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 

# Importation of Fresh
Beef from Northern Argentina

E nv i ronmen t al A ss e ssmen t

, April 2014

# Importation of Fresh Beef from

Northern Argentina

E n v i r on me n t a l A s se s s m e n t, April 2014

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

.

## Table of Contents

I

. Nee d f o r t h e Action

................................ ................................ ................................ ................................ 4

A

. I nt r oduct i on

................................ ................................ ................................ ................................ ...... 4

B

. N eed

................................ ................................ ................................ ................................ .................. 5

II

. A l t er n a t i v e s

................................ ................................ ................................ ................................ ........... 5

A

. N o A ct i on

................................ ................................ ................................ ................................ .......... 6

B. P r eferred Alternative

................................ ................................ ................................ ........................ 6

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

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

A

. N o A ct i on

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

B. P r eferred Alternative

................................ ................................ ................................ ...................... 10

FMD Situation in Northern Argentina

................................ ................................ .............................. 10

FMD and the slaughter processing

................................ ................................ ................................ .. 13

Regulatory Control of FMD

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

Interspecies Transmission of FMD

................................ ................................ ................................ ... 15

Environmental Fate of FMD

................................ ................................ ................................ ............. 18

Public Health

................................ ................................ ................................ ................................ .... 21

IV. Other Environmental Issues

................................ ................................ ................................ ............... 21

A. Environmental Justice and the Preferred Alternative

................................ ................................ .... 21

B. Protection of Children and the Preferred Alternative

................................ ................................ .... 22

C . Threatened and Endangered Species and the Preferred Alternative

................................ ......... 22

D

. P o te n t i a l Cu m u l at i v e I m p acts

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

V. Listing of Agencies Consulted

................................ ................................ ................................ ............. 24

VI. References

................................ ................................ ................................ ................................ .......... 254



## I

. Nee d f o r t h e Action

A

. I nt r oduct i on

T h e impo r

t a tion of livestock and animal products 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 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 livestock a nd livestock p r odu c ts into the Unit e d St a t e s (9 CFR 92.2).

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 inimizing the r isk of t he

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

.

Argentina submitted an official request to A P H I S to export fresh (chilled or frozen) beef under certain conditions from a region in Argentina (referred to as Northern Argentina) located North of Patagonia South and Patagonia

North B . The World Organization for Anim al Health (OIE) recognizes the areas of North Central Argentina including the Cordon Fronterizo as FMD

free with vaccination and the areas including the region of Patagonia (North B and South) and the summer pastures of Calingasta Valleys in the province

of San Juan as FMD free with out vaccination . The last outbrea k of FMD in Northern Argentina occurred in 2006

. Consistent with U.S. regulations

, A P H I S cond u c t e d a 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 into the United States th r o u g h t h e impo r t a tion of fresh (chilled or frozen) beef under certain conditions f ro m Northern Argentina . 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 rr en c e is ra r e ( U S D A

- A P H I S , 2014 )

. All cloven

- hoofed animals including 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 susceptible to F MD

. T he d ea th r a te
fr om this dis ea se is usually low; how e v e r
, the rate of illness is very high in susceptible animals, and clinical signs during the acute phase of the infection

can result in c ost l y l o ss e s in m ea t a nd milk p r odu c tion. The disease is characterized by vesicles that develop in the hooves and mouth areas. F MD

is t ra nsmitt e d to susceptible a nim a ls th r o u g h e x po s u re to t h e ac ti v e vi r us. Transmission 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 ) through direct contact (such as ingestion, sexual transmission, mucous membrane discharge from the eyes, nose or mouth, or from skin or mucous membrane abrasions), or through indirect exposure ( such as feed, drinking water, equipment, animal products, human clothing, transportation vehicles). E x c lusion of this d i s ea se fr om the Unit e d5 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. The United States reported the last FMD outbreak in

1929.

APHIS conducted site visits to Argentina in 2003, 2005, 2006, 2009, and 2013. Specific visits to Northern Argentina occurred in 2005, 2006, and 2013. Based

upon the results of the the risk assessment, APHIS has determined that t he combination of Argentina’s legal framework, animal health infrastructure,

movement and border controls , diagnostic capabilities, surveillance programs, and emergency response capacity provide s a comprehensive system with redundant safeguards that are sufficient to detect, report, prevent, control, and

eradicate FMD outbreaks within the bo undaries of Northe rn Argentina

. Consequently, APHIS concludes that while Northern Argentina cannot be considered free of FMD because it vaccinates against it, the likelihood of introduction of FMD virus (FMDV) into the United States via fresh (chilled or frozen) beef from Northern Argentina subject to specified mitigations and conditions of entry , including maturation and deboning, is low.



### B

. N eed

I n re sponse to a n o ff

i c i a l re qu e st f

r om Argentina an d i n a cco r d an c e with

relevant U.S. statutes

, regulations

, and agreements

, 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 imp ortation of fresh , maturated, and deboned beef susceptible to FMD from Northern Argentina . The p re p a ra t ion of this EA complies with the National Environmental Policy Act of 1969 (NEPA), 42

U.S.C. 4321

- 4327, its implementing regulations, and Executive Order 12114, “Environmental Effects Abroad of Major Federal Actions

. ” The issue of

pot e nt i a l e nvi r onm e nt a l r isks associated with 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 animals and animal products 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.



## II

. A l t er n a t i v e 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 a llow ing the impo r t a tion of fresh (chilled or frozen ), maturated, and deboned beef originating in Northern Argentina 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 recognition of Northern Argentina as an FMD

- affected region ( no ac tion )

, a nd ( 2 ) authorization to import fresh (chilled or frozen), maturated, and deboned beef originating in Northern Argentina under certain conditions ( p r ef e rre d a lt e r n a tiv e)

. The6 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 section 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.



### A

. N o A ct i on

The N o A c 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 r r e nt s a nit a r y

r e g ul a tion of impo r t a tion of animals and animal products from Northern Argentina. 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 fresh (chilled or fro zen) beef that originates in Northern Argentina . 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 fresh beef f

r om Northern Argentina m a int a ins ov e ra ll dis ea se

r isks a t t h e status quo

.



### B. P r eferred Alternative

Under the Preferred Alternative, Northern Argentina would be allowed to
export fresh

, maturated, and deboned beef to the United States , und e r c e r t a i n specified c onditions. 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 Argentina’s re q u e st, APHIS has d et e r min e d th a t fresh, maturated and

deboned beef can be safely imported from Northern Argentina provided that certain specified requirements are met. 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 Argentina

.

T he c on c lusions of the risk assessment for Northern Argentina ( U S DA

– A P H I S , 2014 ) 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 below

. 1

(1) Argentina has made significant improvements to its veterinary

infrastructure since FMD outbr eaks in Argentina in 2000

- 2001. Based upon site visits a nd documentation reviews, APHIS considers Argentina’s Servicio Nacional de Sanidad y Calidad Agroalimentaria (SENASA) to hav e sufficient legal authority to carry out official

disease contr ol, eradication, and quarantine activities. In addition,

APHIS is co nfident that in the unlikely event of another outbreak

, reporting would be prompt and transparent.

(2 ) The last FMD outbreak in Northern Argentina was detected in February 2006 near the border with Paraguay. There is no evidence

1 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(b)) ar e m e t b y Northern Argentina . In 2012, APHIS consolidated the 11 factors into 8 factors. However, since the ev aluation of Northern Argentina started before 2012, and the topics addressed by the 11 factors are contained within the 8 factors, this report follows the

11 factor format.7 to suggest that FMDV is present in this region since 2006.

(3 ) A rgentina is bordered by Paraguay to the north, Bolivia to the northwest, Uruguay and Brazil to the northeast, and Chile to the west. APHIS only recognizes Chile and the State of Santa Catarina,

Braz il to be F MD

- free and has evaluated the Patagonia Region for

FMD freedom. APHIS considers the regions along the northern borders with Bolivia, Brazil, and Paraguay to constitute a potential source of vulnerability for Argentina as t here is a potential risk of

reintroduction of FMD from those countries ; however, SENASA has adopted several measures specifically aimed at prevent ing t he

introduction of FMDV from these countries. APHIS believes that

these enhancements in border control activities and infrastructure provide adequate monitoring and control of the disease in the eve nt of a potential introduction.

(4 ) Argentina has an act ive disease control program at the national and

local levels in Northern Argentina sufficient to respond quickly to FMD emergencies through quarantine and testing of suspicious premises

.

(5 ) Argentina’s FMD vaccine production program is conducted in

accordance with international standards. The structure and application of the vaccination program, in conjunction with

movement contro ls, fosters close interaction between veterinary officials and farmers and facilitates oversight of animal populations and vaccine coverage in the field.

(6 ) Most of the Argentine border is protected by natural barriers that help

reduce the unrestricted f

low of animals and animal products from areas of higher risk. Government movement control measures compensate in areas where natural barriers do not exist.

(7 ) Argentina has adequate controls at ports of entry for leg al commercial

and noncommercial impor tation of FMD

- susceptible species and livestock products. Site visits to border control posts demonstrate adequate staffing levels, knowledge of requirements and procedures, professionalism, and efficiency.

(8 ) Argentina has a system designed to capture farm inventory, animal movement information, sanitary information, identification numbers,

and control movements. Th e animal identification system is comprehensive and enables Argentina to comply with the U.S. certification requirements.

(9 ) Argentina h as a s u rv eill an ce s y st e m d es i g n e d t o estimate herd immunity of the vaccinated cattle population and to demonstrate the8 absence of FMDV circulation. Ongoing surveillance efforts are focused on the effectiveness of local vaccination campaign plans. In

addit ion, Argentina regularly conducts additional studies to continually improve their surveillance system. As of November 2013, more than 50 percent of the planned surveillance samples had

been collected with two reactors identified , both of which were negative at confirmatory testing

.

( 10) Argentina has one di a g n o s tic l a b o r a t o ry fo r F MD in Buenos Aires

. T h e laboratory was 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 accurately diagnose FMD.

( 11) Em e r g e n c y re sponse capabilities in Argentina are adequate. Local veterinary officials are well

- trained in procedures to control and

contain FMD outbreaks. Systems for notification and training ensure emergency preparedness and response with a legal framework to

authorize n eeded actions.

U nd e r t h e P r ef

e rre d A lt e r n ati v e, certain requirem ents must be met to import

fresh beef into the United States from Northern Argentina :

 The beef comes from bovines that have been born, raised, and slaughtered in the export region.

 FMD has not been diagnosed in the export region within 12 months prior to exportation of the beef.

 The beef comes from bovines that originated on premises where FMD has not been present during the lifetime of any bovines that are slaughtered for export of meat to the United States.

 The beef comes from bovines moved directly from the premises of origin to the slaughtering establishment without any contact with other animals.

 The beef comes from bovines that received both ante

- mortem and post

mortem veterinary inspe ctions, which include inspection of the head and feet, at the slaughtering establishment, with no evidence found of

vesicular disease.

 The beef consists only of bovine parts that are, by standard practice, part of the animal's carcass that is placed in a chiller for maturation after slaughter. The bovine parts that may not be imported include all parts of the head, feet, hump, hooves, an d internal organs.

 All bone and visually identifiable blood clots and lymphoid tissue have

been removed from the meat.

 The beef has not been in contact with meat from regions other than the region of origin or those considered as FMD

- free by APHIS (listed under 9 CFR 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 below 6.0 in the loin muscle at the end of the maturation9 period. Measurements fo r pH must be taken at the middle of both longissimus dorsi muscles. Any carcass in which the pH does 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 beef from the carcass may not be exported to the United

States.

 The establishment in which the bovines are slaughtered allows periodic

on

- site evaluation and subsequent inspection of its facilities, records, and operations by an APHIS r epresentative.

 The beef meets additional certification requirements under 9 CFR 94.11(c). Generally speaking, these restrictions (1) prohibit the export

approved slaughter establishment from receiving FMD

- susceptible

animals or animal products that were tr ansported or commingled with animals or animal products from regions that APHIS does not recognize

as FMD

- free and ( 2 ) requir e exporting slaughter establishments to be approved by the USDA’s Food Safety and Inspection Service. In
addition, an official veterin ary official of the government of the exporting region must certify on the foreign meat inspection certificate that all th e listed conditions have been met.



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

A

. N o A ct i on

The No Ac tion A lt e r n a tive would l ea ve the c u r r e nt regulation of beef (no entry) from Northern Argentina un c h a n g e d. Un d e r this a lt er n a tiv e , Northern Argentina would c ontinue to not be a llo we d to e x po r t FM D

- su sceptible fresh

beef to the Unit e d S t a t e s.

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 specific beef fr om Northern Argentina would maintain the status quo with respect to impact on the hum a n

e nvi r o n m e nt. 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

. Due to t he 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
, A P H I S ’ poli c y is 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 its 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.10 All of these measures provide 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 revealed 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 is 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 fresh beef from Northern Argentina

.



### B. P r eferred Alternative

The e nvi r onm e nt a l c ons e qu e n ce s f r om permitting imports of fresh beef from Northern Argentina ar e l a r g e l y c onti n g e nt u p on the effectiveness of v a r ious

miti g a tions a nd p r o ce du re s to p rec lu d e e x posu r e of Northern Argentina to

F MDV and to preclude impor tation from Northern Argentina to the United

Stat es of fresh beef that could potentially be infected with FMDV . The risk analysis ( U S DA

– A P H I S , 2014 ) of importing fresh beef from Northern Argentina evaluates the risk of the introduction and outbreak of FMD disease

in the United States posed by such imports

. W hile p ermitting exports from Northern Argentina is assumed to pose some theoretical risk of exposure beyond the No Ac tion A lt er n a tiv e, APHIS has determined that such risk is

low and that fresh beef c a n be s a fe l y impo r t e d f r om Northern Argentina

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. F indin g s of the r isk analysis are

discussed in that do c um e nt a nd ar e i n c o rpo 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

m it i g a ti v e ac ti on s th 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 the importation of fresh, maturated, and deboned beef from Northern Argentina

. 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 tions , surveillance

, 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.

FMD Situation in Northern Argentina

a. FMD Transmission, Vaccination

, and Safeguards

F MDV is the virus t h at ca us e s F MD. F MDV is an Aphtho v irus belonging to

t h e P i co r n a v i r i d ae fa mi l y. F MDV is a sm a ll vi r us that 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 . The virus c a n su r vive in the e nvi r onm e nt f or e x t e nd e d11 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 of

c lo v e n

- hoofe d an i m a ls. All cloven

- hoofed animals including 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 susceptible to F MD. 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 in cattle

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 a lso may 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 he d ea th r a te fr om this dis ea se is usually low; how e v e r
, the rate of illness is very high in susceptible animals, and clinical signs during the acute phase of the infection can re sult in c ost l y l o ss e s in m ea t a nd

milk p r odu c tion.

F MD is t ra nsmitt e d to susceptible a nim a ls th r o u g h e x po s u re to t h e ac ti v e vi r us. Transmission 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 ) , through direct contact (such as

i n g e stion, s e x u a l t ra nsmission, mucous m e mb ra n e discharge s from the e y e s,

nos e or mouth

, s kin or mucous membrane abrasions), or through indirect

e x posu r e (such as feed, drinking water, equipment, animal products, human clothing, transportation vehicles)

. Infe cted meat, hides , and bones also can carry the FMDV. 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. The United States reported the last FMD outbreak in

1929.

I t is po s sible f

or a nim a ls to car r 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 2 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 the 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 )

.

Vaccination of cattle against FMD is mandatory in Northern Argentina except for the summer pastures of Calingasta Valleys in the province of San

Juan and the Patagonia “North A” region . The National FMD Program provides for the systematic vaccination of bovines while other susceptible

animal s are vaccinated in strategic (e.g., emergency) situations. The

2 A strain is a taxonomic subdivision of a micro

- organism based on characteristic antigens or proteins.12 vaccination strategy takes into consideration various geographic, epidemiological, and production characteristics including animal movements. A regionalization strategy is applied according to the ecological features, production types, and movement flow. Vaccination can only be performed by authorized personnel who are trained, registered, and accredited/audited by SENASA.

Data obtained during the vaccinations are entered in a form called the “vaccination act” (acta de vacunación), which is completed by the official vaccinators after visiting each holding. D ata collected throughout and at the end of the vaccination campaign include: (1) daily records of the number of animals vaccinated, including categories of animals vaccinated, time of vaccination, and compliance of premises with vaccination schedule, and (2) every 2 weeks from each local vaccination delivery center, the proportion of premises/establishments vaccinated and the proportio n of vaccinated animals. Vaccination campaigns last for 60 days. Under Resolution 181/10, animals cannot be moved out of premises that have not completed the vaccination and registration of animals at the end of a vaccination cycle. Vaccination

coverage rates have been more than 97 percent since 2001.

All FMD vaccine used within the territory is produced in Argentina under SENASA oversight. Production and quality control of the vaccine meet the requirements of the OIE Manual of Diagnostic Tests and Vacc ines for

Terrestrial Animals and with the recommendations of the OIE Reference Regional Center, Centro Panamericano de Fiebre Aftosa ( PANAFTOSA )

.

The tetravalent vaccine in use since 2001 is inactivated and contains an oil

adjuvant that provides extended immunity (USDA

- APHIS, 2014 ). SENASA uses vaccines containing the following serotypes: O1/Campos, A24/Cruzeiro, A/Argentina/2001 and C3/Indaial. All vials are identified with technical and manufacturer brand labels, a sequential number, and an official stamp stating the series and the expiration date. SENASA conducts audits of the cold chain at all stages. Trucks used for the transportation of the vaccines are equipped with temperature sensors to ensure a cold chain during transportation (USDA

- APHIS, 2014 ). The vaccine must be tested for quality and safety by the official SENASA laboratory. Quality control tests of each batch of the

vaccine are c onducted and strictly follow international standards, as set by

the OIE.

The risk analysis associated with this proposed rulemaking concludes that Northern Argentina conducts its FMD vaccination programs appropriately

and in accordance with internati onal standards (USDA

- APHIS, 2014 ). There is a system of controls to ensure compliance with vaccination calendars by matching vaccination records to movement permits and census data.13 b. FMD Surveillance

The epidemiological office of th e National Animal Health Office in Argentina is responsible for the regulatory aspects , collection, and

assessments of animal health data . The general field office, the regional supervisors, and the local SENASA veterinarians are responsible for the operations.

The last two out breaks in Argentina were reported in 2003 and 2006. The 2003 outbreak was detected in a local slaughterhouse near the Bolivian border. The 2006 outbreak was detected in the Northeast, in the province of

Corrientes.

FMD has not been diagnosed in South America since the last outbreak reported in Pa raguay in 2012 (USDA

- APHIS, 2014 ). E f f ec ti v e F M D

s u r v eill an c e p r og r a ms in the South America region a r e e ss en t i al 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.

The primary objective of Argentina’s epidemiological surveillance activities

is to search for and eradicate FMD. Argentina employs “active” and “passive” systems of surveillance

. Passive surveillance

— watching for any suspicion of FMD

— in Argentina is bolstered by effective community

educati on and involvement, while the bulk of active surveillance consists of the annual serological sampling of randomly selected animals and regular survey of higher

- risk areas (USDA

– APHIS, 2014 ). APHIS believes that the serological sampling design in Argentina is both valid and efficient, and the sampling coverage is adequate. Further, APHIS concludes that the serological sampling conducted in Argentina under the national serological sampling plan since the July 2000 outbreak is adequate to detect disease and identify and measure viral activity in the area.

If FMD is detected, Argentine a nim a l h ea lth a utho r iti e s m a y re spond to

o utbreaks b y f

ollowing a st a mping out that involv e s the killing of sus ce ptible

a nim a ls that were likely to have been exposed to the index case

. SENASA will manage FMD outbreaks following their contingency plan , and a sanitary state of emergency will be declared with the accompanying quarantine and

movement restrictions , reporting, and other sanitary measures (USDA

– APHIS, 2014 ).

FMD and the slaughter p rocessing

It is possible but extremely unlikely that FMDV could be spread by

im properly immunized cattle. The Preferred A lternativ e would o nly allow importation into the United States of beef originating from bovines slaughter ed in the region of Northern Argentina

. FMD related mitigations14 during the slaughter process will decrease the likelihood that beef could

contain FMDV.

Regulatory Control of FMD

Federal, State, and local veterinary authorities enforce the animal health laws in Argentina. SENASA establishes and enforces animal health regulations at the national level in Argentina to prevent the introduction and spread of animal pests and diseases. Argentina has institut ed the National Identification Sy stem

. Livestock movement controls are stringent

.

The severity of an FMD outbreak may be influenced by a g overnment’s

decisions such as reporting and notification delays. In 2000 and 2001, Argentina did not provide a timely report of its FMD outbreaks

. As noted in the risk analysis, however, Argentina subsequently reported the 2003 and 2006 outbreaks to the international community promptly, followed its contingency plan, and limited the spread of disease.

The establishment of effective surveillance and monitor ing of susceptible

livestock also is important in preventing and limiting FMD outbreaks. Argentina requires that all premises with agricultural animal production register with SENASA and obtain unique identification numbers that encode

informa tion about individual premises, and link to data on the health, test status, and movement of their animals. Animals are tracked from field to slaughter; slaughterhouses must be able to identify every supplier and trace all products intended for export, sh owing compliance with the requirements of SENASA and those of the destination country. The SENASA individual animal and premise s identification system ( Resolution 754/200 6) is mandatory for all bovine and also for ovine destined to the European Union (USD A

- APHIS, 2014 ).

To avoid disease introduction and spread i nto Argentina, Argentina oper ates domestic checkpoints; its international borders are monitored in a regional

disease

- control effort. Even so, di sease incursions into Northern Argentina

from adjacent countries ha ve occurred. Border surveillance and biosecurity measures are in place to control the movement of people, anima ls, and goods as they enter the country. Imports of FMD

- susceptible livestock from approved countries are quarantined and tested. Argentina particip ates with other South American g overnments in the Cuenca del Plata Agreement

— a harmonized regional subprogram of the PANAFTOSA Hemispheric Plan for

the Eradication of FMD

— in reporting and responding to disease risks in neighbori ng countries.

APHIS conducte d site visits to Argentina in 2003, 2005, 2006, 2009, and

2013 to verif

y and complem en t information provided by the Argentine

authorities . Three of these visits were conducted in Northern Argentina15 ( 2005, 2006, and 2013 ) . A P HIS concludes that the risk of introducing FMD

into the United States thr ough the importation of fresh beef under certain

conditions originating in the region of Northern Argentina is low (USDA

– APHIS, 2014 ). APHIS considers that Argentina’s SENASA possesses sufficient legal authority to carry out official prevention, control, and quarantine activities for animal health programs, and that it has demonstrated an infrastructure adeq uate for rapid detection of FMD and for carrying out

surveillance and eradic ation programs (USDA

– APHIS, 2014 ).

Most of the Argentine border is protected by effective natural barriers t hat reduce unrestricted flow of animals and animal products from areas of higher

risk. Areas where there are no natural barrie rs have control mechanisms that include mobile patrols and a permanent coordination between national and provincial entities to maintain a constant presenc e (National Border Police and other police authorities).

Interspecies Tra nsmission of FMD

FMD is one of the most contagious animal diseases known (AVIS/OIE, 2000); although rare

, human cases have occurred . However, FMD is not considered zoonotic under natural conditions (Enserink, 2001; AV M A, 2007). Natural infection with FMD V has been reported worldwide in animal

families

, including the Bovidai, Cervidai, Suidae, Tayasuidae, Camelidae, Giraffidae, Erinaceidae, Muridae, Elephantidae, Tapiridae, and Ursidae (Mouchanta n t et al., 2005). Transmission between susceptible cloven

- hoofed

wild and domesticated animal s is possible and is known to have occurred only once in the United States in 1924 (Rhya n et al., 2006). The virus also

may be transmitted mechanically by humans and nonsusceptible animals

, such as rodents and birds.

There is no known treatment for FMD (AVMA, 2007). Severity of the disease and expression of symptoms can vary greatly, even within a species. Sheep are generally considered to be “carriers

, ” while swine are “amplifiers”

and cattle are “indicators” (CIDRAP, 2007). Although occasionally FMD can be very destructive to wildlife populations (for example, the South African impala in the late 19th century

, or mountain gazelles in Israel more recently (Shimshony et al., 1986; Thomson et al., 2003)), genera lly FMD in

wildlife “results in a relatively mild disease from which the affected animals recover in a week or two. The significance of the disease for wildlife lies largely in the potential that cloven

- hoofed wild animals have for transmitting

the diseas e to domestic livestock . . .” (Thomson et al., 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. FMD in wildlife appears to be an extension of the disease in livestock, with the exception of sub

- Saharan16 Africa. Therefore, if FMD is eradicated from livestock in a region, it generally disappears from wildlife in the region ( 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

.

APHIS considers that the livestock sampling c onducted in Northern Argentina under the national serological sampling plan is adequate to detect disease and identify and measure viral acti vity in the export region (USDA

APHIS, 2014 ).

If FMDV 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 potentially 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 )

.

“ 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 carr y out ( T h omson e t a l.,

2003 )

.

However, despite the fact that se veral South American wildlife species are susceptible to FMD, their role in the epidemiology of FMD is considered to be insig nificant. Research into FMD has determined that wildlife populations, including feral swine, do not play a signif icant role in the

maintenance and transmission of FMD , and that contamination of domestic ruminants by wildlife is unlikely . Analysis and experience from FMD17 outbreaks indicate that adequate management of livestock will eradicate the

disease (Moutou, 2005 )

. D omesticated bovines are considered the primary

reservoir for the FMD virus within South America.

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 , 2014 ) , 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 Northern Argentina 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 both domestic

and international a n i m al mov e m e nt c ont r ols ( U S DA

– A P H I S , 2014 )

.

b

. 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 preventing the introduc tion of FMD virus in to the

United States ( 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 transmission 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

.

For instance, in the event that F M D

- c ont a min a t e d beef w as impo r t e d a nd

d i spos e d of in U. S . l and f

ills , sus ce ptible wildli f

e popul a tions c ould be exposed and b ec ome in fec t e d. T he 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, 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, it 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 it 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 FMD

infection 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

.18 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 are 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

—

• 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 )

.

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 robust 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

.

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 universities, is in the process of developing a n e w F MD v acc ine that 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. A private company is currently developing the vaccine for production. 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 ( USDA

– ARS, 2013 )

.

Environmental Fate of FMD

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 t he 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 1.19 Table 1. Survival Time of FMD Virus on Various Contaminated Objects At Ambient Temperatures.

Contaminated Objects Weeks of Survival

Soil, S

– W 3 1

– 21

Barn dirt; Barn sand 1

– 10

Road sand; garden soil 1.5

– 4

Manure, S

–

W 1

– 24

Sewage, S

–

W 3

– 15

Barns (brick, adobe, wood), S

– W 2

– 11

Walls, brick and plaster 2

– 4

Soil, water, lichens 4

Pasture plants, S

–

W 1

– 7

Haystack, S

–

W 4

– 29

Feed sacks; bran 20

Meal 7

Vegetables 1

Water 3

– 14

Houseflies 10

Ticks 15

– 20

Wool, sheep 2

Hair, cattle 4

– 6

Glass surface 2

Clothing and footwear, S

– W 4 3

– 9, 14

Meat cloth (at 4 o C) 6

In addition to the objects listed in table 1, many other contaminated items have been suspected as the source of FMD outbreaks, including various domestic or wild animals and birds, humans, truck tires, and even postal

materials. The survival time of FMDV is shorter for the virus in the

environment than for the virus in animals. Sunlight, temperature, pH changes, relative humidity, and the dilution effect of rain and melting snow

3 S

– W, 1

– 21: summer 1 week, winter 21 weeks.

4 Cotton garments, leather shoes, rubber boots.20 all affect virus survival; however, sunlight and ultraviolet radiation have little effect on virus persistence (Pharo, 2002). Longer survival times for FMDV on objects would be expected at the low temperatures associated with high altitudes, or the arctic regions, than at sea level or in the tropical regions. Although temperatur es above 50 °C destroy most infectivity, it is likely that a small proportion of the virus particles are relatively resistant to the effects of heat and pH in most populations (Pharo, 2002).

The effect of temperature and pH on time for 90 percent virus inactivation is shown in table 2 and table 3, respectively, based on findings from the

Bachrach et al. (1975) study. There also is the potential for FMDV to be

disseminated over considerable di stances by aerosols (Cottral, 1969). In aerosols, FMDV survives best when the relative humidity exceeds 70 percent and there is a critical humidity level of 55 to 60 percent, below which survival is poor (Pharo, 2002). Based on available scientific data, the survival of residual FMDV in the external environment following eradication of an outbreak of FMD in susceptible animals would be expected to p ersist no longer than 8 months.

Table 2. Effect of Temperature (at pH 7.5) On Time f or 90 Percent FMD V
Inactivation.

Temperature Inactivation T ime (90 percent)

61 o C 30 seconds

55 o C 2 minutes

49 o C 1 hour

43 o C 7 hours

37 o C 21 hours

20 o C 11 days

4 o C 18 weeks

Table 3. Effect of pH (at 4 o C) On Time for 90 Percent FMD V Inactivation.

ph Inactivation T ime (90 percent)

10.0 14 hours

9.0 1 week

8.0 3 weeks

7.0

– 7.5 >5 weeks

6.5 14 hours

6.0 1 minute

5.0 1 second21 Public Health

FMD may affect humans ; however, its occurrence is quite rare. The number of cases reported worldwide is so small when compared with the number of persons exposed to FMD that it is generally not considered a threat to

humans. FMD V has been isolated and typed in only 40 patient s during the last century. Symptoms in humans are mostly mild and mainly include fever and blisters on the hands, feet, mouth, and tongue. Patients usually recover within a week after the last blister formation ( USDA

– APHIS, 2014 ).

Perhaps more importan tly, an FMD outbreak of the magnitude observed in the United Kingdom can result in severe psychosocial effects on farmers and farming communities. Farmers and their families can suffer from grief over losing animals ( in some cases blood lines kept over ma ny generations ) , as well as loss of control over their lives due to movement restrictions, disruptions in community life, and short

- and long

- term stress over their financial future. Researchers from Lancaster University in the United Kingdom conducted a new study on the social consequences of FMD in the Cumbria community . The study revealed high rates of depression, alcohol consumption

, and mortality among farmers during the crisis ( USDA

– APHIS,

2014 ).



## IV. Other Environmental Issues

A. Environmental Justice and the Preferred Alternative

Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and Low

- I ncome Populations,” requires each Federal agency to make achieving environmental justice part of its mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of its programs, policies, and

a ctivities on minority populations and low

- income populations in the United States and its territories and possessi ons. I mportation of fresh, maturated,

and deboned beef from Northern Argentina, under the P referre d A lternative, is not expected to substanti ally affect the condition of minority livestock producers in the United States. Most of the modest impact

- generating compliance actions under the Preferred Alternative will occur outside of the

United States

, and none has any disproportionate adverse effe cts on minority

or low

- income populations in the United States . Although one could design scenarios involving the introduction of FMD to the United States, these are primarily remote and hypothetical. Even if such scenarios could occur, their impact to m inority and low

- income populations would be expected to be negligible.22 

### B. Protection of Children and the Preferred Alternative

Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks,” requires each Federal agency to address disproportionate environmental health risks or safety risks to children that arise in the course of agency policies, programs, activitie s, and standards. Implementation of the Preferred Alternative does not pose gr eater risks to children than to other parts of the affected populations. Control of the risks

associated with ruminant and ruminant product importation depends primarily upon adherence to sanitary requirements. Proper adherence will remove the potentia l for adverse effects to humans and make other commodity introduction

- related risks remote and of very low concern in regard to the protection of children.



### C

. Threatened and Endangered Species and the

Preferred Alternative

Section 7 of the Endangered Species Act and its implementing regulations require Federal agencies to ensure that their actions are not likely to jeopardize the continued existence of threatened or endangered species or

result in the destruction or adverse modific ation of critical habitat. APHIS

considere d the potential effects of the Preferred A lternative on threatened and endangered species and designated critical habitat. There are six listed ungulate species that are potentially susceptible to FMD (table 4); however, based on the supposition of required mitigation measures for the im portation

of FMD

- susceptible products, the risk for these species to be exposed to and, thus, be affected by this action is low . Therefore, APHIS expects allowing the importation of fresh, maturated, and deboned beef from Northern Argentina will have no effect on threatened or endangered species or their

critical habitat in the United States.

APHIS determined that the risk of FMD

- infected beef entering the United

States from Northern Argentina

, and the potential to expose U.S. livestock to

FMD

, to be low (USDA

– APHIS, 2014 ). Importations of beef from Northern Argentina are mitigated by requiring implementation of the measures outlined in 9 CFR § 94.11

. Based upon the effecti veness of the mitigation

measures included in 9 CFR § 94.11 and the risk assessment and the low

likelihood that FMD would establish in U.S. livest ock, allowing the importation of fresh, maturated, and deboned beef from Northern Argentina is expected to hav e no effect on federally listed endangered species or designated critical habitat.23 Table 4. Endangered Species in the United St ates 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

Bighorn sheep Ovis Canadensis Yes Endangered

Sierra Nevada bighorn sheep Ovis canadensis californiana No Endangered



### 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 allowing the importation of fresh, maturated, and deboned beef from Northern Argentina 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 assessment ( U S DA

– A P H I S

, 2014 )

. 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 ondit ions in Northern Argentina

, a s w e ll a s c ompli a n c e w i th impo r t a tion c onditions in the region

a nd oth e r r e g ul a t e d c oun t r i e s. However, APHIS concludes that fresh, maturated, and deboned beef under consideration for importation is a low risk in view of the certification requirements and other conditions for importation that will be implemented , making int r odu c tion of the dis ea s e

e x t re m e l y unlik e l y

. In addition, the nature of disease mitigation is of principal concern for this issue, and the constraints provided by the anticipated mitigations are considered to provide adequate protection.24



## V. Listing of Agencies Consulted

Environmental and Risk Analysis Services Policy and Program Development Animal and Plant Health Inspection Service U.S. Department of Agriculture 4700 River Road, Unit 149 Riverdale, MD 20737

– 1237

Regionalization Evaluation Services

Natio nal Import Export Services Veterinary Services Animal and Plant Health Inspection Service U.S. Department of Agriculture 4700 River Road, Unit 38 Riverdale, MD 20737

– 1231

Regulatory Analysis and Development Policy and Program Development

Animal and Plant Health Inspection Service U.S. Department of Agriculture 4700 River Road, Unit 118 Riverdale, MD 2073725



## VI. References

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 / 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/ 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.

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

C e nt e r f or I n f e c tious Dis ea se R e s e a r c h a nd P oli c y , 2007. U n i v e r si t y o f

Mi nn e s o t a
, A ca d e mic H e a lth C en t er

. F oot

- an d

- m outh dis ea s e

. [ Onlin e .]

Av a il a bl e : http://www. c id ra p.umn. e du/ c id ra p / c o nt e nt/bios ec u r i t y / a g

b i o s ec / an i m

- d i s ea s e / foo t

- mouth.html [ 2007, S e p t

. 13 ]

.

C o r n, J

., a nd F is ch e r
, J ., 2001. W h a t if F MD hits? S outh ea st er n c oop era tive

wildli f e dis e a se stu d y ( SCW D S ) B r i e f s, Ap r il 2001, 17.1 [ Onlin e .]

Av a il a bl e : http://www.u g a

. e du/s c w ds/topi c _ind e x /200 1 / W h a ti fF MDHits.pdf
[ 2007, Nov. 7 ]

.26 Cottral, G.E., 1969. Persistence of foot

- and

- mouth disease virus in animals,
their products and the environment. Bull. Off. Int. Epizoot. , 70(3):549

– 68.

Ens er ink, M., 2001. The En g lish p a ti e nt. S c i e n ce NOW 2001 ( 426 ) : 2. Ap r il 26, 2001. [ Onlin e .] A v ail a b l e : http://s c i e n ce now.s c i e n c e m a g .o r g [ 2007,

S e pt. 2 0 ]

.

F A SS

— S e e Fe d e r a ti o n o f A n i m a l S c i en ce S o ci e t i es

Fed e ra ti o n o f A n i m a l S c i en ce S o ci e ti e s, 2007. F o ot a nd mouth dis ea se

v acc i n e d e v e lop e d b y U S DA, A R S S c i e ntists. A r ti c le #1244, dist r ibut e d

M a y 31, 2007. [ Onlin e .] A v ail ab l e: http://www. fa ss.o r g /

p a g e

. a sp ? p a g e I D = 205 [ 200 7 , O c t. 16 ]

.

F i e lds, B .N., Knip e , D. M

., a nd Howl e y
, P .M., 19 9 6. F und e m e nt a l

Vi r olo g y , 3 r d Edition.

H aa s, B ., K r a m er
, M ., 2 0 00. App e ndix 11: P os si ble int r odu c tion of F MDV

with sh ee p int e st i n e s fr om F MD c ount r i e s. F AO/A G A/The Eu r op ea n C ommission f

or the c ont r ol of f

oot

- an d

- mouth dis ea s e. [ Onlin e .] A v ail ab l e: http://www. fa o.o r g / a g / A GA/AGAH/E U F MD/ re p o r ts/ r g 2000bv/ a pp11.p d f
[ 2007, Nov. 6 ]

.

L D W F

— Se e L ouisi a na D e p ar tm e nt of W ildli f e a nd F ish er i e s

L ouisi a na D e p a r tm e nt of W ildli f e a nd F ish er i e s, 2 007. S u r v e ill a n c e pl a n to
h e lp c ont r ol wild hog popul a tion a dopt e d. R e l ea s e d: 11/13/07. [ Onlin e .]

Av a il a bl e : ht t

p://www. w l f .st a t e .l a .u s /n e ws [ 2007, Nov. 14 ]

.

Mo r g a n, J .T., F is c h er
, J ., Host e tl er , M.E., 2003. I f f oot

- an d

- mouth dis ea s e

ca me to F lo r i d a : pot e nti a l imp ac t on whit e

- t a il e d d ee r in Fl o r i d a. Univ er si t y

o f F lo r id a
, M arc h 2003. [ Onlin e. ] Av a il a bl e : http:// e dis.i fa s.u f

l. e du/ B ODY_U W 183 [ 2004, O c t. 20 ]

.

Mou c h a nt a nt, S ., H aa s, B

., L ut z
, W

., P ohlm e y e r
, K., Fr oli c h , K., 2005.

A b s en ce o f a ntibodi e s to f oot

- an d

- mouth dis ea se v i r us in free

- ra n g i n g r o e d ee r f ro m s e l ec t e d a r ea s o f G er m a n y (200 1

– 2002 )

. W ildli f e Dis ea se Asso c i a tion: J ou r n a l of W ildli f e Dis ea s e s 41 ( 3 )

, J u l y 2005, pp. 599

– 605.

Moutou, F., 2005. Foot and mouth disease in wildlife: risks and risk management proposals for Europe. FAO/EUFMD Reports, 2005 Session of the Research Group of the Standing Technical Committee of EUFMD (Greifswald, Insel

- Riems, Germany: September 2005). [ Online.] Available: http://www.fao.org/ag/againfo/commissions/docs/research_group/germany05

/REPORT

- final.pdf27 ODA

— S e e O r e g on D e p a r tm e nt of A g r i c ultu r e

O r e g on D e p ar tm e nt of A g r i c ultu r e , 2007. S to r y o f the w ee k: fe r a l swi ne

ac tion pl a n g e tting some a tt e ntion in O r e g on. A u g ust 8, 2007. [ Onlin e .]

Av a il a bl e : http://o re g on

. g ov/ODA/d o c s/pd f /n e w s /070808pi g s.pdf [ 2007,

Nov. 14 ]

.

P h ar o, H. J ., 2002. F oot

- an d

- mouth dis ea s e : An a ss e ssm e nt of the r isks

fac i n g N e w Z e a l and

. Ne w Z e aland V e t e rinary J

o urnal , 50 ( 2 ) , 46

– 55.

P into, A.A., 2004. F oot

- an d

- mouth dis ea se in t r o p i ca l wildli fe . Ann a ls of

the N e w Y o r k A c a d e m y of S c i e n ce s, 1026:65

– 72.

R h y a n, J

., S h a l e v, M., Gidl e w ski, T., M c C ollum, M., W ar d, G., D e n g
, M

., M c K e nn a , T., S a lm an
, M

., 2 006. S us ce ptibili t y of No r th Am er i c a n wild

un g ul a t e s to f

oot

- an d

- mou t h dis ea se vi r us: initi a l f indin g s. F AO/E U F MD

R e po r ts, 2006 S e ssion of the R e s ea r c h G r oup o f the S t a nding T e c hni ca l

C ommitt e e of EU F MD ( Pa hphos, C y p r us: O c tob e r 2006 )

. [ Onlin e .]

A v ail ab l e: http://www.fao.org/ag/againfo/commissions/docs/research_group/paphos/Ap p23.pdf [ 2007, O c t. 17 ]

.

S c ho e ni a n, S ., 2005. M a d c ow a nd f oot

- an d

- mou t h. Univ er si t y o f M a r y l a nd,

M a r y l a nd C oop era tive E x t e nsion, W e st er n M a r y l a nd R e s e a rc h an d Edu ca tion

C e nt er

. C o p y

r i g ht 2000; l a st re vis e d: 12/23/05. [ On l in e .] Av a il a bl e : http://www.sh ee p a n d g o a t. c om/ ar ti c l e s /bs e

_ f md.h t ml [ 2007, S ep t . 20 ]

.

S himsho n y e t a l., 1986. S himsho n y , A., O r g a d, U

., B a h a ra v, D., P r udovs k y
, S ., Y a kobso n
, B

., B a r Mosh e
, B

., D a g a n, D., 1986. M a l i g n a nt f oot

- an d

mouth dis ea se i n mount a in g a z e ll e s. V e t er in a r y Re c o r d ( 198 6 ) 119, 175

– 176. [ Onlin e .] A v ail ab l e : http://www.is rae l

- e m b a s s y

. o r g .uk

Thomson, G. R ., Vosloo, W

., B a stos, A.D. S ., 2003. F oot a nd mouth dis ea se in wildli fe . Vi r u s R e s earc h 91 ( 2003) 14 5

– 161. [ Onlin e .] Av a il a bl e :

www

. s c i en c e d i rec t

. c om

U S DA

– A P H I S

— Se e U

. S . D e p ar tm e nt of A g r i c ultu re , Anim a l a nd Pl a nt

H ea lth I nsp e c tion S er vi c e

USDA

– ARS

— See U.S. Department of Agriculture, Agricultural Research

Service

U.S. Department of Agriculture, Agricultural Research Service, 2013. Guarding the country against foreign animal diseases. Agricultural Research, August 2013. [Online.] Available: http://www.ars.usda.gov/is/AR/archive/oct13/animal1013.htm28 U. S . D ep a r tm en t o f A g r i c ultu re
, Anim a l a nd P l a n t H ea lth I nsp ec tion S erv i ce
, 2014

. R isk a n a l y s is: foot

- and

- mouth disease risk from importation of fresh (chilled or frozen), matured, deboned beef from Northern Argentina into the

United States.

U. S . D e p ar tm e nt of A g r i c ultu re , Anim a l a nd P l a n t H ea lth I nsp ec tion S er vi ce
, 2003. I mpo r t a t i on of solid wood p ack i n g m a t er i a l. F in a l e nvi r onm e nt a l

im p a c t st a t e m e nt

— Au g ust 2003. R iv er d a l e , MD.

U S G S

— S e e U. S . D e p ar t m e nt of the I nt er io r
, Unit e d S t a t e s G e ol o g i ca l

S u r v e y

U

. S

. D ep a r tm e nt of the I nt er io r , Unit e d S t a t e s G e olo g i ca l S u r v e y , N a tion a l

W ildli f e H ea lth C e nt er , 2007 a

. W ildli f e H ea lth B ull e tin #0 1

– 01 fr om B ob

M c L ea n, Di re c tor N W H C : f oot a nd mouth dis ea se in Eu r op e

- fac t sh e e t.

L a st modi f

i e d J une 28, 2007. [ On l in e .] Av a il a bl e : http://www.nwh c .us g s

. gov

U. S . D e p ar tm e nt of the I nt er io r , Unit e d S t a t e s G e olo g i ca l S u r v e y , N a tion a l

W ildli f e H ea lth C e nt er , 2007b. F oot a nd mouth dis ea s e

. L a st modi f i e d J une 28, 2007. [ Onlin e .] Av a il a bl e : ht t p://www.nwh c .u s g s

. g ov

U. S . D e p ar tm e nt of the I nt er io r , Unit e d S t a t e s G e olo g i ca l S u r v e y
, O ff i c e of

C ommuni ca tion, 2001. U S GS issu e s wildli f e h ea lth a l er t f

o r f oot

- an d

- mouth

dis ea s e

. R e l ea s e d Ap r il 18, 2001. [ Onlin e .] Av a il a bl e : http://www.us g s. g ov/ n e ws r oom/ ar ti c l e

. a sp ? I D = 4 80

W DN R

— S e e W is con s in D ep a r tm en t o f N a t u r a l R e s ou r ces

W is con s in D ep a r tm en t o f N a t u r a l R e s o u rce s, 20 0 3. F oot

- a nd

- mouth dis ea s e : issu e s f or W is c onsin wildli fe

. L a st mo d i f i e d: Ap r il 17, 2003. [ Onlin e .]

A v ail ab l e: http://www.dn r .st a t e

. w i.u s /o r g /l a nd/wildli fe /wh e a lth/issu e s/ f md.h t m [ 2004,

S e pt. 1 5 ]

.

W I N

— S e e W ildli f

e I n f o r m a tion Ne two r k

W ildli f e I n f o r m a tion N e two r k, 2001. P i c o r n a vi r i d ae : F oot

- an d

- mouth

dis ea se vi r us. [ Onlin e .] Av a il a bl e : http://www.wildli fe in f

o r m a tion.o r g / S ubdi rec to r i e s_ f o r

_ S ea r c h2/ S a mpl e S p

ec i e s/ p i co r n av i r i d a e / P i c o rn a v i r id ae

_ F MDVi r us.h t m