,i #aagth ,,congress #b;d ,session ,h4 ,r4 #gicc ,,in ,,the ,,house ,,of ,,representatives ,june #c1 #bjbb,ms4 ,de,lauro 7for herself1 ,mr4 ,bishop of ,georgia1 ,ms4 ,barragn1 ,ms4 ,pressley1 ,mr4 ,san ,nicolas1 ,mr4 ,larson of ,connecticut1 ,mr4 ,thompson of ,california1 ,ms4 ,wild1 ,ms4 ,norton1 ,mr4 ,nadler1 ,mr4 ,lawson of ,florida1 ,mr4 ,sarbanes1 ,mrs4 ,bustos1 ,ms4 ,tlaib1 ,mrs4 ,napolitano1 ,ms4 ,wilson of ,florida1 ,mr4 ,cooper1 ,mr4 ,blumenauer1 ,mr4 ,carbajal1 ,mr4 ,evans1 ,mrs4 ,trahan1 ,mr4 ,pocan1 ,mr4 ,trone1 ,mr4 ,torres of ,new ,york1 ,mr4 ,cicilline1 ,mr4 ,danny ,k4 ,davis of ,illinois1 ,ms4 ,speier1 ,ms4 ,underwood1 ,mr4 ,de,saulnier1 ,mrs4 ,carolyn ,b4 ,maloney of ,new ,york1 ,mr4 ,carson1 ,mrs4 ,hayes1 ,ms4 ,pingree1 ,ms4 ,bonamici1 ,mr4 ,levin of ,california1 ,mr4 ,courtney1 ,ms4 ,meng1 ,mr4 ,perlmutter1 ,ms4 ,chu1 ,mr4 ,bowman1 ,ms4 ,titus1 ,ms4 ,dean1 ,ms4 ,schakowsky1 ,ms4 ,bass1 ,ms4 ,lee of ,california1 ,mrs4 ,demings1 ,mr4 ,krishnamoorthi1 ,mr4 ,raskin1 ,ms4 ,schrier1 ,mr4 ,pappas1 ,ms4 ,blunt ,rochester1 ,mr4 ,kilmer1 ,mr4 ,casten1 ,ms4 ,ross1 ,ms4 ,stevens1 ,mrs4 ,lawrence1 ,ms4 ,spanberger1 ,mr4 ,cohen1 ,mr4 ,panetta1 ,ms4 ,porter1 ,mrs4 ,watson ,coleman1 ,mr4 ,michael ,f4 ,doyle of ,pennsylvania1 ,mr4 ,connolly1 ,ms4 ,castor of ,florida1 ,mr4 ,himes1 ,ms4 ,mc,collum1 ,mr4 ,crow1 ,mr4 ,gallego1 ,mr4 ,swalwell1 ,ms4 ,scanlon1 ,mr4 ,welch1 ,ms4 ,clark of ,massachusetts1 ,ms4 ,roybal-,allard1 ,mr4 ,soto1 ,mr4 ,case1 ,mr4 ,crdenas1 ,ms4 ,jackson ,lee1 ,ms4 ,kuster1 ,mr4 ,langevin1 and ,ms4 ,lois ,frankel of ,florida7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on ,financial ,services1 ,education and ,labor1 and ,agriculture1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to improve the safety and supply of infant formula1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,keep ,infant ,formula ,safe and ,on the ,shelves ,act of #bjbb4 #b4 ,product safety 7a7 ,inspections and audits ,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 7j7 ,inspections and audits 7#a7 ,in general ,not less than every #f months1 the ,secretary shall inspect the facilities of each manufacturer of infant formula registered under subsection 7c74 7#b7 ,unannounced inspections ,not later than #f months after the date of enactment of the ,keep ,infant ,formula ,safe and ,on the ,shelves ,act of #bjbb1 and not less than once per calendar year thereafter1 the ,secretary shall conduct unannounced inspections of the facilities of each manufacturer of infant formula registered under subsection 7c71 including such facilities with no history of notable regulatory findings4 7#c7 ,automatic comprehensive food safety audit ,if the ,secretary makes a notable regulatory finding at any facility of a manufacturer of infant formula during an inspection or audit1 the ,secretary shall require such facility to undergo a comprehensive food safety audit that includes-- 7,a7 a root cause analysis2 7,b7 enhanced testing2 and 7,c7 comprehensive environmental samples throughout the facility4 7#d7 ,audits ,the ,secretary shall increase the frequency of comprehensive food safety audits of a facility of a manufacturer of infant formula registered under subsection 7c7 if there are persistent notable regulatory findings at such facility4 7#e7 ,microbial test results 7,a7 ,in general ,during any inspection or audit by the ,secretary of a facility of a manufacturer of infant formula1 the manufacturer shall provide to the ,secretary the results of all microbial tests conducted by or for the facility during the period of #ae years preceding the date of the inspection or audit4 7,b7 ,fines ,if the ,secretary finds that a facility is in violation of subparagraph 7,a71 such violation shall be treated as an infraction for purposes of imposing a fine in accordance with title #ah1 ,united ,states ,code4 4 7b7 ,cronobacter sakazakii ,the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 and in consultation with the ,council of ,state and ,territorial ,epidemiologists1 shall consider adding cronobacter sakazakii to the list of nationally notifiable diseases and conditions under the ,national ,notifiable ,diseases ,surveillance ,system4 #c4 ,supply 7a7 ,strategic ,national ,stockpile ,not later than #ij days after the date of enactment of this ,act1 the ,secretary of ,agriculture1 in consultation with the ,assistant ,secretary for ,preparedness and ,response of the ,department of ,health and ,human ,services and the ,administrator of the ,federal ,emergency ,management ,agency1 shall-- 7#a7 perform an assessment of-- 7,a7 short- and long-term storage of infant formula1 including the possibility of storage of infant formula in a ,federal stockpile2 and 7,b7 models for distribution of infant formula during shortages2 and 7#b7 submit a report to the ,congress on the results of such assessment4 7b7 ,notification by manufacturers of circumstances that could lead to a shortage of infant formula or essential medical food 7#a7 ,requirement ,chapter ,,iv of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq47 is amended by adding the following at the end3 #dbd4 ,notice of circumstances that could lead to a shortage 7a7 ,notice requirement ,not later than #e business days after a manufacturer of infant formula or essential medical food becomes aware of circumstances that could lead to a shortage of infant formula or essential medical food in the ,united ,states1 such manufacturer shall give written notice of such circumstances to the ,secretary4 7b7 ,definition ,in this section1 the term essential medical food means a food that-- 7#a7 is formulated to be consumed or administered enterally under the supervision of a physician2 7#b7 is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements1 based on recognized scientific principles1 are established by medical evaluation2 and 7#c7 is identified by the ,secretary as being essential for any urgent medical condition4 7c7 ,fines ,if the ,secretary finds that a manufacturer of infant formula or essential medical food is in violation of the requirement of this section to give written notice1 such violation shall be treated as an infraction for purposes of imposing a fine in accordance with title #ah1 ,united ,states ,code4 4 7c7 ,list of facilities that could be converted ,to manufacture infant formula ,section #dab of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a71 as amended by section #b7;a71 is further amended by adding at the end the following3 7k7 ,list of facilities that could be converted ,the ,secretary shall-- 7#a7 not later than #ij days after the date of enactment of this subsection1 identify and compile a list of all manufacturing facilities in the ,united ,states that could be converted to manufacture infant formula in the event of a shortage2 7#b7 on an annual basis1 update such list2 and 7#c7 post such up-to-date list on the public website of the ,food and ,drug ,administration4 4 7d7 ,reporting by manufacturers during a shortage ,section #dab of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a71 as amended by subsection 7c71 is further amended by adding at the end the following3 7l7 ,reporting by manufacturers during a shortage ,in the event of a shortage of infant formula in the ,united ,states1 the ,secretary may require manufacturers of infant formula to report to the ,secretary-- 7#a7 the quantity of infant formula in the inventories of such manufacturers and their distributors2 7#b7 the location of recent or upcoming shipments of infant formula by such manufacturers and their distributors2 7#c7 the capacity of such manufacturers and their distributors to redistribute their inventories of infant formula based on geographical needs2 and 7#d7 the quantity by which such manufacturers could increase their output of infant formula4 4 #d4 ,use of authorities under the ,defense ,production ,act of #aiej for food ,section #aja of the ,defense ,production ,act of #aiej 7#ej ,u4,s4,c4 #deaa7 is amended by adding at the end the following3 7e7 ,treatment of food ,for purposes of this title1 title ,,iii1 and title ,,vii1 food 7including infant formula and the ingredients necessary to produce infant formula7 is a critical material essential to the national defense4 4 #e4 ,ensuring worker safety and health ,the ,assistant ,secretary of ,labor for ,occupational ,safety and ,health shall issue a fact sheet and provide technical assistance to each manufacturer of infant formula registered under section #dab7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a7c77 to promote compliance with occupational safety and health standards promulgated under section #f of the ,occupational ,safety and ,health ,act of #aigj4 ,such fact sheet and technical assistance shall include information on recognized hazards and on the specific occupational safety and health standards1 and any other legal requirements under the ,occupational ,safety and ,health ,act of #aigj1 that apply to such manufacturer4