,,ii #aai? ,,congress #a/ ,session ,s4 #bjce ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,june #aa1 #bjbe,ms4 ,duckwor? 7= h]self1 ,mrs4 ,murray1 ,mr4 ,book]1 ,mr4 ,s*um]1 ,mr4 ,re$1 ,ms4 ,w>r51 ,mr4 ,padilla1 ,mr4 ,wel*1 ,ms4 ,cantwell1 ,mr4 ,fett]man1 ,mr4 ,hick5loop]1 ,mr4 ,m]kley1 ,mr4 ,s*atz1 ,mr4 ,w>n]1 ,ms4 ,klobu*>1 ,ms4 ,alsobrooks1 ,mr4 ,coons1 ,mr4 ,k+1 ,mr4 ,blum5?al1 ,mr4 ,:iteh\se1 ,mr4 ,s&]s1 ,mr4 ,pet]s1 ,mr4 ,gallego1 ,mr4 ,durb91 ,mr4 ,he9ri*1 ,ms4 ,hirono1 ,mrs4 ,%ahe51 ,ms4 ,ros51 ,mr4 ,murphy1 & ,mrs4 ,gillibr&7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to e/abli% /atutory rights to *oose to receive1 provide1 & cov] f]tility treatm5ts1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,protect ,,ivf ,act4 #b4 ,purposes ,! purposes ( ?is ,act are z foll[s3 7#a7 ,to p]mit pati5ts to seek & receive f]tility treatm5t1 includ+ assi/$ reproductive te*nology s]vices1 & to p]mit heal? c>e provid]s t *oose to provide f]tility treatm5t1 to provide su* s]vices )\t ,/ates enact+ h>mful or unw>rant$ limitations or requirem5ts t s+le out ! provision ( assi/$ reproductive s]vices = re/rictions t are n consi/5t ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e1 & :i* d n significantly advance reproductive heal? or ! efficacy & safety ( f]tility treatm5t1 or make f]tility treatm5t m difficult to access4 7#b7 ,to promote ! "r & ability ( a pati5t resid+ 9 any ,/ate to *oose to receive f]tility treatm5t provid$ 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e by a heal? c>e provid] :o *ooses to provide su* s]vices4 7#c7 ,to protect an individual's "r to make decisions1 9 consultation ) ! individual's heal? c>e provid]1 ab\t ! mo/ appropriate m$ical c>e to maximize ! *ance ( becom+ pregnant & giv+ bir? to a heal?y1 liv+1 human *ild ) ! help ( f]tility treatm5t4 #c4 ,def9itions ,9 ?is ,act3 7#a7 ,f]tility treatm5t ,! t]m f]tility treatm5t includes ! foll[+3 7,a7 ,pres]vation ( human oocytes1 sp]m1 or embryos4 7,b7 ,artificial insem9ation1 includ+ intravag9al insem9ation1 intrac]vical insem9ation1 & intraut]9e insem9ation4 7,c7 ,assi/$ reproductive te*nology1 includ+ 9 vitro f]tilization & o!r treatm5ts or proc$ures 9 :i* reproductive g5etic mat]ial1 su* z oocytes1 sp]m1 & embryos1 are h&l$1 :5 cl9ically appropriate4 7,d7 ,g5etic te/+ ( embryos4 7,e7 ,m$ications prescrib$ or obta9$ ov]-!-c\nt]1 z indicat$ = f]tility4 7,f7 ,gamete donation4 7,g7 ,su* o!r in=mation1 ref]rals1 treatm5ts1 proc$ures1 m$ications1 laboratory te/+1 te*nologies1 & s]vices relat+ to f]tility z ! ,secret>y ( ,heal? & ,human ,s]vices det]m9es appropriate4 7#b7 ,heal? c>e provid] ,! t]m heal? c>e provid] means any entity or individual 7includ+ any physician1 nurse practition]1 physician assi/ant1 ph>maci/1 heal? c>e support p]sonnel1 cl9ical /aff1 & any o!r individual1 z det]m9$ by ! ,secret>y ( ,heal? & ,human ,s]vices7 t-- 7,a7 is engag$ or seeks to engage 9 ! deliv]y ( f]tility treatm5t1 includ+ ?r\gh ! provision ( evid5ce-bas$ in=mation1 c\nsel+1 ref]rals1 or items & s]vices t relate to1 aid 91 or provide f]tility treatm5t2 & 7,b7 if requir$ by ,/ate law to be lic5s$1 c]tifi$1 or o!rwise au?oriz$ to engage 9 ! deliv]y ( su* s]vices-- 7i7 is s lic5s$1 c]tifi$1 or o!rwise au?oriz$2 or 7ii7 w\ld be s lic5s$1 c]tifi$1 or o!rwise au?oriz$ b = ! fact t ! individual or entity has provid$1 is provid+1 or plans to provide f]tility treatm5t 9 accordance ) section #d4 7#c7 ,heal? insurance issu] ,! t]m heal? insurance issu] has ! mean+ giv5 su* t]m 9 section #bgia7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia7;b774 7#d7 ,manufactur] ,! t]m manufactur] means ! manufactur] ( a drug or device approv$1 cle>$1 au?oriz$1 or lic5s$ "u section #eje1 #eaj7k71 #eac7;f77#b71 or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj;c7f77#b71 #cfj;e7 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 or o!rwise legally m>ket$4 7#e7 ,/ate ,! t]m ,/ate includes ea* ( ! #ej ,/ates1 ! ,di/rict ( ,columbia1 ,pu]to ,rico1 ea* t]ritory & possession ( ! ,unit$ ,/ates1 & any political subdivision !re(4 7#f7 ,widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e ,! t]m widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e means any m$ical s]vices1 proc$ures1 & practices t are 9 accordance ) ! guidel9es ( ! ,am]ican ,society = ,reproductive ,m$ic9e4 #d4 ,f]tility treatm5t rights 7a7 ,g5]al rule 7#a7 ,individual rights ,an individual has a /atutory "r "u ?is ,act1 )\t prohibition1 limitation1 int]f]5ce1 or imp$im5t1 to ! ext5t t su* prohibition1 limitation1 int]f]5ce1 or imp$im5t 9 any way or degree ob/ructs1 delays1 or affects comm]ce ov] :i* ! ,f$]al ,gov]nm5t has jurisdiction1 to-- 7,a7 receive f]tility treatm5t f a heal? c>e provid]1 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e2 7,b7 cont9ue or complete an ongo+ f]tility treatm5t previ\sly initiat$ by a heal? c>e provid]1 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e2 7,c7 make decisions & arrangem5ts reg>d+ ! donation1 te/+1 use1 /orage1 or disposition ( _! own reproductive g5etic mat]ial2 & 7,d7 e/abli% contractual agreem5ts ) a heal? c>e provid] relat+ to ! heal? c>e provid]'s s]vices 9 h&l+1 te/+1 /or+1 %ipp+1 & dispos+ ( ! individual's reproductive g5etic mat]ial 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e4 7#b7 ,heal? c>e provid] rights ,a heal? c>e provid] has a /atutory "r "u ?is ,act1 )\t prohibition1 limitation1 int]f]5ce1 or imp$im5t1 to ! ext5t t su* prohibition1 limitation1 int]f]5ce1 or imp$im5t 9 any way or degree ob/ructs1 delays1 or affects comm]ce ov] :i* ! ,f$]al ,gov]nm5t has jurisdiction1 to-- 7,a7 *oose to provide1 or assi/ ) ! provision (1 f]tility treatm5t provid$ 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e2 7,b7 cont9ue or complete ! provision (1 or assi/ance )1 f]tility treatm5t t 0 lawful :5 comm5c$ & is provid$ 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e2 7,c7 provide =1 or assi/ )1 ! te/+1 use1 /orage1 or disposition ( reproductive g5etic mat]ial 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e2 & 7,d7 e/abli% contractual agreem5ts ) individuals or manufactur]s relat+ to ! heal? c>e provid]'s s]vices 9 h&l+1 te/+1 /or+1 %ipp+1 & dispos+ ( ! individual's reproductive g5etic mat]ial4 7#c7 ,heal? insurance issu] rights ,a heal? insurance issu] has a /atutory "r "u ?is ,act1 )\t prohibition1 limitation1 int]f]5ce1 or imp$im5t1 to ! ext5t t su* prohibition1 limitation1 int]f]5ce1 or imp$im5t 9 any way or degree ob/ructs1 delays1 or affects comm]ce ov] :i* ! ,f$]al ,gov]nm5t has jurisdiction1 to *oose to cov] ! provision ( f]tility treatm5t provid$ 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e4 7#d7 ,manufactur] rights ,a manufactur] ( a drug or device t is approv$1 cle>$1 au?oriz$1 or lic5s$ "u section #eje1 #eaj7k71 #eac7;f77#b71 or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee2 #cfj7k72 #cfj;c7f77#b72 #cfj;e7 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 or o!rwise legally m>ket$ & int5d$ = use 9 ! provision ( f]tility treatm5t1 includ+ ! /orage or transport ( reproductive g5etic mat]ial1 has a /atutory "r "u ?is ,act1 )\t prohibition1 limitation1 int]f]5ce1 or imp$im5t1 to ! ext5t t su* prohibition1 limitation1 int]f]5ce1 or imp$im5t 9 any way or degree ob/ructs1 delays1 or affects comm]ce ov] :i* ! ,f$]al ,gov]nm5t has jurisdiction1 to manufacture1 import1 m>ket1 sell1 & di/ribute su* drug or device4 7b7 ,/ate regulation ( m$ic9e ,! en=cem5t ( ,/ate heal? & safety law reg>d+ m$ical facilities or heal? c>e provid]s does n con/itute a violation ( subsection 7a7 if-- 7#a7 su* regulations are 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e = provid+ f]tility treatm5t2 & 7#b7 ! safety or heal? objective _c be advanc$ by a diff]5t means t does n prohibit1 limit1 int]f]e )1 or imp$e ! rights describ$ 9 subsection 7a74 7c7 ,en=cem5t 7#a7 ,! ,attorney ,g5]al 7,a7 ,9 g5]al ,! ,attorney ,g5]al may comm5ce a civil action on behalf ( ! ,unit$ ,/ates aga9/ any ,/ate2 an individual1 employee1 (ficial1 ag5cy head1 contractor1 organization1 or in/rum5tality act+ =1 or on behalf (1 su* a ,/ate2 or any individual act+ "u ! color (1 or pursuant to1 ,/ate law1 t implem5ts1 en=ces1 or ?reat5s to en=ce a limitation or requirem5t t prohibits1 limits1 int]f]es )1 or imp$es ! /atutory rights ( an individual1 a heal? c>e provid]1 a heal? insurance issu]1 or a manufactur] "u subsection 7a74 7,b7 ,effect ( violations ,! c\rt %all hold unlawful & set aside a limitation or requirem5t describ$ 9 subp>agraph 7,a7 if x is 9 violation ( subsection 7a74 7#b7 ,private "r ( action 7,a7 ,9 g5]al ,any individual or entity adv]sely affect$ by an alleg$ violation ( subsection 7a7 may comm5ce a civil action aga9/ an individual1 employee1 (ficial1 ag5cy head1 contractor1 organization1 or in/rum5tality act+ =1 or on behalf (1 su* a ,/ate t enacts1 implem5ts1 or en=ces a limitation or requirem5t t prohibits1 limits1 int]f]es )1 or imp$es ! /atutory rights ( an individual1 a heal? c>e provid]1 a heal? insurance issu]1 or a manufactur] "u subsection 7a74 7,b7 ,effect ( violations ,! c\rt %all hold unlawful & enjo9 a limitation or requirem5t describ$ 9 subp>agraph 7,a7 if x is 9 violation ( subsection 7a74 7#c7 ,heal? c>e provid] 7,a7 ,9 g5]al ,a heal? c>e provid] may comm5ce a civil action = relief on su* provid]'s own behalf1 on behalf ( ! provid]'s /aff1 or on behalf ( ! provid]'s pati5ts :o are or may be adv]sely affect$ by an alleg$ violation ( subsection 7a74 7,b7 ,effect ( violations ,! c\rt %all hold unlawful & enjo9 a limitation or requirem5t describ$ 9 subp>agraph 7,a7 if x is 9 violation ( subsection 7a74 7#d7 ,equitable relief ,9 any action "u ?is section1 ! c\rt may aw>d appropriate equitable relief1 includ+ tempor>y1 prelim9>y1 or p]man5t injunctive relief4 7#e7 ,co/s 7,a7 ,9 g5]al ,9 any action "u ?is section1 ! c\rt %all aw>d co/s ( litigation1 z well z reasonable attorney's fees1 to any prevail+ pla9tiff4 7,b7 ,liability ( pla9tiffs ,a pla9tiff %all n be liable to a def5dant = co/s or attorney's fees 9 any non-frivol\s action "u ?is section unless su* co/s or attorney's fees are impos$ by ! c\rt z "p ( sanctions = violations committ$ dur+ ! discov]y process4 7#f7 ,jurisdiction ,! di/rict c\rts ( ! ,unit$ ,/ates %all h jurisdiction ov] proce$+s "u ?is section & %all ex]cise ! same )\t reg>d to :e!r ! p>ty aggriev$ %all h exhau/$ any adm9i/rative or o!r rem$ies t may be provid$ = by law4 7#g7 ,"r to remove 7,a7 ,9 g5]al ,any p>ty %all h a "r to remove an action br\ght "u ?is subsection to ! di/rict c\rt ( ! ,unit$ ,/ates = ! di/rict & division embrac+ ! place :]e su* action is p5d+4 7,b7 ,review ,an ord] rem&+ ! case to ! ,/ate c\rt f :i* x 0 remov$ "u ?is p>agraph is imm$iately reviewable by appeal or o!rwise4 7d7 ,rules ( con/ruction 7#a7 ,9 g5]al ,= purposes ( ?is ,act1 a ,/ate law1 or ! adm9i/ration1 implem5tation1 or en=cem5t ( a ,/ate law1 con/itutes a prohibition1 limitation1 int]f]5ce1 or imp$im5t on a heal? c>e provid] *oos+ to provide1 an individual *oos+ to receive1 a heal? insurance issu] *oos+ to cov]1 or a manufactur] *oos+ to m>ket drugs or devices = f]tility treatm5t1 provid$ 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e1 z describ$ 9 section #d1 if ! adm9i/ration1 implem5tation1 int]pretation1 or en=cem5t ( su* law has an effect t-- 7,a7 imposes requirem5ts or limitations t are inconsi/5t ) provid+1 receiv+1 provid+ heal? insurance cov]age =1 or provid+ drugs or devices = f]tility treatm5t 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e or t o!rwise violate ! purpose & requirem5ts ( ?is ,act1 :i* may include-- 7i7 requir+ t a heal? c>e provid] provide1 & pati5ts und]take1 m$ically unnecess>y proc$ures & s]vices1 includ+ te/s & proc$ures1 provid+ m$ically inaccurate in=mation reg>d+ f]tility treatm5t1 or requir+ additional unnecess>y 9-p]son visits to a heal? c>e provid]1 t are inconsi/5t ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e2 7ii7 impos+ limitations or requirem5ts conc]n+ physical (fices1 cl9ics1 facilities1 equipm5t1 /aff+1 or hospital transf] arrangem5ts ( facilities :]e f]tility treatm5t is provid$1 or ! cr$5tials or hospital privileges or /atus ( p]sonnel at su* facilities1 t are n consi/5t ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e2 or 7iii7 limit+ a heal? c>e provid]'s "r or ability to *oose to provide1 or a pati5t's "r to *oose to receive1 or impos+ limitations t r$uce ! efficacy (1 f]tility treatm5t 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e1 includ+ retrieval ( multiple eggs dur+ oocyte retrieval2 p]=mance ( insem9ation proc$ures1 includ+ intraut]9e insem9ation2 intracytoplasmic sp]m injections to f]tilize multiple human eggs2 & cryopres]vation ( "o or m eggs or embryos = f]tility pres]vation1 if det]m9$ appropriate by ! heal? c>e provid] & pati5t2 7,b7 infr+es1 limits1 or re/ricts ! ability ( a heal? c>e provid]1 pati5t1 heal? insurance issu]1 or manufactur]1 to ex]cise or en=ce _! /atutory rights "u ?is ,act on ! basis ( m>ital /atus1 sex 7includ+ sexual ori5tation & g5d] id5tity7 or any o!r protect$ class t is cov]$ by ,f$]al law2 7,c7 limits a heal? c>e provid]'s or pati5t's "r or ability to det]m9e ! mo/ appropriate disposition ( reproductive g5etic mat]ials1 includ+ by def9+ reproductive g5etic mat]ials 9 su* a way z to prev5t or re/rict options = ! heal? c>e provid] or pati5t2 7,d7 limits a heal? c>e provid]'s ability to provide1 or a pati5t's ability to receive1 f]tility treatm5t via telem$ic9e1 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e2 7,e7 limits or prohibits a heal? c>e provid]'s ability to provide1 or a pati5t's ability to receive1 f]tility c\nsel+ or f]tility treatm5t bas$ on ! resid5cy ( ! pati5t1 or prohibits or limits ! ability ( any individual to assi/ or support a pati5t seek+ f]tility treatm5t2 7,f7 imposes requirem5ts or limitations t compel heal? c>e provid]s to provide1 or pati5ts to receive1 m$ically unnecess>y c>e1 or )hold m$ically necess>y c>e1 9 a mann] t is n consi/5t ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e = f]tility treatm5t1 includ+ m&at+ ! transf] ( embryos t a heal? c>e provid] w\ld n reasonably expect1 bas$ on widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e1 to lead to a heal?y pregnancy or a live bir?2 7,g7 limits a heal? c>e provid]'s "r or ability to prescribe or disp5se1 or a pati5t's "r or ability to receive or use1 m$ications = f]tility treatm5t 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e1 unless su* a limitation is g5]ally applicable to ! prescription1 disp5s+1 or di/ribution ( m$ications2 or 7,h7 limits a heal? c>e provid]'s "r or ability to p]=m a human sp]m retrieval proc$ure 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e4 7#b7 ,cl>ification ,! descriptions ( specific ,/ate laws t w\ld violate ! /atutory rights & protections describ$ 9 p>agraph 7#a7 %all n be con/ru$ to limit pot5tial violations ( ! /atutory rights & protections "u ?is ,act to only ! re/rictions & limitations li/$ 9 p>agraph 7#a71 & pot5tial violations ( ?is ,act may result f novel ,/ate re/rictions & limitations t are n li/$ "u p>agraph 7#a74 7#c7 ,exclusion ,x %all n con/itute a prohibition1 limitation1 int]f]5ce1 or imp$im5t to a heal? c>e provid] provid+1 an individual receiv+1 a heal? insurance issu] cov]+1 or a manufactur] m>ket+ a drug or device = purposes (1 f]tility treatm5t "u ?is ,act = an entity to act 9 compliance ) ! ,food & ,drug ,adm9i/ration's regulation ( drugs1 devices1 biological products1 human cells1 tissues1 or cellul> or tissue-bas$ products us$ 9 f]tility treatm5t1 consi/5t ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e = f]tility treatm5t4 #e4 ,applicability & preemption 7a7 ,9 g5]al 7#a7 ,g5]al application 7,a7 ,effect on ,/ate law ,?is ,act sup]s$es any ,/ate law t is inconsi/5t ) ! /atutory rights e/abli%$ "u ?is ,act & precludes ! implem5tation ( su* a law1 :e!r /atutory1 common law1 or o!rwise1 & :e!r adopt$ be=e or aft] ! date ( enactm5t ( ?is ,act4 7,b7 ,prohibition ,no ,/ate %all adm9i/]1 implem5t1 or en=ce any law1 rule1 regulation1 /&>d1 or o!r provision hav+ ! =ce & effect ( law t conflicts ) any provision ( ?is ,act1 not)/&+ any o!r provision ( ,f$]al law4 7#b7 ,exclusion ,preemption ( ,/ate law "u p>agraph 7#a7 does n apply to-- 7,a7 ,/ate law reg>d+ ! resolution ( disputes betwe5 #b individuals ) rights describ$ 9 section #d7;a77#a7 ) respect to ! same reproductive g5etic mat]ial2 or 7,b7 any o!r ,/ate law1 to ! ext5t t su* law does n conflict ) ?is ,act & protects an individual's "r & ability to receive f]tility treatm5t 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e1 includ+ any su* law t holds a heal? c>e provid] acc\ntable = n provid+ f]tility treatm5t 9 accordance ) widely accept$ & evid5ce-bas$ m$ical /&>ds ( c>e4 7#c7 ,pres]vation ( ,f$]al public heal? au?orities ,no?+ 9 ?is ,act %all h ! effect ( sup]s$+1 negat+1 or limit+ provisions ( ,f$]al law1 includ+ ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 or ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq471 & regulations promulgat$ "u su* /atutes1 ) respect to ! regulation ( drugs1 devices1 biological products1 human cells1 tissues1 or cellul> or tissue-bas$ products us$ 9 f]tility treatm5t4 7#d7 ,pres]vation ( ,,hipaa rules ,no?+ 9 ?is ,act %all h ! effect ( sup]s$+1 negat+1 or limit+ ! provisions ( ! privacy1 security1 & brea* notification regulations 9 p>ts #afj & #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7#e7 ,subsequ5tly enact$ ,f$]al legislation ,f$]al /atutory law adopt$ aft] ! date ( ! enactm5t ( ?is ,act is subject to ?is ,act unless su* law explicitly excludes su* application by ref]5ce to ?is ,act4 7b7 ,def5se ,9 any cause ( action aga9/ an individual or entity :o is subject to a limitation or requirem5t t violates ?is ,act1 9 addition to ! rem$ies specifi$ 9 section #d7;c71 ?is ,act %all also apply to1 & may be rais$ z a def5se by1 su* an individual or entity4