MEMORANDU M O F UNDERSTANDIN G 

Betwee n 

T h e Foo d Safet y an d Inspectio n Servic e 

Unite d State s Departmen t o f Agricultur e 

A n d 

T h e Foo d an d Dru g Administratio n 

Unite d State s Departmen t o f Healt h an d Huma n Service s 

L Purpos e 

Thi s Memorandu m o f Understandin g (MOU ) betwee n th e Foo d Safet y an d Inspectio n 

Servic e (FSIS) , Unite d State s Departmen t o f Agricultur e (USDA) , an d th e Foo d an d Dru g 

Administratio n (FDA) , Unite d State s Departmen t o f Healt h an d Huma n Services, is intende d 

t o improv e interagenc y cooperatio n o n foo d safet y an d frau d preventio n an d t o maximiz e th e 

effectivenes s o f personne l an d resource s relate d t o examinatio n an d inspectio n o f 

Siluriforme s fis h an d fis h products. 

I I . Backgroun d 

T h e Agricultura l Ac t o f 201 4 (201 4 Far m Bill) , enacte d Februar y 7 , 2014 , directs USD A t o 

execut e a n MO U wit h FD A fo r th e followin g purposes: 

1 . T o improv e interagenc y cooperatio n o n foo d safet y an d frau d prevention , 

buildin g upo n an y othe r prio r agreements. 

2 . T o maximiz e th e effectiveness o f limite d personne l an d resource s b y 

ensurin g tha t -

a. inspection s conducte d b y FSI S satisf y requirement s unde r th e 

Federa l Food , Drug , an d Cosmeti c Act ; 

b . inspection s o f shipments an d processin g facilitie s fo r fis h ofth e 

orde r Siluriforme s b y th e agencie s ar e no t duplicative ; an d 

c. an y informatio n resultin g fro m examination , testing , an d 

inspection s conducte d is considere d i n makin g risk-base d 

determinations , includin g th e establishmen t o f inspectio n priorities . 

Thi s MO U sets fort h th e workin g arrangements betwee n th e agencie s t o facilitat e eac h 

agency's effort s t o discharg e its responsibilitie s relate d t o th e regulator y oversigh t offis h an d 

fis h products an d t o achiev e th e purpose s identifie d i n th e 201 4 Far m Bill . I t build s upo n 

othe r prio r agreements betwee n th e agencies. 

I I . Statutor y Authoritie s 

FSI S administers th e Federa l Mea t Inspectio n Ac t (2 1 U.S.C . 601-695) , as amended , notably , 

b y th e 200 8 Far m Bil l (Pub.L . 110-246 , §4(a), titl e XI , §11016(b)(1)(A), Jun e 18 , 2008 ; 12 2 

1 
Stat . 1664 , 2130) , an d furthe r amende d b y th e 201 4 Far m Bil l (Pub.L . 113-79 , titl e XII , 

§12106(a)-(c), Februar y 7,2014 ; 12 8 Stat . 980-982) . 

F D A operate s unde r authoritie s includin g th e Federa l Food , Drug , an d Cosmeti c Ac t (2 1 

U.S.C . 301 , e t seq.), th e Publi c Healt h Servic e Ac t (4 2 U.S.C . 201 , e t seq.), an d th e Fai r 

Packagin g an d Labelin g Ac t (1 5 U.S.C . 1451 , e t seq.). 

III . Substanc e o f Agreemen t 

A . I t is mutuall y agree d that : 

1 . Th e agencie s wil l pla n fo r th e orderl y transition , i n phases, fro m FD A t o FSI S o f 

primar y regulator y oversigh t o f domesticall y produce d an d importe d Siluriforme s fis h 

a n d fis h products, as provide d i n th e fina l rule . 

2 . Th e agencie s wil l follo w th e provision s o f this MO U a s appropriat e durin g th e 

transitio n perio d an d full y thereafter . 

3 . I n dua l jurisdictio n establishments tha t prepare , pack , hold , o r otherwis e handl e bot h 

Siluriforme s fis h an d fis h products an d othe r fis h an d fis h products, th e agencie s wil l 

follo w th e procedure s fo r dua l jurisdictio n establishments se t ou t i n MO U numbe r 225 ¬

99-2001 , excep t a s supersede d fo r certai n infonnatio n sharin g b y MO U 225-12-000 7 

(sectio n IV , paragrap h 9 an d Appendi x B) . 

4 . Th e agencie s wil l coordinat e i n issuin g regulation s an d guidanc e an d i n conductin g 

outreac h specifi c t o Siluriforme s fis h an d fish products. 

5 . Th e agencie s wil l exchang e informatio n relevan t t o th e regulator y oversigh t o f 

Siluriforme s fish an d fish products a s se t ou t i n MO U numbe r 225-12-0007 . 

6 . Eac h agenc y wil l tak e advantag e o f th e inspectiona l capabilitie s ofth e othe r agenc y 

t o achiev e th e maximu m utilizatio n o f resource s wit h regar d t o Siluriforme s fish an d fish 

products, whe n appropriat e an d as resource s permit . 

B . FSI S will : 

1 . Exercis e primar y regulator y oversigh t ove r Siluriforme s fish an d fish products. 

2 . Infor m FD A i f a n apparen t violatio n is encountere d involvin g fish an d fish products 

othe r tha n Siluriformes . 

2 
C . FD A will : 

1 . No t inspec t Siluriforme s fis h an d fis h products a t domesti c an d foreig n 

establishments tha t grow , slaughter, o r process suc h fis h an d fis h products unless 

requeste d b y FSIS . 

2 . No t sampl e o r analyz e Siluriforme s fis h an d fis h products bearin g a n officia l USD A 

inspectio n legen d o r a n officia l USD A impor t mark , unless requeste d b y FSIS . 

3 . Continu e t o exercis e regulator y oversigh t ove r al l othe r fis h an d fis h products. 

4 . Infor m FSI S whe n a n apparen t violatio n is encountere d involvin g Siluriforme s fis h 

a n d fis h products. 

I V . Liaiso n Officer s 

T o facilitat e th e activitie s describe d i n thi s MOU , eac h agenc y wil l establis h liaison s specifie d i n 

Appendi x A t o thi s MOU . 

V . Effectiv e Date , Termination , an d Modificatio n 

Thi s MO U wil l becom e effectiv e whe n signe d b y th e designate d representative s o f bot h agencie s 

a n d shal l continu e i n effec t unles s modifie d o r terminate d b y mutua l writte n consen t o f th e 

agencies. 

Signe d o n thi s 3 Ot h da y o f April , 2014 . 

FOR THE

Food Safety and Inspection Service

Alfre d V . Almanz a

Administrato r

FOR THE 

Food and Drug Administration 

Michae l M . Land a 

Directo r

Cente r fo r Foo d Safet y 

a n d Applie d Nutritio n 

3 
Appendi x A 

Liaiso n Officer s 

Foo d Safet y an d Inspectio n Servic e 

Polic y Issue s 

Assistan t Administrato r 

Offic e o f Polic y an d Progra m Developmen t 

140 0 Independenc e Avenue , SW. , 

Washington , D C 2025 0 

Mai n # : 202-205-049 5 

Inspectio n Issue s 

Assistan t Administrato r 

Offic e o f Fiel d Operation s 

140 0 Independenc e Avenue , SW. , 

Washington , D C 2025 0 

Mai n # : 202-720-880 3 

Enforcement/Complianc e Issue s 

Assistan t Administrato r 

Offic e o f Investigation , Enforcemen t an d Audi t 

140 0 Independenc e Avenue , SW. , 

Washington , D C 2025 0 

Mai n # : 202-720-860 9 

Foo d an d Dru g Administratio n 

Polic y Issue s 

Director , Divisio n o f Seafoo d Safet y 

Offic e o f Foo d Safet y 

Cente r fo r Foo d Safet y an d Applie d Nutritio n 

510 0 Pain t Branc h Parkwa y 

Colleg e Park , M D 20740-383 5 

Mai n # : 240-402-230 0 

Inspectio n Issue s 

Director , Offic e o f Foo d an d Fee d Operation s 

Offic e o f Regulator y Affair s 

1242 0 Parklaw n Driv e 

Rockville , M D 2085 2 

Mai n # : 240-402-489 4 

Enforcement/Complianc e Issue s 

Director , Offic e o f Complianc e 

Cente r fo r Foo d Safet y an d Applie d Nutritio n 

510 0 Pain t Branc h Parkwa y 

Colleg e Park , M D 20740-383 5 

Main# : 240-402-172 9