Unit e d St a t e s

D e p a rt me nt of

A gri c ulture

Ma r ke t i ng a n d

R e gul a to r y

Progr am s

A nim a l a n d

P lan t H e al th

I ns p ec t ion

S e r v ic e 

# P r opo s e d Ru l e f or

Im po rt a t i o n o f F r esh

B eef fr o m a R e g i o n i n

B r a z il

E nv i ronmen t al A ss e ssmen t

, December 2 01 3

# P roposed R u l e f or I mpor t a ti o n

of Fresh B eef f rom a R eg i on i n

B ra z i l

E n v i r on me n t a l A s se s s m e n t,

December 2 0 1 3

A g e n c y Co n t ac t :

D r

. Sil v i a K r e i nde l

, S en i or S t a f f V e t e r i na r i an

R e g i ona li z a t i on E v a l ua t i on S e r v i ces S t a f f

N a t i onal C en t er f o r Im p o r t and E x po r t

V e t e r i na r y S e r v i ces

A n i m al Pl ant H ea l t h I ns p ec t i on S e r v i ce

U

. S

. D ep a r t m ent o f A g r i c u l t u r e

4700 Ri v er R d. U n i t 38

Ri v e r da l e, M D 20737

T h e U

. S

. Depart m en t o f A gr i c u l t u r e (U S D A ) proh i b i t s d i s c r i mi na t i o n i n a ll i t s

progra m s an d a ct i v i t i e s o n t h e b a s is o f r a c e

, c o l or

, na t i ona l or i g i n

, s e x

,

re li g i on

, age

, d i s a b ili t y

, po l i t i c a l be l i e f s

, s e x ua l or i en t a t i on

, o r m ar i t a l o r f a m ily

st a t us

. (No t a ll proh i b i t e d b a s e s a pp ly t o a ll progr a m s

. ) P er s o n s w i t h

d i s ab il i t i e s w h o requ i r e a l t erna t i v e m ea n s f o r c o m m u n i c a t i o n o f program

i n f o r m a t i o n ( B ra ill e

, l arg e pr i n t

, aud i o t ape

, e t c

. ) s hou ld c on t a c t U S D A ’S

T A R G E T Cen t e r a t (202 ) 720

– 26 0 0 (vo i c e an d T DD)

.

To f i le a c o m p l a i n t o f d i s c r i m i n a t i o n

, w r i t e U S D A

, D i r e ct or , O f f i c e o f C i v il R i ght s

, Roo m 326

–

W

, W h i tt e n B u i l d i ng

, 140 0 I ndependen c e A venue

, S W

, W a sh i ng t on,

D C 20250

– 941 0 o r c a ll (202 ) 72 0

– 596 4 (vo i c e an d T DD)

. U S D A is a n equal

oppor t un i t y prov i de r an d e m p l oyer

.

M en t i o n o f c o m pan i e s o r c o mm erc i a l produ c t s in t h is repor t do e s no t i m p ly

re c o m m endat i o n o r endor s e m en t b y t h e U. S

. Depart m en t o f A gr i c u l tur e over

o t her s no t m e n t i oned

. U S D A ne i the r guaran t ee s no r w arran t s t h e standar d of

an y produ c t m e n t i oned

. P rodu c t n a m e s ar e m ent i one d s o l e ly t o repor t

f ac t ua lly o n ava il ab le da t a an d t o prov i d e s pe c i f ic i n f o r m a t i o n

.

## T a bl e o f Co n t e n ts

I. N e e d f or t he P ro p o se d Rule

................................................... 1

A

. I n t r o d uc ti o n

.......................................................................... 1

B

. N e e d

.................................................................................... 2

II. A l t e rn a t i v e s

.............................................................................. 3

A

. No A c t i o n

................ ............................................................. 3

B

. P ro pos e d R u le

..................................................................... 3

III. E n v ironm e n t a l Con se qu e n c e s

............................................... 7

A

. No A c t i o n

............................................................................. 7

B

. P ro pos e d R u le

.................................................................... 9

1

. F M DV a n d Vacc i n a ti on s

................................................ 9

2

. F M D a n d B e e f P r o c ess i n g

............................................ 14

3

. R e g u l a t o r y C on t r o l o f F M D............................................ 15

4

. I n t e r s p ec i e s T r an s m i ss i o n o f F M D

................................ 17

5

. E n v i r on m e n t a l F a t e o f F M D

.......................................... 23

6

. P ub lic H ea l t h

................................................................. 25

I V

. O t h e r E n v ironm e n t a l I ss u e s

............................................... 2 6

A

. E n v i r on m e n t a l J u s t i c e a n d t h e P r opo s e d A c ti o n

............... 2 6

B

. P ro t ec ti o n o f C h il d r e n a n d t h e P r o p os ed A c ti o n

................ 26

C. T h r ea t e n e d an d E n dan g e r e d S p ec i e s a n d t he

P r opo s e d Ac ti o n

............................................................... 26

D. Po t en ti a l C u m u l a ti v e I m pac t s

............................................ 27

V

. Li s t ing of A g e n c i e s C on s ul t e d............................................. 29

V I. R e f e r e n c e s

............................................................................ 3 01 

## I

. Nee d f o r t h e P r opo se d R ul e

A

. I n t r odu ct i on

The s a nit a r y impo r t r e g u l a tions c ont a in e d in 19 U nit e d S t a t e s C ode

( U. S

. C .) § 1306 p r ohibit or r e g ul a te t h e impo r t a tion of b ee f a nd b e e f

p r odu c ts into the Unit e d S t a t e s. Th e se r e g u l a tions ar e d e s i g n e d to p re v e nt

the int r odu c tion a nd diss e min a tion of inju r ious a nim a l p e sts a nd dis ea s e s

t h at ar e n e w to or not w i d e l y dist r ibut e d in the c o unt r y

. G e n e r a l l y , t h e

impo r t a tion of b ee f is p r o hibit e d e x ce pt und e r c e r t a in c i rc umst a n c e s fr om

s p e c i f ic a rea s, a s st a t e d i n Title 9 C od e o f Fe d era l R e g u l a ti on s ( C F R )

§ 94. Th e se r e st r i c tions ar e d e s i g n e d to p re v e nt t he int r odu c tion of a

numb e r of a nim a l dis ea s e s in c luding f oot

- an d

- m o uth dis ea se ( F MD )

. In

1997, the U. S . D e p ar tm e nt of Ag r i c ultu r e ( U S D A ) , Anim a l a nd P l a nt

H ea lth I nsp e c tion S er vi c e ( A P H I S )

, e st a blish e d p oli c y a nd r ul e s for

rec o g ni z ing r e g ions, ra t h e r th a n on l y c ount r i e s, f o r the pu r pose of

impo r t a tion of a nim a ls a nd a nim a l p r odu c ts into the Unit e d St a t e s

(6 2 F ed er a l R eg i st e r ( F R ) 55999, 62 F R 56027 )

. This ac tion w a s

d e si g n e d to fac ilit a te t r a d e while m a int a ining a low r isk fo r t he

int r odu c tion of an i m a l d i s ea se to the Unit e d St a t e s

.

An o f f i c i a l r e qu e st w a s s ubmitt e d to A P H I S to e x po r t fre sh ( c hill e d or

fr o z e n ) , m a tu ra t e d, a nd d e bon e d b e e f fr om a r e g i o n ( 1 4 S t a t e s) of B ra z il to

the Unit e d S t a t e s. The e x po r ting r e g ion of B ra z il c onsists of the S t a t e s of

B a hi a , Dist r ito F e d e ra l, Espi r ito S a nto, Goi a s, M a to G r osso, M a to G r osso

do S ul, Min a s G era is, P aran á, R io G r a nde do S ul, R io de J a n e i r o,

R ondoni a

, S a o P a ulo, S e r g ip e

, a n d To ca ntins. The most rece nt outb r ea ks

of F MD within the e x po r t re g ion of B r a z il o cc u rre d in M a to G r osso do S ul

a nd P aran á in 2006. Thus, g i v e n the histo r y o f the dis ea se in B ra z il a nd the

fac t th a t B ra z il v acc i n a t e s its ca ttle popu la tion ag ai n s t F MD in most S t a t e s,

A P H I S cond u c t e d a d i s ea se r isk a n a l y sis to e v a lu a te the lik e lihood of F MD

int r odu c tion th r o u g h t h e impo r t a tion of b e e f f ro m B r a z il. The f

indin g s of

th a t do c u m e nt ar e summ ar i z e d a nd in c o rpo ra t e d b y re f ere n c e into this

e nvi r onm e nt a l a ss e ssm e nt ( EA )

.

F MD is a n a c ut e , h i g h l y c ont a g ious vi ra l dis ea se t h at p rim ar i l y af f ec ts

c l ov e n

- hoo f

e d a nim a ls. F MD m a y a ff e c t hum a n s , how e v er , t h at

o c cu r r en c e is ra r e ( U S D A

– A P H I S , 20 13 )

. C a ttl e , sh ee p, g o a ts, d e er

, bu f fa l o

, a n d s wi n e a r e a ll adv e r s e l y af f ec t e d b y F MD, bu t th e ef f ec ts on

ca ttle h e rd s t en d t o b e p a r ti c ul ar l y d e v a st a ti n g

. T he d ea th r a te fr om this

dis ea se is low; how e v e r

, both t e mpo ra r y a nd p er m a n e nt p h y si ca l d a m a ge

to the bo d y of in f

ec t e d a nim a ls re sults in c ost l y l o ss e s in m ea t a nd milk

p r odu c tion. Althou g h l e s ions to the fee t a nd mou t h area s ar e t h e most

p r omin e nt s y

mptoms, the s y st e mic d a m a g e to the g a st r oint e stin a l t r ac t a nd

c i rcu l a t o r y s y st e m f

ro m t h i s d i s ea se cau s e s g r e a t e r d am a g e to t h e an i m a l ’ s

h ea lth a nd p r odu c tivi t y

. F MD is t ra nsmitt e d to h e a lt h y a nim a ls th r o u g h2 e x po s u re to t h e ac ti v e vi r us. E x posu r e m a y o c c ur th r ou g h inh a l a tion of

a i r

- bo r ne d r opl e ts ( p r im a r i l y fr om a nim a ls in c lose c ont ac t ) , i n g e stion,

s e x u a l t ra nsmission, c on

j un c tiv a l m e mb ra n e s ( e

. g

. , e y e s, nos e)

, c ont ac t

with d a m a g e d/dis ea s e d s kin, ino c ul a tion, a nd e x posu r e fr om ti c ks or oth e r

an i m a ls t h at ca n c ar

r y t h e F MD v i ru s ( F MD V )

. E x c lusion of this d i s ea se

fr om the Unit e d St a t e s is p ar ti c ul ar l y impo r t a nt in th a t the vi r us

re sponsible f

or this dis e a se is hi g h l y c ont a g ious a nd ca n su r vive in the

e nvi r onm e nt f

or e x t e nd e d p er iods of tim e

. P re vi o us outb rea ks of F MD in

t h e U n i t e d S t a t e s h a v e b e e n v e r y co s t l y to c on t a in an d e rad i ca t e.

I n re sponse to the re qu e st fr om B r a z il, a nd b a s e d u pon the f indin g s of site

v i sits an d t h e an i m a l d i s ea se r isk a n a l y s e s, A P H I S

– V e t er i n a r y S erv i ces

( V S ) is p r oposing to a ll o w impo r t a tion of fre sh b e e f fr om a r e g ion in

B ra z il to the Unit e d S t a t e s und e r sp ec i f i c c onditions of e nt r y . The a nim a l

d i s ea se r isk a n a l y s e s d e t e r min e d th a t the lik e lihood of b ee f fr om the

e x po r t re g ion of B r a z il i n t r odu c ing a nd e st a blishing F MD in the Unit e d

S t a t e s is lo w

. Th e an a l y s is con c lud e d th a t the p r o pos e d miti g a tions a nd

c onditions f

or e nt r y a r e s u ff

i c i e nt to initi a te t

ra de i n fre sh ( c hill e d or

fro z en ), m a t u r a t e d, a nd d e bon e d b e e f fro m t h e s p e c i f i e d e x po r t r e g ion in

B ra z il.



### B

. N eed

I n re sponse to a n o ff

i c i a l re qu e st f

r om B r a z il an d i n a cco r d an c e with

s an i t a r y an d p h y

tos a nit a r y ( SPS ) a g r ee m e nts to f a c ilit a te impo r t a tion of

b e e f to t h e U n i t e d S t a t e s, A P H I S h as rev i e w e d t h e iss u es re l a t e d t o t h i s

impo r t a tion a nd is p r oposing to a m e nd the s a nit a r y r e g ul a tions ( 9 C F R

§ 94) b y a llowing impo r t a tion o f b e e f fro m th e se r e g i o n s un d e r s p e c i f ic

c onditions. The p re p a ra t ion of this EA w a s p r o m pt e d b y the a nti c ip a t e d

public c on cer n r e g ar di n g the pot e nti a l dis ea se r isk fro m t h e impo r t a tion of

b e ef

, an d th e n e e d t o ad d re ss env i ron m en t a l iss u es re l a t e d t o t h i s d i s ea se

r isk. The issue of pot e nt i a l e nvi r onm e nt a l r isks of a n outb rea k o f F MD in

the Unit e d S t a t e s re sulting f r om impo r t e d b e e f is of g rea t c on c e r n to

A P H I S

. C h a r ac t e r i z a tion of the dis ea se r isk pot e nti a l a nd a d e qu a te

miti g a tion m ea su re s ar e cr iti ca l to e x c luding this dis ea se fr om the

Unit e d S t a t e s.

Th i s EA a n a l y z e s t h e pot e nti a l e nvi r onm e nt a l imp ac ts re sulting fr om

a pp r ov a l of this p r opos e d r ule a nd fr om its c h a n g e in the c u rre nt

r e g ul a tions. T h e r e a r e t a r i f f ra t e quo t a s s e t b y t h e U

. S

. I n te rn ati on a l T r ade

C ommission on the qu a n ti t y o f b e e f th a t c a n be i mpo r t e d fr om di ff e re nt

p ar ts of the wo r ld witho u t t ar i ff s. The a gg r e g a te a nnu a l qu a nti t y of b ee f

p er mitt e d impo r

t to the Unit e d St a t e s fr om B r a z il i s 64,805 m e t r ic ton s

, ( B r a z ili a n E mb a s s y , 20 0 6 )

. S ome of the ca ttle w ould re m a in in B r a z il to

m a int a in the n a tion a l h e r d b eef

, a nd so m e ca ttle e li g ible f or e x po r t would

most lik e l y b e d e stin e d f

or oth e r c ount r i e s. T h e se pot e nti a l impo r t a tions

fr om B r a z il would l ar g e ly c om p e te with e x isting dom e stic sto c ks a nd3 d i s p l ac e impo r ts of f

r e sh b ee f f

r om oth e r c ount r i e s . A P H I S e x p e c ts t he

n e t in crea s e in impo r ts f

r om B ra z il to e qu a l a bout 0.1 p e rcen t o f the U. S

. b ee f supp l y , whi c h is not e x p ec t e d to h a ve a s i g ni f i ca nt ec onomic imp ac t

on e ntiti e s pot e nti a l l y a ff ec t e d b y this r ul e

.

Th i s EA is d e si g n e d to s a tis f y the p r ovisions of the N a tion a l

Envi r onm e nt a l P oli c y A c t of 1969 ( NE P A ) , 42 U

. S

. C . 4321

– 4327, its

impl e m e nting r e g ul a tio n s, a nd E x ec utive O r d e r 1 2114, “ Envi r onm e nt a l

E ffec ts A b r o a d of M a

jor Fe d e ra l A c tions.”



## II

. A l t er n a t i ve s

Th i s EA a n a l y z e s po t e nti a l e nvi r onm e nt a l c on s e q u e n ce s of t h e p r opos a l to

a m e nd the r e g u l a tions g o v er ning impo r t a tion of b ee f into the Unit e d S t a t e s

( 9 C F R § 94 ) . The a m e n dm e nt would a llow the impo r t a tion of fre sh b e e f

fr om ca ttle r a is e d in a pp r ov e d r e g ions in B ra z il und e r c e r t a in c onditions.

T h e two possible a lt er n a t iv e s c onsid ere d in this E A ar e (1 ) t h e c u rrent

p r ohibition of impo r t a ti o n of fre sh b ee f fr om B ra z il ( no ac tion )

, a nd ( 2 )

r e g ul a tion und e r the p r o p os e d r ule ( p r ef e rre d a lt e r n a tiv e)

.



### A

. N o A ct i on

The no ac tion a lt e r n a tive is d ef in e d a s c ontinu a ti o n of the c u rr e nt s a nit a r y

r e g ul a tion of impo r t a tion of b ee f fr om B ra z il. This a lt er n a tive would

involve c ontinu a tion of the p r ohibition of the impo r t a tion of fre sh b ee f

fr om B r a z il. The l ac k of a n y c h a n g e s in c onditions f or t h e e n t r y o f

co m m erc i a l shipm e nts of b ee f f r om B r a z il m a int a ins ov e ra ll dis ea se r isks

a t t h e p r e s en t l o w l e v e ls, w h i c h a r e a c cep t ab l e

. S e l ec ti o n o f t h i s

a lt er n a tive m a y not, ho w e v er , s a tis f y int er n a tion a l t ra de r e g ul a tions

re qui r i n g justi f

i ca tion of the mo r e r i g o r ous s a nit a r y r e qui re m e nts of

m a i n t a i n i n g cu r ren t r e g u l a ti on s ov e r l e ss re st r i c ti v e a lt ern a t e app r o ach es.

I n c ompli a n c e with the S P S m ea su re s stipul a t e d by the W o r ld T ra d e

O r g a ni z a tion, A P H I S is obli g a t e d to c on s id e r l e ss re st r i c tive s a nit a r y

m ea s u r e s t h at p r ovi d e c o mp ara ble p r o t ec tion a g a i nst dis ea se r isks. I n

a ddition, c onsist e nt re g u l a tion of c omp a r a ble r isks is impo r t a nt to A P H I S

. C ount r i e s s u ch as U r u g u a y m ee ti n g A P H I S ’ r e g ion a li z a tion r e qui re m e nts

fo r a n F MD

- f

re e s t a t u s ( b as e d upon simil a r r isk issu e s) h a v e a l r e a d y b e en

a pp r ov e d f

o r impo r t a tion of fre sh b ee f to the Unit e d S t a t e s in c ompli a n c e

with sp ec i f

ic c onditions of e nt r y . The issu e s o f p ot e nti a l e nvi r onm e nt a l

im p a c ts a ss o ci a t e d with t h e d i s ea se r is k s o f e a c h a lt ern ati v e a r e d i s cu s s ed

in c h a pt e r 3, Envi r o n m e n t a l C on s equ e n c e s o f t h e Alt ern ati v es.



### B

. P r opo sed Ru l e

T h e p r e f er r e d alt e rn ati v e will a m en d 9 C F R § 94.22 to a llow the

impo r t a tion of fre sh b e e f fr om B r a z il, und e r c e r t a i n c onditions.

R e qui re m e nts simil a r to tho s e of the p r efe r re d a lt e r n a tive h a ve b ee n

u s ed eff e c tiv e l y f or e st a blishing c onditions of impo r t a t i on of fre sh b ee f4 fr om U r u g u a y , a n e i g hbo r i n g c ount r y wh i c h h a s c omp a r a ble dis ea se

r isks. The p r ef

e rre d a lt ern ative is d e si g n ed to m a int a in s a nit a r y s ec u r i t y

in the Unit e d S t a t e s while fac il i t a ting t ra d e with B r a z il. I mpl e m e n t a tion

of this a lt er n a tive would r e sult in p r omul g a tion of a m e n d e d s a nit a r y

r e g ul a tions fo r t h e impo r t a tion of f r e sh b ee f f

ro m a r e g ion o f B ra z il

und e r sp e c i f

ic c onditions of e nt r y

. The e x po r ting r e g ion of B ra z i l

would c onsist of the S t a t e s of B a hi a

, Dist r ito Fe d e ra l, Espi r ito S a nto,

Goi a s, M a to G r osso, M a to G r osso do S ul, Min a s G e r a is, P aran á, R io

G r a nde do S ul, R io de J an ei r o, R ondoni a

, S a o P a ulo, S e r g ip e

, a nd

To ca ntins.

U nd e r t h e p r ef

e rre d a lt e r n ati v e, f

re sh (ch i ll e d o r f

ro z en ) b e e f fro m B ra z il

would be e x po r

t e d to the Unit e d S t a t e s und e r the f ollowing c onditions

—

• The m ea t is b e e f fr om b o vin e s th a t h a ve b e e n bo r n

, ra is e d, a nd

sl a u g ht e re d inside the e x po r ting r e g ion.

• F M D h a s not b ee n diagnosed in the export r e g ion within 12

months prior to exportation of the beef

.

• The b e e f ca m e fr om bov i n e s th a t o r i g i n a t e d on p r e mis e s w h e r e

F MD h a s not b e e n p re s e nt du r ing the li fe time of a n y bov i n e s

sl a u g ht e re d f

o r the e x po r

t of b ee f to the Unit e d S t a t e s.

• The b e e f ca m e fr om bov i n e s th a t w e r e mov e d di r e c t l y f r om the

p re mis e s of o r i g in to the sl a u g ht e r ing e st a blishm e nt without a n y

c ont ac t with oth e r a nim a l s.

• T h e b e e f ca m e fro m bov i n e s th a t re c e iv e d a nt e

- m o r t e m a nd post

mo r t e m v e t er in a r y ins p e c tions ( p a y i n g p a r ti c ul a r a tt e ntion to the

h e a d a n d f

ee t) a t the sl a u g ht er i n g e st a blishm e nt, w ith no e vid e n c e

f ound of v e si c ul a r dis ea s e

.

• The b e e f c onsists on l y of bovine p ar ts th a t a r e

, b y st a nd ar d

p r ac ti ce

, p ar t o f t h e an i m a l ' s ca r ca ss t h at is p l ace d in a ch i ll e r for

m a tu ra tion af

t e r s l a u g ht e r

. B ovine p ar ts th a t m a y not be impo r t e d

in c lude a ll p ar ts of bovi n e h ea ds, f ee t, hump, ho o v e s, a nd int er n a l

o r g a ns.

• All bone a nd visu a l l y id e nti f i a ble blood c lots a nd l y m phoid tissue

h a ve b e e n re mov e d fr om the b eef

.

• The b e e f h a s not b ee n in c ont ac t with m ea t f r om r e g ions oth e r th a n

those con s i d e re d a s F M D

- fr e e b y A P H I S an d list e d in § 94.1 (a)( 2 )

.

• The beef comes from carcasses that were allowed to maturate at

40 to 50 °F (4 to 10 ° C) for a minimum of 24 hours after slaughter

and that reached a pH of less than 6.0 in the loin muscle at the end

of the maturation period. Measurements for pH must be taken at

the middle of both longissimus dorsi muscles. Any carcass in

which the pH doe s not reach less than 6.0 may be allowed to

maturate an additional 24 hours and be retested, and, if the carcass

still has not reached a pH of less than 6.0 after 48 hours, the meat

from the carcass may not be exported to the United States.

• An a utho r i z e d v e t er in a r y o ff i c i a l of the g o v er nm e nt of the

e x po r ting r e g ion c er ti f

i e s on the f

o re i g n m e a t insp ec tion c er ti f i c a te5 th a t the a bove c onditions h a ve b e e n m e t.

• The e st a blishm e nt in whi c h the bovin e s a r e sl a u g h t ere d a llows

p er iodic on

- site e v a lu a tion a nd subs e qu e nt insp ec t ion of its

fac iliti e s, r ec o rd s

, a n d o p era ti on s b y a n A P H I S r e p r e s en t a ti v e.

I n a ddition to the a bove miti g a tions, th er e a r e s e v era l oth e r a sp ec ts of t h e

p r og r a m th a t a f

f e c t pot e n ti a l F MD r isks; some re l a te to the e x t e nt to w hi c h

the 11 fac to r s ( d ef

in e d b y A P H I S a s n ece s s a r y to r e g i on a li z a ti o n a s

d e s cr ib e d in 9 C F R § 92

. 2) ar e m e t b y t h e e x po r ting r e g ion of B ra z il. In

2012, APHIS consolidated the 11 factors into 8 factors. H owever, since

the evaluation of this region of Brazil started before 2012, and the topics

addressed by the 11 factors are contained within the 8 factors, this report

follows the 11 factor format. The d e s cr iption of B ra z il ’ s c o nsist e nt a nd

on g oi n g f ul f illm e nt of th e se fac to r s is a ssum e d to c ontinue a s p ar t of the

p r opo s e d p r o g r a m re qui r e m e nts. T he c on c lusions of the re v i e w of this

r e g ion of B ra z il, a s p re s e nt e d in the d i s ea se r isk a n a l y sis ( U S DA

– A P H I S

, 2013 ) a r e s u m m ar i z e d f

o r e a ch r e g ion a li z a tion f

ac tor a s f ollo w s

—

(1 ) B a s e d upon site visits a n d do c um e nt a tion re vi e w s , A P H I S

con s i d e r s B ra z il ’ s MA P A to h a ve su ff i c i e nt l e g a l a utho r i t y

,

o r g a ni z a tion, a nd in fra st r u c tu r e to c a r r y out o ff i c i a l c ont r ol,

era di c a tion, a nd qu a r a ntine ac tiviti e s. The c e nsus in f o r m a tion,

c ov er a ge of p r e mis e s in the e x po r t r e g ion, rec o r d

- k ee pi n g

, c ont r ol

of v acc i n a tion, do c um e n t a tion of a nim a l mov e m e nt, f unding

a v a il a ble f

o r ind e mni t y

, a nd s i g ht r ec o g nition of F MD c lini ca l

si g ns a t lo ca l v e t er in a r y units ( L VU s ) suppo r t th e ir dis ea se c ont r ol

mission.

(2 ) A P H I S did not d e t e c t a n y e vi d e n c e to s u gge st t h a t ac ti ve outb rea ks

of F MD e x ist in the e x po r t re g ion. D e s pite o cca sion a l outb rea ks

of F MD in B r az il a nd in n e i g hbo r ing c o unt r i e s of S outh Am er i ca

, A P H I S c onsid e r s the dis ea se to be un d e r c ont r ol in the e x po r t

re g ion. I n a ddition, A P H I S c o n c lud e d th a t MA P A c ould d e t ec t

dis ea s e qui c k l y , limit its sp rea d, a nd would re po r t p r ompt l y . This

w a s e vid e nt in the F MD outb rea ks in 2005 a n d 2006

— t he ca s e s

w er e qu i ck l y i d e n t i f

i ed

, d i s ea se w a s con t a i n e d, a nd int er n a tion a l

a utho r iti e s w er e noti f

i e d in a tim e l y m a nn e r

.

(3 ) A P H I S do e s not c onsi d e r c ount r i e s of S outh Am e r i c a to be F M D

free

, with the e x ce ption of C hil e . Outb rea ks h a v e o cc u r r e d

rece nt l y in A r g e ntin a , U r u g u a y

, a nd P a r a g u a y

, 1 a ll c oun tr i e s th a t

h ad b e e n c l a ssi f

i e d b y t h e W o r ld Or g a ni z a tion f or Anim a l H ea lth

(fo rm er l y O ff

i c e I n t er n a t i on al d es E p iz oo t i e s ( O I E ) ) a s “ fr e e

without v acc in a tion” or “ fre e with v acc i n a tion” p r ior to the

outb rea ks. F M D h a s not b ee n e r a di ca t e d fr om C o l ombi a

, B olivi a

,

1 For the purposes of APHIS’ evaluation of Brazil, the neighboring countries of Brazil are Paraguay, Uruguay, Bolivia,

and Argentina.6 E c u a do r

, V e n e z u e l a , N or th er n A r g e ntin a

, o r P er u. T h e r e cent

histo r y of int r odu c tions ( 2000 to 2006) fr om a dj a c e nt c ount r i e s

re l a t e s to ill e g a l mov e m e nt of a nim a ls a nd m ec h a ni ca l

t ra nsmission of the vi r us. I n 2000 a nd 2001, B ra z il b eca me

vuln era ble to the int

r od u c tion of the dis ea se d u e to t h e l ac k of

re po r ti n g the dis ea s e b y A r g e ntin a

. I n 2002, B r a z il su cce ss f ul l y

institut e d e m er g e n c y m e a su re s w h e n a n outb r e a k o cc u r r e d in

P ar a gu a y , n e a r its bo r d e r with B ra z il. Simil a r su cce ss f ul

e m e r g e n c y ac tions in 2 0 03 a nd 2006 re sult e d in p re v e nti n g t he

int r odu c tion of the dis ea s e fr om A r g e ntina a nd P a r a g u a y

.

(4 ) The dis ea se c ont r ol p r o g r a m a nd n a tion a l re spon s e pl a n to F MD

e m e r g e n c i e s, th r o u g h q u ara ntine a nd t e stin g

, h av e b e en d e t er min e d to

be su f f i c i e nt to re spond qui c k l y

. T h e ac tive su r v e ill a n c e pl a n,

s er ol o g i c a l monito r in g

, a nd c o mmuni t y p ar ti c ip a tion in noti f i ca tion of

dis ea se outb r ea ks h e lp to p re v e nt a nd d et ec t ou t b r eak s e ar l y

.

(5 ) V acc i n a ti o n o f ca ttle an d bu f fa lo o c cu rs twi c e an n u al l y with an

i n a c ti v at ed

, t r iv a l e nt

, 2 oil

- b as e d v ac c i n e w h i c h is m a nd a to r y in the

e x po r t re g i o n. T h e v a cc i ne is f o r mul a t e d w ith F MD vi ra l st ra ins

A 24 , C r u z e i r o, O 1 C a mpos, a nd C 3 I nd a i a l. T h e s y s t e m of c ont r ols

f or c ompli a n c e with timin g , mov e m e nt p er mits, ce nsus d a t a

, f i e ld

insp ec tions, a nd f

in e s f or non c ompli a n c e m ee ts int er n a tion a l

st a n d ar ds f

or v acc in a tion p r o g ra ms.

(6 ) M a n y n a t u r a l b a rr i er s, s u c h as r i v e r s an d f o r e st a r ea s, e x ist a l ong

the bo r d er s of t h e r e g ion. Althou g h mov e m e nt of F MD

sus ce ptible sp ec i e s or pr odu c ts c ould o cc ur d u e t o the l ac k of

su ff i c i e nt p h y si ca l b a rr i e r s, most bo r d er s a r e a c tiv e l y monito re d

f or ca ttl e

, an d c o l l abo r a ti v e eff o r ts o n a n i m a l h e a l t h i ss u es at

bo r d er s h a v e b ee n e st a bl i sh e d to e nsu r e imm e di a te noti f i ca tion.

(7 ) B ra z il h a s a s y st e m of p e r mits in pl ac e to c ont r ol a nim a l

mov e m e nts w h i c h is ti e d to v acc in a tion r e c o r ds. L a nd bo r d e r

c h ec kpoints e x ist a t both int er n a tion a l a nd dom e stic bo r d er s a nd

ar e con s i d ere d ad e qu a t e f or l e g a l mov e m e nt b a s e d on s ite visits b y

A P H I S . Ai r p o r ts a nd s e a po r ts indi ca te a h i g h l e v e l of bios ec u r i t y

.

(8 ) M ar k e ti n g p r a c ti ce s in B ra z il ar e d e s i g n e d to e li m in a te most

dis ea se r isks th r o u g h the liv e sto c k c i rc uits, a nim a l id e nti f i ca tion

s y st e m, sl a u g ht e r fac iliti e s, a nd the l a r g e r c omm e rc i a l op e r a tion s

. C a ttle in B ra z il ar e p r im a r i l y g r a ss

- fe d a nd m a y n o t be subj ec t to

r outine sup er vision und e r cer t a in p a stu r e r ot a tion p l a ns,

p a r ti cu l ar l y s o m e l a r g e r op e ra ti on s

.

(9 ) B ra z il h as a two

- p h a se s u rv eill an ce s y st e m d es i g n e d t o i n cl ude

both ac tive a nd p a ssive s u r v e ill a n c e t e c hniqu e s. The L VUs a r e

2 A trivalent vaccine contains three antibodies capable of counteracting a specific antigen.7 t ra in e d to p r ovide c onsis t e nt impl e m e nt a tion a nd e x ec ution of the

s u r v eill an ce p r o g r a m.

( 10) B ra z il h a s di a g n o s tic l a b o r a t o ri e s fo r F MD a t B e l e m a nd R ec i f e.

T h e f a c iliti e s w er e d e t e r mi n ed b y A P H I S to h a v e s u f f i c i ent

ca p a c i t y to p r o ce ss the s a mpling lo a d a nd t e sti n g p r o ce du r e s th a t

ar e in a cco rd with O I

E guid e lin e s.

( 11) Em e r g e n c y re sponse i n B ra z il is c ontin g e nt upon c ommuni t y

noti f i ca tion of F MD out b rea ks. Th e r e is c onsid e r a ble a utono m y

a t t h e S t a te l ev el to d e a l wi t h s u ch em e r g e n ci e s. T h e rap i d a nd

eff e c ti v e re s pon s e s to the F MD outb r e a ks in R io G ra nde do S ul

in 2001 a nd 2005, a s w e ll a s to the outb rea ks in M a t o G r osso do

S ul an d P ara ná in 2006, indi c a te th a t th e ir F e d e ra l c on t in g e n c y

pl a n fo r F MD in the e x po r t r e g ion is su ff i c i e nt.

P ropo se d A m e ndm e nt t o R e gul a t ions

A P H I S c onsid e r s B ra z il to be a n F M D

- a ff e c t e d c o un tr y t h at p r ac ti ces

v a cc in a tion a g a inst the dis ea s e

. I t h a s not e x p er i e n ce d a n F MD outb r e a k

f or mo r e th a n a y

e a r

. B r a z il h a s re qu e st e d to be a llow e d to e x po r t fre sh

b ee f into the Unit e d S t a t e s. A f t e r cond u c ti n g a r i s k ass e ssm en t in

c onn ec tion with the re q u e st, it h as b e e n d et e r min e d th a t fre sh ( c hill e d or

fr o z e n) b e e f c a n be s a fe l y impo r t e d f r om c e r t a in S t a t e s within B ra z il

p r ov i d ed t h at c e r t a in r e q u i re m en t s ar e m e t. T h e s e S t a t e s ar e B ah i a,

Dist r ito Fe d e r a l, Espi r ito S a nto, Goi a s, M a to G r o s so do S ul, Min a s G era is,

P aran á, R io de J a n e i r o, R ondoni a

, S a o P a ulo, a nd T o c an t ins. ( I mpo r ts will

be a llo we d f

r om a r e g ion of B r a z il th a t e x c lud e s a bu ff e r a r e a lo c a t e d a lo n g

the bo r d e r o f B olivi a

, P ar a g u a y

, a nd A r g e ntin a .) A P H I S wou l d a m e nd 9

C F R § 94 to r ef

l ec t this d e t er min a tion a nd in c lude a list of the s p ec i f ic

r e qui re m e nts f

o r e x po r t und e r § 94.22. I n a ddition, b eca use r ind erp e st h a s

n e v e r b e co m e e st a blish e d in B r a z il a nd is not e nd e mic to the Am er i ca s,

A P H I S would rec o g n iz e t h e en t i r e cou n t r y o f B r a z il a s fre e o f r i n d e rp est.



## III

. E n v i r onm e n t a l C on se qu e n ce s

A

. N o A ct i on

The biolo g i c a l histo r y a n d dis ea se pot e nti a l of F M D sugg e st th a t t he

c ontinu a tion of the c u r r e nt re g u l a tions of b e e f ( no e nt r y ) fr om B r a z il

would re sult in no pot e nti a l f or in cr e a s e d p e st r isk a nd, th er e f o re , no

c h a n g e in pot e nti a l imp a c t on the hum a n e nvi r o n m e nt. Althou g h the

re qui re d mitig a tions und e r the p r opos e d r ule p r o v ide a m ea ns of e x po r t f or

B ra z ili a n p r odu c er s th a t h a ve b e e n shown to be e f fec tive a g a inst a ll known

st ra ins of F M D V, th er e r e m a ins some pot e nti a l r isk th a t do e s not e x ist und e r the

no ac tion a lt er n a tiv e

.8 The l ac k of impo r t a tion o f fre sh b ee f fr om B ra z il h a s m a int a in e d low

dis ea se r isks a nd ne g li g i ble e nvi r onm e nt a l e ff e c ts. A s with most

c ommoditi e s, th er e is a lw a y s some r isk of sm u gglin g ; how e v e r , t he

fre qu e n c y is low due to the hi g h punitive c osts f r o m non c ompli a n ce . The

hi g h po te nti a l r isks fr om dis ea se a sso c i a t e d w ith n on c ompli a n c e m a k e it

A P H I S ’ poli c y to p r ovi d e a st r o n g d e t e rre nt. T h e ref o r e , A P H I S k ee ps

impo r t er s a nd shipp er s i n f o r m e d of th e ir impo r t r e g ul a tions a nd of t h e

p e n a lti e s f

or in a d e qu a te c ompli a n ce . The impo r t e r or shipp e r c ould be

subj ec t to c ivil p e n a lti e s, cr imin a l f in e s, j a il s e nt e n ce s, a nd loss of r e v e n u e

due to A P H I S ’ re

j e c tion of c ommoditi e s, p er mit a ppli ca tions, a nd/or

c ompli a n c e a g ree m e nts. A m a jor tool f or A P H I S is the option to ref use

e nt r y

, re qui r e t r e a tm e nt, or re qui r e d e st r u c tion of i n fec t e d o r pot e nti a l l y

in fec t e d c a r g o. All of t h e se options ar e c ost l y to t he shipping line a nd

e x po r t e r who must a ssume a ll c osts f or the d e l a y s a nd a n y t r e a tm e nts.

This o ffer s st r o n g in c e ntive f or f ull c ompli a n c e w i th impo r t re g ul a tions.

Monito r ing the ra t e s of c ompli a n c e with a p h y tos a nit a r y r ul e , p r omu l g a t e d

in 1998, f ound th a t p r op e r c ompli a n c e with those i mpo r t re qui re m e nts w a s

ach i ev ed app r o x im a t e l y 9 8 p e rcen t o f t h e time ( U S DA

– A P H I S , 2003 )

. C o m p a rab l e co m pli an c e cou l d b e e x p e c t e d f o r a n y p r e s en t o r r ev i s ed

s a nit a r y r e g ul a tions r e l a t e d to t h e impo r t a tion of f re sh b e e f fr om B r a z il.

The issue of pot e nti a l e n vi r onm e nt a l r isks of a n o utb rea k of F MD in the

U n i t e d S t a t e s is o f g r ea t con c er n t o A P H I S a s t h e con s e qu e n c e s of a n

F MD outb r e a k in the Un i t e d S t a t e s would be e x t re m e l y h i g h. The m a j o r

ec onomic c ons e q u e n c e o f impo r ting F M D would be e x po r t t ra de loss e s.

I n B r a z il, the sum of the c onsum e r imp ac ts, di r e c t c osts, a nd t ra de loss e s

ov e r a 15

- y e a r p er iod w o uld b e b etw ee n $37 a nd 44 b i llion, d e p e nding on

t h e m a g n i t ud e o f t h e ou t b r ea k a n d th e e r ad i ca ti o n st ra t e g y ( U S DA

–

A P H I S

, 2013 )

. Although su c h c ons e qu e n ce s ar e subst a nti a l, it is

impo r t a nt to no t e th a t the re sults of th e r isk a n a l y s is fo r re l e a se and

e x posu r e a ss e ssm e nt indi ca t e d low lik e lihood of i nt r odu c tion a nd

e st a blishm e nt of F MD w h e n the p r opos e d p r o g r a m miti g a tions ar e

f ollow e d.

The no ac tion a lt e r n a tive would l ea ve the c u rr e nt impo r t a tion r e g ul a tions

un c h a n g e d. Un d e r this a lt er n a tiv e

, B ra z il would c ontinue not to be

a llo we d to e x po r t b ee f to the Unit e d S t a t e s. T he s t a tus in B ra z il a s low

r isk f or F MD is not r ef

l e c t e d in the c u r re nt impo r t r e g ul a tions. The

c ontinu a n c e of s u c h uns u ppo r t e d t ra de re st r i c tions would be c ont r a r y to

U. S . obli g a tions und e r i n t er n a tion a l t ra de a g r ee m e nts.9 

### B

. P r opo sed Ru l e

The e nvi r onm e nt a l c ons e qu e n ce s f r om p r omulg a tion of the p r opos e d r u l e

ar e l a r g e l y c onti n g e nt u p on the a bili t y of v a r ious miti g a tions a nd

p r og ra m t r e a tm e nt p r o ce du re s to p rec lu d e e x posu r e of the B r a z ili a n ca ttle

h er ds to F MD, a nd to e x c lude the impo r t a tion to the Unit e d S t a t e s of a n y

B ra z ili a n b e e f th a t c ould pot e nti a l l y b e i n f ec t e d w i th FMDV. The

d i s ea se r isk a n a l y sis ( U S DA

– A P H I S

, 2013 ) o f f r e sh b e e f f

ro m a

d e si g n a t e d r e g ion in B r az il e x a min e d the s a nit a r y con c ern s re l a t e d t o

f ul f illing the re q u e st fr o m the B ra z ili a n MA P A. T he a n a l y sis a ss e s s es

the lik e lihood of int r odu c tion a nd outb rea k of F M D to liv e sto c k in the

Unit e d St a t e s fr om impl e m e nt a tion of the r ul e

. F indin g s of the r isk

a ss e ssm e nts ar e summ a r i z e d within this do c um e nt a nd ar e i n c o r po r a t e d

b y r ef e ren c e h e re i n.

C ompli a n c e with N E P A re qui re s A P H I S to c on s i d e r a ll pot e nti a l e f fec ts to

the hum a n e nvi r onm e nt f r om this r ul e

. I

n a ddition to c onsid era tion of

d i s ea se iss u es re l a t e d t o l i v est o c k

, t h i s do c um en t a n a l y z e s c h ar a c t er i z a tion

of the pot e nti a l ef

f ec ts to hum a ns, wildli fe

, a nd e n vi r onm e nt a l qu a li t y

. The in f o r m a tion is p re s e nt e d b y topi c s r e l a t e d to p r og ra m re qu i re m e nts

an d a ss o ci a t e d m it i g a ti v e ac ti on s t h at af f ec t po t en t i a l d i s ea se r is ks

a ss o ci a t e d w ith this p r o p os e d b ee f impo r t a tion r u l e . This in c lud e s

s ec tions with issu e s re l a t e d to the v a c c in a tion p r o ce ss, the m ea t m a tu r a tion

p r o ce ss, the r e g ul a to r y c ont r ol p r o ce ss, the dis ea s e t ra nsmission

m ech a n i sm a s re l a t e d t o wil d l i fe

, a n d t h e p e r sist e n ce o f F MDV und e r

v ar ious e nvi r onm e nt a l c o nditions on or in e nvi r onm e nt a l m e dia su c h a s in

soil, in w a t er , on pl a nts, a nd on a biotic su rf a ce s.

1

. F M DV a nd

V a c c in a t ions F MDV is the mi cr o

- or g a nism t h at ca us e s F MD. F MDVs a r e m e mb e r s of

t h e P i co r n a v i r i d ae fa mi l y a nd vi r us e s of the g e nus Aphtho v irus

. F MDV is

a sm a ll vi r us whi c h is v e r y in f ec tious, multip l y

i n g in a nd ca usi n g d a m a ge

to ce lls th r ou g hout the b od y of su s ce ptible a nim a l s

, a nd whi c h c a n su r vive

in the e nvi r onm e nt f

or e x t e nd e d p er iods of tim e

. F MD is a n a c ut e , h i g h l y

c ont a g ious vi ra l dis ea s e

, m a in l y , but not e x c lusiv e l y , of c lo v e n

- f oot e d

an i m a ls. The r isk to hum a ns fr om F M D V is v e r y sli g ht. C on f i r m e d c a s es

of F MD in hum a ns a r e r a re

. S y mptoms in hum a ns ar e most l y mild a nd

p rim ar i l y in c lu d e fe v e r a nd blist er s on the h a nds, fee t, mouth, a nd to n g u e

. P a ti e nts usu a l l y r e c ov e r within a w ee k a f t e r the l a st blist e r f

o r m a tion

( U S DA

– A P H I S

, 2013 )

. The m a jor host sp ec i e s f

or F MDV is wi d e l y

rec o g n iz e d t o b e do m e st i c ca ttl e

. F MD is ch a r ac t er i z e d b y t h e fo rm a ti on

of l e sions on the fee t a nd mouth, d a m a ge to the mu c ous m e mb ra ne lini n g

the g a st r oint e stin a l s y st e m, a nd hi g h f e v er

. D a m a g e fr om F M DV m a y

a lso o c cu r to t h e h ear t m u s c le ce lls (p a r ti cu l ar l y i n y ou n g an i m a ls )

, t h e

milk

- s ecre ti n g ce lls o f t h e udd e r

, a nd h o r mon e

- pr odu c ing ce lls.

F or F MD to re m a in in a popu la tion, e ac h in f e c t e d a nim a l must in fec t a t

l ea st one oth e r a nim a l. The p r im a r y m e thods in w hi c h F MDV mov e s out10 o f a n i n f e c t e d a n i m a l a r e in ai r

- bo r ne d r opl e ts fr o m the lun g s a nd the

f luid

- f ill e d v e si c l e s; in the s a liv a , u r in e

, f e c e s, s e m e n, a nd milk; s ecre tio n s

fr om the e ye s, no s e , p re p u ce

, a nd v a g in a ; a nd th r o u g h di r e c t c ont a c t with

skin or pi ece s of in f

ec t e d skin th a t m a y d r op o f f t h e a nim a l ( W I N, 2001 ).

I t is a lso po s sible to t ra n s mit F MDV in in fec t e d c a rca ss e s on m e a t, hid e s,

a nd bon e s ( W I

N, 2001 )

. F MDV is c ommon l y s pr ea d b y the mov e m e nt of

i n f ec t e d a n i m a ls; ho w e v e r , the vi r us m a y a lso mo v e ind e p e nd e nt l y outside

of the a nim a l. Hum a ns, t i c ks, bi r ds, r od e nts, d o g s, a nd ca ts m a y c ar r y a nd

sp rea d the vi r us if th e y c ont ac t a n y of the a bov e

- m e ntion e d bo d y

s ub s t an c e s an d

, p ar ti c ul a r l y with hum a ns a nd p r o b a b l y oth e r v er t e b ra t e s,

f or a sho r t time af

t e r th e y h a ve b r e a th e d in the in f e c t e d a i r bo r n e d r opl e ts.

The wind m a y move the a i r

- bo r ne d r opl e ts c ont a i ning the vi r us up to

250 kilom e t er s (k m ) ov e r w a t er

, a nd sh o r t e r dist a n ce s ov e r l a nd ( W I N,

2001 ) . The vi r us must r e e nt e r a sus c e ptible a nim a l in whi c h it ca n

multip l y ; this ca n be th r o u g h inh a l a tion, i n g e stion, s e x u a l t ra nsmission,

c onjun c tiv a l m e mb ra n e s, ino c ul a tion, a nd d a m a g e d skin.

I t is po s sible f

or a nim a ls to carr y F MDV without a pp e ar i n g c lini ca l l y ill

und e r c onditions su c h a s rec ov e r y fr om c lini ca l dis ea se a nd un d e t ec t ed

s ub c li n i ca l d i s ea s e ; n e v e r t h el e ss, r epo r ts o f ca r r i e r an i m a ls i n f ec ti n g

s u s cep t i b l e a nim a ls a r e e x t re m e l y ra r e ( W I N, 20 0 1 )

. Di ff

e ren t st ra in s 3 of

F MD h a v e di ff

e re nt c a p a c iti e s to e st a blish p e r sist e nt in fec tion, a nd the

p r opo r tion of a nim a ls th a t b ec ome c arr i e r s f ollowing e x posu r e to vi r us

v a r i e s d e p end i n g o n th e s ev e r i t y o f t h e ch all e n g e

, but do e s not a pp ea r to

be in f lu e n ce d b y t h e a g e or s e x of the host ( W I N, 2001 ) . The

e st ab l is h m en t o f ca r r i er s is redu c e d i n e n d e mic a r e a s if rou t i n e v a c c i n ati on

is us e d. V acc i n a tion do e s not cau s e a nim a ls to b e c ome F M D V c a rr i er s;

p rop e r l y i n a c ti v a t e d v acc in e , wh e n inj ec t e d into a nim a ls, do e s not g ive

r ise to t h e ca r r i e r st a te ( W I N, 2001 )

.

Th re e g e n e r a l c onditions must be p r e s en t f or a vi r us to p er sist ov e r a lo n g

t er m in a ho s t. F i r st, the vi r us must be a ble to in f e c t ho s t ce lls without

b e ing l e t h a l to the ce ll. S ec ond, th e r e must be m e c h a nisms f or long

- t er m

m a i n t en a n ce o f t

h e v i ra l g e no m e 4 in host ce lls. Thi r d, the vi r us h a s to

a void d e t ec tion a nd e limin a tion b y the ho s t ’ s immune s y st e m (F i e lds,

e t a l., 1996 ) . Vi r us e s h a ve d e vis e d v a r ious st ra t e g i e s to a cc omplish th e se

g o a ls. T h e no r m a l r e sponse of the immune s y s t e m is to d e t ec t an t i g en s 5

a nd e st a blish a n immune re sponse to those a nt i g e n s. A vi r us will modi f y

3 A strain is a taxonomic subdivision of a micro

- organism based on characteristic antigens or proteins.

4 A genome represents all of the genetic information or hereditary material possessed by an

organism or micro

- organism.

5 An antigen is a substance that can trigger an immune response, usually a foreign protein, which is

not found naturally in the body.11 sp ec i f ic a nt i g e ns o r p r ot e ins so a s to e v a de the ho s t ’ s immune s y st e m,

th ere b y e st a blishi n g p er s i st e nt in fec tion in the host. I n t h e ca s e o f F MD,

the modi f i ca tion of sp ec i f

ic a ntig e ns or p r o t e ins g i v e s r ise to a subst ra in of

vi r us.

Giv e n th a t vi r us e s t e nd t o modi f y th e ir a ntig e nic a nd p r ot e in c h ar a c t er isti c s

f o r p er sis t e nt su r viv a l within the ho s t, it is lik e l y th a t F MDV will swit c h

s t ra i n s. Be c au s e v a cc i n ati o n a g a i n s t a cer t a in FMD st ra in do e s not re sult

in p r ot ec tion a g a inst oth e r st r a ins, if a n F M D V st ra in a g a inst whi c h ca ttle

in B r a z il ar e not v acc i n a t e d ca us e s a n outb r e a k, the a nim a ls would be mo r e

l i k e l y to show c lini ca l si g n s a nd the dis ea se would be d e t ec t e d mo r e

qui c k l y

. B ra z ili a n a nim a l h ea lth a utho r iti e s m a y re spond to su c h a n

o cc u r re n c e b y f

ollowing a st a mping out c ou r se o f ac tion whi c h involv e s

the killing of sus ce ptible a nim a ls, the v acc in a tion o f a nim a ls f or the n e w

st r a i n, or a c ombin a tion of b o th with oth e r e m e r g e n c y p r o ce du r e s. No

m a tt e r w h a t st ra in m a y ca u s e a n o utb rea k, MA P A will m a n a g e a n y

outb r ea k in t he s a me m a nn e r

, a nd a s a nit a r y st a t e of e m e r g e n c y will b e

d e c l a r e d with the a c c omp a n y i n g qu a ra ntine a nd m ov e m en t re st r i c ti on s a n d

s an i t a r y m ea s u r e s ( U S DA

– A P H I S

, 2013 )

.

Ad e qu a te p r e p a ra tion f

or up c oming st ra ins of t h e F MDV involv e s re s e a rc h

to p r e di c t f

utu r e st ra ins a nd the p re p ara t i on a nd sto r a g e o f v acc in e s f or

pot e nti a l f

u t u r e outb r e a ks. Di f

f ere nt st ra ins of vi r

us a nd v a cc i n e v a r y in

th e ir a bili t y to stimul a te immune re spon se s. V a cc in a tion with mo r e th a n

one st ra in a t a time n e ith e r e n h a n c e s nor c omp e titiv e l y inhibits re sponse to

the di ffere nt st r a ins. P r obl e ms in d e v e loping e ff e c tive v a cc i n ati o n r e g im e s

fo r a n a re a m a y ar ise re l a t e d t o t h e e x ist en ce o f s ev en di ffere nt

immuno t y

p e s a nd the l a r g e numb e r of s t ra ins a sso c i a t e d with F MDV;

t h e r efo r e , po l y v a l e n t 6 v a cc i n es m a y b e n e ce ss a r y

. V a c c i ne eff i c a c y is

d e p e n d e nt on a numb e r of f ac to r s in c l u din g

—

• the p er c e nt a g e o f the su s ce ptible a nim a l popul a tion v acc in a t e d,

• simil ar i t y b e tw e e n the f i e ld st ra in a nd the v a c c ine st ra in u se d,

• immune re sponse of the i ndividu a l a nim a l,

• time b etw ee n v a cc i n ati o n an d ch all e n g e an d t h e l e v el o f ch all e n g e, a nd

• the mi x ing of sto c k.

a

. V a cc i n a t ion P r a c t i ce s a nd Sa f e gu a rds

C u rren t l y

, B r a z il requ i r e s t h at a ll ca ttle an d bu f f a l o a r e v a cc i n a t e d e v e r y

6 months. V acc in a tion o f ca ttle a nd b u ffa lo is m a nd a to r y in the e x po r t

r e g ion. A n i m a ls ar e v a cc i n at ed twi c e a y e a r o n a s ch e du l e app r op r i a te

fo r e a c h a r e a

. I n s o m e a r ea s, an i m a ls l e ss th a n 2 y e ar s o f a g e a r e

6 A po lyvalent vaccine contains several antibodies (proteins produced by the body as part of its defense), each

capable of counteracting a specific antigen.12 v acc i n a t e d t wo o r m o re tim e s p er y e ar

, a nd some a dult a nim a ls a r e

v a c c in a t e d on l y on c e

. Anim a ls must p ar ti c ip a te in f

our v a c c in a tion

r ounds b ef

o r e th e y ca n be v acc i n a t e d on l y on c e a y e ar

.

T h e v a cc i n e u s ed is a n i n a c ti v at ed

, t r iv a l e n t, oil

- b as e d v ac c i n e. B r az ili a n

l a ws a llow on l y the p r odu c tion of v a cc ine f o r mul a t e d with F MD v i ra l

st ra ins A 24 , C r u z e i r o, O 1 C a mpos, a nd C 3 I n d a i a l. P r odu c tion ca p a c i t y

f o r F M D v acc in e s in B ra z il is ar o u nd 300 million dos e s p e r y ea r

( U S DA

– A P H I S, 2013 )

.

All F MD v a c c in e s p r od u ce d or us e d in B r a z il ar e t e st e d f or qu a li t y a nd

s afe t y

. Q u ali t y con t ro l t e sts o f eac h b a t c h o f t h e v acc i n e ar e condu c t e d i n

the l a bo ra to r i e s in Re c i f

e a nd P o r to Al e g r e a nd st r i c t l y f ollow

i n t ern ati on a l st and a rd s a s s e t b y O I E. A v a cc i n e b a t c h will p ass t he

qu a li t y c ont r ol t e sts wh e n the e x p e c t e d p e r cen ta g e o f p r o te c ti o n i s g r ea t er

th a n or e qu a l to 75 p e rc e nt. Th er e is no e vid e n c e to sug g e st th a t

un ac c e pt a ble biol o g i ca l p r odu c ts or v a c c in e s a r e b e ing us e d in B r a z il.

MA P A m a int a ins a d e qu a te c ont r ol of v a cc ine su p pli e s a nd c ondu c ts

m a nd a to r y r e g ist r a tion a nd t e sting of v a cc in e s f or s afe t y a nd q u a li t y

( U S DA

– A P H I S

, 2013 ).

I n cer t a in c a s e s w h e r e t h e n e e d app ea r s ( s u ch a s in a rea s i n h ab i t e d b y ru r al

l a ndl e ss a nd I ndi a n t r ib e s , or ar e a s d e ns e l y popul a t e d with b ac k y a r d a nd

st ree t ca ttl e)

, v a c c i n ation is sup er vis e d b y a nd s o m e tim e s c ondu c t e d b y

the p er sonn e l of t h e L

V U

. I n some ar e a s with re l a tiv e l y l a r ge numb er s of

sm a ll an d poo r far m er s, a S t a te e m p l o y e e will v a c c i n ate t h e c a ttle a t one

sp ec i f ic lo c a tion. I

n ot h e r ca s e s, l a r g e e st a blishm e nts will s h a r e v a cc i n e

with th e ir sm a ll e r n e i g h b o r s. T his h e lps the sm a ll far m e r a s the v a cc ine is

sold b y the bottle a nd not b y individu a l a nim a l do s e s. Oth er wis e

, far m er s

m a y v acc i n a te t h eir o wn an i m a ls o r h i r e t ra i n e d p r o f

e ssi on a ls. S o m e S t a te

o f f i ce s h a v e e m e r g e n c y f

unds a v a il a ble to a ssist w ith the c ost of

v acc in a tion on I ndi a n re s er v a tions.

V acc i n a tion r ec o r ds m a y be v er i f i e d b y f i e ld insp ec to r s visiting individu a l

p r e mis e s. Fi e ld i n s p e c t o rs m a y requ e st cop i e s o f t h e v a cc i n a ti o n s a l es

rece i p t an d th e v a c c i n at i o n

- use r e c o r ds. L VU p e r sonn e l monitor

v acc in a tion th r o u g h v a c c ine s a l e s. V a cc in e s c a n b e obt a in e d on l y fr om

d esi g n a t e d c o m m e r c i a l e st ab l is h m en t s. O n ce a v a cc i n e is s o l d

, t h e r e co rd

of th a t s a le is f

il e d w ith t h e L

VU. A f t e r a h er d i s v a cc i n a t ed

, the own e r

must p r ovide t h e L

V U w ith a st a t e m e nt/ aff

id a vit do c um e nting the a mount

of v acc i n e us e d. The s t a t e m e nt must be p r ovid e d within 10 d a y s of

v acc in a tion, a nd v acc i n a tion must be c ompl e t e d within a sp ec i f i e d p er iod

o f time af t e r p u rch a s e

. LVU p e r s o n n e l m a t c h the in f o r m a tion on the

own er’ s aff

id a vit to the s a l e s r e c o r ds to d e t er mine wh e th e r the in f o r m a tion

is c onsist e nt. The in f

o r m a tion is a lso us e d to upd a te the ce nsus r ec o r d f or

t h e p r e mis e s. I n a dditio n , v acc i n ati o n r eco r d s ar e co m p a re d t o m ov e m e nt

p e r mits o n a far m

- b y

- f

a r m b a sis f

or a uditing a nd qu a li t y c ont r ol. T h e

re qui re m e nt f

o r v a cc in a t i on a nd v a c c in a tion rec or ds p r ovide a v e hi c l e f or

c ont r ol of a nim a l mov e m e nt a nd f or t h e g e n e r a ti o n o f cen s u s d a t a a t t he13 lo ca l l e v e l. Re g ist ra tion of h er ds with t h e L VU is m a nd a to r y . E a c h

own e r h a s a r e g ist r a tion numb e r f or id e nti f i c a tion. L

V Us m a int a in a list of

individu a l p r op er ti e s, numb e r of a nim a ls, a nd v acc in a tion r ec o r ds f or those

a nim a ls. The ce n s us d a ta a nd in f o r m a tion o n v acc in a tion co m p l i an ce

c oll e c t e d b y L V U p e r s on n e l is p ass e d o n t o F ed e ra l o f f i c i a ls.

The r isk a n a l y sis a sso c i a t e d with this p r opos e d r ul e m a king c on c lud e s th a t

B ra z il condu c ts its F MD v a cc i n e p r o g ra m app r op r i a t e l y an d i n a cc o rd a n ce

with int er n a tion a l st a nd a

r ds ( U S DA

– A P H I S

, 2013 )

. F u r th e r , b a s e d on t h e

p r opo se d miti g a tions a nd c u rre nt mitig a tions a l re a d y in pl a c e in B ra z il, no

si g ni f i ca nt e nvi r onm e nt a l imp ac ts ar e a nti c ip a t e d a s a re sult of a llo w ing

the impo r t a tion of fre sh b ee f f

r om B r a z il ( no r th of the 42 o p a r a ll e l) into

the Unit e d S t a t e s.

b. V a cc in a t ion Com p li a n c e

B ra z ili a n o f

f i c i a ls b e li e v e t h e ov e r a ll co m p l i an ce l ev el fo r v a cc i n ati on

a pp r o ac h e s 100 p e rcen t ( U S DA

– A P H I S

, 2013 )

. The b e st c ompli a n c e

t e nds to be p r ovid e d b y n e i g hbo r i n g ra n c h er s b e c a use th e y w a nt to p r ot e c t

th e ir a nim a ls. T he h i g h c ompli a n c e ra te is s i g ni f i c a nt b e cau s e an i m a l

id e nti f i ca tion is acc omplish e d th r ou g h c ont ac ts m a de du r ing the

v a cc i n ati o n p ro ce ss ( U S DA

– A P H I S

, 2013 ).

Non c ompli a n c e with v ac c in a tion ca n be d e t ec t e d b y l a te f iling or not

re tu r ni n g v a c c in a tion f

o r ms, b y a pp r e h e nsion of i l l e g a l mov e m e nt, or b y

a no n y mous ca ll er s to a n e st a blish e d hotlin e . The o ff i c i a l s er v i c e p r ohibits

a ll a nim a l mov e m e nt fr o m non c ompli a nt far ms until the own e r p r odu c e s

s u f f i c i en t ev i d e n c e t h at t h e an i m a ls w e r e v a cc i n a t ed

. L VU p e r sonn e l

f ollow up with non co m p l i an t far m er s b y h an d

- d e l i v er ing a w a r ni n g l e tt e r

a nd a visit to the p re mis e s. I f the situ a tion w ar r a n ts, ac tion m a y b e t a k e n,

in c luding l e v y i n g a f

i n e ; if this o cc u r s, a S t a te v e t er i n a r i a n v a c c i n at e s t he

an i m a ls a t t h e o w n e r ’ s e x p e n s e . F a ilu r e to va cc in a te m a y re sult in

p e n alti e s o r f

i n es ( U S D A

– A P H I S

, 2013 ).

B ra z il is c oll a bo r a ti n g w i th n e i g hbo r i n g c oun t r i e s in o r d e r to m a ke

d ec isions r e g a rd i n g v a c c in a tion p r og ra ms, as w e ll a s the d e v e lopm e nt of

cr it er ia f o r dis c ontinu a tion of v acc i n a tion. As a r e s u l t o f the 2006

int r odu c tion of the dis ea s e into the e x po r t re g ion, t h e n e e d f o r

int er n a tion a l c oop e ra tion a nd t ra nsp a r e n c y h a s b e c ome v e r y e vid e nt

du r ing re c e nt y e ar s ( U S DA

– A P H I S

, 2013 ).

c

. F M D S ur ve ill a n c e

F MD is c onsid e r e d e nd e mic to most c ount r i e s in S outh Am er i ca

, a nd

outb rea ks of the dis e a se ar e lik e l y to c ontinue to o cc ur in the e x po r ting

r e g ions ( U S DA

– A P H I S

, 2013 )

. I t is po s sible th a t F MD

- a ff e c t e d a nim a ls,

a nim a l p r odu c ts, p e opl e

, a nd v e hi c l e s m a y cr oss d om e stic or int er n a tion a l

bound a r i e s ill e g a l l y

. E f

f ec ti v e F M D s u r v eill an c e p r og r a ms a r e e ss en t i al14 in the p re v e ntion a nd c o n t a inm e nt of dis ea se outb r ea ks. A P H I S h a s

ev al u at e d t h e m o v e m en t an d d e t ec tion c ont r ols in pl ac e f o r B ra z il, a nd h a s

d e t er min e d th a t th e y a r e a d e qu a te to m a int a in a n ov era ll low l e v e l of r isk

of int r odu c ing F MDV to the Unit e d S t a t e s via the p a thw a y of b e e f

e x po r t e d fr om the d e s i g n a t e d r e g ions ( U S DA

– A P H I S

, 2013 )

. T h e F MD s u r v e ill an ce p erfo rm e d i n B r a z il ca n b e b r o a d l y ch a rac t er i z e d as

h a ving two p h a s e s: ( 1) d e monst ra ting f r e e dom fr o m dis ea se in a z on e

,

a nd ( 2) monito r ing o f th a t z on e . A P H I S c onsid er s B ra z il to h a ve

im p l e m en t e d e ff

e c ti v e d i s ea se s u r v e ill an ce st r a t e g i e s fo r t h e p r opo s e d

e x po r t re g ions, a nd is not re qui r i n g a ddition a l m e a su re s f or this miti g a tion

( U S DA

– A P H I S

, 2013 )

.

2

. F M DV a nd

B e e f

P r o c e ss ing B ra z il e m p l o y s d u a l “ a c ti v e” an d “p assi v e” s y st e m s o f s u r v eill an ce w h i ch

ar e d es i g n e d to d et ec t t h e p r e s en c e o f d i s e a s e . T h e du a l s y s t e ms a lso

p r ovi d e a b asis f

o r d em o n s t ra ti n g f

reedo m f ro m F MD ov e r c er t a in a rea s o r

p er iods of tim e . G e n e ra ll y sp ea ki n g , the p a ssive s u r v e ill a n c e g a th er s

qu a lit a tive in f

o r m a tion a bout F MD, an d t h e ac ti v e s u r v eill an c e g a t h e r s

qu a ntit a tive d a t a

. P a ssive su r v e ill a n c e in both c o unt r i e s is bolst ere d b y

eff e c tive c ommuni t y e d u ca tion a nd involv e m e nt, while the bulk of ac tive

su r v e ill a n c e c onsists of the a nnu a l s e r olo g i ca l s a mpling of ra ndom l y

s e l ec t e d a nim a ls a nd r e gul a r su r v e y of h i g h er

- r isk a rea s ( U S DA

– A P H I S,

2013 )

.

Anim a l p r o ce ssi n g ca n l e a d to e x posu r e a nd sp r ea d of F MD. On l y c a ttle

fr om p r odu c tion a r ea s ce r ti f i e d und e r the re qui r e m e nts of the p r opos e d

r ule would be a cce p t e d f

or sl a u g h t er

, a nd p r o ce ss i ng would o c c ur on l y a t

a pp r ov e d f

ac iliti e s in the e x po r

t re g ions of B r a z il. Miti g a tions du r ing

p r o ce ssi n g will be re qui r e d to a llow f or the d e t ec t ion a nd re mov a l of

a nim a ls sho w ing c lini c a l si g ns of dis ea s e

, re mo v a l of a nim a l p ar ts whi c h

ca n c ar r y F MDV, a nd m a tu ra tion of the b e e f in o r d e r to in ac tiv a te a n y

F MDV whi c h m a y be p r e s e nt a nd und e t e c t e d. I n co rr e c t l y p ro c e s s e d b ee f

m a y h ar bour F MDV a nd d e v a st a te e x pos e d dom e s tic a nd wild a nim a l

popul a tions, polluting the e nvi r onm e nt with m a s s ive ca r ca ss dispos a ls, as

w e ll a s a dv e r s e l y a f

fec ti n g the hum a n ec ono m y a n d f ood supp l y

.

A cr iti ca l miti g a tion m ea su r e a f fec ti n g the int r od u c tion po te nti a l of m a n y

e x otic vi r us dis ea s e s is the d r op in the pH of m e a t whi c h a c c omp a ni e s

r i g or mo r tis ( mus c u l a r sti ffe ni n g f ollo w i n g d ea t h )

. F MDV is s e nsitive to

pH a nd ca nnot su rv i v e in s k el e t a l m u s c le af t e r r i go r m o rtis h as d e v el op e d;

t h e re s u l ti n g accu m u l a ti o n o f l ac tic a c id s u f f i c i en t l y d e cr e a s e s t h e p H.

Vi r us su r viv a l is optim a l b e tw ee n pH 7.2 a nd 7.6; a t pH v a lu e s a bo v e 9 or

b e low 6, the vi r us is ra p i d l y d e st r o y e d. As lo n g a s m ea t is m a tu ra t e d to a

pH b e low 6, F M D V is in ac tiv a t e d, if p r e s e nt ( AV I S , 2002 ).

I t is g e n era l l y a ccep t e d th at F MDV in an i m a l tis s ue is tot a l l y in ac tiv a t e d a t

pH 6 or b e low a f

t e r 48 h ou r s a t a t e mp e r a tu r e o f 4 o C

. O I E reco m m end s a

minimum m a tu ra tion ti m e of 24 hou r s, an d a p H v a l u e l e ss t h an 6 f o r b eef15 w h e r e v acc i n a ti o n i s p r a c ti ced

. C u rren t l y , p r o c e s s ing f a c iliti e s in the

B ra z ili a n e x po r

t r e g ions f

ollow the Eu r op ea n Union ( EU) st a nd a r ds of a

minimum of 24 hou r s of m a tu ra tion a t 2 to 10 o C

, a nd re j e c tion of

m a t u r a t e d c ar c a ss e s with a pH g r e a t e r t h an 5.9.

A P H I S is re qui r i n g a ll bovine ca r ca ss e s f r om the e x po r t re g ions be

a llow e d to m a tu ra te a t 40 to 50 oF ( 4 to 10 o C ) f or a minimum of 36 hou r s

af t e r sl a u g h te r an d

, a t the e nd of the m a tu r a tion p r o ce ss, a pH o f 5.8 or

l e ss is reac h e d ( U S DA

– A P H I S

, 2013 )

. T h e d i s e a se r isk a n a l y sis m e ntio n s

th a t a long e r m a tu r a tion time of 36 hou r s mi g ht n o t be e x p ec t e d to re sult

in a hi g h e r re

j ec tion ra te th a n the one c u r re nt l y o b s er v e d in B ra z il.

I n cr e a si n g t h e m a t u r a tion time fr om 24 to 36 hou r s, how e v er , is b e li e v e d

to e nsu r e th a t the p r op o r tion of ca r ca ss e s r e j ec t e d will not be si g ni f

i ca nt l y

mo r e th a n h a s b e e n obs e r v e d p re vious l y in B r a z il. A lon g e r m a tu ra tion

p er iod is suppo r t e d b y s c i e nti f ic e vid e n c e th a t th e r e is a g r ad u a l t rend

tow ar ds low e r p H with time a nd th a t the pH a v er a g e s 5.6 to 5.8 af t e r 48

hou r s of a g i n g

, a ltho u g h the pH do e s t e nd to r ise s li g ht l y af t e r 72 to 96

hou r s of m a tu ra tion ( C ott ra l e t a l., 1960 )

.

T h e sl a u g h t e r p r ot o c ols, whi c h will be re qui r e d u nd e r the p r opo s e d r ule

fo r a ll o wi n g b e e f fro m B ra z il to be e x po r t e d to t h e Unit e d S t a t e s, a r e

d e si g n e d to mitig a te the r isk of F MD in ca ttle s e nt to be sl a u g ht e re d a nd

p r o ce ss e d f

or e x po r t. T h e p r opo se d mitig a tions will util i z e e xisting

t ec hnolo g y a nd g ov er n m e nt in fra st r u c tu r e in B ra z il, a nd ar e d e s i g n e d to

re du c e t h e r isk of F MD o utb rea ks in the Unit e d St a t e s b y mit i g a ti n g r isk

of the dis ea se in the e x po r t r e g ions. Th e r e a r e no a dv er se e nvi r onm e nt a l

con s equ e n c e s e x p e c t e d i n Bra z il or the Unit e d S t a t e s due to

impl e m e nt a tion of the b e e f p r o c e ssing re qui r e m e n ts in the d e si g n a t e d

r e g ions und e r the p r opo s e d r ul e

.

T h e cu rr en t B ra z ili a n risk m iti g a ti o n p r o c e ss e s e v a l u at e d b y A P H I S a r e

c onsid ere d a d e qu a t e a nd will be in c o r po ra t e d a s p ar t o f the r equ i re m en t s

fo r t h e p r e fe r re d a lt ern at i v e ( U S DA

– A P H I S

, 2013 )

.

3

. R e gul a t o r y

Con t rol of

F MD Fed e ra l, S t a t e

, an d l o c a l v et er i n a r y au t ho r iti e s en f o r c e t h e an i m a l h e a lth

l a ws in B r a z il. MA P A e st a blish e s an d e n f o r ce s a nim a l h ea lth r e g ul a tions

a t the n a tion a l l e v e l in B r a z il to p re v e nt the int r odu c tion a nd sp rea d o f

an i m a l p ests an d d i s ea s e s

. B ra z il h a s institut e d n a tion a l a nim a l

id e nti f i ca tion s y st e ms. D om e stic mov e m e nt c ont r ols ov e r a nim a ls a r e

st r in g e nt a nd ar e link e d t o F MD

- v a cc in a tion c o v e r a g e . Th r o u gh th e se

F MD r e g u l a tions, the g o v er nm e nt c ont r ols the m ov e m e nt of ca ttle fr om

one lo ca tion to a noth er

. MA P A, Fe d e ra l a nd S t a t e v e t er in a r y f a c iliti e s,

an d ac cred i t e d v e t er i n a r i an s a ll p la y a ro l e in en s u ri n g t h e h ea lth of

liv e sto c k in B ra z il.

T h e e st ab l is h m en t o f e f

f e c tive su r v e ill a n c e a nd m onito r ing of sus c e ptible

liv e sto c k ar e a lso impo r t a nt in p re v e nti n g a nd limiting F MD outb r ea ks.16 B ra z il is in the f

in a l st a ge of impl e m e nting the n a tion a l id e nti f i ca tion

s y st e m ( S I SB OV) f

o r ca t tle an d bu f

fa l o

. Th e g o al o f S I S B OV is to

individu a l l y i d e nti f

y a nd monitor a ll ca ttle a nd bu f fa lo e s bo r n or impo r t e d

into B ra z il. T he s y st e m i s d e si g n e d to t r ac e a nim a ls fr om bi r th to d e a th,

a nd p ar ti c ip a tion h as b e e n m a nd a to r y f or a ll b e e f p r odu cer s si n c e the e nd

of 2007 ( U S DA

– A P H I S

, 2013 ).

To a void dis ea se int r od u c tion a nd sp rea d, B r a z il op e ra t e s dom e stic

c h ec kpoints, a nd th e ir in t er n a tion a l bo r d er s a r e m onito re d in a r e g ion a l

d i s ea s e

- c on t r ol eff

o r t. E v e n so, dis ea se t r a nsmission into a nd fr om

ad j acen t coun t r i e s h as o c cu r red

. I n a r ea s w h er e n a tu ra l b a r r i er s do not

e x ist, a n d a t s ea

, ai r

, a nd l a nd po r ts of e nt r y

, B ra z i l h a s e nh a n c e d

g ov e r nm e nt a l p r oto c ols t o p r ot ec t th e ir a nim a l p o pul a tions a g a inst F MD.

B o r d e r su r v e ill a n c e a nd e x t e nsive bios ec u r i t y m e a su re s a r e in pl a c e to

c ont r ol the mov e m e nt of p e opl e

, a nim a ls, a nd g o o ds a s th e y e nt e r the

c ount r y

. I mpo r ts of F MD

- sus ce ptible liv e sto c k f r om a pp r ov e d c ount r i e s

ar e qu a ra ntin e d a nd t e st e d. I mpo r ts of live F MD

- s u s cep t i b l e an i m a ls a r e

p r ohibit e d fr om F M D

- a ff ec t e d c oun t r i e s a s s u ch a n i m a ls ar e c onsid e re d

pot e nti a l sou rce s of F M DV. B r a z il p ar ti c ip a t e s with oth e r S outh

Am er i ca n g o v ern m en t s i n t h e C u e n ca d el P l a ta A g r ee m en t

— a h ar m on i z ed

r e g ion a l subp r o g r a m of the P ANA F T O S A H e mi s ph er ic P l a n f or the

E ra di ca tion of F MD

— in re po r ti n g a nd r e sponding to dis ea se r isks in

n e i g hbo r i n g c ount r i e s. S in c e 2006, B ra z il h a s join e d A r g e ntin a

, U r u g u a y

, P ar a gu a y

, a nd B olivia in crea ti n g bu f fe r z on e s wi t h int e nsive mutu a l

su r v e ill a n c e a long t h e ir n a tion a l bound ar i e s. The bu ffe r ar e a f or B r a z il is

app r o x im a t e l y 15 km to e it h er si d e o f t h e b o rd er i t s h a re s with t h ese

c ount r i e s.

A P H I S c ond u c t e d site v i sits to B ra z il in 2002, 2 0 03, 2006, 2008 , and 2013

. The l a st re po r t e d outb r ea

k of F MD in B ra z il o cc u rr e d in 2006. A P H I S

e v a lu a t e d d o c um e nt a tion p r ovid e d b y MA P A a nd s c i en t i f ic lit era tu re

. The

c on c lusion re a c h e d b y A P H I S ’ dis e a s e

- p a th w a y a n a l y sts is th a t the r isk is

l o w fo r F M D

- con t a mi n a t e d b e e f en t er i n g t h e U n i t e d S t a t e s fro m the

p r opos e d e x po r

t r e g ions in B ra z il an d , thus, l o w f o r p r e s en t i n g a t h r ea t to

U. S . liv e sto c k via feed i n g o r con t ac t with s u s cep t i b l e an i m a ls ( U S DA

–

A P H I S

, 2013 ) . To d a y

, A P H I S c onsid e r s th a t B r a z il ’ s MA P A poss e ss es

su ff i c i e nt l e g a l a uth o r i t y to carr y out o f f i c i a l c ont r ol, era di ca tion, a nd

qu ara ntine a c tiviti e s f

or a nim a l h ea lth p r og ra ms, a nd th a t the c ount r y h a s

d e monst ra t e d a n in f

ra st r u c tu r e a d e qu a te f

or r a pid d e t ec tion of F M D a nd

f or c a r r y i n g out su r v e ill a n c e a nd era di c a tion p r o g r a ms ( U S DA

– A P H I S,

2013 )

. C arca s s e s a nd c u t s of m ea t, wh e n p r odu c e d und e r a d e q u a te

r e g ul a tion, p re s e nt a lo w e r h ea lth r isk a nd a r e simpl e r to t rac k the point of

o r i g in th a n oth e r a nim a l p r odu c ts ( B a r c os, 2001 )

. Thus, to miti g a te the

pot e nti a l r isk a sso c i a t e d with impo r ting F MD

- co n t a mi n at e d b e e f an d b e ef

p r odu c ts, the p r opos e d r u le in c o r po ra t e s a s y st e ms a pp r o ac h simil a r to th at

f or the impo r t a tion of U r u g u a y a n b e e f into the U n it e d S t a t e s.17 I n the Unit e d S t a t e s, A P H I S p r ovi d e s F e d e r a l r e gul a tion, a ssist a n ce

, a nd

in f o r m a tion c on c e r ning F MD, a nd op e r a t e s a n o n going s y st e m of

e m e r g e n c y re s pon s e an d d i s ea se con t ro l s ( U S DA

– A P H I S , 2002 ) . T h e

e x po r t re qui re m e nts of t h e p r opos e d r u l e r e f l ec t n o r ms a nd p r o c e du re s th a t

h a ve b e e n shown to a llow s af e e x po r t of un c ook e d m ea t a nd m ea t

p r odu c ts fr om F M D

- a ff

e c t e d S outh Am er i ca n r e gions

( P ANA F T O S A/Tusk e g e e , 1995 )

. R e c e nt outb re a ks of F MD in the

Unit e d Kin g dom a nd a s usp ec t e d c a se of the di s e a se in a dom e stic h e r d of

swine in Minn e sota p r ovid e d oppo r tuniti e s to t e st the F MD p r o g ra ms in

p l ac e in t h e Unit e d S t a t e s ( U S DA

– A P H I S , 2007; D J I N, 2007 ) . A simil a r

re sponse s c e n ar io is lik e l y should a n F MD ep i d e m ic b e cau s e d b y t he

impo r t a tion of b ee f f

r om B ra z il. F or e x a mpl e , should a n insp ec to r

, far m er

, o r oth e r individ u a l re po r t a suspi c ious c a s e

, Fe d era l a g r i cu l t u re

a nd n a tion a l s ec u r i t y p e r sonn e l would be d e pl o y e d, f ollow e d b y

involv e m e nt, a s n e ce s s a r y

, of the D e p a r tm e nts of S t a t e , T ra nspo r t a tion,

a nd H ea lth a nd Hum a n S er vi ce s. A q u ara ntine a r e a would be e st a blish e d,

tiss u e s a m p l e s w ou l d b e an a l y z e d, a nd l a b d e t e r m in a tions publish e d.

D e p e ndi n g on ju r isdi c tion, Fe d e ra l or S t a te a utho r iti e s re g u l a te the

m e thods a nd m a t er i a ls u s e d f or a nim a l mov e m e nt, v acc in a tion, c ulli n g

a nd ca r ca ss dispos a l, c l ea ning a nd disin f e c tion, a n d su r v e ill a n ce

.

G e o g raph i c ch a rac t er isti c s ( su c h a s r iv er s, moun t a ins, s e mi

- ar id, a nd

fo r e st e d a r e a s) a lo n g the bo r d er s of the F MD

- fr e e e x po r t re g ions p r opo s e d

f or B ra z il ca n p r ovide n a tu ra l b arr i e r s a g a inst the sp rea d of dis e a s e s, su c h

a s F MD. B ra z il, how e v e r , h a s num er ous int er n a l a nd e x t er n a l

ju r isdi c tion a l bound ar i e s with fe w or no n a t u ra l b a rr i er s ( U S DA

– A P H I S,

2013 )

. I n a r ea s w h er e n a tu ra l b arr i e r s do not e x is t

, B ra z il h a s e st ab l is h ed

bu ffe r z on e s, c h ec kpoin t s, a nd mo r e int e nsive g o v er nm e nt a l c ont r ols.

Althou g h in B ra z il the pot e nti a l re m a ins f or int r o d u c tion of F MDV b y

a nth r op o g e nic m e a ns, th er e is no e vid e n c e a v a il a ble to subst a nti a te

wildli f e popul a tions a s a possible r isk fac tor f o r s p rea di n g F M D to

dom e stic sp ec i e s in e ith e r e x po r t re g ion ( U S DA

– A P H I S

, 2013 ) . This is

dis c uss e d f

u r th e r in the n e x t s ec tion.

4

. In t e r s p e c i es

Tr a n s mi s s ion

of F MD F MD is one of the most c ont a g ious a nim a l dis e a s e s known ( A V I S / O I E,

2000 ) . Althou g h r a r e

, h u m a n c a s e s h av e o c cu r r e d ; F MD is not c onsid ere d

z oonotic und e r n a tu ra l c o nditions ( Ens er ink, 2001; AVMA, 2007 )

. N a tu ra l in f

e c tion w ith FMDV h a s b ee n re po r t e d wo r ldwide in a nim a l

fa mili e s, in c luding the B ovid a i, C er vid a i, S uid ae

, T a y a s u i d a e

, C a m e li d a e,

Gi raff id a e , E r in a ce id a e

, Mu r id ae , El e ph a ntid a e

, T a pi r id ae

, a nd U r sid a e

( Mou c h a nt a nt e t a l., 2005 ) . T ra nsmission b e tw e e n sus ce ptible c lov e n

hoo fe d wild a nd dom e st i ca t e d a nim a ls is possibl e

, a nd is known to h a ve

o cc u r r e d on c e in the Unit e d S t a t e s in 1924 ( R h y a n e t a l., 2006 ) . The vi r us

m a y a lso be t ra nsmitt e d m ec h a ni c a l l y b y hum a ns a nd nonsus ce ptible

a nim a ls, su c h a s r od e nts a nd bi r ds.18 F MD c a n c au s e b l ist er s a n d f lu

- like s y mptoms in hum a ns, a nd l a sting

d e bilit a tion or d ea th in c lov e n

- hoo fe d a nim a ls. T h er e is no known

t rea tm e nt f

or F MD ( A V MA, 2007 )

. S e v er i t y of t he dis ea se a nd

e x p re ssion of s y

mptoms ca n v a r y g r e a t l y

, e v e n w i thin a sp ec i e s. S h ee p

ar e g e n e r a l l y con s i d e re d to b e “ c a rr i er s

, ” w h i le s w i n e ar e “a m p l i f i er s” and

ca ttle a r e “ i nd i ca t o r s ” ( C I D R A P , 2007 )

. Although o cca sion a l l y F M D ca n

be v e r y d e st r u c tive to wildli f e popul a tions (f

or e x a mpl e , the S outh A fr i ca n

imp a la in the l a te 19th c e ntu r y or moun ta in g a z e ll e s in I s rae l mo r e

rece nt l y ( S himsho n y e t a l., 1986; Thomson e t a l., 2003 ))

, g e n e ra l l y F MD

“re s u l ts in a re l a ti v e l y m i ld d i s ea se fro m w h i c h t h e af f ec t e d an i m a ls

recov e r in a w ee k o r tw o

. T h e si g n i f i c an c e o f t h e d i s ea se fo r wil d l i f e li es

l ar g e l y in the pot e nti a l th a t c lov e n

- hoo f e d wild a n im a ls h a ve f

or

t ra nsmitting the dis ea se t o dom e stic liv e sto c k . . .” ( Thomson e t a l., 2003 )

.

E x p er ts g e n e ra l l y c on s i d e r the t ra n s fe r o f F MD f r om wildli f

e to do me stic

a nim a ls to be unlik e l y

. I n m o s t ca s e s, it do e s no t app e a r t h a t F MD can

long su r vive ind e p e nd e n tl y of dom e sti c a t e d a nim a ls. A f t e r F MD h a s b e en

erad ic a t e d f

ro m li v est o ck in A fr i ca

, f o r e x a m p l e

, “ it h as a lso ge n era l l y

dis a pp ea r e d fr om wildli f

e in those r e g ions . . . W ildli f e a pp e a r to h a ve

b ee n a n e x t e nsion of the dis ea se in liv e sto c k” ( T h omson e t a l., 2003 ).

T h e r e ar e s ev e r a l w a y s t h a t the vi r us m a y be t ra n sf erre d b e tw e e n w ildli f

e

a nd sus ce ptible liv e sto c k ( U S G S , 2001; W DN R

, 2 003 )

—

• e x posu r e to in fec t e d s a l i v a

, fe c e s, u r in e , milk, s e m e n, m ea t, a nd m e a t

b y p r od u c ts of in f

e c t e d a n im a ls;

• e x po s u re to v i ra l p a r ti c l e s carr i e d v i a wind, a nim a ls, or on vi r tu a l l y

a n y ob j ec t ( f ar m e quip m e nt, h a y , sho e s, e t c

. ) ;

• d r inking f

r om a c ommon sou rc e of c ont a min a t e d w a t er ; and

• e x posu r e to ra w or imp r o p er l y c ook e d in f ec t e d g a r b a g e

.

I n o r d e r to c o ndu c t a tho r ou g h a n a l y sis of the e f f e c t th a t the p r opos e d r ule

c ould h a ve on the hum a n e nvi r onm e nt in the Unit e d S t a t e s, A P H I S

e x a mi n ed t h e con s equ e n ce s o f t h e mov e m e nt of F MDV b e tw e e n wild

a nim a ls a nd do me stic liv e sto c k w ithin B ra z il a nd su rr ounding r e g ions, a s

w e ll a s within the Unit e d St a t e s. Su cce ssive s er o l o g i c a l su r v e y s h a v e

b ee n c ond u c t e d sin c e the l a st F MD outb r e a ks in B ra z il, in c luding a r ea s in

the p r opos e d e x po r t r e g i ons wh er e wild a nim a ls m a y b e in c ont ac t with

do m e stic s p e c i e s; s u r v e y re s u l ts h a v e no t re v ea l e d ev i d e n ce o f v i ral

ac tivi t y in do me stic r um i n a nts lik e l y to h a ve c ont a c t with w ildli f e

( U S DA

– A P H I S

, 2013 )

. This c ould indi ca te th a t the vi r us do e s not su r vive

or is not p re s e nt in lo ca l sp ec i e s of wildli f e ca p a b l e of c a r r y i n g or b e ing

in fec t e d w ith F M DV.

The po s sibili t y re m a ins t h a t wildli f e in the e x po r t r e g ions a nd n e i g hbo r i n g

area s m i g ht b e c ome in f

e c t e d with or t ra nspo r t F MDV an d

, b y th e ir n a t ur a l

mov e m e nt, i n f

ec t F M D

- f

re e liv e sto c k b e ing c onsid ere d f o r e x po r t,

ultim a t e l y re sulting in c o nt a min a t e d m ea t b e i n g i mpo r t e d into the19 Unit e d S t a t e s. F MDV ca n su r vive f or lo n g p e r iods in m ea t ( EU F MD,

2007 ) . On c e vi r u s

- in f

e c t e d m ea t e nt e r s the Unit e d S t a t e s, sus ce ptible

liv e sto c k a nd wildli f

e m a y be a t r isk of c ont r ac ti n g a nd s p rea di n g the

d i s ea s e

. N o rth A m er i ca n wil d l i f e ( in c luding whit e

- t a il e d d e e r a nd oth e r

d ee r sp e c i e s, f

era l p i g s, b ison, moos e

, a nt e lop e , p e ccar i e s, musk o x

,

car ibou, sh e e p, an d e lk) a r e known to be sus c e ptible to F MD, a nd would

lik e l y be t a r g e t e d f

or e r a di ca tion in the vi c ini t y of F MD outb r e a ks ( U S G S

, 2007 a ; U S G S , 2007b )

. L oss of liv e sto c k, ra r e sp e c i e s a nd h a bit a t due to

the c ulling p r o ce ss, the p ollution of the e nvi r onm e nt fr om m a ss ca r ca ss

dispos a ls, a nd in crea s e d d a ng e r to hum a ns a nd a n im a ls fr om wid e sp rea d

d i si n f ec t an t o r o t h er ch e mi ca l u s e s ar e a ll li k e l y i n t h e ev e n t o f a n F MD

outb rea k ( P into, 2004 )

.

Althou g h unlik e l y , th er e is the pot e nti a l f or wildli f e to sp rea d F MD into

the p r opos e d e x po r t r e g i on. T h e A P H I S d i s ea se r isk a n a l y sis f o r t he

p r opos e d r ule indi ca t e s th a t th er e is no e vid e n c e t o sug g e st th a t F MD m a y

e x ist in w i ldli f

e in B ra z il. MA P A o ff

i c i a ls b e li e v e th a t B r a z il ’ s wildli f e

do e s not c onstitute a r isk fac tor f o r sp r e a di n g F M D to dom e stic a nim a ls.

T h ese o f f i c i a ls i nd i ca t e d to A P H I S t h at ov e r t h e c ou r se o f m a n y y e ar s of

c omb a ting the dis e a s e

, n o c onsist e nt re l a tionship b e tw ee n outb r ea ks of the

d i s ea se in do m e stic an i m a ls an d c o e x ist en ce o f s u s cep t i b l e wild a n i m a ls

h as ev er b ee n con f

i r m e d ( U S DA

– A P H I S

, 2013 ).

N on e t h el e ss, s c i en t i f

ic s t ud i e s in the Unit e d St a t e s h a ve not d e t er min e d

th a t a re l a tionship do e s n ot e x ist. Mu c h is s till u n known a bout the r isk of

wildli f e b ec oming i n fec t e d w ith F MD or how lik e l y wildli f e a r e to in f

e c t

liv e sto c k. “ All c lov e n

- h oo f e d a n i m a ls an d C a m e l i d ae

. . . ar e s u s cep t i b l e

to in fec tion w ith F MD v i r us e s but the f a c ili t y with whi c h di ffe r en t s p e c i es

an d e v en b r eed s o f an i m a ls d e v el o p c li n i ca l d i s ea s e v a r i e s .

. . This

v ar i a tion is l a r g e l y qu a n t i f i e d in the ca se o f dom e stic a nim a ls but f or most

sp ec i e s of wildli f

e th e ir r e l a tive sus ce ptibili t y is u nkno w n . . . With a fe w

e x cep t i on s

, e x cre tion a nd t ra nsmission of F MD b y wildli f e h a s not b ee n

studi e d in a n y d e t a il. F or th a t rea son mu c h of wh a t is c u rre nt l y a c ce pt e d

in th a t re g ar d h a s b ee n e x t ra pol a t e d fr om wh a t is known to o cc ur in

dom e stic sp ec i e s ( Thom s on e t a l., 2003 ) .” I t is di f f i c ult to di a g nose F MD

in wil d l i f e b e cau s e s y

m p t o m s ca n v a r y g r ea t l y

. T h e d i s ea se t end s to be

sub c lini ca l l y e x p re ss e d, a nd p h y s i ca l e x a min a tions of wild popul a tions ar e

di ff i c ult to car

r y out ( T h omson e t a l., 2003 )

.

a

. The Ex port R e gi o n a nd S urrounding C oun t ri es

W hile F MDV ca n b e t ra n smitt e d ov e r long dist a n c e s a nd re m a in vi a ble f or

up to 15 w ee ks und e r c e r t a in c onditions ( U S DA

– A P H I S

, 2013 ) , t he

pot e nti a l f

or t ra nsmission b e tw ee n w ildli f e a nd d o m e stic liv e sto c k in

B ra z il is o ff

s e t b y st r i c t n a tion a l su r v e ill an ce p r o g r a ms an d a n i m al

mov e m e nt c ont r ols ( U S DA

– A P H I S

, 2013 )

. S u c ce ssi v e s ero l o g i c al

su r v e y s of c a ttle a nd/or s h ee p h a v e b ee n c ondu c t e d b y o f f i c i a l v e t e r in a r y20 s er vi ce s in the d e s i g n a t e d e x po r t re g ions of both c ount r i e s, in c luding

l o c a ti on s w h e r e wild anim a ls m a y c o m e into c ont ac t with do me stic

liv e sto c k; the su r v e y re s u lts h a ve re v e a l e d no e vi d e n c e of v i ra l a c tivi t y

( U S DA

– A P H I S

, 2013 ).

G e n e r a l l y , vi r a l t ra ns f

e r of F MD is possible wh e n wildli f e a nd liv e sto c k

e x ist wit h in c lose p r o x i m i t y to one a noth e r . The A P H I S r isk a n a l y sis for

fre sh b e e f f

r om B r a z il c onsid e r g e o g r a phic b a r r i e r s a nd int er n a tion a l

bo r d er s in t er ms of the l e g a l a nd ill e g a l mov e m e nt of dom e stic liv e sto c k

an d p r o c e s s e d m ea t ( U S DA

– A P H I S

, 2013 ) . Th e se ar e a s cou l d also be

c onsid ere d t e mpo r a r y r e s ervo i r s fo r F MDV if wildli f e b ec om e s in f

ec t e d.

W ildli f e m a y mo v e a c r o s s t ra v er s a b l e n a tion a l b o und ar i e s a nd in f ec t

oth e r wildli f

e a nd liv e st o c k b y m ea ns su c h a s sh a r ing c ont a min a t e d

w a t er

, e x po s u re to i n f

e c t e d s a li v a, f

e ce s, o r u r in e

, or m ech a n ic a l t ran s f er

of the vi r us.

The int er sp ec i e s t ra ns f

e r of F MD is possible if wildli f e a nd liv e sto c k e x ist

wit h in c lose p r o x i m i t y to e a c h oth er

. P o r tio n s of the d e s i g n a t e d e x po r t

re g ion in B ra z il a r e within the Am a z on Ri v e r B a sin w h e r e m o re th a n one

thi r d of a ll id e n t i f

i e d wildli f

e sp ec i e s in t he wo r ld m a y be f ound ( WW F

, 2007 )

. C er t a in lo ca tions within B ra z il e x po r t r e g ions bo r d e r d e nse

woods, indig e nous re s er v a tions, a nd op e n l a nd wh er e re sid e nt a nim a ls

m a y t r a nspo r

t or be in fec t e d with F MDV ( U S DA

– A P H I S

, 2013 ; C a né e t

a l., 2004 )

. W hile the A P H I S r isk an a l y s e s c onsid e r su c h a r e a s eff e c ti v e

b a r r i er s r e l a ti v e to t h e t ran s fe r o f li v est o c k

, t h ese a rea s cou l d be

c onsid ere d r e s er v oi r s f

or the vi r us if wildli f

e th er e b eca me in f

ec t e d. I t is

in su c h n at u r a l a r ea s w h e r e wildli f e h a s the pot e nt i a l to b ec ome in f e c t e d

or c ome into p h y s i ca l c o nt ac t with the F MD

- in f e c t e d liv e sto c k. Wildli f

e

c ould th e n t ra v e l a nd c o me into c ont ac t with F M D

- f r e e li v est o ck, t h e r e b y

i n f ec ti n g s u s cep t i b l e an i m a ls b y con t a mi n ati n g s h a re d w a t e r r e sou r c e s,

b y t h e r e l ea s e o f con t a mi n at e d s a li v a, f ece s, o r u r i n e, o r b y m ec h an i cal

t ran s fe r o f th e v i ru s

.

C er t a in wild a n d do m e stic s p e c i e s m a y b eco m e i n fec t e d an d s h ed t h e vi r us

without showing c lini ca l si g ns, thus ac ti n g a s c arr i er s of F MD ( U S G S

, 2001; Kit c hing a nd H u g h e s, 2002; Thomson e t a l

. , 2003 )

. F MDV can

su r vive up to 91 hou r s on the fea th e r s of live bi r ds a nd ca n p a ss un a lt ere d

th r ou g h th e ir d i g e stive s y st e m ( W DN R , 2003 ) . N e ith e r do e s the p a thw a y

n e e d t o b e a li v e i n f

ec t e d o r ca r r i e r an i m a l. I n f e c tious l e v e ls of vi r us ca n

s u r v i v e in cl ea n e d, s a lt e d

, a nd d r i e d int e stine d e st i n e d f or s a u s a g e c a si n g

,

or in the c lothing or n a s a l p a ss a g e s of hum a n t r a v e l er s ( H aa s a nd K ra m e r

, 2000; S c ho e ni a n, 2005 )

.

I n B r a z il a nd su rr ounding c ount r i e s, th er e is the p ot e nti a l f or wildli f e to

c onsume or c ome into c o nt ac t with vi r us

- con t a m i n at e d g ar b a g e p r e s en t in

liv e sto c k fee d or l a nd f

ill sit e s. A P H I S c onsid e r s the fee di n g o f

con t a mi n at e d w a ste to s wi n e ( whi c h m a y th e n t r a nsmit the vi r us to oth e r21 liv e sto c k popul a tions) to be the p r im a r y p a thw a y f or F MDV int r od u c tion

( U S DA

– A P H I S

, 2013 )

. B e c a use of t h e r isk p re s e nt e d b y F MD

con t a mi n at e d w a st e

, B r az il p r ohibits fee ding unt r ea t e d swill to a nim a ls,

an d i n ci n e ra t e s w a ste a n d oth e r c on f is c a t e d p r od u c ts fr om th e ir

int er n a ti on a l a i rpo r ts a nd s ea po r ts, both of whi c h l e ss e n the possibili t y f or

v i ra l e x posu r e to wild or fera l a nim a ls ( U S DA

– A P H I S

, 2013 ).

b. The Uni t e d S t a t e s

T h e U n i t e d S t a t e s h as r e t a i n ed an F MD

- f re e s t a tus sin c e 1929 ( AVMA,

2007 )

. P r ohibition of i m

po r t a tion of live r umin a n ts a nd swine a nd th e ir

p r odu c ts fr om F M D

- a ff

e c t e d c ount r i e s, a nd the a v oid a n c e of c ont ac t with

liv e sto c k, z oo a nim a ls, an d wildli f e b y r e tu r ni n g t ra v e l e r s c ontinu e s to be

c onsid ere d e ss e nti a l f

or p re v e nti n g F MD out b rea k s ( AVMA, 2007 )

. How e v e r , th er e is the po t e nti a l f or int er sp e c i e s m o v e m e nt of F MD in the

Unit e d S t a t e s should in fec t e d m ea t be impo r t e d in t o the c ount r y

.

I f F M D

- c ont a min a t e d m ea t w e r e impo r t e d a nd d i spos e d of in U. S

. l and f ills o r b e ca me a n i n g r ed i en t of liv e sto c k f ee d , sus ce ptible wildli f

e

popul a tions c ould b ec ome in fec t e d. F or e x a mpl e , the ra pid l y g r owi n g

whit e

- t a il e d d e e r a nd f

e r a l pig popul a tions in the Unit e d S t a t e s ar e l e ad i n g

to in crea s e d f

o r a g i n g , s ca v e n g i n g

, p re d a tion, a nd c ont ac t with t h ese

a nim a ls b y dom e stic liv e sto c k popul a tions; thus, i n f ec t e d s p ec i e s c ould b e

e nti re l y wip e d out or p r o vide a f u r th e r sou r c e of i n fec tion ( U S G S , 2001;

L D W F , 2007; O DA, 20 0 7 ) . Nonsus ce ptible a ni m a ls a nd hum a ns

c onsuming or c ont ac ti n g the c ont a min a t e d m ea t c ould t ran s fe r t h e v i rus

m ech a n ic a l l y

, as p re vio u s l y dis c uss e d.

The Unit e d St a t e s h a s a l r ea d y b a ttl e d F MD in w ildli f e popu la tion s

. In

1924, f or e x a mpl e , in a s ec tion of S t a nisl a us N a tion a l F o re st, C a li f o r n i a

, F MD b e ca me e st a blish e d in d ee r ( C DA, 192 6 )

. A t the time of the

outb rea k it w a s impo s sible to g a t h e r the wild de e r to d e t er mine the e x t e nt

of in fec tion. The era d i c a tion eff o r t, wh e r e a ll d e e r w er e e ith e r poison e d or

shot within a 1,000

- squ a r e mile ar e a of the n a tion a l f o re st, took 2 y e ar s.

Av a il a ble lit era

t u r e do e s no t i nd i ca te th at t h e wild d e e r e v e r r e i n f e c t ed

ca ttle h e rd s . T h e e r ad i c a ti o n p r o c e ss w a s e x p e n s i v e, r e st r i c t e d hu m a n a nd

li v est o ck a c c e ss to t h e a r ea

, a n d a n g e r e d p e op l e w h o w er e con ce rn ed with

t h e w e ll

- b e i n g of the wild d ee r popul a tion. This is the on l y known

o cc u r r e n c e of wildli f

e b e ing in f

e c t e d in the Unit e d S t a t e s, a nd, in 1929,

the l a st outb rea k of F MD in the Unit e d S t a t e s o c c u rre d in c a ttl e

.

A P H I S coo p era t e s with o t h er Fe d e r a l an d S t a te a u t ho r iti e s in the d e t ec tion

an d m an a g e m en t of noti f i a ble dis ea se outb r ea ks i n the Unit e d S t a t e s. I f

sus ce ptibl e , wild sp ec i e s should be e x pos e d to F MD, Mo r g a n e t a l. ( 2003)

sug g e st e d a n a l y z i n g a nd possib l y impl e m e nti n g t h e f ollowing m e a su re s in

o r d e r to p re v e nt the t

ra n s mission of the dis ea se to dom e stic liv e sto c k

—22 • l e th a l c oll ec tion of wild a nim a ls f or di a g no s tic t e stin g

,

• p r ovisions f

or su r v e ill a n c e z on e

,

• the po s sibili t y of re du c i n g the d e nsi t y of su s ce pti b le wildli f e

popul a tions within a n in fec t e d z on e

,

• lon g

- t e r m obs er v a tion, a nd

• a ddition a l p re v e ntion a nd c ont r ol m ea su re s, s u c h a s the c losu r e of

hunting s ea sons a nd re st r i c tion of ac c e ss to public l a nds b y hum a ns

(b e cau s e hum a ns c a n sp r ea d the vi r us via p h y si c a l c ont ac t )

.

A f t e r a d e v a st a ti n g F M D outb rea k in 2001, the g o v er nm e nt of the

Unit e d Kin g dom r ec o g n i z e d th a t “r obust c onting e n c y p l a ns n ee d e d to be

d e v e lop e d to m a n a ge su c h a n outb rea k, should it e v e r o cc u r a g a in, a nd

th a t th e se pl a ns n ee d e d t o be suppo r t e d b y c omp r e h e nsive op e ra tion a l

arra n g e m e nts p r ovidi n g a ca p a bili t y to r e spond to outb rea ks of a n y si z e

a nd s ca l e ” ( D E F R A, 20 0 7 )

. S u c h pl a nning re du c e s pot e nti a l a dv er s e

eff e c ts to the hum a n e nv i r onm e nt wh e n a c ount r y is d ea ling with F M D ’ s

pollution a nd dis ea se c o n t r ol issu e s involving m a ss t ra nspo r t a tion,

e m e r g e n c y f

a c ili t y c on s t r u c tion, lar g e

- s c a le disin f ec tion, h er d d e st r u c tion,

a nd dispos a l of c a rca s s e s a nd w a ste p r od u c ts. I n t h e U n i t e d S t a t e s, A P H I S

h a s a n a tion a l e m e r g e n c y p r og ra m in pl a c e f or e x oti c /inv a sive p e st

d e t ec tion a nd Fe d e ra l r e spons e

. S hould a n outb r e a k of F M D o cc u r in the

Unit e d S t a t e s, A P H I S w i ll c ondu c t f u r th e r e nvi r o nm e nt a l a n a l y s e s sp e c i f ic

to t h e ch a r a c t er isti c s o f t h e l o c a ti o n a n d t h e s c a le o f t h e e m e r g e n c y

.

c

. Ongoing W ild l i f e R esea r c h

I n the e v e nt of a n F M D o utb rea k, the r isk to wildli f e will d e p e nd on the

dist r ibution, d e nsi t y a nd biolo g y of sp e c i e s in the aff e c t e d lo c a tion, the

l e v e l of e x posu r e to in fe c t e d a nim a ls, a nd e x isting e nvi r onm e nt a l

c onditions ( C o r n a nd F i s c h er , 2001 )

. I n o r d e r to d e v e lop mo r e e ff e c tive

c ont r ol of F MD, mo r e n e e ds to be und er stood a b o ut the e pid e miolo g y of

t h e d i s ea se an d th e ro l e o f po s si b l e wil d l i f e re s er v o i r s.

U S DA

– A g r i cu l t u r a l R e s earc h S e rv i ce

, i n a ss o ci a t i o n w ith t h e D ep a r tm ent

o f H o m e l an d S ec u r i t y a n d a M a r y l an d b i oph a r m a ceu t i ca l co m p a n y h as

d e v el op e d a n e w F MD v acc ine whi c h is not on l y c onsid ere d aff o r d a bl e

, but ca n be m a nu f

ac tu r e d in the Unit e d S t a t e s without using in fec tious

F MD m a t er i a ls. The c u r re nt f o r mul a tion is f

or u s e on ca ttl e

, a nd m a y

p r ove e f fec tive in p r ot ec t ing dom e stic a nd wild a n im a l popul a tions. The

v acc ine will a llow f

or imp r ov e d di a g nosis a nd r e s pons e

, an d m a y l ea d t o a

c h a n g e in t ra d e r e st r i c tions a s the n e w f o r mula m a

k e s it po s sible to

d e t er mine w h et h e r the F MD a ntibodi e s poss e ss e d b y a n an i m a l w e r e

ac qui re d fr om v a c c in a ti o n or fr om in f e c tion (F A S S , 2007 )

.

C u rre nt l y

, A P H I S int e ra c ts with the U. S . D e p ar tm e nt of the I nt er i o r

– U. S

. G e olo g i ca l S u r v e y

– N a ti on a l W il d l i f

e H ea lth C en t e r to c oo r d i n a t e re s ea r ch

a nd monitor outb rea ks of F MD in S outh Am er i ca

. This Fe d e ra l t ea m is23 d e v e loping p rev ention a n d c ontin g e n c y pl a ns f or i n f o r ming U. S . l a nd

m an a g e m en t an d con s er v a ti o n a g e n ci e s r e g a rd i n g the r isk F MD pos e s to

wildli f e ( U S G S , 2007 a)

. I

n a ddition to h e lping t h e Unit e d S t a t e s c ont r ol

F MD in w ildli f

e popu la tion s , th e se eff

o r ts m a y a l s o a ssist B ra z il a nd oth e r

c ount r i e s in the f

utu r e w h e n d ea li n g with the pot e nti a l int er sp ec i e s

mov e m e nt of F MD.

5

. E n v iron

m e n t a l F a t e

of F MD F MDV m a y p er sist in the e x t er n a l e nvi r onm e nt f or e x t e nd e d p er iods of

time w h e n e v er s u s cep t i b l e an i m a ls in cl o s e con t ac t ar e e x po s e d t o the

vi r us. F or a vi r us to b e c ome fr e e l y c i rc ul a ti n g , it must be a ble to p e r sist in

the e nvi r onm e nt e ith e r i n side or outside of the ho s t long e no u g h to in f e c t a

sus ce ptible host. T he C ott ra l stu d y ( 1969) re po r ts the su r viv a l time of

F MDV on or within v ar ious c ont a min a t e d obj ec ts a t a mbi e nt

t e m p e ra t u r e s, a s shown i n t a ble 1.

I n a ddition to the obj ec ts list e d in t a ble 1, m a n y o t h e r c ont a min a t e d it e ms

h a v e b e e n s u s p e c t e d a s t h e sou rc e o f F MD out b r e a ks, in c luding v a r ious

dom e stic or wild a nim a ls a nd bi r ds, hum a ns, t r u c k ti re s, a nd e v e n post a l

m a t er i a ls. T he su r viv a l t ime of F MDV is sho r t e r f or vi r us in the

e nvi r onm e nt th a n f

or vi r us in a nim a ls. S unli g ht, t e mp era tu r e , pH c h a n g e s,

re l a tive humidi t y

, a nd t h e dilution e ffec t of ra in a nd m e lting snow a ll

aff e c t vi r us su r viv a l; h o w e v er , sunl i g ht a nd ult r a viol e t ra di a tion h a ve little

eff e c t on vi r us p er sist e n c e ( P h ar o, 2002 )

. L o n g e r su r viv a l tim e s f or

F MDV on obj e c ts would be e x p ec t e d a t t h e l o w t e m p e ra t u r e s a ss o ci a t ed

with hi g h a ltitud e s or the arc tic r e g ions th a n a t s e a l e v e l or in the t r opi cal

r e g ions. Althou g h t e m p e ra tu re s a bo v e 50 o C d e st ro y most in fec tivi t y

, it is lik e l y th a t a sm a ll p r opo r tion of the vi r us p a r t i c l e s ar e re l a ti v e l y

re sist a nt to the ef

f ec ts of h ea t a nd pH in most popul a tions ( P h ar o, 2002 )

.

The ef f ec t of t e mp era tu r e a nd pH on time f or 90 p erce nt vi r us in a c tiv a tion

is shown in t a ble 2 a nd t a ble 3, re s p e c ti v e l y

, b a s e d o n f indin g s fr om the

B ac h r a c h e t a l. ( 197 5 ) stu d y . Th e r e is a lso the p o t e nti a l f or F M D V to be

diss e min a t e d ov e r c onsi d era ble dist a n ce s b y a er o s ols ( C ott ra l, 1969 )

. I n

aero s o l s, F M D V su r viv e s b e st wh e n the r e l a tive h umidi t y e x cee ds

70 p e rcen t an d t h e r e is a cr iti ca l humidi t y l e v e l of 55 to 60 p erce nt, b e low

whi c h su r viv a l is poor ( P h ar o, 2002 )

. B a s e d on a v a il a ble s c i e nti f ic d a t a

, the su r viv a l of re sidu a l F MDV in the e x t er n a l e n v i r onm e nt, f ollowing

era di c a tion of a n outb r ea k of F MD in sus ce ptible a nim a ls, would be

e x p ec t e d to p er sist no lon g e r th a n 8 months.24 T a b le 1. S u r v i v al T i m e o f F M D V i r u s o n V a r i ou s C o nt ami n a t ed Ob jec t s a t

A m b i e n t T e mp e r a tu r e s.

Cont am in a t e d O bj e c ts Week s of Sur v i v al

S oil

, S

– W 7 1

– 21

B a rn di r t; B a rn s a nd 1

– 10

R oa d s and ; ga r d e n so i l 1

. 5

– 4

M anu r e

, S

–

W 1

– 24

S e w age

, S

–

W 3

– 15

B a r n s ( b r i c k

, a do b e

, w ood ), S

– W 2

– 11

W all s

, b r i c k a n d p l as t er 2

– 4

S oil

, w a t e r, l i c he n s 4

P as t u r e p l an t s

, S

–

W 1

– 7

H a y s t a c k

, S

–

W 4

– 29

F ee d sa c k s ; b r a n 20

M eal 7

V ege t a bl e s 1

W at e r 3

– 14

H ouse f li e s 10

T icks 15

– 20

W oo l

, s h ee p 2

H ai r, c a tt l e 4

– 6

G las s su r f ace 2

C lo t h i n g a n d f o o t w ea r, S

– W 8 3

– 9

, 14

M ea t clo th ( a t 4 o C) 6

7 S

– W, 1

– 21: summer 1 week, winter 21 weeks.

8 Cotton garments, leather shoes, rubber boots.25 T a b le 2. E ff ect o f T e mp e r a tu r e ( at p H 7.5) O n T ime fo r 9 0 Pe r ce n t F M D V

I n ac t i v a t i on

.

T em p e r a t ure In ac ti v a tion t i m e ( 9 0 p e r ce n t )

6 1 o C 3 0 s ec o nds

5 5 o C 2 m i nu t e s

4 9 o C 1 hour

4 3 o C 7 hou r s

3 7 o C 2 1 h o u rs

2 0 o C 1 1 da y s

4 o C 1 8 w eek s

T a b le 3. E ff ect o f p H ( at 4 o C) O n T i m e fo r 9 0 P e r ce n t F M D V I n ac t i v a t i on

. ph In ac ti v a tion t i m e ( 9 0 p e r ce n t )

10 .0 1 4 h o u rs

9 .0 1 w eek

8 .0 3 w eek s

7

. 0

– 7 .5 > 5 w eek s

6 .5 1 4 h o u rs

6 .0 1 m i nu te

5 .0 1 s e co nd

6

. P ublic

H ea l t h F MD m a y a ff e c t hu m an s ; ho w ev e r

, i ts o c c u rre n c e is qu i te rare

. T h e

numb e r of c a s e s r e po r t e d is so sm a ll wh e n c omp a r e d with the numb e r of

p er sons e x pos e d to F MD th a t it is g en e r a l l y no t c o n s i d e re d a t h r ea t to

hum a ns. F MDV h a s b e e n isol a t e d a nd t y p e d in on l y 40 p a ti e nts du r i n g the

l a st cen t u r y

. S y mptoms in hum a ns ar e most l y mi l d a nd m a in l y in c lu d e

fe v e r a nd blist er s on the h a nds, fee t, mouth, a nd t on g u e

. P a ti e nts usu a l l y

rec over within a w e e k af

t e r the l a st blist e r f

o r m a tion ( U S DA

– A P H I S,

2013 ).

P er h a ps mo r e impo r t a nt l y

, a n F MD outb r ea k of t h e m a g nitude obs er v e d in

the U n i t e d Ki ngdo m ca n re s u l t in s ev e r e p s y c ho so c i a l ef f ec ts o n f ar m er s

a nd f ar mi n g c ommuniti e s. F ar m e r s a nd th e ir fa m ili e s ca n su ff e r fr om

g r i e f ov e r losi n g a nim a ls ( in some ca s e s blood lin e s k e pt ov e r m a n y

g e n era ti on s )

, a s w e ll a s l oss of c ont r ol ov e r th e ir l iv e s due to mov e m e nt

re st r i c tions, dis r uptions in c ommuni t y li fe

, a nd s h o r t

- a nd lo n g

- t er m st r e ss

ov e r t h eir f

i n a n c i a l fu t u r e

. R e s ea r ch e r s fro m L a n ca st e r U n i v er si t y in t he

Unit e d Kin g dom c ond u c t e d a n e w stu d y on t h e s o c i a l con s equ e n ce s of

F MD in the C umb r ia c o mmuni t y . T h e stu d y re v ea l e d h i g h r a t e s of

d e p re ssion, a l c ohol c on s umption, a nd mo r t a li t y a mong f a r m er s d u r ing the

cr isis ( U S DA

– A P H I S

, 2013 ).26 

## I V. O t h e r E n v i r on me n t a l I ss u es

A

. E n v ir on me n tal J u st i ce a n d t h e P r opo sed A ct i on

E x ec utive O r d e r 12898, “Fe d era l A c tions to Add r e ss Envi r onm e nt a l

J us t i c e in Mino r i t y P opul a tions a nd L o w

- I n c ome P opul a tions,” re qui re s

eac h Fe d era l a g e n c y to m ak e a ch i ev i n g env i ron m e n t a l justi c e p ar t of its

mission b y id e nti f

y i n g a n d a dd re ssi n g

, a s a p p r op r i a t e , disp r opo r tion a t e l y

hi g h a nd a dv er s e hum a n h ea lth or e nvi r onm e n t a l eff e c ts of its p r o g ra ms,

poli c i e s, a nd ac tiviti e s on mino r i t y popu l a tions a n d low

- i n c o m e

popul a tions in the Unit e d S t a t e s a nd its t err ito r i e s a nd poss e ssions. The

p r opos e d r ule a llows f

or the impo r t a tion of fre sh b ee f to the Unit e d S t a t es

fro m a r e g ion o f B ra z il. I mpo r t a tion of fre sh b ee f fr om B r a z il, und e r

impl e m e nt a tion of the p refe r re d a lt e r n a tiv e

, i s no t e x p e c t e d to

subst a nti a l l y a f

fec t p r o f its of b ee f p r odu c e r s in the Unit e d S t a t e s. Most of

the mod e st imp ac t

- g e n e r a ting c ompli a n c e a c tions und e r the p r opo s e d r ule

o cc ur outside of the Unit e d S t a t e s ( in B r a z il )

, a nd none h a ve a n y

disp r opo r tion a te a dv e r se eff e c ts on mino r i t y or l o w

- in c ome popu l a tions.

Althou g h one c ould d e si g n s c e n ar ios involving t h e int r odu c tion of F MD to

the Unit e d St a t e s, th e se a r e p r im ar i l y r e mote a nd h y p oth e ti c a l. E v e n if

su c h s ce n a r ios c ould o c c u r , th e ir imp ac t to mino r i t y a nd lo w

- i n c o m e

popul a tions would be e xp ec t e d to be n e g li g ibl e

.



### B

. P r o te c t i o n o f Ch il d r en a n d t h e P ropo sed A ct i on

E x ec utive O r d e r 13045, “ P r ot ec tion of C hild re n f r om Envi r onm e nt a l

H ea lth R is k s an d S afe t y Fac t o rs

, ” requ i re s e ac h F ed e ra l a g en c y t o add r e ss

disp r opo r tion a te e nvi r o n m e nt a l h ea lth r isks or s a f e t y r isks to c hild r e n

fr om impl e m e nt a tion of p r opos e d poli c i e s, p r o g r a ms, ac tiviti e s, a nd

st a nd ar ds. The p r opos e d r ule c h a n g e s do not pose g r ea t e r r isks to c hild re n

th a n to oth e r p ar ts of the aff e c t e d popul a tions. T h e r isks fr om impo r t a tion

d e p e nd p r im ar i l y upon a dh ere n c e to the s a nit a r y r e qui re m e nts f or e nt r y of

b e ef

, a n d t h i s ad h ere n c e p r ec l ud e s po t en t i a l f o r a d v e r se e ff

e c ts to hu m ans

a nd m a k e s oth e r int r od u c tion

- re l a t e d ris k s r e mote a nd of n e g l i g ible

c on cer n in r e g a r d to the p r ot ec tion of c hild re n.



### C

. T h r eate n ed a n d E nd a ng e r ed S p ec i es a n d t h e

P r opo sed A ct i on

S ec tion 7 of the End a n g e re d S p ec i e s A c t a nd its impl e m e nting r e g u l a tions

requ i r e Fe d era l a g e n ci e s to e nsu r e th e ir a c tions a r e not lik e l y to j e op a r di z e

t h e con t i nu e d e x ist en ce o f t h r ea t e n e d or e n d a n g e r e d s p e c i e s o r r e s u l t in

the d e st r u c tion or a d v er s e modi f i ca tion of cr iti c a l h a bit a t. A P H I S

c onsid ere d the po t e nti a l eff e c ts of the p r opo s e d a c tion on t h r ea t en ed and

end a n g e r e d s p e c i e s an d d e si g n a t e d c r iti ca l h ab i t a t. T h e r e ar e six list ed

un g u l a te s p ec i e s t h at ar e po t en t i a l l y s u s cep t i b l e to F MD ( t ab l e 4 ) ;27 how e v er

, b a s e d on the s u pposition of re qui re d miti g a tion m ea s u re s f or t h e

impo r t a tion of bovine p r od u cts, th er e is no lik e lihood f or th e se sp e c i e s to

be e x pos e d to a nd, thus, aff e c t e d b y t h i s ac ti on

. T h e ref o re

, A P H I S

e x p e c ts the p r opos e d r ule will h a ve no ef f ec t on t h rea t e n e d o r en d a n g e r ed

s p e c i e s or th e ir cr iti ca l h a bit a t in the Unit e d St a t e s.

T a b le 4. Endangered Species in the United States Susceptible to Foot

- and

mouth Disease.

Common Name Scientific Name Critical Habitat Listing Status

Woodland caribou Rangifer tarandus caribou No Endangered

Columbian white

- tailed deer Odocoileus virginianus leuceurus No Endangered

Key deer Odocoileus virginianus clavium No Endangered

Sonoran pronghorn Antilocapra americana sonoriensis No Endangered

Sierra Nevada bighorn sheep Ovis canadensis sierrae Yes Endangered

Peninsular bighorn sheep Ovis canadensis nelsonii Yes Endangered

A P H I S c ond u c t e d r isk a n a l y s e s a nd d e t e r min e d th a t the r isk of in f e c t e d

bovine p r odu c ts e nt er i n g the Unit e d S t a t e s fr om B ra z il a nd a nti c ip a t e s the

pot e nti a l to e x pose U. S

. l iv e sto c k to F MD to be l o w ( U S DA

– A P H I S,

2013 ) . This r isk would be f u r th e r mit i g a t e d b y re q ui r ing impl e m e nt a tion

of the m ea su r e s outlin e d in 9 C F R § 94.11 th a t pl ac e re st r i c tions on the

impo r t a tion of r umin a nts fr om r e g ions f r e e o f F M D but sh ar e a c ommon

l a nd bo r d e r with r e g ions d e si g n a t e d a s in f e c t e d w i th F MD.

B a s e d upon t h e e f

fec tiv e n e ss of the miti g a tion m e a su re s in c lud e d in

9 C F R § 94.11, a nd the low lik e lihood th a t F MD would e st a blish in U. S

. liv e sto c k, impl e m e nt a tion of the p r opos e d r u l e m a king is e x p ec t e d to h a ve

n o e ff e c t o n f e d era l l y list e d end a n g e re d s p ec i e s o r d esi g n a t e d cr iti ca l

h a b i t a t.



### D

. P o te n t i a l Cu m u l at i v e I m p acts

The pot e nti a l imp ac ts fr o m the p r opo se d r ule in c o mbin a tion w ith sim i l a r

ac ti on s ar e re f

err e d t o as cu m u l a ti v e im p a c ts. T h e se im p a c ts ar e not

e x p e c t e d t o p o se a n y su b st a nti a l r isks b a s e d upon the f indin g s of the r isk

an a l y sis ( U S DA

– A P H I S

, 2013 ) . U r u g u a y is c u rr e nt l y impo r ting b e e f to

the Unit e d St a t e s. A s a r e sult of c u rr e nt miti g a tions a sso c i a t e d w ith

r e g ul a tions a llowing U r u g u a y a n b e e f impo r ts, the c ombin a tion of the

U r u gu a y a n b ee f impo r

ts with b e e f impo r

ts fr om B ra z il ar e e x p e c t e d t o

re sult in no a dv er se e nvi r onm e nt a l imp ac ts.28 Althou g h impo r t a tion of fre sh b e e f do e s i n cr e a se t he pot e nti a l f or

int r odu c tion of F MD to t he Unit e d S t a t e s, the re q u i re d miti g a tions m a ke

int r odu c tion of the dis ea s e e x t re m e l y unlik e l y

, e v e n wh e n c onsid er i n g

oth e r impo r t a tions or f

utu r e impo r t a tions of f

r e sh b ee f f

r om c ount r i e s with

c omp ara ble r isks. I

t is d i ff i c ult to p r ec is e l y q u a nti f

y the po t e nti a l

c umul a tive imp ac ts t h at ar e d e p e nd e nt upon dis ea se c onditions in B ra z il,

a s w e ll a s c ompli a n c e w i th impo r t a tion c onditions in B ra z il a nd oth e r

r e g ul a t e d c oun t r i e s. The n a tu r e of dis e a se mitig a tion is of p r in c ip a l

c on cer n f or this issu e

, a n d the c onst ra ints p r ovid e d b y p r o g ra m miti g a tions

ar e c onsi d ere d to p r ovi d e a d e qu a te p r ot ec tion.29



## V

. Li s t i n g o f A g e n c i e s C on s ul t e d

Envi r onm e nt a l a nd R isk An a l y sis S erv i ces

P oli c y a nd P r o g r a m D e v e lopm e nt

Anim a l a nd Pl a nt H ea lth I ns p ec tion S er vi c e

U. S . D e p ar tm e nt of A g r i c ultu r e

4700 R iv e r R o a d, Unit 149

R iv er d a l e , MD 20737

– 1 237

R e g ion a li z a tion Ev a lu a tion S er vi ce s

N a tion a l C e nt e r f

o r I mp o r t & E x po r t

V e t er i n a r y S erv i ces

Anim a l a nd Pl a nt H ea lth I ns p ec tion S er vi c e

U. S . D e p ar tm e nt of A g r i c ultu r e

4700 R iv e r R o a d, Unit 38

R iv er d a l e , MD 20737

– 1 23130 

## V I

. Re f ere nce s

A P H I S

— S e e U. S . D e p a r tm e nt of Ag r i c ultu re , An i m a l a nd P l a nt H ea lth

I n s p ec ti o n S erv i ce

A V I S

— Se e A dv a n ce d V e t er i n a r y I n f o rm a ti o n S y st em

A V I S / O I E

— S e e A d v an c e d V e t er i n a r y I n fo rm a ti o n S y st e m/ I nt er n a tion a l

O ff i c e o f Epi z ooti c s

A dv a n c e d V e t er i n a r y I nf o rm a ti o n S y st e m, 2002. F oot a nd mouth dis ea se

( 2002 suit e)

. A V I S / F M D/ C ont r ol: S p ec i e s of wildli f e sus ce ptible to

F MD. [ Onlin e .] Av a il a bl e : http://www. a l ef f g r o u p. c om/A V I S F MD/

A dv a n c e d V e t er i n a r y I nf o rm a ti o n S y st e m/ I nt er n a tion a l O ff i c e of

Epi z ooti c s, 2000. I

n t er n a tion a l O ff

i c e of Epi z ooti c s: A n i m a l Dis ea se

C ar ds. F oot a nd Mouth Dis ea se ( F MD )

. O ff i c e I nt er n a tion a l d e s

Epi z ooti e s: Au g ust 30, 2000. [ Onlin e .] A v ail able:

http://www. a l ef

f g r oup. c o m/ a vis f

md/ car ds/A010

- f

md

- 00.HTM [ 2007,

Au g ust 21 ]

.

AVMA

— S e e Am e r i ca n V e t er i n a r y M ed i ca l Ass o c i a ti on

Am er i ca n V e t er i n a r y M e d i ca l Ass o ci a ti o n , 2007. F oot a nd Mouth

Dis ea se B ac k g r ound e r

. Fe b r u a r y 14, 2007. [ Onlin e .] Av a il a bl e :

http://www. a vm a .o r g / re f

ere n c e /b ac k g r ound er s/ f

m d_b g nd.pdf [ 2007,

Nov e mb e r 7 ]

.

B ac h r a c h, H

. L

., B r e e s e

, S

. S

., C a llis, J

. J., H e ss, W

. R

., a nd P a t t y

, R .E.,

1975. I n ac tiv a tion of f

oo t

- an d

- mouth dis ea se vi r us b y pH a nd t e mp e r a tu r e

c h a n g e s a nd b y f

o r m a ld e h y d e

. Pr o c e e dings of the So c i e ty for

E x p e rim e ntal Biology a n d Me di c in e , 95, 147

- 52.

B a r c os, L .O., 2001. Rec e nt d e v e lopm e nts in a n i m a l id e nti f i ca tion a nd the

t rac e a bili t y of a nim a l p r o du c ts in int er n a tion a l t r a d e

. O I E: R e v. sc i. t e c h.

O ff . int. Epi z ., 2001, 20 ( 2 ) , 640

- 651. [ Onlin e .] Av a il a bl e :

http://www.oi e .int/ e n g /pub l i ca t/ r t/2002 / B A RC O S .PDF [ 2007, Nov. 27 ]

.

B ra z ili a n Emb a s s y , 200 6

. R e po r t on U. S . t ra de b a rr i er s. M a rc h 2006.

[ Onlin e .] Av a il a bl e :

http://w ww.b ra sil e mb.o r g /t ra d e _inv e stm e nt/2006_Emb a ss_ % 20 R e po r t_on

_U S _T ra d e

_ B a r r i er s_E n g lish.pdf

C a n é

, B .G., L ea n e s, L

. F., M a s c it e lli, L

. O ., 2004. Em e r g i n g dis e a s e s and

t h eir imp ac t on a nim a l c o mm erce : the Ar g e ntine l e sson. Ann a ls of the

N e w Yo r k A ca d e m y of S c i e n ce s, 1026:12

– 18.31 C DA

— S e e C a li f

o r nia D e p ar tm e nt of A g r i c ultu r e

C a li f o r nia D e p a r tm e nt of Ag r i c ultu re , 1926. The e pi z ootic of f oot

- an d

mouth dis ea se in C a li f

o r ni a

. Fe b r u a r y 17, 1924 t o J une 10, 1926.

C h a r l e s K ea n e

, D

. V

. S

. S p ec i a l P ubli ca tion No. 6 5 , 110 pp. S acra m e nto,

C A.

C I D R A P

— S e e C en te r f

o r I n f e c ti ou s Dis ea se R e s e arc h a n d P o l i c y

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