,9 ! ,s5ate ( ! ,unit$ ,/ates1 ,june #bh1 #bjah4 ,am5dm5ts3 ,t ! bill f ! ,h\se ( ,repres5tatives 7,h4,r4 #ajbi7 entitl$ ,an ,act to am5d ! ,f$]al ,insecticide1 ,fungicide1 & ,rod5ticide ,act to improve pe/icide regi/ration & o!r activities "u ! ,act1 to ext5d & modify fee au?orities1 & = o!r purposes41 d pass ) ! foll[+ 7#a7 ,on page #b1 l9e #c1 /rike ,pe/icide ,regi/ration ,enhancem5t ,act ( #bjag & ins]t ,pe/icide ,regi/ration ,improvem5t ,ext5sion ,act ( #bjah4 7#b7 ,on page #b1 l9e#ad & #ae1 /rike #bjag ?r\gh #bjbc & ins]t #bjai ?r\gh #bjbc 7#c7 ,on page #b1 l9e #bj1 /rike #bjag ?r\gh #bjbc & ins]t #bjai ?r\gh #bjbc 7#d7 ,on page #c1 l9e #b1 /rike #bjag ?r\gh #bjbc & ins]t #bjai ?r\gh #bjbc 7#e7 ,on page #c1 l9e #g1 /rike #bjag ?r\gh #bjbc & ins]t #bjai ?r\gh #bjbc 7#f7 ,on page #c1 l9e #aa1 /rike #bjag ?r\gh #bjbc & ins]t #bjai ?r\gh #bjbc 7#g7 ,on page #c1 l9e #ac1 /rike #bjbc & ins]t #bjbj 7#h7 ,on page #c1 l9e#ag ?r\gh l9e #bj1 /rike & ins]t3 7#a7 7,a7 by /rik+ ! date ( enactm5t ( ?is section & end+ on ,septemb] #cj1 #bjai & ins]t+ ! effective date ( ! ,pe/icide ,regi/ration ,improvem5t ,ext5sion ,act ( #bjah & end+ on ,septemb] #cj1 #bjbe2 & 7#i7 ,on page #d1 l9e #d1 /rike #bjbc & ins]t #bjbj 7#aj7 ,on page #d1 l9e #ad1 aft] ?r\gh ins]t3 ! p]iod at ! end ( 7#aa7 ,on page #e1 l9e #bj & #ba1 /rike #bjag ?r\gh #bjbc & ins]t #bjah ?r\gh #bjbj 7#ab7 ,on page #f1 l9e #h1 /rike #bjag ?r\gh #bjba & ins]t #bjah ?r\gh #bjbj 7#ac7 ,on page #g1 l9e #e1 aft] p[d]s1 ins]t or 7#ad7 ,on page #g1 l9e #ac & #ad1 /rike ,june #cj1 #bjag & ins]t3 #cj days aft] ! effective date ( ! ,pe/icide ,regi/ration ,improvem5t ,ext5sion ,act ( #bjah4 7#ae7 ,on page #g1 l9e #be1 /rike #bjbj & ins]t #bjai4 7#af7 ,on page #h1 l9e #ae1 /rike "t-to-"t & ins]t "t to "t 7#ag7 ,on page #i1 l9e #ae1 /rike #bjag ?r\gh #bjbc & ins]t #bjah ?r\gh #bjbj 7#ah7 ,on page #aa1 l9e #bj /rikecov]$ application & ins]tcov]$ applications 7#ai7 ,on page #aa1 /rike l9es #be ?r\gh page #ab ?r\gh l9e #aa & ins]t 7,a7 9 subp>agraph 7,a7-- 7i7 by /rik+ pe/icide regi/ration2 & 7ii7 by /rik+ ,octob] #a1 #bjac1 & end+ on ,septemb] #cj1 #bjae & ins]t+ ,octob] #a1 #bjai1 & end+ on ,septemb] #cj1 #bjba2 7,b7 9 subp>agraph 7,b7-- 7i7 by /rik+ pe/icide regi/ration2 & 7ii7 by /rik+ #bjae ea* place x appe>s & ins]t+ #bjba2 & 7#bj7 ,on page #ad l9e #b /rike #bjbc & ins]t #bjbj 7#ba7 ,on page #ad l9e #g /rike #bjbc & ins]t #bjbj 7#bb7 ,on page #ad l9e #i /rike #bjbc & ins]t #bjbj 7#bc7 ,on page #ad l9e #af /rike ,enhancem5t & ins]t ,improvem5t ,ext5sion 7#bd7 ,on page #ad l9e #be /rike 7#g ,u4,s4,c4 #acfw-#h7;f77#a77 & ins]t 7#g ,u4,s4,c4 #acfw-#h7;f77 7#be7 ,on page #ae l9e #d /rike ,enhancem5t & ins]t ,improvem5t ,ext5sion 7#bf7 ,on page #af l9e #b /rike #bjbc & ins]t #bjbj 7#bg7 ,on page #ah l9e #ah /rike vector-born public heal? pe/s & ins]t inv]tebrate public heal? pe/s t may transmit vector-borne disease 7#bh7 ,on page #bj l9e #ag /rike #bjbc & ins]t #bjbj 7#bi7 ,on page #bj1 /rike l9es #bb & #bc & ins]t ,fiscal ye> #bjbd4--;,dur+ fiscal ye> #bjbd2 & 7#cj7 ,on page #bj l9e #be /rike #bjbc & ins]t #bjbj 7#ca7 ,on page #ba1 /rike l9es #d & #e & ins]t ,fiscal ye> #bjbe4--;,dur+ fiscal ye> #bjbe2 & 7#cb7 ,on page #ba l9e #g /rike #bjbc & ins]t #bjbj 7#cc7 ,on page #ba l9es #aj & #aa /rike #bjai0 & ins]t+ ,septemb] #cj1 #bjbe4--;,effective ,septemb] #cj1 #bjbe2 & & ins]t #bjai0 & ins]t+ ,septemb] #cj1 #bjbe4--;,effective ,septemb] #cj1 #bjbe2 & 7#cd7 ,on page #ba l9e #ad /rike #bjbc & ins]t #bjbj 7#ce7 ,on page #ba l9e #bb ?r\gh page #aje to ! end /rike & ins]t3 7#c7 ,s*$ule ( cov]$ applications & o!r actions & _! regi/ration s]vice fees ,subject to p>agraph 7#f71 ! s*$ule ( regi/ration applications & o!r cov]$ actions & _! correspond+ regi/ration s]vice fees %all be z foll[s3 ,,table #a4 -- ,,regi/ration ,,division -- ,,new ,,active ,,+r$i5tsepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 ,all reque/s = new uses 7food &_/or nonfood7 conta9$ 9 any application = a new active +r$i5t or a fir/ food use are cov]$ by ! base fee = t new active +r$i5t or fir/ food use application & reta9 ! same decision "t review p]iod z ! new active +r$i5t or fir/ food use application4 ,! application mu/ be receiv$ by ! ag5cy 9 "o package4 ,! base fee = ! category cov]s a maximum ( five new products4 ,ea* application = an additional new product regi/ration & new in]t approval t is submitt$ 9 ! new active +r$i5t application package or fir/ food use application package is subject to ! regi/ration s]vice fee = a new product or a new in]t approval4 ,all su* associat$ applications t are submitt$ toge!r w be subject to ! new active +r$i5t or fir/ food use decision review "t4 ,9 ! case ( a new active +r$i5t application1 until t new active +r$i5t is approv$1 any subsequ5t application = ano!r new product conta9+ ! same active +r$i5t or an am5dm5t to ! propos$ label+ w be deem$ a new active +r$i5t application1 subject to ! regi/ration s]vice fee & decision review "t = a new active +r$i5t4 ,9 ! case ( a fir/ food use application1 until t fir/ food use is approv$1 any subsequ5t application = an additional new food use or uses w be subject to ! regi/ration s]vice fee & decision review "t = a fir/ food use4 ,any in=mation t 7a7 0 nei!r reque/$ nor requir$ by ! ,ag5cy1 & 7b7 is submitt$ by ! applicant at ! applicant's initiative to support ! application aft] completion ( ! te*nical defici5cy scre5+1 & 7c7 is n itself a cov]$ regi/ration application1 mu/ be assess$ #be ( ! full regi/ration s]vice fee = ! new active +r$i5t or fir/ food use application47#c7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy4 ,r#jaja,new ,active ,+r$i5t1 ,food use4 7#b77c7bd #gec1jhb ,r#jbjb,new ,active ,+r$i5t1 ,food use2 r$uc$ risk4 7#b77c7ahfbg1efh,r#jdjc,new ,active ,+r$i5t1 ,food use2 ,exp]im5tal ,use ,p]mit application2 e/abli% tempor>y tol]ance2 submitt$ be=e application = regi/ration2 cr$it #de ( fee t[>d new active +r$i5t application t foll[s4 7#c7ahdfb1ejb,r#jfjd,new ,active ,+r$i5t1 ,non-food use2 outdoor4 7#b77c7ba #ebc1bje ,r#jgje,new ,active ,+r$i5t1 ,non-food use2 outdoor2 r$uc$ risk4 7#b77c7afdcf1jjd,r#jijf,new ,active ,+r$i5t1 ,non-food use2 outdoor2 ,exp]im5tal ,use ,p]mit application2 submitt$ be=e application = regi/ration2 cr$it #de ( fee t[>d new active +r$i5t application t foll[s4 7#c7afcbc1fij,r#aajg,new ,active ,+r$i5t1 ,non-food use2 indoor4 7#b77c7bjbij1iid,r#abjh,new ,active ,+r$i5t1 ,non-food use2 indoor2 r$uc$ risk4 7#b77c7adbdb1die,r#abai,new ,active ,+r$i5t1 ,non-food use2 indoor2 ,exp]im5tal ,use ,p]mit application2 submitt$ be=e application = regi/ration2 cr$it #de ( fee t[>d new active +r$i5t application t foll[s4 7#c7ahahb1cbg,r#abbaj;,enri*$ isom]7s7 ( regi/]$ mix$-isom] active +r$i5t4 7#b77c7ahcag1abh,r#abcaa,new ,active ,+r$i5t1 ,se$ treatm5t only2 includes agricultural & non-agricultural se$s2 residues n expect$ 9 raw agricultural commodities4 7#b77c7ahdga1hfa,r#abeab,new ,active ,+r$i5t1 ,se$ treatm5t2 ,exp]im5tal ,use ,p]mit application2 submitt$ be=e application = regi/ration2 cr$it #de ( fee t[>d new active +r$i5t application t foll[s4 7#c7afcbc1fij,,table #b4 -- ,,regi/ration ,,division -- ,,new ,,usesepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 ,all reque/s = new uses 7food &_/or nonfood7 conta9$ 9 any application = a new active +r$i5t or a fir/ food use are cov]$ by ! base fee = t new active +r$i5t or fir/ food use application & reta9 ! same decision "t review p]iod z ! new active +r$i5t or fir/ food use application4 ,! application mu/ be receiv$ by ! ag5cy 9 "o package4 ,! base fee = ! category cov]s a maximum ( five new products4 ,ea* application = an additional new product regi/ration & new in]t approval t is submitt$ 9 ! new active +r$i5t application package or fir/ food use application package is subject to ! regi/ration s]vice fee = a new product or a new in]t approval4 ,all su* associat$ applications t are submitt$ toge!r w be subject to ! new active +r$i5t or fir/ food use decision review "t4 ,9 ! case ( a new active +r$i5t application1 until t new active +r$i5t is approv$1 any subsequ5t application = ano!r new product conta9+ ! same active +r$i5t or an am5dm5t to ! propos$ label+ w be deem$ a new active +r$i5t application1 subject to ! regi/ration s]vice fee & decision review "t = a new active +r$i5t4 ,9 ! case ( a fir/ food use application1 until t fir/ food use is approv$1 any subsequ5t application = an additional new food use or uses w be subject to ! regi/ration s]vice fee & decision review "t = a fir/ food use4 ,any in=mation t 7a7 0 nei!r reque/$ nor requir$ by ! ,ag5cy1 & 7b7 is submitt$ by ! applicant at ! applicant's initiative to support ! application aft] completion ( ! te*nical defici5cy scre5+1 & 7c7 is n itself a cov]$ regi/ration application1 mu/ be assess$ #be ( ! full regi/ration s]vice fee = ! new active +r$i5t or fir/ food use application47#c7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy47#d7 ,am5dm5t applications to add ! new use7s7 to regi/]$ product labels are cov]$ by ! base fee = ! new use7s74 ,all items 9 ! cov]$ application mu/ be submitt$ toge!r 9 "o package4 ,ea* application = an additional new product regi/ration & new in]t approval7s7 t is submitt$ 9 ! new use application package is subject to ! regi/ration s]vice fee = a new product or a new in]t approval4 ,h[ev]1 if a new use application only proposes to regi/] ! new use = a new product & !re are no am5dm5ts 9 ! application1 !n review ( "o new product application is cov]$ by ! new use fee4 ,all su* associat$ applications t are submitt$ toge!r w be subject to ! new use decision review "t4 ,any application = a new product or an am5dm5t to ! propos$ label+ 7a7 submitt$ subsequ5t to submission ( ! new use application & 7b7 prior to conclusion ( its decision review "t & 7c7 conta9+ ! same new uses1 w be deem$ a sep>ate new-use application1 subject to a sep>ate regi/ration s]vice fee & new decision review "t = a new use4 ,if ! new-use application includes non-food 7indoor &_/or outdoor71 & food 7outdoor &_/or indoor7 uses1 ! appropriate fee is due = ea* type ( new use & ! longe/ decision review "t applies to all ( ! new uses reque/$ 9 ! application4 ,any in=mation t 7a7 0 nei!r reque/$ nor requir$ by ! ,ag5cy1 & 7b7 is submitt$ by ! applicant at ! applicant's initiative to support ! application aft] completion ( ! te*nical defici5cy scre51 & 7c7 is n itself a cov]$ regi/ration application1 mu/ be assess$ #be ( ! full regi/ration s]vice fee = ! new use application4,r#acjac;,fir/ food use2 indoor2 food_/food h&l+4 7#b7 7#c7baaia1ddd,r#adjad;,additional food use2 ,indoor2 food_/food h&l+4 7#c7 7#d7aedd1fgb,r#aejae;,fir/ food use4 7#b77c7ba #cag1ajd ,r#aeeaf 7new7,fir/ food use1 ,exp]im5tal ,use ,p]mit application2 a4i4 regi/]$ = non-food outdoor use4 7#c77d7babfd1bec,r#afjag;,fir/ food use2 r$uc$ risk4 7#b77c7afbfd1bec,r#agjah;,additional food use4 7#c7 7#d7aegi1cdi,r#ageai;,additional food uses cov]$ )9 a crop gr\p result+ f ! conv]sion ( exi/+ approv$ crop gr\p7s7 to "o or m revis$ crop gr\ps4 7#c77d7ajff1abd,r#ahjbj;,additional food use2 r$uc$ risk4 7#c77d7ajff1abd,r#aijba;,additional food uses2 #f or m submitt$ 9 "o application4 7#c77d7aedgf1jij ,r#bjjbb;,additional ,food ,use2 #f or m submitt$ 9 "o application2 ,r$uc$ ,risk4 7#c77d7ajcif1gdb,r#bajbc;,additional food use2 ,exp]im5tal ,use ,p]mit application2 e/abli% tempor>y tol]ance2 no cr$it t[>d new use regi/ration4 7#c77d7abdh1ihf,r#bbjbd;,additional food use2 ,exp]im5tal ,use ,p]mit application2 crop de/ruct basis2 no cr$it t[>d new use regi/ration4 7#c77d7fai1hch,r#bcjbe;,additional use2 non-food2 outdoor4 7#c7 7#d7aeca1gac,r#bdjbf;,additional use2 non-food2 outdoor2 r$uc$ risk4 7#c77d7ajbf1dbg,r#bejbg;,additional use2 non-food2 outdoor2 ,exp]im5tal ,use ,p]mit application2 no cr$it t[>d new use regi/ration4 7#c77d7fai1hch,r#beabh;,exp]im5tal ,use ,p]mit application :i* requires no *anges to ! tol]ance7s72 non-crop de/ruct basis4 7#c7hai1hch,r#bfjbi,new use2 non-food2 indoor4 7#c7 7#d7abae1cag,r#bgjcj,new use2 non-food2 indoor2 r$uc$ risk4 7#c77d7iab1gfd,r#bgaca,new use2 non-food2 indoor2 ,exp]im5tal ,use ,p]mit application2 no cr$it t[>d new use regi/ration4 7#c77d7fi1gbe,r#bgccb;,additional use2 se$ treatm5t2 limit$ uptake into ,raw ,agricultural ,commodities2 includes crops ) e/abli%$ tol]ances 7e4g41 = soil or foli> application72 includes food &_/or non-food uses4 7#c77d7abej1dde,r#bgdcc;,additional uses2 se$ treatm5t only2 #f or m submitt$ 9 "o application2 limit$ uptake into raw agricultural commodities2 includes crops ) e/abli%$ tol]ances 7e4g41 = soil or foli> application72 includes food &_/or non-food uses4 7#c77d7 #abcjb1ffc,,table #c4 -- ,,regi/ration ,,division -- ,,import ,,& ,,o!r ,,tol]ancesepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 ,all reque/s = new uses 7food &_/or nonfood7 conta9$ 9 any application = a new active +r$i5t or a fir/ food use are cov]$ by ! base fee = t new active +r$i5t or fir/ food use application & reta9 ! same decision "t review p]iod z ! new active +r$i5t or fir/ food use application4 ,! application mu/ be receiv$ by ! ag5cy 9 "o package4 ,! base fee = ! category cov]s a maximum ( five new products4 ,ea* application = an additional new product regi/ration & new in]t approval t is submitt$ 9 ! new active +r$i5t application package or fir/ food use application package is subject to ! regi/ration s]vice fee = a new product or a new in]t approval4 ,all su* associat$ applications t are submitt$ toge!r w be subject to ! new active +r$i5t or fir/ food use decision review "t4 ,9 ! case ( a new active +r$i5t application1 until t new active +r$i5t is approv$1 any subsequ5t application = ano!r new product conta9+ ! same active +r$i5t or an am5dm5t to ! propos$ label+ w be deem$ a new active +r$i5t application1 subject to ! regi/ration s]vice fee & decision review "t = a new active +r$i5t4 ,9 ! case ( a fir/ food use application1 until t fir/ food use is approv$1 any subsequ5t application = an additional new food use or uses w be subject to ! regi/ration s]vice fee & decision review "t = a fir/ food use4 ,any in=mation t 7a7 0 nei!r reque/$ nor requir$ by ! ,ag5cy1 & 7b7 is submitt$ by ! applicant at ! applicant's initiative to support ! application aft] completion ( ! te*nical defici5cy scre5+1 & 7c7 is n itself a cov]$ regi/ration application1 mu/ be assess$ #be ( ! full regi/ration s]vice fee = ! new active +r$i5t or fir/ food use application4 7#c7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy47#d7 ,am5dm5t applications to add ! revis$ use patt]n7s7 to regi/]$ product labels are cov]$ by ! base fee = ! category4 ,all items 9 ! cov]$ application mu/ be submitt$ toge!r 9 "o package4 ,ea* application = an additional new product regi/ration & new in]t approval7s7 t is submitt$ 9 ! am5dm5t application package is subject to ! regi/ration s]vice fee = a new product or a new in]t approval4 ,h[ev]1 if an am5dm5t application only proposes to regi/] ! am5dm5t = a new product & !re are no am5dm5ts 9 ! application1 !n review ( "o new product application is cov]$ by ! base fee4 ,all su* associat$ applications t are submitt$ toge!r w be subject to ! category decision review "t4,r#bhjcd;,e/abli% import tol]ance2 new active +r$i5t or fir/ food use4 7#b7bacai1jgb,r#bijce;,e/abli% ,import tol]ance2 ,additional new food use4#aefc1haf,r#biacf;,e/abli% import tol]ances2 additional food uses2 #f or m crops submitt$ 9 "o petition4#aechb1hhf,r#bibcg;,am5d an e/abli%$ tol]ance 7e4g41 decrease or increase7 &_/or h>monize e/abli%$ tol]ances ) ,codex ,m,r,ls2 dome/ic or import2 applicant-initiat$4#aade1cda,r#bicch;,e/ abli% tol]ance7s7 = inadv]t5t residues 9 "o crop2 applicant-initiat$4#abec1dhc,r#bidci;,e/ abli% tol]ances = inadv]t5t residues2 #f or m crops submitt$ 9 "o application2 applicant-initiat$4#abcbj1hid,r#biedj;,e /abli% tol]ance7s7 = residues 9 "o rotational crop 9 response to a specific rotational crop application2 submission ( correspond+ label am5dm5ts :i* specify ! necess>y plant-back re/rictions2 applicant-initiat$4 7#c7 7#d7aeff1abd,r#bifda;,e/abli% tol]ances = residues 9 rotational crops 9 response to a specific rotational crop petition2 #f or m crops submitt$ 9 "o application2 submission ( correspond+ label am5dm5ts :i* specify ! necess>y plant-back re/rictions2 applicant-initiat$4 7#c7 7#d7aecif1gdb,r#bigdb;,am5d #f or m e/abli%$ tol]ances 7e4g41 decrease or increase7 9 "o petition2 dome/ic or import2 applicant-initiat$4#aabgb1jcg,r#bihdc;,a m5d an e/abli%$ tol]ance 7e4g41 decrease or increase72 dome/ic or import2 submission ( correspond+ am5d$ labels 7requir+ sci5ce review74 7#c7 7#d7aceh1efe,r#biidd;,am5d #f or m e/abli%$ tol]ances 7e4g41 decrease or increase72 dome/ic or import2 submission ( correspond+ am5d$ labels 7requir+ sci5ce review74 7#c7 7#d7acbhe1bfa,,table #d4 -- ,,regi/ration ,,division -- ,,new ,,productsepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 ,an application = a new end-use product us+ a s\rce ( active +r$i5t t 7a7 is n yet regi/]$ b 7b7 has an application p5d+ ) ! ,ag5cy = review1 w be consid]$ an application = a new product ) an unregi/]$ s\rce ( active +r$i5t47#c7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy47#d7 ,= ! purposes ( classify+ propos$ regi/ration actions into ,,pria categories1 8pe/7s7 requir+ efficacy0 are3 public heal? pe/s li/$ 9 ,,pr ,notice #bjjb-a1 live/ock pe/s 7e4g4 ,horn flies1 ,/able flies71 wood-de/roy+ pe/s 7e4g4 t]mites1 c>p5t] ants1 wood-bor+ beetles7 & c]ta9 invasive species 7e4g4 ,asian ,longhorn$ beetle1 ,em]ald ,a%bor]74 ,?is li/ may be updat$_/ref9$ z invasive pe/ ne$s arise4 ,to det]m9e ! numb] ( pe/s = ! ,,pria categories1 pe/s h be5 plac$ into gr\ps 7g5]al2 e4g41 cockroa*es7 & pe/ specific 7specifically a te/ species74 ,if seek+ a label claim aga9/ a pe/ gr\p 7g5]al71 use ! gr\p li/+ bel[ & ea* gr\p w c\nt z #a4 ,! g5]al pe/s gr\ps are3 mites1 du/ mites1 *igg]s1 ticks1 h>d ticks1 s(t ticks1 cattle ticks1 scorpions1 spid]s1 c5tip$es1 lice1 fleas1 cockroa*es1 k$s1 bot flies1 screwworms1 fil? flies1 bl[ flies1 h\se flies1 fle% flies1 mosquitoes1 bit+ flies1 horse flies1 /able flies1 de] flies1 s& flies1 bit+ midges1 black flies1 true bugs1 b$ bugs1 /++ bees1 wasps1 yell[ jackets1 hornets1 ants 7exclud+ c>p5t] ants71 fire & h>ve/] ants1 wood de/roy+ beetles1 c>p5t] ants1 t]mites1 subt]ranean t]mites1 dry wood t]mites1 arboreal t]mites1 damp wood t]mites & invasive species4 ,if seek+ a claim aga9/ a specific pe/ )\t a g5]al claim !n ea* specific pe/ w c\nt z #a4,r#cjjde,new product2 or simil> comb9ation product 7already regi/]$7 to an id5tical or sub/antially simil> 9 composition & use to a regi/]$ product2 regi/]$ s\rce ( active +r$i5t2 no data review on acute toxicity1 efficacy or ,,crp - only product *emi/ry data2 cite-all data citation1 or selective data citation :]e applicant owns all requir$ data1 or applicant submits specific au?orization lett] f data own]4 ,category also includes #ajj re-package ( regi/]$ end-use or manufactur+-use product t requires no data submission nor data matrix4 7#b77c7da1ehb,r#cjadf,new product2 or simil> comb9ation product 7already regi/]$7 to an id5tical or sub/antially simil> 9 composition & use to a regi/]$ product2 regi/]$ s\rce ( active +r$i5t2 selective data citation only = data on product *emi/ry &_/or acute toxicity &_/or public heal? pe/ efficacy 7id5tical data citation & claims to cit$ product7s771 :]e applicant does n own all requir$ data & does n h a specific au?orization lett] f data own]4 7#b77c7da1hig ,r#cajdg,new end-use or manufactur+-use product ) regi/]$ s\rce7s7 ( active +r$i5t7s72 includes products conta9+ two or m regi/]$ active +r$i5ts previ\sly comb9$ 9 o!r regi/]$ products2 excludes products requir+ or cit+ an animal safety /udy2 requires review ( data package )9 ,,rd only2 includes data &_/or waiv]s ( data = only3 product *emi/ry &_/or acute toxicity &_/or *ild resi/ant packag+ &_/or pe/7s7 requir+ efficacy 7#d7 - = up to #c t>get pe/s4 7#b77c7gg1cja,r#caddh,new end use product conta9+ up to ?ree regi/]$ active +r$i5ts nev] be=e regi/]$ z ?is comb9ation 9 a =mulat$ product2 new product label is id5tical or sub/antially simil> to ! labels ( curr5tly regi/]$ products :i* sep>ately conta9 ! respective compon5t active +r$i5ts2 excludes products requir+ or cit+ an animal safety /udy2 requires review ( data package )9 ,,rd only2 includes data &_/or waiv]s ( data = only3 product *emi/ry &_/or acute toxicity &_/or *ild resi/ant packag+ &_/or pe/7s7 requir+ efficacy 7#d7 - = up to #c t>get pe/s4 7#b77c7hh1fbf,r#caidi,new end use product conta9+ up to ?ree regi/]$ active +r$i5ts nev] be=e regi/]$ z ?is comb9ation 9 a =mulat$ product2 new product label is id5tical or sub/antially simil> to ! labels ( curr5tly regi/]$ products :i* sep>ately conta9 ! respective compon5t active +r$i5ts2 excludes products requir+ or cit+ an animal safety /udy2 requires review ( data package )9 ,,rd only2 includes data &_/or waiv]s ( data = only3 product *emi/ry &_/or acute toxicity &_/or *ild resi/ant packag+ &_/or pe/7s7 requir+ efficacy 7#d7 - = #d to #g t>get pe/s4 7#b77c7ajab1fbf,r#cahej 7new7,new end use product conta9+ f\r or m regi/]$ active +r$i5ts nev] be=e regi/]$ z ?is comb9ation 9 a =mulat$ product2 new product label is id5tical or sub/antially simil> to ! labels ( curr5tly regi/]$ products :i* sep>ately conta9 ! respective compon5t active +r$i5ts2 excludes products requir+ or cit+ an animal safety /udy2 requires review ( data package )9 ,,rd only2 includes data &_/or waiv]s ( data = only3 product *emi/ry &_/or acute toxicity &_/or *ild resi/ant packag+ &_/or pe/7s7 requir+ efficacy 7#d7 - = up to #c t>get pe/s4 7#b77c7iac1beb,r#cbaea 7new7,new end use product conta9+ f\r or m regi/]$ active +r$i5ts nev] be=e regi/]$ z ?is comb9ation 9 a =mulat$ product2 new product label is id5tical or sub/antially simil> to ! labels ( curr5tly regi/]$ products :i* sep>ately conta9 ! respective compon5t active +r$i5ts2 excludes products requir+ or cit+ an animal safety /udy2 requires review ( data package )9 ,,rd only2 includes data &_/or waiv]s ( data = only3 product *emi/ry &_/or acute toxicity &_/or *ild resi/ant packag+ &_/or pe/7s7 requir+ efficacy 7#d7 - = #d to #g t>get pe/s4 7#b77c7aaag1beb,r#caeeb,new end-use1 on-animal product1 regi/]$ s\rce ( active +r$i5t7s71 ) ! submission ( data &_/or waiv]s = only3 animal safety & pe/7s7 requir+ efficacy 7#d7 &_/or product *emi/ry &_/or acute toxicity &_/or *ild resi/ant packag+4 7#b7 7#c7ii1hbj,r#cafec 7new7,new end-use or manufactur+ product ) regi/]$ s\rce7s7 ( active +r$i5t7s7 includ+ products conta9+ two or m regi/]$ active +r$i5ts previ\sly comb9$ 9 o!r regi/]$ products2 excludes products requir+ or cit+ an animal safety /udy2 & requires review ( data &_/or waiv]s = only3 product *emi/ry &_/or acute toxicity &_/or *ild resi/ant packag+ &_/or pe/7s7 requir+ efficacy 7#d7 - = great] ?an #c & up to #g t>get pe/s4 7#b77c7iaa1cja,r#caged 7new7,new end-use or manufactur+ product ) regi/]$ s\rce7s7 ( active +r$i5t7s7 includ+ products conta9+ #b or m regi/]$ active +r$i5ts previ\sly comb9$ 9 o!r regi/]$ products2 excludes products requir+ or cit+ an animal safety /udy2 & requires review ( data &_/or waiv]s = only3 product *emi/ry &_/or acute toxicity &_/or *ild resi/ant packag+ &_/or pe/7s7 requir+ efficacy 7#d7 - = great] ?an #g t>get pe/s4 7#b77c7ajae1cja,r#cbjee,new product2 new physical =m2 requires data review 9 sci5ce divisions4 7#b77c7abac1bbf,r#ccaef,new product2 repack ( id5tical regi/]$ end-use product z a manufactur+-use product1 or id5tical regi/]$ manufactur+-use product z an end use product2 same regi/]$ uses only4 7#b77c7cb1ecj,r#ccbeg,new manufactur+-use product2 regi/]$ active +r$i5t2 unregi/]$ s\rce ( active +r$i5t2 submission ( completely new g5]ic data package2 regi/]$ uses only2 requires review 9 ,,rd & sci5ce divisions4 7#b77c7bdbhc1bae,r#ccceh,new product2 ,,mup or ,end use product ) unregi/]$ s\rce ( active +r$i5t2 requires sci5ce data review2 new physical =m2 etc4 ,cite-all or selective data citation :]e applicant owns all requir$ data4 7#b77c7ajai1hch,r#ccdei,new product2 ,,mup or ,end use product ) unregi/]$ s\rce ( ! active +r$i5t2 requires sci5ce data review2 new physical =m2 etc4 ,selective data citation4 7#b77c7aabc1ajj,,table #e4 -- ,,regi/ration ,,division -- ,,am5dm5tsepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 7a7 ,,epa-initiat$ am5dm5ts %all n be *>g$ regi/ration s]vice fees4 7b7 ,regi/rant-initiat$ fa/-track am5dm5ts are to be complet$ )9 ! timel9es specifi$ 9 ,,fifra ,section #c7;c77#c77;,b7 & are n subject to regi/ration s]vice fees4 7c7 ,regi/rant-initiat$ fa/-track am5dm5ts h&l$ by ! ,antimicrobials ,division are to be complet$ )9 ! timel9es specifi$ 9 ,,fifra ,section #c7;h7 & are n subject to regi/ration s]vice fees4 7d7 ,regi/rant initiat$ am5dm5ts submitt$ by notification "u ,,pr ,notices1 su* z ,,pr ,notice #ih-aj1 cont9ue "u ,,pr ,notice timel9es & are n subject to regi/ration s]vice fees4 7e7 ,submissions ) data & requir+ data review are subject to regi/ration s]vice fees47#c7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy47#d7 ,= ! purposes ( classify+ propos$ regi/ration actions into ,,pria categories1 8pe/7s7 requir+ efficacy0 are3 public heal? pe/s li/$ 9 ,,pr ,notice #bjjb-a1 live/ock pe/s 7e4g4 ,horn flies1 ,/able flies71 wood-de/roy+ pe/s 7e4g4 t]mites1 c>p5t] ants1 wood-bor+ beetles7 & c]ta9 invasive species 7e4g4 ,asian ,longhorn$ beetle1 ,em]ald ,a%bor]74 ,?is li/ may be updat$_/ref9$ z invasive pe/ ne$s arise4 ,to det]m9e ! numb] ( pe/s = ! ,,pria categories1 pe/s h be5 plac$ into gr\ps 7g5]al2 e4g41 cockroa*es7 & pe/ specific 7specifically a te/ species74 ,if seek+ a label claim aga9/ a pe/ gr\p 7g5]al71 use ! gr\p li/+ bel[ & ea* gr\p w c\nt z #a4 ,! g5]al pe/s gr\ps are3 mites1 du/ mites1 *igg]s1 ticks1 h>d ticks1 s(t ticks1 cattle ticks1 scorpions1 spid]s1 c5tip$es1 lice1 fleas1 cockroa*es1 k$s1 bot flies1 screwworms1 fil? flies1 bl[ flies1 h\se flies1 fle% flies1 mosquitoes1 bit+ flies1 horse flies1 /able flies1 de] flies1 s& flies1 bit+ midges1 black flies1 true bugs1 b$ bugs1 /++ bees1 wasps1 yell[ jackets1 hornets1 ants 7exclud+ c>p5t] ants71 fire & h>ve/] ants1 wood de/roy+ beetles1 c>p5t] ants1 t]mites1 subt]ranean t]mites1 dry wood t]mites1 arboreal t]mites1 damp wood t]mites & invasive species4 ,if seek+ a claim aga9/ a specific pe/ )\t a g5]al claim !n ea* specific pe/ w c\nt z #a4,r#cdjfj;,am5dm5t requir+ data review )9 ,,rd 7e4g41 *anges to precaution>y label /atem5ts72 includes add+_/modify+ pe/7s7 claims = up to #b t>get pe/s1 excludes products requir+ or cit+ an animal safety /udy4 7#b77c77d7dd1ihh,r#cdafa 7,new7,am5dm5t requir+ data review )9 ,,rd 7e4g41 *anges to precaution>y label /atem5ts71 includes add+_/modify+ pe/7s7 claims = great] ?an #b t>get pe/s1 excludes products requir+ or cit+ an animal safety /udy4 7#b77c77d7fe1ihh,r#cdefb;,am5d+ on-animal products previ\sly regi/]$1 ) ! submission ( data &_/or waiv]s = only3 animal safety & pe/7s7 requir+ efficacy 7#d7 &_/or product *emi/ry &_/or acute toxicity &_/or *ild resi/ant packag+4 7#b77c7gh1hbj,r#cejfc;,am5dm5t requir+ data review 9 sci5ce divisions 7e4g41 *anges to ,,rei1 or ,,ppe1 or ,,phi1 or use rate1 or numb] ( applications2 or add a]ial application2 or modify ,,gw_/,,sw advisory /atem5t74 7#b77c7iac1bbf,r#ceafd;,am5dm5t add+ a new unregi/]$ s\rce ( active +r$i5t4 7#b77c7hac1bbf,r#cebfe;,am5dm5t add+ already approv$ uses2 selective me?od ( support2 does n apply if ! applicant owns all cit$ data4 7#b7 7#c7hac1bbf,r#cgaff;,am5dm5t to ,exp]im5tal ,use ,p]mit2 7does n include ext5d+ a p]mit's "t p]iod74 7#c7faj1jij,,table #f4 -- ,,regi/ration ,,division -- ,,o!r ,,actionsepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day4,r#abdfg;,conditional ,rul+ on ,pre-application ,/udy ,waiv]s2 applicant-initiat$4#fb1ecj,r#bgbfh,revie w ( ,/udy ,protocol applicant-initiat$2 excludes ,,d>t1 pre-regi/ration conf]5ce1 ,rapid ,response review1 ,,dnt protocol review1 protocol ne$+ ,,hsrb review4#cb1ecj,r#bgefi,rebuttal ( ag5cy review$ protocol1 applicant initiat$4#cb1ecj,r#cgjgj;,canc] reassessm5t2 applicant-initiat$4#ahaih1bej,,table #g4 -- ,,antimicrobials ,,division -- ,,new ,,active ,,+r$i5tsepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 ,all reque/s = new uses 7food &_/or nonfood7 conta9$ 9 any application = a new active +r$i5t or a fir/ food use are cov]$ by ! base fee = t new active +r$i5t or fir/ food use application & reta9 ! same decision "t review p]iod z ! new active +r$i5t or fir/ food use application4 ,! application mu/ be receiv$ by ! ag5cy 9 "o package4 ,! base fee = ! category cov]s a maximum ( five new products4 ,ea* application = an additional new product regi/ration & new in]t approval t is submitt$ 9 ! new active +r$i5t application package or fir/ food use application package is subject to ! regi/ration s]vice fee = a new product or a new in]t approval4 ,all su* associat$ applications t are submitt$ toge!r w be subject to ! new active +r$i5t or fir/ food use decision review "t4 ,9 ! case ( a new active +r$i5t application1 until t new active +r$i5t is approv$1 any subsequ5t application = ano!r new product conta9+ ! same active +r$i5t or an am5dm5t to ! propos$ label+ w be deem$ a new active +r$i5t application1 subject to ! regi/ration s]vice fee & decision review "t = a new active +r$i5t4 ,9 ! case ( a fir/ food use application1 until t fir/ food use is approv$1 any subsequ5t application = an additional new food use or uses w be subject to ! regi/ration s]vice fee & decision review "t = a fir/ food use4 ,any in=mation t 7a7 0 nei!r reque/$ nor requir$ by ! ,ag5cy1 & 7b7 is submitt$ by ! applicant at ! applicant's initiative to support ! application aft] completion ( ! te*nical defici5cy scre5+1 & 7c7 is n itself a cov]$ regi/ration application1 mu/ be assess$ #be ( ! full regi/ration s]vice fee = ! new active +r$i5t or fir/ food use application47#c7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy4,a#chjga,new ,active ,+r$i5t2 ,indirect ,food use2 e/abli% tol]ance or tol]ance exemption if requir$4 7#b77c7bdacg1hda ,a#cijgb,new ,active ,+r$i5t2 ,direct ,food use2 e/abli% tol]ance or tol]ance exemption if requir$4 7#b77c7bdbbi1gcc ,a#dajgc,new ,active ,+r$i5t ,non-food use47#b77c7babbi1gcc ,a#dcagd,new ,active ,+r$i5t1 ,non-food use2 l[-risk4 7#b77c7abhj1bbe ,,table #h4 -- ,,antimicrobials ,,division -- ,,new ,,usesepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 ,all reque/s = new uses 7food &_/or nonfood7 conta9$ 9 any application = a new active +r$i5t or a fir/ food use are cov]$ by ! base fee = t new active +r$i5t or fir/ food use application & reta9 ! same decision "t review p]iod z ! new active +r$i5t or fir/ food use application4 ,! application mu/ be receiv$ by ! ag5cy 9 "o package4 ,! base fee = ! category cov]s a maximum ( five new products4 ,ea* application = an additional new product regi/ration & new in]t approval t is submitt$ 9 ! new active +r$i5t application package or fir/ food use application package is subject to ! regi/ration s]vice fee = a new product or a new in]t approval4 ,all su* associat$ applications t are submitt$ toge!r w be subject to ! new active +r$i5t or fir/ food use decision review "t4 ,9 ! case ( a new active +r$i5t application1 until t new active +r$i5t is approv$1 any subsequ5t application = ano!r new product conta9+ ! same active +r$i5t or an am5dm5t to ! propos$ label+ w be deem$ a new active +r$i5t application1 subject to ! regi/ration s]vice fee & decision review "t = a new active +r$i5t4 ,9 ! case ( a fir/ food use application1 until t fir/ food use is approv$1 any subsequ5t application = an additional new food use or uses w be subject to ! regi/ration s]vice fee & decision review "t = a fir/ food use4 ,any in=mation t 7a7 0 nei!r reque/$ nor requir$ by ! ,ag5cy1 & 7b7 is submitt$ by ! applicant at ! applicant's initiative to support ! application aft] completion ( ! te*nical defici5cy scre5+1 & 7c7 is n itself a cov]$ regi/ration application1 mu/ be assess$ #be ( ! full regi/ration s]vice fee = ! new active +r$i5t or fir/ food use application47#c7 ,if ,,epa data rules are am5d$ to newly require cle>ance "u section #djh ( ! ,,ffdca = an +r$i5t ( an antimicrobial product :]e su* +r$i5t 0 n previ\sly subject to su* a cle>ance1 !n review ( ! data = su* cle>ance ( su* product is n subject to a regi/ration s]vice fee = ! tol]ance action = two ye>s f ! effective date ( ! rule47#d7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy47#e7 ,am5dm5t applications to add ! new use7s7 to regi/]$ product labels are cov]$ by ! base fee = ! new use7s74 ,all items 9 ! cov]$ application mu/ be submitt$ toge!r 9 "o package4 ,ea* application = an additional new product regi/ration & new in]t approval7s7 t is submitt$ 9 ! new use application package is subject to ! regi/ration s]vice fee = a new product or a new in]t approval4 ,h[ev]1 if a new use application only proposes to regi/] ! new use = a new product & !re are no am5dm5ts 9 ! application1 !n review ( "o new product application is cov]$ by ! new use fee4 ,all su* associat$ applications t are submitt$ toge!r w be subject to ! new use decision review "t4 ,any application = a new product or an am5dm5t to ! propos$ label+ 7a7 submitt$ subsequ5t to submission ( ! new use application & 7b7 prior to conclusion ( its decision review "t & 7c7 conta9+ ! same new uses1 w be deem$ a sep>ate new-use application1 subject to a sep>ate regi/ration s]vice fee & new decision review "t = a new use4 ,if ! new-use application includes non-food 7indoor &_/or outdoor71 & food 7outdoor &_/or indoor7 uses1 ! appropriate fee is due = ea* type ( new use & ! longe/ decision review "t applies to all ( ! new uses reque/$ 9 ! application4 ,any in=mation t 7a7 0 nei!r reque/$ nor requir$ by ! ,ag5cy1 & 7b7 is submitt$ by ! applicant at ! applicant's initiative to support ! application aft] completion ( ! te*nical defici5cy scre51 & 7c7 is n itself a cov]$ regi/ration application1 mu/ be assess$ #be ( ! full regi/ration s]vice fee = ! new use application4,a#ddjge,new ,use1 ,indirect ,food ,use1 e/abli% tol]ance or tol]ance exemption4 7#b77c77d7baca1iaj;,a#ddagf;,additional ,indirect food uses2 e/abli% tol]ances or tol]ance exemptions if requir$2 #f or m submitt$ 9 "o application4 7#c77d77e7baaad1hgj;,a#dejgg,new use1 ,direct food use1 e/abli% tol]ance or tol]ance exemption4 7#b77c77d7baie1gbd;,a#deagh;,additional ,direct food uses2 e/abli% tol]ances or tol]ance exemptions if requir$2 #f or m submitt$ 9 "o application4 7#c77d77e7baahb1cce;,a#ejjgi,new use1 non-food4 7#d77e7abca1iaj;,a#ejahj,new use1 non-food2 #f or m submitt$ 9 "o application4 7#d77e7aegf1ehc,,table #i4 -- ,,antimicrobials ,,division -- ,,new ,,products ,,& ,,am5dm5tsepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 ,an application = a new end-use product us+ a s\rce ( active +r$i5t t 7a7 is n yet regi/]$ b 7b7 has an application p5d+ ) ! ,ag5cy = review1 w be consid]$ an application = a new product ) an unregi/]$ s\rce ( active +r$i5t47#c7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy4 7#d77;a7 ,,epa-initiat$ am5dm5ts %all n be *>g$ regi/ration s]vice fees4 7b7 ,regi/rant-initiat$ fa/-track am5dm5ts are to be complet$ )9 ! timel9es specifi$ 9 ,,fifra ,section #c7;c77#c77;,b7 & are n subject to regi/ration s]vice fees4 7c7 ,regi/rant-initiat$ fa/-track am5dm5ts h&l$ by ! ,antimicrobials ,division are to be complet$ )9 ! timel9es specifi$ 9 ,,fifra ,section #c7;h7 & are n subject to regi/ration s]vice fees4 7d7 ,regi/rant initiat$ am5dm5ts submitt$ by notification "u ,,pr ,notices1 su* z ,,pr ,notice #ih-aj1 cont9ue "u ,,pr ,notice timel9es & are n subject to regi/ration s]vice fees4 7e7 ,submissions ) data & requir+ data review are subject to regi/ration s]vice fees4 7#e7 ,! applicant mu/ id5tify ! sub/antially simil> product if opt+ to use cite-all or ! selective me?od to support acute toxicity data requirem5ts47#f7 ,once a submission = a new product ) public heal? organisms has be5 submitt$ & classifi$ 9 ei!r ,a#edj or ,a#eda1 additional organisms submitt$ = ! same product be=e expiration ( ! fir/ submission's orig9al decision review "t p]iod w result 9 reclassification ( bo? ! orig9al & subsequ5t submission into ! appropriate new category bas$ on ! sum ( ! numb] ( organisms 9 bo? submissions4 ,a reclassification w\ld result 9 a new ,,pria />t date & require additional fees to meet ! fee ( ! new category47#g7 ,once a submission = a label am5dm5t ) public heal? organisms has be5 submitt$ & classifi$ 9 ei!r ,a#egj or ,a#egc1 additional organisms submitt$ = ! same product be=e expiration ( ! fir/ submission's orig9al decision review "t p]iod w result 9 reclassification ( bo? ! orig9al & subsequ5t submission into ! appropriate new category bas$ on ! sum ( ! numb] ( organisms 9 bo? submissions4 ,a reclassification w\ld result 9 a new ,,pria />t date & require additional fees to meet ! fee ( ! new category4,a#ecjha ,new product1 id5tical or sub/antially simil> 9 composition & use to a regi/]$ product2 no data review or only product *emi/ry data2 cite all data citation or selective data citation :]e applicant owns all requir$ data2 or applicant submits specific au?orization lett] f data own]4 ,category also includes #ajj re-package ( regi/]$ end-use or manufactur+ use product t requires no data submission nor data matrix4 7#b77c7 #d #a1bgh ,a#ecahb ,new product2 id5tical or sub/antially simil> 9 composition & use to a regi/]$ product2 regi/]$ s\rce ( active +r$i5t3 selective data citation only = data on product *emi/ry &_/or acute toxicity &_/or public heal? pe/ efficacy1 :]e applicant does n own all requir$ data & does n h a specific au?orization lett] f data own]4 7#b77c7da1hbd;,a#ecbhc,new product2 id5tical or sub/antially simil> 9 composition & use to a regi/]$ product2 regi/]$ active +r$i5t2 unregi/]$ s\rce ( active +r$i5t2 cite-all data citation except = product *emi/ry2 product *emi/ry data submitt$4 7#b77c7 #ee1ajg;,a#edjhd ,new end use product2 ,,fifra #b7mm7 uses only2 up to #be public heal? organisms4 7#b77c77e77f7e #e1ajg ,a#edahe 7new7 ,new end use product2 ,,fifra #b7mm7 uses only2 #bf-ej public heal? organisms4 7#b77c77e77f7gh1ejj;,a#edbhf 7new7 ,new end use product2 ,,fifra #b7mm7 uses only2 #ea public heal? organisms4 7#b77c77e7ajae1jjj;,a#eejhg ,new end-use product2 uses o!r ?an ,,fifra #b7mm72 non-,,fqpa product4 7#b77c77e7iac1bbf ,a#efjhh ,new manufactur+ use product2 regi/]$ active +r$i5t2 selective data citation4 7#b77c7fab1eif;,a#efehi 7new7 ,new manufactur+-use product2 regi/]$ active +r$i5t2 unregi/]$ s\rce ( active +r$i5t2 submission ( new g5]ic data package2 regi/]$ uses only2 requires sci5ce review4 7#b77c7 #abah1bcd;,a#egjij ,label am5dm5t requir+ data review2 up to #be public heal? organisms4 7#c77d77e77f7dc1hca;,a#egcia 7new7 ,label am5dm5t requir+ data review2 #bf-ej public heal? organisms4 7#b77c77e77g7ff1cej;,a#egdib 7new7 ,label am5dm5t requir+ data review2 #ea public heal? organisms4 7#b77c77e77g7iaa1jjj;,a#egbic,new ,product or am5dm5t requir+ data review = risk assessm5t by ,sci5ce ,bran* 7e4g41 *anges to ,,rei1 or ,,ppe1 or use rate74 7#b77c77d7iac1bbf,,table #aj4 -- ,,antimicrobials ,,division -- ,,exp]im5tal ,,use ,,p]mits ,,& ,,o!r ,,actionsepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy4,a#ebjid ,exp]im5tal ,use ,p]mit application1 non-food use4 7#b7 #i #f1chc ,a#ebaie,review ( public heal? efficacy /udy protocol )9 ,,ad1 p] ,,ad ,int]nal ,guidance = ! ,efficacy ,protocol ,review ,process2 ,code w also include review ( public heal? efficacy /udy protocol & data review = devices mak+ pe/icidal claims2 applicant-initiat$2 ,ti] #a4dd1gbf;,a#ebbif ,review ( public heal? efficacy /udy protocol outside ,,ad by memb]s ( ,,ad ,efficacy ,protocol ,review ,exp]t ,panel2 ,code w also include review ( public heal? efficacy /udy protocol & data review = devices mak+ pe/icidal claims2 applicant-initiat$2 ,ti] #b4abab1aef;,a#ecgig 7new7 ,new ,active ,+r$i5t_/,new ,use1 ,exp]im5tal ,use ,p]mit application2 ,direct food use2 ,e/abli% tol]ance or tol]ance exemption if requir$4 ,cr$it #de ( fee t[>d new active +r$i5t_/new use application t foll[s4#ah #aec1aef ,a#echih 7new7 ,new ,active ,+r$i5t_/,new ,use1 ,exp]im5tal ,use ,p]mit application2 ,indirect food use2 ,e/abli% tol]ance or tol]ance exemption if requir$ ,cr$it #de ( fee t[>d new active +r$i5t_/new use application t foll[s4#ahie1gbd;,a#eciii 7new7 ,new ,active ,+r$i5t_/,new ,use1 ,exp]im5tal ,use ,p]mit application2 ,nonfood use4 ,cr$it #de ( fee t[>d new active +r$i5t_/new use application t foll[s4#aeib1afc;,a#ebiajj ,am5dm5t to ,exp]im5tal ,use ,p]mit2 requires data review or risk assessm5t4 7#b7 #iaa1dbi ,a#ebcaja ,review ( protocol o!r ?an a public heal? efficacy /udy 7i4e41 ,toxicology or ,exposure ,protocols74#iab1aef;,a#egaajb ,sci5ce reassessm5t3 ,canc] risk1 ref9$ ecological risk1 &_/or endang]$ species2 applicant-initiat$4 #ahie1gbd;,a#eccajc 7new7,exemption f ! requirem5t ( an ,exp]im5tal ,use ,p]mit4 7#b7 #db1dhb;,a#ecdajd 7new7 ,rebuttal ( ag5cy review$ protocol1 applicant initiat$4 #dd1gbf;,a#eceaje 7new7 ,conditional ,rul+ on ,pre-application ,/udy ,waiv] or ,data ,bridg+ ,argum5t2 applicant-initiat$4 #fb1dji;,a#ecfajf 7new7,conditional ,rul+ on ,pre-application ,direct ,food1 ,indirect ,food1 ,nonfood use det]m9ation2 applicant-initiat$4#db1dhb,,table #aa4 -- ,,biope/icides ,,division -- ,,new ,,active ,,+r$i5tsepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 ,all reque/s = new uses 7food &_/or nonfood7 conta9$ 9 any application = a new active +r$i5t or a fir/ food use are cov]$ by ! base fee = t new active +r$i5t or fir/ food use application & reta9 ! same decision "t review p]iod z ! new active +r$i5t or fir/ food use application4 ,! application mu/ be receiv$ by ! ag5cy 9 "o package4 ,! base fee = ! category cov]s a maximum ( five new products4 ,ea* application = an additional new product regi/ration & new in]t approval t is submitt$ 9 ! new active +r$i5t application package or fir/ food use application package is subject to ! regi/ration s]vice fee = a new product or a new in]t approval4 ,all su* associat$ applications t are submitt$ toge!r w be subject to ! new active +r$i5t or fir/ food use decision review "t4 ,9 ! case ( a new active +r$i5t application1 until t new active +r$i5t is approv$1 any subsequ5t application = ano!r new product conta9+ ! same active +r$i5t or an am5dm5t to ! propos$ label+ w be deem$ a new active +r$i5t application1 subject to ! regi/ration s]vice fee & decision review "t = a new active +r$i5t4 ,9 ! case ( a fir/ food use application1 until t fir/ food use is approv$1 any subsequ5t application = an additional new food use or uses w be subject to ! regi/ration s]vice fee & decision review "t = a fir/ food use4 ,any in=mation t 7a7 0 nei!r reque/$ nor requir$ by ! ,ag5cy1 & 7b7 is submitt$ by ! applicant at ! applicant's initiative to support ! application aft] completion ( ! te*nical defici5cy scre5+1 & 7c7 is n itself a cov]$ regi/ration application1 mu/ be assess$ #be ( ! full regi/ration s]vice fee = ! new active +r$i5t or fir/ food use application4 7#c7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy4,b#ehjajg,new active +r$i5t2 food use2 petition to e/abli% a tol]ance4 7#b77c7 #bj #ea1jec ,b#eijajh ,new active +r$i5t2 food use2 petition to e/abli% a tol]ance exemption4 7#b77c7ahca1iaj;,b#fjjaji ,new active +r$i5t2 non-food use4 7#b77c7 #acai1adf;,b#fajaaj ,new active +r$i5t2 ,exp]im5tal ,use ,p]mit application2 petition to e/abli% a tempor>y tol]ance or tempor>y tol]ance exemption4 7#c7 #aj #ab1gfd ,b#faaaaa ,new active +r$i5t2 ,exp]im5tal ,use ,p]mit application2 petition to e/abli% p]man5t tol]ance exemption4 7#c7abab1gfd;,b#fabaab ,new active +r$i5t2 no *ange to a p]man5t tol]ance exemption4 7#b77c7ajag1eej;,b#facaac ,new active +r$i5t2 petition to conv]t a tempor>y tol]ance or a tempor>y tol]ance exemption to a p]man5t tol]ance or tol]ance exemption4 7#b77c7aaag1eej ,b#fbjaad ,new active +r$i5t2 ,exp]im5tal ,use ,p]mit application2 non-food use includ+ crop de/ruct4 7#c7gf1chc,,table #ab4 -- ,,biope/icides ,,division -- ,,new ,,usesepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 ,all reque/s = new uses 7food &_/or nonfood7 conta9$ 9 any application = a new active +r$i5t or a fir/ food use are cov]$ by ! base fee = t new active +r$i5t or fir/ food use application & reta9 ! same decision "t review p]iod z ! new active +r$i5t or fir/ food use application4 ,! application mu/ be receiv$ by ! ag5cy 9 "o package4 ,! base fee = ! category cov]s a maximum ( five new products4 ,ea* application = an additional new product regi/ration & new in]t approval t is submitt$ 9 ! new active +r$i5t application package or fir/ food use application package is subject to ! regi/ration s]vice fee = a new product or a new in]t approval4 ,all su* associat$ applications t are submitt$ toge!r w be subject to ! new active +r$i5t or fir/ food use decision review "t4 ,9 ! case ( a new active +r$i5t application1 until t new active +r$i5t is approv$1 any subsequ5t application = ano!r new product conta9+ ! same active +r$i5t or an am5dm5t to ! propos$ label+ w be deem$ a new active +r$i5t application1 subject to ! regi/ration s]vice fee & decision review "t = a new active +r$i5t4 ,9 ! case ( a fir/ food use application1 until t fir/ food use is approv$1 any subsequ5t application = an additional new food use or uses w be subject to ! regi/ration s]vice fee & decision review "t = a fir/ food use4 ,any in=mation t 7a7 0 nei!r reque/$ nor requir$ by ! ,ag5cy1 & 7b7 is submitt$ by ! applicant at ! applicant's initiative to support ! application aft] completion ( ! te*nical defici5cy scre5+1 & 7c7 is n itself a cov]$ regi/ration application1 mu/ be assess$ #be ( ! full regi/ration s]vice fee = ! new active +r$i5t or fir/ food use application4 7#c7 ,am5dm5t applications to add ! new use7s7 to regi/]$ product labels are cov]$ by ! base fee = ! new use7s74 ,all items 9 ! cov]$ application mu/ be submitt$ toge!r 9 "o package4 ,ea* application = an additional new product regi/ration & new in]t approval7s7 t is submitt$ 9 ! new use application package is subject to ! regi/ration s]vice fee = a new product or a new in]t approval4 ,h[ev]1 if a new use application only proposes to regi/] ! new use = a new product & !re are no am5dm5ts 9 ! application1 !n review ( "o new product application is cov]$ by ! new use fee4 ,all su* associat$ applications t are submitt$ toge!r w be subject to ! new use decision review "t4 ,any application = a new product or an am5dm5t to ! propos$ label+ 7a7 submitt$ subsequ5t to submission ( ! new use application & 7b7 prior to conclusion ( its decision review "t & 7c7 conta9+ ! same new uses1 w be deem$ a sep>ate new-use application1 subject to a sep>ate regi/ration s]vice fee & new decision review "t = a new use4 ,if ! new-use application includes non-food 7indoor &_/or outdoor71 & food 7outdoor &_/or indoor7 uses1 ! appropriate fee is due = ea* type ( new use & ! longe/ decision review "t applies to all ( ! new uses reque/$ 9 ! application4 ,any in=mation t 7a7 0 nei!r reque/$ nor requir$ by ! ,ag5cy1 & 7b7 is submitt$ by ! applicant at ! applicant's initiative to support ! application aft] completion ( ! te*nical defici5cy scre51 & 7c7 is n itself a cov]$ regi/ration application1 mu/ be assess$ #be ( ! full regi/ration s]vice fee = ! new use application4 7#d7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy4,b#fcjaae ,fir/ food use2 petition to e/abli% a tol]ance exemption4 7#b77d7 #ac #ab1gfd ,b#fcaaaf ,new food use2 petition to am5d an e/abli%$ tol]ance4 7#c77d7abab1gfd;,b#fdjaag;,fir/ food use2 petition to e/abli% a tol]ance4 7#b77d7 #aiai1adf;,b#fdcaah,new ,food use2 petition to am5d an e/abli%$ tol]ance exemption4 7#c77d7 #aj #ab1gfd ,b#fdbaai;,fir/ food use2 indoor2 food_/food h&l+4 7#b77d7abca1iaj;,b#fddabj,new use1 no *ange to an e/abli%$ tol]ance or tol]ance exemption4 7#c77d7hab1gfd;,b#fejaba,new use2 non-food4 7#c77d7gf1chc ,b#fdeabb 7new7 ,new food use2 ,exp]im5tal ,use ,p]mit application2 petition to am5d or add a tol]ance exemption4 7#d7abab1gfd;,b#fdfabc 7new7,new use2 non-food use includ+ crop de/ruct2 ,exp]im5tal ,use ,p]mit application4 7#d7 #gf1chc,,table #ac4 -- ,,biope/icides ,,division -- ,,new ,,productsepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 ,an application = a new end-use product us+ a s\rce ( active +r$i5t t 7a7 is n yet regi/]$ b 7b7 has an application p5d+ ) ! ,ag5cy = review1 w be consid]$ an application = a new product ) an unregi/]$ s\rce ( active +r$i5t47#c7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy4,b#febabd,new product2 regi/]$ s\rce ( active +r$i5t2 requires petition to am5d e/abli%$ tol]ance or tol]ance exemption2 requires #a7 submission ( product specific data2 or #b7 citation ( previ\sly review$ & accept$ data2 or #c7 submission or citation ( data g5]at$ at gov]nm5t exp5se2 or #d7 submission or citation ( sci5tifically-s\nd rationale bas$ on publicly available lit]ature or o!r relevant in=mation t addresses ! data requirem5t2 or #e7 submission ( a reque/ = a data requirem5t to be waiv$ support$ by a sci5tifically-s\nd rationale expla9+ :y ! data requirem5t does n apply4 7#b77c7 #ac #ab1gfd ,b#ffjabe ,new product2 regi/]$ s\rce ( active +r$i5t7s72 id5tical or sub/antially simil> 9 composition & use to a regi/]$ product4 ,no data review1 or only product *emi/ry data2 cite-all data citation1 or selective data citation :]e applicant owns all requir$ data or au?orization f data own] is demon/rat$4 ,category includes #ajj re-package ( regi/]$ end-use or manufactur+-use product t requires no data submission or data matrix4 ,= microbial pe/icides1 ! active +r$i5t7s7 mu/ n be re-isolat$4 7#b77c7da1bgh;,b#fgjabf ,new product2 regi/]$ s\rce ( active +r$i5t7s72 requires3 #a7 submission ( product specific data2 or #b7 citation ( previ\sly review$ & accept$ data2 or #c7 submission or citation ( data g5]at$ at gov]nm5t exp5se2 or #d7 submission or citation ( a sci5tifically-s\nd rationale bas$ on publicly available lit]ature or o!r relevant in=mation t addresses ! data requirem5t2 or #e7 submission ( a reque/ = a data requirem5t to be waiv$ support$ by a sci5tifically-s\nd rationale expla9+ :y ! data requirem5t does n apply4 7#b77c7 #ge1ajg;,b#fgaabg ,new product2 unregi/]$ s\rce ( active +r$i5t7s72 requires a petition to am5d an e/abli%$ tol]ance or tol]ance exemption2 requires3 #a7 submission ( product specific data2 or #b7 citation ( previ\sly review$ & accept$ data2 or #c7 submission or citation ( data g5]at$ at gov]nm5t exp5se2 or #d7 submission or citation ( a sci5tifically-s\nd rationale bas$ on publicly available lit]ature or o!r relevant in=mation t addresses ! data requirem5t2 or #e7 submission ( a reque/ = a data requirem5t to be waiv$ support$ by a sci5tifically-s\nd rationale expla9+ :y ! data requirem5t does n apply4 7#b77c7 #ag #ab1gfd ,b#fgbabh ,new product2 unregi/]$ s\rce ( active +r$i5t7s72 non-food use or food use requires3 #a7 submission ( product specific data2 or #b7 citation ( previ\sly review$ & accept$ data2 or #c7 submission or citation ( data g5]at$ at gov]nm5t exp5se2 or #d7 submission or citation ( a sci5tifically-s\nd rationale bas$ on publicly available lit]ature or o!r relevant in=mation t addresses ! data requirem5t2 or #e7 submission ( a reque/ = a data requirem5t to be waiv$ support$ by a sci5tifically-s\nd rationale expla9+ :y ! data requirem5t does n apply4 7#b77c7aci1aah;,b#fgcabi ,new product ,,mup_/,,ep2 unregi/]$ s\rce ( active +r$i5t7s72 citation ( ,te*nical ,grade ,active ,+r$i5t 7,,tgai7 data previ\sly review$ & accept$ by ! ,ag5cy4 ,requires an ,ag5cy det]m9ation t ! cit$ data supports ! new product4 7#b77c7aje1ajg;,b#fgdacj ,new product ,,mup2 ,repack ( id5tical regi/]$ end-use product z a manufactur+-use product2 same regi/]$ uses only4 7#b77c7da1bgh ,b#fgeaca ,new ,product ,,mup2 regi/]$ s\rce ( active +r$i5t2 submission ( completely new g5]ic data package2 regi/]$ uses only4 7#b77c7aji1aah;,b#fgfacb ,new product2 m ?an "o active +r$i5t :]e "o active +r$i5t is an unregi/]$ s\rce2 product *emi/ry data mu/ be submitt$2 requires3 #a7 submission ( product specific data1 & #b7 citation ( previ\sly review$ & accept$ data2 or #c7 submission or citation ( data g5]at$ at gov]nm5t exp5se2 or #d7 submission or citation ( a sci5tifically-s\nd rationale bas$ on publicly available lit]ature or o!r relevant in=mation t addresses ! data requirem5t2 or #e7 submission ( a reque/ = a data requirem5t to be waiv$ support$ by a sci5tifically-s\nd rationale expla9+ :y ! data requirem5t does n apply4 7#b77c7 #aci1aah;,b#fggacc,new end-use non-food animal product ) submission ( two or m t>get animal safety /udies2 includes data &_/or waiv]s ( data = only3 product *emi/ry &_/or acute toxicity &_/or public heal? pe/ efficacy &_/or animal safety /udies &_/or *ild resi/ant packag+4 7#b77c7ajh1hbj,,table #ad4 -- ,,biope/icides ,,division -- ,,am5dm5tsepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 7a7 ,,epa-initiat$ am5dm5ts %all n be *>g$ regi/ration s]vice fees4 7b7 ,regi/rant-initiat$ fa/-track am5dm5ts are to be complet$ )9 ! timel9es specifi$ 9 ,,fifra ,section #c7;c77#c77;,b7 & are n subject to regi/ration s]vice fees4 7c7 ,regi/rant-initiat$ fa/-track am5dm5ts h&l$ by ! ,antimicrobials ,division are to be complet$ )9 ! timel9es specifi$ 9 ,,fifra ,section #c7;h7 & are n subject to regi/ration s]vice fees4 7d7 ,regi/rant initiat$ am5dm5ts submitt$ by notification "u ,,pr ,notices1 su* z ,,pr ,notice #ih-aj1 cont9ue "u ,,pr ,notice timel9es & are n subject to regi/ration s]vice fees4 7e7 ,submissions ) data & requir+ data review are subject to regi/ration s]vice fees47#c7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy4,b#fbaacd;,am5dm5t2 ,exp]im5tal ,use ,p]mit2 no *ange to an e/abli%$ tempor>y tol]ance or tol]ance exemption4 7#c7g #e1ajg ,b#fbbace;,am5dm5t2 ,exp]im5tal ,use ,p]mit2 petition to am5d an e/abli%$ or tempor>y tol]ance or tol]ance exemption4 7#c7aaab1gfd;,b#fdaacf;,am5dm5t ( an e/abli%$ tol]ance or tol]ance exemption4#acab1gfd;,b#fhjacg ,am5dm5t2 regi/]$ s\rces ( active +r$i5t7s72 no new use7s72 no *anges to an e/abli%$ tol]ance or tol]ance exemption4 ,requires data submission4 7#b77c7 #e #e1ajg ,b#fhaach ,am5dm5t2 unregi/]$ s\rce ( active +r$i5t7s74 ,requires data submission4 7#b77c7gf1jgi;,b#fhcaci ,label am5dm5t2 requires review_/update ( previ\s risk assessm5t7s7 )\t data submission 7e4g41 label+ *anges to ,,rei1 ,,ppe1 ,,phi74 7#b77c7fe1ajg;,b#fhdadj ,am5d+ non-food animal product t includes submission ( t>get animal safety data2 previ\sly regi/]$4 7#b77c7hh1hbj ,b#fheada 7new7 ,am5dm5t2 add a new bio*emical unregi/]$ s\rce ( active +r$i5t or a new microbial production site4 ,requires submission ( analysis ( samples data & s\rce_/production site-specific manufactur+ process description4 7#c7ee1ajg,,table #ae4 -- ,,biope/icides ,,division -- ,,sclpepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 ,all reque/s = new uses 7food &_/or nonfood7 conta9$ 9 any application = a new active +r$i5t or a fir/ food use are cov]$ by ! base fee = t new active +r$i5t or fir/ food use application & reta9 ! same decision "t review p]iod z ! new active +r$i5t or fir/ food use application4 ,! application mu/ be receiv$ by ! ag5cy 9 "o package4 ,! base fee = ! category cov]s a maximum ( five new products4 ,ea* application = an additional new product regi/ration & new in]t approval t is submitt$ 9 ! new active +r$i5t application package or fir/ food use application package is subject to ! regi/ration s]vice fee = a new product or a new in]t approval4 ,all su* associat$ applications t are submitt$ toge!r w be subject to ! new active +r$i5t or fir/ food use decision review "t4 ,9 ! case ( a new active +r$i5t application1 until t new active +r$i5t is approv$1 any subsequ5t application = ano!r new product conta9+ ! same active +r$i5t or an am5dm5t to ! propos$ label+ w be deem$ a new active +r$i5t application1 subject to ! regi/ration s]vice fee & decision review "t = a new active +r$i5t4 ,9 ! case ( a fir/ food use application1 until t fir/ food use is approv$1 any subsequ5t application = an additional new food use or uses w be subject to ! regi/ration s]vice fee & decision review "t = a fir/ food use4 ,any in=mation t 7a7 0 nei!r reque/$ nor requir$ by ! ,ag5cy1 & 7b7 is submitt$ by ! applicant at ! applicant's initiative to support ! application aft] completion ( ! te*nical defici5cy scre5+1 & 7c7 is n itself a cov]$ regi/ration application1 mu/ be assess$ #be ( ! full regi/ration s]vice fee = ! new active +r$i5t or fir/ food use application4 7#c7 ,an application = a new end-use product us+ a s\rce ( active +r$i5t t 7a7 is n yet regi/]$ b 7b7 has an application p5d+ ) ! ,ag5cy = review1 w be consid]$ an application = a new product ) an unregi/]$ s\rce ( active +r$i5t47#d7 7a7 ,,epa-initiat$ am5dm5ts %all n be *>g$ regi/ration s]vice fees4 7b7 ,regi/rant-initiat$ fa/-track am5dm5ts are to be complet$ )9 ! timel9es specifi$ 9 ,,fifra ,section #c7;c77#c77;,b7 & are n subject to regi/ration s]vice fees4 7c7 ,regi/rant-initiat$ fa/-track am5dm5ts h&l$ by ! ,antimicrobials ,division are to be complet$ )9 ! timel9es specifi$ 9 ,,fifra ,section #c7;h7 & are n subject to regi/ration s]vice fees4 7d7 ,regi/rant initiat$ am5dm5ts submitt$ by notification "u ,,pr ,notices1 su* z ,,pr ,notice #ih-aj1 cont9ue "u ,,pr ,notice timel9es & are n subject to regi/ration s]vice fees4 7e7 ,submissions ) data & requir+ data review are subject to regi/ration s]vice fees47#e7 ,am5dm5t applications to add ! new use7s7 to regi/]$ product labels are cov]$ by ! base fee = ! new use7s74 ,all items 9 ! cov]$ application mu/ be submitt$ toge!r 9 "o package4 ,ea* application = an additional new product regi/ration & new in]t approval7s7 t is submitt$ 9 ! new use application package is subject to ! regi/ration s]vice fee = a new product or a new in]t approval4 ,h[ev]1 if a new use application only proposes to regi/] ! new use = a new product & !re are no am5dm5ts 9 ! application1 !n review ( "o new product application is cov]$ by ! new use fee4 ,all su* associat$ applications t are submitt$ toge!r w be subject to ! new use decision review "t4 ,any application = a new product or an am5dm5t to ! propos$ label+ 7a7 submitt$ subsequ5t to submission ( ! new use application & 7b7 prior to conclusion ( its decision review "t & 7c7 conta9+ ! same new uses1 w be deem$ a sep>ate new-use application1 subject to a sep>ate regi/ration s]vice fee & new decision review "t = a new use4 ,if ! new-use application includes non-food 7indoor &_/or outdoor71 & food 7outdoor &_/or indoor7 uses1 ! appropriate fee is due = ea* type ( new use & ! longe/ decision review "t applies to all ( ! new uses reque/$ 9 ! application4 ,any in=mation t 7a7 0 nei!r reque/$ nor requir$ by ! ,ag5cy1 & 7b7 is submitt$ by ! applicant at ! applicant's initiative to support ! application aft] completion ( ! te*nical defici5cy scre51 & 7c7 is n itself a cov]$ regi/ration application1 mu/ be assess$ #be ( ! full regi/ration s]vice fee = ! new use application47#f7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy4,b#fijadb,new active +r$i5t2 food or non-food use4 7#b77f7 #g #b1eed ,b#gjjadc ,exp]im5tal ,use ,p]mit application2 new active +r$i5t or new use4 7#f7 #ga1bgh;,b#gjaadd ,ext5d or am5d ,exp]im5tal ,use ,p]mit4 7#f7 #da1bgh;,b#gajade ,new product2 regi/]$ s\rce ( active +r$i5t7s72 id5tical or sub/antially simil> 9 composition & use to a regi/]$ product2 no *ange 9 an e/abli%$ tol]ance or tol]ance exemption4 ,no data review1 or only product *emi/ry data2 cite-all data citation1 or selective data citation :]e applicant owns all requir$ data or au?orization f data own] is demon/rat$4 ,category includes #ajj re-package ( regi/]$ end-use or manufactur+-use product t requires no data submission or data matrix4 7#c77f7 #d #a1bgh ,b#gbjadf ,new product2 regi/]$ s\rce ( active +r$i5t7s72 requires3 #a7 submission ( product specific data2 or #b7 citation ( previ\sly review$ & accept$ data2 or #c7 submission or citation ( data g5]at$ at gov]nm5t exp5se2 or #d7 submission or citation ( a sci5tifically-s\nd rationale bas$ on publicly available lit]ature or o!r relevant in=mation t addresses ! data requirem5t2 or #e7 submission ( a reque/ = a data requirem5t to be waiv$ support$ by a sci5tifically-s\nd rationale expla9+ :y ! data requirem5t does n apply4 7#c77f7ea1bgh;,b#gbaadg ,new product2 unregi/]$ s\rce ( active +r$i5t4 7#c77f7gb1fgf;,b#gbbadh,new use &_/or am5dm5t2 petition to e/abli% a tol]ance or tol]ance exemption4 7#d77e77f7gb1dgg ,b#gcjadi,label am5dm5t requir+ data submission4 7#d77f7ea1bgh,,table #af4 -- ,,biope/icides ,,division -- ,,o!r ,,actionsepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day4,b#fadaej,pre-application2 ,conditional ,rul+ on rationales = address+ a data requirem5t 9 lieu ( data2 applicant-initiat$2 applies to "o rationale at a "t4#c #b1ecj ,b#faeaea,rebuttal ( ag5cy review$ protocol1 applicant initiat$4#cb1ecj;,b#fhbaeb,protocol review2 applicant initiat$2 excludes "t = ,,hsrb review4 #cb1dcb,,table #ag4 -- ,,biope/icides ,,division -- ,,pipepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 ,new ,,pip a ,,pip ) an active +r$i5t t has n be5 regi/]$47#c7 ,regi/]$ ,,pip a ,,pip ) an active +r$i5t t is curr5tly regi/]$47#d7 ,transf] regi/]$ ,,pip ?r\gh conv5tional bre$+ = new food_/fe$ use1 su* z f field corn to sweet corn47#e7 ,! sci5tific data involv$ 9 ?is category are complex4 ,,epa (t5 seeks te*nical advice f ! ,sci5tific ,advisory ,panel on risks t pe/icides pose to wildlife1 f>m work]s1 pe/icide applicators1 non-t>get species1 z well z insect resi/ance1 & novel sci5tific issues surr\nd+ new te*nologies4 ,! sci5ti/s ( ! ,,sap nei!r make nor recomm5d policy decisions4 ,!y provide advice on ! sci5ce us$ to make ^! decisions4 ,_! advice is invaluable to ! ,,epa z x /rives to protect humans & ! environm5t f risks pos$ by pe/icides4 ,due to ! "t x takes to s*$ule & prep>e = meet+s ) ! ,,sap1 additional "t & co/s are ne$$47#f7 ,regi/]$ ,p,i,ps /ack$ ?r\gh conv5tional bre$+47#g7 ,deploym5t ( a regi/]$ ,,pip ) a diff]5t ,,irm plan 7e4g41 se$ bl5d747#h7 ,! negotiat$ acreage cap w dep5d ^u ,,epa's det]m9ation ( ! pot5tial environm5tal exposure1 risk7s7 to non-t>get organisms1 & ! risk ( t>get$ pe/ develop+ resi/ance to ! pe/icidal sub/ance4 ,! unc]ta9ty ( ^! risks may r$uce ! all[able acreage1 bas$ ^u ! quantity & type ( non-t>get organism data submitt$ & ! lack ( insect resi/ance managem5t data1 :i* is usually n requir$ = se$-increase regi/rations4 ,regi/rants are enc\rag$ to consult ) ,,epa prior to submission ( a regi/ration application 9 ?is category47#i7 ,application c be submitt$ prior to or concurr5tly ) an application = comm]cial regi/ration47#aj7 ,= example1 ,,irm plan modifications t are applicant-initiat$47#aa7 ,,epa-initiat$ am5dm5ts %all n be *>g$ fees47#ab7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy4,b#gdjaec;,exp]im5tal ,use ,p]mit application2 no petition = tol]ance_/tol]ance exemption4 ,includes3#a4 non-food_/fe$ use7s7 = a new 7#b7 or regi/]$ 7#c7 ,,pip 7#ab72b4 food_/fe$ use7s7 = a new or regi/]$ ,,pip ) crop de/ruct 7#ab72c4 food_/fe$ use7s7 = a new or regi/]$ ,,pip 9 :i* an e/abli%$ tol]ance_/tol]ance exemption exi/s = ! int5d$ use7s74 7#d77ab7f #ie1gbd ,b#gdaaed 7new7,exp]im5tal ,use ,p]mit application2 no petition = tol]ance_/tol]ance exemption4 ,includes3#a4 non-food_/fe$ use7s7 = a new 7#b7 or regi/]$ 7#c7 ,,pip2#b4 food_/fe$ use7s7 = a new or regi/]$ ,,pip ) crop de/ruct2#c4 food_/fe$ use7s7 = a new or regi/]$ ,,pip 9 :i* an e/abli%$ tol]ance_/tol]ance exemption exi/s = ! int5d$ use7s72,,sap ,review4 7#ab7 #abaei1ech;,b#gejaee;,exp]im5tal ,use ,p]mit application2 ) a petition to e/abli% a tempor>y or p]man5t tol]ance_/tol]ance exemption = ! active +r$i5t4 ,includes new food_/fe$ use = a regi/]$ 7#c7 ,,pip4 7#d77ab7iabg1fcj;,b#ggjaef;,exp]im5tal ,use ,p]mit application2 new 7#b7 ,,pip2 ) petition to e/abli% a tempor>y tol]ance_/tol]ance exemption = ! active +r$i5t2 cr$it #ge ( ,b#gga fee t[>d regi/ration application = a new active +r$i5t t foll[s2 ,,sap review4 7#e77ab7 #ae #aia1ddd ,b#ggaaeg;,exp]im5tal ,use ,p]mit application2 new 7#b7 ,,pip2 ) petition to e/abli% a tempor>y tol]ance_/tol]ance exemption = ! active +r$i5t2 cr$it #ge ( ,b#gga fee t[>d regi/ration application = a new active +r$i5t t foll[s4 7#ab7ajabg1fcj;,b#ggbaeh;,application to am5d or ext5d an ,exp]im5tal ,use ,p]mit2 no petition s9ce ! e/abli%$ tol]ance_/tol]ance exemption = ! active +r$i5t is unaffect$4 7#ab7cab1gfd;,b#ggcaei;,application to am5d or ext5d an ,exp]im5tal ,use ,p]mit2 ) petition to ext5d a tempor>y tol]ance_/tol]ance exemption = ! active +r$i5t4 7#ab7eca1iaj ,b#ghjafj,regi/ration application2 new 7#b7 ,,pip2 non-food_/fe$4 7#ab7abaei1ecg;,b#gijafa,regi/ration application2 new 7#b7 ,,pip2 non-food_/fe$2 ,,sap review4 7#e77ab7 #ahbbc1cea;,b#hjjafb,regi/ration application2 new 7#b7 ,,pip2 ) petition to e/abli% p]man5t tol]ance_/tol]ance exemption = ! active +r$i5t bas$ on an exi/+ tempor>y tol]ance_/tol]ance exemption4 7#ab7acagb1cjj;,b#hajafc,regi/ration application2 new 7#b7 ,,pip2 ) petition to e/abli% p]man5t tol]ance_/tol]ance exemption = ! active +r$i5t bas$ on an exi/+ tempor>y tol]ance_/tol]ance exemption4 ,,sap review4 7#e77ab7aibcf1aad;,b#hbjafd,regi/ration application2 new 7#b7 ,,pip2 ) petition to e/abli% or am5d a p]man5t tol]ance_/tol]ance exemption ( an active +r$i5t4 7#ab7aebjd1bjh;,b#hdjafe,regi/ration application2 new 7#b7 ,,pip2 ) petition to e/abli% or am5d a p]man5t tol]ance_/tol]ance exemption ( an active +r$i5t4 ,,sap review4 7#e77ab7babfh1jbb;,b#heaaff,regi/ration application2 new ev5t ( a previ\sly regi/]$ ,,pip active +r$i5t7s72 no petition s9ce p]man5t tol]ance_/tol]ance exemption is already e/abli%$ = ! active +r$i5t7s74 7#ab7iabg1fcj;,b#hgjafg,regi/ration application2 regi/]$ 7#c7 ,,pip2 new product2 new use2 no petition s9ce a p]man5t tol]ance_/tol]ance exemption is already e/abli%$ = ! active +r$i5t7s74 7#d7 7#ab7ich1bij;,b#hhjafh,regi/ration application2 regi/]$ 7#c7 ,,pip2 new product or new t]ms ( regi/ration2 additional data submitt$2 no petition s9ce a p]man5t tol]ance_/tol]ance exemption is already e/abli%$ = ! active +r$i5t7s74 7#f7 7#g7 7#ab7ica1iaj;,b#hhaafi,regi/ration application2 regi/]$ 7#c7 ,,pip2 new product or new t]ms ( regi/ration2 additional data submitt$2 no petition s9ce a p]man5t tol]ance_/tol]ance exemption is already e/abli%$ = ! active +r$i5t7s74 ,,sap review4 7#e77f77g77ab7aeie1gbd;,b#hhbagj 7new7,regi/ration application2 new 7#b7 ,,pip1 se$ increase ) negotiat$ acreage cap & "t-limit$ regi/ration2 ) petition to e/abli% a p]man5t tol]ance_/tol]ance exemption = ! active +r$i5t bas$ on an exi/+ tempor>y tol]ance_/tol]ance exemption2 ,,sap ,review4 7#h77ab7aeaia1ddd;,b#hhcaga,regi/ration application2 new 7#b7 ,,pip1 se$ increase ) negotiat$ acreage cap & "t-limit$ regi/ration2 ) petition to e/abli% a p]man5t tol]ance_/tol]ance exemption = ! active +r$i5t bas$ on an exi/+ tempor>y tol]ance_/tol]ance exemption4 7#h7 7#ab7iabg1fcj;,b#hhdagb,regi/ration application2 new 7#b7 ,,pip1 se$ increase ) negotiat$ acreage cap & "t-limit$ regi/ration2 ) petition to e/abli% a p]man5t tol]ance_/tol]ance exemption = ! active +r$i5t4 7#h77ab7abaei1ecg;,b#hheagc,regi/ration application2 regi/]$ 7#c7 ,,pip1 se$ increase2 bre$+ /ack ( previ\sly approv$ ,p,i,ps1 same crop2 no petition s9ce a p]man5t tol]ance_/tol]ance exemption is already e/abli%$ = ! active +r$i5t7s74 7#i77ab7fca1iaj;,b#hhfagd 7new7,regi/ration application2 new 7#b7 ,,pip1 se$ increase ) negotiat$ acreage cap & "t-limit$ regi/ration2 ) petition to e/abli% a p]man5t tol]ance_/tol]ance exemption = ! active +r$i5t4 ,,sap ,review4 7#h7 7#ab7ahbbc1cea;,b#hijage;,application to am5d a se$ increase regi/ration2 conv]ts regi/ration to comm]cial regi/ration2 no petition s9ce p]man5t tol]ance_/tol]ance exemption is already e/abli%$ = ! active +r$i5t7s74 7#ab7ifc1haf;,b#hiaagf;,application to am5d a se$ increase regi/ration2 conv]ts regi/ration to a comm]cial regi/ration2 no petition s9ce a p]man5t tol]ance_/tol]ance exemption already e/abli%$ = ! active +r$i5t7s72 ,,sap review4 7#e77ab7aeabg1fcj;,b#ijjagg;,application to am5d a regi/ration1 includ+ actions su* z ext5d+ an expiration date1 modify+ an ,,irm plan1 or add+ an insect to be controll$4 7#aj77aa77ab7fab1gfd;,b#ijaagh;,applicat ion to am5d a regi/ration1 includ+ actions su* z ext5d+ an expiration date1 modify+ an ,,irm plan1 or add+ an insect to be controll$4 ,,sap review4 7#aj7 7#aa7 7#ab7abgf1egh;,b#ijbagi,,pip ,protocol review4#cf1chc;,b#ijcahj;,in]t +r$i5t tol]ance exemption2 e4g41 a m>k] su* z ,,npt ,,ii2 review$ 9 ,,bppd4#ffc1haf;,b#ijdaha;,import tol]ance or tol]ance exemption2 process$ commodities_/food only 7in]t or active +r$i5t74#iabg1fcj;,b#ijeahb 7new7,,sap ,review4#ffc1haf;,b#ijfahc 7new7,petition to e/abli% a tempor>y tol]ance_/tol]ance exemption = "o or m active +r$i5ts4#cca1ijg;,b#ijgahd 7new7,petition to e/abli% a tempor>y tol]ance_/tol]ance exemption = "o or m active +r$i5ts bas$ on an exi/+ tempor>y tol]ance_/tol]ance exemption4#cab1gfd;,b#ijhahe 7new7,petition to e/abli% a tempor>y tol]ance_/tol]ance exemption = "o or m active +r$i5ts or in]t +r$i5ts4#cdd1fga,,table #ah4 -- ,,in]t ,,+r$i5tsepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 ,if ano!r cov]$ application is submitt$ t dep5ds ^u an application to approve an in]t +r$i5t1 ea* application w be subject to its respective regi/ration s]vice fee4 ,! decision review "t l9e = bo? submissions w be ! longe/ ( ! associat$ applications4 ,if ! application cov]s multiple +r$i5ts gr\p$ by ,,epa into "o *emical class1 a s+le regi/ration s]vice fee w be assess$ = approval ( ^? +r$i5ts47#c7 ,if ,,epa data rules are am5d$ to newly require cle>ance "u section #djh ( ! ,,ffdca = an +r$i5t ( an antimicrobial product :]e su* +r$i5t 0 n previ\sly subject to su* a cle>ance1 !n review ( ! data = su* cle>ance ( su* product is n subject to a regi/ration s]vice fee = ! tol]ance action = two ye>s f ! effective date ( ! rule47#d7 ,any o!r cov]$ application t is associat$ ) & dep5d5t on ! ,,hsrb review w be subject to its sep>ate regi/ration s]vice fee4 ,! decision review times = ! associat$ actions run concurr5tly1 b w end at ! date ( ! late/ review "t47#e7 ,any o!r cov]$ application t is associat$ ) & dep5d5t on ! ,,sap review w be subject to its sep>ate regi/ration s]vice fee4 ,! decision review "t = ! associat$ action w be ext5d$ by ! decision review "t = ! ,,sap review47#f7 ,an application = a new end-use product us+ a s\rce ( active +r$i5t t 7a7 is n yet regi/]$ b 7b7 has an application p5d+ ) ! ,ag5cy = review1 w be consid]$ an application = a new product ) an unregi/]$ s\rce ( active +r$i5t47#g7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy47#h7 ,if a new saf5] is submitt$ 9 ! same package z a new active +r$i5t1 & t new active +r$i5t is det]m9$ to be r$uc$ risk1 !n ! saf5] w\ld get ! same r$uc$ timeframe z ! new active +r$i5t4,i#jjaahf;,approval ( new food use in]t +r$i5t4 7#b77c7ac #bg1jjj ,i#jjbahg;,am5d curr5tly approv$ in]t +r$i5t tol]ance or exemption f tol]ance2 new data4 7#b7aag1ejj;,i#jjcahh;,am5d curr5tly approv$ in]t +r$i5t tol]ance or exemption f tol]ance2 no new data4 7#b7ic1cjh;,i#jjdahi;,approval ( new non-food use in]t +r$i5t4 7#b7 #f #aa1jbe ,i#jjeaij;,am5d curr5tly approv$ non-food use in]t +r$i5t ) new use patt]n2 new data4 7#b7fe1eac;,i#jjfaia;,am5d curr5tly approv$ non-food use in]t +r$i5t ) new use patt]n2 no new data4 7#b7cc1cjh;,i#jjgaib;,approval ( sub/antially simil> non-food use in]t +r$i5ts :5 orig9al in]t is compositionally simil> ) simil> use patt]n4 7#b7da1fed ,i#jjhaic;,approval ( new or am5d$ polym] in]t +r$i5t1 food use4 7#b7ec1gdi;,i#jjiaid;,approval ( new or am5d$ polym] in]t +r$i5t1 non-food use4 7#b7 #dc1jhg;,i#jajaie,petition to am5d a s+le tol]ance exemption descriptor1 or s+le non-food use descriptor1 to add #aj ,c,a,s,r,ns2 no new data4 7#b7fa1fed;,i#jaaaif 7new7,approval ( new food use saf5] ) tol]ance or exemption f tol]ance4 7#b77h7bdeig1fhc;,i#jabaig 7new7,approval ( new non-food use saf5]4 7#b77h7badae1bda;,i#jacaih 7new7,approval ( additional food use = previ\sly approv$ saf5] ) tol]ance or exemption f tol]ance4 7#b7aefb1ige;,i#jadaii 7new7,approval ( additional non-food use = previ\sly approv$ saf5]4 7#b7aebe1afh;,i#jaebjj 7new7,approval ( new g5]ic data = previ\sly approv$ food use saf5]4 7#b7bdbfi1gbh;,i#jafbja 7new7,approval ( am5dm5t7s7 to tol]ance & label = previ\sly approv$ saf5]4 7#b7acee1ggf,,table #ai4 -- ,,ext]nal ,,review ,,& ,,miscellane\s ,,actionsepa ,no4,new ,,cr ,no4,action,decision ,review ,"t 7,mon?s77#a7 ,regi/ration ,s]vice ,fee 777#a7 ,a decision review "t t w\ld o!rwise end on a ,saturday1 ,sunday1 or f$]al holiday1 w be ext5d$ to end on ! next bus9ess day47#b7 ,if ano!r cov]$ application is submitt$ t dep5ds ^u an application to approve an in]t +r$i5t1 ea* application w be subject to its respective regi/ration s]vice fee4 ,! decision review "t l9e = bo? submissions w be ! longe/ ( ! associat$ applications4 ,if ! application cov]s multiple +r$i5ts gr\p$ by ,,epa into "o *emical class1 a s+le regi/ration s]vice fee w be assess$ = approval ( ^? +r$i5ts47#c7 ,if ,,epa data rules are am5d$ to newly require cle>ance "u section #djh ( ! ,,ffdca = an +r$i5t ( an antimicrobial product :]e su* +r$i5t 0 n previ\sly subject to su* a cle>ance1 !n review ( ! data = su* cle>ance ( su* product is n subject to a regi/ration s]vice fee = ! tol]ance action = two ye>s f ! effective date ( ! rule47#d7 ,any o!r cov]$ application t is associat$ ) & dep5d5t on ! ,,hsrb review w be subject to its sep>ate regi/ration s]vice fee4 ,! decision review times = ! associat$ actions run concurr5tly1 b w end at ! date ( ! late/ review "t47#e7 ,any o!r cov]$ application t is associat$ ) & dep5d5t on ! ,,sap review w be subject to its sep>ate regi/ration s]vice fee4 ,! decision review "t = ! associat$ action w be ext5d$ by ! decision review "t = ! ,,sap review47#f7 ,an application = a new end-use product us+ a s\rce ( active +r$i5t t 7a7 is n yet regi/]$ b 7b7 has an application p5d+ ) ! ,ag5cy = review1 w be consid]$ an application = a new product ) an unregi/]$ s\rce ( active +r$i5t47#g7 ,:]e ! action involves approval ( a new or am5d$ label1 on or be=e ! end date ( ! decision review "t1 ! ,ag5cy %all provide to ! applicant a draft accept$ label1 includ+ any *anges made by ! ,ag5cy t diff] f ! applicant-submitt$ label & relevant support+ data review$ by ! ,ag5cy4 ,! applicant w notify ! ,ag5cy t ! applicant ei!r 7a7 agrees to all ( ! t]ms associat$ ) ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s t x be issu$ z ! accept$ f9al ,ag5cy-/amp$ label2 or 7b7 does n agree to "o or m ( ! t]ms ( ! draft accept$ label z am5d$ by ! ,ag5cy & reque/s additional "t to resolve ! diff]5ce7s72 or 7c7 )draws ! application )\t prejudice = subsequ5t resubmission1 b =feits ! associat$ regi/ration s]vice fee4 ,= cases describ$ 9 7b71 ! applicant %all h up to #cj cal5d> days to rea* agreem5t ) ! ,ag5cy on ! f9al t]ms ( ! ,ag5cy-accept$ label4 ,if ! applicant agrees to all ( ! t]ms ( ! accept$ label z 9 7a71 includ+ ^u resolution ( diff]5ces 9 7b71 ! ,ag5cy %all provide an accept$ f9al ,ag5cy-/amp$ label to ! regi/rant )9 #b bus9ess days foll[+ ! regi/rant's writt5 or electronic confirmation ( agreem5t to ! ,ag5cy47#h7 ,due to l[ fee & %ort "t frame ?is category is n eligible = small bus9ess waiv]s4 ,gold seal applies to "o regi/]$ product47#i7 ,?is category includes am5dm5ts ! sole purpose ( :i* is to add ,df,e 7or equival5t t]ms t d n use 8safe0 or d]ivatives ( 8safe07 logos to a label4 ,df,e is a volunt>y program4 ,a label be>+ a ,df,e logo is n consid]$ an ,ag5cy endorsem5t because ! +r$i5ts 9 ! qualify+ product mu/ meet objective1 sci5tific crit]ia e/abli%$ & widely publiciz$ by ,,epa4,m#jjabjb,/udy protocol requir+ ,human ,/udies ,review ,bo>d review z def9$ 9 #dj ,,cfr ,"p #bf 9 support ( an active +r$i5t4 7#d7i #g1ich ,m#jjbbjc;,complet$ /udy requir+ ,human ,/udies ,review ,bo>d review z def9$ 9 #dj ,,cfr ,"p #bf 9 support ( an active +r$i5t4 7#d7ig1ich,m#jjcbjd;,ext]nal te*nical pe] review ( new active +r$i5t1 product1 or am5dm5t 7e4g41 consultation ) ,,fifra ,sci5tific ,advisory ,panel7 = an action ) a decision timeframe ( less ?an #ab mon?s4 ,applicant initiat$ reque/ bas$ on a requirem5t ( ! ,adm9i/rator1 z def9$ by ,,fifra #be7;d71 9 support ( a novel active +r$i5t1 or unique use patt]n or application te*nology4 ,excludes ,,pip active +r$i5ts4 7#e7abfc1ide,m#jjdbje;,ext]nal te*nical pe] review ( new active +r$i5t1 product1 or am5dm5t 7e4g41 consultation ) ,,fifra ,sci5tific ,advisory ,panel7 = an action ) a decision timeframe ( great] ?an #ab mon?s4 ,applicant initiat$ reque/ bas$ on a requirem5t ( ! ,adm9i/rator1 z def9$ by ,,fifra #be7;d71 9 support ( a novel active +r$i5t1 or unique use patt]n or application te*nology4 ,excludes ,,pip active +r$i5ts4 7#e7 #ahfc1ide,m#jjebjf,new ,product3 ,comb9ation1 ,conta9s a comb9ation ( active +r$i5ts f a regi/]$ &_/or unregi/]$ s\rce2 conv5tional1 antimicrobial &_/or biope/icide4 ,requires coord9ation ) o!r regulatory divisions to conduct review ( data1 label &_/or v]ify ! validity ( exi/+ data z cit$4 ,only exi/+ uses = ea* active +r$i5t 9 ! comb9ation product4 7#f77g7ibb1jej,m#jjfbjg,reque/ = up to #e lett]s ( c]tification 7,gold ,seal7 = "o actively regi/]$ product 7excludes di/ributor products74 7#h7abgg,m#jjgbjh,reque/ to ext5d ,exclusive ,use ( data z provid$ by ,,fifra ,section #c7;c77#a77;,f77ii74#abe1eac ,m#jjhbji,reque/ to grant ,exclusive ,use ( data z provid$ by ,,fifra ,section #c7;c77#a77;,f77vi7 = a m9or use1 :5 a ,,fifra ,section #b7ll77#b7 det]m9ation is requir$4#aea1fed,m#jjibaj 7new7,non-,,fifra ,regulat$ ,det]m9ation3 ,applicant initiat$1 p] product4#db1cfc,m#jajbaa 7new7,conditional rul+ on pre-application1 product sub/antial simil>ity4#db1cfc,m#jaabab 7new7,label am5dm5t to add ! ,df,e logo2 requires data review2 no o!r label *anges4 7#i7dc1fdh 4 #g4 ,ext5sion ,not)/&+ any o!r provision ( ?is ,act or am5dm5t made by ?is ,act1 any ref]5ce 9 ?is ,act or an am5dm5t made by ?is ,act to #bjbj %all be deem$ to be a ref]5ce to #bjbc4 #h4 ,agricultural work] protection /&>d2 c]tification ( pe/icide applicators 7a7 ,9 g5]al ,except z provid$ 9 subsection 7b71 dur+ ! p]iod beg9n+ on ! date ( enactm5t ( ?is ,act & end+ n e>li] ?an ,octob] #a1 #bjba1 ! ,adm9i/rator ( ! ,environm5tal ,protection ,ag5cy 7ref]r$ to 9 ?is section z ! ,adm9i/rator7-- 7#a7 %all c>ry out-- 7,a7 ! f9al rule ( ! ,adm9i/rator entitl$ ,pe/icides2 ,agricultural ,work] ,protection ,/&>d ,revisions 7#hj ,f$4 ,reg4 #fgdif 7,novemb] #b1 #bjae772 & 7,b7 ! f9al rule ( ! ,adm9i/rator entitl$ ,pe/icides2 ,c]tification ( ,pe/icide ,applicators 7#hb ,f$4 ,reg4 #ieb 7,janu>y #d1 #bjag772 & 7#b7 %all n revise or develop revisions to ! rules describ$ 9 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a74 7b7 ,exceptions ,prior to ,octob] #a1 #bjba1 ! ,adm9i/rator may propose1 & aft] a notice & public comm5t p]iod ( n less ?an #ij days1 promulgate revisions to ! f9al rule describ$ 9 subsection 7a77#a77;,a7 address+ application exclusion zones "u "p #agj ( title #dj1 ,code ( ,f$]al ,regulations1 consi/5t ) ! ,f$]al ,insecticide1 ,fungicide1 & ,rod5ticide ,act 7#g ,u4,s4,c4 #acf et seq474 7c7 ,,gao report ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all-- 7#a7 conduct a /udy on ! use ( ! designat$ repres5tative1 includ+ ! effect ( t use on ! availability ( pe/icide application & haz>d in=mation & work] heal? & safety2 & 7#b7 n lat] ?an ,octob] #a1 #bjba1 make publically available a report describ+ ! /udy "u p>agraph 7#a71 includ+ any recomm5dations to prev5t ! misuse ( pe/icide application & haz>d in=mation1 if t misuse is id5tifi$4 ,secret>y