,,ii  #aaith ,,congress  #b;d ,session  
,s4 #cgda  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,january #bi1  
#bjbf,mr4 ,cotton 7for himself and ,ms4 
,klobuchar7 introduced the following    
bill2 which was read twice and referred 
to the ,committee on ,commerce1         
,science1 and ,transportation  ,a ,,bill
  ,to require the ,secretary of         
,commerce to promulgate regulations to  
improve nucleic acid synthesis security1
 and for other purposes4  #a4 ,short    
title ,this ,act may be cited as the    
,biosecurity ,modernization and         
,innovation ,act of #bjbf4  #b4         
,definitions ,in this ,act3 7#a7        
,covered provider ,the term covered     
provider means a person who-- 7,a7      
synthesizes and sells synthetic nucleic 
acids to persons in the ,united ,states2
 or  7,b7 produces and distributes or   
sells1 including resellers1 equipment   
for synthesizing nucleic acids1         
including benchtop synthesizers1 to     
persons in the ,united ,states4  7#b7   

,director ,the term ,director means the 
,director of the ,office of ,science and
 ,technology ,policy4  7#c7 ,secretary  
,the term ,secretary means the          
,secretary of ,commerce4  7#d7 ,under   
,secretary ,the term ,under ,secretary  
means the ,under ,secretary of ,commerce
 for ,standards and ,technology4  #c4   
,sense of ,congress ,it is the ,sense of
 ,congress that-- 7#a7 the field of     
biotechnology is accelerating and the   
,united ,states is at risk of losing its
 biotechnology leadership to foreign    
adversaries2  7#b7 this acceleration of 
the field brings the ,united ,states    
into a period of both great opportunity 
and risk2  7#c7 policymaking for        
biosecurity1 biosafety1 and responsible 
innovation needs to be flexible to keep 
pace with advances in the biotechnology 
and ensure an environment that allows   
biotechnology research and industry to  
flourish2  7#d7 the current landscape of
 biosecurity and biosafety authorities  
is spread among multiple agencies1      

contributing to slow policymaking1      
which1 coupled with the rapid           
advancement of biotechnology1 becomes   
outdated quickly2  7#e7 previous studies
 conducted by the ,government           
,accountability ,office1 the ,national  
,security ,commission for ,emerging     
,biotechnology1 and several presidential
 administrations have already identified
 gaps in the ,federal ,government's     
oversight of biosecurity and biosafety  
risks2  7#f7 the ,united ,states        
,government needs to streamline         
biosecurity and biosafety authorities to
 ensure efficiency and clarity2  7#g7   
gene synthesis technology is becoming   
increasingly sophisticated and          
accessible1 along with the ability to   
design novel nucleic acid sequences2    
7#h7 both of these factors described in 
paragraph 7#g7 may increase the risk of 
the development and deployment of new   
pathogens by bad actors2 and  7#i7 gene 
synthesis screening of orders and       
customers is immediately needed to      

mitigate risk in the short-term1 which  
will act as a stopgap while the ,united 
,states ,government develops a          
comprehensive biosecurity and biosafety 
strategy that is appropriate for the    
dynamic and rapidly advancing field of  
biotechnology4  #d4 ,nucleic acid       
synthesis security  7a7 ,regulations    
required ,not later than #a year after  
the date of the enactment of this ,act1 
the ,secretary shall1 in coordination   
with the ,under ,secretary and the heads
 of such other agencies as the          
,secretary considers appropriate1       
establish and maintain by regulation the
 following3 7#a7 ,a requirement for     
covered providers to implement screening
 protocols for all sequences of concern 
included in the list established and    
maintained under paragraph 7#c74 ,such  
protocols shall-- 7,a7 include the      
ability for privacy-preserving          
submission of information regarding     
orders for potential sequences of       
concern to a mechanism1 which may be    

maintained by the ,secretary or an      
independent organization designated by  
the ,secretary1 for facilitating        
effective split order detection across  
covered providers1 utilizing the list   
established and maintained under        
paragraph 7#c72 and  7,b7 prioritize the
 mitigation of misuse of sequences      
capable of creating pathogens with      
pandemic potential4  7#b7 ,a requirement
 for covered providers to implement     
screening protocols to verify the       
identity and legitimacy of customers4   
7#c7 ,a list of sequences of concern1   
which shall be determined by the        
,secretary in consultation with such    
heads of ,federal departments and       
agencies1 industry experts1 academics1  
and researchers as the ,secretary       
considers appropriate4  7#d7 ,a system  
for reviewing and updating on a regular 
basis the list of sequences of concern  
established and maintained under        
paragraph 7#c7 that-- 7,a7 uses a docket
 to allow for privacy-preserving        

submissions from the public on          
recommendations for the list of         
sequences of concern2  7,b7 includes an 
expedited procedure to rapidly add      
sequences of concern to the list on a   
provisional basis1 which may include1 as
 far as technically feasible1 automatic 
procedures such as algorithmic          
literature scanning1 industry           
self-reporting1 or inter-agency         
submissions2 and  7,c7 incorporates     
strong data security and confidentiality
 standards4  7#e7 ,a conformity         
assessment system to verify that covered
 providers are adhering to the          
requirements established and maintained 
under paragraphs 7#a7 and 7#b71 which   
will include-- 7,a7 an auditing process 
to ensure orders and customers have been
 scrutinized appropriately1 including   
procedures to conduct adversarial       
testing 7sometimes referred to as       
red-teaming7 at random intervals to     
ensure compliance2 and  7,b7 a process  
to revoke conformity status of covered  

providers that fail to maintain         
compliance with the requirements        
established and maintained under        
paragraphs 7#a7 and 7#b71 including the 
establishment of a grace period for     
covered providers who have failed       
auditing or adversarial testing under   
subparagraph 7,b7 to demonstrate        
compliance or mitigation steps4  7#f7   
,safeguards to ensure regulations       
promulgated under this subsection avoid 
unnecessary burden on innovation and    
industry by-- 7,a7 allowing covered     
providers to offer an expedited review  
process for institutional customers1    
including accredited institutions of    
higher education1 with demonstrated     
records of legitimacy2  7,b7 providing  
exemptions from customer screening      
requirements for sequences or products  
that are clearly non-hazardous and pose 
no credible threat to public health and 
safety based on scientific literature   
and industry best practices for         
biosecurity screening2 and  7,c7        

conducting regular consultations with   
relevant experts to determine exempted  
sequences and minimize regulatory burden
 while maintaining security             
effectiveness4  7#g7 ,a requirement that
 any person who receives ,federal funds 
can only purchase nucleic acid synthesis
 products from a covered provider in    
compliance with the requirements in     
paragraphs 7#a7 and 7#b74  7#h7 ,a      
program to provide technical assistance 
upon request of a covered provider1     
including assistance with orders whose  
screening results are ambiguous1 subject
 to determination by the ,secretary1 in 
consultation with the heads of such     
other ,federal departments and agencies 
as the ,secretary considers appropriate4
  7b7 ,national ,institute of ,standards
 and ,technology requirements ,the      
,under ,secretary shall develop best    
practices1 technical standards1 and     
other tools needed to support the       
administration of subsection 7a71       
including the following3 7#a7 ,testing  

and evaluation of customer and order    
screening protocols to improve accuracy1
 efficacy1 and reliability1 and to      
support the conformity assessment system
 under of subsection 7a77#e74  7#b7     
,evaluation of the sequences recommended
 for the list established and updated   
under paragraphs 7#c7 and 7#d7 of       
subsection 7a71 including by developing 
best practices and guidelines for       
determining if a novel sequence is a    
sequence of concern4  7#c7 ,research and
 prototype sequence-to-function models  
to supplement the system established and
 maintained under subsection 7a77#d74   
7c7 ,updates ,as frequently as the      
,secretary considers appropriate to     
account for technological advances1 but 
not less frequently than once every #b  
years1 the ,secretary shall review and  
update the regulations promulgated under
 subsection 7a74  7d7 ,protection of    
customer information ,any information   
about a customer included in a          
submission under paragraph 7#a77;,a7 or 

7#d77;,a7 of subsection 7a7 shall1 if   
applicable1 be exempt from records      
access under section #eeb7;b77#d7 of    
title #e1 ,united ,states ,code4  7e7   
,relationship with other ,federal       
guidelines and recommendations ,the     
regulations established and maintained  
under paragraphs 7#a7 and 7#b7 of       
subsection 7a7 shall supplant any       
,federal guidelines or recommendations  
relating to nucleic acid synthesis      
screening that-- 7#a7 were in effect    
before the date of the enactment of this
 ,act2 and  7#b7 are voluntary4  7f7    
,civil enforcement  7#a7 ,civil action  
,the ,attorney ,general may bring a     
civil action in a court of competent    
jurisdiction against any person who     
violates a requirement promulgated under
 paragraph 7#a7 or 7#b7 of subsection   
7a71 including through providing false  
or misleading information or engaging in
 other deceptive practices1 or does not 
demonstrate compliance within the grace 
period set forth by subsection          

7a77#e77;,c74  7#b7 ,powers of the court
 ,in an action brought under paragraph  
7#a71 the court may-- 7,a7 enjoin a     
violation described in paragraph 7#a72  
or  7,b7 award damages under paragraph  
7#c74  7#c7 ,award of damages ,a person 
who violates a requirement as described 
in paragraph 7#a7 is liable for         
statutory damages-- 7,a7 in the case of 
an individual1 in the sum of not more   
than #ejj1jjj1 adjusted from time to    
time under paragraph 7#d72 and  7,b7 in 
the case of a person who is not an      
individual1 in the sum of not more than 
#gej1jjj1 adjusted from time to time    
under paragraph 7#d74  7#d7 ,adjustments
 for inflation ,effective on ,october #a
 of each year 7beginning in the first   
fiscal year after the date of the       
enactment of this ,act71 the dollar     
amounts in effect under paragraph 7#c7  
shall be increased by a percentage equal
 to the percentage by which the         
,consumer ,price ,index for all urban   
consumers 7,u4,s4 city average7         

increased during the #ab-month period   
ending with the last month for which    
,consumer ,price ,index data is         
available4 ,in the event that such      
,consumer ,price ,index does not        
increase during such period1 the dollar 
amount in effect under such paragraph   
during the previous fiscal year shall be
 maintained4  7g7 ,reports to ,congress 
,not less frequently than once each     
year1 the ,secretary shall submit to    
,congress a report on the administration
 of this section4 ,each such report     
shall include an overview of how many   
covered providers have been verified by 
the conformity assessment system        
established and maintained under        
subsection 7a77#e74  #e4 ,establishment 
of biotechnology governance sandbox  7a7
 ,in general ,not later than #a year    
after the date of the enactment of this 
,act1 the ,under ,secretary shall1 in   
collaboration with the heads of such    
,federal agencies as the ,under         
,secretary considers relevant and with  

such persons in the private sector1     
academia1 and civil society as the      
,under ,secretary considers appropriate1
 establish a biotechnology governance   
sandbox environment4  7b7               
,responsibilities ,through the          
governance sandbox developed under      
subsection 7a71 the ,under ,secretary   
shall-- 7#a7 provide secure testing of  
innovations or tools developed to       
advance the science of biosecurity1     
biosafety1 and responsible biotechnology
 innovation2  7#b7 foster participation 
of nongovernmental experts in the       
development and testing of appropriate  
levels and methods of governance1 to    
achieve the goals of-- 7,a7 ensuring the
 continued global competitiveness of    
biotechnology innovations in the ,united
 ,states2  7,b7 bolstering the national 
security posture of the ,united ,states2
 and  7,c7 strengthening the ability of 
the ,united ,states to robustly analyze 
emerging threats1 anticipate concerns1  
and govern proactively in the           

biotechnology space2  7#c7 carry out    
biological measurement research to      
support the development and improvement 
of technical standards for biosecurity1 
biosafety1 and responsible biotechnology
 innovation2 and  7#d7 report annually  
to the ,secretary of ,commerce on the   
administration of paragraph 7#b7 and    
whether any promising governance        
strategies have resulted from the       
development and testing4  7c7 ,access to
 environments ,the ,under ,secretary may
 contract with the private sector or    
coordinate with other ,federal agencies 
to access environments necessary to     
provide testing under subsection        
7b77#a74  #f4 ,streamlining biosecurity 
and biosafety authorities across the    
,federal ,government  7a7 ,assessment   
and plan required ,not later than #ij   
days after the date of the enactment of 
this ,act1 the ,director shall1 in      
collaboration with the heads of such    
,federal agencies as the ,director      
considers relevant-- 7#a7 assess the    

current state of biosecurity and        
biosafety oversight by the ,federal     
,government2 and  7#b7 develop1 based on
 the findings of the ,director with     
respect to the assessment conducted     
under paragraph 7#a71 an implementation 
plan to make oversight of biosecurity   
and biosafety by the ,federal           
,government more effective and          
efficient4  7b7 ,elements of assessment 
,the assessment required by subsection  
7a77#a7 shall include the following3    
7#a7 ,a full accounting of ,federal     
biosecurity and biosafety authorities   
and programs1 including which agencies  
hold these authorities1 whether these   
authorities are exercised effectively1  
and where there are overlaps or         
redundancies1 real or perceived1 in     
regulatory and enforcement authorities4 
7#b7 ,engagement with industry          
stakeholders and academia to understand 
where there are challenges with         
compliance1 communication1 and          
information sharing4  7#c7              

,identification of gaps in funding or   
other ,government support for the       
development of research1 innovation1 and
 tools that advance the science of      
applied biosecurity1 biosafety1 and     
responsible biotechnology innovation4   
7#d7 ,identification of gaps in current 
,federal biosecurity and biosafety      
authorities and whether these gaps are  
hindering effective and efficient       
governance and assessment of emerging   
risks and opportunities in              
biotechnology4  7#e7 ,an evaluation of  
how consolidation of biosecurity and    
biosafety guidelines1 authorities1 and  
regulations across ,federal agencies1   
including the regulations established   
and maintained under section #d7;a71    
should be implemented to make oversight 
more effective and efficient and to     
address the gaps in such guidelines1    
authorities1 and regulations1 including 
those identified under paragraphs 7#c7  
and 7#d74  7c7 ,report to ,congress     
7#a7 ,in general ,not later than #ij    

days after the date on which the        
,director completes the assessment      
required by paragraph 7#a7 of subsection
 7a7 and the implementation plan        
required by paragraph 7#b7 of such      
subsection1 the ,director shall submit  
to ,congress-- 7,a7 a report on the     
findings of the ,director with respect  
to the assessment2 and  7,b7 a copy of  
the implementation plan4  7#b7 ,contents
 ,the report submitted pursuant to      
paragraph 7#a77;,a7 shall include the   
following3 7,a7 ,the findings of the    
,director with respect to the assessment
 conducted pursuant to subsection       
7a77#a74  7,b7 ,recommendations for     
legislative or administrative action to 
support the implementation plan         
developed under subsection 7a77#b71     
according to-- 7i7 what1 if any1 new    
biosecurity and biosafety authorities   
are needed2 and  7ii7 where the ,federal
 ,government can consolidate biosecurity
 and biosafety authorities1 including   
which1 if any1 should be reside under a 

common government entity1 and whether   
this necessitates establishing a new    
government entity4  7d7 ,implementation 
7#a7 ,in general ,not later than #ij    
days after the date on which the        
,director completes the implementation  
plan required by subsection 7a77#b71 the
 ,director shall commence implementing  
the plan through administrative action  
in accordance with applicable provisions
 of law4  7#b7 ,governance strategies   
,in carrying out the implementation plan
 developed under subsection 7a77#b71 the
 ,director shall consider which1 if any1
 of the governance strategies reported  
under section #e7;b77#d7 should be      
included in the plan4