* Associate P rofe sso r o f L a w , U n iversity of M ississippi Sch ool of Law . B .A., 1 9 96 , C olgate U niversity; J.D ., 2000, H arvard Law School. T he author thanks th e U n iversity of M ississippi S ch ool of Law for its su pport as w ell as h er colleagu es on th e facu lty for th eir in sigh t du ring faculty colloq uia. 1 . See Jennifer Kuzm a et al., E va luating O versight System s for E m erg ing Technologies: A C ase Stud y of G enetically E ngineered O rganism s, 37 J.L. M ED. & E THICS 546 (2009) (recognizing, through polling data, that “[c]onfidence in re gu lation [of genetically engineered organism s] is not high . . . . This is because the process is not transparen t.”). 2. E lena Kagan, Presid en tia l A d m in istra tio n, 1 1 4 H ARV. L. R EV. 2 2 4 5, 2 3 2 5-2 6 , 2 2 46 , 2 2 50 (2001) (footnotes om itted). Indiana Law Review Volume 46 2013 Number 2 ARTICLES JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION AND BIOENGINEERED FOODS: M AKING THE CASE FOR CONGRESSIONAL GUIDANCE AS A CHECK TO PRESIDENTIAL POLICY SETTING M ICHÈLE ALEXANDRE* INTRODUCTION Imagine a system of government where the President is accorded a great deal of deference in matters of legislation. A combination of these two elements— “president and legislation”— immediately gives us cause for pause, considering our deliberate tripartite system of checks and balances. Imagine also the advancement of a completely new technology, like cloning. As the biotech industry works to perfect this new technology, the q uestion remains as to who is best placed to regulate it. As we explore our options, should one of the op tions be for the Office of the President to set regulations? These are the questions that areas like biotechnology face or will currently face. As biotechnology has evolved, the public has b ecome increasingly concerned that processes for approving biotech foods are not transparent. The power to1 approve biotech foods is delegated to administrative agencies, which receive considerable deference from the courts. Added to this judicial deference is the documented involvement of the President’s office in setting policy in this area. Justice Kagan labeled Presidential involvement in administrative agencies’ decisions as “Presidential Administration.” “Presidential Administration,”2 according to Justice Kagan, refers to the President directly setting policies by 266 INDIANA LAW REVIEW [Vol. 46:265 3 . See generally id . at 2 3 31 . 4 . Id . at 2277-2315 (providing a history of P residential Adm inistration in both “[t]he R eagan E ra” and “ the C linton Y ears”). 5 . Id . at 2 2 50 . 6 . Id . at 2375 (“T he courts, by contrast, have ign ored the President’s role in adm inistration action in defining the scope of the C hevron doctrine. Although this consideration took pride of place in C h evron itself, th e figu re of th e P residen t h as barely appeared in recen t ju dicial discu ssion s of deferen ce. C ou rts gran t (or declin e to gran t) step-tw o d eferen ce to adm in istrative in terpretation s of law irrespective w hether the President poten tially could, or actually did, direct or otherw ise participate in their prom ulgation .”); see C h evron , U .S.A., In c. v. N atu ral R es. D ef. C ou n cil, 4 6 7 U .S. 837 (1984). 7. Kagan, supra n ote 2 , at 2 3 7 4 (“ T h e C ou rt n oted at several poin ts th e special expertise an d experience that agencies bring to the task of interpreting and adm inistering their governing statutes. T he C ourt quoted a prior statem ent that deference w as appropriate w h en ‘a full understanding of the force of the statutory policy in the given situation has depen ded u pon m ore than ordin ary kn ow ledge respectin g th e m atters su bjected to agen cy regu lation s’; th e C ou rt th en added th at in th e instant case ‘the regulatory schem e is technical and com plex, the agency considered the m atter in a detailed an d reason ed fash ion ,’ an d ‘ju dges are n o t e x pe rts in th e field.’ Still fu rth er au gm en tin g the ration ales for deference, the C ou rt proposed that this approach com ported w ith congression al intent. Gaps an d am big u ities in legislation , the C ou rt suggested, them selves could con stitute explicit or im plicit delegation s to an agen cy to ‘elu cidate . . . th e sta tu te by regu lation ,’ in clu din g throu gh the ‘accom m odation of conflicting policies.’” (alteration s in original) (footnotes om itted)); C h evro n, 4 6 7 U .S. at 8 4 2-4 4 . p roviding directives to administrative agencies. Tracing this practice from3 President Reagan to President Clinton, Justice Kagan explains that presidents have regularly used the administrative process to set policies as well as take ownership of administrative policies. This remained the case until President4 Clinton refined the practice even more. According to then Professor Kagan: By the close of the Clinton Presidency, a distinctive form of administration and administrative control— call it “ p residential administration”— had emerged, at the least augmenting, and in significant respects subordinating, other modes of bureaucratic governance. Triggered mainly by the re-emergence of divided government and built on the foundation of President Reagan’s regulatory review process, President Clinton’s articulation and use of directive authority over regulatory agencies, as well as his assertion of personal ownership over regulatory product, pervaded crucial areas of administration.5 This “directive authority” and personal ownership seem to stand in contradiction to the Chevron doctrine. An established administrative standard, the Chevron6 doctrine contemplates a relationship between Congress and administrative agencies and illustrates the type of deference that should be accorded to agencies in the absence of a specific mandate from Congress. T he C hevron doctrine,7 however, does not contemplate the Executive as p laying a role in carrying out 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 267 8 . See gen era lly Patrick M . Garry, A cco m m o d a tin g th e A d m in istra tiv e S ta te: T h e Interrelationship between the C hevron and N ond elegation D octrines, 3 8 ARIZ. ST. L.J. 9 2 1 (2006). 9. Kagan, supra n ote 2 , at 2364 (“In on ly tw o cases, both in 1935, has the Suprem e C ou rt stru c k dow n a federal statu te on th e grou n d th at it delegated too m u ch au th ority to th e ex e cu tiv e branch .”). 1 0 . See gen era lly Gillian E . M etzger, T h e In terd ep en d en t R ela tio n sh ip b etween In tern a l a n d E xternal Separations of Po wers, 5 9 EMORY L.J. 4 2 3 (2009). 11. M adison Sm ith, N ote, Who O wns Your D inner? A D iscussion of A m erica’s Pa tented G enetically E ngineered Food Sources, and Why R eform Is N ecessary, 2 3 LOY. C ONSUMER L. R EV. 1 8 2 , 185-86 (2010) (footnotes om itted) [h ereinafter Sm ith, Who O wns You r D in n er? ]. For addition al discu ssion on “[r]ecom binan t D N A (rD N A) genetic en gineering,” see M ich ael B en nett H om er, Fra n ken fish It’s W h at’s fo r D in n er: T h e FD A , G en etica lly E n g in eered S a lm o n , a n d th e Fla wed R eg u la tio n of B io tech n o lo g y, 4 5 C OLUM. J.L. & SOC. P ROBS. 83, 89 (2011). 12. Sm ith, Who O wns Your D inner?, supra n ote 1 1 , at 1 8 5-8 6 . 1 3 . Id . 1 4 . See gen era lly M atthew R ich, N ote, T h e D eb a te O ver G en etica lly M o d ified C ro p s in th e U nited States: R eassessm ent of N otions of H arm , D ifference, and C hoice, 5 4 C ASE W . R ES. L. R EV. 8 8 9 , 904 (2004). 15. Jeffrey K. Fran cer, N ote, Fra n ken stein Fo o d s o r Fla vo r S a vers? : R eg u la tin g A g ricu ltu ra l B iotechnology in the U ntied States and E uropea n U n io n , 7 V A. J. SOC. P OL’Y & L. 2 5 7, 2 6 5-6 6 (2 000). legislative duties. In fact, the non-delegation doctrine stands for the opposite concept. The non-delegation doctrine which prevents Congress from delegating8 its legislative power, though rarely invoked in our jurisprudence, has been judicially triggered only twice––both in the same year, 1935––to strike down legislation that granted too much legislative power to the President. 9 In our system of government, balancing the duties, limits, and scope of our three branches is a delicate dance, but one which places certain limitations on the President. Specifically, the doctrine of sep aration of powers prohibits a branch from aggrandizing itself by usurping the powers of another branch. Though the10 lines are a bit more blurred in administrative law, a branch’s efforts to aggrandize its powers should not be taken lightly. Biotechnology is a context where such concerns are palpable. Bioengineering “is a term used to describe the process by which recombinant DNA (‘rDNA’) is placed into an organism. When scientists splice together pieces of DNA and then introduce the modified DNA into an organism, it is referred to as ‘rDNA technology.’” “A genetically engineered (‘G E’) plant or animal11 contains this rDNA construct, thus changing the organism by giving it a new12 trait or characteristic.” This science is still under development and the health13 consequences of biotech products are not yet fully known. Still, even at the inception of biotechnology, Congress did not issue any regulations guiding the evaluation of biotech products. Instead, the President issued directives to food14 agencies and set the now accepted policy: a presumption that bioengineered foods are the same as traditional foods. In 1986, 15 268 INDIANA LAW REVIEW [Vol. 46:265 1 6 . Id . 1 7 . See gen era lly Kagan, supra n ote 2 . 1 8 . Id . at 2369 (“[A]ll else equal, adm in istrative action taken pursuant to a delegation to an agency official, but clothed w ith the im prim atur and authority of the President, should receive m axim u m protection against a non delegation ch allen ge. T he P resident’s involvem en t, at least if pu blicly disclosed, vests th e action w ith an in creased dose of a ccou n tability, w h ich . . . ren ders th e action less trou blesom e than solely bureaucratic m easures from the standpoint of dem ocratic values . . . . [T]his is not to say that presidential control of adm inistration is the equivalent of congression al law m aking. It is on ly to say that given the often urgent need for, an d resulting om nipresen ce of, broad delegations, courts should understand and, by so doing, encourage this m echanism of control as m itigating the poten tial threat that adm inistrative discretion poses.”). 1 9 . See E lizabeth V . Foote, S ta tu to ry In terp reta tio n o r Pu b lic A d m in istra tio n : H o w C h evro n M isconceives the Fu nction of A gencies and Why It M atters, 5 9 ADMIN. L. R EV. 6 7 3 , 7 0 0 (2007). 20. M ichael R ichard D im ino, D .C . C ircu it R evives N o n d eleg a tio n D o ctrin e . . . o r D o es It? : Am erican T ru cking Associations, Inc. v. E P A, 175 F.3d 1027 (D .C . C ir. 1 999), M odified, 1 9 5 F.3 d 4 (D .C . C ir. 1 9 99 ), 2 3 H ARV. J.L. & P UB. P OL’Y 5 8 1 , 5 9 7 n .9 8 (2 0 0 0) (“ If agen cies are in depen den t of C on gress bu t depen den t on th e P residen t, th en th e P residen t gain s an u pper h an d in n egotiation s vis-a-vis C on gress, an d vice versa. T h is C o m m e n t treats departm en ts an d agen cies as part of th e presidential adm inistration, bu t agency independence from the President is an area of considerable controversy w ith potential im pacts on the non delegation doctrine. D elegating pow er to an indepen dent agen cy allow s for decision s to be m ade on a non -political basis, w hich m ay or m ay not be ben eficial from the country’s or C on gress’s perspective.”). 2 1 . See M eredith Abern athy, N ote, R un ning on E m pty: Will E xxon M ob il C au se a B reakd own the White House Office of Science and Technology (“ O ST ”) established the federal government’s “Coordinated Framework for Regulation of Biotechnology.” This policy provided the foundation of current regulation for genetically modified foods. The thesis of the Coordinated Framework was the announcement that foods, drugs, medical devices, biologics, and pesticides developed through modern biotechnology would be regulated within the same statutory framework as comparable products using traditional techniques.16 This type of presidential policy setting in the administrative context is exactly what Justice Kagan describes in her 2001 article. While Justice Kagan finds this17 practice beneficial and advocates for greater deference to the President in certain circumstances, the case of biotechnology shows that Presidential Administration18 presents dangers. When applied to biotechnology, which is still new and in need of expertise, deferring to the President for directives is alarming. Reliance on experts and vetting processes, provided by a notice-and-comment, should be a part of administrative rulemaking. Allowing the President an ownership role in this19 process dilutes it, undermining the democratic process and creating extreme public dissatisfaction. This risk is exacerbated by the deference exhib ited by20 courts in reviewing agencies’ actions in cases where congressional guidance is absent. As a result, though new technologies have emerged, courts are still21 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 269 for C hevron and the A d m inistrative State?, 6 4 WASH. & LEE L. R EV. 5 8 3 , 5 8 9 -9 3 (2007). 2 2 . S ee, e.g ., Alison P eck, L eveling the Playing Field in G M O R isk Assessm ent: Im porters, E xp o rters and the Lim its of Science, 28 B .U . INT’L L.J. 24 1, 25 0-25 2 (20 10 ) (discussing th e regulatory fram ew ork for biotech n ology im plem ented du ring the R eagan and (first) Bush adm inistration s). 2 3 . See M on san to C o. v. Geertson Seed Farm s, 1 3 0 S. C t. 2 7 43 , 2 7 66 (2 0 1 0) (explain in g th e court’s role in m aking a determ ination of unlaw ful agency action as being based in equity, and, thus, th e court m ust w eigh “the public interest, private needs, an d com peting private claim s . . . against the background of the court’s ow n lim itations and its particular fam iliarity w ith th e case” (internal quotation m arks om itted) (quoting H echt C o. v. B ow les, 321 U .S. 321, 329-30 (1944))). 2 4 . See T a b s G ro u p S u rvey: O rg a n ic F o o d S a le s H it R eco rd in 2 01 1 ; S a les Ju m p 1 5 -2 0 Percen t, P R N EWSWIRE (Feb. 15, 2012), http://w w w .prnew sw ire.com /new s-releases-test/tabs- group-survey--organ ic-food-sales-h it-record-in -2 0 1 1 -sales-jum p-15-20-percent-139384123.htm l. 25. Francer, supra note 15, at 2 9 7 (“ [A] 1997 poll of 5,000 E uropeans conducted by Greenpeace and M arket & O pinion R esearch Internation al indicated that 59 percent of D anes, D utch, French, B ritish, Italians, and Sw edes do n ot support the developm ent of genetically m odified foods.” (footnotes om itted)). 2 6 . World ’s Fa rm ers Flock to B iotech C rop V arieties, W ESTERN FARM P RESS (Feb. 2 3 , 2011), http://w esternfarm press.com /m anagem ent/w orld-s-farm ers-flock-biotech-crop-varieties. 2 7 . See M onica E ng, D ebate R ages O ver Labeling of Fo od s with G enetically M od ified Ingred ients, L.A. T IMES (June 2, 2011), http://articles.latim es.com /2011/jun/02/business/la-fi-gm o- 2 0 1 10 6 0 2. 28. N eil D . H am ilton, L eg a l Issu es S h ap in g So ciety’s A ccep ta n ce o f B io tech n o lo g y a n d G enetically M o d ified O rganism s, 6 D RAKE J. AGRIC. L. 81, 113-14 (2 0 0 1 ) (stating that a num ber of law suits have been filed challenging the use or approval of biotech products. T he courts often applying old approaches to novel contexts. Courts’ deference has, in fact, already served as a tacit judicial endorsement of Presidential Administration while failing to adequately balance the interests22 of the public and concerns for branch aggrandizement. This approach has23 caused a great deal of unrest, especially since an increasing p ortion of the American public has turned to the organic food market. In addition, it stands24 in contrast to Europe’s precautionary approach. In Europe, where the public has voiced similar unease and disapproval regarding automatic approval of genetically altered foods, the dissemination of genetically altered foods in the market has been curtailed. 25 The European approach, however, only serves as a comparative tool and will not be the central focus of this Article. Instead, this Article focuses on the use of Presidential Administration to promote the introduction of genetically altered foods in the market and argues that such efforts deserve great scrutiny. Throughout the world, biotech companies have pushed for the use of genetically engineered crops, like soy and corn. In the United States, food agencies have26 already approved the use of a number of genetically engineered foods despite protests from a large numb er of Americans. The approval of these products by27 federal agencies has triggered various lawsuits from food watch groups and concerned citizens. In addition, the Food and Drug Administration (the FDA)28 270 INDIANA LAW REVIEW [Vol. 46:265 rule in favor of biotech com panies, even in relation to claim s against the FD A ch allen ging its approval of GM O produ cts w ithou t testing). 2 9 . See H om er, supra note 11, at 8 5-86. 3 0 . See N aom i Starkm an, Ju st L a b el It: W e H a ve a R ig h t to K n o w W h at’s in O u r Fo o d , H UNTINGTON P OST (O ct. 5, 2011, 3:01 PM ), http://w w w .huffingtonpost.com /naom i-Starkm an /just- label-it-w e-h ave-a-r_ b_ 9 9 44 8 8 .h tm l (“ ‘P olls sh ow th at con su m ers dem an d tran sparen cy in th e foods they bu y an d overw helm ingly support labeling of [gen etically en gineered] food,’ said D r. M ichael H ansen, senior scien tist at C on sum ers U nion , the public policy division of C on sum er R eports.”). 3 1 . S ee, e.g ., Jeannie M oulton, U nd erstand Why G enetically E ngineered Salm on is Scary, E AT D RINK B ETTER (Apr. 8, 2011), http://eatdrinkbetter.com /2011/04/08/12784; B ecky Striepe, T ru th in L a belin g : T ell C o n g ress Y o u Wa n t L a b els o n G E S a lm o n, EAT D RINK B ETTER (Apr. 1 9 , 2011), http://eatdrinkbetter.com /2011/04/19/truth-in-labeling-tell-congress-you -w ant-labels-on -ge- salm on . 3 2 . S. 2 2 9, 1 1 2th C on gress (2 0 1 1) (proposin g am en dm en t of “ th e Fe d era l Food, D ru g, an d C osm etic Act to requ ire labeling of genetically engineered fish”); S. 23 0, 11 2th C ongress (2 0 1 1 ) (proposing am endm ent of “the Federal Food, D rug, and C osm etic Act to prevent th e approval of gen etically-en gin eered fish ”); S. 1 7 17 , 1 1 2th C on gress (2 0 1 1) (settin g forth a B ill “ [t]o preven t th e escapem en t of genetically altered salm on in the U nited States, and for other purposes”). 3 3 . See H eather N . E llison, G en etically M od ified O rganism s: D oes the C urrent R egulatory S ystem C o m p ro m ise C o n su m er H ea lth ?, 1 0 PENN ST. E NVTL. L. R EV. 345, 353-60 (2002). 3 4 . See gen era lly Paul E . M cGreal, A m bition’s Playgroun d , 6 8 FORDHAM L. R EV. 1 1 0 7 (2000). 3 5 . See U .S. C ONST. art. 1 1 , § § 1, 2 . is currently considering the ap p roval of biologically engineered salmon. This29 has caused great public outrage, as seen in social media and the b logosp here.30 31 In response, some members of Congress introduced three bills designed to ban or regulate b ioengineered salmon in areas that would be most affected by its introduction. Still, under the entrenched presumption that treats bioengineered32 foods like traditional foods––a policy set by the White House O ffice of Science and Technology (“OST”) under President Bush––cases often are decided in favor of biotech companies.33 This is problematic because inherent in our governmental structure is a process of checks and balances, which, while far from perfect, provides34 interconnected synergy between congressional legislative powers, agencies’ administrative powers to execute legislation, public involvement through comments and questions, and judicial review of administrative decisions. The Constitution establishes the President’s duties, which have not traditionally included lawmaking. T his concern for separation of powers is even more35 relevant when exploring regulations related to genetically modified foods. As such, exercises of Presidential Administration warrant greater, not lesser, scrutiny. Though explicit deference to the President’s assessment of agencies’ decisions would be more efficient in certain ways, judicial evaluations of these decisions must reflect concerns for separation of powers. These concerns are all the more present in the context of genetically modified crops and foods. The 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 271 36. 130 S. Ct. 2743 (2010). 3 7 . Id . at 2 7 49 . 38. E m ily R obertson, N ote, Find ing a C om prom ise in the D ebate O ver G enetically M od ified Food : A n Introd uction to a M od el State C onsum er Right-To-K now A ct, 9 B .U . J. SCI. & T ECH. L. 156, 159-60 (2003). 39. E m ily M arden, R isk and R egulation: U .S. R egulatory Po licy on G enetically M od ified Food and Ag ricultu re, 4 4 B .C . L. R EV. 733, 734 (2003) (stating the U nited States’s “focus is . . . on the end product of GM technology, rather than on the fact that the process of gen etic m odification is used”). 40. T hom as O . M cGarity, Seed s of D istrust: Fed eral R egulation of G enetically M od ified Food s, 35 U . M ICH. J.L. R EFORM 403, 430-31 (2002). 41. R ebecca B ratspies, Som e T houghts on the A m erica n A pproach to R eg ulating G en etically M o d ified O rganism s, 1 6 KAN. J.L. & P UB. P OL’Y 393, 413 (2007). 42. N athan W . E ckley, C om m ent, R ea p in g th e B en efits o f A g ricu ltu ra l B io tech n o lo g y T h ro u g h U n ifo rm R eg u la tio n, 35 J. M ARSHALL L. R EV. 433, 443-45 (2002). 4 3 . See D ebra M . Strauss, T he International R egulation of G enetically M o d ified O rganism : Im porting C aution into the U .S. Fo od Supply, 6 1 FOOD & D RUG L.J. 167, 174 (“W hen [GM crops and non-GM crops] are not significantly different the tw o are regarded as ‘su bstantially equivalent,’ and therefore, the GM food crop is regarded as safe as its con ventional counterpart. . . . [T he] FD A relies on th is su bstantial equivalence for its view that no additional labeling or anim al testing is req uired.”). dangers of Presidential Administration are stark when considering the involvement of the President’s office in setting the regulatory framework for bioengineered foods. This Article explores the issues inherent in presidential control of administrative regulatory p rocesses related to genetically modified foods. In that context, especially, congressional silence is unsatisfactory because it unevenly shifts the balance of power to influential interest groups and to the Pres ident’s office. This awkward balancing has been made all the more evident by Monsanto Co. v. Geertson Seeds Farms, the Supreme Court’s first decision regarding36 genetically altered crops. Monsanto and other cases illustrate the legal and37 ethical complexities of balancing the public’s interest with that of biotech companies and monitoring federal agencies. Thus far, the balancing of interests38 has erred in favor of biotech companies. The standards applied by the courts for39 evaluating biotech foods are insufficient and vague. What is more, the4 0 procedures in place for overseeing and regulating biotech products are needlessly complex and inefficient. 41 This Article points out deficiencies in the regulation of bioengineered foods and demonstrates that regulating agencies have sponsored a policy that fails to concentrate on the potential harm to human health; rather, the policy focuses on market aggrandizement. The “substantial equivalence” doctrine applied b y42 regulating agencies when evaluating bioengineered products is under particular scrutiny in this Article. Under the substantial equivalence test, bioengineered43 p roducts have been assumed to be safe by virtue of the initial presidential 272 INDIANA LAW REVIEW [Vol. 46:265 4 4 . See C oordin ated Fram ew ork for R egu lation of B iotech n ology, 5 1 Fed. R eg. 2 3 30 2 -0 1 (June 2 6, 1986). 45. D iane T hue-V asq uez, G en etic E n g in eerin g a n d Fo o d L a b elin g : A C o n tin u in g C ontroversy, 1 0 SAN JOAQUIN AGRIC. L. R EV. 77, 83-84 (2000). 46. R obertson, supra note 38, at 168-70 (“For exam ple, scientists have inserted chicken genes in to apples, h u m an gen es in to corn , rice an d potatoes, an d cow gen es in to soybean s an d su garcane.”). 47. E llison, supra n ote 3 3 , at 3 6 2 (“ Alth ou gh th ere h ave been recen t developm en ts in th e regulation of GM O s, it is clear that the current regulatory system is insufficient to protect Am erican consum ers and the en viron m en t from the possible adverse effects of genetically engineered foods. T he fragm ented regulatory system that delegates specific respon sibilities to variou s federal agencies has failed to adeq uately determ ine the effects of GM O s on hum an s an d the en viron m en t. M oreover, the decision by the FD A to not require the labeling of genetically m odified foods leaves consum ers in the dark.” (footnotes om itted)). 48. Sarah L. Kirby, N ote, G en etica lly M o d ified Fo o d s: M o re R ea so n s to L a bel T h a n N o t, 6 D RAKE J. AGRIC. L. 351, 366 (2001). 49. George E .C . Y ork, N ote, G lo b a l Fo o d s, L o ca l T a stes a n d B io tech n o lo g y: T h e N ew L eg a l A rchitecture of International A griculture Trad e, 7 C OLUM. J. E UR. L. 423, 432-33 (2001). 50. Kagan, supra n ote 2 , at 2 2 46 , 2 2 50 . 51. Strauss, supra note 43, at 190-91 (stating that 47% of Am ericans are aw are that they can b u y gen etically m odified foods an d 7 5 % of Am erican s believed strict regu lation s w o u ld b e necessary to protect them from the dangers of genetic m odification). 52. D orit R ubinstein R eiss, T a ilo red Pa rticip a tio n : M o d ern izin g th e A PA R u lem a kin g Proced ures, 12 N .Y .U . J. LEGIS. & P UB. P OL’Y 321, 326-27 (2009) (ou tlining the “basic fram ew ork for inform al rulem aking specified in section 553 of th e AP A”). 5 3 . See gen era lly W endy A. B ach, W elfa re R efo rm , Privitiza tio n , a n d Po wer: R eco n fig u rin g A d m inistrative Law Structures from the G round U p, 7 4 B ROOK. L. R EV. 275, 294-95 (2009). command, construing bioengineered foods as equivalent to natural foods. This44 45 standard, however, is a false equivalence since bioengineered products contain foreign and unknown agents. Continued practice of this type of presidential46 control, without consistent input from experts, could lead to greater harm to the population. Considering the high stakes, a more precautionary standard is47 warranted. Food agencies’ failure to adopt a precautionary standard begs the question as to whether the rule furthers the interests of corporations, lobbyists, and biotech companies rather than the public’s interests. The commingling of interests48 without apparent concern for the public also endangers traditional farmers’ and food producers’ ability to achieve sustainability. This harm, among others,49 illustrates the danger posed by presidential rulemaking. Experts are best suited50 to decide administrative issues, in absence of congressional guidance, especially when the technology is so new that little information is available to lay people.51 Expert opinion and public inp ut, common elements of the administrative process, are all the more important in such a fragile context. Only with the5 2 participation of the experts and the public can we hope to counter the disproportionate effects that political agendas can have on such decisions.53 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 273 54. 130 S. Ct. 2743 (2010). 55. H om er, supra note 11, at 9 0-92. 56. H olly B eth From povicz, C om m ent, A G rowing C ontroversy: G en etic E ngineering in A griculture, 1 7 V ILL. E NVTL. L.J. 265, 268-69 (2006). 57. Katharine A. V an T assel, G en etica lly M o d ified Pla n ts U sed fo r Fo o d , R isk A ssessm en t and U ncertainty Principles: D oes the T ransition from Ignorance to Ind eterm inacy Trigger the N eed for Po st-M arket Surveillance?, 15 B .U . J. SCI. & T ECH. L. 220, 226-29 (2009) (discussing risks of genetically m odified foods). 58. H om er, supra note 11, at 92-99 (discussing the “[r]isks of [g]enetically [e]ngineered [f]ood”). For these reasons, this Article takes issue with the particular manifestation of Presidential Administration present in the non-regulation of GMOs (“Genetically Modified Organisms”). As an alternative, it proposes a more adequate regulatory framework that better balances biotech corporations’ and the public’s interest in adequate and equitab le regulation. The proposed regulatory framework will focus on providing proper environmental safeguards against the harm caused by b ioengineered crops and foods, as well as considering how an improved framework could encourage biotech companies to work with small farmers in order to help foster sustainability. Finally, the Article considers possible changes to laws affecting administrative agencies to help reduce the exercise of undue influence by interest groups on future regulations. To do so, this Article is divided into the following parts: Part I discusses the application of the Presidential Administration doctrine to biotechnology; it identifies the flaws with that particular approach and explains why a better ap p roach is needed. Part II outlines the sources of laws and the agencies responsible for regulating genetically altered foods. Part III discusses the Supreme Court’s first ruling regarding genetically modified crops in Monsanto C o . v. Geertson Seeds Farms as an example of the conflicts congressional54 silence creates. Part IV discusses problems with the current judicial standard of review applied to agencies’ decisions. Part V explores the detrimental imp act of b iotechnology on poor farmers, both in the United States and abroad. Part VI proposes better paradigms for dealing with bioengineered foods and calls for specific congressional guidance in that area. Finally, Part VII presents the European approach as a potential model for grassroots lobbying. I. THE DANGERS OF PRESIDENTIAL ADMINISTRATION IN ADMINISTRATIVE LAW G ENERALLY AND IN THE BIOENGINEERED CONTEXT PARTICULARLY The development of bioengineered foods is rooted in contradictory policies. On the one hand, the proponents of bioengineered foods argue that the new products may, someday, be essential in preventing famine, surviving in extreme conditions. In addition, certain scientists view bioengineered, pest-resistant55 plants as ultimately helpful to the traditional farming industry. O p ponents of56 57 biotechnology, on the other hand, point to the great harm that these products58 274 INDIANA LAW REVIEW [Vol. 46:265 59. V an T assel, supra n ote 5 7 , at 2 2 9-3 0 . 6 0 . GOVERNING R ISKS IN GM AGRICULT URE 2 6 (M ichael B aram & M athilde B ourrier eds., 2011) [hereinafter GOVERNING R ISKS]. 61. K agan , su p ra n ote 2 , at 2 3 25 -2 6 (“ [U ]n itarian s argu e th at . . . Article II of th e C onstitution establishes a President w ith plenary control over all h eads of agencies involved in executing, im plem enting, or adm inisterin g federal law . . . . [U ]nitarians insist that the C ou rt has allo w e d C o n g ress too m u ch pow er to in su late th e agen cies from th e P residen t. Alth ou gh focu sin g on th e q uestion of rem oval, the un itarian position equ ally w ould bar legislative inroads into th e P resident’s directive au thority.” (footnotes om itted)). 62. Keith W erh an, D eleg a lizin g A d m in istra tive L a w, 1 9 9 6 U . ILL. L. R EV. 4 2 3, 4 2 7-2 8 (“ T h u s, u n der th e tradition al m odel of adm in istrative law , th e agen cies h ave th e dom in an t decision m aking authority, not the W hite H ou se.”). 63. Kagan, supra n ote 2 , at 2 3 63 -6 4 . 6 4 . Id . at 2 3 18 . 6 5 . Id . a t 2 2 4 6 (“ B ecau se of th e stakes of th e con test an d th e stren gth of th e claim s an d w eapon s possessed by the contestants, no single entity has em erged finally trium ph ant, or is ever likely to do so. B ut at differen t tim es, on e or an oth er has com e to the fore an d asserted at least a com parative prim acy in setting the direction and influencing the outcom e of adm inistrative process. In this tim e, that institu tion is the Presidency. We live today in an era of presidential adm inistration .”). 6 6 . Id . at 2312 (“T he strengthened role of party leadership w ithin C on gress and the increased use of the filibu ster both reflect and exacerbate this heigh tened polarization — and thereby further dim the prospect for real legislative achievem ent in the context of divided governm ent. It is not will cause in the long run. Considering that the bioengineered food market has59 grown into a market worth over $2.5 billion in the last decade––some estimate that it is two/third of the food market––these opponents also contend that the interests of the regulating agencies are misplaced, unevenly favoring biotech comp anies at the expense of customers. The unchecked use of presidential60 authority at the inception of biotechnology seems to strengthen these arguments. Over the years, unitarians and traditionalists have disagreed on the degree6 1 62 of p residential power warranted in the area of administrative law. In the last decade, however, Justice Kagan, then Professor Kagan, departing from both schools of thought, put forth a more nuanced argument. In her article, Presidential Administration, Justice Kagan posited that a form of deference should be accorded to the President’s involvement in administrative law as a more efficient form of policy setting. As Justice Kagan documented, deliberate63 and aggressive policy setting b y the President has been occurring in administrative law these last few decades. Justice Kagan aptly coined this trend64 as “Presidential Administration.” Justice Kagan’s proposal and observations are65 laden with import both for our traditional exploration of administrative law and for new technology— like biotechnology— that Congress has not yet expressly regulated. Added deference to agencies because of the President’s involvement in this context has deep ramifications. Party politics that lead to stagnation in the legislature have encouraged the use of Presidential Administration for regulatory and non-regulatory purposes.66 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 275 surprising, given these ch an ges in the political lan dscape, that a P residen t w ou ld turn to a d m in istration — a sph ere in w h ich h e u n ilaterally can take decisive action . T h e m ore th e dem a n d s on th e P re siden t for policy leadersh ip in crease an d th e less h e can m eet th em th rou gh legislation , th e greater h is in cen tive to tap th e altern ate sou rce of su pply derivin g from h is position a s h e ad o f the federal bu reau cracy.”). 6 7 . S ee, e.g ., id . at 2247 (“In the first m on th of his tenure, R eagan issued an executive order creatin g a m ech an ism by w h ich th e O ffice of M an agem en t an d B u dget (O M B ), an en tity w ith in th e E xecutive O ffice of the Presiden t (E O P ), w ou ld review all m ajor regulation s of executive branch agencies. As R eagan’s and then B u sh ’ s term s proceeded, the antiregulatory effects of this system of review becam e increasingly evident . . . .”). 6 8 . S ee, e.g ., id . at 2247-48 (“P resident C linton issued his ow n executive order providing for O M B review of regulation s . . . in a w ay generally sym pathetic to regulatory efforts.”). 6 9 . Id . at 2348-49 (proposing that presidential influen ce over adm inistrative action is m ore desirable th an con gression al in flu en ce , a s presiden tial action is less fu n ction al, w h ile also bein g m ore representative an d efficien t, than that of the legislature). 7 0 . Id . at 2251 (accepting “C ongress’s broad pow er to insulate adm inistrative activity from the President,” but arguing “that a statutory delegation to an executive agency official— although not to an independent agency head— usually shou ld be read as allow ing the P resident to assert directive au thority . . . over the exercise of the delegated discretion ”). 7 1 . S ee, e.g ., id . at 2248 n.5 (discussing variou s authors w hose view s are consistent w ith that of then Professor Kagan for extending presidential influen ce in adm inistrative decision m aking). 7 2 . Id . at 23 26 (“I do not espouse the un itarian position in this Article, instead takin g th e S u prem e C ou rt’s rem oval cases, an d all that follow s from them , as a given.”); id . at 2 3 2 7 (“ W h en the delegation in question runs to the m em bers of an indepen dent agency, the choice” as to w hether P residential Adm inistration is auth orized “seem s fairly obvious. In establishing such an agency, C on gress has acted self-consciou sly, by m eans of lim iting the President’s appointm ent and rem oval pow er, to insulate agency decisionm aking from the President’s influence . . . . [M ]aking the heads [of these independent agencies] su bordinate in [any] single w ay w ou ld su bvert the very structure an d prem ises of the agen cy.”). 7 3 . S ee, e.g ., T h om as O . Sargentich, T he E m ph asis on the Presid ency in U .S. Public Law: A n E ssa y C ritiq u in g Presid en tia l A d m in istra tio n, 5 9 ADMIN L. R EV. 1 , 1 5 (2 0 0 7) (“ T h e ch ief poin t For example, Justice Kagan argues that while Presidents Bush and President Reagan exercised Presidential Administration to de-regulate, President Clinton67 exercised it to foster a regulation-focused trend in certain areas. Justice Kagan68 paints an attractive picture of presidential control over administrative rule making as a multi-faceted tool, capable of encouraging efficiency and accountability.69 Justice Kagan argues that this practice is most useful and benign in instances when C ongres s delegates broad powers to agencies without specific mention of authority delegation to an independent agency head. Justice Kagan is not the70 first to p ropose that some type of broad power should be granted to the President in administrative law. Unlike, the unitarians, however, Justice Kagan’s proposal71 limits the President’s power to participate in rulemaking to non-independent agencies. By excluding independent agencies, Justice Kagan received72 substantial criticism from the unitarians for not going far enough in recognizing presidential power. Traditionalists, on the other hand, concerned with73 276 INDIANA LAW REVIEW [Vol. 46:265 of distinction betw een the perspective of D ean Kagan an d u n itarian executive branch theorists involves the constitution ality of indepen dent regulatory agencies. T he authorizing statutes of such agen cies, am on g oth er th in gs, lim it presiden tial au th ority to rem ove th e a gen cy h eads, providin g for their rem oval only for inefficiency, neglect of duty, or m alfeasance in office. U nlike such officials, execu tive a g en c y h e ad s c an be rem oved by th e P residen t for an y reason , or at w ill. T h e unitarian theorists argue that constraining the President’s ability to rem ove any agency heads offends th e constitutional text, stru cture, an d original intent.” (footnotes om itted)). 74. Karl M anheim & Allan Ides, T he U nitary Executive, 29 L.A. LAW. 24, 29 (2006) (“At its extrem e, u nitary execu tiv e th eory holds th at executive pow er is as broad as th e executive says it is. T he unitary executive theory— w hen blended w ith other theories of inherent pow er, especially du rin g w artim e— too often leads to excesses, su ch as th ose th at h ave occu rred in th e con du ct of th e w ar on terror.”). 75. Kagan, supra n ote 2 , at 2 3 26 -2 7 . 7 6 . Id . 7 7 . Id . 78. Scott A. Keller, D ep o liticizin g Ju d icia l R eview o f A g en cy R u lem a kin g, 8 4 WASH L. R EV. 4 1 9 , 4 3 8 -3 9 (2009). p residential overreaching, think her proposal goes too far. Their concerns are74 all the more relevant in light of renewed debates over the creation of an imperial presidency. This Article is limited to analyzing the imp ort of presidential control on administrative agencies’ treatment of b ioengineered foods. It further argues that a form of the Presidential Administration defined by Justice Kagan has already taken place in regard to bioengineering. Then Professor Kagan argued that, in the ab sence of congressional restriction, courts, when reviewing administrative decisions, should infer that Congress anticipated presidential control of the administrative process. According to Kagan, 75 [i]f Congress, in a particular statute, has stated its intent with respect to presidential involvement, then that is the end of the matter. But if Congress, as it usually does, simply has assigned discretionary authority to an agency official, without in any way commenting on the President’s role in the delegation, then an interpretive question arises. One way to read a statute of this kind is to assume that the delegation runs to the agency official specified and to that official alone. B ut a second way to read such a statute is to assume that the delegation runs to the agency official specified, rather than to any other agency official, but still subject to the ultimate control of the President. The lawfulnes s of a President’s use of directive p ower depends on the choice between these two readings.76 This presidential presumption should, according to then Professor Kagan, lower the level of scrutiny applied by courts in reviewing agencies’ decisionmaking related to errors of process. This, then, would change the hard look doctrine,77 which requires that courts scrutinize whether agencies have taken a hard look at all the evidence and alternatives before making a decision. Under Kagan’s78 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 277 79. Kagan, supra note 2, at 2380 (“A revised [“hard look”] doctrine w ould acknow ledge and, in deed, prom o te [a] vision cen tered on th e political leadersh ip an d accou n tability provided by th e P resident. T his approach, sim ilar to th e on e I h ave con sidered in discussing the C hevron doctrine, w ou ld relax th e rigors o f h a rd look review w h en dem on strable eviden ce sh ow s th at th e P residen t has taken an active role in, and by so doing has accepted responsibility for, the adm inistrative decision in question .” (footnote om itted)). 8 0 . See C h e v ro n , U .S .A., In c. v. N atu ral R es. D ef. C ou n cil, In c., 4 6 7 U .S. 8 3 7, 8 4 2-4 4 (1984). 8 1 . See Kagan, supra n ote 2 , at 2 3 50 . 8 2 . Id . (“In tw o different respects, the answ er to this threat of presidential law lessness cannot lie in the hands of the current C on gress. First, and apparently com pou nding the threat, C on gress possesses neither the tools nor the incentives effectively to counter w rongful assertions of presidential au thority. C on gress cannot easily obtain the tw o-thirds vote in each hou se n ecessary (given the President’s veto pow er) to overturn a presidential order. And the C on gress existing at th e tim e of th e order m ay h ave n o desire to en force th e en actin g C on gress’s determ in ation of th e appropriate scope of adm inistrative discretion. B ut second, and now placing the threat in som e perspective, this very lack of continuity in congression al preferences suggests that in the absence of strong presidential control over adm inistration, a sim ilar, even if not fully equivalent, threat of congressional law lessness m ight arise to fill the resulting vacuum . For any given C ongress (or m ore precisely, its com m ittees and subcom m ittees) also m ay be disposed to press agencies to engage in conduct unauthorized by prior statute. T he threat of law lessness thus cannot exclusively be associated w ith presidential control.”). proposal, evidence of presidential involvement in the decisionmaking would relax the “hard look” standard.79 This proposal sets up a deep entanglement between the President’s office and the regulatory agencies that goes beyond mere reporting and, instead, substantially changes the courts’ approach to congressional silence in matters of administrative law. What is more, giving deference to Presidential80 Administration seems to conflate the legislative and executive branches in a way that makes it more difficult for the two branches to check each other. It is true,81 as then Professor Kagan argues, that reliance on Congress alone as a check on Presidential Administration can be limited. Still, the dangers of Presidential82 Administration become salient when one examines the case of genetically altered foods. In 1986, the President’s Office of Science and Technology Policy announced A “Coordinated Framework” for federal regulation of “biotechnology products” . . . . It stands as the only policy guidance on federal oversights and regulation of genetically engineered products, including GM crop s and foods. It assigns oversight roles to four federal agencies, asserts that p reviously enacted laws that empower these agencies are sufficient for regulating GM products risks, and warns the agencies that any GM product regulations they enact should be based solely on end product risks without consideration of biotechnological processes involved in making the products. Because Congress has not acted to amend or 278 INDIANA LAW REVIEW [Vol. 46:265 8 3 . GOVERNING R ISKS, supra n ote 6 0 , at 2 6 . 8 4 . See Annou ncem en t of Policy, E xercise of Federal O versigh t Within Scope of Statutory Authority: Planned Introductions of B iotechnology Products in to th e E nvironm ent, 57 Fed. R eg. 6753-01 (O ffice of Sci. & T ech. Pol’y Feb. 27, 1992). 8 5 . Id . at 27. 8 6 . Id . 8 7 . Id . at 2 7 -2 8 . 88. M arden, supra note 39, at 7 38. 8 9 . S ee Sheryl Law rence, C om m ent, What Would You D o with a Fluorescent G reen Pig ? : H o w N o vel T ra n sg en ic Pro d u cts R evea l Fla ws in th e Fo u n d a tio n a l A ssu m p tio n s fo r th e R eg u la tio n o f B io tech n o lo g y, 3 4 ECOLOGY L.Q . 20 1 , 2 4 4 (2 0 0 7) (“H ow ever, because the field of genetic en gin eerin g is re latively n ew an d h as advan ced so q u ickly in recen t years, th ere is trem en dou s uncertainty regarding the existence an d degree of risk presen ted by GM O s an d their progeny.”). 9 0 . See gen era lly Fran cer, supra n ote 1 5 , at 277-90 (discussing “Genetically M odified Food R egulation in the E uropean U nion ”). 91. Law rence, supra note 89, at 244 (“T h e policy decision s m ade in the C oordinated Fram ew ork w ere in spired, at le ast in p a rt, by th e goal of lim itin g regu latory restriction s th at m igh t ham per th e developm ent of th e prom ising and fledgling biotechnology industry.”). 92. M arden, supra note 39, at 741 (“T he R eport ch aracterized federal agencies as override this presidential policy it has been dutifully followed by the designated agencies, including the assigned to GM crops and foods.83 A more detailed version of this p olicy was reissued in 1992. According to the84 directives, the agencies were to use a cost-benefit analysis in assessing risks and determining if the value of additional oversight outweighed its cost. In addition,85 regulators were “further directed to minimize regulatory burdens on product developers, accommodate rapid advances in product development and commercialization, and use flexible performance-based standards rather than rigid p rescriptive or design standards to deal with end product risks.” The directives86 gave developers the benefit of the doubt regarding the level of care, review, and testing required p rior to placing products on the market. The initial policy87 statements regarding the treatment of bioengineered foods purported that (1) U.S. policy would focus on the product of GM techniq ues , not the process itself, (2) only regulation grounded in verifiable scientific risks would be tolerated, and (3) GM products are on a continuum with existing products and, therefore, existing statutes are sufficient to review the products. Within these tenets, industry would be encouraged to continue its rapid pace of development without regulatory impediments.88 T his is radical considering that little was known of this new technology and its potential effect on traditional crops and/or health risks. To recommend full89 support for these products without a rigorous vetting process denotes a desire90 to encourage market growth to the exclusion of other concerns. Under the91 above guidelines, agencies have felt free to develop a minimum approach to regulation of bioengineered foods. Additionally, this approach pushed agencies92 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 279 ‘gatekeepers’ to the developm ent and use of biotechnology. T he docu m ent specified that in order to not inh ibit grow th, the governm ent should presum e that a product poses a m inim al risk in th e absen ce o f a n y e v iden ce to th e con trary. O n th is basis th e docu m en t in dicated ‘[th at th e Adm in istration w ould seek] to elim inate un needed regulatory burdens on all phases of th e developm en t of new biotechnology produ cts— laboratory an d field experim en ts, produ cts developm en t, an d eventual sales and u se.’” (alteration in original) (footnote om itted)). 9 3 . See id . at 748 (“U ltim ately, the 1992 FD A Policy’s GM definition facilitated the view that the risks associated w ith the technology w ere no different from those posed by traditionally produ ced foods.”). 94. R ich, supra note 14, at 904 (footnotes om itted) (recogn izing C on gress’s lack of response to address agency interpretation s of issues related to gen etically m odified products, leading to broad judicial deferen ce to such agen cy interpretation s). 9 5 . See V an T assel, supra n ote 5 7 , at 2 2 9. 9 6 . Id . 97. H om er, supra n ote 1 1 , at 8 5 -8 6 . 98. H arold J. Krent, Separating the Strand s in Separation of Po wers C ontroversies, 7 4 V A. L. R EV. 1 2 53 , 1 2 93 (1 9 8 8) (“ T h e C on stitu tion does n ot place com parable in tern al ch ecks u pon th e executive branch. . . . [T ]he fram ers presum ably believed that such internal checks, aside perhaps from the appointm ents clause, w ere not necessary because the C on stitution already circum scribed execu tive action con siderably by con fin in g it to th e term s of c o n g ression al directives. E n su rin g fidelity to congressional directives provided a m easure of accountability because the legislative enactm ent itself had previously been ‘checked’ in a constitution al sen se. In addition, the need for dispatch in enforcing the law s m ilitated against any cum bersom e requirem ents delaying executive action . Gen erally, the executive m ay therefore act free of an y procedu ral hurdles w ithin the sphere to instantaneously treat biotech foods as identical to traditionally grown foods.93 Congress, even in the face of great objections and public concern, has not deemed it fit to intervene, thereby leaving the agencies to implement presidential94 directives. This is still the case in the face of current evidence available on the effects of bioengineered crops on the traditional farming market, even if the health effects are still too remote to determine. As observers have argued, 95 The FDA’s p resumption that GM plant foods are bioequivalent to traditional food is a consequence of the remarkable growth in the development of new technologies, which far outpaces the science necessary to identify the human health risks associated therewith. This scientific lag time creates a period when there is an information void with regard to risks to human health.96 The unrestrained freedom granted to biotech companies has culminated in the pending approval of the first genetically modified salmon. The bioengineered97 context demonstrates, thus, that Presidential Administration, even if capable of positive outcomes, should not remain unchecked. In cases of first impression and great public concern, as with biotechnology, it is imp erative that Congress p rovides a balance by issuing specific guidelines. Congressional directives provide the added element necessary for adequate, even if not always perfect, checks and balances of the three branches of government. 98 280 INDIANA LAW REVIEW [Vol. 46:265 of action allow ed by Con gress.” (footnote om itted)). 9 9 . See R ich, supra note 14, at 901-02 (“P roponents of GM O s, including the federal governm ent, enthusiastically em braced biotechnology w ithou t seriou s investigation of the potential problem s in w hat am ou nted to a ‘don’t look, don’t see policy.’”). 1 0 0 . Id . (footnotes om itted). 101. 5 U .S.C . §§ 551-559 (2006 & Supp. V 2011). 102. E llison, supra n ote 3 3 , at 3 4 9. 103. 42 U .S.C . §§ 4321-4370 (2006 & Supp. V 2011). 104. 7 U .S.C . §§ 7701-7786 (2006 & Supp. V 2011). As it stands, due to presidential directives at its inception, biotechnology is still not substantially checked and evaluated by agencies. For example, 99 [t]he USDA issues permits for trials of new GM crops, but once they enter into commercial production, the agency has no mandate to oversee them. The EPA has responsibility for any new variety producing its own insecticide, but relies on company-provided data, and is not required to do follow-up inspections or independent monitoring. The FDA is responsible for regulating new foods and food additives under the authority of the Federal Food, Drug, and Cosmetic Act. In 1992, the FDA decided that genetically modified foods would not require FDA approval, except when food safety questions exist sufficient to warrant pre-market review.100 This lack of supervision and follow-through is mind-boggling. It can only be understood in light of the presidential policy encouraging economic growth in an unknown area, without substantially monitoring the potential health risks and the negative impact on small farmers. Such unilateral policy setting runs counter to the purposes of administrative policy setting and overall governance. Still, to fully understand how genetically modified crops and foods are regulated, one must understand the delineation of responsibilities in that context. II. SOURCES OF LAW FOR REGULATING BIOENGINEERED FOODS A. Agencies’ Structure and Responsibilities Three major federal agencies, whose powers are established by the Administrative Procedure Act (“APA”), monitor our food supply — The Food101 and Drugs Administration (“FDA”), the United States Department of Agriculture (“USDA”), and the Environmental Protection Agency (“EPA”). These three102 agencies delegate authorities to subsidiaries that are controlled b y various statutory review procedures. In the case of bioengineered foods, the National Environmental Policy Act (“NEPA”) and the Plant Protection Act (“PPA”)103 104 provide guidelines and requirements for regulating foods and plants. Courts, in evaluating compliance under these acts, abide by specific standards of review. For example, in the context of plants, the PPA authorizes the Secretary of the 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 281 1 0 5 . Id . § § 77 0 1 (2 )-(3 ), 7 7 02 (1 6 ), 7 7 11 -1 2 . 106. 7 C .F.R . § 340.0(a)(2) & n.1 (2013). 107. M arden, supra note 3 9, at 777 (“In the proposed policy, E P A coined the term ‘plan t- pesticide’ to refer to GM products under E P A authority. B y definition , a ‘plant-pesticide’ w as a ‘ pesticidal substance that is produced in a living plant and the genetic m aterial necessary for th e produ ct of th e pesticidal su bstan ce, w h ere th e pesticidal su bstan ce is in ten ded for u se in th e livin g plant.’ E P A also m ade clear that it considered its existing review and risk assessm ent procedures adequ ate for GM products. Like FD A, E P A stated that its approach w ould be product-based: ‘E P A in dicates th at it proposes to focu s its regu la to ry atten tion on th e plan t-pesticide an d n ot on th e plan t per se.’” (footnote om itted)). 108. N eil A. B elson, U S R egulation of A gricultu ra l B iotechnology: An O verview, 3 J. AGROBIOTECHNOLOGY M G M T. & E CON. 268, 269 (2000), a va ila b le a t http://w w w .agbioforum . org/v3 n4/v3 n4a1 5-belson.pdf; see also B ratspies, supra note 4 1 , at 4 07 (“At its m ost superficial, the regulatory regim e establish ed by the C oordinated Fram ew ork is very easy to describe: the FD A is responsible for food safety, th e E P A is responsible for m icrobes and pesticides, and . . . (AP H IS) is respon sible for all plan ts.”). 109. E llison, supra note 3 3, at 350 (internal quotation m arks om itted). USDA to regulate plant pests. The Animal and Plant Health Inspection Service105 (“APHIS”), a subsidiary of the USDA, oversees “the introduction of organisms and products altered or produced through genetic engineering that are plant pests or are believed to be plant pests” or “regulated articles.” Furthermore, the EPA106 regulates plants that emit pesticides.107 B. The Regulatory Framework: The FDA, the USDA and the EPA The regulatory system of biotech products is a tri-partite collaboration: [T]he US Department of Agriculture (USDA), the US Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) share primary responsibility for regulating biotechnology. The United States Department of Agriculture reviews biotechnology-derived ap p lications, which contain or are produced using potential plant pests. The United States Department of Agriculture also regulates veterinary biologics, which are products derived from living sources, such as blood products and vaccines, and is largely responsible for assuring the safety of meat and poultry products. The Environmental Protection Agency regulates biotechnology-derived plant or microbial pesticides or new chemical substances. The Food and Drug Administration, which regulates the safety of most foods, drugs for human or animal use, biologics for human use, and medical devices, is the lead regulatory agency with respect to these products.108 A division of the USDA, the Animal and Plant Health Inspection Service (“APHIS”), regulates field tests and the shipment of bioengineered products; provides permits “for the imp ort, interstate movement, and field testing of genetically altered plants, microorganisms, and invertebrate;” and oversees “the109 282 INDIANA LAW REVIEW [Vol. 46:265 110. From povicz, supra n ote 5 6 , at 2 8 0-8 1 . 1 1 1 . Id . at 2 8 1. 112. B elson, supra note 108, at 2 70 (footnotes om itted). 1 1 3 . Id . at 2 7 0-7 1 . 1 1 4 . Id . at 2 7 1 (explain in g th at after de-regu lation , “ neith er th e produ ct n or its offsprin g req uire further AP H IS review for m ovem en t or release w ithin the U nited States”). 115. 21 U .S.C . §§ 301-399f (2006 & Supp. V 2011). 116. M cGarity, supra note 40, at 4 32. movement of plants . . . developed through genetic engineering” in the event they cause “a risk of plant pest introduction, spread or establishment.” A “plant110 p est” is an organism “which can harm plants either directly or indirectly.”111 Ultimately, then, APHIS is in charge of protecting US agriculture from pests and diseases. When a bioengineered plant is developed for testing or interstate shipment, it falls under the statutory definition of “regulated article,” which triggers a duty to notify APHIS: A “regulated article” is defined in APHIS regulations as “any organism which has been altered or produced through genetic engineering” if the donor organism, recip ient organism, vector or vector agent is a “plant p est.” The Animal and Plant Health Inspection Service defines a plant pest broadly to include “ any living stage” of insects, bacteria, fungi, viruses, or various other organisms which can damage or cause injury to plants or plant parts. Many plant p athogens commonly used as vectors or promoters in agricultural biotechnology, such as Agrobacterium species and cauliflower mosaic viruses, are considered “plant pests” under APHIS regulations. Use of any of these “p lant pests” to make a transgenic p lant makes that plant a “regulated article.” The Agency may also designate as a regulated article any product of genetic engineering which the Agency determines or has reason to believe is a plant pest.112 Additionally, a plant must be deemed by the APHIS “deregulated” in order to be commercialized and transported. Theoretically, once a company petitions for deregulation, researchers are to conduct research and tests for a length of time to determine the potential effects of the plant on others. This fact and similar113 mandates should give the APHIS and other agencies broad power to regulate bioengineered plants, regardless of the modification. In reality, however, strict monitoring of modified plants does not occur. Instead, major problems have114 arisen in the regulation of genetically altered foods, the regulation of pesticidal plants by the APHIS, the FDA, and the EPA pursuant to the Federal Food, Drugs, and Cosmetic Act (“FDCA”).115 Similarly, the power to regulate food additives can be instrumental to the FDA’s oversight of b ioengineered foods. Section 402(a)(1) of the FDCA provides the agency with the p ower to regulate noxious foods and to monitor substitutions in food composition. According to the Act, a substance contains:116 (a) Poisonous, insanitary, etc., ingredients 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 283 117. Federal Food, D rug, an d C osm etic Act, 21 U .S.C . § 342(a)(1) (200 6 & Supp. V 2011). 118. Francer, supra n ote 1 5 , at 2 6 8-6 9 . 1 1 9 . See B ratspies, supra n ote 4 1 , at 4 0 7. 1 2 0 . Id . at 4 0 7-0 9 . 121. Federal Food, D rug, an d C osm etic Act, 21 U .S.C . § 342(b)(1 ) (2006 & Supp. V 2011). (1 ) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health[; or] (2)(A) if it bears or contains any added poisonous or added deleterious sub stance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 346 of this title; or (B) if it bears or contains a p esticide chemical residue that is unsafe within the meaning of section 346a of this title; or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 348 of this title; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 360b of this title; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation . . . .117 This section could cover some bioengineered products. It speaks to the big elephant in the room in the b ioengineering debate: though the FDA regulates poisonous and deleterious sub stances, which are hazardous to health, it has not classified bioengineered products as such. In reality, the FDA has refused to118 avail itself of the power provided by statute. Consequently, most genetically119 modified foods are not classified as harmful because of the application of the mandate that they be treated like their traditional counterparts. 120 In addition, foods can also be classified as adulterated: (1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.121 284 INDIANA LAW REVIEW [Vol. 46:265 122. M cGarity, supra n ote 4 0 , at 4 3 4. 1 2 3 . See gen era lly E d W allis, Fish G enes into Tom atoes: H o w the World R egulated G enetically M od ified Food s, 80 N .D . L. R EV. 4 2 1 , 4 2 6 -2 7 (2 004). 1 2 4 . See, e.g ., M cG arity, supra note 4 0, at 434-35 (recogn izing the FD C A’s broad au thority to regulate food additives under § 402(a)(2)(c) of the FD C A). 1 2 5 . Id . at 4 3 6 -4 0 (“ U ltim ately, th e [FD A] leaves it u p to th e m an u factu rer to determ in e w hether an added su bstance is [generally recogn ized as safe].”). 1 2 6 . Id . at 435 (internal quotation m arks om itted). 1 2 7 . Id . at 4 3 4-3 6 . 1 2 8 . Id . at 4 3 8-4 0 . 129. B ratspies, supra n ote 4 1 , 4 0 8-0 9 . 130. M arden, supra n ote 3 9 , at 7 5 9-6 0 . 1 3 1 . Id . at 747 (“T he 1992 FD A Policy had tw o pu rposes. First, it ou tlined the agency’s view that m ost GM products w ere presum ed or likely to be GR AS, and therefore not subject to food additive review . In addition , it established a voluntary pre-m arket consultation process to reassu re com panies and the public that the food supply w as being safeguarded.”). 132. R ebecca M . B ratspies, M yths of V oluntary C om pliance: Lessons from the StarLink C orn This last characterization applies squarely to bioengineered foods. Despite the fact that some GM foods are the result of genetic substitutions and modifications, “the agency has not invoked its authority.” As a result, agency regulations122 determine that most G M foods are unadulterated.123 Instead, the FDA has relied on its power to implement regulations in ways124 that ab solve biotech companies of responsibilities. While the statute provides support for closer scrutiny of these foods during the approval process, the FDA125 seems to have relinquished that role. The FDA is only permitted to approve a food additive petition if the applicant is able “to demonstrate to a reasonab le certainty that no harm will result from the intended use of the additive.” Such126 a review triggers closer scrutiny by the agency and imposes higher burdens on the company to submit materials proving lack of harm. Nonetheless, the agency127 allows genetically modified foods to undergo a less burdensome process whereby the G MO products can be “generally regarded as safe” (GRAS). Consequently,128 “ [i]n most cases, the substances expected to become components of food as a result of genetic modification of a plant will be the same as or substantially similar to substances commonly found in food, such as proteins, fats and oils, and carbohydrates.” Due to the presumption that modified foods have GRAS129 status, the FDA has also decided not to mandate specific labeling of foods derived from genetically modified plants. Further, determining whether a proposed130 food is GRAS is left to the manufacturer, with only a voluntary consultation process in place in the event the manufacturer wants to consult and seek approval from the FDA prior to marketing. In essence, the FDA seems to have wholly131 delegated its power of review to the very manufacturers whose economic interests run counter to the regulations. Moreover, this deference discourages manufacturers from thoroughly investigating possible risks and latent defects in their proposed products. This lack of regulation is directly connected to the132 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 285 Fiasco, 2 7 WM. & M ARY E NVTL. L. & P OL’Y R EV. 593, 609 (2003) [h ereinafter B ratspies, M yth s of V oluntary C om pliance] (“In developing this policy, FD A conducted no independent research on the effects of genetic engineering on foods, nor did th e agency require m anufacturers to engage in such research. Instead, the policy w as th e produ ct of a political decision to sm ooth a path for this new tech nology. E ven m ore troubling, FD A allow s m anufactu rers to m ake this GR AS determ in ation u nilaterally. T h is approach tran sfers a trem en dou s am ou n t of d isc retion from th e regulatory authority to the regulated com m unity. M anufacturers need not subm it vetted scientific data to convince FD A that a GM crop is GR AS. Instead, FD A perm its m anufacturers to m ake this evaluation entirely on their ow n. N ot surprisingly, m ost m anufacturers have concluded th at their GM products are GR AS and th u s exem pt from expensive and rigorous pre-m arket review . O f cou rse, even w ithou t regulation these m anufacturers do have pow erful incentives not to m arket products they know or suspect to be harm ful. A GM food that causes an allergenic reaction or oth erw ise th reaten s h u m an h ealth w ou ld b e su bject to FD A seizu re, an d th e com pan y, in clu din g its responsible officers, m igh t face crim inal prosecution . And that is not to m ention tort liabilities or the devastating effect such a product w ou ld h ave on the com pany’s reputation .” (footnotes om itted)). 1 3 3 . S ee M arden, supra note 39, at 747 (“T hus, a m em orandu m from FD A C om m ission er D avid Kessler, M .D ., to the Secretary of H ealth and H um an Services, dated M arch 20, 1992, states, ‘T he approach and provision s of the [1992 FD A Policy] are consistent w ith the general biotechnology policy established by the O ffice of th e President in the recently published ‘scope’ docum ent. It also responds to White H ouse interest in assuring the safe, speedy developm ent of the U .S. biotechnology indu stry.’” (alteration in original)). 134. P eck, supra note 22, at 256 (suggestin g th at the 1992 FD A Policy is not rooted in “objective scien tific principles” since the 1992 FD A Policy, the Final Statem ent, and O STP docu m en ts in su pport of th e P olicy “ state con clu sion s abou t th e safety of bio te ch n o lo g y w ith ou t articu latin g th e scien tific m eth ods, research , areas of debate or u n certain ty, or m ean s of arrivin g at a co n sensus opinion that biotechnology poses no distinct risks from other m ethods of m odification ”). 135. N otice, Statem ent of Policy: Foods D erived from N ew Plant V arieties, 57 Fed. R eg. 22,984-01 (Food & D rug Adm in. M ay 29, 1992). initial command in 1986, at the inception of b iotechnology, from the White House OST directing agencies to treat modified foods as substantially equivalent to traditional foods. In the ab sence of guidance and checks from Congress and133 courts, this policy has led to an inadequate approval process for bioengineered foods. As a result, since 1986, the President’s office––rather than Congress, the courts, the administrators, or even the public––has had the most enduring influence on the legal treatment of bioengineered foods. Under our governmental structure, this should not be the case. In addition, there is still too much to uncover regarding the safety of bioengineered foods. 134 The other source of regulatory power for the FDA, with respect to bioengineered products, relates to the supervision of genetically modified, pest- resistant plants. FDA regulations divide these types of plants into two categories: (a) plants genetically modified to express pesticides and (b) plants genetically enhanced to be resistant to herbicides. T he FDA regulates the latter, but it1 3 5 286 INDIANA LAW REVIEW [Vol. 46:265 136. M cGarity, supra n ote 4 0 , at 4 3 3. 1 3 7 . Id . at 465-66 (footnotes om itted). 138. B elson, supra n ote 1 0 8 , at 2 7 2, 2 7 4 (explain in g th at th e E P A’s “ en ablin g statu tes are “ th e Federal In secticide, Fu n gicid e a n d R oden ticide Act (FIFR A); th e Federal Food, D ru g, an d C osm etic Act (FFD C A); and the T oxic Substances an d C ontrol Act (T SC A),” and that the FD A de rives its au th ority from th e FFD C A, w h ich “is th e n ation ’s prin cipal statu te for regu latin g th e safety of the n ation ’s food and drug su pplies”). 139. M cGarity, supra note 40, at 4 64 (footnotes om itted). T h e FIFR A is codified at 7 U .S.C . §§ 136-136y (2006 & Supp. V 2011). 140. 7 U .S.C . § 136(a)(5)(D ) (2006 & Supp. V 2011). 141. M cGarity, supra note 4 0, at 465 (internal quotation m arks om itted). 142. Federal Food, D rug and C osm etic Act, 21 U .S.C . § 346a(a)(1 ) (2006). 1 4 3 . Id . § 346a(b)(2)(A)(i). 1 4 4 . Id . § 346a(b)(2)(A)(ii). 1 4 5 . Id . § 346a. 146. Karen A. Goldm an, L abeling of G enetically M od ified Fo od s: Legal and Scientific Issues, 1 2 GEO. INT’L E NVTL. L. R EV. 717, 747 (2000). delegated authority in 1992 to the EPA to regulate the former. The EPA’s136 authority to regulate these items is discussed below. C. The EPA’s Power to Regulate Bioengineered Foods While the FDA regulates foods and bioengineered products, the EPA has the power to regulate bioengineered foods that express or emit pesticides. The137 EPA “exercises the primary authority for regulating pesticides under the138 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Food Drug and Cosmetic Act (FDC A).” Much like the FDA, however, the EPA has the139 power to authorize pesticides only if it determines that they are safe.140 Under this standard, the EPA deems that a product may be exempt if it “p ossesses a low probability of risk to the environment, and that is not likely to cause unreasonable adverse effects to the environment even in the absence of regulatory oversight under FIFRA.” Similarly, under the FDCA, a product may141 be exempt from being considered adulterated if the EPA demonstrates a tolerance for the pesticide in the plant or has exempted the p lant from the tolerance requirement. The EPA must set their tolerance at a “ safe” level; the FDCA142 143 defines safety as “a reasonable certainty that no harm will result from aggregate ex p osure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” The144 EPA may exempt a p es ticide residue from the tolerance requirement only if the agency finds that the residue will remain “ safe” in the absence of a tolerance in accordance with the same “reasonab le certainty of no harm” standard. Despite145 this strict standard, the EPA routinely deems classes of pesticides safe.146 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 287 147. 130 S. Ct. 2743 (2010). 1 4 8 . See id . at 2 7 64 . 1 4 9 . See id . at 2749 (describing the case as one about the deregulation of genetically en gineered affirm ed”). 1 5 0 . Id . at 2 7 55 -5 6 . 1 5 1 . Id . at 2750 (quoting 4 2 U .S.C . § 4332(2)(C ) (2006 & Supp. V 2011)). 1 5 2 . Id . at 2749 (quoting the Plant Protection Act, 7 U .S.C . § 7711(a) (200 6 )). T h e U SD A delegated the authority to prom ulgate such regulation s to AP H IS pursuant to the Plant Protection Act (“P P A”); see 7 C .F.R . §§ 2.22(a), 2.80(a)(36) (2013). 1 5 3 . GOVERNING R ISK, supra note 60, at 2 8. 1 5 4 . M o n sa n to C o ., 1 3 0 S. C t. at 2 7 50 . III. THE JUDICIARY SETTING THE TONE IN MONSANTO V. GEERTSON Monsanto Co. v. Geertson Seed Farms presents a warning about the147 potentially negative effects that might result from granting substantial deference to the President’s involvement in administrative decisions. Though the Court stayed away from an explicit exploration of the issues related to Presidential Administration, the case is instrumental in showing why the traditional hard look doctrine, applied in judicial review of administrative decisions, is vital to the adequate balancing of governmental duties and justice in administrative law.148 Monsanto Co. was the Supreme Court’s first opportunity to tackle some of the issues raised by biotechnology. Some of the b urning issues, which raise the149 most concern for the public and small farmers, such as contamination and the economic impact on traditional farming, are present in this case. In the absence150 of congressional guidance directly addressing the proper balancing of the various interests at issue, the most relevant statute in this instance is the National Environmental Policy Act (“NEPA”). NEPA imposes certain procedures, among which is the preparation of an Environmental Impact Statement (“EIS”), in relation to “‘every recommendation or report on p rop osals for legislation and other major Federal actio[n] significantly affecting the quality of the human environment.’” Plaintiffs in Monsanto Co. sued, alleging that the agency151 violated NEPA when it approved Monsanto’s genetically modified strand of alfalfa “without first completing a detailed assessment of the environmental consequences of its proposed course of action.” The USDA152 is directed . . . to enhance American agriculture and forestry and protect these sectors from harmful organisms and products. . . . Pursuant to the PPA, APHIS has authority to restrict the import, shipment, field testing, and commercial planting of GM seeds and crops, but has used its discretion to create a permissive regulatory program in keep ing with presidential policy.153 Monsanto, in this case, genetically modified a particular strand of alfalfa “genetically engineered to be tolerant of glyphosate, the active ingredient of the herbicide Roundup.” Monsanto owned the intellectual property rights in the154 288 INDIANA LAW REVIEW [Vol. 46:265 1 5 5 . Id . 1 5 6 . See P lan t P aten t Act of 1 9 30 , 3 5 U .S.C . § § 1 6 1 -1 6 4 (2 0 1 6 & Su pp. V 2 0 11 ) (aw ardin g a patent to the inventor/discoverer of a new plant variety along w ith the right to exclude others from reproducing, using, or selling the plan t “or any of its parts”). 157. T em pe Sm ith, N ote, G o in g to S eed ? : U sin g M o n sa n to a s a C a se S tu d y to E xa m in e th e Patent and A ntitrust Im plications of the Sale and U se of G enetically M od ified S eed s, 6 1 ALA. L. R EV. 629, 632 (2010) (“As of O ctober 26, 2007, M on san to had filed 112 law suits against farm ers for alleged violation s of its T echnology Agreem ent and/or its patents on genetically en gineered seeds.” (internal quotation m arks om itted)). 1 5 8 . M o n sa n to C o ., 1 3 0 S. C t. at 2 7 50 , 2 7 54 -5 5 . 1 5 9 . Id . at 2 7 54 -5 6 . 1 6 0 . Id . at 2 7 52 -5 3 , 2 7 61 -6 2 . 1 6 1 . Id . at 2 7 54 -5 5 . genetically modified alfalfa. As such, the company could sue to stop the155 unapproved use of its seeds and crops. It could, for example, seek relief, under156 intellectual prop erty theories, against farmers whose crops had inadvertently mixed with its patented, genetically engineered seeds. As a result, the Court157 determined that, in this case, the company had standing to appeal the district court’s order to enjoin the APHIS’s decision to deregulate the alfalfa strand. The potential exposure of traditional growers to these intellectual property claims and the restrictions that these patented rights imp ose on traditional farming are the added aspects of biotechnology that render traditional farmers, particularly small farmers, vulnerable. A detailed exploration of the intellectual property158 ramifications of biotechnology is, however, beyond the scope of this Article, which focuses on the regulatory practices of the food agencies. While intellectual prop erty was not the focus of the Court’s analysis in Monsanto Co., the Court, tangentially, touched on the legal treatment of claims alleging contamination and economic loss by Monsanto’s genetically modified alfalfa. In a climate of ever-increasing public frustration with agencies’159 approach to these issues, this decision, which the public eagerly awaited, p resented the Court with an opportunity to offer some guidance on the regulatory treatment of genetically altered crops. The interests at stake were numerous and diverse: protecting the pub lic from harm and contamination; protecting the public’s right to safe food as well as its right to be informed about the food it consumes; protecting the economic interests of traditional farmers; and considering the additional burdens caused b y the risks of contamination. While many hoped that the Court would take a substantial stand in the biotechnology debate, the Court in Monsanto Co., however, essentially restricted its analysis to the procedural issues of standing and the requirements for injunctive relief.16 0 The opinion ultimately revolved around the standard used by the lower court in granting injunctive relief. While this case does not squarely resolve the161 biotechnology debate, which still begs for congressional guidance, it, however, provided the Court with an opportunity to balance the interests of the various stakeholders in the debate regarding bioengineered crops, and to identify potential 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 289 1 6 2 . See Lisa A. C utts, C om m ent, What’s The B ig D eal? T he L et-D own T hat is the Land m ark M onsanto v. Geertson C ase, 2 0 SAN JOAQUIN AGRIC. L. R EV. 117, 145-46 (2011). 1 6 3 . M o n sa n to C o ., 130 S. C t. at 2761-62 (“In sum , the D istrict C ourt abused its discretion in enjoining AP H IS from effecting a partial deregulation and in prohibiting the possibility of planting in accordan ce w ith the term s of such a deregulation . Given those errors, this C ou rt need not express any view on w hether injunctive relief of som e kin d w as available to respondents on the record before us. N or does the C ou rt address the question w hether the D istrict C ou rt w as req u ired to con du ct an eviden tiary h earin g before en terin g th e relief at issu e here. T h e ju dgm en t of the N inth C ircu it is reversed, and the case is rem an ded for further proceedings consistent w ith this opinion .”). 1 6 4 . Id . 1 6 5 . See U SD A E nvironm ental Im pact Statem ent on R oundup R eady Alfalfa C om pleted; Sales C ould R esu m e in E arly 2011, M ONSANTO (D ec. 16, 2010), http://w w w .m on santo.com / new sview s/P ages/U SD A-E IS-on-roundup-ready-alfalfa-com pleted.aspx. 1 6 6 . M o n sa n to C o ., 1 3 0 S. C t. at 2 7 56 , 2 7 62 . 1 6 7 . Id . at 2764 (Steven s, J., dissen ting). 1 6 8 . Id . (alteration in original) (internal citation s om itted). harms that have often been dismissed by proponents of biotechnology. The162 Court, noticing that APHIS did not issue an EIS before deregulation, maintained the lower court’s order to vacate the deregulation order (pending the EIS), but reversed the lower court’s grant of injunctive relief. Thus, despite the Court’s163 determination that the lower court’s standard for injunctive relief was improper, it provided an ephemeral relief to food watch group s b y upholding the lower court’s vacatur of the agency’s deregulation order. This, however, did not last164 as the agency swiftly completed the EIS after the Court’s decision. Still, this165 small step and the Court’s concession that traditional growers have standing in these types of cases may open the door to future litigation on the substantive issues. This ruling was, thus, a limited victory for food rights activists. The case, however, still served an important purpose. Though, the majority in Monsanto Co. saved the resolution of the substantive issues in biotechnological farming for another day, the dissent’s analysis might prove useful in later cases. Convinced166 by the district court’s findings, the dissent would have affirmed the district court’s ruling to enjoin the partial deregulation. This would have resulted in a p rohibition against planting the modified alfalfa, which would have been a sub stantial victory for traditional farmers and food watch activists. The dissent recognized economic costs and contamination as harms that provide standing to complainants in these kinds of cases and considered that future lawsuits might be brought as a result of the APHIS’s decision to p artially deregulate. As Justice167 Stevens pointed out, in the dissenting opinion, “Contamination cannot be undone; it will destroy the crops of those farmers who do not sell genetically modified alfalfa. And because those crops cannot be replanted for two to four years, that loss will be even greater.” On the other hand, although plaintiffs could decide168 to convert to modified seed, the companies were not overly prejudiced because 290 INDIANA LAW REVIEW [Vol. 46:265 1 6 9 . Id . 1 7 0 . Id . 1 7 1 . Id . (alteration in original) (internal quotation m arks om itted). 172. Kagan, supra n ote 2 , at 2 3 42 -4 4 . 1 7 3 . See generally id . 174. N ational E nvironm ental Policy Act of 1969, 42 U .S.C . § 4 3 3 2 (2 )(C ) (2 006 & Supp. V 2011). 1 7 5 . See Fran k J. M iskiel, C om m ent, V o lu n ta ry Labeling of B ioengineered Fo od : Cognitive D issonance in the Law, Science, and Pu blic Po licy, 3 8 C AL. W . L. R EV. 223, 236-37 (2001). 1 7 6 . See R obertson, supra note 3 8, at 168 (explaining h ow “[g]en etic en gineering represen ts a radical departure from tradition al m ethods”). the seeds could be stored. Additionally, the defendants “‘were [fully] aware of169 plaintiffs’ lawsuit’ and ‘nonetheless chose to market.’” Consequently, the170 companies had no “cause to claim surprise” for any loss. This classification not171 only clearly anticipates future litigation involving concrete calculation of legal damages, but it also sends a message to the regulating agencies that failing to properly balance the interests at issue might lead to more complicated procedural issues and entangled judicial p roceedings both for the agencies and the biotech companies. The Monsanto Co. opinion, while not providing the precise formula the parties sought, illustrates the typ e of checks and balances that judicial review establishes in difficult administrative law cases and demonstrates the importance of the judiciary’s implementation of a clear and meaningful standard of review.172 This balance is crucial when dealing with the conflicting interes ts present in the b iotechnology context. Courts should follow the recommendations in Monsanto Co.’s dissent and afford putative plaintiffs an opportunity to litigate these issues. Applying a lower level of scrutiny in cases where presidential control is evident, as recommended by then Professor Kagan, would greatly hinder the173 important role that courts play in balancing interests. NEPA clearly requires the issuance of an EIS before deregulation. Had courts incorporated additional174 deference to Presidential Administration in their analyses, the outcome in Monsanto Co . might have been even more limited. In addition, such added deference could eventually cause courts to find challenges to agencies’ decisions related to biotechnology non-justiciable. IV. INADEQUATE JUDICIAL REVIEW OF AGENCIES DECISIONS Courts’ approach to these issues already gives too much deference to the agencies. Disputes often arise regarding the agencies’ regulations or interpretation of standards. This occurs when Congress does not speak directly on a particular issue. These types of disp utes are common in the case of bioengineered foods because these foods are a fairly new manifestation. Courts, in reviewing these disputes, tend to analogize these typ es of food to existing foods. T his, however, is problematic because bioengineered foods are175 substantially different from regular foods. In reviewing an agency’s176 interpretation, courts have traditionally applied the familiar two-prong Chevron 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 291 1 7 7 . C h evron , U .S.A., In c., v. N atu ral R es. D ef. C ou n cil In c., 4 6 7 U .S. 8 3 7, 8 4 2-4 3 . 1 7 8 . Id . at 843-44. 1 7 9 . Id . at 842-43 (1984); see Jack M . B eerm ann, T he T urn Toward C ong ress in A d m in istra tive L a w, 89 B .U . L. R EV. 727, 728, (2009) (“Som e of the m ost im portant developm en ts in adm in istrative law in recen t ye ars a rise o u t of federal cou rts review in g adm in istrative action an d reinforcing C on gress’s prim acy as the m ost pow erful policym aking branch of the federal governm ent. T his m ovem ent in the law spans seem ingly unrelated doctrinal areas, and is best explain ed as a con tinuing affirm ation and reaffirm ation of the superior legitim acy of C on gress as policym aker.”). 1 8 0 . C h evro n, U .S .A ., 467 U .S. at 8 44. 1 8 1 . Id . at 845 (quoting U nited States v. Shim er, 367 U .S. 374, 383 (1961)). 1 8 2 . See Law rence, supra n ote 8 9 , at 2 4 5-4 6 . 1 8 3 . See Peck, supra n ote 2 2 , at 2 5 0-5 2 . 1 8 4 . See M arden, supra note 39, at 763 (“FD A’s approach to GM labeling has been upheld by the courts.”). 185. 116 F. Su pp. 2d 1 66 (D .C . Cir. 2000). 1 8 6 . Id . at 1 7 5. test. When it is determined that Congress has clearly spoken on an issue, congressional intent prevails. W hen, however, Congress is ambiguous or has1 7 7 not spoken on an issue, courts do not apply its own interpretation of the statute. Instead, courts simply ask whether the agency based its action on a permissible construction of the statute. Courts find agency decisions impermissible under178 this standard only if they are “arbitrary and capricious.” Courts will not179 substitute their judgment for what they deem to be the agency’s reasonable interpretation. This deference to administrative interpretations is one180 entrenched in administrative law. In fact, if the “choice represents a reasonab le accommodation of conflicting policies that were committed to the agency’s care by the statute, we should not disturb it unless it appears from the statute or its legislative history that the accommodation is not one that Congress would have sanctioned.” The Court’s usual deference to agencies and to biotech agencies181 encounters a glitch, however, when applied to genetically modified foods. The biotechnology field raises a number of novel issues that no statute directly addresses. Even more problematic, the food agencies’ current treatment of182 genetically engineered foods is the product of a deliberate policy set by the President’s office during the 1980s, not the result of congressional guidance.183 Accordingly, courts have been implementing the dictates of the Executive rather than those of Congress without assessing whether this form of presidential control is valid in the given context.184 For example, agencies’ presumption that genetically altered foods are safe until proven otherwise was challenged in Alliance for Bio-Integrity v. Shalala (“Alliance”). In Alliance, the district court upheld the FDA’s “presumption that185 rDBA-engineered foods are GRAS.” Alliance was triggered by the publication186 of the FDA’s “statement of Policy” on May 29, 1992, which stated that the agency would presume that foods produced through the rDNA 292 INDIANA LAW REVIEW [Vol. 46:265 1 8 7 . Id . at 170 (internal citation s om itted); see also N otice, Statem ent of Policy: Foods D erived from N ew Plan t V arieties, 57 Fed. Reg. 22,984-01 (Food & D rug Adm in. M ay 29, 1992). 1 8 8 . A lliance for B io-Integrity, 116 F. Supp. 2d at 169. 1 8 9 . Id . 190. Federal Food, D ru g and C osm etic Act, 21 U .S.C . § 342 (2006 & Supp. V 2011). 1 9 1 . A lliance for B io-Integrity, 1 1 6 F. Su pp. 2 d at 1 6 9. 1 9 2 . Id . at 1 7 2-7 3 . 193. N ational E nvironm ental Policy Act of 1969, 42 U .S.C . §§ 4321-4370h (2006 & Supp. V 2011). 1 9 4 . A lliance for B io-Integrity, 116 F. Supp. at 1 73-74. See 42 U .S.C . § 4332(e)(c)(i) (2006); 4 0 C .F.R . § 1 50 8 .1 8 (b)(1 )-(4 ) (2 0 0 3); N otice, Statem en t of P olicy: Foods D eem ed from N ew P lan t V arieties, 57 Fed. Reg. 22, 984-01 (Food & D rug Adm in. M ay 29, 1992). 1 9 5 . A lliance for B io-Integrity, 116 F. Supp. 2d at 173-74. 1 9 6 . Id . at 1 7 5-7 9 (statin g th at th e c o u rt w ou ld defer to th e agen cy’s expertise regardin g w hether the substances w ere exem pt from the additives regulations because they “ are generally recognized to be safe” and that the FD A’s labeling determ ination w as entitled to deference because the level of consum er dem and did not affect the FD A’s finding that “rD N A m odification does not ‘m aterially’ alter foods”). p rocess were “generally recognized as safe” (GRAS) under the Federal Food, Drug and Cosmetic Act (“FDCA”), and therefore not subject to regulation as food additives . While FDA recommended that food producers consult with it before marketing rDNA-produced foods, the agency did not mandate such consultation.187 The types of GM foods in question in the lawsuit involved products developed through “[o]ne of these advances, recombinant deoxyribonucleic acid (rDNA) technology” which “enabled scientists to alter the genetic composition of organisms by mixing genes on the cellular and molecular level in order to create new breeds of plants for human and animal consumption. These new breeds may be designed to repel pests, retain their freshness for a longer period of time, or contain more intense flavor and/or nutritional value.” Alliance involved the188 development of plants expressing pesticidal products as well as plants resistant to pesticides. The FDA should scrutinize these products closely. 189 190 The Alliance court admitted that “[m]uch controversy has attended such developments in biotechnology, and in particular the production, sale, and trade of genetically modified organisms and foods.” The Alliance court also191 determined that the FDA did not have to provide a notice and comment period because the policy was not a substantive ruling. Nor did the FDA violate192 NEPA by failing to complete an EIS along with its Statement of Policy because193 the FDA’s statement did not constitute a “major federal action.” By not194 classifying the agency’s decision as an “action,” as defined by the NEPA, the Alliance court held that the statement of policy did not trigger liability on the part of the FDA. 195 Furthermore, the court determined that the policy violated neither the FDA’s standard for additives nor its labeling mandates. As discussed above, under the196 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 293 197. Federal Food, D rug and C osm etic Act, 21 U .S.C . § 321(s) (2006) (defin in g “food additive”). 1 9 8 . Id . § 348(b); see also 21 C .F.R . § 171.1 (2013). 199. Federal Food, D rug, an d C osm etic Act, 21 U .S.C . § 321(s) (2006). 2 0 0 . A lliance for B io-Integrity, 116 F. S upp. 2d at 177 (“T o be gen erally recognized as safe, a substance m ust m eet tw o criteria: (1) it m ust have technical evidence of safety, usually in pu blished scientific stu dies, and (2) this technical evidence m ust be generally know n and accepted in the scien tific com m unity. Althou gh unan im ity am on g scien tists is not req uired, ‘a severe conflict am ong experts . . . precludes a finding of general recogn ition.’” (alterations in original) (internal citation s om itted)); see 21 C .F.R . § 170.30(a)-(b) (2013). 2 0 1 . A lliance for B io-Integrity, 1 1 6 F. Su pp. 2 d at 1 7 7. 2 0 2 . Id . at 1 7 9, 1 8 1. 203. Federal Food, D rug, an d C osm etic Act, 21 U .S.C . § 321(n) (2006). 2 0 4 . Id . 2 0 5 . A lliance for B io-Integrity, 1 1 6 F. Su pp. 2 d at 1 7 8. 2 0 6 . Id . 207. 895 F. Su pp. 1178, 1193 (W.D . Wis. 1995). 2 0 8 . A lliance for B io-Integrity, 116 F. Su pp. 2d at 179 (alteration s in original). 2 0 9 . In t’l D airy Foods Ass’n v. B oggs, 6 2 2 F.3 d 6 2 8, 6 3 4, 6 3 9, 6 5 0 (6 th C ir. 2 0 1 0 ) (strikin g standard for adulterated products, any substance that may become a part of food is a food additive. This classification requires the producer to submit a food197 additive petition to the FDA. A producer will be exempt from this requirement,198 however, if the FDA determines that experts have demonstrated that the additive is safe. In the Statement of Policy in question in Alliance, the FDA determined199 that rDNA products are safe since the only items added to the rDNA-engineered foods are nucleic acids, which are found in the cells of all organisms.200 Consequently, rDNA foods are presumed to be GRAS, unless proven otherwise. This illustrates the agencies’ built-in presumption favoring GM201 foods and over reliance on the evidence provided by manufacturers. Finally, the district court determined that the FDA did not err when it did not require labeling of the bioengineered products. Section 321(n) of the FDCA202 grants the FDA the authority to require labeling. In general, foods shall be203 deemed misbranded if their labeling “fails to reveal facts . . . material with respect to consequences which may result from the use of the article to which the labeling . . . relates under the conditions of use prescribed in the labeling . . . or under such conditions of use as are customary or usual.” Here again, the court’s implicit204 endorsement of presidential control is palpable. Plaintiffs challenged the FDA’s interpretation of the term “material.” The Alliance court determined that205 because Congress had not specifically defined materiality, the agency was entitled to deference. Even more problematic was the court’s reference to the failure206 to show “material difference” between traditional foods and bioengineered foods. Quoting Stauber v. Shalala, the court reiterated, “[I]n the absence of evidence207 of a material difference between [milk from cows treated with a synthetic hormone] and ordinary milk, the use of consumer demand as the rationale for labeling would violate the Food, Drug, and Cosmetic Act.” This analysis20 8 209 294 INDIANA LAW REVIEW [Vol. 46:265 dow n a provision of a state rule that characterized dairy product labels w hich con tain ed production claim s th at “ th is m ilk is from cow s n ot su pp le m e n te d w ith rbST ” as m isbran ded, w h ile u ph oldin g th e provision of th e ru le req u irin g disclosu re th at “ [t]h e FD A h as determ in ed th at n o sign ifican t difference has been show n betw een m ilk derived from rbS T -su pplem ented and non-rbST - su pplem e n te d c o w s” as reason ably related to th e state’s in terest in preven tin g con su m er deception , bu t not req uiring the disclosure be contigu ou s w ith the production claim ). 2 1 0 . See Int’l D airy Foods Ass’n v. Am estoy, 92 F.3d 67, 73-74 (2d C ir. 1996) (striking dow n a state labelin g law requiring dairy m anufacturers to label products derived from dairy cow s treated w ith syn th etic grow th h orm on es becau se th ere w as n o m aterial differen ce in th e m ilk, an d stron g consum er concern alon e w as not a substantial state interest to justify a restriction on com m ercial speech ). 2 1 1 . See A lliance for B io-Integrity, 1 1 6 F. Su pp. 2 d at 1 7 8 (“ T h u s, th e q u e stion is again on e of statutory interpretation. As is apparent from the statutory language, C ongress has n ot squarely addressed w hether m ateriality pertains only to safety concerns or w hether it also includes consum er interest. Accordingly, interpretation of the § 321(n)’s broad lan gu age is left to the agen cy.”). 2 1 2 . Id . at 177; see also M cGarity, supra note 40, at 440 (recogn izing the A lliance court’s perfunctory an alysis of the FD A’s “presum ption of GR AS status to GM foods,” despite evidence of “num erous internal agency docu m ents produ ced du ring discovery that strongly suggested that there w as ‘significant disagreem ent’ am ong the agency’s ow n scientists as to th e safety of GM foods” an d a requirem en t under the 1 992 Policy Statem en t that m an ufactu rers seeking “ GR AS status for a GM plant” m u st present published scientific evidence of the plant’s safety that is generally accepted by the scien tific com m unity (alteration in original) (footnotes om itted)). 213. E llison, supra n ote 3 3 , at 3 5 6-5 7 (footn otes om itted) (“ T h e cou rt first c on sidered th e plain lan gu age of th e statu te by determ in in g w h eth er C on gress spoke directly to th e issu e. T h e court con clu ded that w hen C ongress passed the Food Additives Am endm ent in 1958, ‘it obviously could n ot account for the late tw entieth-century technologies that w ould perm it genetic m odification of food.’”). 214. M cGarity, supra n ote 4 0 , at 4 3 0. 2 1 5 . See V alerey Federici, N ote, G enetically M od ified Food and Inform ed C onsum er C hoice: indicates that the hurdle faced by plaintiffs in such cases has less to do with proving potential harm and more to do with their ability to adeq uately prove a210 material difference between bioengineered foods and natural foods. Yet, there211 was evidence, which was not submitted as part of the record in Alliance, that the FDA should not have granted the products a safe status (GRAS) because of apparent disagreements among scientists in the company. 212 Courts’ endorsement of these policies reflects the need for specific guidance from Congress. Courts’ and agencies’ treatment of these products as identical213 to traditionally grown foods fails to deal with the crucial issues regarding their genetic alteration and the lack of adequate knowledge about their potential effects. We could b egin to address some of the inequalities present in214 administrative agencies’ treatment of genetically modified products if Congress were to pass a statute creating an independent agency charged with oversight, independent expert reviews and implementation of proper labeling standards. As it stands, our current approach is in stark contrast to Europe, which has adopted a precautionary approach to GMOs. 215 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 295 C om pa ring U .S. an d E .U . Lab eling Laws, 3 5 B ROOK. J. INT’L L. 515, 536-37 (2010). 2 1 6 . See Sm ith, Who O wns Y our D inner?, supra note 11, at 192 (internal quotation m arks om itted). 217. D avid D aniel, N ote & C om m ent, S eed s o f H o p e: H o w N ew G en etic T ech n o lo g ies M a y Increase V alue to Farm ers, Seed C om panies, and the D eveloping World , 3 6 R UTGERS C OMPUTER & T ECH. L.J. 250, 251-52, 255-56, 260, 274, 277-80 (2010) (discu ssing GM -tech nology, the debate about its role in food production, perceived social and environm ental costs, and how the law should address property righ ts and the resu lting torts). 2 1 8 . GREENPEACE, T HE SOCIAL AND E CONOMIC IMPACTS OF G M O S (2008), a va ila b le a t http://w w w .greenpeace.org/eu-unit/en/pu blication s/2 0 0 9 -an d-earlier/social-and-econom ic-im pacts- of-GM O s/. 219. Justin T . R ogers, N ote, T h e E n c ro a ch m en t o f In tellectu a l Pro p erty Pro tectio n s o n th e R ights of Fa rm ers, 1 5 D RAKE J. AGRIC. L . 1 4 9 , 157-64 (2010) (discussing “[t]he Effect of Govern m en t R egulation an d Seed P iracy Litigation on R ural Farm ers”). 220. P eter Straub, Farm ers in the IP Wren ch — H ow Patents on G en e-M od ified C rops V iolate the R ight to Fo od in D eveloping C ountries, 2 9 H ASTINGS INT’L & C O M P. L. R EV. 1 8 7, 1 9 2-2 0 0 (2006) (discu ssing the im pact of GM patents on developing cou ntries and violation s of the righ t to food). 221. Kanchana Kariyaw asam , L egal L iability, Intellectual Property and G enetically M od ified C rops: Their Im p act on World A griculture, 1 9 PAC. R IM L. & P OL’Y J. 4 5 9, 4 6 5-6 6 (2 0 1 0) (“[C ]ontrol over the w orld’s seeds constitutes an overw helm ing threat to agricultural genetic diversity an d sm all-scale tradition al farm ing system s.”). 2 2 2 . Id . at 465-66 (“O ne com m entator has argued that the m ultination al seed corporation s’ ‘control over the w orld’s seeds constitutes an overw helm ing threat to agricu ltural genetic diversity an d sm all-scale tradition al farm ing system s.’”). 223. R ogers, supra note 2 1 9 , at 157 (“T raditionally, the process of a farm er saving seed for plan ting during the follow ing year’s harvest has been a fundam en tal principle in agricu lture.”). V. BIOENGINEERED FOODS AND POOR FARM ERS HERE AND ABROAD Biotech companies, such as Monsanto, place four main restrictions on their seed growers: (1) requiring growers to only use seeds containing Monsanto’s patented biotechnology for planting a single crop; (2) prohibiting transfer or re- use of seeds containing the biotechnology for replanting; (3) prohibiting research or experimentation; and (4) requiring payment of a “technology fee.” This216 structure creates the potential for privatization and monopolization of the food industry. This concern, aside from all others regarding the potential threat217 2 1 8 posed by these products, provides a good basis for a conservative approach to these products. If the government wishes to encourage genetically engineered219 products to help prevent future famine and to encourage development, then the concentration of power in this structure has, thus far, created the opposite220 result. As commentators have observed, biotech companies’ overwhelming221 control over seeds has destabilized conventional farming. Traditionally,222 storing, sharing, and reusing seeds are a part of conventional farming. The223 ability to do so, particularly for poor farmers, has b een greatly compromised by 296 INDIANA LAW REVIEW [Vol. 46:265 2 2 4 . Id . at 161-62 (“T he creation of term inator technology, as w ell as intellectual property protections, has taken aw ay the farm er’s traditional right to save seed. T hese developm en ts have had both econom ic and social consequences. An econom ic consequence results every tim e a farm er replan ts a saved seed, resu ltin g in a lo ss o f p o ten tial sale to th e seed com pan y. T h u s, preclu din g a fa rm e r from savin g seed forces th e farm er to spen d m on ey on n ew seed every year. A resu ltin g social consequence is the trespass on a farm er’s traditional and historical practice of savin g seed.” (footnotes om itted)). 2 2 5 . See Kariyaw asam , supra note 221, at 466 (“T he ability of farm ers to select and save seeds that have been adapted to local condition s is essential for the su ccess of local agricu lture.”). 2 2 6 . S ee, e.g ., R ogers, sup ra n ote 2 1 9, at 1 6 4 (“ T h e m ost rem arkable legal battle stem m in g from a violation of a gen e-licensing agreem en t is a case involving gen etic drift. G en etic drift occurs w hen proprietary genetic m aterial finds its w ay to a neighboring farm er’s organic field, ren dering the n eigh boring farm er liable for patent infringem en t.” (footnotes om itted)). 227. Kariyaw asam , supra note at 221, at 466 (alteration in original). 2 2 8 . See id . at 465 (“M oreover, farm ers w ho choose to raise non-genetically engineered crops intended for GM -free m arkets could, at tim es, be held liable if crops test positive for GM , even if the paten ted plan t or seed w as acq uired unintention ally.” (internal quotation m arks om itted)). 2 2 9 . S ee, e.g ., id . at 466 (“C ritics h ave also question ed the eth ics of exten din g paten t righ ts to plant genes, forcing non -GM farm ers to seek a licence to allow them to replant seeds from an earlier year’s crop or to pu rch ase new seeds from m ultination al com panies.” (footnotes om itted)). 230. H am ilton, supra n ote 2 8 , at 9 5 . the dissemination of bioengineered seeds. Yet, the saving and sharing of seeds224 among small farmers account, in great part, for small farmers’ success and ability to sustain themselves. The seeds that small farmers collect and save are seeds that have b een tested against the local environment for decades. In addition,225 small farmers have to contend with the risk of litigation stemming from the accidental use of genetically modified seeds. For example, “[f]armers that use226 GM seed have to contract with the seed company not to grow the seeds they harvest.” If a farmer replants a seed or accidentally experiences contamination227 with a GM seed, he/she has to seek permission from the multinational GM companies to continue to use that seed. Beyond the ethical debate over whether228 extending patent rights to the use of plants is proper, this poses an enormous229 burden on traditional growers. In fact, growers have been organizing around the world to remedy the detriments they have suffered as a result of this changing landscape.230 Of great concern is the detrimental effect of biotech companies in countries that do not have any regulatory structure in place to evaluate products and to protect their environments. It is reported that the acreage of GM crops has consistently grown each year with the number of countries increasing from 6 in 1996 to 25 and a global area of 134 million hectares in 2009. Herbicide-tolerant soybean continued to be the principal GM crop, followed by insect and/or herbicide tolerant maize, cotton, and rapeseed. The United States, Brazil, Argentina, India, Canada, China, Paraguay, and South Africa are the major growers with 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 297 2 3 1 . GOVERNING R ISKS, supra n ote 6 0 , at 5 7 . 232. P eck, supra note 22, at 265 (stating that the U nited States grow s about half of all “biotech crops”). 233. Federici, supra n ote 2 1 5, at 5 2 6, 5 3 4-3 5 . 234. P eck, supra n ote 2 2 , at 2 6 6, 2 6 8. 235. R enee T . W ilkerson , C om m ent, M an V s. N ature: S hould the O ffspring of Transgen ic A nim als be Pa tentable Subject M atter, 37 U . D AYTON L. R EV. 2 5 7 , 2 7 1 (2 012). 236. D ebra M . Strauss, T he A pplica tion of Trips to G M O s: International Intellectual Property R ig h ts a n d B io tech n o lo g y, 4 5 STAN. J. INT’L. L. 2 8 7 , 2 9 5 -9 7 (2 009). 2 3 7 . S ee, e.g ., Law rence, supra note 89, at 282 (footnote om itted) (“ T h e C oordinated Fram ew ork m u st be ch an ged to su pport th e developm en t o f n ew law w h en existin g statu tes an d regu lation s are sh ow n to be in adeq u ate for iden tified regu latory problem s. T h e relian ce o n fo o d and drug statutes and statutory definitions enacted long before genetic m odification w as foreseeable has been show n to be inadequate to address current technological realities. T he need for new law to adeq uately protect the public an d the en viron m en t from harm m ust be balan ced against the costs of an y proposed restrictions and requ irem ents incurred by the regulated entities and the regulatory agen cy.”). 238. 549 U .S. 497 (2007). 64 to 2.1 million hectares of GM crops, followed by Uruguay, Bolivia, the Philippines, Australia, Burkina Faso, Spain, and Mexico with .0 8 to 0.1 million hectares of GM crops. Among the ten countries that grew less than 50,000 hectares are the Europ ean Union (EU) member-states Czech Republic, Portugal, Romania, Poland and Slovakia.231 It is telling that the United States is leading in the cultivation of GMO crops, given that other countries are deliberately proceeding with caution.232 233 This approach signals a disproportionate emphasis on market growth, rather than on safety and environmental concerns. However, emphasizing economic234 growth via intellectual property rights may backfire because biotech companies endanger the livelihood of small-to-medium farmers through contamination and cross-pollination. In addition, the added costs, shouldered by traditional235 farmers to remain desirable to the public and health conscious consumers by taking measures to prevent contamination, place an added burden on traditional farmers. 236 VI. PROPOSALS FOR DEALING WITH CURRENT DEFICIENCIES PRESENT IN COURTS’ AND AGENCIES’ TREATM ENT OF BIOENGINEERED FOODS A. Lessons from Massachusetts v. EPA The judiciary’s handling of issues raised by bioengineered foods is made difficult because there is no statute that squarely addresses how courts are to treat issues related to biotech foods. In the absence of a congressional statute,237 Massachusetts v. EPA provides the most pointed guidance on the issue. While238 not dealing squarely with bioengineered foods, in that case, the Supreme Court nonetheless considered an important question: what should be done when an 298 INDIANA LAW REVIEW [Vol. 46:265 2 3 9 . Id . at 5 2 8. 2 4 0 . Id . at 5 1 3-1 4 . 2 4 1 . Id . at 5 3 4. 2 4 2 . Id . at 5 3 3. 2 4 3 . Id . at 5 3 2. 2 4 4 . Id . at 5 3 4. 2 4 5 . Id . at 5 3 3-3 4 . 2 4 6 . Id . at 5 3 3. 2 4 7 . Id . at 5 0 4. 2 4 8 . Id . at 5 2 8-2 9 (“ T h e C lean Air Ac t’ s sw e epin g defin ition of ‘air pollu tan t’ in clu des ‘an y air pollution agent or com bination of such agents, including any physical, chem ical . . . substance or m atter w hich is em itted into or otherw ise enters the am bien t air . . . .’ O n its face, the definition em braces all airborn e com pou n ds of w h atever stripe, an d u n derscores th at in te n t th ro u g h th e repeated u se of th e w ord ‘an y.’ C arbon dioxide, m eth an e, n itrou s oxide, an d h ydro flu orocarbon s are w ith ou t a dou bt ‘ph ysical [a n d ] ch em ical . . . su bstan ce[s] w h ich [are] em itted in to . . . th e am bient air.’ T he statute is unam bigu ou s.” (alteration s in original) (footnotes om itted) (internal citation om itted) (quoting 4 2 U .S.C . § 7602(g) (2006))). agency refuses to regulate despite the existence of a statute giving it authority to do so? In Massachusetts v. EPA, the EPA refused to draft policies regulating2 39 carbon dioxide emissions, alleging that despite evidence that carbon dioxide causes damage to the atmosphere, the science was still too uncertain, and regulations might hamper the President’s ability to negotiate with foreign governments. The Court, taking a hard look at the statute and the agency’s240 decisionmaking, ruled that the standard used by the EPA was arbitrary, capricious, and unsupported by the text of the statute. The Court reasoned that241 Congress clearly delegated the duty to regulate pollutants to the EPA and that242 carbon dioxide fit under the definition of “air pollutant.” Furthermore, the243 Court ruled that Congress had not delegated any powers to the State Department under the statute and that any concerns for negotiations with foreign244 governments by the EPA were misplaced. 245 The facts of this case are, of course, distinguishable from the facts of cases involving bioengineered foods. First, the product at issue was carbon dioxide, not a genetically manufactured p roduct, and second, in Massachusetts, the Court could point to a specific statute delineating the EPA’s responsib ilities regarding pollutants. While agency regulations and policies addressing bioengineered246 foods exist, Congress has yet to enact a statute encap sulating its intent and relevant regulations. Consequently, there is less room to infer “silence” on the part of Congress in Massachusetts than in the case of bioengineered foods. These distinctions, nonetheless, highlight key elements that are sorely247 missing and greatly needed in the area of biotechnology. For example, a congressional statute holistically addressing the issues raised by biotechnology is necessary. In Massachusetts v. EPA, unlike in the case of bioengineered foods, there was a statute and an agency regulating pollutants with an express mandate by Congress. Furthermore, the Court took clear notice of congressional248 findings and scientific studies that indicated carbon dioxide emissions’ great harm 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 299 2 4 9 . Id . at 5 0 7-1 0 . 2 5 0 . S ee, e.g ., E llison, su p ra note 3 3, at 363 (advocating “ an independent federal agen cy” to regulate GM O s). 251. C hevron , U .S.A., Inc. v. N atural R es. D ef. C ou ncil, 467 U .S. 837, 842-43 (1984). 252. E llison, supra n ote 3 3 , at 3 5 2 (“ T h e StarLin k scare m ade clear th at as lon g as th e governm ent relies on developers of bio-engineered foods to test their ow n products, there is a danger th at foods not approved for hum an consum ption w ill find their w ay onto m arket shelves. T his lends support for creation of an indepen dent governm en t regulatory system to ensure that consum ers are not exposed to bio-engineered foods that h ave n ot been approved for hum an consum ption .”). 253. B ratspies, M yths of V oluntary C om pliance, supra n ote 1 3 2, at 6 0 9-1 0 . to the atmosphere. Despite the rapid growth of bioengineered products and the249 development of genetically altered fish, a similar congressional fact-finding process has not occurred in the contex t of bioengineered foods. This reveals the need for Congress to step in and take the steps necessary to create both policies and an agency tailored to monitor bioengineered foods and technology. The novel issues and circumstances progressively evolving as a result of this new technology indicate that congressional avoidance of this issue and/or merely chastising the existing agencies is no longer enough. Some scholars have suggested that a new agency should oversee the regulation of bioengineered foods. This idea has merit; an independent agency specifically authorized to250 deal with biotechnology would address issues of imbalance and foster greater accountability. B. Reform Proposals There are a number of changes necessary to achieve an equitable review of cases involving disputes over b ioengineered foods. Currently, there exist many hurdles facing consumers challenging agencies’ treatment and wholesale approval of bioengineered foods. In order to fully increase the likelihood of succeeding in such cases, these groups must battle problems on a number of fronts. Advocacy groups should focus on regulatory, judicial, and grassroots lobbying. T he Chevron doctrine’s deference to agencies in the absence of clear guidance from Congress might limit judicial action. As a result, clear and251 efficient congressional guidance is necessary. Particularly, Congress should consider creating an independent agency, an administrative entity most252 removed from presidential control. In the statute creating such an independent agency, Congress should require that biotechnology experts head the agency. Reliance on manufacturers’ scientific reports, rather than on the agencies’ own neutral and disinterested scientists, is one of the problems present in the agencies’ current treatment of bioengineered foods. Take, for example, the fact the253 manufacturers’ own scientists in Monsanto Co. disagreed over whether the alfalfa was safe. Yet, the Court did not consider the issue since the company omitted it from the record. Agencies’ overreliance on manufacturers’ data can lead to the 300 INDIANA LAW REVIEW [Vol. 46:265 254. M on san to v. Geertson Seeds Farm s, 130 S. Ct. 2743, 2758 (2010). 2 5 5 . See Kagan, supra note 2, at 2250-51 (“Accepted con stitution al doctrine holds that C on gress possesses broad, alth ou gh n ot u n lim ite d , pow er to stru ctu re th e relation sh ip betw een th e P resident and the adm inistration, even to the extent of creating indepen dent agencies, w hose heads have su bstantial protection from presidential rem oval.”). 2 5 6 . See gen era lly M ary Jane An gelo, R eg u la tin g E vo lu tio n fo r S a le: A n E vo lu tio n a ry B io lo g y M o d el fo r R egulating the U nnatural Selection of G enetically M o d ified O rganism s, 4 2 WAKE FOREST L. R EV. 9 3 (2 0 0 7) (discu ssin g th e actu al an d poten tial “ en viro n m e n tal, h u m an h ealth , an d econ om ic risks” associated w ith the com m ercialization an d u se of gen etically m odified organ ism s). 2 5 7 . See J .M . M igai Akech , D evelopin g C ou n tries at C rossroads: Aid, P u blic P articipation , an d th e R egu lation of T rade in Gen e tic ally M odified Foods, 2 9 FORDHAM INT’L L.J. 2 6 5, 2 9 6-9 7 (2 0 0 6) (n otin g th e n e ed to balan ce th e in terests of all of th e stakeh olders w h en approvin g an d im plem en ting biotechnology to en sure public acceptan ce, inclusiveness, an d legitim acy). 2 5 8 . See G M O M yths and T ruth s R eport, E ARTHOPENSOURCE, a va ila b le a t http:// earthopensource.org/index.php/3-health-hazards-of-gm -foods/3 -3 -m yth -th ose-w h o-claim -that-gm - foods-are-u n safe-are-bein g-selective-w ith -the-data-since-m any-oth er-stu dies-sh ow -safety (last visited Apr. 12, 2013). courts doing the same. More disturbing, however, is the fact that the FDA’s254 reliance on the conclusions and res earch provided by manufacturers prevented a reasonable and thorough review of the scientific issues and data related to the genetically modified alfalfa. A model statute creating an independent agency for bioengineered products255 should also include specific mandates req uiring a multi-step review process that uses neutral ex p erts to review proposals for bioengineered foods and technology. T his multi-step process should consist of reviews by two or more committees made up of scientists and policy experts capable of polling and determining consumers’ preferences and needs. Every stage of the review process should also include mandatory disclosure to the pub lic, through notices and public announcements, and op p ortunities for the public to submit comments and requests. A provision stipulating that b iotechnology and policy experts must make up the review committees would help balance the tension caused by the lag between technological advances and scientific understanding of their potential risks. In256 addition, this hybrid composition would also help balance the public’s concern for safety, the preference for a precautionary approach, and the government’s and agencies’ desire to encourage market growth. T o the extent that the public’s257 desire for a precautionary approach conflicts with the desire for market growth, biotechnology and policy experts can join forces to determine whether the approval of certain products presents risks that might destabilize traditional farmers, lead to consumer dissatisfaction and angst, or constitute such an unknown factor that it would be best to hold off dissemination until more information is gathered. In addition, lawmakers and policy experts should encourage the funding of independent research in order to b alance the research funded by manufacturers. For example, additional tax deductions for non-2 58 profit organizations that fund independent research about the risks of 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 301 259. P eck, supra note 22, at 2 60. 2 6 0 . S ee, e.g ., M on san to C o. v. Geertson S eeds Farm s, 130 S. Ct. 2743 (2010); Int’l D airy Foods Ass’n v. Am estoy, 92 F.3d 67 (2d C ir. 1996); Alliance for B io-Integrity v. Shalala, 116 F. Supp. 2d 1 66 (D .C . Cir. 2000). 2 6 1 . 1 3 0 S. C t. 2 7 43 . bioengineered foods to health, the environment, and traditional farming might be helpful. These measures would shift the burden of risk assessment to the regulatory agency, rather than leaving it to manufacturers whose interests may conflict with those of consumers and traditional farmers. Furthermore, it would create more transparency in the approval process for bioengineered foods and restore credibility to the approving agencies. T he p roposed congressional statute should also require a reformulation of a p olicy regarding GMO foods that reverses the “substantial equivalence” and “GRAS” presumptions. For example, a standard that asks manufacturers to259 show cause as to why the genetic modification is not harmful to health and requires them to introduce evidence of consensus among scientists in the field would be a helpful start. Such a standard should also require more details from manufacturers and explicitly formulate rules regarding proper storage and dissemination of genetic products. The model statute should also contain a detailed standard as to what adequate storage, dissemination processes, and labeling practices are appropriate. To accomplish these goals, a congressional fact-finding investigation on the potential environmental and financial impact of bioengineered crops is needed to properly inform lawmakers. Previously litigated cases already provide information on the environmental detriments caused b y bioengineered crop s to farmers. Litigation of these issues is expected to grow260 exponentially b oth b y the Court’s own admission, in its review of Monsanto Co. v. Geertson Seed Farms, and according to the observations and measures under261 way by various consumer watch groups. A prudent Congress should resolve the issues quickly to avoid clogging the dockets and perpetuating additional inequities. C ongressional action will not occur without deliberate pressure from grassroots groups and advocates counterbalancing the existing pressure from biotech companies. To facilitate the creation of sophisticated grassroots efforts, more open and detailed educational programs regarding bioengineered foods are needed. These programs could help foster democratic participation in the proposed approval process during the administrative notice and comment period. The creation of a temporary agency––having clear term limits, partial salaries, and partial performance bonuses––would serve as a great alternative, which could help cure the administrative inertia, lack of accountability and transparency that currently exist across the board in administrative governance. W hether it is an independent agency or a temporary renewable agency, the inclusion of a hybrid team of neutral biotechnology and policy experts as part of a multi-step review process is a necessary requirement. An alternative to congressional action, particularly considering recognized 302 INDIANA LAW REVIEW [Vol. 46:265 262. P roposition 37, w h ich , if passed, w ou ld h ave m ade C aliforn ia the first state to req uire labeling of genetically m odified foods. T he C alifornia electorate u ltim ately voted against adoption of the bill by a vote of 48.6% to 51.4% on N ovem ber 6, 2012, despite earlier in dications of public preference for m andatory labeling. See SEC’Y OF STATE C AL., STATEMENT OF V OTE, N OVEMBER 6 , 2 0 1 2, GENERAL E LECTION 13 (N ov. 2012), a va ila b le a t http://w w w .sos.ca.gov/election s/ sov/2 0 1 2-gen eral/sov-com plete.pdf. Fu ll text of th e p ro p o se d ch an ge to th e C aliforn ia H ealth an d S afety Act can be fou nd at SEC’Y OF STATE OF C AL., T EXT OF P ROPOSED LAWS 1 1 0 (2 0 1 2 ), a va ila b le a t http://vig.cd n .sos.ca.gov/2 0 12/gen eral/pdf/text-proposed-law s-v2 .pdf#nam eddest= prop3 7 . 263. E llison, supra n ote 3 3 , at 3 5 1-5 2 . 264. S. 229, 112th C on gress (2011); S. 230, 112th C on gress (2011); S., 1717, 112th C on gress (2011). 265. 549 U .S. 497 (2007). 266. Kagan, supra note 2, at 2364 (“It is, after all, a com m onplace that the nondelegation doctrine is no doctrine at all. In only tw o cases, both in 1935, has the Suprem e C ourt struck dow n a federal statute on the grou nd that it delegated too m uch au thority to the executive branch .”). congressional inertia in this area and recognized pressure from powerful public interest groups, would be to encourage reform movements at the state level. One possibility is to lobby for a uniform state code regulating genetically modified foods. At least one state, California, is leading the charge by contemplating legislation that would require adequate labels for genetically modified products.262 This might prove to be a fruitful alternative, if preemption is not an issue. It remains to be seen whether the preemption doctrine will present an obstacle to these efforts. As it stands, unlike estate p lanning, marriage, and property, the federal government regulates foods. 263 To the extent that Congress is not able to adequately address the interests of the states, perhaps a uniform bioengineering standard, which would permit the states to opt into the system, might be an option. The recent bills presented against bioengineered salmon and concerns from officials over how bioengineered foods might detrimentally impact their constituents indicate that the time might be ripe for such a measure. In fact, Massachusetts v. EPA264 265 indicates that states, as well as citizens, are wiling to take action against the regulating agencies’ inertia in matters affecting the environment. Still, the value of congressional action lies in Congress’s ability to engage all aspects of government and to provide a national forum to debate these issues. Ideally, such a debate would be most constructive if the reform could come from Congress so as to create clear expectations and responsibilities applicable to everyone. In the meantime, judicial reform might be a fruitful avenue. From a judicial standpoint, pending congressional action, bioengineering might serve as a great test case for the evaluation of the ongoing and pervasive influence of presidential control over administrative issues. The Court has thus far avoided the issue of the constitutionality of p residential administration. It is telling, as Justice Kagan points out, that the Court has implemented the non-delegation doctrine, a pillar of administrative law, only twice— both times in 1935. The non-delegation266 doctrine stands for the proposition that Congress must not delegate too broad a 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 303 267. Garry, supra n ote 8 , at 9 2 6-2 7 (footn otes om itted) (“ T h e textu al b asis for th e non delegation doctrin e is fou n d in Article I, Section 1 of the U nited States C on stitution , w hich provides that ‘all legislative P ow ers herein granted shall be vested in a C on gress of the U nited States.’ T he C ou rt has h eld that this vesting clau se proh ibits the delegating of legislative au thority to the execu tive. H ow ever, because the C on stitution em pow ers the executive branch to ‘execute’ th e la w s, th e C ou rt h as also ru led th at th e n on delegation doctrin e does n ot forbid adm in istrativ e agen cies from fillin g in th e details of broad con gression al statu tes. M o re o ve r, sin ce th e C on stitution contains no express provision forbidding delegation , courts have held that C on gress m ay constitution ally delegate rulem aking pow er to adm inistrative agen cies as lon g as C on gress provides an ‘intelligible principle’ that lim its the agen cy’s decision m aking authority.”). 268. 796 F.2d 1 479 (D .C . Cir. 1986). 2 6 9 . Id . at 1 5 07 . 2 7 0 . T ODD B . T ATELMAN, C ONG. R ESEARCH SERV., R 4 1 2 7 2 , SUPREME C OURT N OMINEE E LENA KAGAN: P RESIDENTIAL AUTHORITY AND THE SEPARATION OF P OWERS 14 (2010), ava ilable a t http://w w w .fas.org/sgp/crs/m isc/R 41272.pdf. 2 7 1 . T yso n, 7 96 F.2d at 1507 (stating that the court had “no occasion to reach the difficult con stitu tion al q u estion s presen ted by O M B ’ s participation ” given its fin din g th at th e ru lem akin g record did n ot su pport agen cy’s decision to delete the m aterial in question ). 2 7 2 . See Federici, supra n ote 2 1 5, at 5 3 6-3 7 . power to the President. Considering that the Court rarely checks congressional267 grants of power to the President, the Court’s avoidance of the issue of Presidential Administration makes perfect sense. In Public Citizen Health Research Group v. Tyson, the court avoided the issue of presidential particip ation in268 rulemaking. In that case, “the court addressed the validity of a rule269 promulgated by the Occupational Safety and Health Agency governing ethylene ox ide, including a challenge based on the argument that a critical portion of the prop osed rule had been deleted based on a command from the Office of Management and Budget (OMB).” Although it recognized that presidential270 involvement in the deletion of the rule presented a difficult constitutional issue, the court declined to address it, finding that the record did not support the claim. A test case involving a challenge to the GRAS policy, based on the2 7 1 theory of improper exercise of control by the President’s office in the food agencies’ formulation of rules regarding bioengineered foods, might be a good point of attack. Such a suit might force the Supreme Court to determine once and for all whether Presidential Administration is constitutional. A successful challenge likely would invalidate the current G RAS standard. Still, there are no guarantees that, in the face of congressional silence and the Court’s own endorsement of the substantial equivalent and G RAS p res umptions, the Court would not limit its analysis to the Chevron doctrine and abstain from determining the validity of Presidential Administration. As a result, congressional action and statutory reform, as proposed above, remain the best route for change. It seems clear that current congressional statutes delegating the authority to regulate traditional foods have not considered the advent of bioengineered foods. Courts, in dealing with these issues, have, thus far, tried to extend the272 rationales applied to traditional foods to b ioengineered foods. However, as 304 INDIANA LAW REVIEW [Vol. 46:265 2 7 3 . See E llison, supra n ote 3 3 , at 3 6 2. 274. 116 F. Su pp. 2d 1 66 (D .C . Cir. 2000). 275. 459 F.3d 1 328 (Fed. Cir. 2006). 2 7 6 . See supra notes 4 3-45 and accom panying text. 277. Law rence, supra n ote 8 9 , at 2 3 8-3 9 . 2 7 8 . Id . 279. R obertson, supra n ote 3 8 , at 1 5 7, 1 6 8. 280. M cGarity, supra note 40, at 428-29 (second and third alteration in origin al) (footnotes discussed above, this analysis is flawed because it does not take into account the foreign nature of these foods. 273 A change in the conceptual p aradigm that has been guiding the regulatory agencies in assessing the p otential risks of bioengineered foods is necessary to achieve a balanced treatment of genetically modified foods. The legal analysis underlying Alliance for Bio-Integrity v. Shalala, and infringement cases like274 Monsanto Co. v. Scruggs, reveals that courts have adopted a constrained275 rationale that agencies have followed since 1992. That rationale, simply put,276 is that if a GMO product is deemed to have “substantial equivalence” to a natural product, then it is not harmful, and it deserves the same legal privileges and rights granted by patent law. These products also enjoy all the rights and accep tance given to foods that have been established for millennia. The irony is that,277 though bioengineered foods are novel enough to be patented, food agencies still insist on treating them the same as traditional foods. The fact remains that278 “genetically modified organisms” are still an unknown. The decisions to treat279 them the same as regular foods was economically motivated rather than based on precautionary or safety concerns. In 1992, a [w]orking Group established by the O rgani[z]ation of Economic Co- Operation and Development (OECD) to study how countries should go about evaluating the safety of GM foods. . . . The Working Group suggested that the substantial equivalence determination should be based up on three primary factors: (1) knowledge of the composition and characteristics of the traditional or parental product or organism; (2) knowledge of the characteristics of the new component(s) or trait(s) derived . . . ; (3) knowledge of the new product/organism with the new components or trait(s) . . . . For GM foods and food components determined to be substantially equivalent to the parental products, the Working Group believed that further safety concerns were likely to be “insignificant” and the GM food could be treated for regulatory purposes just like the natural counterpart. For foods and food components determined not to be substantially equivalent, the Working Group recommended that the regulatory agency focus on the identified differences between the GM food and its natural counterpart. Only when there was no basis whatsoever for comparisons with unmodified foods should the GM food be evaluated on the basis of “its own composition and properties.280 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 305 om itted). 281. E rik M illstone et al., B eyond ‘Substantial E quivalence,’ 4 0 1 N ATURE 5 2 5, 5 2 6 (1 9 9 9) (contending that the substantial eq u ivalence standard “shou ld be replaced w ith a practical approach w h ich w o u ld a ctiv ely in vestigate th e safety an d toxicity of GM foods rath er th an m erely takin g them for gran ted, an d w hich could give du e consideration to public-health principles as w ell as to industrial interests”). 282. Lara B eth W inn, S p ecia l L a b elin g R eq u irem en ts fo r G en etica lly E n g in eered Fo o d : H o w Sound A re the A nalytical Fram eworks U sed by FD A and Fo od Pro d ucers?, 5 4 FOOD & D RUG L.J. 6 6 7 , 6 7 0, 6 7 5 (1 9 9 9) (argu in g th at th e “ FD A sh ou ld h ave u sed th e sam e m ateriality stan dard in th e biotech food labeling con text” and pointing to three exam ples in w hich th e FD A considered w hether certain inform ation could “help consu m ers m ake better food decisions” if th e FD A req uired m an ufactu rers to disclose inform ation ). 283. R ebecca M . B ratspies, G lo win g in th e D a rk: H o w A m erica ’s First T ra n sg en ic A n im a l E sca p ed R eg u la tio n, 6 M INN. J. L. SCI. & T ECH. 457, 459-61, 479-83 (2005) (discu ssing the failure of the FD A to regulate GloFish, the first com m ercially available tran sgen ic an im als on the m arket, and how this lack of regulation w ill affect the approval of transgenic salm on , giving rise to potential hum an an d environ m en tal conseq uen ces). 284. Sm ith, Who O wns Your D inner?, supra note 1 1, at 1 94 (“AquaB ou nty has attem pted to quash concerns in several w ays. In response to concerns over the decim ation of the w ild salm on popu lation , it claim s th at all th e fish w ou ld be bred fem ale a n d ste rile— th ou gh if n atu re h as tau gh t us anything, a sm all percentage m ay be able to breed. Indeed, even AquaB ou nty has conceded that m erely 5 % m ay be able to breed. If so , th e sa lm on w ou ld be bred in con fin ed pools w h ere th e potential for escape w ou ld be m inim al.” (footnotes om itted)). 285. Jesse M ale, N ote, T h e S ta te o f G en etica lly E n g in eered C ro p s in th e E u ro p ea n U n io n Fo llo win g M onsanto v. Italy and the A d option of a N ew R eg ulatory Fram ewo rk for G en etically M od ified Food and Feed , 9 D RAKE J. AGRIC. L. 43 9, 44 1-5 2 (2 00 4) (com parin g th e U .S. an d E U approach es to regulating GM O s an d describing the m odified E U three-part regulatory fram ew ork for GM O s). T he sub stantial equivalence test also rears its head in the “materiality” test281 applied to determine whether to impose labeling requirements. Courts need not282 even abandon the substantial equivalence test to reach more equitable results. For example, in the case of genetically modified salmon, there is an argument that the substantial equivalence rationale simp ly would not apply. Although a reviewing agency might determine that the genetically modified organism is equivalent to other elements found in natural salmons, a type of salmon, twice the size of a natural salmon and unlike other salmons, certainly runs the risk of contaminating the supply of natural salmon in the United States. The visual of a fast283 reproducing salmon––despite the manufacturers’ contention that there is only a 5% chance in fertility and that the fish will be contained in very restricted areas ––gives cause for pause. 284 The FDA’s consideration of the approval of this salmon illustrates the impracticality of the sub stantial equivalence test. As Justice Stevens pointed285 out in his dissent in Monsa n to , a similar danger of contamination exists with 306 INDIANA LAW REVIEW [Vol. 46:265 286. M on santo C o. v. Geertson Seed Farm s, 130 S. C t. 2743, 2762-63, 2768 (2010) (Stevens, J., dissenting) (recognizing “substantial evidence that [M on santo’s R ou n du p R eady Alfalfa] genes could tran sfer to other plan ts”). 287. D avid L. D evern oe, N ote, S u b sta n tia l E q u iva len ce: A V a lid In tern a tio n a l S a n ita ry a n d Ph yto sa n ita ry R isk A ssessm en t O b jective fo r G en etica lly M o d ified Fo o d s, 5 1 C ASE W . R ES. L. R EV. 25 7, 28 8 (20 00 ) (stating that “w here substantial equ ivalence evaluates characteristics of the GM food that are obviou s from the type of m odification , in-depth assessm ent evaluates all health-related criteria of the GM food, regardless of the type of m odification ” (footnote om itted)). 288. V ern R . Walker, S o m e D a n g ers o f T a k in g Preca u tio n s W ith o u t A d o p tin g th e Precautionary Principle: A C ritique of Food Safety R egulation in the U nited States, 3 1 ENVTL. L. R EP. 1 0 04 0 , at 6 -7 (2 0 0 1) (advocatin g for adh eren ce to th e “ precau tion ary prin c ip le ” an d th e adoption of a “ reason able certain ty th at n o h arm w ill resu lt” stan dard as a su bstitu te to cu rren t GR AS standards). 2 8 9 . See Fran cer, supra n ote 1 5 , at 2 7 8. 290. M arc Firestone, A Q u ick L o o k a t T w o A rea s o f D o ctrin a l D ifferen ce B etween E U a n d U .S. D ecision M akers, 2 0 TUL. J. INT’L. & C OMP. L. 1 , 3 (2011). 2 9 1 . Id . 2 9 2 . See gen era lly R eiss, supra n ote 5 2 . genetically modified seeds and plants. Compared to the international286 ap p roaches on these issues, we fall short. We could learn a great deal from the European Union’s scientific review process that largely bases its decisionmaking on expert input. We have continuously applied old methods to a new field, and it is now time to create a separate agency with the expertise to target sp ecific issues related to biotechnology. In an age where technology is progressing at a rapid rate, it is crucial for C ongress and agencies to adopt a standard that287 encapsulates the biotech companies’ promises of benefits as well as concerns for consumers’ health. 288 VII. THE EUROPEAN APPROACH: A HELPFUL M ODEL FOR G RASSROOTS LOBBYING? In the absence of congressional action, grassroots lobbying continues to be a great tool for bringing awareness and exerting pressure on lawmakers. The European approach to bioengineered foods serves as a great model for the United States. Unlike the United States, Europe has used a precautionary policy for biotechnology. This has, in great part, been due to the active and vocal role289 played by the European public in framing food policies . From the inception,290 citizens in many European countries have made it clear that they want more transparency and precautions regarding these products. This form of291 participation is not completely foreign to the American structure as public feedback from interest groups is built into the comments segment of administrative proceedings. For many of our administrative decisions,292 however, there is no required hearing and comments procedure. Consequently, agencies rarely schedule them, and this has insulated us from the issues and inhibited our ability to remain informed. The European approach, in contrast, has 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 307 2 9 3 . GOVERNING R ISKS, supra note 60, at 5 8-59. 2 9 4 . Id . at 5 9 , 6 2 . 295. Jam ie E . Jorg Spence, N ote, R ight to K now: A D iet of the Future Presently U pon U s, 3 9 V AL. U . L. R EV. 1009, 1023-24 (2005) (footnotes om itted) (“T he public perception of GM foods, like that of th e scientific com m unity, is certainly not uniform , especially across the Atlantic. In E urope the pu blic sen tim en t has been quite negative. B etw een 1992 an d 1996, con su m ers in incorporated more direct participation. For example, in the EU, authorization to place GMO products on the market [r]equires a case-by-case assessment of the potential risks to human and animal health of each GMO to be placed on the market. Applications are forwarded to the EU member-state where the GMO or derived product is to be placed on the market for the first time. The application must be accompanied by data and results obtained from lab oratory and greenhouse research, as well as from developmental releases, concerning the ecosystems that could be affected b y the use of product, and by an assessment of any risks to human health and the environment related to the G MO . The risk assessment is performed by the C omp etent Authority (CA) of the EU memb er states that receives the application. The other member- states are invited to provide comments. If the CA confirms in its opinion that the information provided by the applicant establishes that the placing on the market of the GMO would not pose a risk to human health and the environment, and if no objections are raised by other member-s tates, consent is given to the placing on the EU market by CA of the member[-]state that had received the application.293 Additional processes are in place to address the eventuality of an objection by any of the member states. The Commission also has its own scientific teams at its disposal to render an opinion on the sub ject of an objection. This multi-step governmental investigation could be a very useful model in the United States. Implementing checks on biotech companies, as well as on governmental agencies, through scientific review of the companies’ research may eliminate some of the tension surrounding the apparent lack of transparency in U.S. agencies’ evaluation of genetically modified foods. This system also facilitates accountability. For examp le, during the late 90’s and in 2001, due to lack of support for Directive 90/220/EEC concerning GM maize and rapeseed varieties, member-states invoked the safeguard clause of the approval procedures, despite the supervising agencies’ assessment of safety, “on nine separate occasions . . . three times by Austria, twice by France, and once each by Germany, Greece, Luxembourg, and the United Kingdom.” T his invocation is a testament to the294 power of grassroots lobbying and to the transparency existing in these countries regarding such procedures. As a result, concerned citizens in these countries mounted such resistance that their governments refused to introduce these products into their market. This type of transparency and willingness to295 308 INDIANA LAW REVIEW [Vol. 46:265 E urope form ed activist groups that protested the new foods, and by fall of 1999, successfully convinced the U K and E U regulatory agencies to place m oratorium s on th e grow th of these products and to stifle their im port. Furtherm ore, E uropeans appear to be becom ing less supportive of biotechnology in general.”). 2 9 6 . See E llison, supra note 33, at 348 (describing the U .S. view that GM O technology is safe). 297. C onsu m ers D iverge on GE Salm on Labels and “M aterial D ifference,” 16 FD A W EEK (Sept. 24, 2010). 2 9 8 . S ee, e.g ., Letter from Sen . M ark B egich to M argaret A. H am bu rg, C om m ’r o f Fo o d & D ru gs (Sept. 28, 2010), a va ila b le a t http:stopgefish.files.w ordpress.com /2010/09/100928-ham burg- fda-ge-salm on-final.pdf. 299. Allian ce for B io-Integrity v. Shalala, 116 F. Su pp. 2d 1 66, 179 (D .C . Cir. 2000). 300. Sm ith, Who O wns Your D inner?, su p ra note 11, at 195. For additional inform ation regarding the AguAdvantage Salm on , see id . at 193 and Graham M . Wilson, N ote, A D a y o n th e Fish Fa rm : FD A and the R egulation of A quaculture, 2 3 V A. E NVTL. L.J. 351, 384, 390-93 (2004). 3 0 1 . See gen era lly H om er, supra n ote 1 1 , at 1 0 6. educate the pub lic is lacking in the United States. In addition, agencies in the United States do not conduct as strict a review of the scientific data provided by the manufacturers. The FDA’s potential approval of a bioengineered salmon2 9 6 has revived concerns about the increasing presence of unlabeled, genetically altered foods in our food supply. These concerns are currently uniting297 disparate groups, forcing certain members of Congres s to speak on behalf of constituents who depend on the commercial farming of fish and livestock, of consumer groups, and of average consumers eager to be informed about their food consump tion. These grassroots pushes are bearing some fruit. Though298 courts still give great deference to the agency when evaluating the FDA’s decision not to require labeling under the “material difference” standard, the299 agency, itself, has had to be more transparent in its handling of the bioengineered salmon. For example, concerned about the negative p ublic image they may receive should they approve the NADA relating to the AquaBounty salmon . . . the FDA allowed the pub lic to participate in the hearing, and released a preemptive informational background document in August 2010 to better prepare the public for what it would hear. The FDA has stated that if it does approve the AguAdvantage salmon NADA, the ap p roval will include a label that identifies the different types of rDNA constructs that accompany the separate forms of the fish to the growers. These different types include the fish eggs, the young fish, called fry, and the more mature fish that are sold to growers who then bring the fish to market for sale. However, the FDA has made it clear that these labels are much different than the labels that would be placed on the actual food in the marketplace, and the decision to label has not yet been made.300 As in Europe, pressure from an informed public is a necessary part of reforming our approach to biotechnology. 301 2013] JUSTICE KAGAN’S PRESIDENTIAL ADMINISTRATION 309 3 0 2 . See Y ork, supra n ote 4 9 , at 4 3 2-3 3 . 303. 459 F.3d 1 328 (Fed. Cir. 2006); see also M on sa nto C o. v. Geertson Seed Farm s, 130 S. C t. 2743 (2010). 304. Sm ith, Who O wns Your D inner?, su p ra n ote 11, at 192-93 (“In M on santo v. Scruggs, M onsanto accused a farm er of illegally u sing its R oundup R eady technology, w ithout properly com pensating M onsanto. Scruggs argued that he purchased the seeds w ithout ever signing a licen sin g agreem en t, an d th u s, u n der th e doctrin e of paten t exh au stion , h e h ad th e righ t to u se th e seeds free from patent restriction . T he doctrine of patent exhaustion states that the unrestricted first sale by a patentee of his patented article exhau sts his patent righ ts in the article. H ow ever, the court found that the doctrine of patent exhaustion w as inapplicable, stating, ‘[t]he fact that a patented tech n ology can replicate itself does not give a purchaser the right to use replicated copies of th e tech nology, [an d fu rtherm ore] [a]pplying the first sale doctrine to su bseq uen t gen eration s of self- replicating technology w ould eviscerate the rights of the paten t h older.’” (alterations in original) (footnotes om itted)). 3 0 5 . Id . at 1 9 2. Furthermore, Monsanto’s growing monopoly over seeds has generated growing concerns that genetically engineered foods, and their subsequent patents, will lead to privatization of the food supply, which would handicap traditional farming and create a subjugated farming system, rather than opening the food supply to less privileged markets. In Monsanto Co. v. Scruggs, for example,302 303 the court reaffirmed the principles of patent law, ruling that a farmer should not use replicate versions of a patented seed without permission. It is particularly304 troubling that “Monsanto has been remarkably aggressive in its patent protection, hiring people to investigate farmers to expose possible patent infringement, and it has brought suits against several farmers and independent seed companies.”30 5 While food regulating agencies are becoming increasingly aware of these tensions, they seem to need guidance and additional grant of authority from Congress to adopt a precautionary approach. If the current tension around these products is to be resolved, the interests of the public must become part of all administrative delib erations. In addition, Congress and regulating agencies must reconsider current presumptions of equivalence between biotechnology and traditional foods and must implement a thorough evaluation process with experts/scientists. A more open and detailed educational program regarding these foods and their processes also needs to occur to ensure democratic participation in the approval process during the administrative comment period. CONCLUSION The biotechnology context illustrates that deference to Presidential Administration in the absence of specific guidance by Congress renders agencies vulnerable to unilateral usurpation of power by one branch and to market interests. As a consequence, the goals of the doctrine of separation of powers are undermined. The European approach to biotechnology p rovides a good balance of all the interests at stake, while allowing public education and democratic 310 INDIANA LAW REVIEW [Vol. 46:265 3 0 6 . See gene ra lly Stephanie Sholw alter-O tts, U .S. Reg ulatory Fram ework for G en etic B iocontrol of Invasive Fish, J. B IOLOGICAL INVASIONS (2012). 307. 116 F. Su pp. 2d 1 66 (D .C . Cir. 2000). participation. Permitting limited and strictly regulated GMO products to be disseminated in the market, the European approach views the interests and concerns of the public as primordial. Such a model constitutes an effective check on all b ranches of government and fosters greater trust in the democratic system. The reforms proposed in this Article are necessary because bioengineered crops are already harming traditional farming both domestically and internationally, not the least of which is through contamination. Also, farmers around the world have become vulnerable to intellectual property suits by biotech companies; poor farmers in developing countries are particularly affected. Additionally, the FDA’s consideration of b ioengineered salmon raises a variety of other issues regarding the safety of our wildlife and containment of bioengineered animals released into the wild. Little is known about the306 potential risks, and it is likely that this will remain the case for decades. In the meantime, safety measures must be put in place to protect citizens, the environment, and our wildlife. The President, designated with established duties under the Constitution, is traditionally not part of lawmaking. A lower standard of scrutiny in cases evidencing presidential involvement, as proposed by then Professor Kagan, would be even more detrimental to the public’s ab ility to demand transparency and participation in administrative processes. As it stands, and as exemplified by Alliance for Bio-In teg rity v. Shalala, courts’ deference to regulatory agencies307 does not adequately question the assump tions inherent in the substantial equivalence presumption. The exercise of Presidential Administration in the case of biotechnology has contributed further to this lack of transparency. A lower standard of scrutiny that encourages presidential involvement and increases courts’ deference to agencies’ decision-making would be even more detrimental to the public and to our democratic system.