,,ii #aah? ,,congress #b;d ,session ,s4 #ddbh ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #bc1 #bjbd,mr4 ,"y 7= himself & ,mr4 ,padilla7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation ,a ,,bill ,to e/abli% an int]ag5cy committee to coord9ate activities ( ! ,f$]al ,gov]nm5t relat+ to biote*nology ov]sight1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,biote*nology ,ov]sight ,coord9ation ,act ( #bjbd4 #b4 ,f9d+s2 purpose 7a7 ,f9d+s ,congress f9ds t-- 7#a7 biote*nology h>nesses ! p[] ( biology to create new products & provides opportunities to gr[ ! ,unit$ ,/ates economy1 provide jobs = a skill$ work=ce1 improve resili5ce ( supply *a9s1 & improve ! quality ( human lives & ! environm5t2 & 7#b7 a sci5ce-bas$1 risk-proportionate1 pr$ictable1 effici5t1 & transp>5t sy/em to support ! safe use ( products ( biote*nology w enable ! ,unit$ ,/ates to cont9ue to be a _w lead] 9 biote*nology rese>* & developm5t4 7b7 ,purpose ,! purpose ( ?is ,act is to coord9ate & enhance ! ef=ts ( ! ,f$]al ,gov]nm5t "u ! ,coord9at$ ,framework = ! ,regulation ( ,biote*nology to protect heal? & ! environm5t :ile enabl+ ! developm5t1 comm]cialization1 & safe use ( products d]iv$ f plants1 animals1 & microorganisms develop$ ) biote*nology4 #c4 ,biote*nology ,ov]sight ,coord9ation ,committee 7a7 ,e/abli%m5t ( ,committee 7#a7 ,9 g5]al ,! ,presid5t1 act+ ?r\gh ! ,director ( ! ,(fice ( ,sci5ce & ,te*nology ,policy & ! ,director ( ! ,(fice ( ,managem5t & ,budget1 %all e/abli% an int]ag5cy committee to coord9ate activities ( ! ,f$]al ,gov]nm5t relat+ to biote*nology-specific regulation & ov]sight 7ref]r$ to 9 ?is section z ! ,committee74 7#b7 ,*>t] 7,a7 ,9 g5]al ,n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 ! ,committee %all-- 7i7 ratify a *>t] = ! op]ation ( ! ,committee2 & 7ii7 make publicly available on ! ,unifi$ ,website = ,biote*nology ,regulation develop$ pursuant to ,executive ,ord] #achgd 7#g ,u4,s4,c4 #caba note2 relat+ to mod]niz+ ! regulatory framework = agricultural biote*nology products7 7ref]r$ to 9 ?is section z ! ,unifi$ ,website7 t ratifi$ *>t]4 7,b7 ,expansion or modification ,! ,committee may exp& ^u or modify ! initial ratifi$ *>t] "u subp>agraph 7,a77i7 z ne$$4 7b7 ,memb]%ip ,! ,committee %all be compos$ ( ! heads1 or _! designees1 ( ag5cies responsible = biote*nology ov]sight1 includ+-- 7#a7 ! ,animal & ,plant ,heal? ,inspection ,s]vice1 ! ,agricultural ,m>ket+ ,s]vice1 & ! ,food ,safety & ,inspection ,s]vice ( ! ,dep>tm5t ( ,agriculture2 7#b7 ! ,food & ,drug ,adm9i/ration & ! ,national ,in/itutes ( ,heal? ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 7#c7 ! ,environm5tal ,protection ,ag5cy2 7#d7 ! ,(fice ( ,managem5t & ,budget2 7#e7 ! ,(fice ( ,sci5ce & ,te*nology ,policy2 & 7#f7 o!r ,f$]al ag5cies or entities z det]m9$ appropriate by ! ,*air ( ! ,committee4 7c7 ,*air ,! ,director ( ! ,(fice ( ,sci5ce & ,te*nology ,policy %all s]ve z ! ,*air ( ! ,committee4 7d7 ,regulatory /reaml9+ ,! ,committee %all exp& or build ^u ef=ts to coord9ate biote*nology ov]sight1 includ+ ?r\gh measurable /eps-- 7#a7 to align or cl>ify regulatory timel9es1 approa*es1 & data requirem5ts2 7#b7 to facilitate in=mation-%>+ betwe5 regulatory ag5cies1 not)/&+ any o!r provision ( law2 7#c7 to id5tify an initial po9t ( contact = ea* type ( biote*nology product1 includ+ em]g+ products1 & cle> h&-(fs f "o process or ag5cy to ano!r2 7#d7 to id5tify & m9imize any areas ( delay relative to e/abli%$ timeframes1 includ+ by r$uc+ duplicative review & build+ ^u prior reviews to ! maximum ext5t practicable2 & 7#e7 to conduct p]iodic horizon-scann+ = em]g+ biote*nology processes & products to ensure appropriate ov]sight4 7e7 ,report to ,congress ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 & annually !reaft]1 ! ,committee %all submit to ,congress & make publicly available on ! ,unifi$ ,website a description ( ! foll[+3 7#a7 ,actions tak5 & next /eps "u subsection 7d71 ) a description ( successes1 specific /aff+ & res\rce ne$s1 & recomm5dations = remov+ any id5tifi$ b>ri]s1 includ+ *anges to /atutes1 regulations1 or guidance4 7#b7 ,a summ>y ( ! duration ( ov]sight ) respect to biote*nology products1 f ! initial contact ) a develop] to a decision ) respect to ! biote*nology product1 dur+ a p]iod ( n less ?an #e fiscal ye>s prec$+ ! date ( ! report1 includ+-- 7,a7 ! type ( product2 7,b7 ! #a or m types ( review2 7,c7 ! #a or m ag5cies t review$ t product2 & 7,d7 an explanation ( timel9es :]e ne$$4 7f7 ,unifi$ process ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 & annually !reaft]1 ! ,committee %all submit to ,congress & make publicly available on ! ,unifi$ ,website ! foll[+3 7#a7 ,a s+ul>1 unifi$ process to id5tify :e!r a plant1 animal1 or microorganism produc$ ) biote*nology c\ld reasonably h occurr$ naturally or be5 develop$ by conv5tional means 7mean+ ! g5etic sequ5ces ( ! biote*nology product are pres5t 9 ! g5e pool ( ! plant1 animal1 or microorganism or c\ld h aris5 ?r\gh natural mutation me*anisms71 tak+ into acc\nt exi/+ ag5cy assessm5ts :]e appropriate4 7#b7 ,measurable actions ! ,committee & any memb] ( ! ,committee w take to implem5t or consid] ! unifi$ process describ$ 9 p>agraph 7#a7 9 _! ov]sight ( biote*nology products1 tak+ into acc\nt t organisms id5tifi$ via ! process describ$ 9 p>agraph 7#a7 w\ld cont9ue to be regulat$ ) product-specific ov]sight4 7#c7 ,actions tak5 & progress made ) respect to p>agraph 7#b74 7g7 ,molecul> f>m+ & precision f]m5tation ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 & annually !reaft]1 ! ,committee %all submit to ,congress & make publicly available on ! ,unifi$ ,website a description ( ! foll[+3 7#a7 ,*>act]i/ics ( organisms t may increase risk pa?ways or o!rwise h9d] ! production ( sub/ances int5d$ = extraction4 7#b7 ,*>act]i/ics ( organisms t may r$uce risk pa?ways associat$ ) ! production ( sub/ances int5d$ = extraction4 7#c7 ,conditions t are useful = conta9+ or segregat+ organisms produc$ ) biote*nology t may r$uce risk pa?ways associat$ ) ! production ( sub/ances int5d$ = extraction4 7#d7 ,examples ( organisms t-- 7,a7 fit "s or all ( ! *>act]i/ics describ$ 9 p>agraph 7#b72 & 7,b7 are am5able to "s or all ( ! conditions describ$ 9 p>agraph 7#c74 7#e7 ,measurable actions ! ,committee & any memb] ( ! ,committee w take to implem5t or consid] ! *>act]i/ics describ$ 9 p>agraph 7#b7 & ! conditions describ$ 9 p>agraph 7#c7 into _! ov]sight ( biote*nology products4 7#f7 ,actions tak5 "u p>agraph 7#e7 & progress made ) respect to ^? actions4 7h7 ,coord9ation & consultation 7#a7 ,coord9ation ,! ,committee %all coord9ate1 z appropriate1 )-- 7,a7 o!r work+ gr\ps & committees ( ! ,f$]al ,gov]nm5t2 & 7,b7 o!r relevant ag5cies4 7#b7 ,consultation ,! ,committee %all regul>ly consult 9 a coord9at$ fa%ion reg>d+ biote*nology ov]sight1 includ+ ) respect to ! reports "u subsection 7e71 ) ,/ates1 ,indian ,tribes1 t]ritories1 local gov]nm5ts1 biote*nology develop]s & relevant indu/ries1 academic in/itutions1 nongov]nm5tal organizations1 & o!r /akehold]s4 7i7 ,executive ,secret>ies 7#a7 ,dep>tm5t ( ,agriculture ,! ,secret>y ( ,agriculture %all appo9t an ,executive ,secret>y to s]ve ! ,committee1 :o %all be & rema9 a p]man5t employee ( ! ,dep>tm5t ( ,agriculture4 7#b7 ,dep>tm5t ( ,heal? & ,human ,s]vices2 ,environm5tal ,protection ,ag5cy ,! ,secret>y ( ,heal? & ,human ,s]vices & ! ,adm9i/rator ( ! ,environm5tal ,protection ,ag5cy may ea* appo9t an ,executive ,secret>y to s]ve ! ,committee1 :o %all be & rema9 a p]man5t employee ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices & ! ,environm5tal ,protection ,ag5cy1 respectively4 7j7 ,comptroll] ,g5]al review ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all-- 7#a7 n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 beg9 a review to assess ! efficacy ( int]ag5cy coord9ation & o!r activities conduct$ by ! ,committee2 7#b7 n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 provide to ,congress a brief+ ( ! initial f9d+s ( ! ,comptroll] ,g5]al ) respect to ! activities ( ! ,committee2 & 7#c7 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 provide to ,congress a report describ+ ! curr5t /atutory au?orities & ov]sight processes applicable to biote*nology-specific regulation ( products d]iv$ f plants1 animals1 & microorganisms develop$ ) biote*nology1 includ+ a description ( opportunities to r$uce gaps1 duplication1 ov]lap1 & fragm5tation4 7k7 ,exclusions ,?is ,act %all n apply to human m$ical rese>* & products t are regulat$ solely by ! ,food & ,drug ,adm9i/ration4