,,ii #aah? ,,congress #b;d ,session ,s4 #dgbh ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,july #aa 7legislative day1 ,july #aj71 #bjbd,ms4 ,klobu*> 7= h]self & ,ms4 ,duckwor?7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to ensure ! safety ( food & limit ! pres5ce ( contam9ants 9 infant & toddl] food1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,baby ,food ,safety ,act ( #bjbd4 #b4 ,def9ition ( infant or toddl] food ,section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is am5d$ by add+ at ! end ! foll[+3 7tt7 ,! t]m infant or toddl] food means food t purports to be1 or is repres5t$ z be+1 = infants or *ildr5 up to ! age ( #bd mon?s4 ,su* t]m does n include infant =mula4 4 #c4 ,contam9ants 9 food1 includ+ infant or toddl] food 7a7 ,9 g5]al ,*apt] ,,iv ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq47 is am5d$ by add+ at ! end ! foll[+3 #dbe4 ,contam9ants 9 food1 includ+ infant or toddl] food 7a7 ,adm9i/rative ord]s = contam9ants1 includ+ toxic elem5ts1 9 food 7#a7 ,9 g5]al 7,a7 ,requir$ limits ,! ,secret>y1 by adm9i/rative ord]1 %all e/abli% limits on ! toxic elem5ts ( lead1 cadmium1 m]cury1 & ars5ic 7or a species ( any su* toxic elem5t7 9-- 7i7 any infant or toddl] food2 & 7ii7 food pr$om9antly compos$ ( a fruit or vegetable puree or juice2 7,b7 ,additional limits ,if ! ,secret>y det]m9es appropriate ^u review ( relevant heal? data & o!r relevant available in=mation1 ! ,secret>y1 by adm9i/rative ord]1 may-- 7i7 e/abli% limits = contam9ants1 includ+ toxic elem5ts1 9 infant or toddl] food1 9 addition to ! limits = toxic elem5ts describ$ 9 subp>agraph 7,a72 & 7ii7 e/abli% limits = contam9ants1 includ+ toxic elem5ts1 9 food pr$om9antly compos$ ( a fruit or vegetable puree or juice1 9 addition to ! limits = toxic elem5ts describ$ 9 subp>agraph 7,a72 & 7#b7 ,proc$ure ,9 e/abli%+ or revis+ any limit "u p>agraph 7#a71 ! ,secret>y %all-- 7,a7 evaluate relevant heal? data & assessm5ts1 data f ,/ate & local heal? dep>tm5ts1 & o!r in=mation ! ,secret>y consid]s relevant2 7,b7 take into acc\nt relevant diff]5ces among food types1 gr\ps1 & categories1 z appropriate1 includ+ ! ext5t to :i* ! use ( su* sub/ances _c be avoid$ 9 ! production ( ! applicable food & its +r$i5ts1 bas$ on an evaluation ( alt]native +r$i5ts1 use ( be/ manufactur+ & agricultural practices1 & full compliance ) section #dah2 & 7,c7 not)/&+ ! requirem5ts ( sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 & *apt] #f ( title #e1 ,unit$ ,/ates ,code-- 7i7 publi% any adm9i/rative ord] "u p>agraph 7#a7 9 ! ,f$]al ,regi/] foll[+-- 7,i7 publication ( a propos$ ord] 9 ! ,f$]al ,regi/]2 & 7,,ii7 consid]ation ( comm5ts to a public docket op5 = n few] ?an #de cal5d> days2 & 7ii7 set =? 9 any propos$ or f9al adm9i/rative ord] "u p>agraph 7#a7 a sub/antive summ>y ( ! valid sci5tific evid5ce conc]n+ ! propos$ or f9al limit4 7#c7 ,*anges to limits ,if ! ,secret>y det]m9es appropriate aft] review ( relevant data & assessm5ts & o!r available & relevant heal? in=mation1 ! ,secret>y may revise any limit e/abli%$ "u ?is subsection by adm9i/rative ord] publi%$ 9 ! ,f$]al ,regi/] 9 accordance ) p>agraph 7#b74 7#d7 ,timeframe = initial limits 7,a7 ,propos$ ord]s ,subject to ! requirem5ts ( p>agraph 7#b71 ! ,secret>y %all issue propos$ ord]s = limits "u p>agraph 7#a77;,a7 z foll[s3 7i7 ,= lead1 n lat] ?an ,decemb] #ca1 #bjbe4 7ii7 ,= ars5ic1 n lat] ?an ,decemb] #ca1 #bjbe4 7iii7 ,= cadmium1 n lat] ?an ,april #cj1 #bjbf4 7iv7 ,= m]cury1 n lat] ?an ,april #cj1 #bjbh4 7,b7 ,f9al ord]s ,! ,secret>y %all issue ea* f9al adm9i/rative ord] = a limit e/abli%$ pursuant to subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a7 n lat] ?an #ah mon?s aft] issuance ( ! respective propos$ ord]4 7#e7 ,crit]ia ,! limits e/abli%$ "u ?is section %all repres5t ! level at :i* ! contam9ant may r5d] ! infant or toddl] food injuri\s to heal?4 ,9 det]m9+ su* limits ! ,secret>y %all take into acc\nt ! ext5t to :i* ! use ( su* sub/ance _c be avoid$ 9 ! production ( ea* su* food & its +r$i5ts1 bas$ on an evaluation ( alt]native +r$i5ts1 use ( be/ manufactur+ & agricultural practices1 & compliance ) section #dah4 7#f7 ,adult]at$ food ,a food may be det]m9$ adult]at$1 at ! f9al product =m1 "u section #djb7;j71 if su* food be>s or conta9s any contam9ant 7includ+ any toxic elem5t7 9 excess ( a limit e/abli%$ "u ?is subsection4 7#g7 ,p]iodic review ,! ,secret>y %all review1 n less frequ5tly ?an e #d ye>s1 ! limits e/abli%$ "u ?is subsection1 tak+ into consid]ation relevant in=mation & available data to consid] :e!r su* limits %\ld be revis$1 foll[+ ! proc$ure describ$ 9 p>agraph 7#b71 9 accordance ) ! crit]ia specifi$ 9 p>agraph 7#e74 7b7 ,sampl+ & te/+ = toxic elem5ts & contam9ants 9 food1 includ+ infant & toddl] food 7#a7 ,9 g5]al ,beg9n+ n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,baby ,food ,safety ,act ( #bjbd1 ! own]1 op]ator1 or ag5t 9 *>ge ( a facility engag$ 9 manufactur+ or process+ infant or toddl] food2 food pr$om9antly compos$ ( a fruit or vegetable puree or juice2 or su* o!r food z ! ,secret>y may specify by regulation1 = consumption 9 ! ,unit$ ,/ates1 %all-- 7,a7 h a control program 9 place = toxic elem5ts & contam9ants subject to limits "u subsection 7a77#a72 7,b7 collect repres5tative samples ( ea* su* food 9 f9al product =m 9 accordance ) a sampl+ plan describ$ 9 p>agraph 7#b72 & 7,c7 conduct te/+ ( ! samples collect$ f ! f9al food product = toxic elem5ts & contam9ants1 9 accordance ) a sampl+ plan describ$ 9 p>agraph 7#b74 7#b7 ,requirem5ts = sampl+ & te/+ plan 7,a7 ,9 g5]al ,! own]1 op]ator1 or ag5t 9 *>ge ( a facility describ$ 9 p>agraph 7#a7 %all-- 7i7 prep>e a writt5 plan = all sampl+ & te/+ requir$ "u ?is subsection2 & 7ii7 ensure t all sampl+ & te/+ conduct$ "u ?is subsection is conduct$ 9 accordance ) ! plan describ$ 9 clause 7i74 7,b7 ,sampl+ plan ,a sampl+ & te/+ plan requir$ by subp>agraph 7,a7 %all id5tify-- 7i7 ! numb] ( sampl+ units & sample unit size bas$ ^u appropriate crit]ia = id5tify+1 9 a repres5tative fa%ion1 ! levels ( toxic elem5ts & contam9ants 9 ea* food2 7ii7 "o or m appropriate te/ me?ods & proc$ures to be us$ to analyze ! samples2 & 7iii7 appropriate te/+ frequ5cies n less frequ5tly ?an e qu>t] & :5ev] a significant *ange 9 ! product or process necessitates su* te/+4 7,c7 ,guidance ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! ,baby ,food ,safety ,act ( #bjbd1 ! ,secret>y %all issue guidance to assi/ facilities describ$ "u p>agraph 7#a7 ) develop+ sampl+ & te/+ plans4 ,su* guidance %all address ! /&>ds = adequate & appropriate sampl+ & te/+ ( ea* toxic elem5t & contam9ant z requir$ by ! ,secret>y1 ! m9imum frequ5cy at :i* samples %\ld be te/$ = toxic elem5ts & contam9ants or specific species ( toxic elem5ts or contam9ants1 & /&>ds = compliance4 7#c7 ,contam9ants to be te/$ ,9 c>ry+ out ! sampl+ & te/+ "u ?is subsection1 ! own]1 op]ator1 or ag5t 9 *>ge ( a facility describ$ 9 p>agraph 7#a7 %all ensure t ea* sample is te/$ = levels (-- 7,a7 lead1 cadmium1 m]cury1 & ars5ic2 & 7,b7 any o!r contam9ant t ! ,secret>y may specify1 9 accordance ) ! sampl+ plan "u p>agraph 7#b74 7#d7 ,foods to be te/$ ,! sampl+ & te/+ conduct$ "u ?is subsection %all be conduct$ =-- 7,a7 infant & toddl] foods1 9 f9al product =m2 7,b7 foods pr$om9antly compos$ ( a fruit or vegetable puree or juice2 & 7,c7 su* o!r foods 9 f9al product =m z ! ,secret>y has specifi$1 z appropriate = ! protection ( public heal?4 7#e7 ,recordkeep+ 7,a7 ,9 g5]al ,! own]1 op]ator1 or ag5t 9 *>ge ( a facility describ$ 9 p>agraph 7#a7 %all ma9ta91 = n less ?an #b ye>s or ! %elf life ( ea* food product manufactur$ or process$ by ! facility1 :i*ev] is long]1 records docum5t+ ! sampl+ plan & results ( te/+ conduct$ "u ?is subsection ) respect to ! food4 ,! own]1 op]ator1 or ag5t 9 *>ge ( su* a facility %all make su* records available = inspection & copy+ by ! ,secret>y ^u reque/ by ! ,secret>y4 7,b7 ,requirem5ts ,! records ma9ta9$ z requir$ "u subp>agraph 7,a7 %all include-- 7i7 a detail$ description ( ! foods sampl$ & te/$2 7ii7 ! numb] ( samples & te/s p]=m$2 7iii7 ! size & numb] ( items 9 ea* sample unit2 7iv7 a copy ( ! sampl+ plan requir$ "u p>agraph 7#b72 7v7 id5tification ( ! entity conduct+ ! sampl+2 7vi7 id5tification ( ! entity conduct+ ! te/+2 7vii7 id5tification ( ! analytical me?ods us$ to p]=m ! sampl+ & te/+2 7viii7 analytical f9d+s ( ! sampl+ & te/+2 & 7ix7 su* o!r data & in=mation z ! ,secret>y may require4 7,c7 ,applicability ,! requirem5ts ( ?is p>agraph %all apply to all records ( sampl+ & te/+ conduct$ pursuant to ?is subsection1 reg>dless ( ! f9d+s4 7#f7 ,laboratory accr$itation ,! own]1 op]ator1 or ag5t 9 *>ge ( a facility describ$ 9 p>agraph 7#a7 %all ensure t te/+ requir$ pursuant to ?is subsection is p]=m$ 9 accordance ) int]national /&>ds by a laboratory t-- 7,a7 is 9 compliance ) ! requirem5ts reg>d+ laboratory accr$itation describ$ 9 section #dbb2 or 7,b7 if ! requirem5ts describ$ 9 subp>agraph 7,a7 d n apply to ! laboratory1 is accr$it$ by an accr$itation body t con=ms to int]national accr$itation /&>ds4 7#g7 ,sampl+ & te/+ program ,! ,secret>y %all develop & implem5t a sampl+ & te/+ program = infant & toddl] food t is suffici5t to-- 7,a7 support ! p]iodic review "u subsection 7a77#g7 ( limits on toxic elem5ts 9 infant & toddl] food2 & 7,b7 indep5d5tly v]ify t products are compliant ) ! limits proscrib$ pursuant to ?is subsection4 7c7 ,record availability 7#a7 ,9 g5]al ,^u reque/ by ! ,secret>y1 ! own]1 op]ator1 or ag5t 9 *>ge ( a facility describ$ 9 subsection 7b77#a7 %all-- 7,a7 make all records requir$ "u ?is section available promptly to ! ,secret>y = inspection & copy+2 & 7,b7 provide )9 a reasonable "t an ,engli% translation ( su* records ma9ta9$ 9 a language o!r ?an ,engli%4 7#b7 ,record availability ,any records t ! ,secret>y may inspect "u ?is section %all1 ^u ! reque/ ( ! ,secret>y1 be provid$ to ! ,secret>y by ! own]1 op]ator1 or ag5t 9 *>ge ( a facility describ$ 9 subsection 7b77#a71 9 advance ( or 9 lieu ( an inspection1 )9 a reasonable timeframe1 )9 reasonable limits1 & 9 a reasonable mann]1 & 9 ei!r electronic or physical =m1 at ! exp5se ( su* own]1 op]ator1 or ag5t4 ,! ,secret>y's reque/ %all include a suffici5t description ( ! records reque/$4 7#c7 ,confirmation ,^u receipt ( records reque/$ "u p>agraph 7#a7 or 7#b71 ! ,secret>y %all provide to ! own]1 op]ator1 or ag5t describ$ 9 p>agraph 7#b7 confirmation ( ! receipt4 7#d7 ,au?ority ( ! ,secret>y ,no?+ 9 ?is subsection supplants ! au?ority ( ! ,secret>y to conduct sampl+1 te/+1 or inspections o!rwise p]mitt$ "u ?is ,act 9 ord] to ensure compliance ) ?is ,act4 7d7 ,delay$ applicability ,! requirem5ts = sampl+ & te/+ "u ?is section %all apply beg9n+ on ! date t is #b ye>s aft] ! date ( enactm5t ( ?is subsection4 4 7b7 ,import] requirem5ts ,section #hje7;c77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;a7c77#d77 is am5d$1 by ins]t+ monitor+ & v]ify+ ! accuracy ( records describ$ 9 section #dbe7;b7 aft] = %ipm5ts14 7c7 ,en=cem5t 7#a7 ,adult]ation ,section #djb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cdb7 is am5d$ by add+ at ! end ! foll[+3 7j7 ,if x is an article ( food 9 f9al product =m t is an infant & toddl] food1 a food pr$om9antly compos$ ( a fruit or vegetable puree or juice1 or su* o!r food z ! ,secret>y may specify &-- 7#a7 su* food be>s or conta9s any toxic elem5t or contam9ant 9 excess ( a limit e/abli%$ "u section #dbe7;a72 or 7#b7 ! own]1 op]ator1 or ag5t 9 *>ge ( a facility t manufactures or processes ! food is n 9 compliance ) subsection 7b7 or 7c7 ( section #dbe4 4 7#b7 ,prohibit$ act ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is am5d$ by add+ at ! end ! foll[+3 7jjj7 ,! failure ( an own]1 op]ator1 or ag5t 9 *>ge ( a facility t manufactures or processes food to comply ) applicable requirem5ts "u subsection 7b7 or 7c7 ( section #dbe4 4 #d4 ,implem5tation ( food traceability plan2 /udy on inspections2 report+ on inspections 7a7 ,implem5tation plan ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 9 coord9ation ) ! ,,fda ,human ,foods ,program & ! ,c5t] = ,food ,safety & ,appli$ ,nutrition1 %all f9alize an implem5tation plan = ! ,food & ,drug ,adm9i/ration to a*ieve its goal ( compliance1 n lat] ?an ,janu>y #bj1 #bjbf1 ) ! rule issu$ by ! ,food & ,drug ,adm9i/ration titl$1 ,requirem5ts = ,additional ,traceability ,records = ,c]ta9 ,foods 7#hg ,f$4 ,reg4 #gjiaj 7,novemb] #ba1 #bjbb77 7or any successor rule74 ,su* plan %all include a description (-- 7#a7 any res\rce ne$s ( ! ,food & ,drug ,adm9i/ration2 7#b7 /rategies = facilitat+ compliance ) ! rule2 & 7#c7 detail$ plans = communicat+ ) & educat+ regulat$ entities1 non-,f$]al regulatory p>tn]s1 & regulatory /aff ( ! ,food & ,drug ,adm9i/ration ab\t ! requirem5ts "u ! rule4 7b7 ,/udy on inspections ,! ,secret>y %all-- 7#a7 conduct a /udy to-- 7,a7 det]m9e ! annual numb] ( facility inspections t is suffici5t to det]m9e t import$ foods are held to ! same safety /&>ds z dome/ic food2 & 7,b7 id5tify :e!r su* inspection t>gets are consi/5t ) ! t>gets 9 ! mo/ rec5t annual report reg>d+ food conduct$ "u section #ajjc7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cic7;h772 & 7#b7 n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 submit a report to ,congress on ! f9d+s ( su* /udy1 &1 if applicable1 any factors prev5t+ ! ,secret>y f meet+ its goal = ! numb] ( inspections & a plan to ensure t su* goal is met 9 ! next #b ye>s4 7c7 ,annual report reg>d+ food ,section #ajjc7;h77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cic7;h77#a77 is am5d$-- 7#a7 9 subp>agraph 7,e71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,f71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,g7 ! nature ( dome/ic facility & =eign facility inspections describ$ 9 subp>agraph 7,c71 ! aggregate inspection f9d+s ( su* inspections1 & ! compliance rate ( =eign food import]s ) c]tification /&>ds2 4 #e4 ,records = or 9 lieu ( c]ta9 inspections ,section #gjd7;a77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#d77 is am5d$-- 7#a7 by r$esignat+ subp>agraphs 7,b7 ?r\gh 7,d7 z subp>agraphs 7,c7 ?r\gh 7,e71 respectively2 7#b7 by ins]t+ aft] subp>agraph 7,a7 ! foll[+ new subp>agraph3 7,b7 7i7 ,any records or o!r in=mation t ! ,secret>y may remotely inspect or copy "u au?ority ( ?is ,act f a p]son t owns or op]ates1 or is an ag5t 9 *>ge (1 an e/abli%m5t t is engag$ 9 any ( ! activities describ$ 9 clause 7ii7 %all1 ^u ! reque/ ( ! ,secret>y1 be provid$ to ! ,secret>y by su* p]son1 9 advance (1 at ! "t (1 or 9 ! case 9 :i* an 9-p]son inspection w\ld be unsafe1 9 lieu (1 an 9-p]son1 on-site inspection1 )9 a reasonable timeframe1 )9 reasonable limits1 & 9 a reasonable mann]1 & 9 ei!r electronic or physical =m1 at ! exp5se ( su* p]son4 ,! ,secret>y's reque/ %all include a suffici5t description ( ! records or o!r in=mation reque/$4 7ii7 ,! activities describ$ 9 ?is clause are records relat+ to-- 7,i7 ! manufactur+1 process+1 sampl+1 te/+1 pack+1 transport+1 di/ribut+1 receiv+1 hold+1 or import+ ( an article ( food2 or 7,,ii7 ! di/ribution or use ( animal fe$ be>+ or conta9+ a vet]9>y fe$ directive drug1 or ! issuance ( a vet]9>y fe$ directive4 2 & 7#c7 by add+ at ! end ! foll[+3 7,f7 ,section #gjc does n apply to records obta9$ or copi$1 or o!r in=mation obta9$ or copi$ pursuant to a reque/ made "u ?is section4 4 #f4 ,m&atory recall au?ority ,section #dbc7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cejl7a77 is am5d$ by ins]t+ aft] animals1 ! foll[+3 or t an article ( food is adult]at$ "u p>agraph 7a77#a7 or 7j7 ( section #djb14 #g4 ,environm5tal monitor+ ,*apt] ,,iv ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq471 z am5d$ by section #c1 is fur!r am5d$ by add+ ! foll[+3 #dbf4 ,environm5tal monitor+ ( infant & toddl] food 7a7 ,9 g5]al ,a manufactur] ( infant & toddl] food 7o!r ?an infant =mula7 %all e/abli% & implem5t an environm5tal monitor+ program to v]ify ! effectiv5ess ( sanitation & hygi5e controls dur+ ! manufactur+ & packag+ process :]e ! food has ! pot5tial to be expos$ to pa?og5s4 ,! environm5tal monitor+ program %all be writt5 & include proc$ures = det]m9+ sample location1 numb] ( samples to be tak51 & tim+ & frequ5cy ( sample collection & te/+4 7b7 ,organisms sampl$ ,! environm5tal monitor+ program "u subsection 7a7 %all include te/+ = environm5tal pa?og5s or a reliable indicator organism4 7c7 ,sampl+ location & numb] ( samples ,a manufactur] ( infant & toddl] food %all ensure t ! sampl+ locations f :i* samples w be tak51 & ! numb] ( sites to be te/$ dur+ r\t9e environm5tal monitor+ are adequate to det]m9e :e!r sanitation & hygi5e controls are effective4 7d7 ,tim+ & frequ5cy ,! tim+ & frequ5cy = collect+ & te/+ samples %all be adequate to det]m9e :e!r sanitation & hygi5e controls are effective1 & %all occur n less frequ5tly ?an e #c ye>s4 7e7 ,records 7#a7 ,availability to ! secret>y ,a manufactur] ( infant & toddl] food %all make all ! records requir$ "u ?is section available promptly to ! ,secret>y1 ^u reque/ by ! ,secret>y1 = inspection & copy+4 7#b7 ,ma9t5ance ( records p]ta9+ to environm5tal monitor+ ,records ( environm5tal sampl+1 te/+1 & monitor+ conduct$ pursuant to ?is section %all be e/abli%$ & ma9ta9$ by ! manufactur] = n less ?an #b ye>s or ! %elf life ( ! food1 :i*ev] is long]4 7#c7 ,conditions ( inspection ,any records or o!r in=mation t ! ,secret>y may inspect "u ?is section %all1 ^u ! reque/ ( ! ,secret>y1 be provid$ to ! ,secret>y by ! manufactur]1 9 advance (1 at ! "t (1 or 9 ! case 9 :i* an 9-p]son inspection w\ld be unsafe1 9 lieu (1 an 9-p]son1 on-site inspection1 )9 a reasonable timeframe1 )9 reasonable limits1 & 9 a reasonable mann]1 & 9 ei!r electronic or physical =m1 at ! exp5se ( su* manufactur]4 ,! ,secret>y's reque/ %all include a suffici5t description ( ! records reque/$4 7#d7 ,confirmation ( receipt ,^u receipt ( ! records reque/$ "u p>agraph 7#c71 ! ,secret>y %all provide to ! manufactur] confirmation ( receipt4 7f7 ,au?ority ( ! secret>y ,no?+ 9 ?is section supplants ! au?ority ( ! ,secret>y to conduct inspections o!rwise p]mitt$ "u ?is ,act 9 ord] to ensure compliance ) ?is ,act4 7g7 ,effective date ,! requirem5ts ( ?is section %all apply beg9n+ on ! date t is #b ye>s aft] ! date ( enactm5t ( ! ,baby ,food ,safety ,act ( #bjbd4 7h7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to exempt any manufactur] f ! requirem5ts ( ?is ,act1 includ+ ! requirem5ts "u section #dah4 4