,i #aah? ,,congress #a/ ,session ,h4 ,r4 #dgjb ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,july #ah1 #bjbc,ms4 ,e%oo introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to require ! ,secret>y ( ,heal? & ,human ,s]vices to prescribe a regulation r$uc+ ! risks 9 g5e syn!sis products1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,secur+ ,g5e ,syn!sis ,act4 #b4 ,requirem5ts = ! dissem9ation ( syn!tic g5etic mat]ial ,section #cea;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb;a7 is am5d$-- 7#a7 9 subsection 7b77#b71 by /rik+ ! semicolon at ! end & ins]t+ ! foll[+3 1 includ+ by-- 7,a7 assess+ unc]ta9ties1 risks1 co/s1 & b5efits associat$ ) ! implem5tation ( diff]5t types ( protocols or o!r regulations to r$uce ! risk ( pot5tial misuse ( de novo g5e syn!sis products2 7,b7 det]m9+ ! types ( protocols or o!r regulations t c\ld detect ! pot5tial misuse ( de novo g5e syn!sis products :ile g5]at+ b5efits t are l>g] ?an _! co/s2 7,c7 requir+ g5e syn!sis provid]s or manufactur]s ( g5e syn!sis equipm5t to implem5t scre5+ protocols to detect misuse ( de novo g5e syn!sis products2 7,d7 v]ify+ or provisionally v]ify+ t g5e syn!sis provid]s & manufactur]s ( g5e syn!sis equipm5t adh]e to ! regulation prescrib$ pursuant to subp>agraph 7,c72 & 7,e7 assess+1 collect+1 & waiv+ fees = en=c+ ! regulation prescrib$ pursuant to subp>agraph 7,c72 & 7,f7 requir+ any entity receiv+ ,f$]al funds1 or any ,f$]al ag5cy1 :i* pur*ases de novo g5e syn!sis products f a g5e syn!sis provid] or g5e syn!sis equipm5t f a manufactur] ( g5e syn!sis equipm5t to pur*ase su* products & equipm5t only if su* provid]s or manufactur]s are v]ifi$ or provisionally v]ifi$ pursuant to subp>agraph 7,d72 2 7#b7 9 subsection 7e77#a71 by /rik+ ! p]iod at ! end & ins]t+ 1 includ+ ?r\gh ! revocation ( ,f$]al rese>* fund+ = any entity f\nd to be 9 violation ( subsection 7b77#b77;,e71 or ?r\gh ! )hold+ ( su* fund+ = su* an entity until ! entity demon/rates compliance ) su* subsection42 7#c7 9 subsection 7k71 by add+ at ! end ! foll[+3 7#d7 ,use ( g5e syn!sis products & g5e syn!sis equipm5t by ,f$]al ag5cies ,n lat] ?an ,janu>y #a1 #bjbf1 ! ,secret>y %all report to ! appropriate committees ( ,congress a description ( ! policies & proc$ures adopt$ by all ag5cies t fund or conduct life sci5ces rese>* involv+ g5e syn!sis products or g5e syn!sis equipm5t to comply ) ?is section4 2 7#d7 9 subsection 7l7-- 7,a7 by r$esignat+ p>agraphs 7#b71 7#c71 7#d71 7#e71 7#f71 7#g71 & 7#h7 z p>agraphs 7#e71 7#f71 7#h71 7#i71 7#aj71 7#aa71 & 7#ab71 respectively2 7,b7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,! t]m g5e syn!sis equipm5t means equipm5t t c produce g5e syn!sis product1 reg>dless ( ! te*nical me*anism by :i* su* equipm5t works4 7#c7 ,! t]m g5e syn!sis product-- 7,a7 means cu/om s+le-/r&$ or d\ble-/r&$ ,,dna1 or s+le-/r&$ or d\ble-/r&$ ,,rna1 :i* has be5 *emically or enzymatically syn!siz$ or o!rwise manufactur$ de novo & is ( a l5g? exce$+ ! scre5+ ?re%old2 & 7,b7 does n include-- 7i7 base *emical subunits1 su* z individual nucleotides or nucleosides1 or oligonucleotides %ort] ?an ! scre5+ ?re%old typically us$ z polym]ase *a9 reaction prim]s2 7ii7 byproducts g5]at$ dur+ sequ5c+ t are n useful = assembly or clon+1 z det]m9$ by ! ,secret>y2 or 7iii7 products g5]at$ f clon+ or assembl+ ( exi/+ g5e or g5e fragm5t mat]ial1 9 circum/ances 9 :i* ! g5e syn!sis provid] has no access or notice to ! sequ5ce design1 z det]m9$ by ! ,secret>y4 7#d7 ,! t]m g5e syn!sis provid]-- 7,a7 means-- 7i7 an entity t creates g5e syn!sis product = deliv]y to a cu/om] 9 ! ,unit$ ,/ates2 or 7ii7 a di/ributor ( g5e syn!sis product 9 ! ,unit$ ,/ates1 includ+ an entity t manufactures g5e syn!sis product = use by ano!r p>ty1 :e!r su* o!r p>ty is inside & outside ( ! entity2 & 7,b7 does n include-- 7i7 an entity mak+ g5e syn!sis products = ! entity's own use1 9 circum/ances 9 :i* ! sequ5ce has be5 previ\sly scre5$ 9 compliance ) ?is section2 7ii7 an entity t manufactures g5e syn!sis products 9 ! process ( develop+ or manufactur+ ano!r product = a cu/om]1 unless ! g5e syn!sis product is provid$ to ! end us] !re(2 or 7iii7 any class ( entity t ! ,secret>y *ooses to exempt1 aft] consid]ation ( ! co/s & b5efits ( exempt+ t class ( entity f regulation "u ?is section z a g5e syn!sis provid]4 2 7,c7 by ins]t+ aft] p>agraph 7#f71 z s r$esignat$1 ! foll[+3 7#g7 ,! t]m manufactur] ( g5e syn!sis equipm5t means an entity t produces = sale g5e syn!sis equipm5t4 2 & 7,d7 by add+ at ! end ! foll[+3 7#ac7 ,! t]m scre5+ ?re%old means ! m9imal l5g? ( de novo g5e syn!sis product :i* ensures t ! results ( su* scre5+ conta9 en\gh in=mation to all[ an unambigu\s analysis ( su* product's pot5tial misuse4 2 & 7#e7 9 subsection 7m71 by /rik+ = ea* ( ! fiscal ye>s #bjbc ?r\gh #bjbg & ins]t+ = fiscal ye> #bjbc & ea* subsequ5t fiscal ye>4