,,ii  #aah? ,,congress  #a/ ,session    
,s4 #bcef  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,july #ah1 #bjbc,mr4   
,hick5loop] 7= himself & ,mr4 ,budd7    
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]vices to update      
guidance ) respect to g5e syn!sis1 & =  
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,g5e ,syn!sis ,safety &
 ,security ,act4  #b4 ,g5e syn!sis  7a7 
,guidance ,n lat] ?an #a ye> aft] ! date
 ( enactm5t ( ?is ,act1 ! ,secret>y (   
,heal? & ,human ,s]vices 7ref]r$ to 9   
?is section z ! ,secret>y7 %all update !
 ,scre5+ ,framework ,guidance =         
,provid]s ( ,syn!tic ,d\ble-,/r&$ ,,dna 
to acc\nt = sci5tific & te*nological    
advancem5ts ) respect to mitigat+ risk (
 unau?oriz$ individuals or individuals )
 malici\s int5t f us+ nucleic acid      
syn!sis te*nologies to obta9 biological 
ag5ts or tox9s ( conc]n4 ,su* guidance  

%all include recomm5dations relat$ to-- 
7#a7 scre5+ = sequ5ces t ! ,secret>y    
det]m9es may contribute to toxicity1    
pa?og5icity1 or virul5ce2  7#b7 scre5+ &
 v]ification ( ! id5tity & legitimacy ( 
cu/om]s2  7#c7 ! id5tification1         
evaluation1 & use ( appropriate s(tw>e  
or o!r tools to enable ! scre5+ describ$
 9 p>agraphs 7#a7 & 7#b72  7#d7 ensur+  
nucleic acid syn!sis activities are     
c>ri$ out 9 compliance ) exi/+          
regulations "u "p #gc ( *apt] #db1 "p   
#cca ( *apt] #g1 "p #aba ( *apt] #i1 &  
"p #ggd ( *apt] #ae1 ,code ( ,f$]al     
,regulations 7or successor regulations72
  7#e7 implem5t+ appropriate safegu>ds1 
:i* may include ! use ( su* s(tw>e or   
o!r tools1 9 g5e syn!sis equipm5t to    
facilitate scre5+ ( nucleic acid        
sequ5ces &1 z applicable1 cu/om]s2  7#f7
 ma9ta9+ records ( cu/om] ord]s1        
metadata1 & scre5+ sy/em or protocol    
p]=mance 9 specifi$ =mats1 :i* may      
include /&>diz$ ma*9e-readable &        
int]op]able data =mats2 &  7#g7 o!r     

recomm5dations z det]m9$ appropriate by 
! ,secret>y4  7b7 ,sequ5ces ( conc]n ,! 
,secret>y %all ma9ta9 a public docket to
 solicit recomm5dations on pot5tial     
sequ5ces ( conc]n &1 9 consultation )   
o!r ,f$]al dep>tm5ts & ag5cies &        
non-,f$]al exp]ts1 z appropriate1 review
 & update1 on a regul> basis1 a li/ (   
sequ5ces ( conc]n to facilitate scre5+  
"u subsection 7a77#a74  7c7 ,l&scape    
review ,! ,secret>y1 9 coord9ation ) o!r
 ,f$]al dep>tm5ts & ag5cies1 z          
appropriate1 %all conduct a l&scape     
review ( provid]s & manufactur]s ( g5e  
syn!sis equipm5t1 products1 s(tw>e1 &   
o!r tools ) ! purpose ( und]/&+ ! numb]1
 types1 & capabilities ( products &     
equipm5t t exi/ dome/ically & to in=m ! 
developm5t ( any updates to ! guidance  
"u subsection 7a74  7d7 ,te*nical       
assi/ance ,! ,secret>y1 9 consultation )
 o!r ,f$]al dep>tm5ts & ag5cies1 %all   
provide te*nical assi/ance ^u reque/ ( a
 g5e syn!sis provid]1 manufactur] ( g5e 
syn!sis equipm5t1 or develop] ( s(tw>e  

or o!r scre5+ tools to support          
implem5tation ( ! recomm5dations includ$
 9 ! guidance "u subsection 7a74  7e7   
,def9itions ,9 ?is section3 7#a7 ,g5e   
syn!sis equipm5t ,! t]m g5e syn!sis     
equipm5t means equipm5t ne$$ to produce 
g5e syn!sis products4  7#b7 ,g5e syn!sis
 product ,! 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$+
 ! scre5+ ?re%old1 z det]m9$ by !       
,secret>y2 &  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]s1 z det]m9$ by !         
,secret>y2  7ii7 by-products 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#c7 ,g5e syn!sis provid] ,!
 t]m g5e syn!sis provid] means an entity
 t syn!sizes & di/ributes g5e syn!sis   
products1 includ+ bact]ia1 viruses1 or  
fungi conta9+ recomb9ant or syn!tic     
nucleic acid molecules1 = deliv]y to a  
cu/om]4  7#d7 ,manufactur] ( g5e syn!sis
 equipm5t ,! t]m manufactur] ( g5e      
syn!sis equipm5t means an entity t      
produces & sells equipm5t = syn!siz+ g5e
 syn!sis products4