#aad? ,,congress  #a/ ,session  ,h4 ,r4 
#aeii  ,,an ,,act  ,to am5d ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act ) respect
 to food produc$ f1 conta9+1 or consi/+ 
( a bio5g9e]$ organism1 ! label+ (      
natural foods1 & = o!r purposes4  #a4   
,%ort title2 table ( cont5ts  7a7 ,%ort 
title ,?is ,act may be cit$ z ! ,safe & 
,accurate ,food ,label+ ,act ( #bjae4   
7b7 ,table ( cont5ts ,! table ( cont5ts 
( ?is ,act is z foll[s3  ,sec4 #a4 ,%ort
 title2 table ( cont5ts4 ,sec4 #b4      
,sav+s clause4 ,title ,i--,food ,safety 
,affirmation = c]ta9 plant products     
,subtitle ,a--,food & ,drug             
,adm9i/ration ,sec4 #aja4 ,consultation 
process4 ,subtitle ,b--,dep>tm5t (      
,agriculture ,sec4 #aaa4 ,regulation4   
,sec4 #aab4 ,regulations4 ,sec4 #aac4   
,preemption4 ,sec4 #aad4 ,rule (        
con/ruction4 ,sec4 #aae4 ,implem5tation 
report4 ,title ,,ii--,g5etic eng9e]+    
c]tification ,sec4 #bja4 ,g5etic eng9e]+
 c]tification4 ,sec4 #bjb4 ,regulations4
 ,sec4 #bjc4 ,preemption4 ,sec4 #bjd4   

,applicability4 ,title ,,iii--,natural  
foods ,sec4 #cja4 ,label+ ( natural     
foods4 ,sec4 #cjb4 ,regulations4 ,sec4  
#cjc4 ,preemption4 ,sec4 #cjd4          
,effective date4  #b4 ,sav+s clause     
,no?+ 9 ?is ,act 7or ! am5dm5ts made by 
?is ,act7 is int5d$ to alt] or affect ! 
au?orities or regulatory programs1      
policies1 & proc$ures o!rwise available 
to1 or ! def9itions us$ by1 ! ,food &   
,drug ,adm9i/ration "u ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cja et seq47 or ! ,animal & ,plant     
,heal? ,inspection ,s]vice "u ! ,plant  
,protection ,act 7#g ,u4,s4,c4 #ggja et 
seq471 to ensure ! safety ( ! food      
supply & ! protection ( plant heal?4  ,i
 ,food ,safety ,affirmation = c]ta9     
plant products  ,a ,food & ,drug        
,adm9i/ration  #aja4 ,consultation      
process ,*apt] ,,iv ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act is am5d$ by     
ins]t+ aft] section #dbc ( su* ,act 7#ba
 ,u4,s4,c4 #cejl7 ! foll[+3  #dbd4 ,food
 d]iv$ f new plant v>ieties  7a7 ,9     

g5]al ,! ,secret>y %all cont9ue to      
adm9i/] ! consultation process e/abli%$ 
"u ! ,food & ,drug ,adm9i/ration's      
policy /atem5t entitl$ ,/atem5t (       
,policy3 ,food ,d]iv$ f ,new ,plant     
,v>ieties publi%$ 9 ! ,f$]al ,regi/] on 
,may #bi1 #aiib 7#eg ,f$4 ,reg4         
#bb1ihd74  7b7 ,det]m9ation ( mat]ial   
diff]5ce betwe5 food f g5etically       
eng9e]$ plants & comp>able foods  7#a7  
,9 g5]al ,= purposes ( subsection 7a71 !
 use ( g5etic eng9e]+ does n1 by itself1
 con/itute in=mation t is mat]ial =     
purposes ( det]m9+ :e!r !re is a        
diff]5ce betwe5 a food produc$ f1       
conta9+1 or consi/+ ( a g5etically      
eng9e]$ plant & a comp>able food4  7#b7 
,label+ requir$ ,! ,secret>y may require
 t ! label+ ( a food produc$ f1 conta9+1
 or consi/+ ( a g5etically eng9e]$ plant
 conta9 a /atem5t to adequately in=m    
consum]s ( a diff]5ce betwe5 ! food s   
produc$ & its comp>able food if !       
,secret>y det]m9es t-- 7,a7 !re is a    
mat]ial diff]5ce 9 ! functional1        

nutritional1 or compositional           
*>act]i/ics1 all]g5icity1 or o!r        
attributes betwe5 ! food s produc$ & its
 comp>able food2 &  7,b7 ! disclosure ( 
su* mat]ial diff]5ce is necess>y to     
protect public heal? & safety or to     
prev5t ! label or label+ ( ! food s     
produc$ f be+ false or mislead+ 9 any   
p>ticul>4  4  ,b ,dep>tm5t (            
,agriculture  #aaa4 ,regulation ,!      
,plant ,protection ,act 7#g ,u4,s4,c4   
#ggja et seq47 is am5d$ by add+ at ! end
 ! foll[+ new subtitle3  ,f ,coord9ation
 ( food safety & agriculture programs   
#dfa4 ,notification relat+ to c]ta9     
g5etically eng9e]$ plants  7a7 ,9 g5]al 
,subject to subsection 7b71 x %all be   
unlawful to sell or (f] = sale 9        
int]/ate comm]ce a nonregulat$          
g5etically eng9e]$ plant = use or       
application 9 food or a food produc$ f1 
conta9+1 or consi/+ ( a nonregulat$     
g5etically eng9e]$ plant unless-- 7#a7  
7,a7 ! ,secret>y ( ,heal? & ,human      
,s]vices notifi$ ! entity seek+         

evaluation ( a food produc$ f1 conta9+1 
or consi/+ ( ! g5etically eng9e]$ plant 
9 writ+ t ! ,secret>y ( ,heal? & ,human 
,s]vices1 9 evaluat+ ! food f !         
g5etically eng9e]$ plant ?r\gh !        
consultation process ref]r$ to 9 section
 #dbd7;a7 ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act1 has no objections to !  
entity's det]m9ation t food produc$ f1  
conta9+1 or consi/+ ( ! g5etically      
eng9e]$ plant t is ! subject ( !        
notification is safe = use by humans or 
animals1 z applicable1 & lawful "u !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act2 &
  7,b7 ! entity seek+ evaluation ( a    
food produc$ f1 conta9+1 or consi/+ ( ! 
g5etically eng9e]$ plant submits to !   
,secret>y ( ,agriculture ! notification 
( ! f9d+ ( ! ,secret>y ( ,heal? & ,human
 ,s]vices "u subp>agraph 7,a72 or  7#b7 
be=e ! date ( ! enactm5t ( ! ,safe &    
,accurate ,food ,label+ ,act ( #bjae1 ! 
,secret>y ( ,heal? & ,human ,s]vices--  
7,a7 consid]$ ! consultation process    
ref]r$ to 9 section #dbd7;a7 ( ! ,f$]al 

,food1 ,drug1 & ,cosmetic ,act ) respect
 to su* g5etically eng9e]$ plant to be  
complete2  7,b7 notifi$ ! consult+ p>ty 
9 writ+ t all que/ions ) respect to !   
safety ( food produc$ f1 conta9+1 or    
consi/+ ( ! g5etically eng9e]$ plant h  
be5 resolv$2 &  7,c7 publi%$ su*        
notification on ! public ,int]net       
website ( ! ,food & ,drug ,adm9i/ration4
  7b7 ,exceptions ,not)/&+ subsection   
7a71 ?is section does n apply ) respect 
to ! sale or (f]+ = sale 9 int]/ate     
comm]ce ( a g5etically eng9e]$ plant--  
7#a7 = ! purpose ( rese>* or developm5t 
te/+1 includ+-- 7,a7 te/+ conduct$ to   
g5]ate data & in=mation t c\ld be us$ 9 
a submission to ! ,secret>y "u ?is title
 or o!r regulatory submission2 or  7,b7 
multiplication ( se$ or hybrid & v>iety 
developm5t conduct$ be=e submitt+ a     
notification "u subsection 7a77#a77;,b72
  7#b7 solely because a process+ aid or 
enzyme produc$ f ! g5etically eng9e]$   
plant is int5d$ to be us$ to produce    
food2 or  7#c7 solely because !         

g5etically eng9e]$ plant is us$ z a     
nutri5t s\rce = microorganisms4  7c7    
,rule ( con/ruction ,no?+ 9 subsection  
7b77#a7 may be con/ru$ z au?oriz+ ! sale
 or (f]+ = sale 9 int]/ate comm]ce ( a  
nonregulat$ g5etically eng9e]$ plant =  
use or application 9 food or a food     
produc$ f1 conta9+1 or consi/+ ( a      
nonregulat$ g5etically eng9e]$ plant4   
7d7 ,public ,disclosure  7#a7 ,9 g5]al  
,subject to p>agraph 7#b71 ! ,secret>y (
 ,agriculture %all publi% on ! public   
,int]net website ( ! ,dep>tm5t (        
,agriculture1 & update z necess>y1 a    
regi/ry t includes-- 7,a7 a li/ ( ea*   
nonregulat$ g5etically eng9e]$ plant    
int5d$ = a use or application 9 food t  
may be sold or (f]$ = sale 9 int]/ate   
comm]ce1 9 accordance ) subsection 7a72 
7,b7 ! petitions submitt$ to1 &         
det]m9ations made by1 ! ,secret>y (     
,agriculture ) respect to su* a plant2 &
  7,c7 ! notifications ( f9d+s issu$ by 
! ,secret>y ( ,heal? & ,human ,s]vices )
 respect to su* a plant or ! use or     

application ( su* a plant 9 food4  7#b7 
,trade secrets & confid5tial in=mation  
,not)/&+ p>agraph 7#a71 no?+ 9 ?is      
section %all be con/ru$ to alt] !       
protections (f]$ by laws1 regulations1 &
 policies gov]n+ disclosure (           
confid5tial comm]cial or trade secret   
in=mation1 & any o!r in=mation exempt f 
disclosure pursuant to section #eeb7;b7 
( title #e1 ,unit$ ,/ates ,code1 z su*  
provisions w\ld be appli$ to ! docum5ts 
& in=mation ref]r$ to 9 subp>agraphs    
7,a7 ?r\gh 7,c7 ( p>agraph 7#a74  7e7   
,import$ food ,9 ! case ( food import$  
into ! ,unit$ ,/ates t is food produc$  
f1 conta9+1 or consi/+ ( a plant t meets
 ! def9ition ( a nonregulat$ g5etically 
eng9e]$ plant or a plant t1 if sold 9   
int]/ate comm]ce1 w\ld be subject to    
regulation "u "p #cdj ( title #g1 ,code 
( ,f$]al ,regulations 7or any successor 
regulations71 ! provisions ( ?is section
 %all apply to su* food 9 ! same mann] &
 to ! same ext5t z su* provisions apply 
to a food t is n s import$4  #dfb4      

,def9itions ,9 ?is subtitle3 7#a7 ,food 
,! t]m food has ! mean+ giv5 su* t]m 9  
section #bja7;f7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cba7;f774  7#b7 ,nonregulat$ g5etically
 eng9e]$ plant ,! t]m nonregulat$       
g5etically eng9e]$ plant means a        
g5etically eng9e]$ plant-- 7,a7 = :i* ! 
,secret>y ( ,agriculture has approv$ a  
petition "u section #cdj4f ( title #g1  
,code ( ,f$]al ,regulations 7or any     
successor regulations71 = a det]m9ation 
t ! g5etically eng9e]$ plant %\ld n be  
regulat$ "u ?is ,act2 or  7,b7 t-- 7i7  
is n subject to regulation z a plant pe/
 "u ?is ,act2  7ii7 conta9s g5etic      
mat]ial f a diff]5t species2 &  7iii7   
has be5 modifi$ ?r\gh 9 vitro recomb9ant
 deoxyribonucleic acid 7,,dna7          
te*niques4  4  #aab4 ,regulations ,n    
lat] ?an #a ye> aft] ! date ( ! enactm5t
 ( ?is ,act1 ! ,secret>y ( ,agriculture 
%all promulgate int]im f9al regulations 
to c>ry out ! am5dm5ts made by section  
#aaa4  #aac4 ,preemption ,reg>dless (   

:e!r regulations h be5 promulgat$ "u    
section #aab1 beg9n+ on ! date ( !      
enactm5t ( ?is ,act1 no ,/ate or        
political subdivision ( a ,/ate may     
directly or indirectly e/abli% "u any   
au?ority or cont9ue 9 effect z to any   
food 9 int]/ate comm]ce any requirem5t )
 respect to ! sale or (f]+ = sale 9     
int]/ate comm]ce ( a g5etically eng9e]$ 
plant = use or application 9 food t is n
 id5tical to ! requirem5t ( section #dfa
 ( ! ,plant ,protection ,act 7z add$ by 
section #aaa ( ?is ,act74  #aad4 ,rule (
 con/ruction ,no?+ 9 ! am5dm5ts made by 
?is subtitle is int5d$ to alt] or affect
 ! ability (-- 7#a7 ! ,secret>y ( ,heal?
 & ,human ,s]vices to take en=cem5t     
actions ) respect to a violation ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cja et seq471 includ+   
section #cja ( su* ,act 7#ba ,u4,s4,c4  
#cca72 or  7#b7 ! ,secret>y (           
,agriculture to take en=cem5t actions ) 
respect to a violation ( ! ,plant       
,protection ,act 7#g ,u4,s4,c4 #ggja et 

seq471 includ+ section #daa ( su* ,act  
7#g ,u4,s4,c4 #ggaa74  #aae4            
,implem5tation report  7a7 ,/udy ,n lat]
 ?an #a ye> aft] ! date ( ! enactm5t (  
?is ,act1 ! ,secret>y ( ,agriculture & !
 ,secret>y ( ,heal? & ,human ,s]vices   
%all jo9tly submit to ,congress a report
 evaluat+ ! progress made 9 !           
implem5tation ( subtitle ,f ( ! ,plant  
,protection ,act1 z add$ by section     
#aaa4 ,su* report %all include--  7#a7  
an analysis ( plants ov] :i* regulatory 
ov]sight "u su* subtitle is requir$2    
7#b7 an analysis ( ! ext5t to :i* !     
provisions ( su* subtitle e/abli% an    
appropriate scope ( regulatory ov]sight 
= ! ,animal & ,plant ,heal? ,inspection 
,s]vice & ! ,food & ,drug ,adm9i/ration1
 includ+ _! ov]sight ( public rese>*    
programs2 &  7#c7 any pot5tial *anges to
 ! ,plant ,protection ,act t w\ld bett] 
facilitate implem5tation ( a coord9at$1 
pr$ictable1 & effici5t sci5ce-bas$      
regulatory process4  7b7 ,coord9ation ) 
o!r ef=ts ,to mod]nize regulation ,!    

report "u subsection 7a7 %all be prep>$1
 to ! greate/ ext5t practicable1 9      
accordance ) ! process describ$ 9 !     
memor&um issu$ by ! ,executive ,(fice ( 
! ,presid5t on ,july #b1 #bjae1 entitl$ 
,mod]niz+ ! ,regulatory ,sy/em =        
,biote*nology ,products1 includ+ !      
directive specifi$ 9 su* memor&um to    
update ! ,coord9at$ ,framework =        
,regulation ( ,biote*nology publi%$ by !
 ,executive ,(fice ( ! ,presid5t1 ,(fice
 ( ,sci5ce & ,te*nology ,policy1 9 !    
,f$]al ,regi/] on ,june #bf1 #aihf 7#ea 
,f$4 ,reg4 #bccjb74  ,,ii ,g5etic       
eng9e]+ c]tification  #bja4 ,g5etic     
eng9e]+ c]tification ,! ,agricultural   
,m>ket+ ,act ( #aidf 7#g ,u4,s4,c4 #afba
 et seq47 is am5d$ by add+ at ! end !   
foll[+ new subtitle3  ,e ,g5etic eng9e]+
 c]tification  #bia4 ,def9itions ,9 ?is 
subtitle3  7#a7 ,! t]m c]tify+ ag5t     
means ! *ief executive (fic] ( a ,/ate  
or1 9 ! case ( a ,/ate t provides = !   
/atewide election ( an (ficial to be    
responsible solely = ! adm9i/ration ( ! 

agricultural op]ations ( ! ,/ate1 su*   
(ficial1 & any p]son 7includ+ a private 
entity7 :o is accr$it$ by ! ,secret>y z 
a c]tify+ ag5t = ! purpose ( c]tify+ a  
cov]$ product z a product1 ! label+ (   
:i* may indicate :e!r ! product is      
produc$ ) or )\t ! use ( g5etic eng9e]+4
  7#b7 ,! t]m cov]$ product means--     
7,a7 an agricultural product1 :e!r raw  
or process$ 7includ+ any product d]iv$ f
 live/ock t is m>ket$ 9 ! ,unit$ ,/ates 
= consumption by humans or o!r animals72
  7,b7 any o!r food 7z def9$ 9 section  
#bja ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act7 n d]iv$ f an            
agricultural product2 &  7,c7 se$ or o!r
 propagative mat]ial4  7#c7 ,! t]m      
g5etically eng9e]$ plant ref]s to a     
plant or plant product 7z ^? t]ms are   
def9$ 9 section #djc ( ! ,plant         
,protection ,act 7#g ,u4,s4,c4 #ggjb771 
if--  7,a7 x conta9s g5etic mat]ial t   
has be5 modifi$ ?r\gh 9 vitro recomb9ant
 deoxyribonucleic acid 7,,dna7          
te*niques2 &  7,b7 ! modification c\ld n

 o!rwise be obta9$ us+ conv5tional bre$+
 te*niques4  7#d7 ,! t]m comp>able food 
means1 ) respect to a cov]$ product     
produc$ f1 conta9+1 or consi/+ ( a      
g5etically eng9e]$ plant-- 7,a7 ! p>5tal
 v>iety ( ! plant2  7,b7 ano!r commonly 
consum$ v>iety ( ! plant2 or  7,c7 a    
commonly consum$ cov]$ product )        
prop]ties comp>able to ! cov]$ product  
produc$ f1 conta9+1 or consi/+ ( !      
g5etically eng9e]$ plant4  7#e7 ,! t]m  
h&le means to sell1 process1 or package 
cov]$ products4  7#f7 ,! t]m produc]    
means a p]son :o engages 9 ! bus9ess (  
gr[+ or produc+ cov]$ products4  7#g7 ,!
 t]m ,secret>y means ! ,secret>y (      
,agriculture1 act+ ?r\gh ! ,agricultural
 ,m>ket+ ,s]vice4  #bia;,a4 ,national   
g5etically eng9e]$ food c]tification    
program  7a7 ,9 g5]al ,! ,secret>y %all 
e/abli% a volunt>y g5etically eng9e]$   
food c]tification program = cov]$       
products ) respect to ! use ( g5etic    
eng9e]+ 9 ! production ( su* products1 z
 provid$ = 9 ?is subtitle4 ,! ,secret>y 

%all e/abli% ! requirem5ts & proc$ures z
 ! ,secret>y det]m9es are necess>y to   
c>ry out su* program4  7b7 ,consultation
 ,9 develop+ ! program "u subsection    
7a71 ! ,secret>y %all consult ) su* o!r 
p>ties z are necess>y to develop su*    
program to ensure t produc]s or h&l]s   
seek+ to make claims "u section #bia;,b 
or #bia;,c are c]tifi$ to make su*      
claims4  7c7 ,c]tification ,! ,secret>y 
%all implem5t ! program e/abli%$ "u     
subsection 7a7 ?r\gh c]tify+ ag5ts4 ,su*
 c]tify+ ag5ts may c]tify t cov]$       
products 7 or 7 n produc$ ) ! use (     
g5etic eng9e]+ or a g5etically eng9e]$  
plant1 9 accordance ) ?is subtitle4  7d7
 ,seal ,! ,secret>y %all e/abli% a seal 
to id5tify cov]$ products 9 int]/ate    
comm]ce us+ t]m9ology ! ,secret>y       
consid]s appropriate = cov]$ products   
c]tifi$ "u ?is title1 includ+ t]m9ology 
commonly us$ 9 int]/ate comm]ce or      
e/abli%$ by ! ,secret>y 9 regulations4  
#bia;,b4 ,national /&>ds = label+       
nong5etically eng9e]$ food  7a7 ,9 g5]al

 ,to be sold or label$ z a cov]$ product
 produc$ )\t ! use ( g5etic eng9e]+--   
7#a7 ! cov]$ product %all-- 7,a7 be     
subject to supply *a9 process controls t
 address--  7i7 ! produc] plant+ se$ t  
is n g5etically eng9e]$2  7ii7 ! produc]
 keep+ ! crop sep>at$ dur+ gr[?1 h>ve/+1
 /orage1 & transportation2 &  7iii7     
p]sons 9 direct contact ) su* crop or   
products d]iv$ f su* crop dur+          
transportation1 /orage1 or process+     
keep+ ! product sep>at$ f o!r products t
 are1 or are d]iv$ f1 g5etically eng9e]$
 plants2 &  7,b7 be produc$ & h&l$ 9    
compliance ) a nong5etically eng9e]$    
food plan develop$ & approv$ 9          
accordance ) subsection 7c72  7#b7 9 !  
case ( a cov]$ product d]iv$ f live/ock 
t is m>ket$ 9 ! ,unit$ ,/ates = human   
consumption1 ! cov]$ product & !        
live/ock1 products consum$ by su*       
live/ock1 & products us$ 9 process+ !   
products consum$ by su* live/ock %all be
 produc$ )\t ! use ( products d]iv$ f   
g5etic eng9e]+2 &  7#c7 label+ or       

adv]tis+ mat]ial on1 or 9 conjunction )1
 su* cov]$ product %all n sugge/ ei!r   
expressly or by implication t cov]$     
products develop$ )\t ! use ( g5etic    
eng9e]+ are saf] or ( high] quality ?an 
cov]$ products produc$ f1 conta9+1 or   
consi/+ ( a g5etically eng9e]$ plant4   
7b7 ,exceptions ,a cov]$ product %all n 
be consid]$ z n meet+ ! crit]ia specifi$
 9 subsection 7a7 solely because ! cov]$
 product-- 7#a7 is manufactur$ or       
process$ us+ a g5etically eng9e]$       
microorganism or a process+ aid or      
enzyme2  7#b7 is d]iv$ f microorganisms 
t consum$ a nutri5t s\rce produc$ f1    
conta9+1 or consi/+ ( a g5etically      
eng9e]$ plant2 or  7#c7 is an approv$   
sub/ance on ! ,national ,li/ e/abli%$ "u
 section #baah ( ! ,organic ,foods      
,production ,act ( #aiij 7#g ,u4,s4,c4  
#feag74  7c7 ,nong5etically eng9e]$ food
 plan  7#a7 ,9 g5]al ,a produc] or h&l] 
seek+ c]tification "u ?is section %all  
submit a nong5etically eng9e]$ food plan
 to ! c]tify+ ag5t & su* plan %all be   

review$ by ! c]tify+ ag5t :o %all       
det]m9e if su* plan meets ! requirem5ts 
( ?is section4  7#b7 ,cont5ts ,a        
nong5etically eng9e]$ food plan %all    
conta9 a description (--  7,a7 !        
proc$ures t w be foll[$ to assure       
compliance ) ?is section2  7,b7 a       
description ( ! monitor+ records t w be 
ma9ta9$2 &  7,c7 any corrective actions 
t w be implem5t$ 9 ! ev5t !re is a      
deviation f ! plan4  7#c7 ,availability 
,! nong5etically eng9e]$ food plan & !  
records ma9ta9$ "u ! plan %all be       
available = review & copy+ by !         
,secret>y or a c]tify+ ag5t4  7d7       
,treatm5t ( live/ock ,9 ! case ( a cov]$
 product d]iv$ f live/ock t is m>ket$ 9 
! ,unit$ ,/ates = human consumption1 !  
cov]$ product %all n be consid]$ to be  
g5etically eng9e]$ solely because !     
live/ock consum$ fe$ produc$ f conta9+1 
or consi/+ ( a g5etically eng9e]$ plant4
  #bia;,c4 ,national /&>ds = label+     
g5etically eng9e]$ food  7a7 ,9 g5]al   
,to be sold or label$ z a cov]$ product 

produc$ ) ! use ( g5etic eng9e]+--  7#a7
 ! cov]$ product %all be produc$ & h&l$ 
9 compliance ) a g5etically eng9e]$ food
 plan develop$ & approv$ 9 accordance ) 
subsection 7b72 &  7#b7 ! label+ (1 or  
adv]tis+ mat]ial on1 or 9 conjunction )1
 su* cov]$ product %all--  7,a7 n       
expressly or impli$ly claim t a cov]$   
product develop$ ) ! use ( g5etic       
eng9e]+ is saf] or ( high] quality      
solely because ! cov]$ product is a     
product develop$ ) ! use ( g5etic       
eng9e]+2  7,b7 n make any claims t are  
false or mislead+2 &  7,c7 conta9 su*   
in=mation z ! ,secret>y consid]s        
appropriate4  7b7 ,g5etically eng9e]$   
food plan  7#a7 ,9 g5]al ,a produc] or  
h&l] seek+ c]tification "u ?is section  
%all submit a g5etically eng9e]$ food   
plan to ! c]tify+ ag5t & su* plan %all  
be review$ by ! c]tify+ ag5t :o %all    
det]m9e if su* plan meets ! requirem5ts 
( ?is section4  7#b7 ,cont5ts ,a        
g5etically eng9e]$ food plan %all conta9
 a description (-- 7,a7 ! proc$ures t w 

be foll[$ to assure compliance ) ?is    
section2  7,b7 a description ( !        
monitor+ records t w be ma9ta9$2 &  7,c7
 any corrective actions t w be implem5t$
 9 ! ev5t !re is a deviation f ! plan4  
7#c7 ,availability ,! g5etically eng9e]$
 food plan & ! records ma9ta9$ "u ! plan
 %all be available = review & copy+ by !
 ,secret>y or a c]tify+ ag5t4  7c7      
,prohibition aga9/ re/rict+ c]ta9       
disclosures ,) respect to a cov]$       
product t o!rwise meets ! crit]ia       
specifi$ 9 subsection 7a71 ! ,secret>y  
may n prev5t a p]son--  7#a7 f disclos+ 
volunt>ily on ! label+ ( su* a cov]$    
product develop$ ) ! use ( g5etic       
eng9e]+ ! mann] 9 :i* ! product has be5 
modifi$ to express traits or *>act]i/ics
 t diff] f its comp>able food2 or  7#b7 
f disclos+ 9 adv]tisem5ts1 on !         
,int]net1 9 response to consum]         
inquiries1 or on o!r communications1 o!r
 ?an 9 ! label+1 t a cov]$ product 0    
develop$ ) ! use ( g5etic eng9e]+4      
#bia;,d4 ,import$ products ,import$     

cov]$ products may be sold or label$ z  
produc$ ) or )\t ! use ( g5etic eng9e]+ 
if ! ,secret>y det]m9es t su* products h
 be5 produc$ & h&l$ "u a g5etic eng9e]+ 
c]tification program t provides         
safegu>ds & guidel9es gov]n+ !          
production & h&l+ ( su* products t are  
at lea/ equival5t to ! requirem5ts ( ?is
 subtitle4  #bia;,e4 ,accr$itation      
program  7a7 ,9 g5]al ,! ,secret>y %all 
e/abli% & implem5t a program to accr$it 
a gov]n+ ,/ate (ficial1 & any private   
p]son1 t meets ! requirem5ts ( ?is      
section z a c]tify+ ag5t = ! purpose (  
c]tify+ a cov]$ product z hav+ be5      
produc$ ) or )\t ! use ( g5etic eng9e]+ 
or a g5etically eng9e]$ plant1 9        
accordance ) ?is subtitle4  7b7         
,requirem5ts ,to be accr$it$ z a c]tify+
 ag5t "u ?is section1 a gov]n+ ,/ate    
(ficial or private p]son %all-- 7#a7    
prep>e & submit to ! ,secret>y an       
application = su* accr$itation2  7#b7 h 
suffici5t exp]tise 9 agricultural       
production & h&l+ te*niques z det]m9$ by

 ! ,secret>y2 &  7#c7 comply ) !        
requirem5ts ( ?is section4  7c7         
,duration ( accr$itation ,an            
accr$itation made "u ?is section %all be
 = a p]iod ( n to exce$ #e ye>s1 z      
det]m9$ appropriate by ! ,secret>y1 &   
may be r5ew$4  7d7 ,coord9ation ) exi/+ 
organic program accr$itation ,a gov]n+  
,/ate (ficial or private p]son :o is    
accr$it$ to c]tify a f>m or h&l+        
op]ation z a c]tifi$ organic f>m or h&l+
 op]ation pursuant to section #baae ( ! 
,organic ,foods ,production ,act ( #aiij
 7#g ,u4,s4,c4 #fdae7 7& su*            
accr$itation is 9 effect7 %all be deem$ 
to be accr$it$ to c]tify cov]$ products 
"u ?is subtitle4  #bia;,f4 ,recordkeep+1
 inve/igations1 & en=cem5t  7a7         
,recordkeep+  7#a7 ,9 g5]al ,except z   
o!rwise provid$ 9 ?is title1 ea* p]son  
:o sells1 labels1 or repres5ts any cov]$
 product z hav+ be5 produc$ ) or )\t !  
use ( g5etic eng9e]+ or a g5etically    
eng9e]$ plant %all-- 7,a7 ma9ta9 records
 9 a mann] prescrib$ by ! ,secret>y2 &  

7,b7 make available to ! ,secret>y1 on  
reque/ by ! ,secret>y1 all records      
associat$ ) ! cov]$ product4  7#b7      
,c]tify+ ag5ts  7,a7 ,9 g5]al ,a c]tify+
 ag5t %all--  7i7 ma9ta9 all records    
conc]n+ ! activities ( ! c]tify+ ag5t ) 
respect to ! c]tification ( cov]$       
products "u ?is subtitle 9 a mann]      
prescrib$ by ! ,secret>y2 &  7ii7 make  
available to ! ,secret>y1 on reque/ by !
 ,secret>y1 all records associat$ ) su* 
activities4  7,b7 ,transf]5ce ( records 
,if a private p]son t 0 c]tifi$ "u ?is  
subtitle is dissolv$ or loses           
accr$itation1 all records & copies (    
records conc]n+ ! activities ( ! p]son  
"u ?is subtitle %all be transf]r$ to !  
,secret>y4  7b7 ,inve/igations  7#a7 ,9 
g5]al ,! ,secret>y may take su*         
inve/igative actions z ! ,secret>y      
consid]s to be necess>y--  7,a7 to v]ify
 ! accuracy ( any in=mation report$ or  
made available "u ?is subtitle2 &  7,b7 
to det]m9e :e!r a p]son cov]$ by ?is    
subtitle has committ$ a violation ( any 

provision ( ?is subtitle1 includ+ an    
ord] or regulation promulgat$ by !      
,secret>y pursuant to ?is subtitle4     
7#b7 ,specific inve/igative p[]s ,9     
c>ry+ out ?is subtitle1 ! ,secret>y     
may-- 7,a7 adm9i/] oa?s & affirmations2 
7,b7 subpo5a witnesses2  7,c7 compel    
att5dance ( witnesses2  7,d7 take       
evid5ce2 &  7,e7 require ! production ( 
any records requir$ to be ma9ta9$ "u ?is
 subtitle t are relevant to an          
inve/igation4  7c7 ,violations (        
subtitle  7#a7 ,failure to provide      
in=mation ,any p]son cov]$ by ?is       
subtitle :o1 aft] notice & an           
opportunity to be he>d1 has be5 f\nd by 
! ,secret>y to h fail$ or refus$ to     
provide accurate in=mation 7includ+ a   
delay 9 ! timely deliv]y ( su*          
in=mation7 requir$ by ! ,secret>y "u ?is
 subtitle1 %all be assess$ a civil      
p5alty ( n m ?an #aj1jjj4  7#b7 ,misuse 
( label  7,a7 ,9 g5]al ,any p]son :o1   
aft] notice & an opportunity to be he>d1
 is f\nd by ! ,secret>y to h kn[+ly sold

 or label$ any cov]$ product z hav+ be5 
produc$ ) or )\t ! use ( g5etic eng9e]+ 
or a g5etically eng9e]$ plant1 except 9 
accordance ) ?is subtitle1 %all be      
assess$ a civil p5alty ( n m ?an        
#aj1jjj4  7,b7 ,cont9u+ violation ,ea*  
day dur+ :i* a violation describ$ 9     
subp>agraph 7,a7 occurs %all be consid]$
 to be a sep>ate violation4  7#c7       
,ineligibility  7,a7 ,9 g5]al ,except z 
provid$ 9 subp>agraph 7,c71 any p]son t 
c>ries out an activity describ$ 9       
subp>agraph 7,b71 aft] notice & an      
opportunity to be he>d1 %all n be       
eligible1 = ! #e-ye> p]iod beg9n+ on !  
date ( ! occurr5ce1 to receive a        
c]tification "u ?is subtitle ) respect  
to any cov]$ product4  7,b7 ,description
 ( activities ,an activity ref]r$ to 9  
subp>agraph 7,a7 is-- 7i7 mak+ a false  
/atem5t2  7ii7 a violation describ$ 9   
p>agraph 7#b77;,a72  7iii7 attempt+ to h
 a label indicat+ t a cov]$ product has 
be5 produc$ ) or )\t ! use ( g5etic     
eng9e]+ or a g5etically eng9e]$ plant   

affix$ to a cov]$ product t a p]son     
kn[s1 or %\ld h reason to "k1 to h be5  
produc$ 9 a mann] t is n 9 accordance ) 
?is subtitle2 or  7iv7 o!rwise violat+ !
 purposes ( ! g5etically eng9e]$ food   
c]tification program e/abli%$ "u section
 #bia;,a1 z det]m9$ by ! ,secret>y4     
7,c7 ,waiv] ,not)/&+ subp>agraph 7,a71 !
 ,secret>y may modify or waive a p]iod (
 ineligibility "u ?is p>agraph if !     
,secret>y det]m9es t ! modification or  
waiv] is 9 ! be/ int]e/s ( ! g5etically 
eng9e]$ food c]tification program       
e/abli%$ "u section #bia;,a4  7#d7      
,report+ ( violations ,a c]tify+ ag5t   
%all imm$iately report any violation (  
?is subtitle to ! ,secret>y4  7#e7      
,cease-&-desi/ ord]s  7,a7 ,9 g5]al ,!  
,secret>y may1 aft] provid+ notice & an 
opportunity to be he>d1 issue an ord]1  
require any p]son :o ! ,secret>y        
reasonably believes is sell+ or label+ a
 cov]$ product 9 violation ( ?is        
subtitle to cease & desi/ f sell+ or    
label+ su* cov]$ product z hav+ be5     

produc$ ) or )\t ! use ( g5etic eng9e]+ 
or a g5etically eng9e]$ plant4  7,b7    
,f9al & conclusive ,! ord] ( ! ,secret>y
 impos+ a cease-&-desi/ ord] "u ?is     
p>agraph %all be f9al & conclusive      
unless ! affect$ p]son files an appeal f
 ! ,secret>y's ord] ) ! appropriate     
di/rict c\rt ( ! ,unit$ ,/ates n lat]   
?an #cj days aft] ! date ( ! issuance ( 
! ord]4  7#f7 ,violations by c]tify+    
ag5t ,a c]tify+ ag5t t is a private     
p]son t violates ! provisions ( ?is     
subtitle or falsely or neglig5tly       
c]tifies any cov]$ product t does n meet
 ! t]ms & conditions ( ! g5etically     
eng9e]$ food c]tification program       
e/abli%$ "u section #bia;,a1 z det]m9$  
by ! ,secret>y1 %all1 aft] notice & an  
opportunity to be he>d--  7,a7 lose     
accr$itation z a c]tify+ ag5t "u ?is    
subtitle2 &  7,b7 be ineligible to be   
accr$it$ z a c]tify+ ag5t "u ?is        
subtitle = a p]iod ( n less ?an #c ye>s1
 beg9n+ on ! date ( ! det]m9ation4  7#g7
 ,susp5sion  7,a7 ,9 g5]al ,! ,secret>y 

may1 aft] fir/ provid+ ! c]tify+ ag5t   
notice & an opportunity to be he>d1     
susp5d ! accr$itation ( ! c]tify+ ag5t =
 a p]iod specifi$ 9 subp>agraph 7,b7 = a
 violation ( ?is subtitle4  7,b7 ,p]iod 
( susp5sion ,! p]iod ( a susp5sion "u   
subp>agraph 7,a7 %all t]m9ate on ! date 
! ,secret>y makes a f9al det]m9ation )  
respect to ! violation t is ! subject ( 
! susp5sion4  7#h7 ,en=cem5t by         
,attorney ,g5]al ,on reque/ ( !         
,secret>y1 ! ,attorney ,g5]al may br+ a 
civil action aga9/ a p]son 9 a di/rict  
c\rt ( ! ,unit$ ,/ates to en=ce ?is     
subtitle or a requirem5t or regulation  
prescrib$1 or an ord] issu$1 "u ?is     
subtitle4 ,! action may be br\ght 9 !   
judicial di/rict 9 :i* ! p]son does     
bus9ess or 9 :i* ! violation occurr$4   
#bia;,g4 ,au?orization ( appropriations2
 fees  7a7 ,au?orization (              
appropriations ,!re are au?oriz$ to be  
appropriat$ to e/abli% ! g5etically     
eng9e]$ food c]tification program "u    
section #bia;,a1 #b1jjj1jjj1 to rema9   

available until exp5d$4  7b7 ,fees  7#a7
 ,9 g5]al ,^u e/abli%m5t ( ! g5etically 
eng9e]$ food c]tification program "u    
section #bia;,a1 ! ,secret>y %all       
e/abli% by notice1 *>ge1 & collect fees 
to cov] ! e/imat$ co/s to ! ,secret>y ( 
c>ry+ out ?is subtitle4  7#b7           
,availability ,fees collect$ "u p>agraph
 7#a7 %all be deposit$ into a fund 9 !  
,treasury ( ! ,unit$ ,/ates & %all rema9
 available until exp5d$1 subject to     
appropriation1 to c>ry out ?is subtitle4
  4  #bjb4 ,regulations ,9 promulgat+   
regulations to c>ry out ! am5dm5ts made 
by section #bja1 ! ,secret>y (          
,agriculture %all-- 7#a7 provide a      
process to acc\nt = c]tifi$             
nong5etically eng9e]$ cov]$ products    
conta9+ mat]ial f g5etically eng9e]$    
plants due to ! inadv]t5t pres5ce ( su* 
mat]ial2  7#b7 to ! greate/ ext5t       
practicable1 e/abli% consi/5cy betwe5 ! 
c]tification programs e/abli%$ "u       
subtitle ,e ( ! ,agricultural ,m>ket+   
,act ( #aidf 7z add$ by section #bja (  

?is ,act71 ! organic c]tification       
program e/abli%$ "u ! ,organic ,foods   
,production ,act ( #aiij 7#g ,u4,s4,c4  
#feja et seq471 & o!r volunt>y label+   
programs adm9i/]$ by ! ,secret>y2  7#c7 
) respect to regulations = cov]$        
products int5d$ = consumption by        
non-food animals1 take into acc\nt !    
inh]5t diff]5ces betwe5 food int5d$ =   
animal & human consumption1 includ+ !   
ess5tial vitam9s1 m9]als1 &             
micronutri5ts requir$ to be add$ to     
animal food to =mulate a complete &     
balanc$ diet2 &  7#d7 provide a process 
= reque/+ & grant+ exemptions f !       
requirem5ts ( subtitle ,e ( !           
,agricultural ,m>ket+ ,act ( #aidf 7z   
add$ by section #bja ( ?is ,act7 "u     
conditions e/abli%$ by ! ,secret>y4     
#bjc4 ,effective date2 preemption  7a7  
,effective date ,reg>dless ( :e!r       
regulations h be5 promulgat$ "u section 
#bjb ( ?is ,act1 ! am5dm5ts made by     
section #bja %all take effect beg9n+ on 
! date ( ! enactm5t ( ?is ,act4  7b7    

,prohibitions aga9/ m&atory label+ (    
food develop$ us+ g5etic eng9e]+  7#a7  
,9 g5]al ,subject to p>agraph 7#b71 no  
,/ate or political subdivision ( a ,/ate
 may directly or indirectly e/abli% "u  
any au?ority or cont9ue 9 effect z to   
any cov]$ product 7z def9$ 9 section    
#bia ( ! ,agricultural ,m>ket+ ,act (   
#aidf1 z add$ by section #bja ( ?is     
,act7 9 int]/ate comm]ce1 any requirem5t
 = ! label+ ( a cov]$ product indicat+ !
 product z hav+ be5 produc$ f1 conta9+1 
or consi/+ ( a g5etically eng9e]$ plant1
 includ+ any requirem5ts = claims t a   
cov]$ product is or conta9s an +r$i5t t 
0 produc$ f1 conta9s1 or consi/s ( a    
g5etically eng9e]$ plant4  7#b7         
,exception ,not)/&+ p>agraph 7#a71 a    
,/ate 7or a political subdivision !re(7 
may e/abli% ei!r ( ! foll[+ volunt>y    
programs = ! regulation ( claims        
describ$ 9 su* p>agraph3 7,a7 ,a program
 t relates to volunt>y claims to :i*    
p>agraph 7#a7 ( section #bjd7;a7 ( ?is  
,act applies4  7,b7 ,a program t-- 7i7  

is volunt>y2  7ii7 is accr$it$ by !     
,secret>y pursuant to section #bia;,e ( 
! ,agricultural ,m>ket+ ,act ( #aidf 7z 
add$ by section #bja ( ?is ,act72 &     
7iii7 e/abli%es /&>ds t are id5tical to 
! /&>ds e/abli%$ "u section #bia;,b or  
#bia;,c ( ! ,agricultural ,m>ket+ ,act (
 #aidf1 z applicable 7z add$ by section 
#bja ( ?is ,act74  7c7 ,rule (          
con/ruction ,= ! sole purpose (         
subsection 7b77#a71 a cov]$ product     
d]iv$ f live/ock t consum$ g5etically   
eng9e]$ plants %all be deem$ z hav+ be5 
produc$ f1 conta9+1 or consi/+ ( a      
g5etically eng9e]$ plant4  #bjd4        
,applicability  7a7 ,exi/+ claims ,a    
volunt>y claim made ) respect to :e!r a 
cov]$ product 7z def9$ 9 section #bia ( 
! ,agricultural ,m>ket+ ,act ( #aidf1 z 
add$ by section #bja ( ?is ,act7 0      
produc$ ) or )\t ! use ( g5etic eng9e]+ 
or g5etically eng9e]$ plants be=e ! date
 ( ! enactm5t ( ?is ,act--  7#a7 may be 
made = su* a product dur+ ! #cf-mon?    
p]iod t beg9s on ! date ( ! enactm5t (  

?is ,act2 &  7#b7 aft] ! expiration (   
su* #cf-mon? p]iod1 may be made s long z
 ! labels associat$ ) su* a claim meet !
 /&>ds specifi$ 9 section #bia;,b or    
#bia;,c ( ! ,agricultural ,m>ket+ ,act (
 #aidf1 z applicable 7z add$ by section 
#bja ( ?is ,act74  7b7 ,organic         
c]tification ,9 ! case ( a cov]$ product
 7z def9$ 9 section #bia ( !            
,agricultural ,m>ket+ ,act ( #aidf1 z   
add$ by section #bja ( ?is ,act7 produc$
 by a f>m or h&l+ op]ation t is c]tifi$ 
z an organic f>m or h&l+ op]ation "u !  
,organic ,foods ,production ,act ( #aiij
 7#g ,u4,s4,c4 #feja et seq471 su*      
product is deem$ to be c]tifi$ z a      
product produc$ )\t ! use ( g5etic      
eng9e]+ "u ! g5etically eng9e]$ food    
c]tification program e/abli%$ "u section
 #bia;,a ( ! ,agricultural ,m>ket+ ,act 
( #aidf 7z add$ by section #bja ( ?is   
,act74  ,,iii ,natural foods  #cja4     
,label+ ( natural foods ,section #djc ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cdc7 is am5d$ by add+ at

 ! end ! foll[+3  7z7  7#a7 ,if its     
label+ conta9s an express or impli$     
claim t ! food is natural unless ! claim
 is made 9 accordance ) subp>agraph     
7#b74  7#b7 ,a claim describ$ 9         
subp>agraph 7#a7 may be made only if !  
claim uses t]ms t h be5 def9$ by1 & !   
food meets ! requirem5ts t h be5        
e/abli%$ 91 regulations promulgat$ to   
c>ry out ?is p>agraph4  7#c7 ,not)/&+   
subp>agraph 7#b71 prior to ! f9alization
 ( regulations to c>ry out ?is p>agraph1
 ! use ( any claim t a food is natural  
%all be all[$ if consi/5t ) !           
,secret>y's exi/+ policy = su* claims4  
7#d7 ,9 promulgat+ regulations to c>ry  
out ?is p>agraph1 ! ,secret>y %all      
diff]5tiate betwe5 food = human         
consumption & food int5d$ = consumption 
by animals o!r ?an humans4  7#e7 ,=     
purposes ( subp>agraph 7#a71 a natural  
claim includes ! use (-- 7,a7 ! t]ms    
natural1 #ajj natural1 naturally gr[n1  
all natural1 & made ) natural +r$i5ts2 &
  7,b7 any o!r t]ms specifi$ by !       

,secret>y4  4  #cjb4 ,regulations  7a7  
,propos$ regulations ,n lat] ?an #ah    
mon?s aft] ! date ( enactm5t ( ?is ,act1
 ! ,secret>y ( ,heal? & ,human ,s]vices 
%all issue propos$ regulations to       
implem5t section #djc7z7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act1 z add$  
by section #cja ( ?is ,act4  7b7 ,f9al  
regulations ,n lat] ?an #cj mon?s aft] !
 date ( enactm5t ( ?is ,act1 ! ,secret>y
 ( ,heal? & ,human ,s]vices %all issue  
f9al regulations to implem5t su* section
 #djc7z74  #cjc4 ,preemption ,section   
#djc;,a7a7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4           
#cdc-a7;a77 is am5d$--  7#a7 9 p>agraph 
7#d71 by /rik+ or at ! end2  7#b7 9     
p>agraph 7#e71 by /rik+ ! p]iod & ins]t+
 a comma2 &  7#c7 by ins]t+ aft]        
p>agraph 7#e7 ! foll[+3  7#f7 any       
requirem5t = ! label+ ( food ( ! type   
requir$ by section #djc7z7 t is n       
id5tical to ! requirem5t ( su* section4 
4  #cjd4 ,effective date ,! label+      
requirem5ts ( section #djc7z7 ( ! ,f$]al

 ,food1 ,drug1 & ,cosmetic ,act1 z add$ 
by section #cja ( ?is ,act1 %all take   
effect on ! effective date ( f9al       
regulations promulgat$ "u section       
#cjb7;b7 ( ?is ,act4 ,! provisions (    
section #djc;,a7a77#f7 ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act1 z add$ by     
section #cjc ( ?is ,act1 take effect on 
! date ( enactm5t ( ?is ,act4  ,pass$ ! 
,h\se ( ,repres5tatives ,july #bc1      
#bjae4;,cl]k4