,,ii #aaf? ,,congress #a/ ,session ,s4 #cjec ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,decemb] #af1 #bjai,mr4 ,enzi 7= himself & ,mr4 ,te/]7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,agriculture1 ,nutrition1 & ,=e/ry ,a ,,bill ,to provide = ! regulation1 inspection1 & label+ ( food produc$ us+ animal cell culture te*nology1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,food ,safety ,mod]nization = ,innovative ,te*nologies ,act4 #b4 ,regulation ( food produc$ us+ animal cell culture te*nology ,*apt] ,,iv ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq47 is am5d$ by add+ at ! end ! foll[+3 #dbd4 ,food produc$ us+ animal cell culture te*nology 7a7 ,9 g5]al ,! ,secret>y %all regulate food int5d$ = humans t is produc$ us+ animal cell culture te*nology d]iv$ f cell l9es ( animals o!r ?an live/ock or p\ltry &1 9 coord9ation ) ! ,secret>y ( ,agriculture1 food int5d$ = humans t is produc$ us+ animal cell culture te*nology d]iv$ f cell l9es ( live/ock or p\ltry4 7b7 ,duties ,pursuant to subsection 7a71 ! ,secret>y %all-- 7#a7 conduct prem>ket consultation processes to evaluate production mat]ials1 processes1 & manufactur+ controls ) respect to food int5d$ = humans t is produc$ us+ animal cell culture te*nology1 d]iv$ f cell l9es ( live/ock or p\ltry & food int5d$ = humans t is produc$ us+ animal cell culture te*nology1 d]iv$ f cell l9es ( animals o!r ?an live/ock or p\ltry1 includ+ ov]sight ( tissue collection1 cell l9es1 cell banks1 & all compon5ts & inputs2 7#b7 ov]see initial cell collection & ! developm5t & ma9t5ance ( qualifi$ cell banks1 includ+ by issu+ regulations or guidance & conduct+ inspections1 z appropriate2 7#c7 ov]see prolif]ation & diff]5tiation ( cells ?r\gh ! "t ( cell h>ve/1 includ+ by issu+ regulations or guidance & conduct+ inspections1 z appropriate2 7#d7 ensure t cell bank & cell cultur+ facilities comply ) facility regi/ration1 applicable good manufactur+ practices & prev5tive controls1 & requirem5ts applicable to sub/ances t become a compon5t ( food or o!rwise affect ! *>act]i/ics ( food2 7#e7 develop pursuant to notice & comm5t rulemak+ additional requirem5ts = cell bank & cell cultur+ facility conditions & processes to ensure t biological mat]ial exit+ ! culture process is safe & n adult]at$ )9 ! mean+ ( ?is *apt]2 7#f7 conduct appropriate inspections & foll[-up activities1 includ+ tak+ en=cem5t action if necess>y1 to ensure t cell bank & cell-cultur+ facilities are 9 compliance ) applicable laws & regulations2 7#g7 coord9ate ! transf] ( regulatory ov]sight ( h>ve/$ cells d]iv$ f live/ock or p\ltry to ! ,secret>y ( ! ,dep>tm5t ( ,agriculture dur+ cell h>ve/1 includ+ provid+ su* ,secret>y ) any in=mation necess>y to det]m9e :e!r h>ve/$ cells are eligible to be process$ into food int5d$ = humans t is produc$ us+ animal cell culture te*nology1 d]iv$ f cell l9es ( live/ock or p\ltry2 7#h7 inspect e/abli%m5ts t process1 package1 & label food int5d$ = humans t is produc$ us+ animal cell culture te*nology1 d]iv$ f cell l9es o!r ?an live/ock or p\ltry2 7#i7 promulgate regulations reg>d+ ! safety & accurate label+ ( food int5d$ = humans t is produc$ us+ animal cell culture te*nology1 d]iv$ f cell l9es o!r ?an live/ock or p\ltry2 & 7#aj7 e/abli% appropriate nom5clature = food int5d$ = humans t is produc$ us+ animal cell culture te*nology1 d]iv$ f cell l9es o!r ?an live/ock or p\ltry4 7c7 ,collaboration ) ,,usda ,9 c>ry+ out ?is section1 ! ,secret>y %all %>e in=mation1 z appropriate1 ) ! ,dep>tm5t ( ,agriculture1 includ+ notify+ ! ,dep>tm5t ( ,agriculture if objectionable conditions are id5tifi$ at a facility c>ry+ out any ( ! activities describ$ 9 subsection 7b71 includ+ conditions :i* may result 9 production ( adult]at$ or misbr&$ food1 collaborat+ ) su* dep>tm5t to address su* conditions ) respect to ! h>ve/+ ( cell cultures1 & rely on ! ,dep>tm5t ( ,agriculture to address su* conditions ) respect to process+1 packag+1 & label+4 7d7 ,limitation ,! ,secret>y %all n inspect activities ( an e/abli%m5t t are solely regulat$ by ! ,secret>y ( ,agriculture4 7e7 ,def9itions ,9 ?is section-- 7#a7 ! t]m live/ock means cattle1 %eep1 sw9e1 goats1 & fi% ( ! ord] ,siluri=mes2 & 7#b7 ! t]m p\ltry means any dome/icat$ bird1 :e!r live or dead4 7f7 ,au?orities relat$ to live/ock & p\ltry ,not)/&+ any o!r provision ( law1 ! provisions ( ?is section %all n d]ogate f any au?ority "u ! ,f$]al ,meat ,inspection ,act or ,p\ltry ,product ,inspection ,act1 z 9 effect on ! date ( enactm5t ( ! ,food ,safety ,mod]nization = ,innovative ,te*nologies ,act1 ) respect to ! regulation ( meat & p\ltry produc$ 9 ! traditional mann]4 7g7 ,no inspection ( f>ms ,no?+ 9 ?is section %all be con/ru$ to au?orize ! ,secret>y to conduct an inspection ( a f>m4 4 #c4 ,inspection & label+ ( food produc$ us+ animal cell culture te*nology f live/ock & p\ltry cell l9es 7a7 ,def9itions ,9 ?is section3 7#a7 ,adult]at$ ,! t]m adult]at$1 ) respect to food int5d$ = humans t is produc$ us+ animal cell culture te*nology1 d]iv$ f cell l9es ( live/ock or p\ltry1 means food-- 7,a7 t be>s or conta9s any poison\s or delet]i\s sub/ance :i* may r5d] x injuri\s to heal?1 except t ! food %all n be consid]$ adult]at$ if ! sub/ance is n an add$ sub/ance & ! quantity ( ! sub/ance 9 ! food does n ord9>ily r5d] ! food injuri\s to heal?2 7,b7 7i7 t be>s or conta9s any add$ poison\s or add$ delet]i\s sub/ance 7o!r ?an a sub/ance t is a pe/icide *emical residue 9 or on a raw agricultural commodity or process$ food1 a food additive1 or a color additive7 t is unsafe )9 ! mean+ ( section #djf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cdf72 7ii7 t be>s or conta9s a pe/icide *emical residue t is unsafe )9 ! mean+ ( section #djh7;a7 ( t ,act 7#ba ,u4,s4,c4 #cdf;a7a772 or 7iii7 t be>s or conta9s-- 7,i7 any food additive t is unsafe )9 ! mean+ ( section #dji ( t ,act 7#ba ,u4,s4,c4 #cdh72 or 7,,ii7 a new animal drug 7or conv]sion product !re(7 t is unsafe )9 ! mean+ ( section #eab ( t ,act 7#ba ,u4,s4,c4 #cfj;b72 7,c7 t consi/s 9 :ole or 9 "p ( any fil?y1 putrid1 or decompos$ sub/ance1 or if ! food is o!rwise unfit = food2 7,d7 t has be5 prep>$1 pack$1 or held "u insanit>y conditions :]eby x may h become contam9at$ ) fil? or r5d]$ injuri\s to heal?2 7,e7 t1 9 :ole or 9 "p1 is ! product ( a diseas$ animal or ( an animal :i* has di$ o!rwise ?an by slaught]2 7,f7 ! conta9] ( :i* is compos$1 9 :ole or 9 "p1 ( any poison\s or delet]i\s sub/ance :i* may r5d] ! cont5ts injuri\s to heal?2 7,g7 t has be5 int5tionally subject$ to radiation1 unless ! use ( ! radiation 0 9 con=mity ) a regulation or exemption 9 effect pursuant to section #dji ( t ,act 7#ba ,u4,s4,c4 #cdh72 7,h7 7i7 ( :i* any valuable con/itu5t has be5 9 :ole or 9 "p omitt$ or ab/ract$ !refrom2 7ii7 = :i* any sub/ance has be5 sub/itut$ 9 :ole or 9 "p2 7iii7 = :i* damage or inf]iority has be5 conceal$ 9 any mann]2 or 7iv7 to :i* any sub/ance has be5 add$ or mix$ or pack$ s z to increase ! bulk or weight ( ! food1 r$uce ! quality or /r5g? ( ! food1 or make ! food appe> bett] or ( great] value ?an ! food is2 7,i7 t be>s or conta9s a color additive :i* is unsafe )9 ! mean+ ( section #gba7;a7 ( t ,act 7#ba ,u4,s4,c4 #cgi;e7a772 or 7,j7 t is transport$ or (f]$ = transport by a %ipp]1 c>ri] by motor vehicle or rail vehicle1 receiv]1 or any o!r p]son engag$ 9 ! transportation ( food "u conditions t are n 9 compliance ) regulations promulgat$ "u section #daf ( t ,act 7#ba ,u4,s4,c4 #cej;e74 7#b7 ,live/ock ,! t]m live/ock has ! mean+ giv5 ! t]m 9 section #dbd7;e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7#c7 ,misbr&$ ,! t]m misbr&$1 ) respect to food int5d$ = humans t is produc$ us+ animal cell culture te*nology1 d]iv$ f cell l9es ( live/ock or p\ltry1 means food-- 7,a7 ! label ( :i*-- 7i7 does n be>-- 7,i7 ! "n ( ! food1 9 accordance ) subsection 7c72 7,,ii7 9 ! case ( ! food be+ fabricat$ f #b or m +r$i5ts1 ! common or usual "n ( ea* +r$i5t1 except t spices1 flavor+s1 & color+s may1 :5 au?oriz$ by ! appropriate ag5cy head1 be designat$ z spices1 flavor+s1 & color+s )\t nam+ ea*1 provid$ t to ! ext5t t compliance is impracticable1 or results 9 deception or unfair competition1 exemptions %all be e/abli%$ by regulations promulgat$ by ! ,secret>y2 or 7,,iii7 an (ficial inspection leg5d directly on ! food or on ! conta9] ( ! food & su* o!r in=mation z ! ,secret>y requires to assure t ! food w n h false or mislead+ label+ & t ! public w be in=m$ ( ! mann] ( h&l+ requir$ to ma9ta9 ! food 9 a :olesome condition2 7,b7 ! label ( :i* is false or mislead+2 7,c7 t is 9 a package or o!r conta9] ! label ( :i* does n be>-- 7i7 ! "n & place ( bus9ess ( ! manufactur]1 pack]1 or di/ributor2 or 7ii7 an accurate /atem5t ( ! quantity ( ! cont5ts 9 t]ms ( weight1 measure1 or num]ical c\nt1 subject to-- 7,i7 reasonable v>iations p]mitt$ by ! ,secret>y2 & 7,,ii7 9 ! case ( a small package or conta9]1 exemptions e/abli%$ by ! ,secret>y by regulation2 7,d7 = :i* any ^w1 /atem5t1 or o!r in=mation requir$ by ! ,secret>y to appe> on ! label is n prom95tly plac$ on ! label ) su* conspicu\sness 7comp>$ to any o!r words1 /atem5ts1 designs1 or devices on ! label7 & 9 su* t]ms z to r5d] x likely to be read & und]/ood by ! ord9>y individual "u cu/om>y conditions ( pur*ase & use2 7,e7 t is (f]$ = sale "u ! "n ( ano!r food2 7,f7 t is an imitation ( ano!r food1 unless ! label be>s ! ^w imitation1 9 type ( uni=m size & prom95ce1 & ! "n ( ! food imitat$ imm$iately aft] ! ^w imitation2 7,g7 ! conta9] ( :i* is made1 =m$1 or fill$ z to be mislead+2 7,h7 t purports to be or is repres5t$ = special diet>y uses b ! label ( :i* does n be> su* in=mation conc]n+ ! vitam91 m9]al1 & o!r diet>y prop]ties ( ! food z ! ,secret>y1 aft] consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 det]m9es to be1 & by regulations prescribes z1 necess>y 9 ord] to in=m pur*as]s fully ( ! value ( ! food = ^? uses2 or 7,i7 t be>s or conta9s any artificial flavor+1 artificial color+1 or *emical pres]vative b ! label ( :i* does n /ate t fact1 subject to exemptions e/abli%$ by ! ,secret>y by regulation 9 cases ( compliance be+ impracticable4 7#d7 ,(ficial inspection leg5d ,! t]m (ficial inspection leg5d means ! symbol describ$ 9 subsection 7b77#b74 7#e7 ,p\ltry ,! t]m p\ltry has ! mean+ giv5 ! t]m 9 section #dbd7;e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7#f7 ,secret>y ,! t]m ,secret>y means ! ,secret>y ( ,agriculture4 7b7 ,inspections 7#a7 ,9 g5]al ,! ,secret>y %all inspect e/abli%m5ts t process1 package1 & label food int5d$ = humans t is produc$ us+ animal cell culture te*nology1 d]iv$ f cell l9es ( live/ock or p\ltry-- 7,a7 to ensure t-- 7i7 ! food is-- 7,i7 n adult]at$2 & 7,,ii7 n misbr&$2 & 7ii7 ! e/abli%m5t is op]at+ 9 accordance ) ! regulations promulgat$ "u p>agraph 7#c74 7#b7 ,(ficial inspection leg5d ,! ,secret>y %all e/abli% an (ficial inspection leg5d = ! food describ$ 9 p>agraph 7#a71 :i* %all be a symbol t %[s t a product made f t food 0 inspect$ & pass$ 9 accordance ) ! regulations describ$ 9 p>agraph 7#c74 7#c7 ,regulations ,! ,secret>y %all promulgate regulations reg>d+-- 7,a7 ! mann] & frequ5cy ( inspections requir$ =-- 7i7 ! food describ$ 9 p>agraph 7#a72 & 7ii7 e/abli%m5ts t process1 package1 & label t food2 & 7,b7 ! requirem5ts = a product ( ! food describ$ 9 p>agraph 7#a7 to satisfactorily pass an inspection & receive an (ficial inspection leg5d1 includ+-- 7i7 sanitation & physical product inspection requirem5ts2 7ii7 food product te/+ & recordkeep+ requirem5ts2 & 7iii7 ! requirem5t = ,haz>d ,analysis & ,critical ,control ,po9ts v]ification4 7#d7 ,limitation ,! ,secret>y %all n inspect activities ( an e/abli%m5t "u section #dbd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act t are solely regulat$ by ! ,secret>y ( ,heal? & ,human ,s]vices4 7c7 ,label+ 7#a7 ,9 g5]al ,! ,secret>y %all-- 7,a7 approve1 be=e introduction into comm]ce1 ! label+ ( food int5d$ = humans t is produc$ us+ animal cell culture te*nology1 d]iv$ f cell l9es ( live/ock or p\ltry2 & 7,b7 v]ify ! accuracy ( t label+ ?r\gh inspection4 7#b7 ,requirem5ts ,! ,secret>y %all e/abli%1 aft] provid+ notice & an opportunity = comm5t1 any appropriate requirem5ts 9 addition to ! requirem5ts "u p>agraph 7#a7 to ensure ! safety & accurate label+ ( ! food describ$ 9 p>agraph 7#a77;,a74 7#c7 ,regulations ,! ,secret>y %all promulgate regulations-- 7,a7 to e/abli% appropriate nom5clature = ! label+ approv$ "u p>agraph 7#a77;,a72 & 7,b7 to c>ry out p>agraph 7#a77;,b74 7d7 ,en=cem5t ,! ,secret>y %all1 pursuant to relevant en=cem5t au?orities gov]n+ ! regulation ( am5able species 7z def9$ 9 section #a ( ! ,f$]al ,meat ,inspection ,act 7#ba ,u4,s4,c4 #fja771 conduct su* en=cem5t action z is necess>y to ensure t food int5d$ = humans t is produc$ us+ animal cell culture te*nology1 d]iv$ f cell l9es ( live/ock or p\ltry1 t is adult]at$ or misbr&$ does n ent] or is remov$ f comm]ce4 7e7 ,collaboration ) ,,hhs ,9 c>ry+ out ?is section1 ! ,secret>y %all-- 7#a7 review in=mation %>$ by ! ,secret>y ( ,heal? & ,human ,s]vices "u section #dbd7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7#b7 %>e appropriate in=mation relat+ to food int5d$ = humans t is produc$ us+ animal cell culture te*nology1 d]iv$ f cell l9es ( live/ock or p\ltry1 ) ! ,secret>y ( ,heal? & ,human ,s]vices1 z appropriate2 & 7#c7 7,a7 notify ! ,secret>y ( ,heal? & ,human ,s]vices if objectionable conditions at an e/abli%m5t are id5tifi$ "u an inspection "u subsection 7b77#a72 7,b7 collaborate ) ! ,secret>y ( ,heal? & ,human ,s]vices to address ^? conditions ) respect to cell h>ve/+2 & 7,c7 rely on ! ,secret>y ( ,heal? & ,human ,s]vices to address ^? conditions ) respect to initial cell collection1 developm5t & ma9t5ance ( qualifi$ cell banks1 & prolif]ation & diff]5tiation ( cells4