,i  #aaith ,,congress  #ast ,session    
,h4 ,r4 #bdgb  ,,in ,,the ,,house ,,of  
,,representatives  ,march #bg1          
#bjbe,mrs4 ,sykes 7for herself1 ,mr4    
,pallone1 and ,mr4 ,krishnamoorthi7     
introduced the following bill2 which was
 referred to the ,committee on ,energy  
and ,commerce  ,a ,,bill  ,to amend the 
,federal ,food1 ,drug1 and ,cosmetic    
,act to ensure the safety of infant and 
toddler food1 and for other purposes4   
#a4 ,short title ,this ,act may be cited
 as the ,improving ,newborns' ,food and 
,nutrition ,testing ,safety ,act of     
#bjbe or the ,,infants ,act of #bjbe4   
#b4 ,definition of infant and toddler   
food ,section #bja of the ,federal      
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cba7 is amended by adding at 
the end the following3  7tt7 ,the term  
infant and toddler food means food which
 purports to be or is represented as    
food for children up to #bd months of   
age1 including infant formula4  4  #c4  
,contaminants in food ,chapter ,,iv of  

the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cda et seq47 is   
amended by adding at the end the        
following3  #dbe4 ,sampling and testing 
for contaminants in food  7a7 ,sampling 
and testing  7#a7 ,in general ,the      
owner1 operator1 or agent in charge of a
 food facility that manufactures or     
processes food1 including infant and    
toddler food1 in final product form     
intended for sale to consumers shall--  
7,a7 collect representative samples of  
each such food2 and  7,b7 conduct       
testing of the samples for contaminants1
 including toxic elements4  7#b7        
,requirement for sampling plan  7,a7 ,in
 general ,the owner1 operator1 or agent 
in charge of a facility described in    
paragraph 7#a7 shall--  7i7 prepare a   
written sampling plan for all sampling  
and testing required under this section2
 and  7ii7 ensure that all sampling and 
testing conducted under this section is 
conducted in accordance with the        
sampling plan4  7,b7 ,requirements ,a   

sampling plan under subparagraph 7,a7   
shall identify-- 7i7 the number of      
sampling units and sample unit size     
based upon appropriate criteria for     
identifying1 in a representative        
fashion1 the levels of contaminants in  
each food2 and  7ii7 one or more        
appropriate test methods and procedures 
to be used to analyze the samples4  7,c7
 ,guidance ,not later than #ah months   
after the date of enactment of this     
section1 the ,secretary shall issue     
guidance to assist food facilities in   
developing sampling plans4 ,such        
guidance may1 as determined appropriate 
by the ,secretary1 address when samples 
should be tested for specific species of
 contaminants4  7#c7 ,contaminants to be
 tested ,each sample taken pursuant to a
 sampling plan under this section shall 
be tested for levels of lead1 cadmium1  
mercury1 arsenic1 and any other         
contaminant1 including other toxic      
elements1 that the ,secretary may       
specify by regulation4  7#d7 ,frequency 

of testing ,the sampling and testing    
conducted under this section shall be   
conducted at least once per quarter of  
each calendar year4  7#e7 ,foods to be  
tested ,the sampling and testing        
conducted under this section shall be   
conducted for-- 7,a7 infant and toddler 
foods1 in final package form2 and  7,b7 
such other foods as the ,secretary may  
specify1 by regulation1 as appropriate  
to protect public health4  7b7          
,recordkeeping  7#a7 ,in general ,the   
owner1 operator1 or agent in charge of a
 facility described in subsection       
7a77#a7 shall maintain1 for not less    
than #b years or the shelf-life of each 
infant and toddler food manufactured or 
processed at the facility1 whichever is 
longer1 records documenting the sampling
 and testing conducted under this       
section with respect to the food4  7#b7 
,requirements ,records required by      
paragraph 7#a7 to be maintained shall   
include a detailed description of the   
foods sampled and tested1 the number of 

samples and tests performed1 the size   
and number of items in each sample unit1
 a copy of the facility's sampling plan1
 identification of the entity conducting
 the sampling1 identification of the    
entity conducting the testing1 and the  
analytical methods used to perform the  
sampling and testing4  7#c7             
,applicability ,this subsection applies 
to all records of sampling and testing  
conducted under this section1 regardless
 of the findings4  7c7 ,laboratory      
accreditation ,the owner1 operator1 or  
agent in charge of a food facility      
described in subsection 7a77#a7 shall   
ensure that testing conducted pursuant  
to this section is performed in         
accordance with international standards 
by a laboratory that is accredited by an
 accreditation body that conforms to    
international accreditation standards4  
,testing conducted under this section is
 not subject to the requirements        
regarding laboratory accreditation      
described in section #dbb4  7d7 ,records

 availability  7#a7 ,in general ,the    
owner1 operator1 or agent in charge of a
 food facility described in subsection  
7a77#a7 shall make all records required 
under this section available promptly to
 the ,secretary1 upon request1 for      
inspection and copying4 ,upon request of
 the ,secretary1 such an owner1         
operator1 or agent in charge shall      
provide within a reasonable time an     
,english translation of records         
maintained in a language other than     
,english4  7#b7 ,records availability in
 lieu of an inspection ,any records that
 the ,secretary may inspect under this  
section shall1 upon the request of the  
,secretary1 be provided to the          
,secretary by the owner1 operator1 or   
agent in charge of a food facility      
described in subsection 7a77#a71 in     
advance of or in lieu of an inspection1 
within a reasonable timeframe1 within   
reasonable limits1 and in a reasonable  
manner1 and in either electronic or     
physical form1 at the expense of such   

owner1 operator1 or agent4 ,the         
,secretary's request shall include a    
sufficient description of the records   
requested4  7#c7 ,confirmation ,upon    
receipt of records requested under      
paragraph 7#b71 the ,secretary shall    
provide to the person confirmation of   
receipt4  7#d7 ,authority of the        
,secretary ,nothing in this subsection  
supplants the authority of the          
,secretary to conduct inspections       
otherwise permitted under this ,act in  
order to ensure compliance with this    
,act4  7e7 ,delayed applicability ,the  
requirements for sampling and testing   
under this section apply beginning on   
the date that is #ahj days after the    
date on which the ,secretary publishes  
the guidance required by subsection     
7a77#b77;,c74  4  #d4 ,adulteration     
,section #djb of the ,federal ,food1    
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cdb7 is amended by adding at the end  
the following3  7j7 ,if it is an article
 of food and the owner1 operator1 or    

agent in charge of a food facility that 
manufactures or processes such food--   
7#a7 is subject to the requirements of  
section #dbe2 and  7#b7 fails to comply 
with the requirements of such section   
with regard to that article4  4  #e4    
,records for or in lieu of certain      
inspections ,section #gjd7;a77#d7 of the
 ,federal ,food1 ,drug1 and ,cosmetic   
,act 7#ba ,u4,s4,c4 #cgd7;a77#d77 is    
amended-- 7#a7 by redesignating         
subparagraphs 7,b71 7,c71 and 7,d7 as   
subparagraphs 7,c71 7,d71 and 7,e71     
respectively2  7#b7 by inserting after  
subparagraph 7,a7 the following3  7,b7  
7i7 ,any records or other information   
that the ,secretary may inspect under   
authority of this ,act from a person    
that owns or operates an establishment  
that is engaged in any of the activities
 described in clause 7ii7 shall1 upon   
the request of the ,secretary1 be       
provided to the ,secretary by such      
person1 in advance of or in lieu of an  
inspection1 within a reasonable         

timeframe1 within reasonable limits1 and
 in a reasonable manner1 and in either  
electronic or physical form1 at the     
expense of such person4 ,the            
,secretary's request shall include a    
sufficient description of the records   
requested4  7ii7 ,the activities        
described in this clause are the        
following3 7,i7 ,the manufacturing1     
processing1 packing1 transporting1      
distributing1 receiving1 holding1 or    
importing of an article of food4  7,,ii7
 ,the distribution or use of animal feed
 bearing or containing a veterinary feed
 directive drug1 or the issuance of a   
veterinary feed directive4  2 and  7#c7 
by adding at the end the following3     
7,f7 ,section #gjc does not apply to    
requests for records or other           
information when those requests are made
 under this section4  4  #f4 ,mandatory 
recall authority ,section #dbc7;a7 of   
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cejl7a77 is       
amended by inserting or if the          

,secretary determines through any means 
that an article of infant and toddler   
food 7other than infant formula7 bears  
or contains a contaminant that renders  
the product adulterated under section   
#djb7;a77#a71 after animals14  #g4      
,report final product positive test     
results for relevant pathogens in infant
 formula ,section #dab of the ,federal  
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cej;a7 is amended-- 7#a7 in  
subsection 7e7--  7,a7 in paragraph     
7#a7-- 7i7 in the first sentence1 by    
striking promptly and inserting 1 within
 #bd hours of acquiring such knowledge12
 and  7ii7 in the second sentence1 by   
striking the infant formula and         
inserting an infant formula2  7,b7 by   
redesignating paragraph 7#b7 as         
paragraph 7#d72  7,c7 in paragraph 7#d71
 as so redesignated1 by striking        
paragraph 7#a7 and inserting paragraphs 
7#a7 and 7#b72 and  7,d7 by inserting   
after paragraph 7#a7 the following3     
7#b7 ,if the result of any in-process or

 finished product testing of an infant  
formula that has been processed by the  
manufacturer is confirmed as a positive 
analytical result for any environmental 
pathogen 7as defined in section #aag4c  
of title #ba1 ,code of ,federal         
,regulations 7or any successor          
regulation771 the manufacturer shall--  
7,a7 within #bd hours of acquiring such 
confirmation1 notify the ,secretary of  
such confirmation regardless of whether 
such infant formula has left an         
establishment subject to the control of 
the manufacturer2  7,b7 consult with the
 ,secretary for proper disposal and     
properly dispose of the affected        
product2 and  7,c7 provide to the       
,secretary results and isolates from a  
positive sample of such infant formula4 
7#c7 ,not later than #ij days after     
receipt of a notification under         
paragraph 7#a7 or 7#b71 the ,secretary  
shall confirm through the collection of 
documentation that the manufacturer     
submitting the notification performed1  

or is performing1 appropriate corrective
 action4 ,the manufacturer shall make   
such documentation available to the     
,secretary during an inspection and1    
upon request of the ,secretary1         
electronically or by other means4  4    
#h4 ,environmental monitoring ,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 ,requirements for       
environmental monitoring for            
,cronobacter spp and ,salmonella  7#a7  
,in general ,a manufacturer of powdered 
infant formula shall establish and      
implement an environmental monitoring   
program to verify the effectiveness of  
sanitation and hygiene controls where   
the food has the potential to be exposed
 to ,cronobacter spp4 or ,salmonella4   
,the environmental monitoring program   
shall be written and include procedures 
for determining sampling location1      
number of samples to be taken1 and      
timing and frequency of sample          

collection and testing4  7#b7 ,sampling 
location and number of samples ,a       
manufacturer of powdered infant formula 
shall ensure that the sampling locations
 from which samples will be taken1 and  
the number of sites to be tested during 
routine environmental monitoring        
pursuant to an environmental monitoring 
program under paragraph 7#a71 are       
adequate to determine whether sanitation
 and hygiene controls are effective4    
7#c7 ,timing and frequency ,a           
manufacturer of powdered infant formula 
shall ensure that the timing and        
frequency for collecting testing samples
 pursuant to an environmental monitoring
 program under paragraph 7#a7 are       
adequate to determine whether sanitation
 and hygiene controls are effective4    
7#d7 ,records  7,a7 ,availability to the
 ,secretary ,a manufacturer of powdered 
infant formula shall make all records   
required under this subsection available
 promptly to the ,secretary1 upon       
request1 for inspection and copying4    

7,b7 ,maintenance ,records of           
environmental monitoring conducted      
pursuant to this subsection shall be    
maintained for not less than #b years or
 the shelf-life of the infant formula1  
whichever is longer4  7,c7 ,conditions  
of inspection ,any records that the     
,secretary may inspect under this       
subsection shall1 upon the request of   
the ,secretary1 be provided to the      
,secretary by the manufacturer of       
powdered infant formula1 in advance of  
or in lieu of an inspection1 within a   
reasonable timeframe1 within reasonable 
limits1 and in a reasonable manner1 and 
in either electronic or physical form1  
at the expense of such manufacturer4    
,the ,secretary's request shall include 
a sufficient description of the records 
requested4  7,d7 ,confirmation of       
receipt ,upon receipt of records        
requested under subparagraph 7,c71 the  
,secretary shall provide to the person  
confirmation of receipt4  7#e7          
,authority of the ,secretary ,nothing in

 this subsection supplants the authority
 of the ,secretary to conduct           
inspections otherwise permitted under   
this ,act in order to ensure compliance 
with this ,act4  7#f7 ,delayed          
applicability ,the requirements of this 
subsection apply beginning on the date  
that is #ahj days after the date of     
enactment of this subsection4  7#g7     
,rule of construction ,nothing in this  
subsection shall be construed to exempt 
an infant formula manufacturer from the 
requirements of this ,act1 including the
 requirements of this section and       
section #dah4  4