,,ii  #aag? ,,congress  #b;d ,session   
,s4 #dbef  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #ah 7legislative  
day1 ,may #ag71 #bjbb,mr4 ,casey 7=     
himself1 ,mr4 ,br[n1 ,ms4 ,duckwor?1    
,mrs4 ,gillibr&1 & ,ms4 ,w>r57 introduc$
 ! foll[+ bill2 :i* 0 read twice &      
ref]r$ to ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions  ,a      
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to prev5t food         
%ortages1 includ+ %ortages ( infant     
=mula & c]ta9 m$ical foods4  #a4 ,%ort  
title ,?is ,act may be cit$ z !         
,protect+ ,infants f ,=mula ,%ortages   
,act ( #bjbb4  #b4 ,discont9uance or    
int]ruption 9 ! production ( ess5tial   
s\rces ( nutrition  7a7 ,discont9uance  
or int]ruption 9 ! production ( ess5tial
 food ,! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act is am5d$ by ins]t+ aft]  
section #dab 7#ba ,u4,s4,c4 #cej;a7 !   
foll[+ new section3  #dab;,a4           
,discont9uance or int]ruption 9 !       
production ( food1 includ+ infant =mula 

& c]ta9 m$ical foods = inborn errors (  
metabolism  7a7 ,9 g5]al ,a manufactur] 
( an ess5tial s\rce ( nutrition %all    
notify ! ,secret>y1 9 accordance )      
subsection 7b71 ( a p]man5t             
discont9uance 9 ! manufacture ( su* food
 or an int]ruption ( ! manufacture ( an 
ess5tial s\rce ( nutrition or any o!r   
circum/ance t is likely to lead to a    
mean+ful disruption 9 ! supply ( su*    
food 9 ! ,unit$ ,/ates1 & ! reasons =   
su* discont9uance or int]ruption4  7b7  
,tim+ ,except z provid$ 9 subsection    
7g71 a notice requir$ "u subsection 7a7 
%all be submitt$ to ! ,secret>y-- 7#a7  
at lea/ #f mon?s prior to ! date ( !    
discont9uance or int]ruption2 or  7#b7  
if compliance ) p>agraph 7#a7 is n      
possible1 z soon z practicable4  7c7    
,di/ribution ,to ! maximum ext5t        
practicable1 ! ,secret>y %all di/ribute1
 to ! ,secret>y ( ,agriculture & to     
appropriate organizations1 z det]m9$ by 
! ,secret>y1 ?r\gh su* means z !        
,secret>y det]m9es appropriate1         

in=mation on ! discont9uance or         
int]ruption ( ! manufacture ( an        
ess5tial s\rce ( nutrition1 or o!r      
circum/ance1 report$ "u subsection 7a74 
7d7 ,confid5tiality ,no?+ 9 ?is section 
au?orizes ! ,secret>y to disclose any   
in=mation t is a trade secret or        
confid5tial in=mation subject to section
 #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates 
,code1 or section #aije ( title #ah1    
,unit$ ,/ates ,code4  7e7 ,failure ,to  
meet requirem5ts ,if a p]son fails to   
submit in=mation requir$ "u subsection  
7a7 9 accordance ) subsection 7b7-- 7#a7
 ! ,secret>y %all issue to su* p]son a  
lett] t-- 7,a7 in=ms su* p]son ( !      
failure to comply2  7,b7 describes !    
basis = noncompliance2 &  7,c7 requires 
! p]son to comply n lat] ?an #cj cal5d> 
days aft] ! date on :i* ! lett] 0 issu$2
  7#b7 n lat] ?an #cj cal5d> days aft] !
 issuance ( a lett] "u p>agraph 7#a71 ! 
p]son :o receives su* lett] %all submit 
to ! ,secret>y a writt5 response to su* 
lett] t provides ! in=mation requir$ "u 

subsection 7a72 &  7#c7 n lat] ?an #de  
cal5d> days aft] ! issuance ( a lett] "u
 p>agraph 7#a71 ! ,secret>y %all make   
su* lett] & any response to su* lett] "u
 p>agraph 7#b7 available to ! public on 
! website ( ! ,food & ,drug             
,adm9i/ration1 ) appropriate r$actions  
made to protect in=mation describ$ 9    
subsection 7d71 except t1 if ! ,secret>y
 det]m9es t ! lett] "u p>agraph 7#a7 0  
issu$ 9 error or1 aft] review ( su*     
response1 ! p]son _h a reasonable basis 
= n notify+ z requir$ "u subsection 7a71
 ! requirem5ts ( ?is p>agraph %all n    
apply4  7f7 ,regulations  7#a7 ,9 g5]al 
,n lat] ?an #a ye> aft] ! date (        
enactm5t ( ! ,protect+ ,infants f ,=mula
 ,%ortages ,act ( #bjbb1 ! ,secret>y    
%all promulgate regulations reg>d+ !    
requirem5ts "u ?is section4  7#b7       
,cont5ts ,su* regulations-- 7,a7 %all   
include a li/ ( ea* category ( food =   
:i* a manufactur] is requir$ to notify !
 ,secret>y 9 accordance ) subsection    
7a72 &  7,b7 may-- 7i7 designate foods n

 o!rwise def9$ z an ess5tial s\rce (    
nutrition1 giv+ special consid]ation to 
foods-- 7,i7 ^u :i* individuals ) c]ta9 
diseases or conditions may be p>ticul>ly
 reliant2 or  7,,ii7 t are adm9i/]$ "u  
m$ical sup]vision2  7ii7 designate      
additional categories ( foods = :i* !   
,secret>y det]m9es notification describ$
 9 subsection 7a7 is appropriate dur+ a 
public heal? em]g5cy decl>$ "u section  
#cai ( ! ,public ,heal? ,s]vice ,act2 & 
7iii7 prescribe additional conditions on
 ! tim+ & mann] ( su* notifications z   
are reasonable & appropriate dur+ su* a 
public heal? em]g5cy4  7g7 ,ord] ,dur+ a
 public heal? em]g5cy decl>$ "u section 
#cai ( ! ,public ,heal? ,s]vice ,act1 ! 
,secret>y may ord] any manufactur] ( an 
ess5tial s\rce ( nutrition to provide   
notification requir$ by ?is section4    
,su* ord] may-- 7#a7 impose additional  
conditions on ! tim+ & mann] (          
notification z are reasonable &         
appropriate 9 light ( ! circum/ances ( !
 public heal? em]g5cy2 &  7#b7 designate

 additional categories ( food = :i* !   
,secret>y det]m9es notification is      
appropriate dur+ ! public heal? em]g5cy4
  7h7 ,risk managem5t plans ,ea*        
manufactur] ( an ess5tial s\rce (       
nutrition %all develop1 ma9ta91 &1 z    
appropriate1 implem5t a r$undancy risk  
managem5t plan t id5tifies & evaluates  
risks to ! supply ( ! food1 z           
applicable1 = ea* e/abli%m5t 9 :i* su*  
food is manufactur$4 ,a risk managem5t  
plan "u ?is subsection-- 7#a7 may       
id5tify & evaluate risks to ! supply ( m
 ?an "o food1 or food category1         
manufactur$ at ! same e/abli%m5t2 &     
7#b7 %all be subject to inspection &    
copy+ by ! ,secret>y pursuant to section
 #gjd or at ! reque/ ( ! ,secret>y4  7i7
 ,def9itions ,9 ?is section3 7#a7       
,ess5tial s\rce ( nutrition ,! t]m      
ess5tial s\rce ( nutrition means-- 7,a7 
an infant =mula2  7,b7 a food t-- 7i7   
meets ! def9ition ( m$ical food 9       
section #e7;b7 ( ! ,orphan ,drug ,act2 &
  7ii7 is int5d$ = use by individuals   

)-- 7,i7 c]ta9 inborn errors (          
metabolism2 or  7,,ii7 o!r conditions   
requir+ a m$ical food1 z det]m9$ by !   
,secret>y 9 guidance issu$ "u subsection
 7f72 or  7,c7 a food s designat$       
pursuant to subsection 7f74  7#b7       
,mean+ful disruption ,! t]m mean+ful    
disruption-- 7,a7 means a *ange 9       
production t is reasonably likely to    
lead to a r$uction 9 ! supply ( an      
ess5tial s\rce ( nutrition by a         
manufactur] t is m ?an negligible &     
affects ! ability ( ! manufactur] to    
fulfill contractual obligations or meet 
expect$ dem& = its product2 &  7,b7 does
 n include int]ruptions 9 manufactur+   
due to matt]s su* z r\t9e ma9t5ance or  
insignificant *anges 9 manufactur+ s    
long z ! manufactur] expects to resume  
op]ations 9 a %ort p]iod ( "t4  4  7b7  
,prohibit$ acts ,section #cja ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cca7 is am5d$ by add+ at !   
end ! foll[+ new subsection3  7fff7 ,!  
failure to provide in=mation z requir$  

"u section #dab;,a aft] receipt ( a     
lett] f ! ,secret>y "u subsection 7e7 ( 
su* section4  4  #c4 ,remote records    
assessm5t = ess5tial s\rces ( nutrition 
7a7 ,factory inspection ,section        
#gjd7;a77#d77;,a7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgd7;a77#d77;,a77 is am5d$ 9 ! fir/    
s5t5ce by ins]t+ or ! manufactur+1      
process+1 pack+1 or hold+ ( an ess5tial 
s\rce ( nutrition 7z def9$ 9 section    
#dab;,a7 aft] process+ ( a drug4  7b7   
,regulations ,n lat] ?an #a ye> aft] !  
date ( enactm5t ( ?is ,act1 ! ,secret>y 
( ,heal? & ,human ,s]vices 7ref]r$ to 9 
?is section z ! ,secret>y7 %all         
promulgate regulations describ+         
circum/ances 9 :i* ! ,secret>y may issue
 reque/s = records or o!r in=mation 9   
advance (1 or 9 lieu (1 an inspection   
pursuant to section #gjd7;a77#d77;,a7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1
 z am5d$ by subsection 7a71 processes = 
respond+ to su* reque/s electronically  
or 9 physical =m1 & factors ! ,secret>y 

may consid] 9 evaluat+ :e!r su* records 
are provid$ )9 a reasonable timeframe1  
)9 reasonable limits1 & 9 a reasonable  
mann]1 acc\nt+ = res\rce & o!r          
limitations t may exi/1 includ+ = small 
bus9esses4