,,ii  #aag? ,,congress  #b;d ,session   
,s4 #debj  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,july #ac1 #bjbb,mr4   
,durb9 7= himself & ,mr4 ,blum5?al7     
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to e/abli% ! ,food ,safety  
,adm9i/ration to protect ! public heal? 
by ensur+ ! safety ( food1 prev5t+      
foodborne illness1 ma9ta9+ safety       
reviews & reassessm5ts ( food additives1
 en=c+ pe/icide residue tol]ances1      
improv+ ! surveillance ( foodborne      
pa?og5s1 & = o!r purposes4  #a4 ,%ort   
title ,?is ,act may be cit$ z ! ,food   
,safety ,adm9i/ration ,act ( #bjbb4  #b4
 ,def9itions ,9 ?is ,act3 7#a7          
,adm9i/ration ,! t]m ,adm9i/ration means
 ! ,food ,safety ,adm9i/ration e/abli%$ 
"u section #aja7;a77#a74  7#b7          
,adm9i/rator ,! t]m ,adm9i/rator means !
 ,adm9i/rator ( ,food ,safety appo9t$ "u
 section #aja7;a77#b74  7#c7 ,facility  
,! t]m facility means any factory1      

w>eh\se1 or e/abli%m5t t is subject to !
 requirem5ts ( section #dae or #dai ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cej;d2 #cej;h74  #c4    
,effective date ,?is ,act1 includ+ !    
am5dm5ts made by ?is ,act1 %all take    
effect #ahj days aft] ! date ( enactm5t 
( ?is ,act4  #d4 ,fund+  7a7 ,transf] ( 
funds ,! appropriations1 allocations1 & 
o!r funds t relate to ! au?orities1     
functions & ag5cies transf]r$ "u section
 #ajb %all be transf]r$ to !            
,adm9i/ration4  7b7 ,au?orization (     
appropriations ,!re are au?oriz$ to be  
appropriat$ to c>ry out ?is section1 su*
 sums z may be necess>y = fiscal ye>    
#bjbc & ea* fiscal ye> !reaft]4  ,i     
,e/abli%m5t ( food safety adm9i/ration  
#aja4 ,e/abli%m5t ( food safety         
adm9i/ration  7a7 ,e/abli%m5t  7#a7 ,9  
g5]al ,!re is e/abli%$ )9 ! ,dep>tm5t ( 
,heal? & ,human ,s]vices an ag5cy to be 
kn[n z ! ,food ,safety ,adm9i/ration4   
7#b7 ,head ( adm9i/ration ,!            
,adm9i/ration %all be head$ by !        

,adm9i/rator ( ,food ,safety1 :o %all h 
food safety exp]tise1 & be appo9t$ by ! 
,presid5t1 by & ) ! advice & cons5t ( ! 
,s5ate4  7#c7 ,effect ,! ,f$]al ,food & 
,drug ,adm9i/ration %all be r5am$ ,f$]al
 ,drug ,adm9i/ration & reta9            
responsibility = c>ry+ out its          
responsibilities relat$ to drugs1       
cosmetics1 devices1 biological products1
 color additives1 & tobacco4 ,!         
,commission] ( ,food & ,drugs %all be   
r5am$ ! ,commission] ( ,drugs1 & %all   
reta9 ! responsibilities ( !            
,commission] ( ,food & ,drugs1 except   
su* responsibilities t relate to food1  
:i* %all be assum$ by ! ,adm9i/rator (  
,food ,safety4 ,ea* ref]5ce 9 /atute to 
! ,food & ,drug ,adm9i/ration %all be   
deem$ a ref]5ce to ! ,f$]al ,drug       
,adm9i/ration1 & ea* ref]5ce 9 /atute to
 ! ,commission] ( ,food & ,drugs %all be
 deem$ a ref]5ce to ! ,commission] (    
,drugs4  7b7 ,duties ( ! adm9i/rator ,! 
,adm9i/rator %all-- 7#a7 adm9i/] & en=ce
 all au?orities "u *apt] ,,iv ( ! ,f$]al

 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cda et seq472  7#b7 s]ve z a 
repres5tative to int]national food      
safety bodies & discussions2  7#c7      
promulgate & en=ce regulations to ensure
 ! security ( ! food supply f all =ms ( 
contam9ation1 includ+ int5tional        
contam9ation2 &  7#d7 ov]see-- 7,a7     
implem5tation ( ,f$]al food safety2     
7,b7 inspection1 label+1 en=cem5t1 &    
rese>* ef=ts to protect ! public heal?2 
7,c7 developm5t ( consi/5t & sci5ce-bas$
 /&>ds = safe food2  7,d7 safety reviews
 & reassessm5ts ( food additives2  7,e7 
e/abli%m5t & en=cem5t ( tol]ances =     
poison\s or delet]i\s sub/ances2  7,f7  
monitor+ & en=cem5t ( pe/icide residue  
tol]ances 9 or on foods2  7,g7          
coord9ation & prioritization ( food     
safety rese>* & education programs ) o!r
 ,f$]al ag5cies2  7,h7 prioritization ( 
,f$]al food safety ef=ts & deploym5t (  
,f$]al food safety res\rces to a*ieve ! 
greate/ b5efit 9 r$uc+ foodborne        
illness2  7,i7 coord9ation ( ! ,f$]al   

response to foodborne illness outbreaks 
) o!r ,f$]al & ,/ate ag5cies2  7,j7     
integration ( ,f$]al food safety        
activities ) ,/ate & local ag5cies2 &   
7,k7 assignm5t ( tol]ances = animal     
drugs us$ 9 food-produc+ animals4  #ajb4
 ,transf] ( au?ority1 functions1 &      
ag5cies  7a7 ,transf] ( au?ority ,!     
,ag5cy %all assume responsibility =     
c>ry+ out *apt] ,,iv ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cda et seq47 & ma9ta9 all en=cem5t     
au?orities ) respect to food held by !  
,food & ,drug ,adm9i/ration on ! date ( 
enactm5t ( ?is ,act4  7b7 ,transf] (    
functions ,= ea* ,f$]al ag5cy1 (fice1 & 
c5t] specifi$ 9 subsection 7c71 !re are 
transf]r$ to ! ,adm9i/ration all        
functions t ! head ( ! ,f$]al ag5cy     
ex]cis$ on ! day be=e ! date ( enactm5t 
( ?is ,act 7includ+ all relat$ functions
 ( any (fic] or employee ( ! ,f$]al     
ag5cy7 t relate to adm9i/ration or      
en=cem5t ( ! food safety law1 z det]m9$ 
by ! ,presid5t4  7c7 ,transf]r$ ag5cies 

,! ,f$]al ag5cies ref]r$ to 9 subsection
 7b7 are-- 7#a7 ! res\rces & facilities 
( ! ,c5t] = ,food ,safety & ,appli$     
,nutrition ( ! ,food & ,drug            
,adm9i/ration t adm9i/] *apt] ,,iv ( !  
,f$]al ,food1 ,drug1 & ,cosmetics ,act  
7#ba ,u4,s4,c4 #cda et seq472  7#b7 !   
res\rces & facilities ( ! ,(fice (      
,regulatory ,affairs ( ! ,food & ,drug  
,adm9i/ration t adm9i/] & conduct       
inspections ( food & fe$ facilities &   
imports2  7#c7 ! res\rces & facilities (
 ! ,c5t] = ,vet]9>y ,m$ic9e ( ! ,food & 
,drug ,adm9i/ration t adm9i/] *apt] ,,iv
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetics  
,act 7#ba ,u4,s4,c4 #cda et seq472  7#d7
 ! ,(fice ( ,food ,policy & ,response ( 
! ,food & ,drug ,adm9i/ration2 &  7#e7  
su* o!r (fices1 s]vices1 or ag5cies z ! 
,presid5t designates by ,executive ord] 
to c>ry out ?is ,act4  7d7 ,con=m+      
am5dm5t ,sub*apt] ,a ( *apt] ,,vii ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cga et seq47 is am5d$ by
 add+ at ! end ! foll[+3  #gjc4         

,regulation ( food ,not)/&+ any o!r     
provision ( ?is ,act1 beg9n+ on ! date t
 is #ahj days aft] ! date ( enactm5t ( !
 ,food ,safety ,adm9i/ration ,act (     
#bjbb1 any au?ority "u ?is ,act t       
relates to food %all be "u ! au?ority ( 
! ,food ,safety ,adm9i/ration1 & %all be
 c>ri$ out by ! ,adm9i/rator ( ,food    
,safety4 ,any ref]5ce 9 ?is ,act to     
au?orities relat$ to food held by !     
,secret>y %all be deem$ to be ref]5ces  
to au?orities held by ! ,adm9i/rator (  
,food ,safety4  4  #ajc4 ,additional    
duties ( ! adm9i/ration  7a7 ,(fic]s &  
employees ,! ,adm9i/rator may-- 7#a7    
appo9t (fic]s & employees = !           
,adm9i/ration 9 accordance ) !          
provisions ( title #e1 ,unit$ ,/ates    
,code1 relat+ to appo9tm5t 9 !          
competitive s]vice2 &  7#b7 fix !       
comp5sation ( ^? (fic]s & employees 9   
accordance ) *apt] #ea & ) sub*apt]     
,,iii ( *apt] #ec ( t title1 relat+ to  
classification & ,g5]al ,s*$ule pay     
rates4  7b7 ,exp]ts & consultants ,!    

,adm9i/ration may-- 7#a7 procure !      
s]vices ( tempor>y or int]mitt5t exp]ts 
& consultants z au?oriz$ by section     
#caji ( title #e1 ,unit$ ,/ates ,code2 &
  7#b7 pay 9 connection ) ^? s]vices !  
travel exp5ses ( ! exp]ts & consultants1
 includ+ transportation & p] diem 9 lieu
 ( subsi/5ce :ile away f ! homes or     
regul> places ( bus9ess ( ! individuals1
 z au?oriz$ by section #egjc ( t title4 
7c7 ,bureaus1 (fices1 & divisions ,!    
,adm9i/rator may e/abli% )9 !           
,adm9i/ration su* bureaus1 (fices1 &    
divisions z ! ,adm9i/rator det]m9es are 
necess>y to p]=m ! duties ( !           
,adm9i/rator4  7d7 ,advisory committees 
7#a7 ,9 g5]al ,! ,adm9i/rator %all      
e/abli% advisory committees t consi/ (  
repres5tative ( sci5tific exp]t bodies1 
academics1 indu/ry speciali/s1 &        
consum]s4  7#b7 ,duties ,! duties ( an  
advisory committee e/abli%$ "u p>agraph 
7#a7 may include develop+ recomm5dations
 ) respect to ! developm5t ( regulatory 
sci5ce & processes1 rese>*1             

communications1 p]=mance /&>ds1 &       
inspection4  ,,ii ,adm9i/ration ( food  
safety program  #bja4 ,e/abli%m5t (     
inspection program  7a7 ,9 g5]al ,!     
,adm9i/rator %all e/abli% an inspection 
program1 :i* %all include inspections ( 
food facilities subject to subsection   
7b7 & 9 accordance ) section #bjb4  7b7 
,facility categories ,n lat] ?an #f     
mon?s aft] ! date ( enactm5t ( ?is ,act1
 ! ,adm9i/rator %all issue =mal guidance
 def9+ ! crit]ia by :i* food facilities 
w be divid$ into                        
high-risk1int]m$iate-risk1 & l[-risk    
facilities4  7c7 ,inspection frequ5cies 
,frequ5cy ( inspections ( food          
facilities "u ?is ,act %all be bas$ on !
 categories def9$ pursuant to subjection
 7b7 & 9 accordance ) section #bjb4     
#bjb4 ,inspections ( food facilities    
7a7 ,frequ5cy ( inspections  7#a7       
,high-risk facilities ,! ,adm9i/rator   
%all inspect high-risk facilities n less
 ?an once p] a ye>4  7#b7               
,int]m$iate-risk facilities ,!          

,adm9i/rator %all inspect               
int]m$iate-risk facilities n less ?an   
once e #b ye>s4  7#c7 ,l[-risk          
facilities ,! ,adm9i/rator %all inspect 
l[-risk facilities1 :i* %all include    
w>eh\ses or simil> facilities t engage 9
 packag+ or di/ribution1 & pose v m9imal
 public heal? risk1 n less ?an once e #c
 ye>s4  7b7 ,infant =mula manufactur+   
facilities ,! ,adm9i/rator %all inspect 
! facilities ( ea* manufactur] ( infant 
=mula n less ?an e #f mon?s4  7c7 ,f$]al
 & ,/ate coop]ation ,! ,adm9i/rator %all
 contract ) ,/ate (ficials to c>ry out  
half ( ! safety inspections requir$ "u  
?is section4  #bjc4 ,compliance *ecks ,n
 lat] ?an #cj days aft] issu+ a =m t is 
equival5t to an ,,fda ,=m #dhc to a     
facility1 pursuant to an inspection "u  
section #gjd ( ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4 #cgd71 !  
,adm9i/rator %all conduct a foll[-up    
compliance *eck ) ! facility4  #bjd4    
,traceability rule ,n lat] ?an ,novemb] 
#g1 #bjbb1 ! ,adm9i/rator %all          

promulgate a f9al rule t is bas$ on !   
propos$ rule issu$ by ! ,food & ,drug   
,adm9i/ration titl$1 ,requirem5ts =     
,additional ,traceability ,records =    
,c]ta9 ,foods 7#he ,f$4 ,reg4 #eiihd    
7,sept4 #bc1 #bjba774  #bje4 ,notice (  
circum/ances t c\ld lead to a %ortage   
,*apt] ,,iv ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4 #cda et   
seq47 is am5d$ by add+ at ! end !       
foll[+3  #dbd4 ,notice ( circum/ances t 
c\ld lead to a %ortage  7a7 ,notice     
requirem5t ,n lat] ?an #e bus9ess days  
aft] a manufactur] ( infant =mula or    
ess5tial m$ical food becomes aw>e (     
circum/ances t c\ld lead to a %ortage ( 
infant =mula or ess5tial m$ical food 9 !
 ,unit$ ,/ates1 su* manufactur] %all    
give writt5 notice ( su* circum/ances to
 ! ,adm9i/rator4  7b7 ,f9es ,if !       
,adm9i/rator f9ds t a manufactur] (     
infant =mula or ess5tial m$ical food is 
9 violation ( ! requirem5t ( ?is section
 to give writt5 notice1 su* violation   
%all be treat$ z an infraction =        

purposes ( impos+ a f9e 9 accordance )  
title #ah1 ,unit$ ,/ates ,code4  7c7    
,def9itions ,9 ?is section3 7#a7 ,! t]m 
,adm9i/rator means ! ,adm9i/rator (     
,food ,safety4  7#b7 ,! t]m ess5tial    
m$ical food means a food t-- 7,a7 is    
=mulat$ to be consum$ or adm9i/]$       
ent]ally "u ! sup]vision ( a physician2 
7,b7 is int5d$ = ! specific diet>y      
managem5t ( a disease or condition = :i*
 di/9ctive nutritional requirem5ts1 bas$
 on recogniz$ sci5tific pr9ciples1 are  
e/abli%$ by m$ical evaluation2 &  7,c7  
is id5tifi$ by ! ,adm9i/rator z be+     
ess5tial = any urg5t m$ical condition4  
4