,i #aah? ,,congress #a/ ,session ,h4 ,r4 #ecaf ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,augu/ #bi1 #bjbc,ms4 ,port] 7= h]self & ,mrs4 ,mc,clain7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d section #dab ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to enhance ! safegu>ds applicable ) respect to infant =mula4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,safegu>d+ ,kids & ,families f ,critical ,food ,disruptions ,act ( #bjbc4 #b4 ,safegu>d+ kids & families f critical food disruptions 7a7 ,9 g5]al ,subsection 7e7 ( section #dab ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a7 is am5d$ to read z foll[s3 7e7 7#a7 ,if ! manufactur] ( an infant =mula has k :i* reasonably supports ! conclusion t an infant =mula :i* has be5 process$ by ! manufactur] & :i* has left an e/abli%m5t subject to ! control ( ! manufactur]-- 7,a7 may n provide ! nutri5ts requir$ by subsection 7i72 or 7,b7 may be o!rwise adult]at$ or misbr&$1 ! manufactur] %all1 )9 #bd h\rs1 notify ! ,secret>y & ! ,director ( ! ,(fice ( ,critical ,foods ( su* k4 7#b7 ,if ! manufactur] ( an infant =mula has k :i* reasonably supports ! conclusion t an infant =mula :i* has be5 process$ by ! manufactur] may be adult]at$ due to pa?og5 contam9ation 7su* z confirmation ( a positive analytical result f any 9-process or f9i%$ product te/+71 ! manufactur] %all-- 7,a7 )9 #bd h\rs1 notify ! ,secret>y & ! ,director ( ! ,(fice ( ,critical ,foods ( su* k1 reg>dless ( :e!r su* infant =mula has left an e/abli%m5t subject to ! control ( ! manufactur]2 & 7,b7 provide to ! ,secret>y1 = ! purpose ( sequ5c+1 results & isolates f a positive sample ( su* infant =mula4 7#c7 ,9 submitt+ a notification "u p>agraph 7#a7 or 7#b71 a manufactur] %all adh]e to any submission requirem5ts or proc$ures specifi$ by ! ,secret>y4 7#d7 ,if ! ,secret>y det]m9es t an infant =mula pres5ts a risk to human heal?1 ! manufactur] %all imm$iately take all actions necess>y to cease di/ribution ( su* infant =mula & recall %ipm5ts ( su* infant =mula f all :olesale & retail e/abli%m5ts1 consi/5t ) recall regulations & guidel9es issu$ by ! ,secret>y4 7#e7 7,a7 ,n lat] ?an #gb h\rs aft] receipt by ! ,director ( ! ,(fice ( ,critical ,foods ( a notification "u p>agraph 7#a7 or 7#b71 ! ,director %all contact ! manufactur] ( ! infant =mula1 or an affiliate !re( 9 ! ,unit$ ,/ates1 to discuss corrective action4 7,b7 ,if !re is a failure ( ! ,director ( ! ,(fice ( ,critical ,foods to act )9 #gb h\rs aft] receipt ( a notification z requir$ by subp>agraph 7,a71 ! ,secret>y %all imm$iately notify ! appropriate congressional committees :at1 if any1 acc\ntability me*anisms 71 or w be1 invok$ = su* failure4 7#f7 ,! ,director ( ! ,(fice ( ,critical ,foods-- 7,a7 n lat] ?an #ij days aft] receipt by ! ,director ( a notification "u p>agraph 7#a7 or 7#b71 %all confirm t ! manufactur] submitt+ ! notification p]=m$1 or is p]=m+1 appropriate corrective action1 includ+ a root cause analysis2 7,b7 9 mak+ su* confirmation1 may collect docum5tation dur+ an inspection1 electronically1 or by o!r means2 & 7,c7 %all notify ! appropriate congressional committees if ! ,director is unable to make su* confirmation & :at1 if any1 acc\ntability me*anisms 71 or w be1 invok$ = su* failure4 7#g7 ,n lat] ?an ! end ( ea* ( cal5d> ye>s #bjbd1 #bjbe1 & #bjbf1 ! ,secret>y %all submit to ! ,congress a report conta9+-- 7,a7 ! numb] ( notifications receiv$ "u p>agraph 7#a7 or 7#b7 dur+ ! fiscal ye> end+ 9 ! respective cal5d> ye>2 7,b7 ! av]age numb] ( h\rs x took ! ,director ( ! ,(fice ( ,critical ,foods to initiate contact1 z requir$ by p>agraph 7#e71 9 response to su* notifications2 7,c7 ! longe/ & %orte/ "t x took ! ,director ( ! ,(fice ( ,critical ,foods to s initiate contact2 7,d7 ! av]age numb] ( days x took ! ,director ( ! ,(fice ( ,critical ,foods to confirm corrective action1 z requir$ by p>agraph 7#f71 9 response to su* notifications2 & 7,e7 ! longe/ & %orte/ numb] ( days x took ! ,director ( ! ,(fice ( ,critical ,foods to s confirm corrective action4 7#h7 ,= purposes ( p>agraphs 7#a7 & 7#b71 ! t]m k z appli$ to a manufactur] means-- 7,a7 ! actual k t ! manufactur] _h2 or 7,b7 ! k :i* a reasonable p]son w\ld h _h "u l circum/ances or :i* w\ld h be5 obta9$ ^u ! ex]cise ( due c>e4 7#i7 ,= purposes ( p>agraph 7#b71 ! t]m pa?og5 means a microorganism ( public heal? significance4 4 7b7 ,tim+ 7#a7 ,notification requirem5ts ,p>agraphs 7#a71 7#b71 7#c71 7#d71 7#h71 & 7#i7 ( subsection 7e7 ( section #dab ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a71 z am5d$ by subsection 7a71 apply ^u ! enactm5t ( ?is ,act4 7#b7 ,response by ,secret>y ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,director ( ! ,(fice ( ,critical ,foods1 %all e/abli% a process = c>ry+ out p>agraphs 7#e7 & 7#f7 ( subsection 7e7 ( section #dab ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;a71 z am5d$ by subsection 7a71 & beg9 implem5tation ( su* process4