,,ii #aai? ,,congress #b;d ,session ,s4 #dbbg ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #bf1 #bjbf,ms4 ,cortez ,ma/o 7= h]self & ,mr4 ,banks7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to require ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 to c>ry out a program "u :i* ! ,secret>y requires ea* cov]$ di/ributor ( a highly pa?og5ic ag5t to comply ) c]ta9 logbook requirem5ts1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,prev5t+ ,illegal ,laboratories & ,protect+ ,public ,heal? ,act ( #bjbf4 #b4 ,requir+ c]ta9 di/ributors ( highly pa?og5ic ag5ts to keep a logbook ( sales1 leases1 loans1 & o!r transf]s 7a7 ,program ,! ,secret>y %all c>ry out a program "u :i* ! ,secret>y requires ea* cov]$ di/ributor ( a highly pa?og5ic ag5t to comply ) ! logbook requirem5ts ( subsection 7c74 7b7 ,li/ ( highly pa?og5ic ag5ts 7#a7 ,developm5t ,! ,secret>y %all develop & ma9ta9 a li/ ( all ag5ts t meet ! def9ition ( a highly pa?og5ic ag5t 9 subsection 7e74 7#b7 ,initial li/ ,! ,secret>y %all develop ! initial li/ requir$ by p>agraph 7#a7 n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is ,act4 7#c7 ,p]iodic review ,! ,secret>y %all annually review & update ! li/ requir$ by p>agraph 7#a74 7#d7 ,consultation2 consid]ation ,9 develop+ & updat+ ! li/ requir$ by p>agraph 7#a71 ! ,secret>y %all-- 7,a7 consult ) relevant ag5cies1 includ+ ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,national ,in/itutes ( ,heal?1 ! ,dep>tm5t ( ,homel& ,security1 ! ,dep>tm5t ( ,agriculture1 ! ,dep>tm5t ( ! ,int]ior1 & ! ,dep>tm5t ( ,def5se2 7,b7 take into consid]ation ! late/ edition ( ,biosafety 9 ,microbiological & ,biom$ical ,laboratories publi%$ by ! ,c5t]s = ,disease ,control & ,prev5tion & ! ,national ,in/itutes ( ,heal? 7or any successor to su* publication72 & 7,c7 take into consid]ation ! late/ edition ( ,,nih ,guidel9es = ,rese>* ,involv+ ,recomb9ant or ,syn!tic ,nucleic ,acid ,molecules publi%$ by ! ,national ,in/itutes ( ,heal? 7or any successor to su* publication74 7c7 ,logbook requirem5ts 7#a7 ,9 g5]al ,ea* cov]$ di/ributor %all ma9ta91 9 accordance ) su* crit]ia & =mat z ! ,secret>y may require1 an electronic li/ 79 ?is section ref]r$ to z a logbook7 ( ! sales1 leases1 loans1 or o!r transf]s by su* di/ributor ( ea* highly pa?og5ic ag5t on ! li/ "u subsection 7b74 7#b7 ,cont5ts ,! cov]$ di/ributor %all1 = ea* sale1 lease1 loan1 or o!r transf] ref]r$ to 9 p>agraph 7#a71 include 9 ! logbook-- 7,a7 ! ag5t by "n2 7,b7 ! "n1 address1 telephone numb]1 & email address ( ! pur*as]2 7,c7 o!r relevant id5tify+ bus9ess in=mation ( ! pur*as]1 z ! ,secret>y det]m9es appropriate2 7,d7 a %ort description (-- 7i7 ! pur*as]'s int5d$ use ( ! highly pa?og5ic ag5t2 & 7ii7 :]e ! pur*as] w h\se ! ag5t2 7,e7 ! date & "t ( ! sale1 lease1 loan1 or o!r transf]2 7,f7 ! me?od1 date1 & "t ( transf] ( ! highly pa?og5ic ag5t2 7,g7 a physical or electronic signature ( ! pur*as]2 & 7,h7 su* o!r data elem5ts z ! ,secret>y may require4 7#c7 ,sale requirem5ts ,9 ! case ( a sale1 lease1 loan1 or o!r transf] to :i* p>agraph 7#a7 applies1 ! cov]$ di/ributor %all n sell ! highly pa?og5ic ag5t unless-- 7,a7 ! prospective pur*as]1 9 physical =m or electronically 9 compliance ) ! ,electronic ,signatures 9 ,global & ,national ,comm]ce ,act 7#db ,u4,s4,c4 #gjja et seq47-- 7i7 pres5ts an id5tification c>d t provides a photograph & is issu$ by a ,/ate or ! ,f$]al ,gov]nm5t1 or a docum5t t1 ) respect to id5tification1 is consid]$ acceptable = purposes ( sections #bgd;a4#b7;b77#a77v77,a7 & #bgd;a4#b7;b77#a77v77,b7 ( title #h1 ,code ( ,f$]al ,regulations 7or successor regulations72 & 7ii7 v]ifies by signature 9 ! logbook-- 7,i7 ! pur*as]'s "n & address2 7,,ii7 a %ort description (-- 7aa7 ! pur*as]'s int5d$ use ( ! ag5t2 & 7bb7 :]e ! pur*as] w h\se ! ag5t2 7,,iii7 ! date & "t ( ! sale1 lease1 loan1 or o!r transf]2 & 7,,iv7 ! me?od1 date1 & "t ( transf] ( ! ag5t2 & 7,b7 ! cov]$ di/ributor-- 7i7 det]m9es t ! "n ent]$ 9 ! logbook corresponds to ! "n provid$ on ! id5tification c>d describ$ 9 subp>agraph 7,a77i71 & t ! in=mation ent]$ pursuant to subp>agraph 7,a77ii7 is correct2 & 7ii7 ent]s 9 ! logbook ! "n ( ! highly pa?og5ic ag5t4 7#d7 ,notice ,! cov]$ di/ributor %all include 9 ! logbook1 9 accordance ) crit]ia ( ! ,secret>y1 a notice to pur*as]s t ent]+ false /atem5ts or misrepres5tations 9 ! logbook may subject ! pur*as]s to crim9al p5alties "u section #ajja ( title #ah1 ,unit$ ,/ates ,code1 :i* notice specifies ! maximum f9e & t]m ( imprisonm5t "u su* section4 7#e7 ,duration ( ma9t5ance ( entries 7,a7 ,ret5tion p]iod ,! cov]$ di/ributor %all ma9ta9 ea* entry 9 ! logbook = n few] ?an #c ye>s aft] ! date on :i* ! entry is made4 7,b7 ,successor entity ,if own]%ip ( a cov]$ di/ributor *anges1 ! successor entity %all assume cu/ody ( & responsibility = all logbooks = ! rema9d] ( ! #c-ye> ret5tion p]iod requir$ by subp>agraph 7,a74 7#f7 ,disclosure ( logbooks ,! ,secret>y %all e/abli% re/rictions on disclosure ( in=mation 9 logbooks4 ,su* regulations %all-- 7,a7 provide = ! disclosure ( ! in=mation1 z appropriate1 to ! ,secret>y1 ,f$]al1 ,/ate1 local1 ,tribal1 & t]ritorial law en=cem5t ag5cies1 & ,/ate heal? (ficials2 & 7,b7 prohibit access+1 us+1 or %>+ in=mation 9 ! logbooks = any purpose o!r ?an-- 7i7 to ensure compliance ) ?is section2 7ii7 to protect public heal? & safety2 or 7iii7 to protect national security4 7#g7 ,,foia exemption ,logbooks & any d]ivative data are exempt f disclosure "u section #eeb7;b77#c7 ( title #e1 ,unit$ ,/ates ,code4 7#h7 ,applicability ,a transf] ( a highly pa?og5ic ag5t betwe5 laboratories )9 a s+le in/itution ( high] education 7z def9$ 9 section #aja ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajja77 does n con/itute a sale1 lease1 loan1 or o!r transf] ( ! ag5t = purposes ( p>agraph 7#a74 7#i7 ,audits ,! ,secret>y %all e/abli% a risk-bas$ compliance review process by :i* ! ,secret>y may conduct audits ( logbooks :5 ! ,secret>y has cause to believe a violation ( ?is section has occurr$4 ,! ,secret>y %all focus audits conduct$ "u ?is p>agraph on high]-risk di/ributors & suspici\s patt]ns4 7d7 ,false /atem5ts or misrepres5tations by pur*as]s ,= purposes ( section #ajja ( title #ah1 ,unit$ ,/ates ,code1 provid+ in=mation to a cov]$ di/ributor = purposes ( ent]+ su* in=mation 9 a logbook %all be consid]$ a matt] )9 ! jurisdiction ( ! executive1 legislative1 or judicial bran* ( ! ,gov]nm5t ( ! ,unit$ ,/ates4 7e7 ,def9itions ,9 ?is section3 7#a7 ,! t]m cov]$ di/ributor-- 7,a7 means an entity t sells1 leases1 loans1 or o!rwise transf]s = value or n = value a highly pa?og5ic ag5t1 except t su* t]m does n include an employee or ag5t ( su* a di/ributor2 & 7,b7 includes a publicly fund$ repository or biobank t sells1 leases1 loans1 or o!rwise transf]s a highly pa?og5ic ag5t1 z describ$ 9 subp>agraph 7,a74 7#b7 ,! t]m highly pa?og5ic ag5t-- 7,a7 subject to subp>agraph 7,b71 means a pa?og5ic ag5t t meets ! crit]ia ( risk gr\p #c or any high] level risk gr\ps z su* risk gr\ps are def9$ 9 ! late/ edition ( ,,nih ,guidel9es = ,rese>* ,involv+ ,recomb9ant or ,syn!tic ,nucleic ,acid ,molecules publi%$ by ! ,national ,in/itutes ( ,heal? 7or any successor to su* publication72 & 7,b7 excludes any biological ag5t or tox9 t is regulat$ "u section #cea;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb;a7 or section #bab ( ! ,agricultural ,biot]rorism ,protection ,act ( #bjjb 7#g ,u4,s4,c4 #hdja74 7#c7 ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,assi/ant ,secret>y = ,/rategic ,prep>$ness & ,response4 7f7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to sup]s$e or o!rwise affect ! ,f$]al ,select ,ag5t ,program "u section #cea;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb;a7 & section #bab ( ! ,agricultural ,biot]rorism ,protection ,act ( #bjjb 7#g ,u4,s4,c4 #hdja74 #c4 ,evaluation ( high-conta9m5t laboratories 7a7 ,9 g5]al ,! ,national ,security ,advisor1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,agriculture1 ! ,secret>y ( ,def5se1 ! ,secret>y ( ,homel& ,security1 ! ,secret>y ( ! ,int]ior1 ! ,director ( ,national ,intellig5ce1 & su* o!r ,f$]al (ficials z ! ,national ,security ,advisor det]m9es appropriate1 %all id5tify a s+le ,f$]al entity to ov]see a p]iodic /rategic evaluation ( high-conta9m5t laboratories 9 ! ,unit$ ,/ates4 7b7 ,topics ,ea* /rategic evaluation "u subsection 7a7 %all include-- 7#a7 an assessm5t (-- 7,a7 ! numb]1 location1 & mission ( high-conta9m5t laboratories2 7,b7 ! capacity ( su* exi/+ laboratories to effectively meet national goals to c\nt] ?reats to biosafety & biosecurity2 7,c7 ! physical security measures at high-conta9m5t laboratories2 7,d7 ! aggregate risks associat$ )-- 7i7 su* exi/+ laboratories2 & 7ii7 exp&+ ! numb]s & facilities ( su* laboratories2 & 7,e7 ! type ( ov]sight ne$$ = high-conta9m5t laboratories2 & 7#b7 up-to-date national /&>ds1 develop$ by ! ,f$]al entity id5tifi$ "u subsection 7a71 t-- 7,a7 are develop$ by ! ,f$]al entity id5tifi$ "u subsection 7a7 9 consultation ) memb]s ( ! sci5tific community1 = ! design1 con/ruction1 commission+1 op]ation1 & long-t]m ma9t5ance ( high-conta9m5t laboratories2 & 7,b7 take into consid]ation applicable regulations & guidance = high-conta9m5t laboratories4 7c7 ,report+ ,^u completion ( ea* /rategic evaluation "u subsection 7a71 ! ,f$]al entity id5tifi$ "u subsection 7a7 %all submit to ! ,presid5t & to ,congress a report on ! results ( su* evaluation & include 9 ea* su* report recomm5dations on-- 7#a7 address+ gaps 9 ,f$]al ov]sight ( high-conta9m5t laboratories2 & 7#b7 utiliz+ high-conta9m5t laboratories = protect+ public heal? & ensur+ biosafety & biosecurity 9 ! ,unit$ ,/ates4 7d7 ,public heal? biosafety & biosecurity team 7#a7 ,9 g5]al ,! ,f$]al entity id5tifi$ "u subsection 7a7 %all ma9ta9 a team1 to be kn[n z ! ,public ,heal? ,biosafety & ,biosecurity ,team1 to s]ve z a s+le po9t ( contact = ,/ate1 local1 ,tribal1 & t]ritorial ag5cies reg>d+ que/ions relat+ to laboratory biosafety & biosecurity4 7#b7 ,e/abli%m5t ,! ,f$]al entity id5tifi$ "u subsection 7a7 %all e/abli% ! ,public ,heal? & ,biosecurity ,team1 z requir$ by p>agraph 7#a71 n lat] ?an "o ye> aft] su* (ficial is fir/ designat$4 7#c7 ,duties ,! ,public ,heal? ,biosafety & ,biosecurity ,team %all be ! s+le po9t ( contact 9 ! ,f$]al ,gov]nm5t = ,/ate1 local1 ,tribal1 & t]ritorial ag5cies on-- 7,a7 issues relat$ to-- 7i7 ov]sight ( high-conta9m5t laboratories2 7ii7 ! impact ( high-conta9m5t laboratories on public heal?2 or 7iii7 connect+ ,/ate1 local1 ,tribal1 & t]ritorial (ficials ) ! relevant ,f$]al ag5cy or ag5cies on matt]s relat$ to high-conta9m5t laboratories2 & 7,b7 o!r issues z ! ,f$]al entity id5tifi$ "u subsection 7a7 det]m9es appropriate4 7e7 ,feasibility /udy 7#a7 ,9 g5]al ,! ,f$]al entity id5tifi$ "u subsection 7a7 %all conduct a feasibility /udy on e/abli%+ & ma9ta9+ a database on exi/+ high-conta9m5t laboratories 9 ! ,unit$ ,/ates = ! purpose ( mak+ su* database accessible to ,f$]al1 ,/ate1 local1 ,tribal1 & t]ritorial (ficials4 7#b7 ,database describ$ ,! database consid]$ "u p>agraph 7#a7 %all be a database design$ to include1 ) respect to ea* high-conta9m5t laboratory1 ! foll[+ in=mation3 7,a7 ,! id5tity ( ! own]s ( ! laboratory4 7,b7 ,! address ( ! laboratory4 7,c7 ,! /atus ( any lic5s+ or c]tification ( ! laboratory requir$ "u ,f$]al1 ,/ate1 local1 ,tribal1 or t]ritorial law4 7,d7 ,any legal violations by1 & discipl9>y action tak5 aga9/1 ! laboratory4 7,e7 ,su* additional in=mation z ! ,f$]al entity id5tifi$ "u subsection 7a7 det]m9es appropriate to protect biosafety & biosecurity4 7#c7 ,report to ,congress ,^u completion ( ! feasibility /udy "u ?is subsection1 ! ,f$]al entity id5tifi$ "u subsection 7a7 %all submit to ,congress a report on ! results ( su* /udy4 7f7 ,def9ition ,9 ?is section1 ! t]m high-conta9m5t laboratory means a laboratory t is suitable = biosafety level #c or any high] biosafety level proc$ures1 z def9$ 9 ! late/ edition ( ,biosafety 9 ,microbiological & ,biom$ical ,laboratories publi%$ by ! ,c5t]s = ,disease ,control & ,prev5tion & ! ,national ,in/itutes ( ,heal? 7or any successor to su* publication74