,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #bdgb  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,m>* #bg1 #bjbe,mrs4  
,sykes 7= h]self1 ,mr4 ,pallone1 & ,mr4 
,kri%namoor?i7 introduc$ ! foll[+ bill2 
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act to ensure
 ! safety ( infant & toddl] food1 & =   
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,improv+ ,newborns'    
,food & ,nutrition ,te/+ ,safety ,act ( 
#bjbe or ! ,,infants ,act ( #bjbe4  #b4 
,def9ition ( infant & toddl] food       
,section #bja ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is 
am5d$ by add+ at ! end ! foll[+3  7tt7  
,! t]m infant & toddl] food means food  
:i* purports to be or is repres5t$ z    
food = *ildr5 up to #bd mon?s ( age1    
includ+ infant =mula4  4  #c4           
,contam9ants 9 food ,*apt] ,,iv ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cda et seq47 is am5d$ by
 add+ at ! end ! foll[+3  #dbe4 ,sampl+ 

& te/+ = contam9ants 9 food  7a7 ,sampl+
 & te/+  7#a7 ,9 g5]al ,! own]1 op]ator1
 or ag5t 9 *>ge ( a food facility t     
manufactures or processes food1 includ+ 
infant & toddl] food1 9 f9al product =m 
int5d$ = sale to consum]s %all-- 7,a7   
collect repres5tative samples ( ea* su* 
food2 &  7,b7 conduct te/+ ( ! samples =
 contam9ants1 includ+ toxic elem5ts4    
7#b7 ,requirem5t = sampl+ plan  7,a7 ,9 
g5]al ,! own]1 op]ator1 or ag5t 9 *>ge (
 a facility describ$ 9 p>agraph 7#a7    
%all--  7i7 prep>e a writt5 sampl+ plan 
= all sampl+ & te/+ requir$ "u ?is      
section2 &  7ii7 ensure t all sampl+ &  
te/+ conduct$ "u ?is section is conduct$
 9 accordance ) ! sampl+ plan4  7,b7    
,requirem5ts ,a sampl+ plan "u          
subp>agraph 7,a7 %all id5tify-- 7i7 !   
numb] ( sampl+ units & sample unit size 
bas$ ^u appropriate crit]ia = id5tify+1 
9 a repres5tative fa%ion1 ! levels (    
contam9ants 9 ea* food2 &  7ii7 "o or m 
appropriate te/ me?ods & proc$ures to be
 us$ to analyze ! samples4  7,c7        

,guidance ,n lat] ?an #ah mon?s aft] !  
date ( enactm5t ( ?is section1 !        
,secret>y %all issue guidance to assi/  
food facilities 9 develop+ sampl+ plans4
 ,su* guidance may1 z det]m9$           
appropriate by ! ,secret>y1 address :5  
samples %\ld be te/$ = specific species 
( contam9ants4  7#c7 ,contam9ants to be 
te/$ ,ea* sample tak5 pursuant to a     
sampl+ plan "u ?is section %all be te/$ 
= levels ( lead1 cadmium1 m]cury1       
ars5ic1 & any o!r contam9ant1 includ+   
o!r toxic elem5ts1 t ! ,secret>y may    
specify by regulation4  7#d7 ,frequ5cy (
 te/+ ,! sampl+ & te/+ conduct$ "u ?is  
section %all be conduct$ at lea/ once p]
 qu>t] ( ea* cal5d> ye>4  7#e7 ,foods to
 be te/$ ,! sampl+ & te/+ conduct$ "u   
?is section %all be conduct$ =-- 7,a7   
infant & toddl] foods1 9 f9al package   
=m2 &  7,b7 su* o!r foods z ! ,secret>y 
may specify1 by regulation1 z           
appropriate to protect public heal?4    
7b7 ,recordkeep+  7#a7 ,9 g5]al ,! own]1
 op]ator1 or ag5t 9 *>ge ( a facility   

describ$ 9 subsection 7a77#a7 %all      
ma9ta91 = n less ?an #b ye>s or !       
%elf-life ( ea* infant & toddl] food    
manufactur$ or process$ at ! facility1  
:i*ev] is long]1 records docum5t+ !     
sampl+ & te/+ conduct$ "u ?is section ) 
respect to ! food4  7#b7 ,requirem5ts   
,records requir$ by p>agraph 7#a7 to be 
ma9ta9$ %all include a detail$          
description ( ! foods sampl$ & te/$1 !  
numb] ( samples & te/s p]=m$1 ! size &  
numb] ( items 9 ea* sample unit1 a copy 
( ! facility's sampl+ plan1             
id5tification ( ! entity conduct+ !     
sampl+1 id5tification ( ! entity        
conduct+ ! te/+1 & ! analytical me?ods  
us$ to p]=m ! sampl+ & te/+4  7#c7      
,applicability ,?is subsection applies  
to all records ( sampl+ & te/+ conduct$ 
"u ?is section1 reg>dless ( ! f9d+s4    
7c7 ,laboratory accr$itation ,! own]1   
op]ator1 or ag5t 9 *>ge ( a food        
facility describ$ 9 subsection 7a77#a7  
%all ensure t te/+ conduct$ pursuant to 
?is section is p]=m$ 9 accordance )     

int]national /&>ds by a laboratory t is 
accr$it$ by an accr$itation body t      
con=ms to int]national accr$itation     
/&>ds4 ,te/+ conduct$ "u ?is section is 
n subject to ! requirem5ts reg>d+       
laboratory accr$itation describ$ 9      
section #dbb4  7d7 ,records availability
  7#a7 ,9 g5]al ,! own]1 op]ator1 or    
ag5t 9 *>ge ( a food facility describ$ 9
 subsection 7a77#a7 %all make all       
records requir$ "u ?is section available
 promptly to ! ,secret>y1 ^u reque/1 =  
inspection & copy+4 ,^u reque/ ( !      
,secret>y1 su* an own]1 op]ator1 or ag5t
 9 *>ge %all provide )9 a reasonable "t 
an ,engli% translation ( records ma9ta9$
 9 a language o!r ?an ,engli%4  7#b7    
,records availability 9 lieu ( an       
inspection ,any records t ! ,secret>y   
may inspect "u ?is section %all1 ^u !   
reque/ ( ! ,secret>y1 be provid$ to !   
,secret>y by ! own]1 op]ator1 or ag5t 9 
*>ge ( a food facility describ$ 9       
subsection 7a77#a71 9 advance ( or 9    
lieu ( an inspection1 )9 a reasonable   

timeframe1 )9 reasonable limits1 & 9 a  
reasonable mann]1 & 9 ei!r electronic or
 physical =m1 at ! exp5se ( su* own]1   
op]ator1 or ag5t4 ,! ,secret>y's reque/ 
%all include a suffici5t description ( !
 records reque/$4  7#c7 ,confirmation   
,^u receipt ( records reque/$ "u        
p>agraph 7#b71 ! ,secret>y %all provide 
to ! p]son confirmation ( receipt4  7#d7
 ,au?ority ( ! ,secret>y ,no?+ 9 ?is    
subsection supplants ! au?ority ( !     
,secret>y to conduct inspections o!rwise
 p]mitt$ "u ?is ,act 9 ord] to ensure   
compliance ) ?is ,act4  7e7 ,delay$     
applicability ,! requirem5ts = sampl+ & 
te/+ "u ?is section apply beg9n+ on !   
date t is #ahj days aft] ! date on :i* !
 ,secret>y publi%es ! guidance requir$  
by subsection 7a77#b77;,c74  4  #d4     
,adult]ation ,section #djb ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cdb7 is am5d$ by add+ at !   
end ! foll[+3  7j7 ,if x is an article (
 food & ! own]1 op]ator1 or ag5t 9 *>ge 
( a food facility t manufactures or     

processes su* food--  7#a7 is subject to
 ! requirem5ts ( section #dbe2 &  7#b7  
fails to comply ) ! requirem5ts ( su*   
section ) reg>d to t article4  4  #e4   
,records = or 9 lieu ( c]ta9 inspections
 ,section #gjd7;a77#d7 ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cgd7;a77#d77 is am5d$-- 7#a7 by        
r$esignat+ subp>agraphs 7,b71 7,c71 &   
7,d7 z subp>agraphs 7,c71 7,d71 & 7,e71 
respectively2  7#b7 by ins]t+ aft]      
subp>agraph 7,a7 ! foll[+3  7,b7 7i7    
,any records or o!r in=mation t !       
,secret>y may inspect "u au?ority ( ?is 
,act f a p]son t owns or op]ates an     
e/abli%m5t t is engag$ 9 any ( !        
activities describ$ 9 clause 7ii7 %all1 
^u ! reque/ ( ! ,secret>y1 be provid$ to
 ! ,secret>y by su* p]son1 9 advance (  
or 9 lieu ( an inspection1 )9 a         
reasonable timeframe1 )9 reasonable     
limits1 & 9 a reasonable mann]1 & 9 ei!r
 electronic or physical =m1 at ! exp5se 
( su* p]son4 ,! ,secret>y's reque/ %all 
include a suffici5t description ( !     

records reque/$4  7ii7 ,! activities    
describ$ 9 ?is clause are ! foll[+3 7,i7
 ,! manufactur+1 process+1 pack+1       
transport+1 di/ribut+1 receiv+1 hold+1  
or import+ ( an article ( food4  7,,ii7 
,! di/ribution or use ( animal fe$ be>+ 
or conta9+ a vet]9>y fe$ directive drug1
 or ! issuance ( a vet]9>y fe$          
directive4  2 &  7#c7 by add+ at ! end !
 foll[+3  7,f7 ,section #gjc does n     
apply to reque/s = records or o!r       
in=mation :5 ^? reque/s are made "u ?is 
section4  4  #f4 ,m&atory recall        
au?ority ,section #dbc7;a7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cejl7a77 is am5d$ by ins]t+  
or if ! ,secret>y det]m9es ?r\gh any    
means t an article ( infant & toddl]    
food 7o!r ?an infant =mula7 be>s or     
conta9s a contam9ant t r5d]s ! product  
adult]at$ "u section #djb7;a77#a71 aft] 
animals14  #g4 ,report f9al product     
positive te/ results = relevant pa?og5s 
9 infant =mula ,section #dab ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     

,u4,s4,c4 #cej;a7 is am5d$-- 7#a7 9     
subsection 7e7--  7,a7 9 p>agraph 7#a7--
 7i7 9 ! fir/ s5t5ce1 by /rik+ promptly 
& ins]t+ 1 )9 #bd h\rs ( acquir+ su* k12
 &  7ii7 9 ! second s5t5ce1 by /rik+ !  
infant =mula & ins]t+ an infant =mula2  
7,b7 by r$esignat+ p>agraph 7#b7 z      
p>agraph 7#d72  7,c7 9 p>agraph 7#d71 z 
s r$esignat$1 by /rik+ p>agraph 7#a7 &  
ins]t+ p>agraphs 7#a7 & 7#b72 &  7,d7 by
 ins]t+ aft] p>agraph 7#a7 ! foll[+3    
7#b7 ,if ! result ( any 9-process or    
f9i%$ product te/+ ( an infant =mula t  
has be5 process$ by ! manufactur] is    
confirm$ z a positive analytical result 
= any environm5tal pa?og5 7z def9$ 9    
section #aag4c ( title #ba1 ,code (     
,f$]al ,regulations 7or any successor   
regulation771 ! manufactur] %all-- 7,a7 
)9 #bd h\rs ( acquir+ su* confirmation1 
notify ! ,secret>y ( su* confirmation   
reg>dless ( :e!r su* infant =mula has   
left an e/abli%m5t subject to ! control 
( ! manufactur]2  7,b7 consult ) !      
,secret>y = prop] disposal & prop]ly    

dispose ( ! affect$ product2 &  7,c7    
provide to ! ,secret>y results &        
isolates f a positive sample ( su*      
infant =mula4  7#c7 ,n lat] ?an #ij days
 aft] receipt ( a notification "u       
p>agraph 7#a7 or 7#b71 ! ,secret>y %all 
confirm ?r\gh ! collection (            
docum5tation t ! manufactur] submitt+ ! 
notification p]=m$1 or is p]=m+1        
appropriate corrective action4 ,!       
manufactur] %all make su* docum5tation  
available to ! ,secret>y dur+ an        
inspection &1 ^u reque/ ( ! ,secret>y1  
electronically or by o!r means4  4  #h4 
,environm5tal monitor+ ,section #dab ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cej;a7 is am5d$ by add+ 
at ! end ! foll[+3  7n7 ,requirem5ts =  
environm5tal monitor+ = ,cronobact] spp 
& ,salmonella  7#a7 ,9 g5]al ,a         
manufactur] ( p[d]$ infant =mula %all   
e/abli% & implem5t an environm5tal      
monitor+ program to v]ify ! effectiv5ess
 ( sanitation & hygi5e controls :]e !   
food has ! pot5tial to be expos$ to     

,cronobact] spp4 or ,salmonella4 ,!     
environm5tal monitor+ program %all be   
writt5 & include proc$ures = det]m9+    
sampl+ location1 numb] ( samples to be  
tak51 & tim+ & frequ5cy ( sample        
collection & te/+4  7#b7 ,sampl+        
location & numb] ( samples ,a           
manufactur] ( p[d]$ infant =mula %all   
ensure t ! sampl+ locations f :i*       
samples w be tak51 & ! numb] ( sites to 
be te/$ dur+ r\t9e environm5tal monitor+
 pursuant to an environm5tal monitor+   
program "u p>agraph 7#a71 are adequate  
to det]m9e :e!r sanitation & hygi5e     
controls are effective4  7#c7 ,tim+ &   
frequ5cy ,a manufactur] ( p[d]$ infant  
=mula %all ensure t ! tim+ & frequ5cy = 
collect+ te/+ samples pursuant to an    
environm5tal monitor+ program "u        
p>agraph 7#a7 are adequate to det]m9e   
:e!r sanitation & hygi5e controls are   
effective4  7#d7 ,records  7,a7         
,availability to ! ,secret>y ,a         
manufactur] ( p[d]$ infant =mula %all   
make all records requir$ "u ?is         

subsection available promptly to !      
,secret>y1 ^u reque/1 = inspection &    
copy+4  7,b7 ,ma9t5ance ,records (      
environm5tal monitor+ conduct$ pursuant 
to ?is subsection %all be ma9ta9$ = n   
less ?an #b ye>s or ! %elf-life ( !     
infant =mula1 :i*ev] is long]4  7,c7    
,conditions ( inspection ,any records t 
! ,secret>y may inspect "u ?is          
subsection %all1 ^u ! reque/ ( !        
,secret>y1 be provid$ to ! ,secret>y by 
! manufactur] ( p[d]$ infant =mula1 9   
advance ( or 9 lieu ( an inspection1 )9 
a reasonable timeframe1 )9 reasonable   
limits1 & 9 a reasonable mann]1 & 9 ei!r
 electronic or physical =m1 at ! exp5se 
( su* manufactur]4 ,! ,secret>y's reque/
 %all include a suffici5t description ( 
! records reque/$4  7,d7 ,confirmation (
 receipt ,^u receipt ( records reque/$  
"u subp>agraph 7,c71 ! ,secret>y %all   
provide to ! p]son confirmation (       
receipt4  7#e7 ,au?ority ( ! ,secret>y  
,no?+ 9 ?is subsection supplants !      
au?ority ( ! ,secret>y to conduct       

inspections o!rwise p]mitt$ "u ?is ,act 
9 ord] to ensure compliance ) ?is ,act4 
7#f7 ,delay$ applicability ,!           
requirem5ts ( ?is subsection apply      
beg9n+ on ! date t is #ahj days aft] !  
date ( enactm5t ( ?is subsection4  7#g7 
,rule ( con/ruction ,no?+ 9 ?is         
subsection %all be con/ru$ to exempt an 
infant =mula manufactur] f ! requirem5ts
 ( ?is ,act1 includ+ ! requirem5ts ( ?is
 section & section #dah4  4