,,ii ,cal5d> ,no4 #cjf #aai? ,,congress 
#b;d ,session  ,s4 #bgb  ,,9 ,,! ,,s5ate
 ,,( ,,! ,,unit$ ,,/ates  ,janu>y #bh1  
#bjbe,mr4 ,pet]s 7= himself1 ,mr4       
,hoev51 ,ms4 ,coll9s1 ,ms4 ,smi?1 ,mrs4 
,%ahe51 ,ms4 ,hassan1 ,mr4 ,ka9e1 & ,ms4
 ,baldw97 introduc$ ! foll[+ bill2 :i* 0
 read twice & ref]r$ to ! ,committee on 
,heal?1 ,education1 ,labor1 & ,p5sions  
,janu>y #bh1 #bjbf,report$ by ,mr4      
,cassidy1 ) an am5dm5t & an am5dm5t to !
 title,strike out all aft] ! enact+     
clause & ins]t ! "p pr9t$ 9 italic  ,a  
,,bill  ,to improve ! safety ( infant   
=mula ?r\gh te/+ ( infant =mula =       
microorganisms & toxic elem5ts1 & = o!r 
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,protect ,infant ,=mula f  
,contam9ation ,act4  #b4 ,notifications 
= te/+ ( infant =mula ,section #dab7;e7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cej;a7e77 is       
am5d$-- 7#a7 9 p>agraph 7#a71 9 ! matt] 
foll[+ subp>agraph 7,b7-- 7,a7 by /rik+ 
promptly2  7,b7 by ins]t+ 1 )9 #a       

bus9ess day ( acquir+ su* k aft] su* k2 
&  7,c7 by /rik+ ! infant =mula & ins]t+
 an infant =mula2  7#b7 by r$esignat+   
p>agraph 7#b7 z p>agraph 7#e72 &  7#c7  
by ins]t+ aft] p>agraph 7#a7 ! foll[+3  
7#b7 ,if ! result ( any te/+ ( a sample 
f any production aggregate ( f9i%$      
infant =mula product is confirm$ z a    
positive analytical result = any        
microorganism = :i* f9i%$ product te/+  
is requir$ "u section #ajf4ee7;e7 (     
title #ba1 ,code ( ,f$]al ,regulations  
7or any successor regulation71 !        
manufactur] %all-- 7,a7 )9 #a bus9ess   
day ( acquir+ a confirm$ positive       
analytical result1 notify ! ,secret>y ( 
su* result1 reg>dless ( :e!r su* product
 has left an e/abli%m5t subject to !    
control ( ! manufactur]2  7,b7 promptly 
consult ) ! ,secret>y = prop] isolation 
( ! affect$ product1 &1 z ! ,secret>y   
may require1 cease di/ribution & prop]ly
 dispose ( ! affect$ product2 &  7,c7   
promptly provide to ! ,secret>y results 
& isolates f a positive sample ( su*    

product or ! :ole g5etic sequ5ce f any  
confirm$ positive analytical result4    
7#c7 ,n lat] ?an #a bus9ess day aft]    
receipt by ! ,secret>y ( a notification 
"u p>agraph 7#b77;,a71 ! ,secret>y %all 
respond to ! manufactur] ( ! infant     
=mula to beg9 discussions reg>d+        
inve/igation & corrective action1 &1 z  
appropriate1 %>e ! f9d+s ( ! ,secret>y )
 ! manufactur]4  7#d7 ,n lat] ?an #ij   
days aft] receipt ( a notification "u   
p>agraph 7#a7 or 7#b71 ! ,secret>y %all 
confirm1 includ+ ?r\gh ! collection (   
docum5tation1 t ! manufactur] submitt+ !
 notification p]=m$1 or is p]=m+1 an    
appropriate inve/igation & corrective   
action1 if applicable4 ,! ,secret>y %all
 consid]1 z "p ( ! review ( ! root cause
 inve/igation1 ! analytical me?od us$ to
 conduct laboratory te/+ &1 z           
appropriate1 ! pot5tial = cross         
contam9ation ( ! sample by h&l+ & te/+4 
,! manufactur] %all make su*            
docum5tation available to ! ,secret>y   
electronically & = inspection "u section

 #gjd4  4  #c4 ,report+ to improve !    
safety & supply ( infant =mula ,section 
#dab ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a7 is
 am5d$ by add+ at ! end ! foll[+3  7n7  
,report+ ,to improve ! safety & supply (
 infant =mula  7#a7 ,progress report ,n 
lat] ?an #ahj days aft] ! date (        
enactm5t ( ! ,protect ,infant ,=mula f  
,contam9ation ,act1 ! ,secret>y %all    
issue a progress report on implem5tation
 ( ! recomm5dations to improve ! safety 
& supply ( infant =mula conta9$ 9 !     
report titl$1 ,long-,t]m ,national      
,/rategy to ,increase ! ,resili5cy ( !  
,u4,s4 ,infant ,=mula ,m>ket1 issu$ by !
 ,food & ,drug ,adm9i/ration 9 ,janu>y  
#bjbe4 ,su* progress report %all include
 additional au?orities or res\rces t !  
,secret>y may require = purposes (      
improv+ ! safety & supply ( infant      
=mula4  7#b7 ,qu>t]ly reports on supply 
*a9 ,n lat] ?an #bgj days aft] ! date ( 
enactm5t ( ! ,protect ,infant ,=mula f  
,contam9ation ,act1 & n less frequ5tly  

?an qu>t]ly = ! #e-ye> p]iod !reaft]1 ! 
,secret>y %all submit a report on ! mo/ 
curr5t1 critical supply *a9 data =      
infant =mula1 includ+ 9-/ock rates1 to--
 7,a7 ! ,committee on ,heal?1           
,education1 ,labor1 & ,p5sions2 !       
,committee on ,agriculture1 ,nutrition1 
& ,=e/ry2 & ! ,subcommittee on          
,agriculture1 ,rural ,developm5t1 ,food 
& ,drug ,adm9i/ration1 & ,relat$        
,ag5cies ( ! ,committee on              
,appropriations ( ! ,s5ate2 &  7,b7 !   
,committee on ,en]gy & ,comm]ce2 !      
,committee on ,agriculture2 & !         
,subcommittee on ,agriculture1 ,rural   
,developm5t1 ,food & ,drug              
,adm9i/ration1 & ,relat$ ,ag5cies ( !   
,committee on ,appropriations ( ! ,h\se 
( ,repres5tatives4  7#c7 ,consultation  
,! ,secret>y %all engage ) ! ,dep>tm5t (
 ,agriculture & o!r relevant ag5cies ( !
 ,f$]al ,gov]nm5t reg>d+ ongo+ ef=ts to 
address imm$iate =mula ne$s & build     
long-t]m resili5cy into ! infant =mula  
m>ket4  7#d7 ,reports on adequacy (     

supply ,n lat] ?an #a ye>1 #c ye>s1 & #e
 ye>s aft] ! date ( enactm5t ( !        
,protect ,infant ,=mula f ,contam9ation 
,act1 ! ,secret>y %all-- 7,a7 engage )  
public /akehold]s1 infant =mula         
manufactur]s1 & o!r /akehold]s1 z       
det]m9$ by ! ,secret>y1 to det]m9e      
evid5ce-bas$ practices t c be implem5t$ 
to maximize infant =mula supply & infant
 safety1 :i* may include ! value ( high 
frequ5cy te/+ = purposes ( id5tify+     
contam9ation ev5ts & bracket+ pot5tially
 contam9at$ product1 ! impact (         
corrective action on contam9ation ev5ts1
 & evid5ce-bas$ recomm5dations = enhanc+
 infant =mula supply & safety2 &  7,b7  
submit a report to ! committees describ$
 9 subp>agraphs 7,a7 & 7,b7 ( p>agraph  
7#b7 t id5tifies ! modifications to     
manufactur] practices & actions describ$
 9 subp>agraph 7,a71 if any1 t c\ld be  
implem5t$ to improve infant =mula supply
 & safety4  4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,protect ,infant ,=mula
 f ,contam9ation ,act4  #b4             

,notifications = te/+ ( infant =mula    
,section #dab7;e7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cej;a7e77 is am5d$-- 7#a7 9 p>agraph   
7#a71 9 ! matt] foll[+ subp>agraph      
7,b7-- 7,a7 by /rik+ promptly2  7,b7 by 
ins]t+ 1 )9 #a bus9ess day ( acquir+ su*
 k aft] su* k2 &  7,c7 by /rik+ ! infant
 =mula & ins]t+ an infant =mula2  7#b7  
by r$esignat+ p>agraph 7#b7 z p>agraph  
7#e72 &  7#c7 by ins]t+ aft] p>agraph   
7#a7 ! foll[+3  7#b7 ,if ! result ( any 
te/+ ( a sample f any production        
aggregate ( f9i%$ infant =mula product  
is confirm$ z a positive analytical     
result = any microorganism = :i* f9i%$  
product te/+ is requir$ "u section      
#ajf4ee7;e7 ( title #ba1 ,code ( ,f$]al 
,regulations 7or any successor          
regulation71 ! manufactur] %all-- 7,a7  
)9 #a bus9ess day ( acquir+ a confirm$  
positive analytical result1 notify !    
,secret>y ( su* result1 reg>dless ( :e!r
 su* product has left an e/abli%m5t     
subject to ! control ( ! manufactur]2   

7,b7 promptly consult ) ! ,secret>y =   
prop] isolation ( ! affect$ product1 &1 
z ! ,secret>y may require1 cease        
di/ribution & prop]ly dispose ( !       
affect$ product2 &  7,c7 promptly       
provide to ! ,secret>y results &        
isolates f a positive sample ( su*      
product or ! :ole g5ome sequ5ce data f  
any confirm$ positive analytical result4
  7#c7 ,n lat] ?an #a bus9ess day aft]  
receipt by ! ,secret>y ( a notification 
"u p>agraph 7#b77;,a71 ! ,secret>y %all 
respond to ! manufactur] ( ! infant     
=mula to beg9 discussions reg>d+        
inve/igation & corrective action1 &1 z  
appropriate1 %>e ! f9d+s ( ! ,secret>y )
 ! manufactur]4  7#d7 ,n lat] ?an #ij   
days aft] receipt ( a notification "u   
p>agraph 7#a7 or 7#b71 ! ,secret>y %all 
confirm1 includ+ ?r\gh ! collection (   
docum5tation1 t ! manufactur] submitt+ !
 notification p]=m$1 or is p]=m+1 an    
appropriate inve/igation & corrective   
action1 if applicable4 ,! ,secret>y %all
 consid]1 z "p ( ! review ( ! root cause

 inve/igation1 ! analytical me?od us$ to
 conduct laboratory te/+ &1 z           
appropriate1 ! pot5tial = cross         
contam9ation ( ! sample by h&l+ & te/+4 
,! manufactur] %all make su*            
docum5tation available to ! ,secret>y   
electronically & = inspection "u section
 #gjd4  4  #c4 ,report+ to improve !    
safety & supply ( infant =mula ,section 
#dab ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a7 is
 am5d$ by add+ at ! end ! foll[+3  7n7  
,report+ ,to improve ! safety & supply (
 infant =mula  7#a7 ,progress report ,n 
lat] ?an #ahj days aft] ! date (        
enactm5t ( ! ,protect ,infant ,=mula f  
,contam9ation ,act1 ! ,secret>y %all    
issue a progress report on implem5tation
 ( ! recomm5dations to improve ! safety 
& supply ( infant =mula conta9$ 9 !     
report titl$1 ,long-,t]m ,national      
,/rategy to ,increase ! ,resili5cy ( !  
,u4,s4 ,infant ,=mula ,m>ket1 issu$ by !
 ,food & ,drug ,adm9i/ration 9 ,janu>y  
#bjbe4 ,su* progress report %all include

 additional au?orities or res\rces t !  
,secret>y may require = purposes (      
improv+ ! safety & supply ( infant =mula
 & any revisions to ! recomm5dations z a
 result ( any infant =mula recalls s9ce 
! publication ( ! report1 z appropriate4
  7#b7 ,qu>t]ly reports on supply *a9 ,n
 lat] ?an #bgj days aft] ! date (       
enactm5t ( ! ,protect ,infant ,=mula f  
,contam9ation ,act1 & n less frequ5tly  
?an qu>t]ly = ! #e-ye> p]iod !reaft]1 ! 
,secret>y %all submit a report on ! mo/ 
curr5t critical supply *a9 data = infant
 =mula1 includ+ 9-/ock rates1 to-- 7,a7 
! ,committee on ,heal?1 ,education1     
,labor1 & ,p5sions2 ! ,committee on     
,agriculture1 ,nutrition1 & ,=e/ry2 & ! 
,subcommittee on ,agriculture1 ,rural   
,developm5t1 ,food & ,drug              
,adm9i/ration1 & ,relat$ ,ag5cies ( !   
,committee on ,appropriations ( !       
,s5ate2 &  7,b7 ! ,committee on ,en]gy &
 ,comm]ce2 ! ,committee on ,agriculture2
 & ! ,subcommittee on ,agriculture1     
,rural ,developm5t1 ,food & ,drug       

,adm9i/ration1 & ,relat$ ,ag5cies ( !   
,committee on ,appropriations ( ! ,h\se 
( ,repres5tatives4  7#c7 ,consultation  
,! ,secret>y %all engage ) ! ,dep>tm5t (
 ,agriculture & o!r relevant ag5cies ( !
 ,f$]al ,gov]nm5t reg>d+ ongo+ ef=ts to 
address imm$iate =mula ne$s & build     
long-t]m resili5cy into ! infant =mula  
m>ket4  7#d7 ,reports on adequacy (     
supply ,n lat] ?an #a ye>1 #c ye>s1 & #e
 ye>s aft] ! date ( enactm5t ( !        
,protect ,infant ,=mula f ,contam9ation 
,act1 ! ,secret>y %all-- 7,a7 engage )  
public /akehold]s1 infant =mula         
manufactur]s1 & o!r /akehold]s1 z       
det]m9$ by ! ,secret>y1 to det]m9e      
evid5ce-bas$ practices t c be implem5t$ 
to maximize infant =mula supply & infant
 safety1 :i* may include ! value ( high 
frequ5cy te/+ = purposes ( id5tify+     
contam9ation ev5ts1 includ+ ev5ts       
associat$ ) botulism or o!r contam9ants1
 & bracket+ pot5tially contam9at$       
product1 ! impact ( corrective action on
 contam9ation ev5ts1 includ+ ev5ts      

associat$ ) botulism or o!r contam9ants1
 & evid5ce-bas$ recomm5dations = enhanc+
 infant =mula supply & safety2 &  7,b7  
submit a report to ! committees describ$
 9 subp>agraphs 7,a7 & 7,b7 ( p>agraph  
7#b7 t id5tifies ! modifications to     
manufactur] practices & actions describ$
 9 subp>agraph 7,a71 if any1 t c\ld be  
implem5t$ to improve infant =mula supply
 & safety4  4  ,am5d ! title s z to     
read3 ,a bill to improve ! safety (     
infant =mula ?r\gh te/+ ( infant =mula =
 microorganisms1 & = o!r purposes44     
,janu>y #bh1 #bjbf,report$ ) an am5dm5t 
& an am5dm5t to ! title