,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #ajaig  ,,9 ,,! ,,h\se ,,(         
,,repres5tatives  ,augu/ #ca1 #bjbf,mr4 
,pflug] 7= himself & ,ms4 ,h\lahan7     
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to improve ! security ( nucleic
 acid syn!sis 9 int]/ate & =eign        
comm]ce1 & = o!r purposes4  #a4 ,%ort   
title ,?is ,act may be cit$ z !         
,biosecurity ,mod]nization & ,innovation
 ,act4  #b4 ,requirem5ts = cov]$        
entities ) respect to high-risk sequ5ces
  7a7 ,9 g5]al ,a cov]$ entity %all     
e/abli% a program ( reasonable          
adm9i/rative & te*nical protocols to    
c>ry out1 ) respect to any nucleic acid 
sequ5ce made available 9 int]/ate or    
=eign comm]ce by su* cov]$ entity1 !    
foll[+ requirem5ts3 7#a7 ,v]ify !       
id5tity ( any buy] or prospective buy] (
 su* a nucleic acid sequ5ce1 includ+ )  
respect to any su* nucleic acid sequ5ce 
g5]at$ by a b5*top nucleic acid         
syn!siz]4  7#b7 ,e/abli% ! purpose = :i*

 any su* buy] or prospective buy] seeks 
to obta9 any su* nucleic acid sequ5ce4  
7#c7 ,id5tify :e!r su* a nucleic acid   
sequ5ce1 includ+ any su* nucleic acid   
sequ5ce g5]at$ by a b5*top nucleic acid 
syn!siz]1 is a cov]$ sequ5ce z det]m9$  
by ! ,secret>y "u p>agraph 7#a77;,a7 (  
subsection 7e71 & on ! li/ e/abli%$ &   
made available "u p>agraph 7#a77;,c7 (  
su* subsection4  7#d7 ,e/abli% risk-bas$
 crit]ia = refus+ ! sale ( a cov]$      
sequ5ce to a buy]1 prospective buy]1 or 
any comb9ation !re(1 & docum5t ea*      
in/ance ( refusal by ! cov]$ entity 9   
accordance ) su* crit]ia4  7#e7 ,provide
 timely notification to ! ,secret>y if !
 cov]$ entity has a reasonable belief t 
su* a buy] or prospective buy] is likely
 to use a cov]$ sequ5ce 9 a mann] t     
poses a high risk to ! national security
 ( ! ,unit$ ,/ates or to ! security &   
safety ( p]sons 9 ! ,unit$ ,/ates4  7#f7
 ,ensure regul> indep5d5t assessm5t (   
compliance by ! cov]$ entity ) p>agraphs
 7#a7 ?r\gh 7#e7 & p>agraph 7#g71       

includ+ ?r\gh adv]s>ial te/+1 ?ird-p>ty 
c]tifications1 indep5d5t int]nal or     
ext]nal audits1 direct exam9ation by !  
,secret>y1 or any comb9ation !re(4  7#g7
 ,ma9ta9 records suffici5t to demon/rate
 to ! ,secret>y compliance ) !          
requirem5ts describ$ 9 p>agraphs 7#a7   
?r\gh 7#f7 = a p]iod ( n less ?an #e    
ye>s1 z practicable4  7b7 ,guidance     
7#a7 ,9 g5]al ,n lat] ?an #ahj days aft]
 ! date ( ! enactm5t ( ?is ,act1 !      
,secret>y1 9 consultation ) relevant    
heads ( o!r ,f$]al dep>tm5ts1 ag5cies1  
or (fices1 z appropriate1 %all issue    
guidance t id5tifies ! foll[+3 7,a7     
,approa*es1 be/ practices1 frameworks1 &
 me?ods t may be implem5t$1 alone or 9  
comb9ation1 by a cov]$ entity to satisfy
 ! requirem5ts "u subsection 7a74  7,b7 
,h[ a cov]$ entity may ensure regul>    
indep5d5t assessm5t ( compliance z      
describ$ 9 p>agraph 7#f7 ( su*          
subsection4  7,c7 ,:at con/itutes a     
timely notification "u p>agraph 7#e7 (  
su* subsection1 includ+ by :5 & 9 :at   

mann] a cov]$ entity is requir$ to      
provide su* a notification to !         
,secret>y4  7#b7 ,en=cem5t plan ,n lat] 
?an #a ye> aft] ! date ( ! enactm5t (   
?is ,act1 ! ,secret>y %all issue        
guidance relat+ to ! priorities ( !     
,secret>y = en=c+ ! requirem5ts "u      
subsection 7a74  7#c7 ,process ,any     
guidance issu$ by ! ,secret>y "u        
p>agraphs 7#a7 & 7#b7 %all be develop$  
?r\gh a cov]$ process4  7#d7 ,no conf]r+
 ( rights or b9d+ effect ,any guidance  
issu$ by ! ,secret>y "u p>agraphs 7#a7 &
 7#b7 may n conf] any rights on any     
p]son1 ,/ate1 or locality or b9d !      
,secret>y or any p]son recomm5d$ 9 su*  
guidance4  7c7 ,notification1           
coord9ation1 & direct exam9ation ,n lat]
 ?an #ahj days aft] ! date ( ! enactm5t 
( ?is ,act1 ! ,secret>y %all e/abli% a  
means1 us+ a cov]$ process1 = !         
,secret>y to c>ry out ! foll[+3 7#a7    
,accept a notification provid$ by a     
cov]$ entity "u p>agraph 7#e7 (         
subsection 7a74  7#b7 ,facilitate       

coord9ation ) cov]$ entities &          
/akehold]s to id5tify a buy]1           
prospective buy]1 or any comb9ation     
!re(1 t has split ord]s across two or m 
cov]$ entities ) ! purpose ( obta9+ or  
syn!siz+ a cov]$ sequ5ce4  7#c7 ,at !   
reque/ ( a cov]$ entity1 provide direct 
exam9ation to c>ry out ! requirem5t "u  
p>agraph 7#f7 ( su* subsection4  7d7    
,id5tification ( approa*es1 be/         
practices1 frameworks1 & me?ods  7#a7 ,9
 g5]al ,n lat] ?an #a ye> aft] ! date ( 
! enactm5t ( ?is ,act1 ! ,secret>y %all1
 9 consultation ) ! relevant heads ( o!r
 ,f$]al dep>tm5ts1 ag5cies1 or (fices1 z
 appropriate1 regul>ly consult )        
/akehold]s1 includ+ p]sons f academia & 
! private sector1 to id5tify !          
approa*es1 be/ practices1 frameworks1 & 
me?ods "u subsection 7b77#a77;,a71      
includ+ relat$ to ! foll[+3 7,a7        
,improv+ ! accuracy1 effici5cy1 &       
reliability ( any adm9i/rative &        
te*nical protocols requir$ "u subsection
 7a71 includ+ ) respect to ! indep5d5t  

assessm5t requirem5t "u p>agraph 7#f7 ( 
su* subsection4  7,b7 ,h[ a cov]$ entity
 may (f] an exp$it$ review process to a 
previ\s buy] ( su* cov]$ entity )       
respect to :i* ! cov]$ entity has c>ri$ 
out ! requirem5ts "u p>agraphs 7#a7 &   
7#b7 ( subsection 7a74  7,c7 ,h[ !      
,secret>y & any cov]$ entity may id5tify
 nucleic acid sequ5ces ) a l[ pot5tial =
 misuse4  7,d7 ,h[ ! ,secret>y & any    
cov]$ entity may id5tify nucleic acid   
sequ5ces1 includ+ novel nucleic acid    
sequ5ces1 t may be us$ 9 a mann] t w\ld 
pose a high risk to ! national security 
( ! ,unit$ ,/ates or to ! security &    
safety ( p]sons 9 ! ,unit$ ,/ates4  7,e7
 ,mitigate any risk relat$ to misuse (  
b5*top nucleic acid syn!siz]s4  7#b7    
,report ,n lat] ?an #b ye>s aft] ! date 
( ! enactm5t ( ?is ,act1 & annually     
!reaft] = #f ye>s1 ! ,secret>y %all     
submit to ! ,committee on ,en]gy &      
,comm]ce ( ! ,h\se ( ,repres5tatives & !
 ,committee on ,comm]ce1 ,sci5ce1 &     
,transportation ( ! ,s5ate a report--   

7,a7 develop$ ?r\gh a cov]$ process2 &  
7,b7 t includes in=mation relat$ to any 
approa*es1 be/ practices1 frameworks1 or
 me?ods id5tifi$ "u p>agraph 7#a74  7e7 
,report & recomm5dations  7#a7 ,9 g5]al 
,n lat] ?an #b ye>s aft] ! date ( !     
enactm5t ( ?is ,act1 & e #b ye>s !reaft]
 = #f ye>s1 ! ,secret>y %all publi% on a
 publicly available website a report t  
includes ! foll[+3 7,a7 ,an assessm5t on
 ! foll[+3 7i7 ,! economic              
competitiv5ess ( ! ,unit$ ,/ates )      
respect to biote*nology1 includ+ !      
manufactur+ ( nucleic acids4  7ii7 ,!   
ability ( ! ,secret>y1 cov]$ entities1 &
 any o!r relevant entity to mitigate any
 national security risk relat$ to cov]$ 
sequ5ces manufactur$ & sold 9 int]/ate  
or =eign comm]ce4  7,b7 ,any legislative
 recomm5dation relat$ to ! foll[+3 7i7  
,advanc+ su* competitiv5ess4  7ii7      
,mitigat+ any su* national security     
risk4  7#b7 ,public consultation ,9     
c>ry+ out p>agraph 7#a71 ! ,secret>y    
%all use a cov]$ process4  7#c7         

,congressional notification ,prior to   
publi%+ a report "u p>agraph 7#a71 !    
,secret>y %all submit to ! ,committee on
 ,en]gy & ,comm]ce ( ! ,h\se (          
,repres5tatives & ! ,committee on       
,comm]ce1 ,sci5ce1 & ,transportation ( !
 ,s5ate su* report4  7f7 ,cov]$ sequ5ce 
li/  7#a7 ,9 g5]al ,n lat] ?an #ahj days
 aft] ! date ( ! enactm5t ( ?is ,act1 & 
regul>ly !reaft]1 ! ,secret>y1 9        
consultation ) ! relevant heads ( o!r   
,f$]al dep>tm5ts1 ag5cies1 or (fices1 z 
appropriate1 %all c>ry out ! foll[+3    
7,a7 ,a det]m9ation ( :e!r a nucleic    
acid sequ5ce is a cov]$ sequ5ce4  7,b7  
,if ! ,secret>y makes a det]m9ation t a 
nucleic acid sequ5ce is a cov]$ sequ5ce1
 make available to cov]$ entities a     
/atem5t t expla9s ! basis = su*         
det]m9ation1 includ+ any basis specifi$ 
9 p>agraph 7#b71 z applicable4  7,c7    
,e/abli% & make available to cov]$      
entities a li/ t includes any su* cov]$ 
sequ5ce4  7,d7 ,e/abli% a proc$ure to   
make any su* /atem5t & su* li/ available

 to /akehold]s 9 a mann] t does n pose  
an unacceptable risk to ! national      
security ( ! ,unit$ ,/ates or ! security
 & safety ( ,unit$ ,/ates p]sons4  7#b7 
,basis ,a det]m9ation "u p>agraph       
7#a77;,a7 %all be bas$ on "o or m ( !   
foll[+3 7,a7 ,an assessm5t by ! head (  
any o!r ,f$]al ag5cy1 includ+ a relevant
 national security ag5cy or public heal?
 ag5cy4  7,b7 ,a submission by a memb] (
 ! public or a cov]$ entity "u p>agraph 
7#c77;,a74  7,c7 ,a det]m9ation by !    
,secret>y t a nucleic acid sequ5ce poses
 an imm95t or high likelihood ( use 9   
su* a mann] t x poses an unacceptable   
risk to ! national security ( ! ,unit$  
,/ates or ! security & safety ( ,unit$  
,/ates p]sons4  7#c7 ,updates  7,a7 ,9  
g5]al ,! ,secret>y %all update1 z !     
,secret>y det]m9es appropriate1 any li/ 
e/abli%$ & made available to cov]$      
entities "u subp>agraph 7,c7 ( p>agraph 
7#a71 & any /atem5t or li/ made         
available to /akehold]s pursuant to !   
proc$ure e/abli%$ "u subp>agraph 7,d7 ( 

su* p>agraph1 includ+ 9 response to a   
novel nucleic acid sequ5ce4  7,b7       
,submission process ,n lat] ?an #ahj    
days aft] ! date ( ! enactm5t ( ?is     
,act1 ! ,secret>y %all1 ?r\gh a cov]$   
process1 e/abli% a process = ! foll[+3  
7i7 ,a memb] ( ! public to submit to !  
,secret>y a recomm5dation relat$ to add+
 a nucleic acid sequ5ce to1 remov+ a    
cov]$ sequ5ce f1 or o!rwise modify+ any 
li/ e/abli%$ & made available to cov]$  
entities "u subp>agraph 7,c7 ( p>agraph 
7#a71 & any /atem5t or li/ made         
available to /akehold]s pursuant to !   
proc$ure e/abli%$ "u subp>agraph 7,d7 ( 
su* p>agraph4  7ii7 ,a cov]$ entity to  
c>ry out ! foll[+3 7,i7 ,submit to !    
,secret>y a reque/ = ! ,secret>y to     
review ! inclusion ( a cov]$ sequ5ce 9  
any li/ e/abli%$ & made available to    
cov]$ entities "u subp>agraph 7,c7 (    
p>agraph 7#a71 & any /atem5t or li/ made
 available to /akehold]s pursuant to !  
proc$ure e/abli%$ "u subp>agraph 7,d7 ( 
su* p>agraph1 to remove ! cov]$ sequ5ce 

f1 or o!rwise modify1 su* li/ or        
/atem5t4  7,,ii7 ,submit evid5ce to !   
,secret>y relat$ to su* reque/4  7,c7   
,confid5tiality ,any in=mation relat$ to
 a recomm5dation1 reque/1 or evid5ce    
submitt$ pursuant to ! process e/abli%$ 
"u subp>agraph 7,b7 %all be treat$ z a  
trade secret & comm]cial or f9ancial    
in=mation1 & %all be exempt f           
disclosure1 "u section #eeb7;b77#d7 (   
title #e1 ,unit$ ,/ates ,code4  7,d7    
,option to reque/ nondisclosure ,9 c>ry+
 out subp>agraph 7,b71 ! ,secret>y %all 
(f] any memb] ( ! public or cov]$ entity
 t utilizes ! process e/abli%$ "u su*   
subp>agraph ! ability to reque/ t any   
in=mation relat$ to a recomm5dation1    
reque/1 or evid5ce submitt$ pursuant to 
su* process is n publi%$ or disclos$ 9  
any id5tifiable =m1 includ+ any         
publication or disclosure ( any su*     
in=mation t w\ld all[ ! id5tity ( !     
memb] ( ! public or cov]$ entity to be  
reasonably inf]r$4  7#d7 ,congressional 
notification ,) respect to any li/      

e/abli%$ & made available to cov]$      
entities "u subp>agraph 7,c7 ( p>agraph 
7#a71 & any /atem5t or li/ made         
available to /akehold]s pursuant to !   
proc$ure e/abli%$ "u subp>agraph 7,d7 ( 
su* p>agraph1 ! ,secret>y %all-- 7,a7 at
 lea/ #e days be=e e/abli%+ & mak+      
available su* a li/ "u su* p>agraph1 or 
add+ a nucleic acid sequ5ce to1 remov+ a
 cov]$ sequ5ce f1 or o!rwise modify+ su*
 li/1 submit to ! ,committee on ,en]gy &
 ,comm]ce ( ! ,h\se ( ,repres5tatives & 
! ,committee on ,comm]ce1 ,sci5ce1 &    
,transportation ( ! ,s5ate su* li/2 &   
7,b7 provide to su* committees a brief+ 
relat$ to su* li/1 ^u reque/ by su*     
committees4  7g7 ,en=cem5t  7#a7        
,au?ority ,! ,secret>y %all h ! au?ority
 to c>ry out any ( ! foll[+ to en=ce    
subsection 7a73 7,a7 ,require1 inspect1 
& compel ! provision ( any physical &   
electronic records & any o!r in=mation f
 su* cov]$ entity4  7,b7 ,adm9i/] oa?s  
or affirmations & require any p]son to  
appe> & te/ify or to appe> & produce any

 su* record or o!r in=mation by subpo5a4
  7,c7 ,conduct inve/igations )9 !      
,unit$ ,/ates & outside ! ,unit$ ,/ates4
  7#b7 ,civil actions  7,a7 ,9 g5]al ,! 
,secret>y may comm5ce a civil action    
aga9/ a cov]$ entity = a violation (    
subsection 7a7 9 any di/rict c\rt ( !   
,unit$ ,/ates = appropriate relief1     
includ+-- 7i7 ! p5alty describ$ "u      
subp>agraph 7,b72 or  7ii7 an           
injunction4  7,b7 ,p5alty ,! p5alty = a 
violation ( subsection 7a7 may n exce$  
#gej1jjj p] violation 7z adju/$ on      
,janu>y #a ea* ye> by ! p]c5tage        
increase1 if applicable1 9 ! consum]    
price index = all urban consum]s publi%$
 by ! ,bureau ( ,labor ,/ati/ics )      
respect to ! #ab-mon? p]iod prec$+ !    
date ( su* adju/m5t74  7,c7 ,"r to cure 
7i7 ,9 g5]al ,! ,secret>y may initiate a
 civil action "u subp>agraph 7,a7 only  
if-- 7,i7 ! ,secret>y has provid$ to !  
relevant cov]$ entity a writt5 notice t 
describes ! alleg$ violation & id5tifies
 ! provision "u subsection 7a7 relat$ to

 su* alleg$ violation2 &  7,,ii7 at lea/
 #cj days h pass$ s9ce ! date on :i* su*
 writt5 notice 0 s provid$4  7ii7       
,effect ( cure ,if a cov]$ entity t     
receives a writt5 notice "u clause      
7i77,i7 cures ! alleg$ violation        
describ$ 9 su* notice n lat] ?an #cj    
days aft] ! date on :i* su* cov]$ entity
 0 provid$ su* notice1 ! ,secret>y %all 
consid] ! requirem5ts "u subsection 7a7 
z satisfi$ ) respect to su* cov]$       
entity4  7iii7 ,failure to cure ,aft]   
c>ry+ out clause 7i71 ! ,secret>y may   
initiate an action "u subp>agraph 7,a7--
 7,i7 if ! relevant cov]$ entity fails  
to cure ! alleg$ violation describ$ 9 ! 
writt5 notice provid$ pursuant to clause
 7i77,i72 or  7,,ii7 if1 aft] ! cur+ !  
alleg$ violation z specifi$ 9 clause    
7ii71 ! cov]$ entity violates ! relevant
 provision "u subsection 7a7 aga94  7#c7
 ,relation to guidance ,! ,secret>y may 
n comm5ce a civil action "u p>agraph    
7#b7 solely on ! basis t a cov]$ entity 
has c>ri$ out ! requirem5ts "u          

subsection 7a7 9 a mann] t is inconsi/5t
 ) any guidance issu$ "u subsection     
7b77#a74  7h7 ,relation%ip ) o!r ,f$]al 
guidel9es & recomm5dations ,!           
requirem5ts 9 subsection 7a7 %all       
sup]s$e any ,f$]al guidel9e or          
recomm5dation relat$ to ! scre5+ (      
nucleic acid sequ5ces made available 9  
int]/ate or =eign comm]ce if su*        
guidel9e or recomm5dation is volunt>y & 
9 effect be=e ! date ( ! enactm5t ( ?is 
,act4  7i7 ,preemption  7#a7 ,9 g5]al   
,no ,/ate or political subdivision ( a  
,/ate may prescribe1 ma9ta91 or en=ce   
any law1 rule1 regulation1 requirem5t1  
/&>d1 or o!r provision hav+ ! =ce &     
effect ( law to ! ext5t su* law1 rule1  
regulation1 requirem5t1 /&>d1 or o!r    
provision is cov]$ by a requirem5t "u   
subsection 7a74  7#b7 ,exception        
,not)/&+ p>agraph 7#a71 no?+ 9 ?is ,act 
may be con/ru$ to preempt any law1 rule1
 requirem5t1 or regulation ( a ,/ate1 or
 political subdivision ( a ,/ate1 )     
respect to any ( ! foll[+3 7,a7         

,contract1 tort1 or product liability4  
7,b7 ,consum] protection1 data privacy1 
or data security4  7,c7 ,any su* g5]ally
 applicable law1 rule1 requirem5t1 or   
regulation ( a ,/ate1 or a political    
subdivision ( a ,/ate1 z x relates to   
public heal?4  7,d7 ,! procurem5t or use
 ( nucleic acids or nucleic acid        
sequ5ces by a ,/ate or a political      
subdivision ( a ,/ate4  7j7 ,rule (     
con/ruction ,no?+ 9 ?is ,act may be     
con/ru$ to prohibit a cov]$ entity f    
syn!siz+ a nucleic acid sequ5ce or      
prohibit a cov]$ entity f produc+       
equipm5t = syn!siz+ a nucleic acid1     
includ+ a b5*top nucleic acid syn!siz]4 
7k7 ,effective date ,! requirem5t "u    
subsection 7a7 %all take effect on !    
date t is #a ye> aft] ! date ( !        
enactm5t ( ?is ,act4  7l7 ,def9itions ,9
 ?is section3 7#a7 ,b5*top nucleic acid 
syn!siz] ,! t]m b5*top nucleic acid     
syn!siz] means a product1 device1 or    
integrat$ sy/em 9 int]/ate or =eign     
comm]ce t is-- 7,a7 capable ( g5]at+ de 

novo a nucleic acid sequ5ce-- 7i7 at !  
direction ( an end us] ( su* product1   
device1 or sy/em2 or  7ii7 )\t requir+  
an end us] ( su* product1 device1 or    
sy/em to submit to ano!r cov]$ entity an
 ord] to p]=m ! g5]ation ( su* nucleic  
acid sequ5ce2 &  7,b7 int5d$ =          
di/ribution to1 or use by1 end us]s o!r 
?an ! develop] ( ! product1 device1 or  
sy/em1 reg>dless ( ! physical dim5sions 
( su* product1 device1 or sy/em4  7#b7  
,cov]$ entity  7,a7 ,9 g5]al ,! t]m     
cov]$ entity means a p]son op]at+ 9     
int]/ate or =eign comm]ce :o-- 7i7      
syn!sizes & sells nucleic acids to a    
p]son 9 ! ,unit$ ,/ates or 9 a =eign    
c\ntry2 or  7ii7 produces1 di/ributes1  
sells1 or resells equipm5t = syn!siz+   
nucleic acids1 includ+ a b5*top nucleic 
acid syn!siz]1 to p]sons 9 ! ,unit$     
,/ates or 9 a =eign c\ntry4  7,b7       
,exception ,subp>agraph 7,a7 does n     
apply to ! ext5t a p]son produces1      
di/ributes1 sells1 or resells syn!tic   
acids )9 a comm]cial entity solely = !  

int]nal use ( su* comm]cial entity4     
7#c7 ,cov]$ process ,! t]m cov]$ process
 means1 ) respect to ! implem5tation ( a
 requirem5t "u ?is section1 a process by
 :i* ! ,secret>y-- 7,a7 publi%es 9 !    
,f$]al ,regi/] a reque/ = public fe$back
 on ! matt]s describ$ 9 su* provision2  
7,b7 provides ! public ) an opportunity 
to comm5t on ! matt]s describ$ 9        
subp>agraph 7,a7 = a p]iod ( n less ?an 
#fj days2  7,c7 ensures t public comm5ts
 made "u subp>agraph 7,b7 t are n m>k$  
confid5tial are available = public      
inspection2 &  7,d7 demon/rates         
consid]ation ( any su* public comm5ts ) 
respect to su* implem5tation4  7#d7     
,secret>y ,! t]m ,secret>y means !      
,secret>y ( ,comm]ce1 act+ ?r\gh !      
,(fice ( ! ,secret>y4