,i  #aaith ,,congress  #b;d ,session    
,h4 ,r4 #hifd  ,,in ,,the ,,house ,,of  
,,representatives  ,may #ba1 #bjbf,ms4  
,de,lauro 7for herself1 ,mrs4 ,trahan1  
,mr4 ,van ,drew1 ,mr4 ,pappas1 ,ms4     
,dean of ,pennsylvania1 and ,mr4        
,mc,garvey7 introduced the following    
bill2 which was referred to the         
,committee on ,energy and ,commerce  ,a 
,,bill  ,to improve the safety of       
pasteurized donor human milk and enhance
 regulation4  #a4 ,short title ,this    
,act may be cited as the ,developing    
,oversight for ,nutrition through the   
,official ,regulation of ,milk ,act or  
the ,,donor ,milk ,act4  #b4 ,regulation
 of pasteurized donor human milk  7a7   
,definitions ,section #bja of the       
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cba7 is amended--  
7#a7 in subsection 7ss7-- 7,a7 in       
paragraph 7#a71 by striking or at the   
end2  7,b7 in paragraph 7#b71 by        
striking the period at the end and      
inserting 2 or2 and  7,c7 by adding at  

the end the following3  7#c7 pasteurized
 donor human milk4  2 and  7#b7 by      
adding at the end the following3  7tt7  
,the term pasteurized donor human milk  
means human milk which-- 7#a7 is        
expressed by a mother and donated for   
use by a recipient that is not the      
mother's own infant2 and  7#b7 has been 
collected1 pasteurized1 and dispensed   
without additives4  4  7b7              
,clarification of food manufacturer     
registration requirement ,section       
#dae7;c77#a7 of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cej;d7c77#a77 is amended by adding at 
the end the following3 ,beginning on the
 date of the enactment of the ,,donor   
,milk ,act1 a food establishment that   
manufactures1 processes1 packs1 or holds
 critical foods shall not be considered 
a nonprofit food establishments in which
 food is prepared for or served directly
 to the consumer and the exception in   
the preceding sentence shall no longer  
apply to such a facility4  7c7 ,annual  

inspections of donor human milk         
manufacturers ,section #dab of the      
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cej;a7 is amended  
by adding at the end the following3  7n7
 ,annual inspections of donor human milk
 manufacturers ,beginning not later than
 #a year after the date of the enactment
 of this subsection1 and not less       
frequently than once each year          
thereafter1 the ,secretary shall conduct
 inspections1 including unannounced     
inspections1 of the facilities of each  
entity that manufactures1 processes1    
packs1 or holds pasteurized donor human 
milk in accordance with a risk-based    
approach to ensure compliance with      
relevant food safety and food labeling  
requirements under this ,act or any     
other provision of law administered by  
the ,secretary4  4  7d7 ,compliance     
grants for donor human milk             
manufacturers ,section #dab of the      
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cej;a71 as amended 

by subsection 7c7 of this section1 is   
further amended by adding at the end the
 following3  7o7 ,compliance grants for 
donor human milk manufacturers  7#a7 ,in
 general ,the ,secretary shall make     
grants to nonprofit entities that       
manufacture1 process1 pack1 or hold     
pasteurized donor human milk and are    
registered under section #dae7;c7 to    
assist such entities in complying with  
this ,act1 including through assisting  
such entities with respect to making any
 upgrades in equipment1 obtaining       
necessary certifications1 and entering  
into contracts with third parties for   
food safety quality consultations4  7#b7
 ,authorization of appropriations ,there
 are authorized to be appropriated      
#h1jjj1jjj1 to remain available until   
expended1 to carry out paragraph 7#a74  
4