,,ii  #aahth ,,congress  #ast ,session  
,s4 #bcef  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,july #ah1     
#bjbc,mr4 ,hickenlooper 7for himself and
 ,mr4 ,budd7 introduced the following   
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to require the ,secretary of   
,health and ,human ,services to update  
guidance with respect to gene synthesis1
 and for other purposes4  #a4 ,short    
title ,this ,act may be cited as the    
,gene ,synthesis ,safety and ,security  
,act4  #b4 ,gene synthesis  7a7         
,guidance ,not later than #a year after 
the date of enactment of this ,act1 the 
,secretary of ,health and ,human        
,services 7referred to in this section  
as the ,secretary7 shall update the     
,screening ,framework ,guidance for     
,providers of ,synthetic                
,double-,stranded ,,dna to account for  
scientific and technological            
advancements with respect to mitigating 

risk of unauthorized individuals or     
individuals with malicious intent from  
using nucleic acid synthesis            
technologies to obtain biological agents
 or toxins of concern4 ,such guidance   
shall include recommendations related   
to-- 7#a7 screening for sequences that  
the ,secretary determines may contribute
 to toxicity1 pathogenicity1 or         
virulence2  7#b7 screening and          
verification of the identity and        
legitimacy of customers2  7#c7 the      
identification1 evaluation1 and use of  
appropriate software or other tools to  
enable the screening described in       
paragraphs 7#a7 and 7#b72  7#d7 ensuring
 nucleic acid synthesis activities are  
carried out in compliance with existing 
regulations under part #gc of chapter   
#db1 part #cca of chapter #g1 part #aba 
of chapter #i1 and part #ggd of chapter 
#ae1 ,code of ,federal ,regulations 7or 
successor regulations72  7#e7           
implementing appropriate safeguards1    
which may include the use of such       

software or other tools1 in gene        
synthesis equipment to facilitate       
screening of nucleic acid sequences and1
 as applicable1 customers2  7#f7        
maintaining records of customer orders1 
metadata1 and screening system or       
protocol performance in specified       
formats1 which may include standardized 
machine-readable and interoperable data 
formats2 and  7#g7 other recommendations
 as determined appropriate by the       
,secretary4  7b7 ,sequences of concern  
,the ,secretary shall maintain a public 
docket to solicit recommendations on    
potential sequences of concern and1 in  
consultation with other ,federal        
departments and agencies and            
non-,federal experts1 as appropriate1   
review and update1 on a regular basis1 a
 list of sequences of concern to        
facilitate screening under subsection   
7a77#a74  7c7 ,landscape review ,the    
,secretary1 in coordination with other  
,federal departments and agencies1 as   
appropriate1 shall conduct a landscape  

review of providers and manufacturers of
 gene synthesis equipment1 products1    
software1 and other tools with the      
purpose of understanding the number1    
types1 and capabilities of products and 
equipment that exist domestically and to
 inform the development of any updates  
to the guidance under subsection 7a74   
7d7 ,technical assistance ,the          
,secretary1 in consultation with other  
,federal departments and agencies1 shall
 provide technical assistance upon      
request of a gene synthesis provider1   
manufacturer of gene synthesis          
equipment1 or developer of software or  
other screening tools to support        
implementation of the recommendations   
included in the guidance under          
subsection 7a74  7e7 ,definitions ,in   
this section3 7#a7 ,gene synthesis      
equipment ,the term gene synthesis      
equipment means equipment needed to     
produce gene synthesis products4  7#b7  
,gene synthesis product ,the term gene  
synthesis product-- 7,a7 means custom   

single-stranded or double-stranded      
,,dna1 or single-stranded or            
double-stranded ,,rna1 which has been   
chemically or enzymatically synthesized 
or otherwise manufactured de novo and is
 of a length exceeding the screening    
threshold1 as determined by the         
,secretary2 and  7,b7 does not include--
 7i7 base chemical subunits1 such as    
individual nucleotides or nucleosides1  
or oligonucleotides shorter than the    
screening threshold typically used as   
polymerase chain reaction primers1 as   
determined by the ,secretary2  7ii7     
by-products generated during sequencing 
that are not useful for assembly or     
cloning1 as determined by the           
,secretary2 or  7iii7 products generated
 from cloning or assembling of existing 
gene or gene fragment material1 in      
circumstances in which the gene         
synthesis provider has no access or     
notice to the sequence design1 as       
determined by the ,secretary4  7#c7     
,gene synthesis provider ,the term gene 

synthesis provider means an entity that 
synthesizes and distributes gene        
synthesis products1 including bacteria1 
viruses1 or fungi containing recombinant
 or synthetic nucleic acid molecules1   
for delivery to a customer4  7#d7       
,manufacturer of gene synthesis         
equipment ,the term manufacturer of gene
 synthesis equipment means an entity    
that produces and sells equipment for   
synthesizing gene synthesis products4