt p e sts, nor a n y t ra ns f o r m a tion m e thod or v ec tor

involving a pl a nt p e st, w a s us e d to p r odu c e H C E M485 c o r n. T he on l y m o di f i ca tion to the c o r n

DN A s e qu e n c e is the int r odu c tion of t w o sin g l e

- n u c l e otide a lt e r a tions, w hi c h re sults in t w o

c h a n g e s to the a mino a c i ds (T h re onin e

- 102 → I so l e u c ine a nd P r olin e

- 10 6 →S er in e ) of the

e x p re ss e d E PSPS p r ot e i n

. Co r n pl a nts c ont a ining the ins er t e d g e n e tic m a t e r i a l we r e initi a l l y

isol a t e d b y g r o w ing them on s e l ec tive m e dia c on t a ining g l y phos a t e

. Stine S ee d u s e d a South er n

blot a n a l y sis to c o n f i r m ins er t ion a nd to e stim a te the numb e r of c opi e s ins e r t e d into the rec ipi e nt

c o r n p r odu c t, H C E M485 ( Stine 2011, p a g e s 14

- 1 8 )

. E v id e n c e f r om the submitt e d p e tition

e st a blish e s th a t multiple c opi e s of the modi f i e d e psps g e ne w er e ins er t e d a t a si n g le l o c us (a lso

simil a r to the a nt ece d e nt) a nd th a t th er e do e s not a pp e a r to be a n y t r un c a t e d or a bno r m a ll y si z e d

p r ot e in p r odu c ts re sulting fr om t he ins er t e d g e n e tic m a t e r i a l (a s d e t er min e d b y we s t er n blot

a n a l y sis ) ( Stine 2011, p a g e s 20

- 2 2 )

.

T he not a ble di f f ere n c e b e t wee n H C E M485 a nd G A 21 is the ins er t e d non

- c oding DNA

r e g ul a to r y s e q u e n ce s b e f o r e a nd a f t e r the s e qu e n c e s e n c odi n g the modi f i e d E PSPS p r ot e in. I n

HCEM485 a ll r e g u l a to r y s e qu e n ce s up

- a nd do w n

- s t rea m of the modi f i e d e p s ps ar e d er iv e d

di

r e c t l y fr om n a t ive c o r n D N A

, w hereas in GA 21 t hose s e qu e n c e s a r e d er iv e d fr om v ar ious

DN A isol a t e d fr om oth e r o r g a nisms, in c luding r i c e ( O r y za sati v a ) , su n f lo w e r ( H e lianthus annus )

a nd the b ac t er ium A groba c t e rium tu me fa c i e ns th a t is list e d a s a pl a nt p e st in 7 C F R p ar t 340.2

( s e e Stine 2011, Ta ble 1 )

. A s A P H I S h a s a l r e a d y a pp r ov e d the p e tition re q u e st f or a

d e t er min a tion of nonr e g u l a t e d st a tus of GA 21 a nd th eref o r e GA 21 is not c o nsid ere d to p re s e nt a

pl a n t p e st r isk, th e se di ffe r e n ce s in the int r odu ce d DN A do not p r ovide a n y in crea s e in the pl a nt

p e st r isk pot e nti a l f or H C E M485 c omp are d to GA 21.



### E x pr e s s i o n o f t h e G ene P r o d u c t, Enz y m e s , o r C h a n g es t o Pl a n t M e t a b ol ism

A P H I S a s s e ss e d w h e t h e r c h a n g e s in pl a nt m e t a bo l ism or c omposition in H C E M485 ar e lik e l y to

a lt e r pl a nt p e st r isk. T he a ss e ssm e nt e n c omp a s s e s a c onsid e r a tion of the e x p re ss e d modi f i e d

e

psps g e ne a nd its e ff e c t on pl a nt m e t a bolism, a nd a n e v a lu a tion of w h e th e r H C E M485 is

nut r ition a l l y e quiv a l e nt t o oth e r c o r n, a s h a s b e e n d e t er min e d f or GA 21. T he modi f i e d e psps

g e n e ins er t e d d o e s not r e pl ac e the n a tiv e , unmodi f i e d e psps g e ne o r E PSPS p r ot e in; both

modi f i e d a nd unmodi f i e d v er sions of the g e n e a nd p r ot e in ar e p re s e nt w ith i n H C E M485. T he

int r odu ce d g e ne re spons i ble f or c on f err i n g the h e r bi c ide re sist a n c e e n c o d e s a f o r m of E PSPS th a t

is ins e nsitive to the h er bi c ide g l y pho s a t e , simil a r to the a nt e c e d e nt GA 21. T his g e n e e n c o d e s a

p r ot e in th a t di ffer s fr om the n a tive c o r n E PSPS p r ot e in b y t w o k e y a mino a c ids, w hi c h is the

4s a me modi f i ca tion a s int r odu ce d into GA 21 ( F un k e , 2009 ) m a ki n g the E PSPS e n z y me

si g ni f i ca nt l y l e ss s e nsiti v e to the p re s e n c e of g l y p hos a te c omp a r e d to the n a tive f o r m ( s e e Stine

2011, S ec tion I V f or f u r t h e r d e t a ils of the ins e r t e d g e n e tic m a t er i a l a nd re s ulting p r ot e in

p r odu c t )

. T he e n g in e e re d c h a n g e d o e s not imp ac t the e ss e nti a l c e llul a r f un c t ions of the E PSPS

e n z y m e

, a nd t h er e is no e vid e n c e th a t the p r o t e in c ont r ibut e s to a n y c h a n g e s to the a g r onomic

p r op er ti e s, dis ea s e sus c e ptibili t y , or c omposition of H C E M485 c o r n c om p are d to oth e r

c omm erc i a l l y a v a il a ble c o r n ( s e e “ Pot e nti a l I m p a c ts of Ge n e tic Modi f i c a tions on A lt ere d

D is ea se a nd P e st Sus ce p t ibiliti e s” b e lo w)

. T he only e x p ec t e d di f fe r e n c e is the d e si re d c h a n g e in

s e nsitivi t y to the h er bi c i d e g l y pho s a t e

. GA 21 a nd its p r o g e n y

, c ont a ini n g a simil a r f o r m of

modi f i e d E PSPS, h a ve b ee n a v a il a ble a s non re g u l a t e d c o r n pl a nt v ar i e ti e s s in c e 1997, a lo n g side

oth e r v ar i e ti e s o f g l y pho s a te re sist a nt c o r n th a t a l s o e x p re ss g l y phos a te re s i st a nt v er sions of the

E PSPS e n z y m e (e

. g

. NK 603, M O N 88017, a nd M O N 802 )

. T he w i d e a nd s u cce ss f ul a d o ption of

th e se v e r y simil a r c o r n v ar i e ti e s e st a blish e s th a t e x t e nding a d e t er min a tion of nonr e g ul a t e d st a tus

to g l y phos a te r e sist a nt c o r n line H C E M485 is unlik e l y to p r e s e nt n e w p l a nt p e st r isk issu e s.

T he d a ta p r e s e nt e d in the submitt e d re qu e st a lso indi ca te no subst a ntive di f f ere n c e in

c omposition a l a nd nut r it i on a l or a nti

- nut r ition a l qu a lit y of H C E M485 c o r n t rea t e d w ith

g l y phos a te a t the no r m a l c omm erc i a l a ppli c a tion r a te c omp a r e d to oth e r c o mm erc i a l l y a v a il a ble

c o r n ( Stine 2011, Ta bl e s 12

- 20 )

. N one o f the v a l u e s f or the f o r a g e a nd g r a in c omposition

c h ar a c t er isti c s w er e outs i de the ra n ge of n a tu r a l v a r i a bili t y of c on v e ntion a l c o r n re p o r t e d b y the

I nt e r n a tion a l L i f e S c i e n c e s I nstitute C r op Composition Da t a b a se ( I L S I , 20 0 6 ) a nd/or in the

OE CD c ons e nsus do c u m e nt on c o r n c omposition ( OE C D , 2002 ) . Stine S e e d a lso e v a lu a t ed

l e v e ls of p h y tost e r ols, a c ommon c ompon e nt of pl a nts, a nd did not f ind signi f i ca nt di ff e re n c e s in

m ea n l e v e ls of tot a l p h y t ost er ols or individu a l ph y t ost er ols ( c hol e st er ol, c a mp e st er ol,

sti g m a st er ol, β

- sitost er ol, sti g m a st a nol) b e t w ee n g ra in s a mpl e s fr om H C E M485 a nd the

c ombin e d s a mpl e s of the c ont r ol h y b r ids. A lthough host pl a nt qu a li t y a nd c omposition is kno w n

to aff e c t h er bivo r e p e r f o r m a n c e a nd fec undit y ( A w m ac k a nd L e a th e r , 20 0 2 ) a nd s ec on d a r y

m e t a bolit e s in pl a nts ca n aff e c t d e f e nse a g a inst mi cr ob e s ( D i x on, 2001 ) , t h e simil a r

c omposition a l p r o f il e s b e t wee n H C E M485 a nd o t h e r c omm e r c i a l c o r n c ultiv ar s w ould sugg e st

th a t p e st popul a tions or in fe st a tions w ould not be e x p ec t e d to be a lt e r e d if a d e t er min a tion of

non r e g ul a t e d st a tus is e x t e nd e d to H C E M485. T h e c oll ec tive d a t a a nd the simil ar it y o f

H C E M485 to oth e r c omm erc i a l l y p r odu c e d c o r n in c luding GA 21, suppo r t the p e tition er’ s c l a im

th a t H C E M485 c o r n do e s not h a ve in cr e a s e d sus c e ptibili t y to a n y ins e c ts, pl a nt p a thog e ns, or

oth e r pl a nt p e sts.



### P o ten t i a l I m p a c t s o f Ge n et i c M o d i f i c a t io ns o n Al tered D is e as e a nd P e st

S u s ce p t i b i l i t i es

U S DA

- A P H I S a ss e ss e d w h e th e r H C E M485 c o r n is lik e l y to h a ve s i g ni f i c a nt l y in cr e a s e d dis e a se

a nd p e st c h a rac t er isti c s or sus ce ptibilit y c omp a re d to both nonre g ul a t e d G E c o r n line GA 21 a nd

non

- G E c ont r ol c o r n.

Co r n is not a pl a nt p e st in the U nit e d St a t e s (U S D A

- A P H I S, 2000 ). F u r th e r mo re , none o f the

ins er t e d g e n e tic s e qu e n ce s ar e d e r iv e d fr om a n y pl a nt p e sts list e d in 7 C F R p ar t 340.2

. T he

d e s cr iption of the g e n e tic m odi f i ca tion, in c luding the int r odu ce d g e n e tic e l e m e nts a nd the

r e sulting e x p re ssion a nd f un c tion of the modi f i e d E PSPS e n z y me in H C E M485 c o r n, h a s b ee n

summ a r i z e d a bov e . Stine S ee d c ond u c t e d a g r onomic f i e ld t r i a ls du r ing the 2007 g r o w ing

s e a son a c r oss 15 lo ca tions in 9 st a t e s, re p r e s e nt a tive of the m a jor c o r n

- g r o w ing ar e a s of t h e

U .S., to e v a lu a te h y b r i d s of H C E M485 in c omp a r ison to th re e c ont r ol h y b r ids d e r iv e d f r om the

s a me inb re d lin e s us e d to g e n era t e the H C E M485 h y b r ids. ( Stine 2011, p a g e s 23

- 43 ) . StineS ee d r outin e l y monito re d th e ir c o r n f i e ld t r i a ls f o r c o r n dis ea s e s su c h as South er n r ust dis ea s e

,

g ra y l ea f spot, N o r th er n m a i z e l ea f bli g ht, c ommon r ust a nd smut ( Stine 2011, p a ge 30 )

. T h er e

w e r e no m ea ni n g f ul di f fe re n ce s in a g r onomic c h a r a c t er isti c s th a t mi g ht be indi ca tive of a lt e r e d

s e n s itivit y to p e sts a nd dis e a s e s b e t wee n H C E M485 g l y p hos a te re sist a nt c o r n d er i v e d h y b r ids,

a nd the c ont r ol c ount er p ar ts l ac king t h e g l y pho s a te re sist a nt t ra it und e r st a nd ar d c o r n

m a n a g e m e nt p rac ti ce s a nd w ithout g l y phos a te t r ea tm e nt. C omp ar ison of dis ea se ra tin g s in one

o r mo r e of f our sit e s ( one eac h in I o wa

, Ne b ra sk a , Minn e sot a

, a nd I llinois) w h er e the

individu a l dis ea se in c id e n c e w a s su ff i c i e nt l y h i g h to w a rra nt a s s e ssm e n t did not show a n y

re m ar k a ble di f f ere n ce s b e t wee n the H C E M485 a n d c ont r ol h y b r ids. T he d a ta submitt e d b y

Stine S ee d c on f i r ms th a t the i n s er t e d g e n e tic m a t er i a l d i d not c on fe r a n y a lt e r e d dis ea se or p e st

sus ce ptibili t y to H C E M 4 85 c o r n.

I n summ a r y

, a ll e vid e n c e re vi ewe d b y A P H I S ind i ca te th a t a s w ith GA 21 c o r n, H C E M485 c o r n

is no mo r e sus ce ptible to pl a nt p a thog e ns a nd oth e r pl a nt p e st sp ec i e s th a n oth e r c omm e r c i a l l y

a v a il a ble c o r n, a nd th a t t h er e is no a d d e d pl a nt p e st r isk th a t re sults fr om the ins er tion a nd

e x p re ssion of the g e n e tic m a t er i a l d e s c r ib e d in the P e tition. I t th e ref o r e f ol l o w s th a t re l a tive to

oth e r c omm e r c i a l l y a v a i l a ble c o r n, in c ludi n g GA 2 1, th er e should be no ind i rec t pl a nt p e st e ff e c ts

on oth e r a g r i c ultu r a l p r o du c ts.



### P o ten t i a l I m p a c t s B as e d o n the R e l a t i v e Weed i n e s s o f H C E M 4 8 5 C o rn

Co r n is not t y pi c a l l y c o n sid ere d a s a wee d ( C r o c k e tt, 1977 ; H olm e t a l., 1979 ; Mu e ns c h er , 1980 )

a nd is not list e d on the F e d era l no x ious wee d list ( 7 C F R p ar t 360 ) . Co r n p oss e ss e s fe w o f the

c h ar a c t er isti c s of not a b l y su cce ss f ul w ee ds a nd is g r o w n a s a cr op th r o u g h o ut the w o r ld w ithout

a n y re po r t th a t it is a s er i ous wee d or th a t it f o r ms p er sist e nt fe r a l popul a tions ( B a k er , 1965 ;

Kee l er , 198 9 )

. H o w e v er

, as is the case with other crop cultivation, after harvest any seeds left in

the field ca n g er min a te and become volunteers during subsequent cropping seasons. A c o mmon

e x a mple of this is the a pp e a ra n c e of c o r n s e e dlin g s in s o y b ea n f i e lds f ollo w ing a c o r n c r op,

a sso c i a t e d w ith re d u c e d s o y b ea n y i e lds ( B e c k e tt a nd Stoll er , 1988 ) . Comp are d to oth e r c o r n

v ar i e ti e s, H C E M485 h a s imp r ov e d f itn e ss (re d u c e d inju r y ) in the p re s e n c e of g l y phos a te

h er bi c id e s, w hi c h t r a nsl a t e s into fewe r options f or t he re mov a l of volunt ee r pl a nts. N on e t h e l e ss,

simil a r to the a nt e c e d e nt GA 21 a nd ot h e r g l y p hos a te tol e ra nt c o r n v ar i e ti e s, th e r e a r e m a n y

a v a il a ble options f or the c ont r ol of H C E M485 pl a nts so th a t g r o w er s ca n a void loss e s in f i e lds

w h er e u n wa nt e d H C E M 485 mi g ht be g r o w i n g

.

A P H I S a s s e ss e d w h e t h e r H C E M485 c o r n is a n y mo r e lik e l y to b e c ome a wee d th a n a n y oth er

c o r n v ar i e ti e s c u r r e nt l y u nd e r c ultiv a tion. T his a s s e ssm e nt e n c omp a ss e s a tho r ou g h

c onsid era tion of the b a sic biolo g y of c o r n a nd a n e v a lu a tion of the unique c h ar a c t er isti c s of

H C E M485 c o r n e v a l u a t e d und e r f i e ld c onditions. Stine S ee d c ondu c t e d a g r onomic f i e ld t r i a ls

du r ing the 2007 g r o w i n g s ea son a c r oss 15 lo ca tio n s re p re s e nt a tive of the m a jor c o r n

- g r o w i n g

area s o f the U .S. ( Stine 2 011, p a g e s 25

- 30 a nd A n n e x 1 )

. T hou g h not a ll t r a its wer e a ss e s s e d at

a ll lo ca tions, up to 17 di ffere nt a g r onomic c h ar a c t er isti c s we r e a ss e ss e d, i n c luding the p er c e nt of

b arre n p l a nts, p er c e nt d r o pp e d ear s, ear l y g r o w th r a tin g

, e ar l y st a nd c ount, s ee dling v i g o r

, e a r

h e i g ht, e ar l y r oot lo d g i n g, g r a in moistu r e p e r ce nt, f in a l st a nd c ount, h ea t u n its to 50% poll e n

sh e d, h ea t units to 50% silkin g , l ea f c olor r a tin g s, pl a nt h e i g ht, r oot lo d g i n g ra tin g , st a lk lo d g i n g

ra

tin g

, g ra in we i g ht, a nd g r a in y i e ld. N o di ff e re n c e s in ph e no t y pic c h a rac t e r isti c s th a t w ould

c ont r ibute to e nh a n c e d w ee din e ss w e r e obs e r v e d b e t wee n H C E M485 c o r n a nd c ont r ol lin e s f or

the ra n g e o f ph e no t y pic e ndpoints a ss e ss e d. T h e r e wer e some st a tisti ca l l y s i g ni f i c a nt di ff e re n c es

b e t wee n fr om H C E M485 c o r n a n d c ont r ol c ount er p ar ts. T he si g ni f i c a nt di ffere n ce s th a t w er e

s e e n in ea r h e i g ht, pl a nt h e i ght, h ea t units to 50% silk i n g , h e a t units to 50% poll e n sh e d, g ra iny i e ld, a nd f in a l st a nd c ount a r e ac tu a l l y re p re s e nt a tive o f v e r y sm a ll di ffere n ce s, c omp are d to the

ov era ll r a n g e of c o r n, a nd th e se di f f ere n ce s did not a pp ea r both g e no t y p e sp ec i f i c a nd c o nsist e nt

acr oss t e st e d f i e l d lo ca tions ( Stine 2011, p a g e s 28

- 30 a nd A nn e x 1 )

.

B a s e d on t h e a g r onomic f i e ld d a ta a nd lit e r a tu r e s u r v e y a bout c o r n w e e din e ss pot e nti a l,

H C E M485 c o r n l ac ks the a bili t y to p er sist a s a t r o ubl e some or inv a sive w e e d. Still, b eca use

H C E M485 c o r n mi g ht g r ow in area s w h e r e it is und e si re d, the G E c o r n, simil a r to oth e r c o r n

v ar i e ti e s, w ould be c onsid ere d a wee d ( B ec k e tt a n d Stoll er , 1988 )

. B e c a u s e the g e n e tic e l e m e nts

ins er t e d into H C E M485 c o r n c on f er s g r ea t e r re si s t a n c e to g l y phos a te h e r b i c id e s the m ea su r es

th a t ca n be us e d to re m o ve volunt ee r H C E M485 c o r n a r e mo r e limit e d c o mp are d to oth e r

g l y phos a t e

- s e nsitive c o r n v ar i e ti e s. N on e t h e l e ss, a s dis c uss e d in the n e x t p ar a g ra ph, most of the

c u rre nt l y us e d c ont r ol m ea su re s f or r e moving vo l unt ee r c o r n a r e a lso a v a il a ble f or the re mov a l of

H C E M485 c o r n. F u r th e r mo re , simil a r g l y phos a t e re sist a nt c o r n pl a nts, su c h a s GA 21 a nd its

p r og e n y

, a r e a l r ea d y w i d e l y dist r ibut e d f o r a g r i c u l tu ra l p r odu c tion a nd g r o wer s a r e f a mili a r w ith

p r o ce du r e s f or re movi n g a n y u n wa nt e d c o r n th a t i s g l y phos a te re sist a nt.

Co r n is c ommon l y g r o w n in r ot a tion w ith oth e r c r op v ar i e ti e s in c ludi n g

, b ut not n ece ss ar i l y

limit e d to, o a ts, f o ra ge c r ops, p ea nut, w h e a t, r y e

, c otton, a nd s o y b e a n. Co r n s ee d l ef t in a f i e ld

af

t e r h ar v e st is c ommon, a nd th a t s ee d c a n g e r min a t e , or “ volunt e er ,” d u r ing the cultivation of

the f ollo w ing r ot a tion a l cr o p

. I f volunteer c o r n is not d e st r o y e d o r re mo v e d, the sub s e qu e nt cr op

pl a nti n g m a y h a ve lo w e r y i e lds a n d re du ce d v a lue due to c omp e tition a nd m i x ing w ith the

volunt ee r s ( B e c k e tt a nd Stoll er , 19 8 8 ; B ec kie a nd O w e n, 20 0 7 )

. T he a d v e nt a nd w ide a doption of

h er bi c ide re sist a nt cr ops h a ve a l rea d y c h a n g e d the a pp r o a c h e s g r o w er s c a n a dopt to re du c e cr op

y i e ld loss e s

7re sulting f r om volunt ee r c o r n. F o r e x a mpl e

, g l y p hos a t e

- re sist a nt s o y b e a n pl a nts, g r o w n af t e r

g l y phos a t e

- re sist a nt c o r n

, ca n h a v e re d u c tions in s o y b e a n y i e ld, due to c o m p e tition w ith

volunt ee r c o r n, if g l y ph o s a te is the on l y w ee d c o n t r ol m e thod us e d ( Solt a ni e t a l., 2006 ) . Simil a r

studi e s h a ve a lso b ee n d o ne f or c o r n

- c otton r ot a ti o ns ( T hom a s e t a l., 2007 ; Cl ew is e t a l., 2008 )

a nd c o r n

- w h ea t r o t a tions ( M ar tin, 2008 ) . Simil a r to oth e r c o r n v ar i e ti e s, in c luding the GA 21

a nt ece d e nt, H C E M485 pl a nts or s ee d l e f t in a f i e ld af t e r h ar v e st m a y b e c o n sid ere d a w ee d w h en

p re s e nt du r i n g the subs e q u e nt pl a nting of oth e r cr o ps, in c luding r ot a tion a l c r ops su c h a s s o y b e a n.

W h e n this o cc u r s, far m er s h a ve the option to use o th e r h er bi c i d e s to c ont r ol the volunt ee r pl a nts

( Dee n e t a l., 2006 ; Solt a ni e t a l., 2006 ; T hom a s e t a l., 2007 ; W SS A , 2007 ; Cl ew is e t a l., 2008 )

. U se of a n y h er bi c ide f or the c ont r ol of volunt ee r H C E M485 c o r n is subj e c t to a n y l a b e ling

re st r i c tions e st a blish e d b y the E P A

, a s p e r F I F R A

. A ddition a l l y , th er e a r e a lso m a n y non

c h e mi ca l m e thods of w e e d c ont r ol ( tillin g , m ec h a n i ca l re mov a l, e t c .) th a t ar e ef f ec tive f o r

re moving a n y un wa nt e d H C E M485 c o r n.

I n summ a r y

, A P H I S f o u nd th a t H C E M485 is no mo r e lik e l y th a n t h e a nt e ce d e nt GA 21 c o r n or the

control to b ec ome a t r oub l e some w ee d or p r e s e nt w e e d m a n a g e m e nt issu e s.



### P o ten t i a l I m p a c t s f r o m O u tcr o ss i ng ( G e ne F l o w ) t o Se x u a l l y

- c o m p a t i b l e W i ld

R e la t i v es

Ge ne f low is a n a tu ra l b i olo g i ca l p r o ce ss w ith s i gni f i ca nt e volution a r y impo r t a n ce . A num b e r of

a n g iosp e r m t a x a ar e b e li e v e d to be d e r iv e d fr om h y b r idi z a tion or int r og re s sion b e t wee n c los e l y

re l a t e d t a x a ( G r a nt, 198 1 ; Soltis a nd S o ltis, 1993 ; Ri e s e b e r g , 1997 ; H e g d e e t a l., 2006 ). E v e n in

e x isting f lo ra s, the o cc u r r e n c e of h y b r idi z a tion or int r o g r e ssion is re po r t e d t o be w id e sp r e a d

( K noblo c h, 1972 ; St ace

, 1987 ; Ri e s e b e r g a nd We nd e l, 1993 )

. I t h a s b e e n a c ommon p rac ti c e b y

pl a nt b ree d e r s to ar ti f i c i a l l y int r og re ss t ra its f r om w ild re l a tiv e s into cr op p l a nts to d e v e lop n e w

c ultiv ar s. H o we v er

, g e n e f low fr om cr ops to w ild re l a tiv e s is a lso thou g ht o f a s h a vi n g a

pot e nti a l to e nh a n c e the wee din e ss of w ild re l a ti v e s, a s obs er v e d in r i ce , s o r g hum, sun f lo w er

,

a nd oth e r c r ops ( E llst ra n d e t a l., 1999 )

.

Co r n is a mono ec ious sp ec i e s w ith s e p a ra te m a l e a nd fe m a le i n f lo re s c e n c e s th a t e n a ble c r oss

pollin a tion. Co r n is p re domin a nt l y a w ind pollin a t e d out cr oss e r w ith o c ca s ion a l b e e visit a tion f or

poll e n. B ee s ra r e l y visit fe m a le in f lo re s ce n c e s ( si l k ) . R e s ea r c h er s rec o g ni z e th a t: ( i) the p e r ce nt

g e n e f low w ill v a r y b y p opul a tion, h y b r id or inb r e d, ( ii) the l e v e l of g e ne f low d ecr e a s e s w ith

g r ea t e r dist a n c e b e t wee n the sou rc e a nd r e c ipi e nt pl a nts; ( iii) e nvi r onm e nt a l fac to r s a ff e c t the

l e v e l of g e ne f lo w

, ( iv) c o r n poll e n is vi a ble f or a re l a tiv e l y sho r t p er iod of time und e r f i e ld

c onditions, ( v) c o r n p r o d u ce s a mple poll e n ov e r a n e x t e nd e d p er iod of tim e

, a nd ( vi) c o r n is not

pollin a t e d b y ins ec ts ( po l lin a ting ins ec ts, e sp e c i a l l y b e e s, a r e o c ca sion a l vi s ito r s to the t a ss e ls but

rare l y visit silks of c o r n) ( L u n a , 2001 ; J e mison a nd V a y d a , 2002 )

.

A P H I S e v a lu a t e d the po t e nti a l f or g e n e int r og re s s ion to o cc ur fr om H C E M 485 c o r n to s e x u a l l y

c omp a tible w ild re l a tiv e s a nd c onsid e r e d w h e th e r su c h int r og re ssion w ould re sult in in crea s e d

wee din e ss. Cultiv a t e d c o r n, or m a i z e

, Z e a m a y s L

. subsp. m a y s , is s e x u a l l y c omp a tible w ith

oth e r m e mb er s of t h e g e n us Z e a with a few exceptions (Kermicle, 1997)

, a nd to a mu c h l e s s e r

d e g r e e w ith m e mb e r s of the g e nus Tripsa c um ( OE C D , 2003 )

. W ild diploid a nd t e t ra ploid

m e mb er s of Z e a, c o l l ec tiv e l y re f er r e d to

8a s t e osint e

, ar e n o r m a l l y c on f in e d to the t r opi c a l a nd subt r opi ca l r e g ions of M e x i c o, G u a t e m a l a

,

a nd N i ca ra g ua ( W ilk e s, 1967 ; F u k una g a , 2005 )

. T e osinte do e s not a pp e a r t o be p re s e nt in the

U .S. oth e r th a n a s a n o c c a sion a l bot a ni ca l g a r d e n or re s e arc h s p ec im e n. A l thou g h the Pl a nts

P r o f ile f or Z. mex i c ana ( http://pl a nts.usd a

. g ov/j a v a /p r o f il e ? s y mbol

= Z E ME ) in the P L A N T S

Da t a b a se ( U S DA

- N RCS, 2012 ) sho w s dist r ibutions in South C ar olin a

, A l a b a m a , M a r y l a nd, a nd

F lo r id a , the c it e d s p ec i e s acc ount ( W und er lin e t a l., 1996 ; W und er lin a nd Ha ns e n, 2002 ) as

upd a t e d ( W und er lin a nd Ha ns e n, 2008b ) on l y sh o w s dist r ibution of n a tive or n a tu ra li z e d

popul a tions in F lo r ida ( Mi a mi

- Da d e

, O ra n g e a n d L e v y Counti e s )

. T h e c it a tion f or this

dist r ibution, ho we v er , links to a U niv er sit y o f F lo r ida Her b a r ium Coll ec tions C a t a log a c c e ssion

numb e r 191119 th a t lists the sp ec im e n a s c ultiv a t e d a t a U S D A Soil Cons er v a tion S er vi c e Pl a nt

M a t er i a ls C e nt e r in H er a n a ndo Coun t y a nd c oll e c t e d in Oc tob e r 21, 1993. Cont ra r y to the Pl a nts

P r o f ile f or Z. mex i c ana , it is not list e d in the c it a t i on p r ovid e d f or dist r ibution in M a r y l a nd

( B r o w n a nd B r o w n, 198 4 )

, nor a r e a n y Z e a sp e c i e s or subsp ec i e s oth e r th a n Z. m a y s (c o r n) list e d

in A l a b a ma ( K ra l e t a l., 2 012 ). T he sp e c i e s a c c o u nt in the P L ANT S Da t a b a se ( U S D A

- N RCS,

2012 ) wr itt e n b y H u g h I l tis f or Z e a p e r e nnis

( s e e http://h er b ar ium.usu. e du/ we bm a nu a l/in f o2. a sp ? n a m e = Z ea

_ p e r e nnis & t y p e = t rea tm e nt

,

a c c e ss ed 6/4/2012) d e s cr ib e s it a s cr ossing in f re q u e nt l y w ith Z. m a y s subsp. m a y s , but the

h y b r ids, b e i n g t r iploid, ar e st er il e

. W hile it is d e s cr ib e d a s h a ving b e e n c ultiv a t e d a t re s ea rc h

st a tions in the U nit e d St a t e s f or m a n y y ear s, a nd H it c h c o c k ( H it c h c o c k, 1951 ) r e po r t e d t h a t it

wa s e st a blish e d at J a m e s I sl a nd, South C ar olin a , it is not kno w n if the popul a tion h a s p er si s t e d.

T h er e ar e no Z ea sp ec i e s oth e r th a n Z e a m a y s (c o r n ) f ound in the c omp re h e nsive online So u th

C ar olina Pl a nt A tl a s host e d b y the U niv er sit y of South C ar olina A .C. Moo r e H e r b ar ium a nd t h e

South C ar olina Her it a g e T r ust ( South C ar olina Her it a ge Tr ust, 2 0 11 )(a v a il a b l e

at http://h er b ar ium.biol.s c

. e du/s c pl a nt a tl a s.html

, ac c e ss e d J une 11, 2012 ) ; the a bs e n c e o f Z ea

p e r e nnis wa s c o n f i r m e d w ith h er b ar ium c u r a to r s ( Ne lson a nd Da m r e l, 20 1 2 )

. I sol a t e d pl a nts of

t e osinte id e nti f i e d a s Z e a m a y s ssp par v iglu m is v a r

. par v iglu m is wer e c oll e c t e d in 1975 in

Mi a mi

- Da de Coun t y

, F l o r ida ( F L A S a c ce ssion n u mb er s 121428

- 121430) ( W und er lin a nd

Ha ns e n, 2008 a ) in a n a r e a th a t is now u r b a n, a nd Z. lu x urians h a s b ee n re p o r t e d a s c ultiv a t e d a s a

f odd e r in t r opi ca l F lo r ida in the ear l y 1900s ( T a b a

, 1995 )

. E x p er ts fa mili a r w ith the t e osinte

c oll ec tions in the U nit e d St a t e s (T . Cho c h ra n e

, U n iv er sit y of W is c onsin

- M a dison Her b ar ium; M.

B ar k w o r th, U t a h St a te U niv er si t y ; a nd J

. D o e bl e y

, a nd H

. I ltis, U niv er sit y of W is c onsin,

p er son a l c ommuni ca tion, J un e , 2012) ( B ar k w o r th, 2012 ; Co c h ra n e , 2012 ) s ome of w hom a r e

c u rre nt l y involv e d w ith r e vision of the M anual of G rass e s for North Ame ri c a, ar e not aw a r e of

a n y n a tu ra li z e d or n a tive popul a tions of t e osinte c u rre nt l y g r o w i n g in the U nit e d St a t e s.

T he g e nus Tripsa c um c o nt a ins up to 16 rec o g ni z e d sp ec i e s, most of w hi c h ar e n a tive to M e x i c o,

C e nt ra l a nd South A m er i ca , but th re e ( T. da c t y lo i d e s, T. floridatu m

, a nd T. lan ce olatu m ) e x ist as

w ild a nd/or c ultiv a t e d s p ec i e s in the c ontin e nt a l U .S. ( OE C D , 2003 )

, a nd t w o t a x a ( T.

fas c i c ulatum a nd T. latif o liu m ) a lso o cc ur in Pu er t o Ri c o) ( U S DA

- N RCS, 2011 )

. T hou g h m a n y

of th e se sp ec i e s o cc u r w h er e c o r n mi g ht b e c ultiv a t e d, g e ne int r o g r e ssion f r om H C E M485 c o r n

und e r n a tu r a l c onditions is hi g h l y unlik e l y

. I n c o n t ra st w ith c o r n a nd t e osi n t e

, w hi c h m a y

h y b r idi z e re l a tiv e l y ea si l y und e r c e r t a in c onditio n s, sp ec i a l t ec hniqu e s ar e re qui re d to h y b r idi z e

c o r n a nd Tripsa c um th e r e b y m a king h y b r ids of Tripsa c um sp ec i e s w ith Z e a di ff i c ult to obt a in

outside of a l a bo ra t o r y ; a nd o ff sp r i n g a r e o f t e n st e r ile or h a ve g rea t l y r e du c e d fer tili t y

, a nd a r e

un a ble to w ithst a nd e v e n mild w int e r c onditions ( M a ng e lsdo rf , 1974 ; Russ e ll a nd Ha ll a u e r

,

91980 ; Ga lin a t, 1988 )

. F u r th er mo re , no n e of the s e x u a l l y c om p a tible re l a ti v e s of c o r n in the U .S.

ar e c onsi d ere d to be we e ds in the U .S. ( H olm e t a l., 1979 )

.

I nt r o g re ssion of g e n e s f r om c o r n into t e osinte or Tripsa c um sp ec i e s in the U .S. h a s not b ee n

d e s cr ib e d to o c c ur in n a t u re

. W hile some t e osinte m a y b e c onsid e r e d w e e d s in cer t a in inst a n ce s,

th e y ar e a lso us e d b y s o me far m e r s f or b r ee di n g i mp r ov e d c o r n ( S ánchez a nd R u i z , 1997 )

. Te osinte is d e s cr ib e d a s b e ing sus c e ptible to m a n y of the s a me p e sts a nd d is ea s e s th a t a tt ack

c ultiv a t e d c o r n. I n t h e w i ld, int r o g re ssive h y b r idi z a tion fr om c o r n to t e osin t e is c u rre nt l y limit e d

b y s e v era l f ac to r s in c lud i ng g e o g ra phic isol a tion, di ffer i n g d e g ree s o f g e n e tic in c omp a tibili t y

, di ffere n ce s in f lo w er i n g t im e , d e v e lopm e nt a l mo r pholo g y , diss e min a tion, a nd do r m a n c y

( Ga lin a t, 1988 ; D o e bl e y

, 1990 a ; D o e bl e y , 1990b ; E llst ra nd e t a l., 2007 )

. F i r st

- g e n e r a tion h y b r ids

ar e g e n e r a l l y l e ss f it f o r s u r viv a l a nd diss e min a tion in the w ild, a nd show subst a nti a l l y re d u ce d

re p r odu c tive ca p ac i t y

, w hi c h s er v e s a s a s i g ni f i c a nt c onst ra int to int r o g r e ssion. G u a d a g nuolo e t

a l. ( 2006 ) did re p o r t th a t h y b r ids b e t w ee n a g l y p h os a t e

- re sist a nt m a i z e c ul t iv a r a nd “ c h a l co

t e osint e ” ( Z. m a y s ssp. m ex i c ana ) sho w e d g r ea t e r vi g or a nd p r odu c e d mo r e s ee ds th a n the w ild

p are nt. N on e t h e l e ss, in the a bs e n c e of s e l ec tive p re ssu r e fr om g l y phos a te t h er e w a s no di rec t

positive or n e g a tive imp a c t of the t ra n s g e n e on the f itn e ss or vi g o r of e ith e r the h y b r ids o r the

pu r e m a i z e p r o g e n y

. T h er e h a v e b e e n no re p o r ts th a t the w id e sp r e a d c ultiv a tion of g l y phos a t e

re sist a nt c o r n in the U nit e d St a t e s h a s re sult e d in t he int r og re ssion of the e n g in e ere d t r a it into

re l a t e d sp e c i e s in the f i e l d; no re l a t e d sp e c i e s a r e l ist e d a s g l y phos a te re sis t a nt ( Hea p, 2 0 12 )

.

Da ta in c lud e d in the P e tition ( Stine 2011, p a g e 31, Ta ble 11 a nd F i g u r e 12) d e monst ra t e d th a t

th er e w e r e no dis c er nible di ffere n ce s b e t wee n H C E M485 c o r n a nd c ont r ol c o r n in the a bs e n c e of

g l y phos a te t r ea tm e nt in t er ms of m ea n poll e n di a m e t e r a nd ov e ra ll poll e n mo r pholo g y

. T he

p e tition e r did f ind a st a tisti ca l di ffe r e n c e in poll e n vi a bili t y b e t w e e n H C E M485 a nd c ont r ol

pl a nts, thou g h the v a lu e s f or both c o r n v ar i e ti e s w er e still w ithin the no r m a l ra nge of c o r n poll e n

ref e re n c e s a mpl e s a nd t h e out

- cr ossi n g r a te of H C E M485 c o r n w ill lik ew ise not be di ff e re nt

c omp are d to oth e r c o r n v ar i e ti e s. B a s e d on the d a t a p re s e n t e d in the P e tition, H C E M485 c o r n

do e s not e x hibit c h arac t e r isti c s th a t ca use it to be a n y wee d i e r th a n oth e r c ultiv a t e d c o r n; a nd the

e x t re m e l y limit e d pot e nti a l f or g e n e int r og re ssion fr om H C E M485 c o r n in t o t e osinte or

Tripsa c um sp ec i e s is not e x p ec t e d to be a n y di f f e r e nt th a n th a t of oth e r c ultiv a t e d c o r n v a r i e ti e s.

E v e n in the unlik e l y e v e n t th a t g e n e f low w e r e to o cc ur b e t w ee n H C E M485 c o r n a nd w ild

re l a tiv e s, th e r e is no rea s on to e x p ec t th a t the possible e x p re ssion of modi f i e d E PSPS w ould

t ra ns f o r m c o r n w ild re l a t iv e s into mo r e wee d y sp e c i e s, e sp e c i a l l y in the a b s e n c e of h er bi c i d e

s e l ec tion p re ssu r e

. H y b r i ds, if th e y o cc u r re d, c ou l d possib l y h a ve diminish e d sus ce ptibilit y to

g l y phos a te h er bi c id e s if the g e ne e n c odi n g the d o uble mut a t e d 2m E PSPS i s inh er it e d a nd

e x p re ss e d in the h y b r id, but the h y b r ids w ould still be sus ce ptible to m a n y oth e r h er bi c i d e s, a s is

H C E M485, a nd a s a r e t h e m a n y oth e r g l y phos a te re sist a nt c o r n v a r i e ti e s t h a t h a ve b e e n a v a il a ble

f or a pp r o x im a t e l y 15 y ea r s.

I n summ a r y

, H C E M485 c o r n, like the a nt e ce d e nt G 21 or the control corn

, w ill not a dv er s e l y

i mp ac t s e x u a l l y c omp a tible w ild re l a tiv e s or the wee di n e ss a tt r ibut e s of those w ild re l a tiv e s.

10

### P o ten t i a l I m p a c t s o f H C E M 4 8 5 o n Non

- target Or ga n is m s C o n si d ered

B e n ef i c i a l t o A g r i c u l t u re

H C E M485 is a g r onomi c a l l y a nd c omposition a l l y simil a r to GA 21 a nd oth e r c o r n v a r i e ti e s in

c omm erc i a l p r od u c tion a nd th eref o r e w ill not a d v er s e l y a f f e c t oth e r o r g a nisms in a n y n e w o r

nov e l w a y

. I n p ar ti c ul a r

, w ith re sp ec t to the s e c o nd a r y m e t a bolit e s a nd a n tinut r i e nts (fer ulic

ac id, ρ

- c oum a r ic a c id, f u rf u ra l, inositol, p h y tic ac i d, raff inose a nd t r y psin inhibito r ) a n a l y z e d in

g r a in s a mpl e s fr om H C E M485 a nd c ont r ol h y b r i d s ( Stine 2011, Ta ble 19, p a ge 41 ) , the on l y

si g ni f i ca nt di f fe r e n c e no t e d wa s a sm a ll in c r ea s e ( c a. 3.4 % ) in t r y psin p r ot e a se inhibitor in

H C E M485 g r a in s a mpl e s , but this di ffere n c e wa s not c onsist e nt acr oss a ll g r o w ing l o ca tions

a nd the l e v e l is we ll w ithin the ra n g e re po r t e d in the lit era tu r e f or c o r n. A P H I S h a s f ound no

e vid e n c e o r r e a son to b e l i e ve th a t a n y di f f ere n ce s b e t wee n H C E M485 a nd GA 21, or b e t w ee n

H C E M485 a nd oth e r c o r n v ar i e ti e s, in e ith e r the g e n e tic m a t er i a l p re s e nt or the p r ot e ins

p r odu ce d, w ould h a ve a n y imp ac t on oth e r o r g a ni s ms, in c luding o r g a nisms b e n ef i c i a l to

a g r i c ultu r e ( s u c h a s e ar t h w o r ms, hon e y b ee s, p re d a to r s or p ara sit e s o f c o r n p e sts )

. T he E PSPS

p r ot e in is e x p re ss e d in a v ar i e t y of pl a nt tissu e s in c o r n, a nd e x p re ssion of 2m E PS P S in

H C E M485 c o r n is e x p ec t e d to be e x p re ss e d in the s a me tissu e s sin c e it is d r iv e n b y the s a me

r e g ul a to r y s e q u e n ce s a s the n a tive g l y phos a t e

- s e n sitive E PS P S g e n e

. L imit e d d a ta fr om

w e st er n blot a n a l y sis p r ovid e d in the p e tition ( Stine 2011, F i g u r e 8, p a g e 20) d e monst ra t e d th a t

the l e v el of e x p re ssion of 2m E P S PS in l ea f a nd s ee d of H C E M485 is l e ss th a n th a t obs er v e d in

the a nt ece d e nt o r g a nism G A 21. T he ins er t e d g e n e tic m a t er i a l is not s ec r e t e d, is not toxi c

, a nd

do e s not p r odu c e a n y subst a n c e th a t is s ecre t e d or th a t w ould be c onsid e r e d to x i c

. T he s a f e t y of

modi f i e d E PSPS p r ot e ins fr om both pl a nt a nd b ac t er i a l sou r c e s h a s b e e n p r e vious l y a d d re ss e d

in oth e r p e titions f or d e re g u l a tion (e

. g . Mon s a nto submitt e d p e titions 97

- 099

- 01p f or GA 21

c o r n a nd 00

- 011

- 01p f o r NK 6 03 c o r n) a nd b y t h e OE C D ( 1999 ))

. T h e E PSPS p r ot e in, both

modi f i e d a nd unmodi f i e d, do e s not sh ar e m e a ning f ul a mino ac id s e qu e n c e simil ar iti e s w ith

kno w n to x i n s a nd is a l rea d y p re s e nt in a l a r g e p o r tion of c o r n t h a t is p re s e nt in the f ood s upp l y

c h a in.



### Potential Impacts of Associated Changes in Agricultural Practices on Plant

Pests

APHIS evaluated whether the genetic modification causes changes in agricultural practices that

affect the incidence, severity or control of plant pests. Considering that glyphosate resistant corn

already has achieved a wide

- adoption rate among U.S. growers , (approximately 66% of corn

acres were treated with glyphosate in 2010, per http://quickstats.nass.usda.gov/, accessed June

2011) and that HCEM485 will be grown in a similar manner to other glyphosate resistant corn,

with the same glyphosate application r ates, it can be concluded that there will not be any

significant changes in agricultural practices if a determination of nonregulated status is extended

to HCEM485. While growers may opt for different corn varieties to meet their anticipated needs,

the ava ilability of HCEM485 will not alter current or future methods that growers use to produce

corn nor any of the methods used to minimize the damage caused by any plant pests. The

methods applicable to production of GA21 corn are expected to be applicable to HCEM485

corn.

11

### P o ten t i a l to T r a n s f e r Gene t i c I n f o r m a t i o n f r o m H C E M 48 5 C o rn

to Or g a n i s m s wi th w h i ch i t c a n n o t I n t erb r eed

A P H I S e x a min e d the po t e nti a l f or the g e n e tic m a t er i a l ins er t e d into H C E M 485 c o r n to be

ho r i z ont a l l y t r a ns f e rre d t o oth e r o r g a nisms w ithout s e x u a l re p r odu c tion a nd w h e th e r su c h a n

e v e nt c ould l ea d di r ec t l y or indi rec t l y to dis ea s e

, d a m a g e , inju r y or h ar m to pl a nts, in c luding

the crea tion of mo r e vi r ul e nt pl a nt p e sts. T he ho r i z ont a l g e ne t ra n s fe r (HGT ) b e t wee n unr e l a t ed

o r g a nisms is one of the most int e nsiv e l y studi e d f i e lds in the bio

- s c i e n c e s sin c e 1940, a nd the

issue g a i n e d e x t r a a tt e ntion w ith the re l ea s e of t r a ns g e nic p l a nts into the e n vi r onm e nt ( Dr ö g e et

a l., 1998 ) . Pot e nti a l r isks fr om st a ble HG T fr om g e n e ti ca l l y e n g in e ere d o r g a nisms to a noth e r

o r g a nism w ithout re p r o d u c tion or hum a n int er v e n tion wa s re c e nt l y r e vi e w e d ( K e e s e , 2008 )

. M ec h a nisms of HG T i n c lude c onj u g a tion, t ra ns f o r m a tion a nd t ra nsdu c tion, a nd oth e r div er s e

m ec h a nisms of DN A a nd R N A upt a k e

, r e c ombin a tion, a nd rea r ra n g e m e nt, th a t o cc ur most

not a b l y th r o u g h vi r us e s a nd mobile g e n e tic e l e m e nts. HG T h a s b ee n impli ca t e d a s a c ont r ibutor

to m a jor t ra nsitions in e volution, in c luding the sp r ea d of a ntibiotic r e sist a n c e a mo n g st

p a thog e nic b a c t er ia a nd the e m e r g e n c e o f in c r ea s e d vi r ul e n c e in b a c t er i a

, e uk a r y ot e s, a nd

vi

r us e s.

P o t e n t ial f or Ho r i z on t al G e ne T r ans f e r t o Ba c t e r ia or F ungi

HG T fr om a p l a nt sp ec i e s to oth e r b ac t er i a l sp ec i e s is unlik e l y to o cc ur b a s e d on the f ollo w ing

obs er v a tions. A lthou g h t h er e a r e m a n y opp o r tuniti e s f or pl a nts to di rec t l y i nt erac t w ith f u n g i

a nd b ac t er ia (e

. g

. a s c omm e n s a ls, s y mbionts, p ara sit e s , p a thog e ns, d ec ompos er s, or in the g uts

of h er bivo re s ) , t h er e ar e a l most no e volution a r y e x a mpl e s of HG T to b ac t e r ia fr om e uk a r y o t e s

or fr om pl a nts to f un g i ( a s r e vi ewe d in K ee se 200 8 )

. T he on l y g e n e s lik e l y to be t ra ns f e rre d

su cce ss f ul l y fr om g e n e ti c a l l y e n g i n ee r e d pl a nts to b ac t er ia a r e oth e r b a c t er i a l g e n e s. H o r i z ont a l

t ra ns fe r o f the g e n e c ons t r u c t fr om the nu c l ea r g e n ome of H C E M485 c o r n a nd subs e qu e nt

e x p re ssion in b ac t er ia is unlik e l y to o cc u r

. F i r st, m a n y g e nom e s ( or p ar ts th ere o f ) h a ve b een

s e qu e n ce d fr om b a c t er ia th a t ar e c lo s e l y a sso c i a t e d w ith pl a nts in c luding A groba c t e rium a nd

Rhi z obi u m ( Ka n e ko e t a l ., 2000 ; W ood e t a l., 2001 ; Ka n e ko, 2002 )

. T h er e is no e vid e n c e th at

th e se o r g a nisms c ont a in g e n e s d er i v e d fr om pl a n t s. S ec ond, in ca s e s w h er e re vi e w of s e qu e n ce

d a ta impli e d th a t HG T o c c u rre d, t h e se e v e nts ar e i n fer r e d to o cc u r on a n e v olution a r y time s c a le

on the o r d e r o f millions o f y e ar s ( K oonin e t a l., 2 0 01 ; B r o w n, 2003 )

. T h i r d, the 6000

- b a se p a ir

ins er tion m a de to c on f e r the h er bi c ide re sist a n c e to H C E M485 c o r n is a sm a ll frac tion of a

p erce nt (a pp r o x im a t e l y 0 .00024 % ) of the tot a l D N A (a pp r o x im a t e l y 2500 million b a se p a i r s)

f ound in the c o r n g e no m e

, a nd a ll of the 6000 b a s e p a i r s w e r e d e r iv e d di r e c t l y f r om the c o r n

g e no m e

. F o r th, t ra n s g e ne DN A p r omot er s a nd c o d ing s e qu e n ce s ar e optimi z e d f or pl a nt

e x p re ssion, not p r ok a r y otic b ac t er i a l e x p re ssion so e v e n if HG T o cc u rre d, p r ot e ins

c o rre spondi n g to the t r a n s g e n e s a r e not lik e l y to b e p r odu ce d. F in a l l y , the F D A e v a lu a t e d H GT

fr om the use of a ntibiotic re sist a n c e m a r k e r g e n e s a nd c on c lud e d t h a t the lik e lihood of t ra ns f e r

of a ntibiotic re sist a n c e g e n e s fr om pl a nt g e nom e s to mi cr oo r g a nisms in the g a st r oint e stin a l t rac t

of hum a ns or a nim a ls, or in the e nvi r onm e nt, is re m o te ( F D A , 1998 )

.

P o t e n t ial f or Ho r i z on t al G e ne T r ans f e r t o V i r us es

A P H I S a lso c onsi d ere d w h e th e r ho r i z ont a l t ra ns f e r of D N A fr om H C E M 4 85 c o r n to pl a nt

vi

r us e s wa s lik e l y to o c c ur a nd w ould l ea d to the crea tion or s e l ec tion of a mo r e vi r ul e nt pl a nt

12p a thog e n th r o u g h r e c o m bin a tion w ith oth e r pl a nt vi r us e s. T his issue h a s b ee n c onsid e re d

b e f o r e b y oth e r s c i e n c e re v i e w p a n e ls a nd g ov e r nm e nt r e g ul a to r y bodi e s (f or a g e n era l r e vi e w

of the issue s e e ( K ee se 200 8 )

. B e c a use th e r e a r e no vi r u s s e qu e n ce s u s e d a s p a r t of the ins er t e d

g e n e ca ss e tte a nd no s e qu e n ce s th a t h a ve b ee n impli ca t e d in vi ra l r e c ombin a tion or

p a th o g e ni c i t y , th er e is no r e a son to think th a t vi ra l rec ombin a ti o n of the h er bi c i d e

- r e sist a n c e

c on f err i n g g e n e tic m a t er i a l w ill o cc u r

, o r th a t su c h th e o re ti c a l r e c ombin a tion w ould h a ve a n y

imp ac t on pl a nt p e st r isk.

P o t e n t ial f or Ho r i z on t al G e ne T r ans f e r t o P a r a si t ic P lan t s

R ece nt l y

, Y oshida e t a l. ( 2010 ) th r ou g h a c omp a r a tive g e nomi c s a n a l y sis impli ca t e d HG T f or

t h e in c o r po ra tion of a s p ec i f i c g e n e tic s e q u e n c e in the p ara sitic pl a nt pu r ple w it c h wee d ( Striga

h e r m onthi c a )

, w hi c h in fe sts cerea l f i e lds ( mono c o ts) in c luding c o r n a nd so r g hum ( Sorghum

bi c olor )

. Acc o r ding to t h is stu d y , t h e in c o r po r a tion of the sp ec i f ic g e n e tic s e qu e n c e (w ith an

unkno w n f un c tion) o c c u r re d b e t w e e n so r g hum a n d pu r ple w it c h w e e d b ef o r e sp ec i a tion of

pu r ple w it c h wee d a nd r e l a t e d c o w p e a w it c h wee d ( S. g e sn e rioid e s ) , a p a r a sitic pl a nt of di c ots,

fr om th e ir c omm o n a n ce sto r

. I n oth e r w o r d s, HG T b e t w e e n a p a ra sit ic pl a nt a nd its host

is a n e x t re m e l y r ar e e v e n t, a nd f u r th er mo r e

, purple witchweed is not f ound in the U .S. a nd

Asiatic witchweed ( S. asiati c a )

, a noth e r re l a t e d p ara site of ce r ea l c r ops, is on l y p re s e nt in N o r th

C ar olina a nd South C ar olina (U S DA

- N RCS, 2011 )

.

F or a ll the r ea sons list e d a bov e

, A P H I S c o n c lud e s th a t a s w ith GA 21 c o r n or the control corn

, HG T fr om H C E M485 c o r n to oth e r o r g a nisms is unlik e l y to o cc ur a nd thus po s e s no

si g ni f i ca nt pl a nt p e st r isk.



### C o n c l us i o n

A PH I S h as r e v ie w ed and co n d uc ted a p l ant pest r isk assess m ent o n gl y p ho sate

- r esistant

H C EM 48 5 cor n. Du e to si m i l a r ities to t h e an t e c e d ent gly p ho sate

- r esistant GA21cor n and to

the control corn, in clu d ing t h e l a c k o f p l a nt pest r isk fro m t h e inse r ted g enetic m ate r ia l

, t h e

l a c k o f at y pi c al r esp o nses o f H C EM 485 cor n to d isease o r p l ant pests in t h e f ie l d

, the lack of

weediness characteristics of HCEM485 corn, the lack of gene flow potential to sexually

compatible wild relatives to impact their weediness attributes

, t h e l a c k o f d e l ete r i ou s e f f e c ts

o n n o n

- ta rg ets o r bene f i c ial org anis m s in t h e a g ro

- e co s y ste m

, the lack of changes in

agricultural practices which would affect the incidence, severity or control of plant pests

, and

t h e l a c k o f co n c e r ns o f hor i z o ntal g ene t r ans f e r

, A PH I S co n clu d es t h at H C E M 48 5 cor n i s

u n l i k e l y to p o se a p l a n t pest r is k.

13

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