,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #ebgi ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,decemb] #c1 #bjai,mr4 ,pallone introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to improve cosmetic safety1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,title ,i--,cosmetic ,safety ,sec4 #aja4 ,regi/ration ( cosmetics facilities & cosmetic +r$i5t /atem5ts4 ,sec4 #ajb4 ,review ( +r$i5ts & nonfunctional con/itu5ts2 safety ( f9i%$ products4 ,sec4 #ajc4 ,good manufactur+ practices = cosmetics4 ,sec4 #ajd4 ,adv]se ev5t reports4 ,sec4 #aje4 ,records inspection2 m&atory recall au?ority4 ,sec4 #ajf4 ,label+ & int]net sales4 ,sec4 #ajg4 ,consum] in=mation4 ,sec4 #ajh4 ,small bus9esses4 ,sec4 #aji4 ,animal te/+ re/rictions4 ,sec4 #aaj4 ,c\nt]feit cosmetics4 ,sec4 #aaa4 ,=eign suppli] v]ification4 ,sec4 #aab4 ,applicability ) respect to c]ta9 cosmetics4 ,sec4 #aac4 ,sav+ clause4 ,sec4 #aad4 ,en=cem5t4 ,title ,,ii--,fees ,relat$ to ,cosmetic ,products ,sec4 #bja4 ,f9d+s4 ,sec4 #bjb4 ,au?ority to assess & use cosmetic product fees4 ,sec4 #bjc4 ,direct hir+ au?ority to support activities relat$ to cosmetics4 ,sec4 #bjd4 ,sunset dates4 ,i ,cosmetic ,safety #aja4 ,regi/ration ( cosmetics facilities & cosmetic +r$i5t /atem5ts ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq47 is am5d$ by add+ at ! end ! foll[+3 #fjd4 ,def9itions ,9 ?is *apt]3 7#a7 ,animal te/ ,! t]m animal te/ means ! int]nal or ext]nal application or exposure ( a cosmetic product1 cosmetic =mulation1 or cosmetic +r$i5t to ! sk91 eyes1 or o!r body "p ( a live non-human v]tebrate = ! purpose ( evaluat+ ! safety ( a cosmetic product1 cosmetic =mulation1 or cosmetic +r$i5t4 7#b7 ,contract manufactur] ,! t]m contract manufactur] means a manufactur] 7includ+ ! own]1 op]ator1 or ag5t 9 *>ge 7or any affiliate !re(77 ( a cosmetic +r$i5t1 cosmetic =mulation1 or cosmetic product t does n sell any su* cosmetic +r$i5t1 cosmetic =mulation1 or cosmetic product unless !re is a specific contractual agreem5t 9 place ) respect to t sale4 7#c7 ,cosmetic =mulation ,! t]m cosmetic =mulation means a prep>ation ( cosmetic raw mat]ials ) a qualitatively & quantitatively set composition4 7#d7 ,cosmetic +r$i5t ,! t]m cosmetic +r$i5t means any s+le *emical entity or mixture us$ z a compon5t 9 ! manufacture ( a f9i%$ cosmetic product or cosmetic =mulation4 7#e7 ,cosmetic product 7,a7 ,! t]m cosmetic product means a f9i%$ cosmetic compris$ ( a specifi$ set ( cosmetic +r$i5ts1 :i* may come 9 a range ( possible am\nts = ea* cosmetic +r$i5t & :i* may include a v>iety ( fragrances & colors1 & 9 "s specific cosmetic applications1 flavors4 7,b7 ,su* t]m %all include tattoo ink :e!r or n label$ z a f9i%$ cosmetic4 7#f7 ,facility ,! t]m facility includes any factory1 w>eh\se1 or e/abli%m5t 7includ+ a factory1 w>eh\se1 or e/abli%m5t ( an import] or ( any o!r entity ^: "n & address appe> on ! label ( a cosmetic product7 t manufactures1 processes1 packs1 or holds cosmetic products or cosmetic =mulations4 ,su* t]m does n include-- 7,a7 beauty %ops & salons t d n o!rwise manufacture1 process1 or package cosmetic products or cosmetic =mulations at t location1 includ+ beauty /ores or c\nt]s t (f] cu/omiz$ or p]sonaliz$ cosmetic products or cosmetic =mulations tailor$ to individual consum]s = sale solely 9-p]son2 7,b7 cosmetic product retail]s1 includ+ individual sales repres5tatives1 direct sell]s 7z def9$ 9 section #cejh ( ! ,int]nal ,rev5ue ,code ( #aihf71 retail di/ribution facilities1 retail fran*ises1 retail w>eh\ses1 & ph>macies1 t d n o!rwise manufacture1 process1 or package cosmetic products or cosmetic =mulations at t location2 7,c7 entities t manufacture or comp\nd cosmetic products solely = use 9 rese>*1 tea*+1 or pilot plant production & n = sale2 7,d7 hospitals1 physicians' (fices1 & heal? c>e cl9ics2 7,e7 hotels1 airl9es1 & o!r entities t provide complim5t>y cosmetic products to gue/s2 7,f7 public heal? ag5cies & o!r nonpr(it entities t provide cosmetic products or cosmetic =mulations directly to ! consum]2 or 7,g7 trade %[s & o!r v5ues :]e cosmetic product samples are provid$ free ( *>ge4 7#g7 ,=eign facility ,! t]m =eign facility means a facility t manufactures1 processes1 packs1 or holds1 cosmetic products or cosmetic =mulations t are export$ to ! ,unit$ ,/ates )\t fur!r process+ or packag+ inside ! ,unit$ ,/ates4 ,a cosmetic product or cosmetic =mulation is n consid]$ to h und]gone fur!r process+ or packag+ = purposes ( ?is def9ition solely on ! basis t label+ 0 add$ or t any simil> activity ( a de m9imis nature 0 c>ri$ out ) respect to ! cosmetic product or cosmetic =mulation4 7#h7 ,nonfunctional con/itu5t ,! t]m nonfunctional con/itu5t means any sub/ance t is an incid5tal compon5t ( an +r$i5t1 a breakd[n product ( an +r$i5t1 or a byproduct ( ! manufactur+ process t has n be5 int5tionally add$ z a sep>ate sub/ance & s]ves no te*nical function 9 ! cosmetic product4 7#i7 ,pr(essional ,) respect to a cosmetic product1 ! t]m pr(essional means-- 7,a7 a d]matologi/ or o!r heal? c>e pr(essional t adm9i/]s or provides cosmetic products to pati5ts2 or 7,b7 a cosmetologi/1 nail te*nician1 b>b]1 or e/hetician :o adm9i/]s or provides cosmetics )9 ! scope ( _! bus9ess practices4 7#aj7 ,pr(essional use ,) respect to a cosmetic product1 ! t]m pr(essional use means a prep>ation ( a cosmetic =mulation int5d$ only = use by pr(essionals 9 sett+s su* z cosmetology1 nail c>e1 b>b]+1 e/hetics1 heal? c>e1 & o!r pr(essions z det]m9$ by ! ,secret>y ?r\gh regulation4 7#aa7 ,responsible p]son ,! t]m responsible p]son means ! br& own]1 op]ator1 or ag5t 9 *>ge :o is ! dome/ic or =eign manufactur]1 processor1 or entity ^: "n appe>s on ! label ( a cosmetic product or a cosmetic =mulation di/ribut$ 9 ! ,unit$ ,/ates4 #fje4 ,regi/ration ( cosmetic facilities 7a7 ,regi/ration = manufactur+ & process+ facilities 7#a7 ,9 g5]al ,! own]1 op]ator1 or ag5t 9 *>ge ( 7or an affiliate !re(7 a facility engag$ 9 manufactur+1 or process+1 ( a cosmetic product or a cosmetic =mulation di/ribut$ 9 ! ,unit$ ,/ates %all regi/] ) ! ,secret>y4 7#b7 ,electronic regi/ration sy/em ,! ,secret>y %all-- 7,a7 ma9ta9 an electronic regi/ration sy/em = purposes ( ?is section2 & 7,b7 n lat] ?an "o ye> aft] ! date ( enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai1 ann\nce t su* sy/em is op]ational4 7#c7 ,initial regi/ration ( exi/+ facilities ,n lat] ?an ! date t is #f mon?s aft] ! date ( ! ann\ncem5t requir$ by p>agraph 7#b77;,b71 ea* facility engag$ 9 an activity describ$ 9 p>agraph 7#a7 %all be regi/]$ "u su* p>agraph4 7#d7 ,initial regi/ration ( new facilities ,9 ! case ( a facility t fir/ engages 9 an activity describ$ 9 p>agraph 7#a7 on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai1 su* a facility %all regi/] ) ! ,secret>y imm$iately ^u engag+ 9 su* activity4 7#e7 ,s+le regi/ration ,! ,secret>y %all require only a s+le regi/ration p] regi/ration p]iod = a facility requir$ to be regi/]$ "u p>agraph 7#a71 reg>dless ( :e!r su* facility is manufactur+ or process+-- 7,a7 its own cosmetic products or cosmetic =mulations2 or 7,b7 cosmetic products or cosmetic =mulations on behalf ( m ?an "o own]1 op]ator1 or ag5t 9 *>ge 7or affiliate !re(74 7b7 ,regi/ration = pack+ or hold+ facilities ,ea* facility engag$ 9 pack+ or hold+ a cosmetic product or cosmetic =mulation di/ribut$ 9 ! ,unit$ ,/ates %all regi/] ) ! ,food & ,drug ,adm9i/ration4 ,ea* su* facility %all1 n lat] ?an #f mon?s aft] ! ,secret>y ann\nces ! e/abli%m5t ( an electronic regi/ration sy/em = purposes ( ?is section1 submit a regi/ration utiliz+ su* sy/em4 7c7 ,annual regi/ration r5ewal ,a facility t cont9ues to engage 9 any activity t w\ld require regi/ration "u subsection 7a7 or 7b7 %all submit to ! ,secret>y an annual regi/ration dur+ ! fir/ qu>t] ( ! fiscal ye> = :i* su* r5ew$ regi/ration %all be effective4 7d7 ,fees ,if ! av]age gross annual sales ( cosmetic products 9 ! ,unit$ ,/ates ( all ( ! facilities ( ! responsible p]son regi/]$ "u subsection 7a77#a7 = ! previ\s #c-;fiscal-ye> p]iod is great] ?an #a1jjj1jjj1 a regi/ration %all n be complete "u ?is subsection until ! responsible p]son has paid any regi/ration fee requir$ "u section #gdd,m4 7e7 ,*anges to in=mation ,a facility t submitt$ a regi/ration "u ?is section %all notify ! ,secret>y ( any *ange to ! in=mation requir$ "u subsection 7a7 or 7b7 n lat] ?an #cj days aft] ! date ( su* *ange1 unless o!rwise specifi$ by ! ,secret>y4 7f7 ,=mat2 cont5ts 7#a7 ,electronic =mat ,ea* regi/ration %all be submitt$ us+ an electronic =mat1 z specifi$ 9 a regi/ration =m provid$ by ! ,secret>y4 7#b7 ,cont5ts ,! regi/ration %all conta9 ! foll[+ in=mation3 7,a7 ,ea* facility's "n 7includ+ any p>5t company ( ! facility7 & full address1 id5tify+ ! precise physical location ( ! facility4 7,b7 ,! id5tity ( ! facility1 includ+ ! unique facility id5tifi]1 if any1 previ\sly assign$ by ! ,secret>y to ! facility "u subsection 7i74 7,c7 ,all bus9ess trad+ names us$ by ! facility4 7,d7 ,! product category 7z id5tifi$ "u section #gbj4d7;c7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation771 or o!r cosmetic categories z det]m9$ appropriate by ! ,secret>y 7includ+ by guidance7 ( ea* cosmetic product or cosmetic =mulation manufactur$1 process$1 pack$1 or held at ! facility or on ^: label ! facility's "n & address appe>4 7,e7 ,! type or types ( activities conduct$ at ! facility 7su* z manufactur+1 process+1 pack+1 or hold+74 7,f7 ,! "n1 title1 /reet address1 telephone numb]1 & electronic contact in=mation ( ! em]g5cy contact = ! facility4 7,g7 ,9 ! case ( a =eign facility1 ! "n1 /reet address1 telephone numb]1 em]g5cy contact in=mation = ! facility1 ! "n ( ! ,unit$ ,/ates ag5t = ! facility1 & ! phone numb] & electronic contact in=mation ( ! ,unit$ ,/ates ag5t4 7,h7 ,! "n1 title1 /reet address1 telephone numb]1 & electronic contact in=mation ( ! individual submitt+ ! regi/ration4 7,i7 ,an assurance t ! ,secret>y w be p]mitt$ to inspect su* facility at ! times & 9 ! mann] p]mitt$ by ?is ,act4 7,j7 ,additional in=mation p]ta9+ to ! facility or to ! cosmetic products or cosmetic =mulations manufactur$1 process$1 pack$1 or held at ! facility1 or on ^: label ! facility's "n & address appe>1 includ+ all br& names kn[n to consum]s1 z ! ,secret>y may require by regulation4 7#c7 ,abbreviat$ regi/ration ,! ,secret>y %all provide = an abbreviat$ regi/ration r5ewal process = any facility t has n _h any *anges to ! in=mation submitt$ by ! facility = ! prec$+ regi/ration4 7g7 ,incomplete or inaccurate regi/ration 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! ,secret>y may cancel a regi/ration ( a facility "u ?is section if-- 7,a7 ! ,secret>y has reasonable gr\nds to believe t ! regi/ration 0 n prop]ly complet$ or updat$ 9 accordance ) ?is section2 7,b7 a requir$ regi/ration fee has n be5 paid )9 #cj days2 or 7,c7 ! regi/ration o!rwise conta9s false1 incomplete1 or inaccurate in=mation4 7#b7 ,notification ,! ,secret>y %all1 at lea/ #aj days be=e cancel+ a regi/ration pursuant to p>agraph 7#a71 provide notice to ! facility ( ! int5t ( ! ,secret>y to cancel su* regi/ration t conta9s ! ,secret>y's basis = ! det]m9ation to s cancel ! regi/ration4 7#c7 ,timely update or correction ,if1 n lat] ?an #g days aft] receipt ( a notice ( int5t to cancel "u p>agraph 7#b71 ! facility corrects ! regi/ration 9 accordance ) ! basis = ! cancellation1 & ! requir$ regi/ration fee1 if any1 is paid1 ! ,secret>y %all n cancel su* regi/ration4 7h7 ,unique id5tifi] ,at ! "t ( ! initial regi/ration ( any cosmetic facility "u ?is section1 ! ,secret>y %all assign a unique id5tifi] to ! facility & provide su* id5tifi] to su* facility 9 writ+4 7i7 ,regi/ry ( facilities 7#a7 ,9 g5]al ,! ,secret>y %all compile1 ma9ta91 & update a regi/ry ( facilities t are regi/]$ "u ?is section1 & %all remove f su* regi/ry ! "n ( any facility ^: regi/ration "u ?is section is cancell$4 ,! regi/ry %all be publicly available4 7#b7 ,public availability exceptions ,in=mation d]iv$ f ! regi/ry or regi/ration docum5ts t discloses ! resid5tial address ( an own]1 op]ator1 or ag5t 9 *>ge ( 7or an affiliate !re(7 a facility engag$ 9 manufactur+1 process+1 pack+1 or hold+ a cosmetic product or =mulation1 or a facility own$ by su* p]son1 or t discloses specific facilities :]e specific br&s ( cosmetic products are manufactur$ or process$ %all n be subject to disclosure "u section #eeb ( title #e1 ,unit$ ,/ates ,code4 #fjf4 ,cosmetic +r$i5t /atem5ts 7a7 ,9 g5]al ,= ea* cosmetic product1 ! responsible p]son %all submit to ! ,secret>y a cosmetic +r$i5t /atem5t1 at su* "t & 9 su* mann] z ! ,secret>y may prescribe4 ,! cosmetic +r$i5t /atem5t %all n become effective until ! responsible p]son pays any applicable fee requir$ "u section #gdd,m4 7b7 ,submission ( a cosmetic +r$i5t /atem5t 7#a7 ,exi/+ cosmetic products ,9 ! case ( a cosmetic product or cosmetic =mulation t is m>ket$ on ! date ( enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai1 ! responsible p]son %all-- 7,a7 n lat] ?an ! date t is #f mon?s aft] ! date ( ! ann\ncem5t ( an electronic regi/ration sy/em requir$ by section #fje1 submit to ! ,secret>y a cosmetic +r$i5t /atem5t 9 accordance ) ?is section2 & 7,b7 beg9n+ "o ye> aft] ! +r$i5t /atem5t is submitt$ "u subp>agraph 7,a7 & ea* ye> !reaft]1 submit to ! ,secret>y a r5ewal ( su* /atem5t1 consi/5t ) ! requirem5ts 9 subsection 7e71 dur+ ! fir/ qu>t] ( ! fiscal ye> = :i* su* r5ew$ /atem5t is applicable4 7#b7 ,cosmetic +r$i5t /atem5t = new cosmetic products 7,a7 ,9 g5]al ,except z provid$ "u subp>agraph 7,b71 9 ! case ( a cosmetic product or cosmetic =mulation t is fir/ m>ket$ aft] ! date ( enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai or a cosmetic product or cosmetic =mulation t is re=mulat$ aft] su* date ( enactm5t1 ! responsible p]son %all-- 7i7 submit to ! ,secret>y a cosmetic +r$i5t /atem5t prior to fir/ m>ket+ ! new cosmetic product1 new cosmetic =mulation1 or ! re=mulat$ cosmetic product or re=mulat$ cosmetic =mulation2 & 7ii7 beg9n+ "o ye> aft] ! +r$i5t /atem5t is submitt$ "u clause 7i71 submit to ! ,secret>y annually !reaft] a r5ewal ( su* /atem5t dur+ ! fir/ qu>t] ( ! fiscal ye> = :i* ! cosmetic +r$i5t /atem5t is applicable1 consi/5t ) ! requirem5ts 9 subsection 7e74 7,b7 ,small bus9esses ,9 ! case ( a responsible p]son t is a small bus9ess1 ! ,secret>y %all all[ su* responsible p]son to h an additional "t p]iod1 ( a duration to be det]m9$ by ! ,secret>y1 9 :i* to submit ! fir/ cosmetic +r$i5t /atem5t "u subp>agraph 7,a74 ,su* responsible p]son %all1 consi/5t ) ! requirem5ts 9 subsection 7e71 submit a cosmetic +r$i5t /atem5t annually !reaft] dur+ ! fir/ qu>t] ( ! applicable fiscal ye>4 7,c7 ,applicability ,9 apply+ subp>agraph 7,a71 a cosmetic product or cosmetic =mulation %all n be consid]$ to be fir/ m>ket$ or re=mulat$ aft] ! date ( enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai if ! only *ange 9 su* product or =mulation is-- 7i7 a *ange 9 ! am\nt ( an exi/+ +r$i5t t is previ\sly report$ "u subsection 7c77#b77;,e72 or 7ii7 ! addition or subtraction ( a fragrance1 flavor1 or color1 or su* o!r int]*angeable +r$i5ts specifi$ by ! ,secret>y 9 regulations or guidance1 previ\sly report$ z a pot5tial +r$i5t "u subsection 7c77#b74 7#c7 ,abbreviat$ r5ewal ,! ,secret>y %all provide = an abbreviat$ process = ! r5ewal ( any cosmetic +r$i5t /atem5t "u ?is subsection ) respect to :i* !re has be5 no *ange s9ce ! responsible p]son submitt$ ! previ\s /atem5t4 7c7 ,=mat2 cont5ts 7#a7 ,=m ,= ea* cosmetic +r$i5t /atem5t submitt$ ) respect to a cosmetic product or cosmetic =mulation "u ?is section1 su* /atem5t %all be submitt$ us+ an electronic =mat1 9 a =m specifi$ by ! ,secret>y4 7#b7 ,cont5ts ,ea* su* cosmetic +r$i5t /atem5t %all include ! foll[+ in=mation3 7,a7 ,! unique id5tifi]1 assign$ "u section #fje7;h71 z applicable1 (-- 7i7 ! facility or facilities :]e ! cosmetic product or cosmetic =mulation is manufactur$1 process$1 pack$1 or held or1 if ! same cosmetic product or cosmetic =mulation is manufactur$1 process$1 pack$1 or held 9 m ?an "o facility1 ! unique facility id5tifi] ( ea* facility :]e x is manufactur$1 process$1 pack$1 or held2 & 7ii7 ! facility ^: "n & address appe> on ! label1 unless ! /atem5t is fil$ by a contract manufactur]1 describ$ 9 section #fjd7f77;,b74 7,b7 ,! br& "n & ! full "n = ! cosmetic product or cosmetic =mulation z x appe>s on ! label4 7,c7 ,! li/+ numb]1 if any1 previ\sly assign$ by ! ,secret>y "u subsection 7f7 to ! cosmetic product or cosmetic =mulation4 7,d7 ,! applicable cosmetic category = ! cosmetic product or cosmetic =mulation4 7,e7 ,a li/ ( +r$i5ts 9 ! cosmetic product or cosmetic =mulation t-- 7i7 ) respect to ea* su* +r$i5t1 ! "n adopt$ 9 regulations promulgat$ by ! ,secret>y1 if any1 or by ! common or usual "n ( ! +r$i5t2 7ii7 is consi/5t ) ! regulations promulgat$ by ! ,food & ,drug ,adm9i/ration relat$ to cosmetic label+ requirem5ts2 & 7iii7 conta9s a li/ ( fragrances1 flavors1 & colors t may be includ$ 9 ! product1 int]*angeably1 :i* %all include-- 7,i7 9 ! case ( fragrances1 ea* fragrance all]g5 conta9$ 9 ! cosmetic product z describ$ 9 section #fae1 & = fragrances t are pur*as$ f a fragrance suppli]1 ! fragrances %all be id5tifi$ by ! "n or code provid$ by ! suppli]1 & include ! "n & contact in=mation = ! fragrance suppli]2 & 7,,ii7 9 ! case ( flavors t are pur*as$ f a flavor suppli]1 ! flavors %all be id5tifi$ by ! "n or code provid$ by ! suppli]1 & include ! "n & contact in=mation = ! flavor suppli]2 7iv7 o!r appropriate int]*angeable +r$i5ts z ! ,secret>y may specify 9 regulations or guidance t may be includ$ 9 ! product2 & 7v7 9 ! case ( an +r$i5t 7o!r ?an a fragrance1 flavor1 or color7 t has be5 designat$ = review "u section #fjh1 includes pot5tial ranges & am\nts ( su* +r$i5t4 7,f7 ,! title & full contact in=mation ( ea* individual submitt+ ! /atem5t4 7,g7 ,if applicable1 in=mation on label+ requir$ "u section #fad4 7,h7 ,su* additional in=mation p]ta9+ to ! cosmetic product z ! ,secret>y may require by regulation4 7#c7 ,confid5tiality ,fragrance +r$i5ts includ$ 9 a cosmetic +r$i5t /atem5t "u p>agraph 7#b77;,e71 o!r ?an fragrance all]g5s1 %all be treat$ z confid5tial comm]cial or trade secret in=mation4 7#d7 ,contract manufactur+ organization facilities ,if a facility manufactures or processes cosmetic products or cosmetic =mulations on behalf ( an own]1 op]ator1 or ag5t 9 *>ge ^: "n appe>s on ! label ( su* products or =mulations1 ! ,secret>y %all require only a s+le cosmetic +r$i5t /atem5t = su* cosmetic product4 ,su* s+le cosmetic +r$i5t /atem5t %all be submitt$ to ! ,secret>y by ! responsible p]son4 7#e7 ,cosmetic +r$i5t /atem5t = c]ta9 small bus9esses 7,a7 ,9 ,g5]al ,not)/&+ any o!r provision ( ?is subsection1 9 ! case ( a responsible p]son t has _h an av]age ( less ?an #a1jjj1jjj 9 annual dome/ic cosmetic sales ov] ! previ\s #c ye>s1 ! ,secret>y may all[ su* responsible p]son-- 7i7 to submit a simplifi$ cosmetic +r$i5t /atem5t "u ?is section2 & 7ii7 an additional "t p]iod1 ( a duration to be det]m9$ by ! ,secret>y1 9 :i* to submit su* simplifi$ cosmetic +r$i5t /atem5t4 7,b7 ,cont5ts ,a responsible p]son describ$ 9 subp>agraph 7,a7 %all include 9 ea* cosmetic +r$i5t /atem5t submitt$ "u ?is section1 at a m9imum-- 7i7 a li/ ( +r$i5ts 9 ! cosmetic product or cosmetic =mulation1 includ+ any fragrance all]g5s z describ$ 9 section #fae2 7ii7 ! applicable cosmetic category = ! cosmetic product or cosmetic =mulation2 & 7iii7 9 ! case ( a cosmetic product or cosmetic =mulation t includes a fragrance or flavor pur*as$ f a fragrance or flavor suppli]1 ! contact in=mation = ! fragrance or flavor suppli]1 includ+ ! suppli]'s "n1 /reet address1 telephone numb]1 & electronic contact in=mation4 7d7 ,incomplete or inaccurate cosmetic +r$i5t /atem5t 7#a7 ,9 g5]al ,n e>li] ?an #cj days aft] provid+ notice "u p>agraph 7#b7 & subject to p>agraph 7#c71 ! ,secret>y may nullify a cosmetic +r$i5t /atem5t submitt$ "u ?is section if ! ,secret>y has reasonable gr\nds to believe t1 except = m9or or immat]ial errors1 ! cosmetic +r$i5t /atem5t 0 n complet$ or updat$ 9 accordance ) ?is section or o!rwise conta9s false1 incomplete1 or inaccurate in=mation4 7#b7 ,notice ( nullification ,if ! ,secret>y nullifies a cosmetic +r$i5t /atem5t "u p>agraph 7#a71 ! ,secret>y %all provide to ! responsible p]son submitt+ su* cosmetic +r$i5t /atem5t "u ?is section notice ( any su* nullification1 includ+ ! basis = su* nullification4 7#c7 ,timely update or correction ,9 ! case ( a cosmetic +r$i5t /atem5t ) respect to :i* ! ,secret>y has provid$ notice "u p>agraph 7#b71 ! ,secret>y %all n nullify su* cosmetic +r$i5t /atem5t if ! cosmetic +r$i5t /atem5t is appropriately updat$ or correct$ n lat] ?an #aj days aft] ! date on :i* su* notice is provid$4 7#d7 ,effect ( nullification ,no p]son %all import1 export1 or o!rwise di/ribute any cosmetic product or cosmetic =mulation t is ! subject ( a cosmetic +r$i5t /atem5t t is nullifi$ "u ?is subsection4 7e7 ,additional requirem5ts 7#a7 ,safety requirem5ts ,9 submitt+ a cosmetic +r$i5t /atem5t = ea* cosmetic product or cosmetic =mulation "u ?is section1 a responsible p]son %all include an atte/ation t ! safety ( ! product or =mulation1 includ+ ! individual +r$i5ts ( su* product or =mulation1 has be5 sub/antiat$ 9 accordance ) section #fji4 7#b7 ,*anges to in=mation ,n lat] ?an #ij days aft] any *ange to ! in=mation requir$ to be 9 a cosmetic +r$i5t /atem5t "u ?is section1 ! responsible p]son %all notify ! ,secret>y ( su* *ange1 includ+ ! discont9uation ( ! manufacture ( a cosmetic product4 ,su* notification is n requir$ = a *ange describ$ 9 subsection 7b77#b77;,c74 7f7 ,cosmetic products li/ 7#a7 ,li/+ numb] ,at ! "t ( ! initial submission ( any cosmetic +r$i5t /atem5t "u ?is section1 ! ,secret>y %all-- 7,a7 assign a unique cosmetic product li/+ numb] to ! cosmetic +r$i5t /atem5t2 & 7,b7 provide su* numb] to ! responsible p]son :o submitt$ su* /atem5t 9 writ+4 7#b7 ,cosmetic products li/ ,us+ cosmetic +r$i5t /atem5ts submitt$ "u ?is section1 ! ,secret>y %all-- 7,a7 compile & ma9ta9 a li/ ( cosmetic products or cosmetic =mulations di/ribut$ 9 ! ,unit$ ,/ates1 includ+ ! +r$i5ts ( ea* su* product or =mulation2 & 7,b7 ^u reque/ ( any ,/ate1 %all make su* li/ available to su* ,/ate4 7#c7 ,confid5tiality ,in=mation disclos$ to a ,/ate t is exempt f disclosure "u section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 %all be treat$ z a trade secret & confid5tial in=mation by ! ,/ate4 ,su* ,/ate & its employees 9 possession ( su* in=mation %all be subject to ! same laws gov]n+ in=mation disclosure z employees ( ! ,food & ,drug ,adm9i/ration4 7g7 ,exemption ,a responsible p]son %all be exempt f ! requirem5ts ( ?is section if su* p]son has _h an av]age ( less ?an #ejj1jjj 9 annual dome/ic cosmetic product sales ov] ! previ\s ?ree ye>s4 ,su* exemption %all n apply to cosmetic products t are int5d$ to be inject$ "u ! sk9 or into ! eye1 includ+ tattoo ink1 or +r$i5ts select$ by ! ,food & ,drug ,adm9i/ration = review "u section #fjh if su* +r$i5t is includ$ 9 a cosmetic product or cosmetic =mulation di/ribut$ by su* p]son describ$4 #fjg4 ,susp5sion ( regi/ration or cosmetic +r$i5t /atem5t 7a7 ,susp5sion ( regi/ration ( a facility ,if ! ,secret>y det]m9es t a cosmetic product or cosmetic =mulation manufactur$1 process$1 pack$1 or held by a facility regi/]$ "u section #fje has a reasonable probability ( caus+ s]i\s adv]se heal? consequ5ces or dea? to humans1 ! ,secret>y may susp5d ! regi/ration ( su* facility4 7b7 ,susp5sion ( cosmetic +r$i5t /atem5t ,if ! ,secret>y det]m9es t a cosmetic product or cosmetic =mulation manufactur$ 9 a regi/]$ facility has a reasonable probability ( caus+ s]i\s adv]se heal? consequ5ces or dea? to humans1 ! ,secret>y may susp5d ! cosmetic +r$i5t /atem5t ( t product or =mulation4 7c7 ,notice ( susp5sion ,be=e susp5d+ ! regi/ration ( a facility or a cosmetic +r$i5t /atem5t "u ?is section1 ! ,secret>y %all provide-- 7#a7 notice to ! facility or responsible p]son1 z appropriate1 ( ! int5t to susp5d su* regi/ration or ! cosmetic +r$i5t /atem5t1 :i* %all specify ! basis ( ! det]m9ation by ! ,secret>y = t susp5sion2 & 7#b7 an opportunity1 )9 #b bus9ess days ( ! notice provid$ "u p>agraph 7#a71 = ! facility or responsible p]son t is ! subject ( su* notice1 z appropriate1 to address ! reasons = possible susp5sion ( ! regi/ration ( ! facility or cosmetic +r$i5t /atem5t4 7d7 ,re9/atem5t ,^u a det]m9ation by ! ,secret>y t adequate gr\nds d n exi/ to cont9ue ! susp5sion actions "u subsection 7a7 or 7b71 ! ,secret>y %all promptly vacate ! susp5sion & re9/ate ! regi/ration ( ! facility or ! cosmetic +r$i5t /atem5t4 7e7 ,effect ( susp5sion ,if ! regi/ration ( a facility is susp5d$ "u ?is section1 no p]son %all import or export cosmetics or o!rwise di/ribute cosmetic products or cosmetic =mulations f su* facility4 7f7 ,no delegation ,! au?ority conf]r$ by ?is section to issue an ord] to susp5d a regi/ration or vacate an ord] ( susp5sion %all n be delegat$ to any (fic] or employee o!r ?an ! ,commission]4 4 #ajb4 ,review ( +r$i5ts & nonfunctional con/itu5ts2 safety ( f9i%$ products 7a7 ,am5dm5ts ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #aja1 is fur!r am5d$ by add+ at ! end ! foll[+3 #fjh4 ,review ( +r$i5ts & nonfunctional con/itu5ts 7a7 ,+r$i5ts & nonfunctional con/itu5ts subject ,to review 7#a7 ,9 g5]al ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai1 ! ,secret>y %all review ! safety ( cosmetic +r$i5ts or nonfunctional con/itu5ts 7or categories !re(74 ,^u ! completion ( su* review1 ! ,secret>y %all issue an ord] "u subsection 7d7 ) respect to ! use ( ea* su* +r$i5t 7or a category !re(7 & pres5ce ( ea* su* nonfunctional con/itu5t 9 cosmetic products or cosmetic =mulations 7or a category !re(74 7#b7 ,+r$i5ts & nonfunctional con/itu5ts to be review$ ,! ,secret>y %all select & complete a review1 on an ongo+ basis1 ( cosmetic +r$i5ts or nonfunctional con/itu5ts t 7 n review$ 9 ! prior #c ye>s4 ,su* +r$i5ts or nonfunctional con/itu5ts1 includ+ any classes ( +r$i5ts or nonfunctional con/itu5ts1 %\ld be select$ aft] consultation ) /akehold]s1 includ+ indu/ry & consum] gr\ps4 7#c7 ,process = review ,! ,secret>y %all-- 7,a7 publi% 9 ! ,f$]al ,regi/] a li/ ( ! +r$i5ts1 nonfunctional con/itu5ts 7or categories !re(7 id5tifi$ = review "u p>agraph 7#b72 & 7,b7 op5 a public docket to solicit public input & data relevant to ! safety ( ! +r$i5ts1 nonfunctional con/itu5ts 7or classes or categories !re(7 s li/$ = a p]iod ( n less ?an #fj days4 7#d7 ,public comm5t ,comm5ts may be submitt$ to ! ,secret>y at any "t ) respect to ! safety ( cosmetic +r$i5ts or nonfunctional con/itu5ts 7or categories !re(71 reg>dless ( :e!r su* +r$i5ts or con/itu5ts 7or categories !re(7 h be5 select$ = review "u ?is subsection4 7b7 ,review$ +r$i5ts & nonfunctional con/itu5ts ,! ,secret>y %all ma9ta9 a li/1 po/$ on ! int]net website ( ! ,food & ,drug ,adm9i/ration1 ( ea* cosmetic +r$i5t1 nonfunctional con/itu5t1 & category ( +r$i5ts or nonfunctional con/itu5ts = :i* f9al ord]s h be5 issu$ "u subsection 7d77#c71 & ) respect to ea* su* +r$i5t or nonfunctional con/itu5t-- 7#a7 ! f9d+ made = ea* su* +r$i5t1 nonfunctional con/itu5t1 or category "u subsection 7d77#d71 z modifi$ by any ord] "u subsection 7e72 & 7#b7 if applicable1 compliance dates t are ! subject ( a f9al ord] "u subsection 7d77#c74 7c7 ,initiative ( ! ,,fda ,! ,secret>y may1 at any "t1 propose ! issuance ( an ord] on ! safety ( a cosmetic +r$i5t or nonfunctional con/itu5t 7or category !re(7 t 0 n previ\sly li/$ pursuant to subsection 7a74 7d7 ,det]m9ation on safety 7#a7 ,propos$ adm9i/rative ord] ,foll[+ consid]ation ( data & comm5ts to ! public docket op5$ "u subsection 7a77#c7 & any o!r in=mation be=e ! ,secret>y ) respect to ! safety ( a cosmetic +r$i5t or nonfunctional con/itu5t 7or category !re(71 ! ,secret>y %all-- 7,a7 det]m9e :e!r !re is adequate evid5ce to make an initial f9d+ = purposes ( mak+ a det]m9ation describ$ 9 p>agraph 7#d72 7,b7 if ! ,secret>y det]m9es t !re is adequate evid5ce to make su* a f9d+1 issue a propos$ adm9i/rative ord] conta9+ ! ,secret>y's initial det]m9ation on ! safety ( su* +r$i5t or nonfunctional con/itu5t 7or category !re(7 z describ$ 9 p>agraph 7#d7 & %all po/ su* ord] on ! int]net website ( ! ,food & ,drug ,adm9i/ration1 not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code2 & 7,c7 9 ! case ( a propos$ adm9i/rative ord] 9 :i* ! ,secret>y makes a det]m9ation describ$ 9 subp>agraph 7,b7 or 7,c7 ( p>agraph 7#d71 include 9 su* ord] a compliance date4 7#b7 ,public comm5t ,! ,secret>y %all op5 a public docket = ! submission ( public comm5ts 7includ+ comm5ts on :e!r any propos$ compliance date includ$ 9 su* ord] is feasible7-- 7,a7 9 ! case ( a propos$ adm9i/rative ord] "u p>agraph 7#a71 = a p]iod ( n less ?an #fj days1 beg9n+ on ! date ( ! issuance ( ! ord]2 or 7,b7 9 ! case ( a f9al adm9i/rative ord] "u p>agraph 7#c71 = a p]iod ( n less ?an #fj days1 beg9n+ on ! date t is at lea/ #fj days be=e ! effective date ( ! ord]4 7#c7 ,f9al adm9i/rative ord] ,foll[+ ! public comm5t p]iod "u p>agraph 7#b7 & consid]ation ( comm5ts to ! public docket "u su* p>agraph & any o!r in=mation be=e ! ,secret>y1 ! ,secret>y %all-- 7,a7 det]m9e :e!r !re is adequate evid5ce to make an initial f9d+ = purposes ( mak+ a det]m9ation describ$ 9 p>agraph 7#d72 7,b7 if ! ,secret>y det]m9es t !re is adequate evid5ce to make su* a f9al f9d+1 ! ,secret>y %all issue a f9al adm9i/rative ord] & %all po/ su* ord] on ! int]net website ( ! ,food & ,drug ,adm9i/ration1 not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code2 & 7,c7 9 ! case ( a f9al adm9i/rative ord] 9 :i* ! ,secret>y makes ! det]m9ation describ$ 9 subp>agraph 7,b7 or 7,c7 ( p>agraph 7#d71 include 9 su* ord] a compliance date4 7#d7 ,det]m9ations ,9 a propos$ adm9i/rative ord] issu$ "u p>agraph 7#a7 or a f9al adm9i/rative ord] issu$ "u p>agraph 7#c71 z applicable1 ! ,secret>y %all make a det]m9ation t ! +r$i5t or nonfunctional con/itu5t is-- 7,a7 safe 9 cosmetic products )\t ! ne$ = specifi$ conditions ( use or tol]ances2 7,b7 safe 9 cosmetic products "u specifi$ conditions ( use or tol]ances2 or 7,c7 n safe 9 cosmetic products4 7#e7 ,conditions ( use & tol]ances ,an ord] "u p>agraph 7#d77;,b7 %all include su* conditions on ! use ( an +r$i5t or su* tol]ances on ! pres5ce ( a nonfunctional con/itu5t 7or category !re(7 z are necess>y = ! safety ( cosmetic products conta9+ su* +r$i5t or nonfunctional con/itu5t 7or category !re(71 includ+-- 7,a7 limits on ! am\nt or conc5tration ( ! +r$i5t or nonfunctional con/itu5t 7or category !re(7 t may be pres5t 9 a cosmetic product1 includ+ limits 9 products int5d$ = *ildr51 pregnant wom51 & o!r vuln]able populations1 & limits on use ne> ! eye or mucosal membranes2 7,b7 w>n+s t are necess>y or appropriate "u section #fad1 includ+ w>n+s relat$ to use by *ildr51 pregnant wom51 populations ) high exposure to ! +r$i5t 7su* z work]s :o are expos$ ?r\gh production practices or h&l+ ( f9al products71 or o!r vuln]able populations1 to help ensure safe use ( cosmetic products conta9+ ! +r$i5t or nonfunctional con/itu5t 7or a category !re(72 & 7,c7 su* o!r conditions z are necess>y = ! safety ( cosmetic products conta9+ su* +r$i5t or nonfunctional con/itu5t 7or category !re(74 7#f7 ,cont5ts ( ord] ,a f9al adm9i/rative ord] "u ?is subsection %all-- 7,a7 set =? ! det]m9ation ( ! ,secret>y on safety2 7,b7 include a summ>y ( ! valid sci5tific evid5ce support+ ! det]m9ation2 7,c7 include any conditions ( use or tol]ances "u p>agraph 7#d77;,b72 & 7,d7 be effective ^u its publication on ! int]net website ( ! ,food & ,drug ,adm9i/ration & %all be consid]$ f9al ag5cy action unless a lat] compliance date is o!rwise specifi$4 7e7 ,modification ( an ord] ,an ord] issu$ "u subsection 7d7 may be modifi$ or revok$ by ! ,secret>y on ! initiative ( ! ,secret>y or 9 response to a petition4 7f7 ,inadequate evid5ce 7#a7 ,notice2 ,ext5sion ,if ! ,secret>y det]m9es t available data & in=mation are n adequate to make a propos$ or f9al det]m9ation "u subsection 7d71 ) respect to ! safety ( a cosmetic +r$i5t or nonfunctional con/itu5t 7or a category !re(71 ! ,secret>y %all-- 7,a7 publi% su* det]m9ation on ! int]net website ( ! ,food & ,drug ,adm9i/ration n lat] ?an #ahj days aft] ! close ( ! relevant comm5t p]iod = ! +r$i5t or nonfunctional con/itu5t 7or category !re(7 "u p>agraph 7#b7 or 7#c7 ( subsection 7d71 z applicable2 & 7,b7 include 9 su* publication a notice provid+ int]e/$ p]sons an additional #cj days f ! date on :i* ! notice is publi%$ to provide additional data & in=mation & an opportunity = a meet+ pursuant to p>agraph 7#b74 7#b7 ,meet+s ,! ,secret>y may (f] a responsible p]son ( su* cosmetic +r$i5t or nonfunctional con/itu5t 7or category !re(7 a confid5tial meet+ ) respect to a f9d+ "u p>agraph 7#a71 to discuss matt]s relat+ to ! data & in=mation requirem5ts to support a det]m9ation ( safety ( su* +r$i5t or nonfunctional con/itu5t 7or category !re(71 :i* may involve confid5tial in=mation4 ,su* meet+ %\ld be conv5$ 9 a reasonable "t p]iod agre$ ^u betwe5 ! responsible p]son & ! ,secret>y4 7#c7 ,det]m9ation2 ,ord] 7,a7 ,inadequate data & in=mation ,if ! ,secret>y det]m9es t ! available data & in=mation are n adequate to make a propos$ or f9al det]m9ation "u subsection 7d7 ) respect to ! safety ( a cosmetic +r$i5t or nonfunctional con/itu5t 7or category !re(71 ! ,secret>y %all-- 7i7 publi% su* f9d+ on ! int]net website ( ! ,food & ,drug ,adm9i/ration n lat] ?an #ahj days aft] ! close ( ! relevant comm5t p]iod = ! +r$i5t or nonfunctional con/itu5t 7or category !re(7 "u p>agraph 7#b7 or 7#c7 ( subsection 7d71 z applicable2 & 7ii7 include 9 su* publication a notice provid+ int]e/$ p]sons an additional #cj days f ! date on :i* ! notice is publi%$ to provide additional data & in=mation & an opportunity = a meet+ pursuant to p>agraph 7#b74 7,b7 ,adequate data & in=mation ,if ! ,secret>y det]m9es1 aft] consid]+ any additional data & in=mation submitt$ pursuant to p>agraph 7#a77;,b71 t ! available data & in=mation are adequate to make a det]m9ation ) respect to ! safety ( a cosmetic +r$i5t or nonfunctional con/itu5t 7or category !re(71 ! ,secret>y %all-- 7i7 9 ! case ( a det]m9ation describ$ 9 subp>agraph 7,a7 ( subsection 7d77#d71 )9 #ahj days ( ! close ( ! applicable comm5t p]iod "u subsection 7d77#b71 issue a f9al adm9i/rative ord]1 ) respect to su* cosmetic +r$i5t or nonfunctional con/itu5t 7or category !re(71 9 accordance ) subsection 7d77#c72 7ii7 9 ! case ( a det]m9ation describ$ 9 subp>agraph 7,b7 ( subsection 7d77#d71 )9 #ahj days ( ! close ( ! applicable comm5t p]iod "u subsection 7d77#b71 issue a propos$ adm9i/rative ord]1 foll[$ by a f9al adm9i/rative ord]1 ) respect to su* cosmetic +r$i5t or nonfunctional con/itu5t 7or category !re(71 9 accordance ) subsection 7d77#c72 & 7iii7 9 ! case ( a det]m9ation describ$ 9 subp>agraph 7,c7 ( subsection 7d77#d71 )9 #ahj days ( ! close ( ! applicable comm5t p]iod "u subsection 7d77#b71 issue a f9al adm9i/rative ord]1 ) respect to su* cosmetic +r$i5t or nonfunctional con/itu5t 7or category !re(71 9 accordance ) subsection 7d77#c7 specify+ ! date by :i* sale ( su* +r$i5t or nonfunctional con/itu5t mu/ cease4 7g7 ,safety assessm5t /&>ds 7#a7 ,9 g5]al ,9 assess+ ! safety ( an +r$i5t or nonfunctional con/itu5t 7or category !re(7 "u ?is section1 ! ,secret>y %all consid]-- 7,a7 :e!r !re is adequate evid5ce to support a reasonable c]ta9ty among compet5t sci5ti/s t-- 7i7 9 ! case ( a cosmetic +r$i5t1 ! +r$i5t is n h>mful "u ! recomm5d$ or sugge/$ conditions ( use or cu/om>y or usual use2 or 7ii7 9 ! case ( a nonfunctional con/itu5t1 t ! nonfunctional con/itu5t is n h>mful "u ! recomm5d$ or sugge/$ tol]ance levels or ! level at :i* x is cu/om>ily or usually pres5t2 7,b7 ! probable human exposure to ! +r$i5t or nonfunctional con/itu5t 7or category !re(7 f expect$ use 9 cosmetic products & cosmetic =mulations2 7,c7 ! probable cumulative & aggregate effect 9 humans ( relevant exposure to ! +r$i5t or nonfunctional con/itu5t 7or category !re(7 or to any *emically or ph>macologically relat$ sub/ances f use 9 cosmetics or o!r products ) simil> r\tes ( exposure "u recomm5d$ or sugge/$ conditions ( use or _! cu/om>y use1 to ! ext5t adequate data are available = analysis1 & if appropriate1 available in=mation on ! total exposure to a cosmetic +r$i5t or nonfunctional con/itu5t f all s\rces2 & 7,d7 :e!r w>n+s or recomm5dations 9 a cosmetic product label1 z "p ( any conditions ( use or tol]ances impos$ by ! ,secret>y 9 a det]m9ation describ$ 9 subp>agraph 7,b7 ( subsection 7d77#d71 w\ld be necess>y & appropriate to help ensure ! safety ( ! +r$i5t or nonfunctional con/itu5t 7or category !re(74 7#b7 ,m9or adv]se reactions ,! ,secret>y may n consid] a cosmetic +r$i5t or nonfunctional con/itu5t 7or category !re(7 h>mful "u p>agraph 7#a7 solely because x c cause m9or adv]se heal? reactions1 su* z m9or transi5t all]gic reactions or m9or transi5t sk9 irritations1 9 "s us]s4 7#c7 ,data & in=mation 7,a7 ,requir$ in=mation ,a det]m9ation t a cosmetic +r$i5t or nonfunctional con/itu5t 7or category !re(7 is safe 9 cosmetics "u ?is section %all be bas$ ^u adequate evid5ce submitt$ or o!rwise kn[n to ! ,secret>y1 :i* %all include full reports ( all available /udies1 publi%$ or unpubli%$1 t are adequately design$ to %[ :e!r ! +r$i5t or nonfunctional con/itu5t is safe4 ,su* /udies may include 9 vitro & 9 silico /udies & epidemiological /udies1 biomonitor+ /udies1 & /udies focus$ on v>i\s po9ts dur+ ! lifespan ( ! subject1 t use sci5tifically valid me?odology4 7,b7 ,additional relevant in=mation ,! ,secret>y %all consid] any o!r relevant in=mation relat$ to ! safety ( a cosmetic +r$i5t or nonfunctional con/itu5t 7or category !re(71 includ+-- 7i7 adv]se ev5t reports2 7ii7 f9d+s & in=mation f ,/ate1 ,f$]al1 national1 & int]national entities & o!r bodies compos$ ( sci5tific & m$ical exp]ts2 7iii7 if ! +r$i5t or nonfunctional con/itu5t 7or category !re(7 is lawfully us$ or pres5t 9 o!r products regulat$ by ! ,secret>y1 ! sci5tific basis = su* use2 & 7iv7 exp]i5ce ) ! +r$i5t or nonfunctional con/itu5t 7or category !re(7 9 products t are di/ribut$ 9 ! ,unit$ ,/ates or 9 o!r c\ntries1 if su* exp]i5ce is well-docum5t$ & has result$ 9 sub/antial human exposure to ! +r$i5t or nonfunctional con/itu5t ov] "t4 7h7 ,coal t> hair dye ,9 assess+ = purposes ( ?is section ! safety ( coal t> hair dye or any +r$i5t or nonfunctional con/itu5t !re91 ! ,secret>y %all n make a det]m9ation t ! dye1 +r$i5t1 or nonfunctional con/itu5t is n safe = use 9 cosmetic products solely because ! dye1 +r$i5t1 or nonfunctional con/itu5t c cause all]gic reactions4 #fji4 ,safety ( f9i%$ cosmetic products 7a7 ,det]m9ation 7#a7 ,9 g5]al ,ea* responsible p]son = a f9i%$ cosmetic product %all1 be=e fir/ di/ribut+ ! product = sale1 make a writt5 det]m9ation t ! product is safe "u ! conditions ( use recomm5d$ 9 ! label+ ( ! product4 ,su* det]m9ation %all be bas$ on adequate evid5ce t-- 7,a7 ea* +r$i5t 9 ! f9i%$ product is safe = ! use recomm5d$ or sugge/$ 9 ! label+ ( ! product & = ! cu/om>y or usual use ( ! product2 & 7,b7 ! f9i%$ product is safe4 7#b7 ,new in=mation ,if new in=mation relevant to ! det]m9ation becomes available1 ! responsible p]son %all promptly update ! det]m9ation to address t in=mation4 7b7 ,presumption ( adequate evid5ce 7#a7 ,9 g5]al ,except z provid$ 9 subsection 7c71 a det]m9ation made "u subsection 7a7 ) respect to a f9i%$ cosmetic product %all be presum$ to be bas$ on adequate evid5ce if x is support$ by-- 7,a7 ) respect to ea* +r$i5t 9 ! f9i%$ cosmetic product-- 7i7 ref]5ces to an (ficial /atem5t by "o or m exp]t m$ical or sci5tific bodies t ! +r$i5t is safe "u ! conditions ( use recomm5d$ or sugge/$ 9 ! product's label+ or "u su* conditions ( use z are cu/om>y or usual2 or 7ii7 appropriate safety te/+ ( ! +r$i5t2 & 7,b7 appropriate safety sub/antiation ( ! f9i%$ cosmetic product beyond ! safety sub/antiation ( individual +r$i5ts & consid]ation ( ! comb9ation ( +r$i5ts4 7#b7 ,/atem5t ( an exp]t m$ical or sci5tific body ,= purposes ( apply+ p>agraph 7#a77;,a77i71 a /atem5t ( an exp]t m$ical or sci5tific body is an (ficial /atem5t ( t body1 if-- 7,a7 ! m$ical or sci5tific body is a ,f$]al1 ,/ate1 national1 or int]national entity ) recogniz$ exp]tise 9 *emical or cosmetic safety1 or o!r simil>ly recogniz$ body compos$ ( sci5tific & m$ical exp]ts2 7,b7 ! /atem5t is bas$ ^u adequate data to support ! f9d+ ( safety1 & su* data are available to ! ,secret>y2 & 7,c7 ! /atem5t is publi%$ & endors$ by ! m$ical or sci5tific body & is n a /atem5t ( an employee ( su* body made 9 ! individual capacity ( ! employee4 7c7 ,rebuttal ( presumption ,n)/&+ subsection 7b71 a det]m9ation "u subsection 7a7 w n be presum$ to be bas$ on adequate evid5ce if-- 7#a7 ! ,secret>y issues an ord] "u section #fjh t an +r$i5t or nonfunctional con/itu5t 9 ! f9i%$ product is n safe "u ! product's conditions ( use or cu/om>y or usual use2 or 7#b7 ! ,secret>y has provid$ ! manufactur] ) notice t-- 7,a7 ! manufactur] has n met ! crit]ia "u subsection 7b72 or 7,b7 ! ,secret>y has in=mation t raises significant que/ions ab\t ! safety ( ! product or any ( its +r$i5ts4 7d7 ,timely update ,^u notice ( inadequate evid5ce "u subsection 7c71 ! responsible p]son %all h #aj days to submit additional evid5ce to ! ,secret>y reg>d+ ! safety ( an +r$i5t1 nonfunctional con/itu5t1 or ! entire cosmetic product1 & ! ,secret>y %all h #cj days f ! date ( receipt ( su* additional evid5ce to provide ! responsible p]son ) notice t ! crit]ia "u subsection 7b7 h be5 met or n met4 7e7 ,records ma9t5ance ,! responsible p]son %all ma9ta9 records docum5t+ ! det]m9ation requir$ "u ?is section & ! in=mation on :i* x is bas$ until #e ye>s aft] ! f9i%$ product is no long] m>ket$4 7f7 ,submission ( records 7#a7 ,9 g5]al ,! records requir$ "u subsection 7e7 %all1 ^u ! writt5 reque/ ( ! ,secret>y to ! responsible p]son1 be provid$ to ! ,secret>y )9 a reasonable timeframe n to exce$ #cj days1 9 electronic =m4 7#b7 ,crit]ia ,! ,secret>y may require records "u p>agraph 7#a7 if-- 7,a7 ! ,secret>y has a reasonable belief1 describ$ 9 writt5 notice1 t-- 7i7 ! f9i%$ product may be h>mful bas$ on adv]se ev5t reports or o!r sci5tific in=mation2 7ii7 sci5tific in=mation raises cr$ible & relevant que/ions ab\t ! safety ( ! product or any ( its +r$i5ts2 7iii7 ! det]m9ation requir$ "u subsection 7a7 is n support$ by adequate evid5ce2 or 7iv7 "o or m ( ! crit]ia to e/abli% a presumption ( adequate evid5ce ( safety 9 subsection 7b7 has n be5 satisfi$2 7,b7 ! ,secret>y1 an exp]t regulatory body1 or an exp]t body compos$ ( sci5tific & m$ical exp]ts f9ds an +r$i5t 9 ! product to be unsafe "u ! conditions ( use ( ! product2 or 7,c7 ! ,secret>y concludes t submission ( ! records w s]ve ! public heal? or o!rwise enable ! ,secret>y to fulfill ! cosmetic safety purposes ( ?is section4 7g7 ,guidance & regulations 7#a7 ,9 g5]al ,! ,secret>y %all issue guidance describ+ ! evid5ce necess>y to support a det]m9ation "u subsection 7a71 & may1 by regulation1 e/abli% exemptions to ! requirem5ts ( ?is section1 if ! ,secret>y det]m9es t su* exemptions are support$ by adequate evid5ce & w\ld h no adv]se effect on public heal?4 7#b7 ,small bus9esses ,! ,secret>y %all1 aft] consultation ) ! ,small ,bus9ess ,adm9i/ration & small bus9esses t manufacture cosmetics1 provide additional guidance = small bus9esses on compliance ) ! requirem5ts ( ?is section4 ,su* guidance %all include specific examples ( options = compliance t d n place an undue burd5 on small bus9esses4 4 7b7 ,effective date ,section #fji ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 %all take effect #ahj days aft] ! date ( enactm5t ( ?is ,act4 7c7 ,public meet+ & guidance 7#a7 ,public meet+ ,n lat] ?an #ab mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is subsection ref]r$ to z ! ,secret>y7 %all conv5e a public meet+ to describe & solicit public input reg>d+ ! +r$i5t review process "u section #fjh ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a774 ,su* meet+ %all include repres5tatives f ! cosmetics indu/ry1 m$ical practition]s & sci5tific exp]ts ) cosmetic exp]tise1 & consum] & public heal? advocacy organizations4 7#b7 ,guidance ,n less ?an "o ye> aft] ! public meet+ conduct$ "u p>agraph 7#a71 ! ,secret>y %all issue "o or m guidance docum5ts to implem5t section #fjh ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a774 ,su* guidance docum5ts %all include in=mation reg>d+-- 7,a7 ! types ( sci5tific evid5ce1 cl9ical /udies1 data1 or o!r in=mation ne$$ to support ! review ( cosmetic +r$i5ts or nonfunctional con/itu5ts 7or categories !re(7 select$ = review "u su* section2 7,b7 ! recomm5d$ =mat 9 :i* to submit to ! ,secret>y su* data & in=mation1 includ+ any applicable =eign data & in=mation1 relat$ to a cosmetic +r$i5t or nonfunctional con/itu5t 7or category !re(7 t has be5 select$ = su* review2 7,c7 ! mann] & ! numb] ( days by :i* ! ,secret>y int5ds to review & respond to su* data & in=mation1 includ+ ) respect to provid+ a sci5tific rationale = any additional data & in=mation2 7,d7 ! process = communication betwe5 ! ,secret>y & indu/ry relat$ to an +r$i5t or nonfunctional con/itu5t 7or a category !re(7 t has be5 select$ = review2 & 7,e7 includes su* o!r in=mation z ! ,secret>y det]m9es appropriate4 7#c7 ,tim+ ,n lat] ?an #bd mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all issue draft guidance "u p>agraph 7#a7 on ! implem5tation ( section #fjh ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a774 ,! ,secret>y %all issue f9al guidance on ! implem5tation ( su* section n lat] ?an #f mon?s aft] ! date on :i* ! comm5t p]iod = ! draft guidance closes4 7d7 ,,gao /udy ,n lat] ?an #f ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report address+ ! effectiv5ess & ov]all impact ( ! +r$i5t review program e/abli%$ "u section #fjh ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a771 includ+ ) respect to its impact on ! safety ( cosmetic +r$i5ts-- 7#a7 = ea* +r$i5t or nonfunctional con/itu5t 7or category !re(7 select$ = review-- 7,a7 :e!r ! +r$i5t or nonfunctional con/itu5t 7or category !re(7 0 det]m9$-- 7i7 to be safe 9 cosmetic products )\t ! ne$ = specifi$ conditions ( use or tol]ances2 7ii7 to be safe 9 cosmetic products "u specifi$ conditions ( use ( tol]ances2 or 7iii7 to be n safe 9 cosmetic products2 7,b7 ! timel9e = su* review2 7,c7 ! types ( sci5tific evid5ce1 cl9ical /udies1 data1 or o!r in=mation us$ to make su* a det]m9ation2 7,d7 :e!r1 & to :at ext5t1 ! review ( ! +r$i5t or nonfunctional con/itu5t 7or category !re(7 result$ 9 cosmetic products be+ re=mulat$ or remov$ f ! m>ket2 & 7,e7 ! impact ! review & det]m9ation _h on consum] use & access to su* product2 & 7#b7 an analysis ( ! +r$i5t1 nonfunctional con/itu5t 7or category !re(7 review conduct$ "u su* section #fjh1 includ+-- 7,a7 ! res\rces us$ by ! ,secret>y 9 review+ +r$i5ts & nonfunctional con/itu5ts 7or categories !re(71 includ+ ! effects ( ! program on o!r cosmetic safety activities ( ! ,secret>y2 7,b7 ! impact ( su* section on innovation & consum] access to cosmetic products2 & 7,c7 :e!r any improvem5ts to ! program "u su* section #fjh are necess>y = increas+ ! effici5cy & effectiv5ess ( ! review ( cosmetic +r$i5ts1 nonfunctional con/itu5ts1 or categories !re(4 #ajc4 ,good manufactur+ practices = cosmetics 7a7 ,9 g5]al ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #ajb1 is fur!r am5d$ by add+ at ! end ! foll[+3 #faj4 ,good manufactur+ practices = cosmetics 7a7 ,9 g5]al ,! ,secret>y %all-- 7#a7 review national & int]national /&>ds = cosmetic good manufactur+ practices t are 9 effect on ! date ( enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai2 & 7#b7 issue a rule e/abli%+ curr5t good manufactur+ /&>ds consi/5t1 to ! ext5t ! ,secret>y det]m9es practicable & appropriate1 ) su* national & int]national /&>ds4 7b7 ,cont5t ( regulations ,! regulations issu$ pursuant to subsection 7a77#b7-- 7#a7 may specify requirem5ts = ! use ( c]ta9 analytical or recordkeep+ me?ods by a manufactur] z may be necess>y to ensure t a cosmetic product or cosmetic =mulation is n injuri\s to heal? "u ! recomm5d$ or sugge/$ conditions ( use1 or cu/om>y or usual use ( ! product or =mulation2 & 7#b7 %all n-- 7,a7 impose /&>ds = :i* !re is no curr5t & g5]ally available analytic me?od2 or 7,b7 apply to facilities meet+ ! crit]ia to be consid]$ a facility "u section #fjd7f71 includ+ retail /ores or c\nt]s (f]+ cu/omiz$ or p]sonaliz$ cosmetics to consum]s1 or to entities t are 9 compliance ) ! good manufactur+ practice regulations specifi$ 9 p>ts #baj & #baa ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7c7 ,timeframe ,! ,secret>y %all publi% a propos$ rule describ$ 9 subsection 7a7 n lat] ?an #bd mon?s aft] ! date ( enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai & %all publi% a f9al su* rule n lat] ?an #cf mon?s aft] su* date ( enactm5t4 4 7b7 ,effective date = cosmetic manufactur]s ,regulations issu$ pursuant to section #faj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a77 %all apply ) respect to-- 7#a7 l>ge manufactur]s 7z def9$ 9 section #gdd,l ( su* ,act 7z add$ by section #bjb ( ?is ,act771 beg9n+ #ahj days aft] ! date on :i* ! f9al rule describ$ 9 subsection 7a7 is effective2 7#b7 midsize manufactur]s 7z def9$ 9 section #gdd,l ( su* ,act 7z add$ by section #bjb ( ?is ,act771 beg9n+ #baj days aft] su* date2 & 7#c7 small manufactur]s 7z def9$ 9 section #gdd,l ( su* ,act 7z add$ by section #bjb ( ?is ,act771 beg9n+ #b ye>s aft] su* date4 7c7 ,en=cem5t ,section #fja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,if ! me?ods us$ 91 or ! facilities or controls us$ =1 its manufacture1 process+1 pack+1 or hold+ d n con=m to curr5t good manufactur+ practice1 z prescrib$ by ! ,secret>y4 4 #ajd4 ,adv]se ev5t reports ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #ajc7;a71 is fur!r am5d$ by add+ at ! end ! foll[+3 #faa4 ,adv]se ev5t report+ = cosmetics 7a7 ,submission ( s]i\s adv]se ev5t reports 7#a7 ,9 g5]al ,) respect to any cosmetic product di/ribut$ 9 ! ,unit$ ,/ates1 ! responsible p]son %all submit1 n lat] ?an #ae days aft] ! receipt by ! responsible p]son1 us+ an electronic sy/em develop$ "u subsection 7b71 to ! ,secret>y any report ( a s]i\s adv]se ev5t associat$ ) ! use ( ! cosmetic product1 accompani$ by a copy ( ! label on or ) ! retail packag+ ( ! cosmetic product4 7#b7 ,new m$ical in=mation ,dur+ ! #ab-mon? p]iod foll[+ ! submission ( a s]i\s adv]se ev5t report "u p>agraph 7#a71 ) respect to any cosmetic product di/ribut$ 9 ! ,unit$ ,/ates1 ! responsible p]son %all submit1 n lat] ?an #ae days aft] ! receipt by ! responsible p]son1 us+ an electronic sy/em develop$ "u subsection 7b71 to ! ,secret>y any new m$ical in=mation relat$ to su* s]i\s adv]se ev5t report t is receiv$ by ! responsible p]son4 7#c7 ,publication ,! ,secret>y %all make publicly available on ! int]net website ( ! ,food & ,drug ,adm9i/ration reports submitt$ "u p>agraph 7#a74 7#d7 ,no duplication ,9 ! case ( cosmetic product t is also a drug = :i* a s]i\s adv]se ev5t report is fil$ us+ ,=m ,,fda #cejj;,a 7or any successor =m develop$ = su* purpose7 or its electronic equival5t = ov]-!-c\nt] drugs1 ! responsible p]son %all n be requir$ to submit a s]i\s adv]se ev5t report "u p>agraph 7#a7 ) respect to t cosmetic product4 7b7 ,requirem5ts = s]i\s adv]se ev5t reports 7#a7 ,electronic sy/em 7,a7 ,9 g5]al ,! ,secret>y %all1 n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai1 develop & implem5t an electronic sy/em = use = ! submission ( s]i\s adv]se ev5t reports "u ?is section4 7,b7 ,modification ,! =mat ( ! electronic sy/em develop$ & implem5t$ "u p>agraph 7#a7 may be modifi$ by ! ,secret>y & ! reports may include additional in=mation4 ,! ,secret>y may1 9 guidance1 fur!r specify ! =mat & cont5ts ( requir$ reports4 7#b7 ,cont5t ( reports ,a s]i\s adv]se ev5t report submitt$ "u p>agraph 7#a7 ( subsection 7a7 %all include all in=mation submitt$ ) ! initial report & any in=mation subsequ5tly add$ to su* report pursuant to p>agraph 7#b7 ( su* subsection &-- 7,a7 any report by ! responsible p]son "u section #gef ) respect to ! safety ( ! cosmetic product t is ! subject ( ! report2 7,b7 in=mation on ! individual or individuals ) respect to :om ! adv]se ev5t report is submitt$1 9 accordance ) ! disclosure requirem5ts ( section #eeb;a ( title #e1 ,unit$ ,/ates ,code2 7,c7 not)/&+ section #eeb7;b77#f7 ( title #e1 ,unit$ ,/ates ,code1 m$ical 7or simil>7 docum5tation ( ! s]i\s adv]se ev5t t is ! subject ( ! report1 ) all p]sonally id5tifiable in=mation r$act$2 & 7,d7 contact in=mation = ! individual or individuals report+ ! s]i\s adv]se ev5t4 7#c7 ,responsibility to ga!r in=mation ,aft] an individual initiates ! report+ ( a s]i\s adv]se ev5t1 ! responsible p]son = ! cosmetic product %all actively ga!r all ( ! in=mation reasonably available to su* p]son to complete & file ! report ) ! ,secret>y "u subsection 7a77#a74 7#d7 ,no adv]se ev5ts to report ,! ,secret>y %all provide an option z "p ( ! electronic regi/ration process = ! responsible p]son to indicate if su* responsible p]son _h no adv]se ev5ts to report ov] ! previ\s ye>4 ,) respect to a responsible p]son :o receiv$ no adv]se ev5t reports = a ye>1 ! annual adv]se ev5t report requirem5t may be met by indicat+ no su* ev5ts on ! annual regi/ration =m4 7#e7 ,exemption ,! ,secret>y may e/abli% by regulation an exemption to any ( ! requirem5ts "u ?is section if ! ,secret>y det]m9es t su* exemption is support$ by adequate evid5ce & w\ld h no adv]se effect on public heal?4 7c7 ,requirem5ts = o!r adv]se ev5t reports 7#a7 ,9 g5]al ,ea* responsible p]son %all ma9ta9 records relat$ to ea* report ( an adv]se ev5t 7includ+ s]i\s adv]se ev5ts7 associat$ ) ea* cosmetic product m>ket$ by su* responsible p]son & receiv$ by su* responsible p]son = a p]iod ( #f ye>s4 ,su* records %all be made available to an (fic] or an employee duly designat$ by ! ,secret>y ^u reque/1 at reasonable times & )9 reasonable limits & 9 a reasonable mann]1 includ+ all[+ electronic access & to copy su* records4 7#b7 ,cont5t ,records requir$ to be ma9ta9$ "u ?is p>agraph %all conta9 all in=mation reasonably available1 includ+-- 7,a7 a summ>y ( all adv]se ev5ts receiv$ dur+ ! cal5d> ye> = ea* cosmetic product m>ket$2 7,b7 a complete li/ ( individual reports ( adv]se ev5ts = ea* cosmetic product m>ket$ & ) respect to ea* su* ev5t1 ! same in=mation requir$ to be includ$ 9 a report ) respect to a s]i\s adv]se ev5t "u subsection 7b77#b71 subject to ! same conditions ) respect to ! disclosure ( su* in=mation2 7,c7 an e/imate ( ! total numb] ( product units e/imat$ to h be5 di/ribut$ to consum]s dur+ ! p]iod specifi$ 9 p>agraph 7#a72 & 7,d7 su* o!r in=mation z may be specifi$ 9 regulation or guidance issu$ by ! ,secret>y4 7#c7 ,rule ( con/ruction ,?is section %all n be con/ru$ to require ! inclusion 9 any report "u ?is section any consum] compla9t t conc]ns solely efficacy & does n conta9 any in=mation ab\t an adv]se ev5t4 7d7 ,limitation ) respect to adv]se ev5t reports ,section #gef %all apply ) respect to ! submission ( an adv]se ev5t report 9 compliance ) subsection 7a74 7e7 ,contact in=mation ,! label ( a cosmetic product %all be> ! dome/ic address1 & ei!r ! dome/ic telephone numb] or electronic contact in=mation1 ?r\gh :i* ! responsible p]son may receive a report ( an adv]se ev5t4 7f7 ,availability to ,/ates ,! ,secret>y %all make records submitt$ "u ?is section available to any ,/ate1 ^u reque/1 to ! ext5t p]missible "u ! laws gov]n+ disclosure ( in=mation by ! ,secret>y4 ,in=mation disclos$ to a ,/ate t is exempt f disclosure "u section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 %all be treat$ z a trade secret & confid5tial in=mation by ! ,/ate4 ,su* ,/ate & its employees 9 possession ( su* in=mation %all be subject to ! same laws gov]n+ in=mation disclosure z employees ( ! ,food & ,drug ,adm9i/ration4 7g7 ,protection ( in=mation ,a s]i\s adv]se ev5t report submitt$ to ! ,secret>y "u subsection 7a71 includ+ any new m$ical in=mation submitt$ "u p>agraph 7#b7 ( su* subsection1 or an adv]se ev5t report volunt>ily submitt$ to ! ,secret>y1 %all be consid]$ to be a safety report "u section #gef & may be accompani$ by a /atem5t1 :i* %all be a "p ( any report t is releas$ = public disclosure1 t d5ies t ! report or ! records con/itute an admission t ! product involv$ caus$ or contribut$ to ! adv]se ev5t4 7h7 ,effective dates 7#a7 ,s]i\s adv]se ev5ts ,! requirem5t "u ?is section to report s]i\s adv]se ev5ts %all become effective on ! date t ! ,secret>y publicizes ! availability ( ! electronic sy/em describ$ 9 subsection 7b77#a74 7#b7 ,o!r adv]se ev5ts ,! requirem5t "u ?is section to ma9ta9 records relat+ to adv]se ev5ts :i* are n s]i\s adv]se ev5ts %all become effective #ah mon?s aft] ! date ( ! enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai4 7i7 ,def9itions ,9 ?is section3 7#a7 ,adv]se ev5t ,! t]m adv]se ev5t means1 ) respect to a cosmetic product1 a heal?-relat$ or m$ical ev5t associat$ ) ! use ( su* product1 includ+ a risk ( illness or injury4 ,su* t]m does n include any in/ance ( a consum] compla9t t su* product did n "w z adv]tis$ or m>ket$4 7#b7 ,s]i\s adv]se ev5t ,! t]m s]i\s adv]se ev5t means1 ) respect to a cosmetic product1 an adv]se ev5t t-- 7,a7 results 9-- 7i7 dea?2 7ii7 a life-?reat5+ exp]i5ce2 7iii7 inpati5t hospitalization2 7iv7 a p]si/5t or significant adv]se heal? condition1 disability1 or incapacity2 7v7 cong5ital anomaly or bir? defect2 or 7vi7 significant disfigurem5t1 includ+ s]i\s or p]si/5t ra%es & infections1 burns1 or significant hair loss2 or 7,b7 requires1 bas$ on reasonable m$ical judgm5t1 a m$ical or surgical int]v5tion to prev5t an outcome describ$ 9 subp>agraph 7,a74 4 #aje4 ,records inspection2 m&atory recall au?ority ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #ajd1 is fur!r am5d$ by add+ at ! end ! foll[+3 #fab4 ,inspection ( cosmetic records 7a7 ,inspection ( records ,ea* facility1 includ+ a facility own$ or op]at$ by a responsible p]son = a cosmetic product %all1 at ! reque/ ( an (fic] or employee duly designat$ by ! ,secret>y1 p]mit su* (fic] or employee1 ^u pres5tation ( appropriate cr$5tials & writt5 notice to su* p]son1 at reasonable times & )9 reasonable limits & 9 a reasonable mann]1 to h access to & copy1 or receive electronically records ma9ta9$ by or on behalf ( su* p]son 9 any =mat 7includ+ pap] & electronic =mats7 & at any location1 includ+-- 7#a7 all records ma9ta9$ "u section #faa & 9 accordance ) ! rules promulgat$ by ! ,secret>y "u section #faj1 z applicable2 7#b7 all records ma9ta9$ "u section #fji2 7#c7 any records relat+ to ! li/ ( +r$i5ts 9 specific fragrances or flavors ( a cosmetic product or cosmetic =mulation1 if reque/$ by ! ,secret>y by means ( a writt5 notification2 & 7#d7 except z provid$ 9 subsection 7b71 all o!r records relat+ to ! cosmetic product or cosmetic =mulation & to any o!r cosmetic product or cosmetic =mulation ! ,secret>y reasonably believes is likely to be affect$ 9 a simil> mann]1 if ! ,secret>y-- 7,a7 has a reasonable belief t ! cosmetic product or cosmetic =mulation-- 7i7 is adult]at$2 7ii7 has caus$ a reportable s]i\s adv]se ev5t2 or 7iii7 conta9s an +r$i5t = :i* new sci5tific in=mation %[s may be unsafe :5 pres5t 9 a cosmetic product or cosmetic =mulation2 & 7,b7 provides writt5 notice to ! responsible p]son ( ! basis = ! ,secret>y's reasonable belief describ$ 9 subp>agraph 7,a71 z applicable4 7b7 ,exclusions 7#a7 ,9 g5]al ,no inspection au?oriz$ by ?is section %all ext5d to-- 7,a7 recipes1 f9ancial data1 pric+ data1 p]sonnel data 7o!r ?an data z to qualification ( te*nical & pr(essional p]sonnel p]=m+ functions subject to ?is ,act71 rese>* data 7o!r ?an safety data7 or sales data o!r ?an %ipm5t & di/ribution data2 or 7,b7 except z provid$ 9 p>agraph 7#b71 in=mation relat$ to +r$i5ts 9 fragrances or flavors ( a cosmetic product or cosmetic =mulation4 7#b7 ,exception ,! ,secret>y may obta9 in=mation relat$ to ! +r$i5ts 9 fragrances or flavors 9 an id5tifi$ cosmetic product or cosmetic =mulation only by a reque/ 9 a writt5 notification provid$ to ! manufactur] pursuant to a =-cause inspection4 ,9 response to su* writt5 notification1 ! manufactur] ( su* fragrance or flavor %all provide in=mation ab\t ! +r$i5ts 9 ! specifi$ fragrance or flavor t ! ,secret>y det]m9es is necess>y to assi/ its inve/igation1 9 ! manufactur]'s pref]r$ electronic or writt5 =mat1 to ! ,secret>y ^u receipt ( su* notification4 ,any in=mation provid$ 9 response to su* writt5 notification %all be consid]$ a trade secret "u section #cja7;j7 &1 not)/&+ su* section1 %all only be disclos$ if ! ,secret>y det]m9es su* disclosure is necess>y to protect ! public heal?4 ,! au?ority to det]m9e su* disclosure is necess>y to protect ! public heal? %all n be delegat$ to any (fic] or employee o!r ?an ! director ( ! applicable (fice4 7c7 ,protection ( s5sitive in=mation ,! ,secret>y %all take appropriate measures to ensure t !re are effective proc$ures to prev5t ! unau?oriz$ disclosure ( any trade secret or confid5tial in=mation t is obta9$ by ! ,secret>y pursuant to ?is section4 ,in=mation disclos$ to a ,/ate %all be pursuant to ! laws gov]n+ disclosure ( in=mation4 ,confid5tial in=mation disclos$ to ! ,/ate t is exempt f disclosure "u section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 %all be treat$ z confid5tial in=mation by ! ,/ate4 ,su* ,/ate & its employees 9 possession ( su* in=mation "u ?is section %all be subject to ! same laws gov]n+ in=mation disclosure z employees ( ! ,food & ,drug ,adm9i/ration4 7d7 ,limitations ,?is section %all n be con/ru$-- 7#a7 to limit ! au?ority ( ! ,secret>y to inspect records or to require e/abli%m5t & ma9t5ance ( records "u any o!r provision ( ?is ,act2 or 7#b7 to require ! ,secret>y to publicly disclose any in=mation t is exempt f disclosure "u section #ebb ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 #fac4 ,m&atory recall au?ority 7a7 ,volunt>y proc$ures ,if ! ,secret>y det]m9es t !re is a reasonable probability t a cosmetic product is adult]at$ "u section #fja or misbr&$ "u section #fjb & ! use (1 & exposure to1 su* cosmetic product is likely to cause s]i\s adv]se heal? consequ5ces or dea?1 ! ,secret>y %all provide ! responsible p]son ) an opportunity to volunt>ily cease di/ribution & recall su* article4 7b7 ,prehe>+ ord] ,to m&atorily cease di/ribution & give notice 7#a7 ,9 g5]al ,if ! dome/ic responsible p]son refuses to or does n volunt>ily cease di/ribution or recall su* cosmetic product )9 ! "t & 9 ! mann] prescrib$ by ! ,secret>y1 ! ,secret>y may ord] su* p]son to-- 7,a7 imm$iately cease di/ribution ( su* cosmetic product2 & 7,b7 z applicable1 imm$iately ord] all facilities-- 7i7 manufactur+1 process+1 pack+1 transport+1 hold+1 receiv+1 di/ribut+1 or import+ & sell+ su* cosmetic product2 & 7ii7 to :i* su* cosmetic product has be5 di/ribut$1 transport$1 or sold1 to imm$iately cease di/ribution ( su* cosmetic product4 7#b7 ,requir$ additional in=mation 7,a7 ,9 g5]al ,9 ! case ( a cosmetic product t is subject to a recall ord] issu$ "u p>agraph 7#a77;,b7 ) respect to :i* ! responsible p]son1 be=e ! issuance ( su* ord]1 di/ribut$ to a w>eh\se-bas$1 ?ird-p>ty logi/ics provid] )\t provid+ su* logi/ics provid] ) suffici5t in=mation to "k or reasonably det]m9e ! precise id5tity ( su* cosmetic product1 ! notice provid$ by ! dome/ic responsible p]son pursuant to su* ord] %all include su* in=mation z is necess>y = ! logi/ics provid] to id5tify ! cosmetic product4 7,b7 ,rules ( con/ruction ,no?+ 9 ?is p>agraph %all be con/ru$ to exempt a w>eh\se-bas$1 ?ird-p>ty logi/ics provid] f-- 7i7 ! requirem5ts ( ?is *apt]1 includ+ ! requirem5ts ( ?is section & section #fab2 or 7ii7 be+ ! subject ( a m&atory recall ord] "u ?is section4 7#c7 ,det]m9ation to limit areas affect$ ,if ! ,secret>y requires a dome/ic responsible p]son to cease di/ribution "u p>agraph 7#a77;,a7 ( a cosmetic product1 ! ,secret>y may limit ! size ( ! geographic area & ! m>kets affect$ by su* cessation if su* limitation w\ld n compromise ! public heal?4 7c7 ,he>+ on ord] ,! ,secret>y %all provide ! responsible p]son subject to an ord] "u subsection 7b7 ) an opportunity = an in=mal he>+1 to be held z soon z possible1 b n lat] ?an #b days aft] ! issuance ( ! ord]1 on ! actions requir$ by ! ord] & on :y ! cosmetic product t is ! subject ( ! ord] %\ld n be recall$4 7d7 ,po/he>+ recall ord] & modification ( ord] 7#a7 ,am5dm5t ( ord] ,if1 aft] provid+ opportunity = an in=mal he>+ "u subsection 7c71 ! ,secret>y det]m9es t removal ( ! cosmetic product f comm]ce is necess>y1 ! ,secret>y %all1 z appropriate-- 7,a7 am5d ! ord] to require recall ( su* cosmetic product or o!r appropriate action2 7,b7 specify a timetable 9 :i* ! recall %all occur2 7,c7 require p]iodic reports to ! ,secret>y describ+ ! progress ( ! recall2 & 7,d7 provide notice to consum]s to :om su* cosmetic product 01 or may h be51 di/ribut$4 7#b7 ,vacat+ ( ord] ,if1 aft] su* he>+1 ! ,secret>y det]m9es t adequate gr\nds d n exi/ to cont9ue ! actions requir$ by ! ord]1 or t su* actions %\ld be modifi$1 ! ,secret>y %all vacate ! ord] or modify ! ord]4 7e7 ,coop]ation & consultation ,! ,secret>y %all "w ) ,/ate & local public heal? (ficials 9 c>ry+ out ?is section1 z appropriate4 7f7 ,public notification ,9 conduct+ a recall "u ?is section1 ! ,secret>y %all-- 7#a7 ensure t a press release is publi%$ reg>d+ ! recall1 & t al]ts & public notices are issu$1 z appropriate1 9 ord] to provide notification-- 7,a7 ( ! recall to consum]s & retail]s to :om su* cosmetic product 01 or may h be51 di/ribut$2 & 7,b7 t includes1 at a m9imum-- 7i7 ! "n ( ! cosmetic product subject to ! recall2 7ii7 a description ( ! risk associat$ ) ! use ( su* cosmetic product2 & 7iii7 to ! ext5t practicable1 in=mation = consum]s ab\t simil> cosmetic products t are n affect$ by ! recall2 & 7#b7 ensure publication on ! int]net website ( ! ,food & ,drug ,adm9i/ration ( an image ( ! cosmetic product t is ! subject ( ! press release describ$ 9 p>agraph 7#a71 if available4 7g7 ,no delegation ,! au?ority conf]r$ by ?is section to ord] a recall or vacate a recall ord] %all n be delegat$ to any (fic] or employee o!r ?an ! ,commission] ( ,food & ,drugs4 7h7 ,rule ( con/ruction ,no?+ 9 ?is section %all affect ! au?ority ( ! ,secret>y to reque/ or p>ticipate 9 a volunt>y recall1 or to issue an ord] to cease di/ribution or to recall any article "u any o!r provision ( ?is ,act or "u ! ,public ,heal? ,s]vice ,act4 7i7 ,def9ition ,9 ?is section1 ! t]m dome/ic responsible p]son means a p]son :o is ! dome/ic contact = a responsible p]son4 4 #ajf4 ,label+ & int]net sales 7a7 ,9 g5]al ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #aje1 is fur!r am5d$ by add+ at ! end ! foll[+3 #fad4 ,label+ & int]net sales 7a7 ,safety review & label+ ,if a w>n+ or condition ( use is requir$ pursuant to section #fjh7;d77#d7 to ensure ! safe use ( a cosmetic +r$i5t1 ! ,secret>y %all require appropriate label+ ( any cosmetic product t conta9s su* +r$i5t1 includ+ if su* +r$i5t-- 7#a7 is n appropriate = use 9 ! entire population2 or 7#b7 requires w>n+s t *ildr51 pregnant wom51 & o!r vuln]able populations %\ld limit or avoid us+ ! product4 7b7 ,cosmetic products = pr(essional use 7#a7 ,li/+ ( +r$i5ts ,! label+ ( cosmetic products us$ & sold by pr(essionals %all li/ all +r$i5ts1 z requir$ = o!r cosmetic products pursuant to section #fjb7;g74 7#b7 ,pr(essional use label+ ,9 ! case ( a cosmetic product t is int5d$ to be us$ only by a pr(essional on acc\nt ( a specific +r$i5t or increas$ conc5tration ( an +r$i5t & requires safe h&l+ by tra9$ pr(essionals1 ! product %all be> a /atem5t z foll[s3 ,= ,pr(essional ,use ,only4 7c7 ,display ,a w>n+ requir$ "u subsection 7a7 & any /atem5t requir$ "u subsection 7b77#b7 %all be prom95tly display$-- 7#a7 9 ! prim>y language us$ on ! label or on packag+2 & 7#b7 9 conspicu\s & legible type 9 contra/ by typography1 lay\t1 or color ) o!r mat]ial pr9t$ or display$ on ! label4 7d7 ,int]net sales 7#a7 ,9 g5]al ,9 ! case ( int]net sales ( cosmetic products1 ea* prim>y sell] (f]+ a cosmetic product = sale to consum]s on an int]net website %all prom95tly & conspicu\sly display on su* int]net website-- 7,a7 ! same in=mation t is includ$ on ! packag+ ( ! cosmetic product z regul>ly available1 su* z any w>n+s1 +r$i5t li/1 & contact in=mation2 & 7,b7 ! w>n+s & /atem5ts describ$ 9 subsection 7c74 7#b7 ,def9ition ,= purposes ( ?is subsection1 ! t]m prim>y sell] ref]s to ! entity :o (f]s a cosmetic product = sale on an int]net website1 includ+ ! responsible p]son4 #fae4 ,fragrance +r$i5ts 7a7 ,fragrance +r$i5ts ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai1 ! responsible p]son %all include on ! label ( any cosmetic products conta9+ "o or m fragrance all]g5s1 a li/ ( ea* su* fragrance all]g5 includ$ 9 su* cosmetic product t is consi/5t ) national & int]national regulations = fragrance all]g5s label+4 7b7 ,contact in=mation 7#a7 ,9 g5]al ,! contact in=mation on ! label on a cosmetic product = consum]s to report adv]se ev5ts %all also provide a means = consum]s to obta9 additional in=mation ab\t ! inclusion ( any recogniz$ fragrance all]g5 requir$ to be includ$ on su* label "u subsection 7a74 7#b7 ,response 7,a7 ,9 g5]al ,! responsible p]son %all-- 7i7 ^u receipt ( a reque/ = in=mation "u p>agraph 7#a71 promptly obta9 & provide su* in=mation to ! reque/+ consum]2 & 7ii7 9 ! case ( in=mation 9 ! possession ( a suppli]1 promptly obta9 su* in=mation f su* suppli]1 if reasonably available4 7,b7 ,suppli] ,a suppli] %all promptly provide in=mation reque/$ pursuant to subp>agraph 7,a77ii74 4 7b7 ,+r$i5t /atem5t ,section #fjb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfb7 is am5d$ by add+ at ! end ! foll[+3 7g7 ,if its label+ or packag+ does n conta9 a li/+ ( +r$i5ts t meets ! requirem5ts ( "p #gja ( title #ba1 ,code ( ,f$]al ,regulations 7z 9 effect on date ( enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai7 7or any successor regulations74 4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to products introduc$ or deliv]$ = introduction into int]/ate comm]ce on or aft] ! date t is #b ye>s aft] ! date ( enactm5t ( ?is ,act4 #ajg4 ,consum] in=mation ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all po/ on its int]net website in=mation = consum]s reg>d+-- 7#a7 f9al ord]s reg>d+ ! safety ( a cosmetic +r$i5t or nonfunctional con/itu5t "u section #fjh7;d77#c72 7#b7 cosmetic product recalls 7includ+ volunt>y & m&atory recalls72 & 7#c7 id5tifi$ c\nt]feit cosmetic products4 #ajh4 ,small bus9esses ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #ajf1 is fur!r am5d$ by add+ at ! end ! foll[+3 #faf4 ,small bus9esses 7a7 ,9 g5]al ,! ,commission]1 9 coord9ation ) ! ,adm9i/rator ( ! ,small ,bus9ess ,adm9i/ration1 %all provide te*nical assi/ance1 su* z guidance & exp]tise1 to small bus9esses reg>d+ compliance ) ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai1 includ+ ! am5dm5ts made by su* ,act4 7b7 ,compliance guide ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ,cosmetic ,safety ,enhancem5t ,act ( #bjai1 ! ,secret>y %all issue a small bus9ess guide sett+ =? 9 pla9 language ! requirem5ts ( sections #fje & #fjf 9 ord] to assi/ small bus9esses 9 comply+ ) su* requirem5ts4 4 #aji4 ,animal te/+ re/rictions 7a7 ,9 g5]al ,section #fja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,if ! cosmetic product1 cosmetic =mulation1 or cosmetic +r$i5t 0 develop$ or manufactur$ us+ an animal te/ t 0 conduct$ or contract$ by ! manufactur]1 or any affiliate or suppli] ( ! manufactur]1 unless "o ( ! foll[+ applies3 7#a7 ,) respect to a cosmetic +r$i5t ( ! cosmetic product or cosmetic =mulation1 an animal te/ is requir$ by ! ,secret>y to evaluate ! safety ( su* +r$i5t or =mulation4 7#b7 ,) respect to a cosmetic +r$i5t ( ! cosmetic product or cosmetic =mulation1 ! cosmetic +r$i5t or cosmetic =mulation is 9 wide use & _c be replac$ by ano!r +r$i5t t is capable ( p]=m+ a simil> function )\t pos+ a pot5tially great] risk to human heal? & !re is n an alt]native me?od = te/+ ! cosmetic +r$i5t t is accept$ by ! ,secret>y & ! ,int]ag5cy ,coord9at+ ,committee on ,validation ( ,alt]native ,me?ods4 7#c7 ,! animal te/ 0 conduct$ to comply ) a requirem5t ( ano!r ,f$]al ag5cy or a ,/ate or =eign regulatory au?ority4 7#d7 ,9 ! case ( a cosmetic product1 cosmetic =mulation1 or cosmetic +r$i5t t is also a drug1 ! animal te/ 0 conduct$ ) respect to ! approval "u *apt] ,v ( ! application submitt$ ) respect to su* product1 =mulation1 or +r$i5t4 7#e7 ,! animal te/ 0 conduct$ = purposes n relat$ to develop+ or manufactur+ ! cosmetic product1 cosmetic =mulation1 or cosmetic +r$i5t1 & 9 response to a requirem5t ( a ,f$]al1 ,/ate1 or =eign regulatory au?ority4 4 7b7 ,applicability ,! am5dm5t made by subsection 7a7 %all apply ) respect to cosmetic products or cosmetic =mulations introduc$ or deliv]$ = introduction into int]/ate comm]ce on or aft] ! date t is two ye>s aft] ! date ( enactm5t ( ?is ,act4 7c7 ,guidance ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all issue guidance on ! acceptability ( sci5tifically reliable & relevant alt]natives to animal te/+ = ! safety ( cosmetic products1 cosmetic =mulations1 & cosmetic +r$i5ts1 & enc\rag+ ! use ( su* me?ods4 7d7 ,res\rces reg>d+ animal te/+ alt]natives ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all publi% in=mation on ! int]net website ( ! ,food & ,drug ,adm9i/ration reg>d+ res\rces available = in=mation ab\t non-animal me?ods1 & me?ods t r$uce animal usage1 9 te/+ = ! safety ( cosmetic products1 cosmetic =mulations1 & cosmetic +r$i5ts4 7e7 ,rules ( con/ruction 7#a7 ,use ( evid5ce ,no?+ 9 ?is section1 or ! am5dm5t made by ?is section1 %all be con/ru$ to prohibit any entity f review+1 assess+1 or reta9+ evid5ce g5]at$ f animal te/+4 7#b7 ,acceptance ( data by ,secret>y ,no?+ 9 ?is section1 or ! am5dm5t made by ?is section1 %all be con/ru$ to prohibit ! ,secret>y f accept+ data f animal te/+ conduct$-- 7,a7 prior to ! date specifi$ 9 subsection 7b72 or 7,b7 on or aft] su* date-- 7i7 9 ! case ( a cosmetic product1 cosmetic =mulation1 or cosmetic +r$i5t t is also a drug1 ) respect to ! approval "u *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 ( ! application submitt$ ) respect to su* product1 =mulation1 or +r$i5t2 or 7ii7 pursuant to requirem5ts ( a ,f$]al1 ,/ate1 or =eign regulatory au?ority4 #aaj4 ,c\nt]feit cosmetics 7a7 ,c\nt]feit cosmetics def9$ ,section #bja7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;i77 is am5d$-- 7#a7 by /rik+ 7i7 ,! t]m ins]t+ 7i77#a7 ,! t]m2 7#b7 by /rik+ 7#a7 articles int5d$ to be & ins]t+ 7,a7 articles int5d$ to be2 7#c7 by /rik+ 7#b7 articles int5d$ = use & ins]t+ 7,b7 articles int5d$ = use2 & 7#d7 by add+ at ! end ! foll[+3 7#b7 ,! t]m c\nt]feit cosmetic means a cosmetic :i*1 or ! conta9] or label+ ( :i*1 )\t au?orization-- 7,a7 be>s ! tradem>k1 trade "n1 or o!r id5tify+ m>k1 impr9t1 or device1 or any lik5ess !re(1 ( a cosmetic manufactur]1 processor1 pack]1 or di/ributor o!r ?an ! p]son or p]sons :o 9 fact manufactur$1 process$1 pack$1 or di/ribut$ su* cosmetic2 & 7,b7 !reby falsely purports or is repres5t$ to be ! product (1 or to h be5 pack$ or di/ribut$ by1 su* o!r cosmetic manufactur]1 processor1 pack]1 or di/ributor4 4 7b7 ,prohibit$ act ,section #cja7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;i77 is am5d$-- 7#a7 9 subp>agraph 7#b7-- 7,a7 by ins]t+ digital pr9t]1 aft] /one12 7,b7 by ins]t+ cosmetic aft] drug or2 & 7,c7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 or su* cosmetic a c\nt]feit cosmetic2 & 7#b7 9 subp>agraph 7#c7-- 7,a7 by ins]t+ or a cosmetic to be a c\nt]feit cosmetic aft] to be a c\nt]feit drug2 & 7,b7 by ins]t+ or c\nt]feit cosmetic be=e ! p]iod at ! end4 7c7 ,p5alties ,section #cjc7;c77#e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;c77#e77 is am5d$-- 7#a7 by ins]t+ digital pr9t] aft] /one12 7#b7 by ins]t+ or a cosmetic be+ a c\nt]feit cosmetic aft] drug be+ a c\nt]feit drug2 & 7#c7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 or ! cosmetic 0 a c\nt]feit cosmetic4 7d7 ,seizure ,section #cjd7;a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccd7;a77#b77 is am5d$-- 7#a7 by /rik+ 7,b7 ,any conta9] & all t foll[s ?r\gh 7,d7 ,any adult]at$ & ins]t+ 7,b7 ,any cosmetic t is a c\nt]feit cosmetic1 7,c7 ,any conta9] ( a c\nt]feit drug or c\nt]feit cosmetic1 7,d7 ,any pun*1 die1 plate1 /one1 label+1 conta9]1 digital pr9t]1 or o!r ?+ us$ or design$ = use 9 mak+ a c\nt]feit drug or drugs or a c\nt]feit cosmetic or cosmetics1 7,e7 ,any adult]at$2 & 7#b7 by /rik+ 7,e7 & ins]t+ 7,f7 be=e ,any adult]at$ or misbr&$ tobacco product4 7e7 ,exam9ations & inve/igations ,section #gjb7;e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgb7;e77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ or c\nt]feit cosmetics aft] c\nt]feit drugs2 7#b7 9 p>agraph 7#d71 by ins]t+ or cosmetics aft] su* drugs2 & 7#c7 9 p>agraph 7#e7-- 7,a7 by /rik+ drugs or conta9]s & ins]t+ drugs1 cosmetics1 or conta9]s2 & 7,b7 by ins]t+ digital pr9t]s1 aft] label+14 #aaa4 ,=eign suppli] v]ification 7a7 ,9 g5]al ,*apt] ,,viii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha et seq47 is am5d$ by add+ at ! end ! foll[+3 #haj4 ,cosmetics =eign suppli] v]ification program 7a7 ,9 g5]al 7#a7 ,v]ification requirem5t ,except z provid$ "u subsection 7e71 ea* import] %all p]=m risk-bas$ =eign suppli] v]ification activities = ! purpose ( v]ify+ t ! cosmetic product or cosmetic +r$i5t import$ by ! import] 7or ag5t !re(7-- 7,a7 has be5 manufactur$ accord+ to ! cosmetic product good manufactur+ practices e/abli%$ "u section #faj2 & 7,b7 is n adult]at$ "u section #fja or misbr&$ "u section #fjb4 7#b7 ,import] def9$ ,= purposes ( ?is section1 ! t]m import] means1 ) respect to a cosmetic product or cosmetic +r$i5t-- 7,a7 ! ,unit$ ,/ates own] or consignee ( ! cosmetic product or cosmetic +r$i5t at ! "t ( entry ( su* cosmetic product or cosmetic +r$i5t into ! ,unit$ ,/ates2 or 7,b7 9 ! case :5 !re is no ,unit$ ,/ates own] or consignee z describ$ 9 subp>agraph 7,a71 ! ,unit$ ,/ates ag5t or repres5tative ( a =eign own] or consignee ( ! cosmetic product or cosmetic +r$i5t at ! "t ( entry ( su* article into ! ,unit$ ,/ates4 7b7 ,guidance ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai1 ! ,secret>y %all issue guidance to assi/ import]s 9 develop+ =eign suppli] v]ification programs4 7c7 ,regulations 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ,cosmetic ,safety ,enhancem5t ,act ( #bjai1 ! ,secret>y %all promulgate regulations to provide = ! cont5t ( ! =eign suppli] v]ification program e/abli%$ "u subsection 7a74 7#b7 ,requirem5ts ,! regulations promulgat$ "u p>agraph 7#a7-- 7,a7 %all require t ! =eign suppli] v]ification program ( ea* import] be adequate to provide assurances t ea* =eign suppli] to ! import] produces ! import$ cosmetic product or cosmetic +r$i5t 9 compliance )-- 7i7 ) cosmetic good manufactur+ practices e/abli%$ "u section #faj2 & 7ii7 sections #fja & #fjb2 & 7,b7 %all include su* o!r requirem5ts z ! ,secret>y deems necess>y & appropriate to v]ify t cosmetic products & cosmetic +r$i5ts import$ into ! ,unit$ ,/ates are z safe z cosmetic products & cosmetic +r$i5ts produc$ & sold )9 ! ,unit$ ,/ates4 7#c7 ,consid]ations ,9 promulgat+ regulations "u ?is subsection1 ! ,secret>y %all1 z appropriate1 take into acc\nt diff]5ces among import]s & types ( import$ cosmetic products & cosmetic +r$i5ts1 includ+ bas$ on ! level ( risk pos$ by ! import$ cosmetic product or cosmetic +r$i5t4 7#d7 ,activities ,v]ification activities "u a =eign suppli] v]ification program "u ?is section may include monitor+ records = %ipm5ts1 lot-by-lot c]tification ( compliance1 annual on-site inspections1 compliance ) cosmetic good manufactur+ practices & o!r safety processes1 & p]iodically te/+ & sampl+ %ipm5ts4 7d7 ,record ma9t5ance & access ,records ( an import] relat$ to a =eign suppli] v]ification program %all-- 7#a7 be ma9ta9$ = a p]iod ( n less ?an #b ye>s2 & 7#b7 be made available promptly to a duly au?oriz$ repres5tative ( ! ,secret>y ^u reque/4 7e7 ,exemptions ,! ,secret>y1 by notice publi%$ 9 ! ,f$]al ,regi/]1 %all e/abli% an exemption f ! requirem5ts ( ?is section = cosmetic products or cosmetic +r$i5ts import$ 9 small quantities = rese>* & evaluation purposes or = p]sonal consumption1 provid$ t su* cosmetic products or cosmetic +r$i5ts are n int5d$ = retail sale & are n sold or di/ribut$ to ! public4 7f7 ,publication ( li/ ( p>ticipants ,! ,secret>y %all publi% & ma9ta9 on ! int]net website ( ! ,food & ,drug ,adm9i/ration a curr5t li/ t includes ! "n (1 location (1 & o!r in=mation deem$ necess>y by ! ,secret>y ab\t1 import]s p>ticipat+ "u ?is section4 4 7b7 ,prohibit$ act ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 z am5d$ by section #aac1 is fur!r am5d$ by add+ at ! end ! foll[+3 7ggg7 ,! importation or (f]+ = importation ( a cosmetic product or cosmetic +r$i5t if ! import] 7z def9$ 9 section #haj7 does n h 9 place a =eign suppli] v]ification program 9 compliance ) su* section #haj4 4 7c7 ,imports ,section #hja7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is am5d$ by /rik+ or ! import] 7z def9$ 9 section #hje7 is 9 violation ( su* section #hje & ins]t+ 1 or be+ import$ or (f]$ = import into ! ,unit$ ,/ates by an import] 7z def9$ 9 section #hje or #haj1 z applicable7 t is 9 violation ( section #hje or #haj1 respectively4 7d7 ,effective date ,! am5dm5ts made by ?is section %all take effect #b ye>s aft] ! date ( enactm5t ( ?is ,act4 #aab4 ,applicability ) respect to c]ta9 cosmetics ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #ajh1 is fur!r am5d$ by add+ at ! end ! foll[+3 #fag4 ,applicability ) respect to c]ta9 cosmetics ,9 ! case ( a cosmetic product or a facility t is subject to ! requirem5ts "u ?is *apt] & *apt] ,v1 if any requirem5t "u *apt] ,v ) respect to su* cosmetic or facility is sub/antially simil> to a requirem5t "u ?is *apt]1 ! cosmetic product or facility %all be deem$ to be 9 compliance ) ! applicable requirem5t "u ?is *apt] if su* product or facility is 9 compliance ) su* sub/antially simil> requirem5t "u *apt] ,v1 provid$ t ! product or facility has n obta9$ a waiv] f ! requirem5t "u *apt] ,v4 4 #aac4 ,sav+ clause ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by section #aab1 is fur!r am5d$ by add+ ! foll[+3 #faf4 ,sav+s clause ,no?+ 9 ! am5dm5ts to ?is ,act made by ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai1 nor any /&>d1 rule1 requirem5t1 regulation1 adv]se ev5t report1 safety assessm5t1 safety det]m9ation1 sci5tific assessm5t1 or ord] issu$ or implem5t$ pursuant to su* am5dm5ts1 %all be con/ru$ to modify or o!rwise affect1 preempt1 or displace any cause ( action or ,/ate or ,f$]al law creat+ a rem$y = civil relief or crim9al cause ( action1 :e!r /atutory or bas$ 9 common law4 4 #aad4 ,en=cem5t 7a7 ,prohibit$ acts ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is am5d$-- 7#a7 9 p>agraph 7e7-- 7,a7 by /rik+ #ejd1 #efd1 & ins]t+ #ejd1 #efd1 #faa1 #fab2 & 7,b7 by /rik+ #eai1 #efd1 & ins]t+ #eai1 #efd1 #fji1 #faa12 7#b7 9 p>agraph 7j7 by ins]t+ #fjg1 #fjh1 #faj1 #faa be=e #gjd2 7#c7 9 p>agraph 7ii7-- 7,a7 by /rik+ #gfj or #gfa7 & ins]t+ #fjd1 #gfj1 or #gfa72 & 7,b7 by /rik+ #gfj or #gfa7 submitt$ & ins]t+ #faa1 #gfj1 or #gfa7 submitt$2 7#d7 9 p>agraph 7xx71 by ins]t+ or #fac aft] #dbc2 & 7#e7 by add+ at ! end ! foll[+3 7fff7 ,! failure to regi/] 9 accordance ) section #fje1 ! failure to submit a cosmetic +r$i5t /atem5t "u section #fjf1 ! failure to provide in=mation requir$ by section #fje or #fjf1 or ! failure to update ! in=mation requir$ by section #fje or #fjf1 z requir$4 4 7b7 ,adult]ation ,section #fja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa71 z am5d$ by section #fjc1 is fur!r am5d$ by add+ at ! end ! foll[+3 7g7 ,if x conta9s1 aft] ! date prescrib$ "u section #fjh7;d77#c71 an +r$i5t t ! ,secret>y has det]m9$ "u section #fjh7;d77#d7 to be n safe1 or n safe "u ! conditions ( use recomm5d$ or sugge/$ 9 ! label bas$ on an ord] issu$ by ! ,secret>y "u section #fjh7;d77#d74 7h7 ,if x is a cosmetic product = :i* any requirem5t ( section #fji is n met4 4 7c7 ,misbr&+ ,section #fjb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfb71 z am5d$ by section #ajf1 is fur!r am5d$-- 7#a7 9 p>agraph 7b7-- 7,a7 by /rik+ & 7#b7 & ins]t+ 7#b72 & 7,b7 by ins]t+ 2 & 7#c7 a dome/ic address or a dome/ic telephone numb]1 or electronic contact in=mation1 ?r\gh :i* ! responsible p]son may receive a report ( an adv]se ev5t associat$ ) ! use ( su* cosmetic product aft] num]ical c\nt2 & 7#b7 by add+ at ! end ! foll[+3 7h7 ,if x is a cosmetic product & x has be5 manufactur$1 process$1 pack$1 or held 9 any factory1 w>eh\se1 or e/abli%m5t & ! responsible p]son delays1 d5ies1 or limits an inspection1 or refuses to p]mit entry or inspection4 7i7 ,if a fragrance +r$i5t describ$ 9 section #fae is n disclos$ to consum]s ?r\gh a me?od id5tifi$ by ! ,food & ,drug ,adm9i/ration 9 ! guidance docum5t issu$ "u su* section4 7j7 ,if its label+ does n con=m ) a requirem5t "u section #fad4 4 7d7 ,guidance ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all issue guidance t def9es ! circum/ances t w\ld con/itute delay+1 d5y+1 or limit+ inspection1 or refus+ to p]mit entry or inspection1 = purposes ( section #fjb7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7c77#b74 7e7 ,imports ,section #hja7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is am5d$-- 7#a7 by /rik+ section #gfj or #gfa ! fir/1 ?ird1 & f\r? place su* t]m appe>s & ins]t+ section #faa1 #gfj1 or #gfa2 & 7#b7 by /rik+ #gfj or #gfa7 & ins]t+ #fjd1 #gfj1 or #gfa74 7f7 ,facility inspection ,section #gjd7;a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#a77 is am5d$ by ins]t+ aft] ! ?ird s5t5ce ! foll[+3 ,9 ! case ( any p]son :o manufactures1 processes1 packs1 holds1 di/ributes1 or imports a cosmetic product1 or di/ributes a cosmetic product & affixes its "n on ! cosmetic label1 ! inspection %all ext5d to all records & o!r in=mation describ$ 9 section #fab 7reg>d+ inspection ( cosmetic records71 subject to ! limitations "u ( su* section44 ,,ii ,fees ,relat$ to ,cosmetic ,products #bja4 ,f9d+s ,! ,congress f9ds t ! fees au?oriz$ by ! am5dm5t made by section #bjb ( ?is ,act w be d$icat$ to cosmetic safety activities1 z def9$ 9 section #gdd,l ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by su* section #bjb4 ,su* fees %\ld supplem5t1 n supplant1 fund+ d$icat$ to cosmetic safety activities ( ! ,food & ,drug ,adm9i/ration4 ,future fees au?oriz$ by ! reau?orization ( "p #aj ( sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to be collect$ by ! ,secret>y ( ,heal? & ,human ,s]vices %\ld be d$icat$ to cosmetic safety activities z set =? 9 ! goals id5tifi$ = purposes ( su* "p #aj1 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,*airman ( ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,*airman ( ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 #bjb4 ,au?ority to assess & use cosmetic product fees ,sub*apt] ,c ( *apt] ,,vii ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq47 is am5d$ by add+ at ! end ! foll[+3 #aj ,fees ,relat+ to ,cosmetic ,products #gdd,l4 ,def9itions ,= ! purposes ( ?is "p3 7#a7 ,adju/m5t factor ,! t]m adju/m5t factor applicable to a fiscal ye> means ! ,consum] ,price ,index = all urban consum]s 7all items2 ,unit$ ,/ates city av]age7 = ,octob] ( ! prec$+ fiscal ye> divid$ by su* index = ,octob] #bjah4 7#b7 ,cosmetic =mulation ,! t]m cosmetic =mulation has ! mean+ giv5 to su* t]m 9 section #fjd4 7#c7 ,contract manufactur] ,! t]m contract manufactur] means a cosmetic manufactur] :]e nei!r ! own]1 op]ator1 or ag5t 9 *>ge ( su* entity nor any affiliate ( su* own]1 op]ator1 or ag5t 9 *>ge sells ! cosmetic +r$i5t1 cosmetic =mulation1 or cosmetic product unless !re is a specific contractual agreem5t 9 place4 7#d7 ,cosmetic product ,! t]m cosmetic product has ! mean+ giv5 to su* t]m 9 section #fjd4 7#e7 ,cosmetic safety activities ,! t]m cosmetic safety activities-- 7,a7 means activities ( ! ,secret>y relat$ to compliance by responsible p]sons requir$ to regi/] "u section #fje ) respect to cosmetics1 includ+ adm9i/rative activities1 su* z-- 7i7 in=mation te*nology acquisition1 managem5t1 ma9t5ance1 & support2 7ii7 ! acquisition1 adm9i/ration1 & ma9t5ance ( ! cosmetic regi/ration sy/em "u section #fje & ! cosmetic +r$i5t /atem5t sy/em "u section #fjf2 7iii7 fee assessm5t & collection "u ?is "p2 & 7iv7 ! acquisition1 leas+1 ma9t5ance1 r5ovation1 & repair ( facilities1 fixtures1 furniture1 sci5tific equipm5t1 & o!r necess>y mat]ials & supplies = purposes ( clauses 7i7 ?r\gh 7iii72 7,b7 includes activities ( ! ,secret>y relat$ to implem5tation ( section #fjh1 reg>d+ ! review ( cosmetic +r$i5ts & nonfunctional con/itu5ts2 7,c7 includes activities ( ! ,secret>y relat$ to implem5tation ( section #fjf2 7,d7 includes activities ( ! ,secret>y relat$ to implem5tation & en=cem5t1 su* z ! e/abli%m5t ( good manufactur+ practices1 ! review ( adv]se ev5t reports1 inspection plann+ & inspections1 & use ( en=cem5t tools2 & 7,e7 includes activities ( ! ,secret>y relat$ to meet+s ) regulat$ indu/ry reg>d+ det]m9ations "u section #fjh4 7#f7 ,gross annual sales ,! t]m gross annual sales means ! av]age ,unit$ ,/ates gross annual sales = ! previ\s #c fiscal ye>s ( cosmetic products = a responsible p]son1 includ+ ! sales ( cosmetic products ( all ( its affiliates1 z report$ 9 ! regi/ration "u section #fje4 7#g7 ,l>ge manufactur] ,! t]m l>ge manufactur] means any entity t manufactures cosmetic products or cosmetic =mulations = sale or di/ribution 9 ! ,unit$ ,/ates & has gross annual sales ( ov] #ejj1jjj1jjj4 7#h7 ,midsize manufactur] ,! t]m midsize manufactur] means any entity t manufactures cosmetic products or cosmetic =mulations = sale or di/ribution 9 ! ,unit$ ,/ates & has gross annual sales t are n m ?an #ejj1jjj1jjj & ov] #cj1jjj1jjj4 7#i7 ,small manufactur] ,! t]m small manufactur] means any entity t manufactures cosmetic products or cosmetic =mulations = sale or di/ribution 9 ! ,unit$ ,/ates & has gross annual sales t are n m ?an #cj1jjj1jjj & ov] #a1jjj1jjj4 7#aj7 ,responsible p]son ,! t]m responsible p]son means ! own]1 op]ator1 ag5t 9 *>ge1 or affiliate t owns ! br& "u :i* a cosmetic product is sold4 #gdd,m4 ,regi/ration fee 7a7 ,assessm5t & collection 7#a7 ,9 g5]al ,beg9n+ 9 fiscal ye> #bjbj1 ! ,secret>y %all 9 accordance ) ?is section assess & collect an annual fee f e responsible p]son t manufactures or di/ributes cosmetic products or cosmetic =mulations 9 ! ,unit$ ,/ates4 7#b7 ,payable date ,fees "u ?is section %all be due & payable-- 7,a7 = fiscal ye> #bjbj1 ) respect to responsible p]sons z describ$ 9 p>agraph 7#a7 = su* fir/ program ye>1 on ! date t is #ahj days aft] ! id5tification 9 subsection 7b72 & 7,b7 = fiscal ye> #bjba & ea* subsequ5t fiscal ye>1 on ! lat] (-- 7i7 ! date ( regi/ration or regi/ration r5ewal1 z applicable1 "u section #fje2 or 7ii7 ! date ( enactm5t ( an appropriations ,act provid+ = ! collection & obligation ( fees "u ?is section = ! fiscal ye> involv$4 7b7 ,"o-,"t id5tification ( responsible p]sons = purposes ( apportion+ fees 7#a7 ,requir$ id5tification ( responsible p]sons ,n lat] ?an #abj days aft] enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai1 ea* responsible p]son t m>kets or sells a cosmetic product %all submit to ! ,secret>y ! in=mation requir$ "u ?is subsection4 7#b7 ,in=mation requir$ to be submitt$ ,at a m9imum1 ! submission requir$ by p>agraph 7#a7 %all include = ea* su* responsible p]son-- 7,a7 ! gross annual sales ( cosmetic products or cosmetic =mulations = ! previ\s #c fiscal ye>s z w be report$ 9 ! fir/ regi/ration "u section #fje = su* responsible p]son1 & an assessm5t ( :e!r su* responsible p]son qualifies z a small1 midsize1 or l>ge manufactur] = ! purposes ( subsection 7c77#c77;,a72 7,b7 id5tification ( facilities :]e su* responsible p]son's cosmetic products or cosmetic =mulations are manufactur$1 :i* cosmetic products or cosmetic =mulations are manufactur$ !re1 & any o!r products regulat$ "u ?is ,act t ! facility manufactures2 7,c7 ! location ( all su* facilities id5tifi$ 9 subp>agraph 7,b72 & 7,d7 :e!r ! facility is own$ & op]at$ by a contract manufactur]4 7#c7 ,notice ,! ,secret>y may1 by notice publi%$ 9 ! ,f$]al ,regi/]1 specify ! means & =mat = submission ( ! in=mation "u p>agraph 7#b7 & may specify1 z necess>y = purposes ( ?is section1 any additional in=mation relevant to sett+ ! annual fee "u ?is section to be submitt$4 7c7 ,fee sett+ & am\nts 7#a7 ,9 g5]al ,subject to subsection 7d71 ! ,secret>y %all e/abli% ! fees to be collect$ "u ?is section = ea* fiscal ye> beg9n+ 9 fiscal ye> #bjbj1 bas$ on ! me?odology describ$ 9 p>agraph 7#c77;,a71 & %all publi% su* fees 9 ea* fiscal ye> aft] fiscal ye> #bjbj 9 a ,f$]al ,regi/] notice n lat] ?an #fj days be=e ! beg9n+ ( ea* su* fiscal ye>4 ,= fiscal ye> #bjbj1 ! ,secret>y %all publi% ! fees #aej days aft] ! date ( enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai4 7#b7 ,fee exemption ,any facility requir$ to regi/] "u section #fje ^: av]age gross annual sales ( cosmetic products 9 ! #c fiscal ye>s imm$iately prec$+ ! fiscal ye> = :i* ! annual fee w be paid 0 n m ?an #a1jjj1jjj1 %all be exempt f regi/ration fees "u ?is section = t fiscal ye>4 7#c7 ,annual fee sett+ 7,a7 ,fee sett+ ,= fiscal ye>s #bjbj to #bjbg1 ! am\nt ( ! regi/ration fee "u subsection 7a7 %all be apportion$ z foll[s3 7i7 ,sev5ty p]c5t %all be d]iv$ f fees f l>ge manufactur]s4 7ii7 ,tw5ty p]c5t %all be d]iv$ f fees f midsize manufactur]s4 7iii7 ,t5 p]c5t %all be d]iv$ f fees f small manufactur]s4 7,b7 ,total rev5ue ,! ,secret>y %all e/abli% ! fee am\nts = ea* fiscal ye> 9 accordance ) subp>agraph 7,a71 9 ord] to g5]ate a total e/imat$ rev5ue (-- 7i7 #aj1jjj1jjj = fiscal ye> #bjbj2 7ii7 #bj1jjj1jjj = fiscal ye> #bjba2 7iii7 #ce1jjj1jjj = fiscal ye> #bjbb2 & 7iv7 #df1jjj1jjj = ea* ( fiscal ye>s #bjbc ?r\gh #bjbg4 7d7 ,adju/m5ts 7#a7 ,inflation adju/m5ts 7,a7 ,adju/m5t to total rev5ue am\nts ,= fiscal ye> #bjbj & ea* subsequ5t fiscal ye>1 ! ,secret>y %all adju/ ! total rev5ue am\nt specifi$ 9 subsection 7c77#c7 = su* fiscal ye> by multiply+ su* am\nt by ! applicable inflation adju/m5t "u subp>agraph 7,b7 = su* ye>4 7,b7 ,applicable inflation adju/m5t ,! applicable inflation adju/m5t = fiscal ye> #bjbb & ea* subsequ5t fiscal ye> is ! product (-- 7i7 ! base inflation adju/m5t "u subp>agraph 7,c7 = su* fiscal ye>2 & 7ii7 ! product ( ! base inflation adju/m5t "u subp>agraph 7,c7 = ea* ( ! fiscal ye>s prec$+ su* fiscal ye>1 beg9n+ ) fiscal ye> #bjbj4 7,c7 ,base inflation adju/m5t 7i7 ,9 g5]al ,subject to fur!r adju/m5t "u clause 7ii71 ! base inflation adju/m5t = a fiscal ye> is ! sum ( "o plus-- 7,i7 ! av]age annual p]c5t *ange 9 ! co/1 p] full-"t equival5t position ( ! ,food & ,drug ,adm9i/ration1 ( all p]sonnel comp5sation & b5efits paid ) respect to su* positions = ! fir/ #c fiscal ye>s ( ! prec$+ #d fiscal ye>s1 multipli$ by #j4fj2 & 7,,ii7 ! av]age annual p]c5t *ange t occurr$ 9 ! ,consum] ,price ,index = urban consum]s 7,wa%+ton-,arl+ton-,alex&ria2 ,n ,seasonally ,adju/$2 ,all items2 ,annual ,index7 = ! fir/ #c fiscal ye>s ( ! prec$+ #d ye>s ( available data multipli$ by #j4dj4 7ii7 ,limitations ,= purposes ( subp>agraph 7,b71 if ! base inflation adju/m5t = a fiscal ye> "u clause 7i7-- 7,i7 is less ?an #a1 su* adju/m5t %all be consid]$ to be equal to #a2 or 7,,ii7 is great] ?an #a4jd1 su* adju/m5t %all be consid]$ to be equal to #a4jd4 7#b7 ,f9al ye> adju/m5t ,= fiscal ye> #bjbg1 ! ,secret>y may1 9 addition to adju/m5ts "u p>agraph 7#a71 fur!r increase ! fee rev5ues & fees e/abli%$ 9 subsection 7c7 if su* an adju/m5t is necess>y to provide = n m ?an #c mon?s ( op]at+ res]ves ( c>ryov] fees = cosmetic safety activities = ! fir/ #c mon?s ( fiscal ye> #bjbh4 ,if su* an adju/m5t is necess>y1 ! rationale = ! increase %all be conta9$ 9 ! annual ,f$]al ,regi/] notice e/abli%+ fees = fiscal ye> #bjbg4 ,if ! ,food & ,drug ,adm9i/ration has c>ryov] balances = su* activities 9 excess ( #c mon?s ( su* op]at+ res]ves1 ! adju/m5t "u ?is p>agraph %all n be made4 7e7 ,limitations 7#a7 ,9 g5]al ,) respect to ! am\nt t is appropriat$ = a fiscal ye> = ! cosmetics program ( ! ,c5t] = ,food ,safety & ,appli$ ,nutrition ( ! ,food & ,drug ,adm9i/ration & relat$ field activities1 fees may n be assess$ "u subsection 7a7 = ! fiscal ye> unless ! am\nt s appropriat$ 7exclud+ ! am\nt ( fees appropriat$ = ! fiscal ye>71 is equal to or great] ?an ! am\nt t is appropriat$ = su* program = fiscal ye> #bjai1 multipli$ by ! adju/m5t factor applicable to ! fiscal ye> involv$4 ,if ! am\nt s appropriat$ prev5ts ! ,secret>y f assess+ fees "u subsection 7a71 ! ,secret>y is n requir$ to c>ry out any activities describ$ 9 section #fjh dur+ t fiscal ye>4 7#b7 ,au?ority ,if ! ,secret>y does n assess fees "u subsection 7a7 dur+ any portion ( a fiscal ye> because ( p>agraph 7#a7 & if at a lat] date 9 su* fiscal ye> ! ,secret>y may assess su* fees1 ! ,secret>y may assess & collect su* fees1 )\t any modification 9 ! rate1 = regi/ration "u section #fje at any "t 9 su* fiscal ye>4 7f7 ,cr$it+ & availability ( fees 7#a7 ,9 g5]al ,fees au?oriz$ "u subsection 7a7 %all be collect$ & available = obligation only to ! ext5t & 9 ! am\nt provid$ 9 advance 9 appropriations ,acts4 ,su* fees are au?oriz$ to rema9 available until exp5d$4 ,su* sums z may be necess>y may be transf]r$ f ! ,food & ,drug ,adm9i/ration sal>ies & exp5ses appropriation acc\nt )\t fiscal ye> limitation to su* appropriation acc\nt = sal>ies & exp5ses ) su* fiscal ye> limitation4 ,! sums transf]r$ %all be available solely = cosmetic safety activities4 7#b7 ,collections & appropriations ,acts 7,a7 ,9 g5]al ,subject to subp>agraphs 7,c7 & 7,d71 ! fees au?oriz$ by ?is section %all be collect$ & available 9 ea* fiscal ye> 9 an am\nt n to exce$ ! am\nt specifi$ 9 appropriation ,acts1 or o!rwise made available = obligation1 = su* fiscal ye>4 7,b7 ,use ( fees & limitation ,! fees au?oriz$ by ?is section %all be collect$ & available only to defray ! co/s ( cosmetic safety activities4 7,c7 ,fee collections dur+ fir/ program ye> ,until ! date ( enactm5t ( discretion>y appropriations ?r\gh ,septemb] #cj1 #bjbj1 = ! ,food & ,drug ,adm9i/ration--,sal>ies & ,exp5ses acc\nt1 fees au?oriz$ by ?is section = fiscal ye> #bjbj may be collect$1 & any fees s collect$ %all be cr$it$ to su* acc\nt1 to rema9 available until exp5d$4 7,d7 ,/>tup co/s ,until "o ye> aft] ! ,secret>y beg9s collect+ us] fees "u subsection 7a71 any am\nts available = ! ,c5t] = ,food ,safety & ,appli$ ,nutrition & relat$ field activities 7exclud+ us] fees7 %all be available & allocat$ z ne$$ to pay ! co/s ( any cosmetic safety activities n au?oriz$ be=e enactm5t ( ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai4 7,e7 ,reimbursem5t ( />tup am\nts 7i7 ,9 g5]al ,any am\nts allocat$ = ! />tup p]iod pursuant to subp>agraph 7,d7 %all be reimburs$ ?r\gh any appropriat$ fees collect$ "u subsection 7a71 9 su* mann] z ! ,secret>y det]m9es appropriate to ensure t su* allocation results 9 no net *ange 9 ! total am\nt ( funds o!rwise available1 = a p]iod n to exce$ two ye>s aft] ! ,secret>y beg9s collect+ us] fees "u subsection 7a71 = ! ,c5t] = ,food ,safety & ,appli$ ,nutrition & relat$ field activities 7o!r ?an cosmetic safety activities & relat$ field activities fund$ ?r\gh su* allocation7 = su* p]iod4 7ii7 ,treatm5t ( reimburs$ am\nts ,am\nts reimburs$ "u clause 7i7 %all be available = ! programs & activities = :i* funds allocat$ = ! />tup p]iod 7 available1 prior to su* allocation1 until #a ye> aft] ! ,secret>y beg9s collect+ us] fees "u subsection 7a71 not)/&+ any o!rwise applicable limits on am\nts = su* programs or activities = a fiscal ye>4 7#c7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ = fees "u ?is section ! foll[+3 7,a7 #aj1jjj1jjj = fiscal ye> #bjbj2 7,b7 #bj1jjj1jjj = fiscal ye> #bjba2 7,c7 #ce1jjj1jjj = fiscal ye> #bjbb2 & 7,d7 #df1jjj1jjj = ea* ( fiscal ye>s #bjbc ?r\gh #bjbg4 7g7 ,effect ( failure ,to pay fees ,! ,secret>y %all n consid] a regi/ration by a responsible p]son submitt$ "u section #fje to be complete until all fees ow$ by su* p]son "u subsection 7a7 are paid4 ,until ! fees are paid1 ! regi/ration is incomplete & ! responsible p]son is deem$ to h fail$ to regi/] 9 accordance ) section #fje4 7h7 ,collection ( unpaid fees ,9 any case :]e ! ,secret>y does n receive paym5t ( a fee assess$ "u subsection 7a71 su* fee %all be treat$ z a claim ( ! ,unit$ ,/ates ,gov]nm5t subject to sub*apt] ,,ii ( *apt] #cg ( title #ca1 ,unit$ ,/ates ,code4 7i7 ,con/ruction ,?is section may n be con/ru$ to require t ! numb] ( full-"t equival5t positions 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 = (fic]s1 employees1 & advisory committees n engag$ 9 cosmetic safety activities1 be r$uc$ to (fset ! numb] ( (fic]s1 employees1 & advisory committees s engag$4 7j7 ,records ,ea* responsible p]son t is requir$ to regi/] "u section #fje %all reta9 all records necess>y to demon/rate gross annual sales = at lea/ #b fiscal ye>s aft] su* in=mation is report$ 9 its regi/ration4 ,su* records %all be made available to ! ,secret>y = review & duplication ^u reque/ ( ! ,secret>y4 7k7 ,limitation ,?is "p does n au?orize ! assessm5t or collection ( a fee = regi/ration "u section #fje occurr+ aft] fiscal ye> #bjbg4 4 #bjc4 ,direct hir+ au?ority to support activities relat$ to cosmetics ,"p #aj ( sub*apt] ,c ( *apt] ,,vii1 z add$ by section #bjb1 is am5d$ by ins]t+ aft] section #gdd,m ! foll[+3 #gdd,n4 ,direct hir+ au?ority to support activities relat$ to cosmetics ,! ,secret>y %all h direct hir+ au?ority ) respect to ! appo9tm5t ( employees into ! competitive s]vice or ! except$ s]vice to adm9i/] ! ,cosmetic ,safety ,enhancem5t ,act ( #bjai & ! am5dm5ts made !reby4 #gdd,o4 ,report+ requirem5ts2 reau?orization 7a7 ,p]=mance report ,beg9n+ ) fiscal ye> #bjba1 & n lat] ?an #abj cal5d> days aft] ! end ( ea* fiscal ye> !reaft] = :i* fees are collect$ "u ?is "p1 ! ,secret>y %all prep>e & submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report conc]n+ ! progress ( ! ,food & ,drug ,adm9i/ration on cosmetic safety activities dur+ su* fiscal ye>1 includ+ ! future plans ( ! ,food & ,drug ,adm9i/ration = su* activities4 7b7 ,fiscal report ,n lat] ?an #abj cal5d> days aft] ! end ( fiscal ye> #bjba & ea* subsequ5t fiscal ye> = :i* fees are collect$ "u ?is "p1 ! ,secret>y %all prep>e & submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on ! implem5tation ( ! au?ority = su* fees dur+ su* fiscal ye> & ! use1 by ! ,food & ,drug ,adm9i/ration1 ( ! fees collect$ = su* fiscal ye>4 7c7 ,public availability ,! ,secret>y %all make ! reports requir$ "u subsections 7a7 & 7b7 available to ! public on ! int]net website ( ! ,food & ,drug ,adm9i/ration4 7d7 ,reau?orization 7#a7 ,consultation ,9 develop+ recomm5dations to pres5t to ! ,congress ) respect to p]=mance goals develop$ by ! ,food & ,drug ,adm9i/ration1 & plans = meet+ ! goals1 = cosmetic safety activities = ! fir/ #e fiscal ye>s aft] fiscal ye> #bjbg1 & = ! reau?orization ( ?is "p = su* fiscal ye>s1 ! ,secret>y %all consult )-- 7,a7 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 7,b7 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate2 7,c7 sci5tific & academic exp]ts2 7,d7 heal? c>e pr(essionals2 7,e7 repres5tatives ( public heal? & consum] advocacy gr\ps2 & 7,f7 ! regulat$ indu/ry4 7#b7 ,public review ( recomm5dations ,aft] negotiations ) ! regulat$ indu/ry1 ! ,secret>y %all-- 7,a7 pres5t ! recomm5dations develop$ "u p>agraph 7#a7 to ! congressional committees specifi$ 9 su* p>agraph2 7,b7 publi% su* recomm5dations 9 ! ,f$]al ,regi/]2 7,c7 provide = a p]iod ( #cj cal5d> days = ! public to provide writt5 comm5ts on su* recomm5dations2 7,d7 hold a meet+ at :i* ! public may pres5t its views on su* recomm5dations2 & 7,e7 aft] consid]ation ( su* public views & comm5ts1 revise su* recomm5dations z necess>y4 7#c7 ,transmittal ( recomm5dations ,n lat] ?an ,janu>y #ae1 #bjbf1 ! ,secret>y %all transmit to ! ,congress ! revis$ recomm5dations "u p>agraph 7#b71 a summ>y ( ! views & comm5ts receiv$ "u su* p>agraph1 & any *anges made to ! recomm5dations 9 response to su* views & comm5ts4 4 #bjd4 ,sunset dates 7a7 ,au?orization ,sections #gdd,l1 #gdd,m1 & #gdd,n ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #bjb1 %all cease to be effective ,octob] #a1 #bjbg4 7b7 ,report+ requirem5ts ,section #gdd,o ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #bjc1 %all cease to be effective ,janu>y #ca1 #bjbh4