,,ii  #aaith ,,congress  #ast ,session  
,s4 #bfig  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,september #c1 
#bjbe ,mr4 ,young 7for himself and ,mr4 
,padilla7 introduced the following bill2
 which was read twice and referred to   
the ,committee on ,health1 ,education1  
,labor1 and ,pensions  ,a ,,bill  ,to   
authorize the ,national ,science        
,foundation to conduct research for     
biotechnology risk assessment1 and for  
other purposes4  #a4  ,short title      
,this ,act may be cited as the ,national
 ,biotechnology ,safety ,act4  #b4      
,findings  ,congress finds the          
following3 7#a7 ,biotechnology is       
routinely used to modify genetic        
sequences in plants1 animals1 and       
microorganisms1 resulting in useful     
products across agriculture1 medicine1  
industry1 and defense4  7#b7 ,specific  
research would help inform the ,federal 
,government1 ,state governments1        
industry1 and other stakeholders on how 
best to address safety of biotechnology 

products4  #c4  ,biotechnology risk     
assessment research  7a7  ,purposes     
,the purposes of this section are to    
authorize and support research-- 7#a7 to
 address regulatory concerns about      
potential environmental1 human health1  
or animal health risks of organisms     
produced with biotechnology2 and  7#b7  
that aids regulators in developing clear
 regulatory pathways for products       
produced with biotechnology4  7b7       
,establishment  7#a7  ,in general  ,the 
,director of the ,national ,science     
,foundation 7referred to in this section
 as the ,director7 shall establish a    
program within the ,directorate for     
,technology1 ,innovation1 and           
,partnerships to provide funding for    
research concerning the introduction    
into the environment of organisms that  
were produced with biotechnology4  7#b7 
,mechanisms  ,the ,director may choose  
funding mechanisms under this section as
 appropriate to meet the scientific     
need1 including research grants1        

cooperative agreements1 and temporary   
research consortia4  7c7  ,recipients   
,recipients of funds under this section 
may include-- 7#a7 institutions of      
higher education1 as defined in section 
#ajb of the ,higher ,education ,act of  
#aife 7#bj ,u4,s4,c4 #ajjb72  7#b7      
federally funded research and           
development centers2  7#c7 nonprofit    
research institutions2  7#d7 industry   
and other private sector entities2  7#e7
 other entities determined appropriate  
by the ,director to carry out the       
purposes of this section2 and  7#f7     
consortia of entities described in      
paragraphs 7#a7 through 7#e74  7d7      
,award basis  7#a7 ,selection criteria  
,in selecting recipients for an award   
under this section1 the ,director shall 
consider1 at a minimum--  7,a7 the path 
for developing and1 as appropriate1     
commercializing the organism or similar 
organisms produced with biotechnology   
and resulting products in the ,united   
,states2  7,b7 the current knowledge of 

similar organisms 7as of the date of the
 award71 the limits of such current     
knowledge1 and the novelty and risks of 
the proposed project2  7,c7 the         
relevance of the project to the research
 priorities under paragraph 7#b7 and the
 potential of the project to advance    
such priorities2 and  7,d7 the ethical1 
legal1 and social implications of the   
project4  7#b7 ,research priorities ,in 
awarding funding under this section1 the
 ,director shall give priority to       
research designed to--  7,a7 identify   
unintended effects of biotechnology     
methods1 including unintended genetic   
changes2  7,b7 identify and develop     
management practices to minimize        
environmental1 human health1 or animal  
health risks associated with organisms  
produced with biotechnology1 in research
 or field trial conditions1 in          
commercial production1 and in use as a  
final product2  7,c7 develop methods to 
monitor the dispersal and persistence of
 organisms produced with biotechnology1 

including gene drives2  7,d7 identify   
the characteristics1 rates1 and methods 
of gene transfer that may occur between 
organisms produced with biotechnology   
and related wild and agricultural       
organisms2  7,e7 compare the impacts of 
organisms produced with biotechnology to
 impacts of comparable organisms that   
were not produced with biotechnology or 
to other human activities in the        
environment2  7,f7 identify potential   
risks of convergence of biotechnology   
with artificial intelligence and other  
emerging technologies2 or  7,g7 address 
other topics that further the purposes  
of this section4  7e7 ,metrics ,when    
appropriate1 the ,director may--  7#a7  
set metrics in the terms of an award    
under this section1 including goals and 
deadlines2 and  7#b7 use such metrics to
 determine whether a project carried out
 under this section shall be eligible   
for continued or additional funding4    
7f7  ,regulatory coordination  ,the     
,director shall consult with the        

,secretary of ,agriculture1 the         
,commissioner of ,food and ,drugs1 the  
,administrator of the ,environmental    
,protection ,agency1 and the heads of   
other ,federal agencies with relevant   
expertise as determined by the          
,director1 to--  7#a7 determine the     
applicability of specific areas of      
research to the regulation of products  
produced with biotechnology2  7#b7      
provide ongoing oversight and execution 
of projects carried out under this      
section2 and  7#c7 provide regulatory   
assistance to facilitate the purposes of
 this section4  7g7  ,funding  7#a7     
,authorization of appropriations  ,there
 are authorized to be appropriated to   
the ,directorate for ,technology1       
,innovation1 and ,partnerships to carry 
out this section #ej1jjj1jjj for each of
 fiscal years #bjbf through #bjcj4  7#b7
  ,additional funding  ,in addition to  
using amounts made available under      
paragraph 7#a7 for the program carried  
out under this section1 the ,director   

may--  7,a7 make this program a priority
 of the ,national ,science ,foundation2 
and  7,b7 elect to use other funds that 
are available to the ,director and not  
otherwise restricted in their use to    
carry out the program4  #d4  ,national  
academies biotechnology #b-phase study  
and reports  7a7  ,in general  ,not     
later than #ij days after the date of   
enactment of this ,act1 the ,director of
 the ,national ,science ,foundation     
7referred to in this section as the     
,director71 in consultation with the    
,secretary of ,agriculture1 the         
,commissioner of ,food and ,drugs1 the  
,administrator of the ,environmental    
,protection ,agency1 and heads of other 
,federal agencies with relevant         
expertise as determined by the          
,director1 shall enter into an agreement
 with the ,national ,academies of       
,science1 ,engineering1 and ,medicine   
7referred to in this section as the     
,national ,academies7--  7#a7 to conduct
 a #b-phase study1 in accordance with   

subsections 7b7 and 7c71 on the safety  
and benefits of biotechnology2 and  7#b7
 to submit reports describing the       
results of the studies and including    
findings and recommendations1 in        
accordance with subsection 7d74  7b7    
,phase one of study  ,not later than #a 
year after the date on which the        
agreement described in subsection 7a7 is
 entered into1 the ,national ,academies 
shall complete phase one of the study1  
which shall1 at a minimum--  7#a7       
consider the characteristics and risks  
of biotechnology tools used to modify   
genetic sequences in comparison to the  
characteristics and risks of comparable 
conventional methods used to modify     
genetic sequences2  7#b7 make           
recommendations about risk-proportionate
 frameworks to assess risks of products 
made with biotechnology tools2 and  7#c7
 identify research needed to further    
understand the safety of biotechnology  
tools4  7c7  ,phase two of study  ,not  
later than #b years after the date on   

which the agreement described in        
subsection 7a7 is entered into1 the     
,national ,academies shall complete     
phase two of the study1 which shall1 at 
a minimum--  7#a7 consider the safety   
and benefits of commercialized          
biotechnology products alongside        
comparable conventional products and    
other human activities that may impact  
human health or the environment2  7#b7  
make recommendations about evaluating   
the safety and potential benefits of    
future biotechnology products that are  
under development or not yet widely     
commercialized2  7#c7 make              
recommendations about processes1        
analysis1 or tests that could be used to
 rapidly reduce or remove               
biotechnology-specific oversight of     
products that do not present a greater  
risk than comparable conventional       
products or other human activities2 and 
7#d7 identify research needed to further
 understand safety or benefits of       
biotechnology products4  7d7  ,reports  

,within #ij days of completion of each  
phase of the study under subsections 7b7
 and 7c71 the ,national ,academies      
shall--  7#a7 submit a report that      
includes any findings and               
recommendations of the ,national        
,academies made pursuant to the         
applicable phase of the study to the    
,director1 the heads of the agencies    
with which the ,director consulted under
 subsection 7a71 and the ,committee on  
,commerce1 ,science1 and ,transportation
 of the ,senate and the ,committee on   
,science1 ,space1 and ,technology of the
 ,house of ,representatives2 and  7#b7  
make each such report submitted under   
paragraph 7#a7 available on a publicly  
accessible website4  7e7                
,implementation plan  ,not later than   
#ahj days after the date on which all   
reports from the ,national ,academies   
under subsection 7d7 have been submitted
 to the ,director1 the ,director1 in    
consultation with the heads of the      
agencies named in subsection 7a71 shall 

submit to ,congress an implementation   
plan for ,federal research1 development1
 and demonstration activities for the   
purpose of closing any research gaps    
related to the safety of biotechnology  
tools and products4  7f7  ,authorization
 of appropriations  ,there are          
authorized to be appropriated to carry  
out this section #a1ejj1jjj for fiscal  
year #bjbf4