,,ii  #aai? ,,congress  #b;d ,session   
,s4 #cgda  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,janu>y #bi1 #bjbf,mr4 
,cotton 7= himself & ,ms4 ,klobu*>7     
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,comm]ce1 ,sci5ce1 & ,transportation  ,a
 ,,bill  ,to require ! ,secret>y (      
,comm]ce to promulgate regulations to   
improve nucleic acid syn!sis security1 &
 = o!r purposes4  #a4 ,%ort title ,?is  
,act may be cit$ z ! ,biosecurity       
,mod]nization & ,innovation ,act (      
#bjbf4  #b4 ,def9itions ,9 ?is ,act3    
7#a7 ,cov]$ provid] ,! t]m cov]$ provid]
 means a p]son :o-- 7,a7 syn!sizes &    
sells syn!tic nucleic acids to p]sons 9 
! ,unit$ ,/ates2 or  7,b7 produces &    
di/ributes or sells1 includ+ resell]s1  
equipm5t = syn!siz+ nucleic acids1      
includ+ b5*top syn!siz]s1 to p]sons 9 ! 
,unit$ ,/ates4  7#b7 ,director ,! t]m   
,director means ! ,director ( ! ,(fice (
 ,sci5ce & ,te*nology ,policy4  7#c7    
,secret>y ,! t]m ,secret>y means !      

,secret>y ( ,comm]ce4  7#d7 ,"u         
,secret>y ,! t]m ,"u ,secret>y means !  
,"u ,secret>y ( ,comm]ce = ,/&>ds &     
,te*nology4  #c4 ,s5se ( ,congress ,x is
 ! ,s5se ( ,congress t-- 7#a7 ! field ( 
biote*nology is accel]at+ & ! ,unit$    
,/ates is at risk ( los+ its            
biote*nology lead]%ip to =eign          
adv]s>ies2  7#b7 ?is accel]ation ( !    
field br+s ! ,unit$ ,/ates into a p]iod 
( bo? great opportunity & risk2  7#c7   
policymak+ = biosecurity1 biosafety1 &  
responsible innovation ne$s to be       
flexible to keep pace ) advances 9 !    
biote*nology & ensure an environm5t t   
all[s biote*nology rese>* & indu/ry to  
fl\ri%2  7#d7 ! curr5t l&scape (        
biosecurity & biosafety au?orities is   
spread among multiple ag5cies1          
contribut+ to sl[ policymak+1 :i*1 c\pl$
 ) ! rapid advancem5t ( biote*nology1   
becomes outdat$ quickly2  7#e7 previ\s  
/udies conduct$ by ! ,gov]nm5t          
,acc\ntability ,(fice1 ! ,national      
,security ,commission = ,em]g+          

,biote*nology1 & sev]al presid5tial     
adm9i/rations h already id5tifi$ gaps 9 
! ,f$]al ,gov]nm5t's ov]sight (         
biosecurity & biosafety risks2  7#f7 !  
,unit$ ,/ates ,gov]nm5t ne$s to /reaml9e
 biosecurity & biosafety au?orities to  
ensure effici5cy & cl>ity2  7#g7 g5e    
syn!sis te*nology is becom+ increas+ly  
sophi/icat$ & accessible1 along ) !     
ability to design novel nucleic acid    
sequ5ces2  7#h7 bo? ( ^! factors        
describ$ 9 p>agraph 7#g7 may increase ! 
risk ( ! developm5t & deploym5t ( new   
pa?og5s by bad actors2 &  7#i7 g5e      
syn!sis scre5+ ( ord]s & cu/om]s is     
imm$iately ne$$ to mitigate risk 9 !    
%ort-t]m1 :i* w act z a /opgap :ile !   
,unit$ ,/ates ,gov]nm5t develops a      
compreh5sive biosecurity & biosafety    
/rategy t is appropriate = ! dynamic &  
rapidly advanc+ field ( biote*nology4   
#d4 ,nucleic acid syn!sis security  7a7 
,regulations requir$ ,n lat] ?an #a ye> 
aft] ! date ( ! enactm5t ( ?is ,act1 !  
,secret>y %all1 9 coord9ation ) ! ,"u   

,secret>y & ! heads ( su* o!r ag5cies z 
! ,secret>y consid]s appropriate1       
e/abli% & ma9ta9 by regulation ! foll[+3
 7#a7 ,a requirem5t = cov]$ provid]s to 
implem5t scre5+ protocols = all sequ5ces
 ( conc]n includ$ 9 ! li/ e/abli%$ &    
ma9ta9$ "u p>agraph 7#c74 ,su* protocols
 %all-- 7,a7 include ! ability =        
privacy-pres]v+ submission ( in=mation  
reg>d+ ord]s = pot5tial sequ5ces (      
conc]n to a me*anism1 :i* may be ma9ta9$
 by ! ,secret>y or an indep5d5t         
organization designat$ by ! ,secret>y1 =
 facilitat+ effective split ord]        
detection across cov]$ provid]s1 utiliz+
 ! li/ e/abli%$ & ma9ta9$ "u p>agraph   
7#c72 &  7,b7 prioritize ! mitigation ( 
misuse ( sequ5ces capable ( creat+      
pa?og5s ) p&emic pot5tial4  7#b7 ,a     
requirem5t = cov]$ provid]s to implem5t 
scre5+ protocols to v]ify ! id5tity &   
legitimacy ( cu/om]s4  7#c7 ,a li/ (    
sequ5ces ( conc]n1 :i* %all be det]m9$  
by ! ,secret>y 9 consultation ) su*     
heads ( ,f$]al dep>tm5ts & ag5cies1     

indu/ry exp]ts1 academics1 & rese>*]s z 
! ,secret>y consid]s appropriate4  7#d7 
,a sy/em = review+ & updat+ on a regul> 
basis ! li/ ( sequ5ces ( conc]n e/abli%$
 & ma9ta9$ "u p>agraph 7#c7 t-- 7,a7    
uses a docket to all[ = privacy-pres]v+ 
submissions f ! public on recomm5dations
 = ! li/ ( sequ5ces ( conc]n2  7,b7     
includes an exp$it$ proc$ure to rapidly 
add sequ5ces ( conc]n to ! li/ on a     
provisional basis1 :i* may include1 z f>
 z te*nically feasible1 automatic       
proc$ures su* z algori?mic lit]ature    
scann+1 indu/ry self-report+1 or        
int]-ag5cy submissions2 &  7,c7         
incorporates /rong data security &      
confid5tiality /&>ds4  7#e7 ,a con=mity 
assessm5t sy/em to v]ify t cov]$        
provid]s are adh]+ to ! requirem5ts     
e/abli%$ & ma9ta9$ "u p>agraphs 7#a7 &  
7#b71 :i* w include-- 7,a7 an audit+    
process to ensure ord]s & cu/om]s h be5 
scrut9iz$ appropriately1 includ+        
proc$ures to conduct adv]s>ial te/+     
7sometimes ref]r$ to z r$-team+7 at r&om

 int]vals to ensure compliance2 &  7,b7 
a process to revoke con=mity /atus (    
cov]$ provid]s t fail to ma9ta9         
compliance ) ! requirem5ts e/abli%$ &   
ma9ta9$ "u p>agraphs 7#a7 & 7#b71       
includ+ ! e/abli%m5t ( a grace p]iod =  
cov]$ provid]s :o h fail$ audit+ or     
adv]s>ial te/+ "u subp>agraph 7,b7 to   
demon/rate compliance or mitigation     
/eps4  7#f7 ,safegu>ds to ensure        
regulations promulgat$ "u ?is subsection
 avoid unnecess>y burd5 on innovation & 
indu/ry by-- 7,a7 all[+ cov]$ provid]s  
to (f] an exp$it$ review process =      
in/itutional cu/om]s1 includ+ accr$it$  
in/itutions ( high] education1 )        
demon/rat$ records ( legitimacy2  7,b7  
provid+ exemptions f cu/om] scre5+      
requirem5ts = sequ5ces or products t are
 cle>ly non-haz>d\s & pose no cr$ible   
?reat to public heal? & safety bas$ on  
sci5tific lit]ature & indu/ry be/       
practices = biosecurity scre5+2 &  7,c7 
conduct+ regul> consultations ) relevant
 exp]ts to det]m9e exempt$ sequ5ces &   

m9imize regulatory burd5 :ile ma9ta9+   
security effectiv5ess4  7#g7 ,a         
requirem5t t any p]son :o receives      
,f$]al funds c only pur*ase nucleic acid
 syn!sis products f a cov]$ provid] 9   
compliance ) ! requirem5ts 9 p>agraphs  
7#a7 & 7#b74  7#h7 ,a program to provide
 te*nical assi/ance ^u reque/ ( a cov]$ 
provid]1 includ+ assi/ance ) ord]s ^:   
scre5+ results are ambigu\s1 subject to 
det]m9ation by ! ,secret>y1 9           
consultation ) ! heads ( su* o!r ,f$]al 
dep>tm5ts & ag5cies z ! ,secret>y       
consid]s appropriate4  7b7 ,national    
,in/itute ( ,/&>ds & ,te*nology         
requirem5ts ,! ,"u ,secret>y %all       
develop be/ practices1 te*nical /&>ds1 &
 o!r tools ne$$ to support !            
adm9i/ration ( subsection 7a71 includ+ !
 foll[+3 7#a7 ,te/+ & evaluation (      
cu/om] & ord] scre5+ protocols to       
improve accuracy1 efficacy1 &           
reliability1 & to support ! con=mity    
assessm5t sy/em "u ( subsection 7a77#e74
  7#b7 ,evaluation ( ! sequ5ces         

recomm5d$ = ! li/ e/abli%$ & updat$ "u  
p>agraphs 7#c7 & 7#d7 ( subsection 7a71 
includ+ by develop+ be/ practices &     
guidel9es = det]m9+ if a novel sequ5ce  
is a sequ5ce ( conc]n4  7#c7 ,rese>* &  
prototype sequ5ce-to-function models to 
supplem5t ! sy/em e/abli%$ & ma9ta9$ "u 
subsection 7a77#d74  7c7 ,updates ,z    
frequ5tly z ! ,secret>y consid]s        
appropriate to acc\nt = te*nological    
advances1 b n less frequ5tly ?an once e 
#b ye>s1 ! ,secret>y %all review &      
update ! regulations promulgat$ "u      
subsection 7a74  7d7 ,protection (      
cu/om] in=mation ,any in=mation ab\t a  
cu/om] includ$ 9 a submission "u        
p>agraph 7#a77;,a7 or 7#d77;,a7 (       
subsection 7a7 %all1 if applicable1 be  
exempt f records access "u section      
#eeb7;b77#d7 ( title #e1 ,unit$ ,/ates  
,code4  7e7 ,relation%ip ) o!r ,f$]al   
guidel9es & recomm5dations ,!           
regulations e/abli%$ & ma9ta9$ "u       
p>agraphs 7#a7 & 7#b7 ( subsection 7a7  
%all supplant any ,f$]al guidel9es or   

recomm5dations relat+ to nucleic acid   
syn!sis scre5+ t-- 7#a7 7 9 effect be=e 
! date ( ! enactm5t ( ?is ,act2 &  7#b7 
are volunt>y4  7f7 ,civil en=cem5t  7#a7
 ,civil action ,! ,attorney ,g5]al may  
br+ a civil action 9 a c\rt ( compet5t  
jurisdiction aga9/ any p]son :o violates
 a requirem5t promulgat$ "u p>agraph    
7#a7 or 7#b7 ( subsection 7a71 includ+  
?r\gh provid+ false or mislead+         
in=mation or engag+ 9 o!r deceptive     
practices1 or does n demon/rate         
compliance )9 ! grace p]iod set =? by   
subsection 7a77#e77;,c74  7#b7 ,p[]s ( !
 c\rt ,9 an action br\ght "u p>agraph   
7#a71 ! c\rt may-- 7,a7 enjo9 a         
violation describ$ 9 p>agraph 7#a72 or  
7,b7 aw>d damages "u p>agraph 7#c74     
7#c7 ,aw>d ( damages ,a p]son :o        
violates a requirem5t z describ$ 9      
p>agraph 7#a7 is liable = /atutory      
damages-- 7,a7 9 ! case ( an individual1
 9 ! sum ( n m ?an #ejj1jjj1 adju/$ f "t
 to "t "u p>agraph 7#d72 &  7,b7 9 !    
case ( a p]son :o is n an individual1 9 

! sum ( n m ?an #gej1jjj1 adju/$ f "t to
 "t "u p>agraph 7#d74  7#d7 ,adju/m5ts =
 inflation ,effective on ,octob] #a (   
ea* ye> 7beg9n+ 9 ! fir/ fiscal ye> aft]
 ! date ( ! enactm5t ( ?is ,act71 !     
doll> am\nts 9 effect "u p>agraph 7#c7  
%all be increas$ by a p]c5tage equal to 
! p]c5tage by :i* ! ,consum] ,price     
,index = all urban consum]s 7,u4,s4 city
 av]age7 increas$ dur+ ! #ab-mon? p]iod 
end+ ) ! la/ mon? = :i* ,consum] ,price 
,index data is available4 ,9 ! ev5t t   
su* ,consum] ,price ,index does n       
increase dur+ su* p]iod1 ! doll> am\nt 9
 effect "u su* p>agraph dur+ ! previ\s  
fiscal ye> %all be ma9ta9$4  7g7        
,reports to ,congress ,n less frequ5tly 
?an once ea* ye>1 ! ,secret>y %all      
submit to ,congress a report on !       
adm9i/ration ( ?is section4 ,ea* su*    
report %all include an ov]view ( h[ _m  
cov]$ provid]s h be5 v]ifi$ by !        
con=mity assessm5t sy/em e/abli%$ &     
ma9ta9$ "u subsection 7a77#e74  #e4     
,e/abli%m5t ( biote*nology gov]nance    

s&box  7a7 ,9 g5]al ,n lat] ?an #a ye>  
aft] ! date ( ! enactm5t ( ?is ,act1 !  
,"u ,secret>y %all1 9 collaboration ) ! 
heads ( su* ,f$]al ag5cies z ! ,"u      
,secret>y consid]s relevant & ) su*     
p]sons 9 ! private sector1 academia1 &  
civil society z ! ,"u ,secret>y consid]s
 appropriate1 e/abli% a biote*nology    
gov]nance s&box environm5t4  7b7        
,responsibilities ,?r\gh ! gov]nance    
s&box develop$ "u subsection 7a71 ! ,"u 
,secret>y %all-- 7#a7 provide secure    
te/+ ( innovations or tools develop$ to 
advance ! sci5ce ( biosecurity1         
biosafety1 & responsible biote*nology   
innovation2  7#b7 fo/] p>ticipation (   
nongov]nm5tal exp]ts 9 ! developm5t &   
te/+ ( appropriate levels & me?ods (    
gov]nance1 to a*ieve ! goals (-- 7,a7   
ensur+ ! cont9u$ global competitiv5ess (
 biote*nology innovations 9 ! ,unit$    
,/ates2  7,b7 bol/]+ ! national security
 po/ure ( ! ,unit$ ,/ates2 &  7,c7      
/r5g!n+ ! ability ( ! ,unit$ ,/ates to  
robu/ly analyze em]g+ ?reats1 anticipate

 conc]ns1 & gov]n proactively 9 !       
biote*nology space2  7#c7 c>ry out      
biological measurem5t rese>* to support 
! developm5t & improvem5t ( te*nical    
/&>ds = biosecurity1 biosafety1 &       
responsible biote*nology innovation2 &  
7#d7 report annually to ! ,secret>y (   
,comm]ce on ! adm9i/ration ( p>agraph   
7#b7 & :e!r any promis+ gov]nance       
/rategies h result$ f ! developm5t &    
te/+4  7c7 ,access to environm5ts ,! ,"u
 ,secret>y may contract ) ! private     
sector or coord9ate ) o!r ,f$]al ag5cies
 to access environm5ts necess>y to      
provide te/+ "u subsection 7b77#a74  #f4
 ,/reaml9+ biosecurity & biosafety      
au?orities across ! ,f$]al ,gov]nm5t    
7a7 ,assessm5t & plan requir$ ,n lat]   
?an #ij days aft] ! date ( ! enactm5t ( 
?is ,act1 ! ,director %all1 9           
collaboration ) ! heads ( su* ,f$]al    
ag5cies z ! ,director consid]s          
relevant-- 7#a7 assess ! curr5t /ate (  
biosecurity & biosafety ov]sight by !   
,f$]al ,gov]nm5t2 &  7#b7 develop1 bas$ 

on ! f9d+s ( ! ,director ) respect to ! 
assessm5t conduct$ "u p>agraph 7#a71 an 
implem5tation plan to make ov]sight (   
biosecurity & biosafety by ! ,f$]al     
,gov]nm5t m effective & effici5t4  7b7  
,elem5ts ( assessm5t ,! assessm5t       
requir$ by subsection 7a77#a7 %all      
include ! foll[+3 7#a7 ,a full acc\nt+ (
 ,f$]al biosecurity & biosafety         
au?orities & programs1 includ+ :i*      
ag5cies hold ^! au?orities1 :e!r ^!     
au?orities are ex]cis$ effectively1 &   
:]e !re are ov]laps or r$undancies1 real
 or p]ceiv$1 9 regulatory & en=cem5t    
au?orities4  7#b7 ,engagem5t ) indu/ry  
/akehold]s & academia to und]/& :]e !re 
are *all5ges ) compliance1              
communication1 & in=mation %>+4  7#c7   
,id5tification ( gaps 9 fund+ or o!r    
,gov]nm5t support = ! developm5t (      
rese>*1 innovation1 & tools t advance ! 
sci5ce ( appli$ biosecurity1 biosafety1 
& responsible biote*nology innovation4  
7#d7 ,id5tification ( gaps 9 curr5t     
,f$]al biosecurity & biosafety          

au?orities & :e!r ^! gaps are h9d]+     
effective & effici5t gov]nance &        
assessm5t ( em]g+ risks & opportunities 
9 biote*nology4  7#e7 ,an evaluation (  
h[ consolidation ( biosecurity &        
biosafety guidel9es1 au?orities1 &      
regulations across ,f$]al ag5cies1      
includ+ ! regulations e/abli%$ & ma9ta9$
 "u section #d7;a71 %\ld be implem5t$ to
 make ov]sight m effective & effici5t & 
to address ! gaps 9 su* guidel9es1      
au?orities1 & regulations1 includ+ ^?   
id5tifi$ "u p>agraphs 7#c7 & 7#d74  7c7 
,report to ,congress  7#a7 ,9 g5]al ,n  
lat] ?an #ij days aft] ! date on :i* !  
,director completes ! assessm5t requir$ 
by p>agraph 7#a7 ( subsection 7a7 & !   
implem5tation plan requir$ by p>agraph  
7#b7 ( su* subsection1 ! ,director %all 
submit to ,congress-- 7,a7 a report on !
 f9d+s ( ! ,director ) respect to !     
assessm5t2 &  7,b7 a copy ( !           
implem5tation plan4  7#b7 ,cont5ts ,!   
report submitt$ pursuant to p>agraph    
7#a77;,a7 %all include ! foll[+3 7,a7 ,!

 f9d+s ( ! ,director ) respect to !     
assessm5t conduct$ pursuant to          
subsection 7a77#a74  7,b7               
,recomm5dations = legislative or        
adm9i/rative action to support !        
implem5tation plan develop$ "u          
subsection 7a77#b71 accord+ to-- 7i7    
:at1 if any1 new biosecurity & biosafety
 au?orities are ne$$2 &  7ii7 :]e !     
,f$]al ,gov]nm5t c consolidate          
biosecurity & biosafety au?orities1     
includ+ :i*1 if any1 %\ld be reside "u a
 common gov]nm5t entity1 & :e!r ?is     
necessitates e/abli%+ a new gov]nm5t    
entity4  7d7 ,implem5tation  7#a7 ,9    
g5]al ,n lat] ?an #ij days aft] ! date  
on :i* ! ,director completes !          
implem5tation plan requir$ by subsection
 7a77#b71 ! ,director %all comm5ce      
implem5t+ ! plan ?r\gh adm9i/rative     
action 9 accordance ) applicable        
provisions ( law4  7#b7 ,gov]nance      
/rategies ,9 c>ry+ out ! implem5tation  
plan develop$ "u subsection 7a77#b71 !  
,director %all consid] :i*1 if any1 ( ! 

gov]nance /rategies report$ "u section  
#e7;b77#d7 %\ld be includ$ 9 ! plan4