Swimming Upstream- The Need to Resolve Inconsistency in the FDAs

Journal of Law and Policy Volume 27 | Issue Article Fall 10-1-2018 Swimming Upstream: The Need to Resolve Inconsistency in the FDA's Fishy Regulatory Scheme Kelsie Kelly Follow this and additional works at: https://brooklynworks.brooklaw.edu/jlp Part of the Agriculture Law Commons, Food and Drug Law Commons, and the Science and Technology Law Commons Recommended Citation Kelsie Kelly, Swimming Upstream: The Need to Resolve Inconsistency in the FDA's Fishy Regulatory Scheme, 27 J L & Pol'y 185 (2018) Available at: https://brooklynworks.brooklaw.edu/jlp/vol27/iss1/5 This Note is brought to you for free and open access by the Law Journals at BrooklynWorks It has been accepted for inclusion in Journal of Law and Policy by an authorized editor of BrooklynWorks S IN I IN PS NSIS N IN N S IS S S L L Kelsie Kelly* The citizens of the United States rely on the federal government to maintain the safety of their food through effective regulation As the technology used to develop food has advanced, the outermost limits of the current regulatory framework are being tested The result has been a circuitous and ineffective attempt to regulate transgenic organisms, intended for human consumption, using multiple agencies and a patchwork of laws The ability to incorporate DNA from nearly any organism into the genome of another provides immense potential for innovative new food products, but may also allow for unintended health and environmental consequences Proper regulation of genetically engineered organisms is necessary in order to safely and effectively utilize biotechnology to benefit the American people IN RO U ION On No e er , 201 , a ro ed e fir e ood and ru d ini ion ran enic ani al for u an J andida e, Brooklyn Law c ool, 201 M ulane Uni er i y, 201 B ulane Uni er i y, 201 ank you o y o for er unwai erin u or in all a I ank you o y dad for in irin y lo e of na ure and learnin ank you o y fianc lec ried an, ro er Nic ola elly, and i er uincy and Peri elly for eir endle encoura e en and ren inally, ank you o e e er of e Journal of Law and Policy for eir in alua le edi and in i ful co en U ood and ru d in , FDA Mission, U EP O E L N UM N ERV , www fda o a ou fda w a wedo defaul la i i ed No e er , 2018 18 18 JOURNAL OF LAW AND POLICY u ion rou ene ic en ineerin , u d an a e wa a le o roduce an lan ic al on a row a wice e eed of i non ran enic eer e u d an a e al on can e roduced ore uickly and c ea ly, and erefore ro ide a ore u aina le e od of roduc ion an e al erna i e a uacul ure ec ni ue curren ly a aila le Becau e e re ula ion of ene ically odified or ani are a ed on a re ula ory fra ework de elo ed in e 80 , e a ency olicie a e NI OLE E R E ENNE IBILLE, GENETICALLY MODIFIED ANIMALS, EN Y LOPE I O NEUROP Y OP RM OLO Y Ian oler an ed , 201 eryl Lawrence, What Would You Do with a Fluorescent Green Pig: How Novel Transgenic Products Reveal Flaws in the Foundational Assumptions for the Regulation of Biotechnology, E OLO Y L 201, 211 200 ran enic refer o or ani , and eir re ul in roduc , w ic a e een en ineered o ain e ene ic a erial fro ore an one arie y of life for eidi Ledford, Salmon is First Transgenic Animal to Win U.S Approval for Food, N URE No , 201 , www na ure co new al on i fir ran enic ani al o win u a ro al for food 188 See N L RE E R OUN IL, E YO ENE I LLY EN INEERE OO PPRO E O E IN UNIN EN E E L E E , 200 ene ic en ineerin , e ar e ed ani ula ion of ene ic a erial, and non ar e ed, non ran enic e od includin c e ical u a ene i and reedin are co onen of e en ire ran e of ene ic odifica ion e od u ed o al er e ene ic co o i ion of lan , ani al , and icroor ani J Pandian, Guidelines for Research and Utilization of Genetically Modified Fish, 81 URREN IEN E 11 2, 11 2001 ene ic en ineerin i defined a e ec ni ue y w ic eri a le a erial, w ic doe no u ually and or na urally occur in e or ani or e cell concerned, u i enera ed ou ide e or ani or cell, i in er ed in o e aid cell or or ani and re ul in i ene ic odifica ion owe er, a roader er ion of MO include ro enie of y ridi a ion, loidy induc ion, and ran ene i Ledford, supra no e e fi row o full i e in 18 on er an year Brady enni , The FDA Just Approved the Nation’s First Genetically Engineered Animal: A Salmon that Grows Twice as Fast, PO No , 201 , www wa in on o co new o your eal w 201 11 e fda u a ro ed e na ion fir ene ically en ineered ani al a al on a row wice a fa u er d e 12 ndrew Pollack, Genetically Engineered Salmon Approved for Consumption, N Y IME , No , 201 , a di cu in e u e of u d an a e al on a a u aina le al erna i e o e curren rac ice of u in wild cau al on a a food ource SWIMMING UPSTREAM 18 failed o kee ace wi e id ad ance en of cience wi re ec o food and a ricul ure ua d an a e de elo en of e ran enic al on, forced e o a ly i curren re ula ory y e for ran enic or ani , w ic , ad re iou ly only een u ed for iolo ic and ar aceu ical de elo en , o a no el roduc in ended for u an u ion i re ul ed in e cla ifica ion of e u d an a e al on a a new ani al dru a new ani al dru , e a lica ion for a ro al y e u d an a e al on wa re iewed y e Ve erinary en er of Medicine wi in e ood and ru d ini ion 10 Re ula in ran enic or ani a new ani al dru 11 w en al on are nei er a dru , nor in ended for u e in ani al i i leadin , and Lawrence, supra no e 2, a 201 02 see also Mic ael P McE illy, No e, Lack of Transparency in the Premarket Approval Process for AquAdvantage Salmon, 11 U E L E REV , 201 Lawrence, supra no e 2, a 220 By fi in e roduc of ioen ineerin in o e e i in re ula ory ca e orie , e a lie e eneral conce of roduc a ro al, adul era ion, and i randin o re ula e afe y and effec i ene acro e ec ru of M food and dru roduc owe er, M roduc are eco in ore inno a i e a ene ic en ineer co ine ene fro co le ely unrela ed or ani o crea e no el life for uc co ina ion crea e or ani a e re c e ical no na i e o en ional or ani M roduc eco e ore inno a i e, ca e ori in e re ul in or ani and eir deri a i e roduc c allen e e i in food and dru defini ion see generally U OO RU MIN , UI N E OR IN U RY RE UL ION O ENE I LLY EN INEERE NIM L ON ININ ERI BLE RE OMBIN N N ON RU 2011 ereinaf er U OO RU MIN , UI N E OR IN U RY McE illy, supra no e , a 20 U OO RU MIN , UI N E OR IN U RY, supra no e 8, a 10 U OO RU MIN , MO ERNI IN E RE UL ORY Y EM OR BIO E NOLO Y PRO U IN L VER ION O E 201 UP E O E OOR IN E R ME OR OR E RE UL ION O BIO E NOLO Y 201 ereinaf er U OO RU MIN , MO ERNI IN E RE UL ORY Y EM 11 ederal ood, ru , and o e ic c , 21 U 201 2018 e er dru ean a r icle o er an food in ended o affec e ruc ure or any func ion of e ody of an or o er ani al U OO RU MIN , UI N E OR IN U RY, supra no e 8, a U OO RU MIN , MO ERNI IN E RE UL ORY Y EM, supra no e 10, a 18 188 JOURNAL OF LAW AND POLICY fur er work o encoura e u lic di ru of e cien ific 12 co uni y and ene ically en ineered or ani e a ro al of e u d an a e al on re re en e unc ion e ween cien ific inno a ion and our co uni y dinner a le If ocie y i o afely and effec i ely rea e enefi of recen io ec nolo ical ad ance en , we u e in wi e i en a lica ion of a ore accura e and co re en i e re ula ory fra ework i No e e a ine e curren federal c e e under w ic ene ically en ineered ani al are re ula ed and de er ine i effec i ene in oni orin io ec nolo ical ad ance en in ended for u an u ion Par I of i No e will e for a rief i ory of ran enic or ani and eir re en role in e Uni ed a e a ricul ural rac ice I will al o ro ide an e lana ion of e cien ific rinci le u ili ed in e crea ion of ran enic or ani Par II will analy e e curren U federal re ula ory fra ework u ed for e re ula ion of ran enic or ani in li of e idly de elo in cien ific field, and 12 See nne Miller, Time for the Government to Get Mooo-ving: Facing up to the RBST Labeling Problem, 18 MLINE L REV , 11 12 di cu in e o en ial for a e en uc a RB free o i lead u er in o elie in a ere i a co o i ional difference e ween ilk fro rea ed and un rea ed cow or a ilk fro un rea ed cow i afer or of i er uali y an ilk fro rea ed cow Lawrence, supra no e 2, a 211 e er io ec nolo y i u ed o refer o e field of ene ic ani ula ion, a i i co only u ed in u lic di cour e, al ou di cre e ene ic odifica ion i in fac u one e en of e rea er field of io ec nolo y See re ory N Mandel, Gaps, Inexperience, Inconsistencies, and Overlaps: Crisis in the Regulation of Genetically Modified Plants and Animals, M M RY L REV 21 , 21 200 Effec i e and efficien re ula ion i e edia or a will de er ine w e er ocie y rea e ec acular ad an a e of io ec nolo y or uccu oi o en ial dan er i ou ro er re ula ion, ocie y will face unnece ary ri k , e enefi of io ec nolo y will e lowed e erely and ade ore e en i e, and e u lic will lack confidence in io ec nolo y roduc see also Re ecca Bra ie , No e, Glowing in the Dark: How America’s First Transgenic Animal Escaped Regulation, MINN J L I E , 200 e in re ula ory olicy ri i cri ical Only a ro ria e and i en re ula ory ruc ure will en ure a i new ec nolo y i e lored in a fa ion a ro ec u an eal and e en iron en , w ile ill encoura in inno a ion SWIMMING UPSTREAM 18 ow e e re ula ion a e een a lied o ene ically en ineered ani al Par III will di cu e re ula ory aradi u ed y anada for cla ifyin and e alua in ene ically odified or ani for u an u ion inally, Par IV will ou line a ore accura e and co re en i e e of re ula ory uideline for u e in e Uni ed a e I ENE I EN INEERIN A History of Genetic Engineering in Agriculture ene ic en ineerin of ani al and lan i a dee ly en renc ed a ricul ural rac ice wi in ocie y radi ional e od of ene ic odifica ion allowed for e odifica ion of cro o e er ui u an need O er i e, far er a e odified li e ock o fi eir need rou e od uc a elec i e reedin and y ridi a ion 18 cience a ad anced, ea R In , No e, Got Bacon?: The Use of A Bioethics Advisory Board in Assessing the Future of Transgenic Animal Technology, N J E IN ELL PROP , 201 u an a e een odifyin cro and elec i ely reedin ani al ince e e innin of u ani y Lawrence, supra no e 2, a 20 ar er , ranc er , and e en e crea ure e el e a e u ed elec i e reedin and cullin o influence e ene of fu ure enera ion for cen urie See N L RE E R OUN IL, E YO ENE I LLY EN INEERE OO PPRO E O E IN UNIN EN E E L E E 200 e olde a roac o lan ene ic odifica ion i i le elec ion, w ere lan e i i in de ired c arac eri ic are elec ed for inued ro a a ion Modern ec nolo y a i ro ed u on i le elec ion wi e u e of olecular analy i o de ec lan likely o e re de ired fea ure Plan a are elec ed for de ired rai , uc a reduced le el of c e ical a roduce un ala a le a e, ay di ini e a ili y of lan o ur i e in e wild ecau e ey are al o ore a rac i e o e elec ion for o er rai , uc a c e ical a increa e e re i ance of lan o di ea e, ay al o e ar ful o u an no er a roac , cro in , can occur wi in a ecie or e ween differen ecie Mike da , The Anti-GMO Way: Modern Corn Was Created Through Thousands of Generations of Selective Breeding by Indigenous Mesoamericans, N UR L NE e 0, 2012 , www na uralnew co 81 e corn elec i e reedin l elec i e reedin occur w en u an facili a e e re roduc ion of only JOURNAL OF LAW AND POLICY o oo a our a ili y o crea e or ani ui ed o e ecific need of indi idual co uni ie cien i re ain o i i ic a e e ad ance en in ene ic en ineerin will ran la e o e de elo en of new and i ro ed rain of li e ock 20 rou e in roduc ion of forei n deo yri onucleic acid 21 N in o rei lan a ion e ryo , e ene ic of differen or ani can e in roduced in o a lan or ani al, re ul in in e e re ion of uni ue c arac eri ic 22 ere are a arie y of ec ni ue u ed in e roduc ion of ene ically odified or ani , and e c arac eri ic of e re ul in ene ically odified or ani can a ear ur ri in ly differen fro o e of eir non odified coun er ar owe er, e e c an e no o e lan or ani al arie ie a ain e rai o eneficial for e el e 18 Ray ould J ray, Genetically Modified Crops and Hybridization with Wild Relatives: A UK Perspective, J O PPLIE E OLO Y , 1 or cen urie e only ec ni ue for in roducin ene ic aria ion in o cro wa e ual y ridi a ion wo aren al y e , eac a in rai of in ere , would e cro ed, and e ro eny e a ined and elec ed for u e or fur er round of y ridi a ion Of en i roce wa carried ou unwi in ly in early a ricul ure, u re en day reedin can en ail i ly co le cro in de i n l ou i a roac a een enor ou ly ucce ful in i ro in cro uali y and roduc i i y See id a 200 di cu in new ec ni ue u ili ed y lan reeder in order o circu en e rain of radi ional reedin e od , w ic allow for an increa ed ran e of ene ic aria ion due o a ir ually ene ool li i le 20 MB eeler e al , Transgenic Animals in Biomedicine and Agriculture: Outlook for the Future, NIM L REPRO U ION IEN E , 200 21 DNA, N URE, www na ure co u ec dna la i i ed ec , 201 N deo yri onucleic acid i e nucleic acid oly er a for e ene ic code for a cell or iru Mo N olecule i of wo oly er dou le randed of four nucleo ide a eac i of a nucleo a e, e car o ydra e deo yri o e and a o a e rou , w ere e car o ydra e and o a e ake u e ack one of e oly er 22 Ray ould J ray, supra no e 18, a 200 M B eeler e al , supra no e 20, a 2 MB eeler e al , supra no e 20, a ere are e eral e odolo ie a can e u ed for e roduc ion of ran enic ani al , includin N ran fer y re ro iru e , icroin ec ion of ene in o ronuclei of fer ili ed o a in ec ion of e ryonic e E cell and or SWIMMING UPSTREAM 1 ray oo far fro o e ac ie ed rou e e iculou cro reedin of or ani o er any enera ion Of en i e , e oal of ene ic en ineerin i ly irror o e of radi ional far in rac ice y i ro in and ol in ro le a ocia ed wi a cro e conce of ene ically en ineered food i no in new On May 18, , e la r a r o a o eca e e fir ene ically odified food o e a ro ed y e e la r a r o a o wa de i ned o ain ain fir fle a i ri ened on e ine 28 e increa ed fir ne wa in ended o re en rui in a e o a oe were i ed o arke and o a oli e need for ar ificial ri enin rea en ince e fir ran ed field e in er i for ene ically en ineered lan in , a ul i ude of odified a ricul ural arie ie a e rolifera ed e e ic food arke e ryonic er E cell , re iou ly e o ed o forei n N , in o e ca i y of la ocy er edia ed e o enou N ran fer durin in i ro fer ili a ion li o o e edia ed N ran fer in o cell and e ryo elec ro ora ion of N in o er , o a or e ryo ioli ic , and nuclear ran fer N wi o a ic cell , E or E cell a e en of Policy ood eri ed ro New Plan Varie ie , 10 ed Re 1, May , o e codified R oc 12 Reco inan N ec ni ue are u ed o ac ie e e a e y e of oal a radi ional ec ni ue e de elo en of new lan arie ie wi en anced a rono ic and uali y c arac eri ic See Bra ie , supra no e , a See A History of Genetic Engineering, IEN E ROUP r , 200 , e lon i ory www cience rou or uk if ene i ory di cu in of ene ic en ineerin Ro Pifer, Mandatory Labeling Laws: What Do Recent State Enactments Portend for the Future of GMOs?, 118 PENN L REV , 201 see e of eal and u an er , Statement of Policy - Foods Derived From New Plant Varieties, U OO RU MIN May , , www fda o ood uidanceRe ula ion uidance ocu en Re ula oryInfor a ion Bio ec nolo y uc 0 28 Bruenin J M Lyon , The Case of the FLAVR SAVR Tomato, LI ORNI RI UL URE 2000 Pifer, supra no e , a Pifer, supra no e , a a id J Ear , o en , The Regulation of Genetically Engineered Plants: Is Peter Rabbit Safe in Mr McGregor’s Transgenic Vegetable Patch?, ENV L L ,1 1 JOURNAL OF LAW AND POLICY In 2011, i wa e i a ed a 88 of corn lan ed in e Uni ed a e wa rown fro ene ically odified eed arie ie oday, ore an ercen of e corn, oy ean , and co on rown in e U a e forei n ene in er ed in o e N o ake e cro re i an o er icide , in ec , or o i e ro al of e u d an a e al on, e a e e a e for i ilar inno a ion wi re ec o far ed li e ock B The Creation of the AquAdvantage Salmon uaBoun y ec nolo ie , a Ma ac u e a ed co any, ained a ro al o co erciali e ene ically en ineered al on e ua d an a e al on af er co le in a nearly wen y year re iew roce e u d an a e al on i crea ed rou e in er ion of a reco inan N co le ainin a ro o er e uence fro e ocean ou Zoarces americanus) and a row or one ene fro e inook al on Oncorhynchus tshawytscha in o an lan ic al on Salmo salar) lan ic al on no ordinarily roduce row McE illy, supra no e , a Lynn L Ber e on arla N u on, Biotechnology: White House Announces Effort to Modernize the Regulatory System for Biotechnology Products, PE I I E L N POLI Y BLO July , 201 , e icide lo law c co en ry io ec nolo y w i e ou e announce effor o oderni e e re ula ory y Madelyn earn , AquaBounty Sells First Batch of Genetically Engineered Salmon, E OO OUR E u , 201 , www eafood ource co new u ly rade a ua oun y ell fir a c of ene ically en ineered al on e oe e a, Skepticism About Biotechnology Isn’t Anti-Science, L E r , 201 , www la e co ar icle ec nolo y fu ure en e 201 e a uad an a e al on de a e and ke ici a ou io ec nolo y l Yolanda i , What is Recombinant DNA?, NE ME I L LI E I May , 201 , www new edical ne life cience a i Reco inan N a Reco inan N , or r N , i e er u ed o a are ruc ed ar ificially de cri e e co ina ion of wo N rand ene ic cien i can i o crea e uni ue N rand for differen ur o e , u in e eral y e of ec ni ue Lar Noa , ollo uiu , Whatever Happened to the “Frankenfish”?: The FDA’s Foot-dragging on Transgenic Salmon, ME L REV , 08 SWIMMING UPSTREAM or one durin e win er, and erefore only row durin e war er on e added ene fro e inook al on and ocean ou work in concer o allow e lan ic al on o row year round, ere y allowin i o ac ie e i a i u i e wice a uickly a i non ran enic eer In addi ion o e id row of i al on, u d an a e oa e efficiency and u aina ili y of i a uacul ure e od a in a o ur u d an a e al on row o arke i e u in ercen le feed an radi ional lan ic al on on e arke oday u d an a e fur er indica e a roduc ion of e u d an a e al on ay re ul in a car on foo rin a i o i e le an for radi ional far ed al on ur er ore, y rai in e u d an a e al on in ank er an far in e in ocean a ed a uacul ure facili ie , ey no encoun er e ara i e or di ea e w ic re ularly afflic far ed al on ue o e ene ically odified al on co e i i e ad an a e, e a e een aken o i i a e e 201 E ily al , First Genetically Engineered Salmon Sold in Canada: U.S Firm AquaBounty Technologies Says That Its Transgenic Fish Has Hit the Market After a 25-Year Wait, N URE NE u , 201 , www na ure co new fir ene ically en ineered al on old in canada 2211 ro idin e cien ific na e of eac fi ecie u ili ed in e crea ion of e u d an a e al on ifea a a , GM Salmon Hits Shelves in Canada - But People May Not Know They’re Buying It, E U R I N u , 201 , www e uardian co world 201 au ene ically odified al on ale canada a ua oun y Noa , supra no e , a 08 see also Mic ael o er, No e, Frankenfish It’s What’s for Dinner: The FDA, Genetically Engineered Salmon, and the Flawed Regulation of Biotechnology, OLUM J L O PROB , 108 2011 o er, supra no e , a 108 Low Impact Fish Farming, U BOUN Y, a ua oun y co u aina le la i i ed ec 2, 201 Id al , supra no e See Pa rick i le, Literally Lousy: Parasite Plagues Workld Farmed-Salmon Industry, E LE IME e , 201 www ea le i e co life food drink any lice wi a al on ara i e la ue lo al indu ry 20 JOURNAL OF LAW AND POLICY a ou e co i ee credi ili y wi e u lic 10 e irec or ro o ed a ore a i fac ory co i ee co o i ion a in we elie e a ree fi ecolo i , four food afe y e er includin eciali in food aller ie and in e effec of or one on u an eal , and cien i fro e u er and en iron en al co uni y u e added o e o i ee, o ro ide a ro ria e alance and e er i e 108 e concern o er e auci y of e er i e i fur er co ounded y e lack of ran arency in ol ed in e new ani al dru a lica ion 10 roce e new ani al dru a lica ion roce i ro ec ed y federal re ula ion , w ic re en e fro di clo in infor a ion a ou a new ani al dru efore a de er ina ion i e a li ed 110 ou infor a ion re ardin e u d an a e al on wa ade a aila le due o e relea e of e infor a ion y uaBoun y, e concern urroundin e ade uacy and lack 111 of ran arency, were lar ely di re arded y e e i e e re ula or in i ence a e curren y e ade ua ely ro ec u an and en iron en al eal wi re ard o new io ec nolo ie ,112 concern a o e effec i ene of e oordina ed ework a e een e a li ed ince e ince ion Nine of e e er are e erinarian or old doc ora e in ani al cience wo ore a e een in ol ed in de elo in ene ically en ineered ani al e el e , includin one w o a worked for Mon an o e u er re re en a i e, ou knowled ea le, i a lawyer er an a cien i e ue ion ow e o i ee can accura ely a e e afe y of i al on for u an and e en iron en w en i lack e e en ial e er i e o o e elie e a wi ou e e en ion of e re iew eriod, and e addi ion of cer ain cien ific e er o e VM , e o i ee findin will no a e e needed credi ili y wi e u lic e al o elie e a wi ou e e e er , will fail o e e ound cien ific ad ice i need and de er e 10 Id 108 Id 10 McE illy, supra no e , a 22 110 21 U 200 21 R 11 d 2012 111 See o er, supra no e , a 12 112 U OO RU MIN , MO ERNI IN E RE UL ORY Y EM, supra no e 10, a 1, , SWIMMING UPSTREAM 20 of reco inan io ec nolo y 11 ou ue ion re ail a o e func ionali y of e oordina ed ework a roac and e a ro ria ene for re ula ion y e en er for Ve erinary Medicine, e rue i ue urroundin e re ula ion of ene ically en ineered ani al lie in e incon i en a lica ion of i curren re ula ory c e e 11 o fully under and e re ula ory oid faced y e u d an a e al on, i i e en ial o e a ine e re ula ion of e fir food roduc deri ed fro ene ically en ineered ani al and e fir co erciali ed ene ically en ineered ani al C The FDA’s Approval of Transgenic Milk e u d an a e al on i e fir ene ically en ineered ani al a ro ed for u e a a food roduc owe er, i i no e fir roduc deri ed fro a ene ically en ineered ani al a e a allowed for u an u ion 11 i e a ro al of ilk roduced rou e u e of reco inan N ec nolo y, e e an i ourney down w a a eco e a li ery lo e of incon i en re ula ion 11 ur er ore, concern a ou e andard for e re ula ion of ene ically en ineered roduc deri ed fro ani al i no a odern dile a 11 In fac , concern kyrocke ed in , a Mon an o118 e an e roce of rin in ilk roduced y cow rea ed wi a ene ically en ineered 11 See Ro er Bo rer, Food Products Affected by Biotechnology, U PI L REV , di cu in e ro er y urroundin e re ula ion of e fir ene ically en ineered food 11 See Lawrence, supra no e 2, a 11 Miller, supra no e 12, a 20 di cu in ow ilk roduced y ene ically en eneered cow wa e fir food roduc deri ed fro an ani al 11 Id 11 See Mara Bo un, Hormone Battle Takes to Streets After BST Finally Hits U.S Market, BIO E NOLO Y NE , 1, di cu in e i ed re on e o a ro al of reco inan o ine o a o ro in 118 About Monsanto Company, MON N O, on an o co co any la i i ed ec , 201 Mon an o i a lo al odern a ricul ure co any e de elo roduc and ool o el far er around e world row cro w ile u in ener y, wa er, and land ore efficien ly 208 JOURNAL OF LAW AND POLICY u ance o arke 11 By a ro in e u e of reco inan 120 o ine o a o ro in r , a row or one analo u ed o increa e ilk roduc ion in dairy cow ,121 e anc ioned e fir u e of ene ic en ineerin on an ani al u ed o roduce 122 roduc in ended for u an u ion in e i e, ere wa o e di cre ancy wi re ec o w ic re ula ory a ency would ro ide e ri ary o er i of r ,a e roduc could a e een re ula ed a a new ani al iolo ical roduc y e U under e Viru eru o in c , or y e 12 a a new ani al dru ince e wa ou o ea ore credi le a ency y u er , e a ency wa i en e 12 ri ary re on i ili y for re ula in r In addi ion o e rela i ely ar i rary de er ina ion o re ula e e roduc ion of r ilk a a new ani al dru , e en er for Ve erinary Medicine failed o fully i le en e afe y ro i ion re uired for e a ro al of a new ani al dru a lica ion 12 e afe y ro i ion re uired y 21 U and 21 U are a follow 12 ilin a lica ion for u e of new ani al dru en a en infor a ion a re ia ed a lica ion re u i ion conference ny er on ay file wi e ecre ary an a lica ion wi re ec o any in ended u e or u e of a new ani al dru uc er on all u i o e ecre ary a a ar of e a lica ion a de cri ion of rac ica le e od for de er inin e uan i y, if any, of uc dru in or on food, and any u ance for ed in or on food, ecau e of i u e and 11 JO UIN 120 121 122 12 12 12 12 ri ine erro, No e, High-Tech Cows: The BST Controversy, RI L REV , 1 Bo rer, supra no e 11 , a erro, supra no e 11 , a erro, supra no e 11 , a Id Id a 18 Id a 18 Id a 21 U 1 N SWIMMING UPSTREAM 20 e ro o ed olerance or wi drawal eriod or o er u e re ric ion for uc dru if any olerance or wi drawal eriod or o er u e re ric ion are re uired in order o a ure a e ro o ed u e of uc dru will e afe urin e a ro al roce for r , e did no re uire Mon an o o u i a e od for de er inin e uan i y of r in e ilk deri ed fro e rea ed cow a a ar of eir a lica ion 12 e al o did no re uire e u i ion of a ro o ed olerance le el of r , w ic would indica e e a oun of r a would e er i ed o re ain in e ilk wi ou renderin i unadul era ed128 under e ederal ood, ru , and o e ic c 12 i failure o enforce e re ula ory re uire en of e fir co erciali ed ene ically en ineered ani al roduc a inued o uc o a o e a e referred o e re ula ory y e a woefully inade ua e D The FDA’s Refusal to Regulate the GloFish e incon i en a lica ion of e federal re ula ory uideline i fur er illu ed y e ore recen failure o o er ee e co erciali a ion of e fir ran enic ani al, e lo i 1 e lo i i ene ically en ineered u in reco inan N ec nolo y o ain N ruc fro ea 12 erro, supra no e 11 , a 18 Id 12 ed ood, ru , and o e ic c , 21 U a 2012 food all e dee ed o e adul era ed i f i ear or ain any oi onou or dele eriou u ance w ic ay render i in uriou o eal Mic ael Bara e al , Transgenic Agriculture: Biosafety and International Trade, B U J I E L ,1 1 FDA Statement Regarding Glofish, U OO RU MIN , ec , 200 , way ack arc i e i or 201 0 0 www fda o ni alVe erinary e elo en ro alProce ene icEn ineerin ene icallyEn ineered ni al uc see Bra ie , supra no e , a , Ra er an en a in in ei ened or e en ordinary re ula ory cru iny, e ood and ru d ini ion , e lead a ency for re ula in ran enic ani al , in ead announced in 200 a i would er i lo i o en er in o in er a e co erce w olly unre ula ed 128 210 JOURNAL OF LAW AND POLICY coral e in roduc ion of e coral N re ul in a flore cen orna en al fi , w ic low w en e o ed o ecific li condi ion In Int’l Ctr for Tech Assessment v Thompson, e lain iff alle ed a , e i ro erly refu ed o re ula e e lo i , and a e failure o a er re ula ory au ori y o er e lo i iola e e N , new ani al dru a lica ion ro i ion of e , ederal ood, ru , and o e ic c e lain iff ar ued in fa or of re ula ion y e , e a i in e o en ial for acciden al relea e, re ul in in en iron en al i ac and in roduc ion in o e u an food u ly e cour di i ed e clai , reaffir in e di cre ion in de er inin w e er or no o enforce new ani al dru a lica ion e i le el of di cre ion afforded o e de er ina ion of w a and ow ene ically en ineered e need for orou or ani are re ula ed fur er i li and i en re ula ion 1 See In l r for ec e en Lea i , u 2d 200, 200 ndrew Pollack, Business; So the Fish Glow But Will They NY IME Jan , 200 , www ny i e co 200 01 u ine u ine o e fi low u will ey ell l Leavitt, u 2d a 202 Lawrence, supra no e 2, a In l r for ec e en o on, 21 u 2d 1, 200 Id a l ou lo i are in ended for u e in o e a uariu , e lain iff alle e a ey could e u o o er u e and readily en er e ani al and u an food c ain rou acciden al or in en ional relea e uo in o l Id a e cour di i ed e wo clai , ar ued in e al erna i e, ecau e e enforce en deci ion rela in o una ro ed new ani al dru roduc are di cre ionary and are no u ec o udicial re iew under e P uo in Me O a 18 See Maria R Lee Mura o o, Reforming the “Uncoordinated” Framework for Regulation of Biotechnology, R EJ RI L 11, 8, 2012 di cu in e ineffec i ene of e oordina ed ework and e concernin a u ion y e a e lo i wa afe wi ou u or in e idence Lawrence, supra no e 2, a 228 di cu in e i de ree of deference afforded o e followin eir deci ion no o re ula e e lo i and e need for effec i e re ula ory roce e for addre in e ri k o ed y ene ically odified or ani 202 Sell?, SWIMMING UPSTREAM 211 In a i ilar ca e rou a ro i a ely one year la er, e lain iff ar ued a , e ad failed o re ula e e lo i olely on e i aken elief a i did no a e uri dic ion o re ula e e co erciali a ion of e fi e cour de er ined a , a o , e wa , for o e i e, undecided on e i ue of w e er o re ula e lo i no on e i ue of w e er i could re ula e lo i aken o e er, e e ca e ake i clear a e ad e ower o re ula e a co erciali ed, ene ically en ineered or ani , w ic ad e o en ial o i ac o e en iron en and u an food u ly, ye did no ake e o fully e alua e e i ac y re ula in e lo i a a new ani al dru l ou lo i ee e defini ion of a dru , due o e incor ora ion of e c oe o reco inan N ruc wi in e fi , e i nore e fac a , a a dru , lo i i in eren ly un afe 1 In re on e o concern urroundin e co erciali a ion of lo i , e relea ed a or a e en e lainin e ionale e ind e deci ion no o re ula e e ene ically en ineered fi Becau e ro ical a uariu fi are no u ed for food ur o e , ey o e no rea o e food u ly ere i no e idence a e e ene ically en ineered e danio fi o e any ore rea o e en iron en an eir un odified coun er ar w ic a e lon een widely old in e Uni ed a e In e a ence of a clear ri k o e u lic eal , e find no rea on o re ula e e e ar icular fi Leavitt, u 2d a 20 Id a 208 See Lee Mura o o, supra no e , a 1 See McE illy, supra no e , a 20 new ani al dru i dee ed un afe under e c unle e a a ro ed a N for a ar icular ue U ood ru d in , Statement Regarding Glofish, U EP O E L N UM N ERVI E r , 201 , way ack arc i e i or 201 0 0 www fda o ni alVe erinary e elo en ro alProce ene icEn ineerin ene icallyEn ineered ni al uc 1 212 JOURNAL OF LAW AND POLICY By a in a e ene ically en ineered e danio fi no o e any ore rea an eir un odified coun er ar , e i i ly u in e oordina ed ework idea a ran enic or ani are u an ially i ilar o eir non ran enic coun er ar a a ield o a oid erfor in i re ula ory du ie ue o e lead role in e re ula ion of ene ically odified or ani , e refu al o en a e in e re arke re iew roce for e lo i allowed i o a oid re iew and eco e co erciali ed al o i edia ely e incon i en a lica ion and enforce en of re ula ory uideline under ine e credi ili y of Uni ed a e re ula ory a encie , and lend credence o e idea a w a we a e a oun o a olun ary y e for a e in e ri k of ran enic food lack of i ency i ar icularly dan erou w en e Uni ed e in erna ional co uni y in o e unc ar ed a e i leadin wa er of io ec nolo ical inno a ion e Uni ed a e inue o co e wi e af er a of e a ro al of e u d an a e al on and new ene ically en ineered ani al e in a e o en er e food u ly,1 olicy aker can look o o er leadin coun ie for uidance 1 See id Bra ie , supra no e , a Lar Noa , Managing Biotechnology’s Revolution: Has Guarded Enthusiasm Become Benign Neglect , 11 V J L E , 200 Bara e al , supra no e 2, a 21 See Law Li rary of on re , Restrictions on Genetically Modified Organisms: European Union, LIBR RY O ON RE , www loc o law el re ric ion on o eu la u da ed June , 201 See erican ocie y of ni al cience, Scientists Improve Transgenic “Enviropigs”, IEN E ILY Mar , 201 , www ciencedaily co relea e 201 0 12 802 See a eera Bonala, Countries Leading in Biotechnology Industry – Global Rankings, BIO N UP No , 201 , www io andu co io ec coun rie leadin io ec nolo y indu ry lo al rankin SWIMMING UPSTREAM IV E RE UL ION O OO E NOLO IE IN N EVELOPE 21 ROU NE e u d an a e al on i curren ly only a aila le on e anadian arke of e e er 2018, onne of u d an a e al on a e een old a food in anada i year 1 ou e Uni ed a e wa e fir coun ry o a ro e e ene ically en ineered al on in No e er 201 ,1 anada re ula ory a encie followed ui i on la er i re ard o allowin ene ically en ineered ani al in o e food u ly, e anadian y e a ro en co re en i e ye fle i le ou anada a i le en ed a re ula ory y e for io ec nolo y i ilar o a of e Uni ed a e ,1 i li difference allow i o ore effec i ely kee ace wi cien ific ad ance en rea ed in , e anadian fra ework relie on ree ain a encie o e ecu e all re ula ory ro i ion rela in o eor e or ky, Canadians Are Now the First to Eat Genetically Modified Salmon, I MO O u , 201 , www i odo co au 201 08 canadian are now e fir o ea ene ically odified al on al , supra no e 1 Mic ael ack, Maker of GMO Samlon Says it Sold 4.5 Tonnes in Canada This Year But Won’t Say To Whom, B NE e , 2018 www c c ca new u ine a ua oun y o al on 81 arrie enne , Seafood: Genetically Engineered Salmon, 18 O Y IE I I N 18, 18 201 , www oday die i ian co newarc i e 081 18 l Health Canada and Canadian Food Inspection Agency Approve AquAdvantage Salmon, E L N May , 201 , www canada ca en eal canada new 201 eal canada and canadian food in ec ion a ency a ro e a uad an a e al on l al , supra no e See ou la J R Moodie, The Cautious ‘Frankenfish’: Environmental Protection and Other Canadian Regulatory Issues Relating to Transgenic Fish, 1M U RIE J IN L OMP ENV L L , 200 di cu in e eral federal de ar en and a encie wi ada in re on i ili ie See ara M Van lyck, No e, Salmon with a Side of Genetic Modification: the FDA’s Approval of the AquAdvantage Salmon and Why the Precautionary Principle is Essential for Biotechnology Regulation, E LE U L REV 11, 201 di cu in e Uni ed a e and anada a ro al of u d an a e al on 21 JOURNAL OF LAW AND POLICY io ec nolo y in e a ricul ure and food ec or e anadian 1 ood In ec ion ency, eal anada, and En iron en anada in e Uni ed a e , anada c o e o ela ora e u on i e i in re ula ory y e i wa done in order o OV rai 201 Regulating Agricultural Biotechnology in Canada: An Overview, N, www in ec ion c ca lan lan wi no el eneral u lic o er iew en 818 810 8188 July , O Food, N I N OO IN PE ION EN Y, www in ec ion c ca food en 12 12 022 la u da ed June 12, 2018 e anadian ood In ec ion ency o i i a e ri k o u lic eal a ocia ed wi di ea e and o er eal a ard in e food u ly y e and o ana e food afe y e er encie and inciden e I ac ie e i o ec i e y ro o in food afe y awarene rou u lic en a e en and erifica ion of co liance y indu ry wi andard and cience a ed re ula ion Regulating Agricultural Biotechnology in Canada: An Overview, supra no e 1 eal anada, Genetically Modified (GM) Foods and Other Novel Foods, OV O N, www canada ca en eal canada er ice food l la u da ed ec nu ri ion ene ically odified food o er no el food 22, 201 eal anada a e e e afe y of all ene ically odified and o er no el food ro o ed for ale in anada o anie are re uired o u i de ailed cien ific da a for re iew and a ro al y eal anada, efore uc food can e old Regulating Agricultural Biotechnology in Canada: An Overview, supra no e 1 En iron en and li a e an e anada, About Environment and Climate Change Canada, OV O N, www ec c ca defaul a lan En n B E1 w di a le rue la u da ed ec 1, 201 En iron en and li a e an e anada E , our u ine i ro ec in e en iron en , er in e coun ry na ural eri a e, and ro idin wea er and e eorolo ical infor a ion o kee anadian infor ed and afe En iron en and li a e an e anada i a di er e or ani a ion w ere our ro , er ice , and eo le lead e way in i le en in e o ern en of anada en iron en al a enda e colla ora e wi our ar ner a o e and a road, o reali e concre e ro re on ini ia i e a will ro ec e eal of our eo le and our lane see Regulating Agricultural Biotechnology in Canada: An Overview, supra no e 1 See Regulating Agricultural Biotechnology in Canada: An Overview, supra no e In , e federal o ern en announced a fra ework for e re ula ion of io ec nolo y roduc in anada One of e rinci le of e fra ework wa a e i in le i la ion and re ula ory odie would e u ed o re ula e io ec nolo y roduc , and a ey would uild on e i in law and SWIMMING UPSTREAM 21 ini i e co and a oid e a le of de elo in an en irely new re ula ory ody and i le en in new law 1 e ain difference e ween Uni ed a e and anadian re ula ory ro ocol i anada u e of a no el food cla ifica ion ccordin o e anadian ood and ru c No el food ean a a u ance, includin a icroor ani , a doe no a e a i ory of afe u e a a food a food a a een anufac ured, re ared, re er ed or acka ed y a roce a i a no een re iou ly a lied o a food, and ii cau e e food o under o a a or c an e and c a food a i deri ed fro a lan , ani al or icroor ani a a een ene ically odified uc a i e lan , ani al or icroor ani e i i c arac eri ic a were no re iou ly o er ed in a lan , ani al or icroor ani , no lon er ii e lan , ani al or icroor ani e i i c arac eri ic a were re iou ly o er ed in a lan , ani al or icroor ani , or iii one or ore c arac eri ic of e lan , ani al or icroor ani no lon er fall wi in e an ici a ed ran e for a lan , ani al or icroor ani ali en nou eau i no el food ca e ory allow for e cla ifica ion of newly de elo ed roduc in ended for u an u ion wi ou e er i e, er an de elo in en irely new law and a encie i ean a a ricul ural roduc of io ec nolo y are re ula ed under e a e road le i la ion and ruc ure , wi e addi ion of o e new re ula ion and ad ini i e rocedure , a a ricul ural roduc roduced in ore radi ional way Moodie, supra no e , a ere i re en ly no e ara e and di inc re on i le ody or rocedural a roac for M food roduc 1 Moodie, supra no e , a anada i e only coun ry w ere re ula ory o er i i ri erd y no el y er an roce see also N BIO E NOLO Y VI ORY OMM , IMPROVIN E RE UL ION O ENE I LLY MO I IE OO IN N 2001 ood and ru Re ula ion R , c B 28 001 c 201 Id 21 JOURNAL OF LAW AND POLICY re ard for e ec nolo y u ed in e crea ion of e roduc e inclu ion of e no el food ca e ory allow anada o re ula e new food wi ou a in o an ici a e e io ec nolo y u ed o roduce i i ro ide e o ernin a encie wi e a ili y o de elo uideline ecific o e new ec nolo ie a ey co e a ou er an nece i a in e de elo en of crea i e way o a ly an i ua ed uideline V NOVEL OLU ION or o er ir y year , e Uni ed a e a incon i en ly a lied in ufficien re ula ion and olicy w en i co e o e a ro al roce for ene ically en ineered or ani l ou no o er ene ically en ineered or ani a e ye een a ro ed for u an u ion y e ,1 any are curren ly under de elo en , and eac new or ani oe a uni ue e of re ula ory c allen e If we are o a i i e e enefi of io ec nical ad ance en wi re ec o food, w ile reducin e o en ial eal and en iron en al ri k a ocia ed wi e de elo en of ene ically en ineered ani al , we u de elo a re ula ory y e a accura ely cla ifie io ec nolo ical roduc and i en ly a lie e re ula ory ea ure w ic are u in o lace Ra er an lookin ackward and a e in o a ly an i ua ed re ula ion o new and unfore een ec nolo ie , we u ada e fra ework o Moodie, supra no e , a See Bra ie , supra no e , a di cu in e increa in ly crea i e in er re a ion of e i in re ula ory law a e en ional re ula ory ca e orie are wi ed in order o a ly o ene ically odified or ani See Lawrence, supra no e 2, a e lainin a encie failure o ee e oordina ed ework o ec i e See U ood ru d in , Consumer Q & A, U EP O E L N UM N ERVI E , www fda o ani al e erinary de elo en a ro al roce ene icen i neerin ene icallyen ineeredani al uc la u da ed ec 1, 201 indica in a e u d an a e al on i e only a ro ed ene ically en ineered ani al in e food u ly See Jere y ooke, GM Pigs: Green Ham with Your Eggs , BB NE Jan , 2011 , www c co new world u canada 1211 SWIMMING UPSTREAM 21 acco oda e e roduc of our idly ad ancin world e curren focu on e cla ifica ion of roduc a ed on e roce y w ic ey are ade a led o e i c arac eri a ion of ene ically en ineered ani al a dru e ene ic en ineerin of ani al ro re e , e di inc ion e ween food and dru will eco e increa in ly difficul e ri idi y of e re ula ory olicie co ined wi a lack of fore i in o e o en ial for io ec nolo ical ad ance en on e alf of e de elo er of e oordina ed ework, a re ul ed in e incon i en a lica ion of a fra ework la ued y a and conflic in olicie 1 l ou e curren fra ework i e en ially unworka le a a ool for re ula in curren io ec nolo y, any of e uildin lock u ed o crea e e re en c e e can e olded o for a ore effec i e e of re ula ory uideline o add fle i ili y and accuracy o e Uni ed a e re ula ion of ene ically en ineered ani al , e o ern en ould i le en e u e of a no el ca e ory i ilar o e cla ifica ion u ed in e anadian re ula ory fra ework Under i c e e, e o ern en will ain ain e curren ri a ency re ula ory o aic and i ly a end e ood, ru and o e ic c o include a no el y ca e ory By cla ifyin ene ically en ineered ani al a no el food , and allowin re iew y a co i ee of ualified e er , e can a oid e ro le , uc a e er i e deficiency, a ocia ed wi c arac eri in a li in ani al a a e erinary dru ur er ore, wi e de elo en of ore ene ically en ineered ani al , e roce for a ro al will eco e fa er and ore rea lined, a a i ory of afe u e and an ici a ed ran e of c arac eri ic eco e known In i way, e can a oid e lo e lo e dile a of ei er fore allin See Moodie, supra no e , a Lawrence, supra no e 2, a 281 82 Lawrence, supra no e 2, a 1 See Lawrence, supra no e 2, a 2 See on a le, e al , History of Safe Use as Applied to the Safety Assessment of Novel Foods and Foods Derived From Genetically Modified Organisms, OO N EMI L OXI OLO Y , 1 200 di cu in e eanin of afe u e and a ro al wi re ec o ene ically odified ani al in ended for u an u ion see ood and ru Re ula ion , supra no e 218 JOURNAL OF LAW AND POLICY inno a ion y re iewin a roduc for nearly wen y year ,1 or y declinin o orou ly re iew a roduc ere y allowin for id co erciali a ion i increa ed efficiency, co ined wi e ocial enefi re ul in fro e de elo en of new food , will likely off e e co of e a li in a re iew co i ee i ilar o e Ve erinary en er for Medicine, w ic would re iew no el food a lica ion ddi ionally, y ain ainin e ri a ency re ula ory o aic, e o ern en will a oid e co of crea in a new re ula ory a ency dedica ed olely o e re iew of roduc de elo ed rou u e of io ec nolo y owe er, o re en e ro le a ocia ed wi di cordan di cre ionary a lica ion of re ula ion , i i e en ial a e ,a e ri ary a ency re on i le for e re ula ion of ene ically en ineered ani al , i en ly e erci e i a u ory au ori y o e full e en ro ided y e ederal ood, ru , and o e ic c e U da e o e oordina ed ework ro ide a u eful ar in oin y delinea in eac a ency re ec i e du ie wi re ard o re ula in ene ically en ineered ani al owe er, e funda en al a u ion a ene ically en ineered or ani are u an ially i ilar o eir non ran enic coun er ar ould 180 e eli ina ed ou facially i re u ion a ear in fa or of ene ic en ineerin , i i ul i a ely de ri en al o cien ific oe e a, supra no e e re ula ory roce e ind e a ro al u d an a e al on ook al o 20 year Noa , supra no e , a See EN Y IN BER , RE IN E ER L VI ORY OMMI EE IN E EXE U IVE BR N 201 Re ula in ricul ural Bio ec nolo y in anada n O er iew, supra no e e lainin e c allen e a ocia ed wi crea in an en irely new o ern en a ency Bra ie , supra no e , a 21 U 12 1 U OO RU MIN , MO ERNI IN E RE UL ORY Y EM, supra no e 10 180 See generally re or indley, Genetically Engineered Crops: How the Courts Dismantled the Doctrine of Substantial Equivalence, U E ENV L L POL Y 11 201 e lainin e a u ion a ene ically en ineered or ani are u an ially i ilar o non en ineered or ani see also Lawrence, supra no e 2, a of e SWIMMING UPSTREAM 21 ad ance en a i fail o ake in o idera ion e uni ue 181 c arac eri ic of ene ically en ineered or ani ene ic en ineerin eco e ore ad anced, o en ially allowin for rea er ercen a e of reco inan N wi in an or ani , i will likely eco e increa in ly difficul o di in ui , for e a le, w e er an or ani uc a a lo i i u an ially i ilar o a e fi or a ea coral 182 e a ili y o incor ora e N fro nearly any or ani in o e eno e of ano er ro ide i en e o en ial for inno a i e new food roduc , u al o ro ide o en ial for unin ended en iron en al or oral e uence 18 e addi ion of a no el y ca e ory re uirin e re iew of ene ically en ineered or ani rior o co erciali a ion will no only a oid c allen e re en ed y a u an ial i ilari y re u ion, u will al o en ure i en re ula ion e a een u in i re ula ory di cre ion a o a word and a ield in order o elec i ely decide w ic ene ically odified roduc i will re ula e, and e e en o w ic i will e erci e i a u ory anda e 18 o en ure u lic ru in e re ula ory roce , and ini i e e o en ially de ri en al effec of ene ically odified or ani , e deci ion o re iew a ene ically en ineered ani al canno e lef o e di cre ion 18 e addi ion of a no el y ca e ory will increa e confidence in e o ern en a a re ula ory ody, and in ene ically en ineered or ani a food y ro idin rea er ran arency in e a ro al roce By re o in e new ani al 181 See Lawrence, supra no e 2, a See id a 18 Ellen Rolfe , When Does Genetic Modification of Animals Cross a Line?, PB NE OUR June 10, 201 , www or new our cience w en doe ene ic odifica ion of ani al cro a line di cu in e a ili y o ran fer ene acro ecie see also Lawrence, supra no e 2, a di cu in c allen e a ocia ed wi cro kin ran enic or ani 18 See Lee Mura o o, supra no e , a see generally indley, supra no e 180, a 11 di cu in e elec i e re ula ion of roduc 18 See o er, supra no e , a di cu in e need for cau ion and dili ence in for co in re ula ion 182 220 JOURNAL OF LAW AND POLICY dru la el fro ene ically en ineered ani al , e will no lon er e re en ed fro di clo in infor a ion o e u lic 18 ON LU ION ile e a ro al of e ua d an a e al on i a e a en o e re arka le ad ance en our ec nolo y a ade, i i li e weakne e of e curren re ula ory fra ework e fir ene ically odified or ani o eco e a ro ed for u an u ion, e u d an a e al on a o ened e door o e en rea er o i ili ie ccordin ly, e need o re are now for e fu ure of ene ically en ineered food ur er ore, e Uni ed a e o ern en u ac wif ly in order o effec i ely lead e world in o a new a e of ec nolo ical inno a ion 18 21 U 200 21 R 11 2012 ...S IN I IN PS NSIS N IN N S IS S S L L Kelsie Kelly* The citizens of the United States rely on the federal government to maintain the safety of their food through effective regulation As the. .. Miller, Time for the Government to Get Mooo-ving: Facing up to the RBST Labeling Problem, 18 MLINE L REV , 11 12 di cu in e o en ial for a e en uc a RB free o i lead u er in o elie in a ere i a co... OO RU MIN , UI N E OR IN U RY RE UL ION O ENE I LLY EN INEERE NIM L ON ININ ERI BLE RE OMBIN N N ON RU 2011 ereinaf er U OO RU MIN , UI N E OR IN U RY McE illy, supra no e , a 20 U OO RU MIN ,