2014-11-04 aphis second complaint scbt

8/16/2019 2014-11-04 APHIS Second Complaint SCBT

http://slidepdf.com/reader/full/2014-11-04-aphis-second-complaint-scbt 1/10

OV

4

2 14

UNITED STATES DEP RTMENT OF AGRICU

LT

URE

BEFORE THE SECRET RY

OF

AGRICULTURE

In re :

}

}

W

Dkt . No .

5 00; ..3

Sa nta Cruz Biotechnology , Inc

.

Resp

ondent

Compl

a i n t

There

i s rea

so

n to

be l iev

e t ha t t he

re

spo

ndent nam

ed

here in has wi l l f u l l y v io la ted

the

Animal Welfare

Act,

as

am

ended

(7 U.

S.C

.

§

2131 e t

seq

. ) ,

here inaf t e r r e fe r red to

as

the Act ,

and

the regula t ions and

s tandards

(9

C.F . R . § 1 .1 t

s eq . ) i s

sued

pursuant to the

Act, and, t he re fo re

the

Adminis tr

a

t o r o f the Animal and Plant Heal th In spec t

ion

Service

( APHIS )

i s sues

th i s compla int

a l

l eg ing the fol lowing:

I

A. Santa

Cruz

Biotechno

lo g

y ,

I nc .

here inaf t e r

r e f e r r ed

to as

respondent , i s a Delaware

co

rpora t

ion whose address i s

2145 Delaware Avenue, Santa Cruz, Cal i f o r n ia 95060 .

B.

The

re spondent

,

a t

a t imes

mate r

i

a l he r

e to , was

r eg i s te r ed and opera t ing as a research f a c i l i t y as def ined in

th

e

Act and the

regula t ions and w

as a l so r e g i s t e r e d and

opera t ing as

a

dea le r

as

def ined

i n

th

e

Act and

the

regula t ions .

C. The

respondent

has

r ece ived

a copy

of

the

1



regula t ions

and

the

s tandards i s sued

pursuant to the Act and

agreed in wr i t i ng to comply

with

them

.

A. On September 26, 2012, APHIS

inspec ted re sponden t s

premises and r ecords and found t ha t th e I ns t i t u t i ona l Animal

Care and Use

Comm

i

t t e e

IACUC)

did

not

in s u r

e t ha t

procedures

involving

animals

w il l avoid or minimize discomfor t , d i s t r e s s

and pain to

the

animals

, in v io la t ion

o f

sec t ion 2 .

3l(d) 1) i)

of the

regula t ions

9

C.F

.R.

§ 2 .

3 l ( d ) ( l

) ( i )}

.

8 . On September 26, 2012, PH I S inspec ted responde n t s

prem

i s e s and

found t

ha

t

the

respondent had f a i l ed to e s tab l i

sh

and

main ta in

programs

of

adequate ve t care t ha t inc lud ed da i ly

observa t ion o f a l

l

animals

to assess

t he i r

hea l th and we -

being, in v io la t ion o f s e c t i on 2 .

33 b)

3) of the r egu la t ions

9 C.F . R. §§

2.33 b)

3) ) ,

and in

wil l fu l v io la t ion

of

sec t ion

2.40 b) 3} of the

regula t ions

9 C. F.R . § 2.40(b }

{3)}

.

C. On September 26, 2012, APHIS inspec ted

re sponden t s

fac i l

i t y

and

r ecords

and found the

fo l lowing

v io la t ions

o f

s e c t i

on

2.26

of t he regula t ions 9

C.F.R. 2.26) and

the

s tandards

s pe c i f i ed

below,

and w i l l f

u l

v io l a t

ions of

sec t ion

2.100 a}

o f the regu

l

a t ions

9

C.F

. R. § 2 . 100 a) }

and t he

s tandards

spec i f i ed below:

1 . The

f ac i

ty

was

no t

cons t ruc ted of

such mate r i a l

2



7

U. S

.

C. § 2146 a)}.

IV

A. On

October

31,

2012,

APHIS

inspec ted re sponden t s

premi ses

and

r ecords

and

found

that

the I ACUC did not

review

and appro

ve

, require modif ica t ions in

( to

secure approva l ) or

withhold

approva

l o f proposed

s ign i f i c a n t changes

r egard ing

the care an

d u

se

o f animals

in ongoing a c t i v i t i e s , in

vio

l a t i

on of sec t ion

2 . 3

1

c}

7)) o f

t he

regula t ions

9

C.F.R

.

§

2.3 l (c )

(

7} )

.

B.

On

October

31, 2012, APHIS i n spec t ed

respondent s premises

and

found t ha t the respondent had

fa

i l ed

to e

s t ab

l i s h and mainta in

programs

of

adequate ve t

care

t ha t i nc luded

the

use o f

appropr ia te

methods to prevent

,

contro l , diagnose, and t r e a t d is eases and i n ju r i e s , and the

ava i lab i lit

y

o f

emergency,

weekend, and

hol iday care

and

inc lude d d a i l y

obse r va t i

o n

of

a l l animals

to

as se s s t he i r

hea l t h and we ll-be ing , in v io la t ion

of sec

t

io

ns 2.33 (b) {2)

and

3)

of

the

regu l a t ions

9

C.F .

R.

§§ 2.33 b)

2)

a nd 3)} ,

and

in

wi

l

l fu

l

v io la t ion of sec t ion

s 2

.4 0 b)

2) and

(

}

o f

the r

egu l a t i ons

{9 C. F.R . §§ 2 .40 b) (2}

and 3))

.

C.

On October

31, 2012,

APH I S

in spected responden

t

s

f ac i l i t y

and r ecords

and found

the

respondent v io la t ed sec t ion

2.26 of t he reg

u la t ions

9

C.

F . R.

§

2 .

26) and

the s tandards ,

4



and

w i l l f u l l y v i o l a t e d sec t i o n 2 .10 0 a} o f

t he

regu

lations

9

C.F.R. §

2 . 100(a) )

and t he s t an

d a r

ds s i nce

t he premises

bui

ld i

ngs

and grounds)

wer

e

not

kep

t

c l e a n

and

in

good

r epa

ir

and

f ree

o f accumula t i ons o f t r a sh 9 C.F.R. § 3.131 {c ) ) .

v

On December 18 , 2012 ,

P

IS

i n s pec t e

d

r e s ponden t s

premises

and

fo

und

t h a t th

e

r esponden t

had

f a i l e d

to

e s t a b l i s h

and

main ta in programs o f adequa

t e ve t

ca r e

t h a t inc luded t he

use

of

appropr

i a t e

methods

t o

preven

t ,

con t ro l ,

d iagnose ,

and

tr

e a t d i s eas es and in

j u r i e s , and the a v a i l

a b i

li t y o f

emergency, weekend, and ho l iday c

a r e

and inc luded d a i l y

obse rva t ion

o f all

animals to

assess th e

ir

he

a

l t h an

d we ll-

be ing ,

in v i o l a t i o n

o f sec t ions 2.33(b) 2) and 3)

o f th

e

r egu la t io n s 9 C.F .R .

§§

2 . 33 {b ) 2) and and in willfu l

v i o l a t i o n o f

sec

t

ions

2

.40{b)

2) and

3 )

o f

t he

regu

l

a t i o n s C

C •.

F.

R.

§

2 .40 b )

2)

and 3

) ) .

VI

On

February

20, 2013, APHIS

insp

ec t e d

r e s ponden t s

prem

i ses and

fo und

t h a t

t he

r e

sponden t

h a d

f a i l e d t o e s t a b

l i s h

and main ta in

programs

o f adequa te

ve t

c a.re

th

a t in c l

ud

e d

appropr

i a t e me

thod

s

t o

preven

t con t ro

l

d iagn

o

se

and

t

r e a t

d i s e a

se nd i n j u r i e s and t he a v a i l abil i t y

o f

e me rgency ,

weekend a n d

h o l id a y a ~ ~ e

i n

v io

l a

t i on

o f s e c t

ion

2 .

33(b

)

{2) o f

5



the r egu la t ions 9 C.F.R. §§ 2.33 b)

2)} ,

and in w i l l f u l

v io la t ion of

sec t ion 2

.4

0

b) 2} of the

r egu la t ions

9 C .

F.R

.

§

2 .40( b)

2}) -

VII

On May

14

, 2013, APHIS

inspec ted

respondent s premises

and

records

and found

t h a t the

I CUC

d id not

review

and

approve,

r equ i r e modi f i ca t ions

in

( to secure

approva

l }

or

w

i thhold

approval

of

proposed

s i g n i f i c a n t

changes

r egard ing

the

care

and

use

of

animals

in

ongoing a c t i v i t i e s

, in

v io la t ion of sec t ion 2 .3 1

c)

7 )

of the r egu la t ions

9

C.F.R .

§ 2.3 l (c )

7) ) .

V I U

On

September 10, 2013,

APHIS inspec ted re sponden t s

f a c i l i t y

and

r ecords

and found

the fol lowing

v io la t ions

o f

sec t ion

2.26

o f the regu la t ions

9

C . F .R.

§

2 .

26}

and the

s tandards s p e c i f i e d

below,

and w i l l f u l v i o l a t i o n s o f sec t ion

2.100 a)

o f the

regula t ions

9 C.F.R. § 2 . 100 a ) }

and

the

s ta ndards

s p e c i f i

ed

below:

1 .

S u f f i c i e n t shade

by na tu r a l o r

a r t i f i c i a l

means was

not

provided

to

a l

l

ow

ll

anima

l s kept

outdoors

to p r o t e c t

themselves

from

d i r e c t

sun l igh t when

sun

l i g h t i s

l i k e l y t o

cause

overheat i ng

or discomfor

t o f the animals 9

C.

F . R.



§ 3.127 a

)) .

X

A. On

Apr i l

22

,

2014,

APHIS

in

sp

ec t ed

respondent

s

pre

mis es and

records

and

foun

d t ha t th e IACUC

did not

review

a nd

approve

, r equ i r e

modi f i ca t ions

in to sec ure

approval}

or

withhold

approval

o f proposed s ign i f i

cant

changes r egard in g

the ca r

e

and

us e o f animals in

ongoing

a c t i v i t i es , l n

v io la t ion of sec t ion

2.31

(

c) 7) of

the r egu la t ions 9 C.F .R .

§

2 .

3l(c)

(

7))

.

B. On Apri l 22, 2014, APHIS inspec ted r espondent

s

pr

em

i s

es and

r ecords

and

foun

d

tha t

the IACUC

did

not rev i e w

and

approve

a proposa l to

conduct

an a c t i v i t y

involv

ing

an im a l s ,

or

to make a

s ig

n if i

cant change

in an

ongoing

ac t iv

i t y in vol

vin

g

animals ,

t ha t con t a ined a

complete

descr ip t ion

of

th

e

proposed

u s e

of

th

e

an

ima l s ,

in

v

i o l a t i on

of sec t ion 2 . 3l e} 3 } o f

th

e r egula tions ( 9 C.F.R . §

2 . 31 e 3)) .

C. On Apri l

22,

2014, APHIS in spec t ed th e

responden t s

f a c i l i t y

and records and fou

nd

the fo l lowing

v io la t ions

of

sec t ion 2 . 26

o f the

r egu la t i ons 9 C. F.R .

§ 2 . 26} and the s tandards spe

c i f i e d

be low,

and

wi l

l f u l

v io la t ions

o f

s e c t

ion

2.100 (a ) o f the regula t ions 9 C. F . R.

§ 2 . 100{a)) and the standar-ds spec i f i ed

be

l ow :



1 .

Primary

enclosures were not kept reasonab l y

f r

ee

of excre ta

, h a i r ,

cobwebs and other debr i s

b y

pe r iod ic

c leaning

9 C . F . R.

§

3 .

56 a))

;

2 .

The

food p rovided f or

r abbi

t s was not f ree

from

contaminat ion, wholesome

, pa l a tab le and

o f su

f f i c ien t

quant i ty

and n u t r i t i v e

value

to meet t

he

normal da i ly

requirements for

th e

condi t ion and

s i

ze

of

th

e

rabb ts {9

c .

F. R. § • 54 a } ) ;

3.

Food was

not

whol

esome,

pa la tab le ,

and

f

ree

from contaminat ion and of

s u f f i c i e n t quan t i t y and nu t r i t i ve

value

to maintain a l l

animals

in

good

hea l t h 9 C.F . R.

§

3.129 a )

.

WHEREFORE t i s hereby ordered

tha

t

for

the purpose

of

determining whe the r th e respondent ha s in fac t

v io la t ed

the

regula t ions

and

s tandards

i

ss ued un

d

e r

t he

Ac t , t h i s

com

p

l a i

n t

sha l

l be

served

upon

t he respondent .

The

respon

dent

s ha l l

f i l e an

answe

r with

t he

Hear ing Clerk , Onited Sta tes

Departm

e n t o f Agr icu l tu re , Washington, D.

C.

20250 -

920

0 ,

in

accor

d ance

w it

h the Rul

es

of Prac t ice

governing

proceedings

under

t he Act 7 C. F

.R.

§ 1 .13 0 t seq. } .

Fai lure

to f i l e a n answer s ha l l

c o n s t i t u t e an admiss ion

of

a l l

the

mater i a l

a l l

ega t ions

o f

t h i s complaint .

The Anim

a l a n d Plant

Hea

l th Insp

e c t

ion Ser

v i

ce requ e s t

s :

8



1 . Tha t

unless

the respondent fa i l s to f i l e an answer

with in

the t m al lowed

the r e fo r , o r

f i l e s an answer admi t t ing

a ll

the

mate r ia l a l l ega t ions

of

th i s

compl a i nt , t h i s

proceeding be

s e t

for ora l hear ing

in

conformity wit h the

Rules

of

Prac t ice

governing proceedings

under the Act;

and

2 . That

such

order

o r

orders be i s sued as

are

author ized

by the Act and warranted

under

th e ci rcumstances , inc lud ing an

order

a) Requir ing th e respondent to cease

and des i s t

from v io la t ing

the

Act and

the

regu

l a t i

ons

and

s tandards i

ssued

thereunder ;

and

b) Assessing c i v i l pena l t i e s agains

t

the

respondent in

acc

o rdance

with

sec t ion 19 of the Act 7 U. S.C.

§ 2 1 49 .

9



{c} Suspending

or revoking the respondent s

l i cense

in

accordance with

sec t ion

19

of

th

e

Act

(7

U.S

. C.

§

2149) .

Sharlene Deskins

Attorney

for

Complainant

Off ice of the General

C

ounsel

Unite

d Sta tes

Departm

en t o f

Agricul ture

M IL STOP

1417

14

00

Independence

Ave

. ,

SW

Washington,

D. C.

20250-1417

Telephone 2

02} 720-2595

Done a s h i n g t o n t

t h i s L / day of QV

nima l and

Plant

He a l t h

Inspec t ion Ser

v i c e

10

20

r

2014-11-04 aphis second complaint scbt

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