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Can Roundup Ready TM Seeds, Ever beCorralled?: Restraining Genetic Drift

Through Criminal Sanctions

Imagine that you make your livelihood as an organic farmer. You till thesoil, plant seeds, and care for the plants until they are mature. You do all ofthis with the expertise of tradition without chemical fertilizers or chemicalpesticides.2 You go through an expensive certification process to be li-censed.3 You do all of this because you believe in the preservation of theearth, because you support your family, because your vegetables and fruitscan get a premium at the grocery store. Each season you face all the possi-ble problems of gardening, such as drought, insects, weeds, and too muchrain. Each day you greet the sunrise, you bend with the rain falling on yourback as you pull weeds. In the fall you warm your hands against the frostas you harvest your crop.

Imagine that the farm next to you, six miles away, plants geneticallyengineered ("GE") corn seeds. These seeds turn into plants with silky tas-sel, and the wind and bees carry that pollen to your organic corn. Nowimagine that because of this cross-pollination your crops are worthless, yourorganic certification is revoked, and your livelihood as an organic farmer isover. You want compensation for this damage. You do not want the GEpollen to be able to reach your farm. Now imagine that you have no legalrecourse.

I. INTRODUCTION

Organic farmers' property rights are being infringed upon by genetic driftentering their land.4 GE crops are not containable since pollination, dis-persed through wind, birds, bees, water, and humans, does not adhere to the

1. See MARC LAPPt & BRITT BAILEY, AGAINST THE GRAIN BIOTECHNOLOGY AND THE

CORPORATE TAKEOVER OF YOUR FOOD 4 (Common Courage Press 1998). "MonsantoCompany, based in St. Louis, Missouri, has capitalized on its glyphosate herbicide known asRoundup@ by selectively engineering crops to be resistant to high levels of this herbicide."Id.

2. See A Guide to the Recommendations of the National Organic Standards Board,available at http://www.organic.org/7/guide/ (Natural Organic Standard Board) (last visitedAug. 14, 2002) [hereinafter A Guide to the Recommendations].

3. See id.4. See MARTIN TEITEL, PH.D. & KIMBERLY A. WILSON, GENETICALLY ENGINEERED

FOOD: CHANGING THE NATURE OF NATURE: WHAT You NEED TO KNOW TO PROTECT YOUR-

SELF, YOUR FAMILY, AND OUR PLANET 94-96 (Park Street Press 1999).

CRIMINAL AND CIVIL CONFINEMENT [Vol. 29:255

construct of property lines nor to the cellular integrity of plant species.5

The law of property rights is inherent in our national structure and stemsfrom both the discovery doctrine established in Johnson v. M'lntosh6 andJohn Locke's theory of laboring upon the land.7 Concurrently, the constitu-tion protects against the government taking private property for public usewithout "just compensation. '

Nuisance law provides a useful comparison to understand the type ofproperty rights the organic farmers seek to uphold. Massachusetts definesnuisance as the interference of a property owner's use and enjoyment oftheir property by another.9 "A private nuisance is actionable when a prop-erty owner creates, permits, or maintains a condition or activity on his prop-erty that causes a substantial and unreasonable interference with the use andenjoyment of the property of another."'" Genetic drift is a nuisance to theorganic farmer because it interferes with their crops and their business byturning their organic plants into non-organic plants through cross-pollination. '

Generally, a nuisance claim rests on damage to another's property fromsuch conditions as audible intrusions, odors, water, fumes, and/or vibra-tions. 1 As an emerging technology, GE foods have not yet been added tothe rubric of nuisance law.' 3 Although the organic farmer's geneticallycontaminated land, loss of organic certification, loss of a sellable organicproduct, and loss of their business would likely fulfill the "substantial andunreasonable interference" requirement,' 4 nuisance law, by itself, does notprovide enough protection for the organic farmer because of the unique

5. See id.6. 21 U.S. 543 (1823).7. See PETER DRAHOS, A PHILOSOPHY OF INTELLECTUAL PROPERTY 43-44 (Dartmouth

Publishing Company Ltd. 1996).8. U.S. CONST. amend. V.9. See Asiala v. City of Fitchburg, 505 N.E.2d 575 (Mass. 1987).10. Id. at 577 (citing Morash & Sons, Inc. v. Commonwealth, 363 Mass. 612, 616

(1973); Leary v. Boston, 20 Mass. App. Ct. 605, 609 (1985)).11. See A Guide to the Recommendations, supra note 2, at http://www.organic.org/7/

guide/.12. See Allison v. Barberry Homes, Inc., 2000 WL 1473121, at *3 (Mass. Super. Aug. 1,

2000).13. See generally Margaret Rosso Grossman, Biotechnology, Property Rights and the

Environment, 50 AM. J. COMP. L. 215 (2002). See also Thomas P. Redick & Christine G.Bernstein, Nuisance Law and the Prevention of "Genetic Pollution": Declining a DinnerDate with Damocles, 30 ENVTL. L. REP. 10328 (2000).

14. See Colonial Color Corp. v. Massachusetts Highway Dep't, 1999 WL 791956 (Mass.Super. 1999) (denying motion to dismiss as to the nuisance claim that the MassachusettsHighway Department's vibrations caused a nuisance to Colonial Color Corp.'s photographywhen the vibrations damaged the film processing and caused harm to their business)."[P]Iaintiff must prove negligence as an element of this [particular] claim and its damagesmay not include purely economic loss." Id.

RESTRAINING GENETIC DRIFT

composition of genetic drift. 5 Odors, fumes, water and/or vibrations canbe mitigated through redirecting water or installing improved pollution fil-ters on factories to reduce polluting fumes, however, GE organisms cannotbe easily mitigated.

Genetic engineering" is a process "by which segments of genetic mate-rial (DNA) from the cells of virtually any plant, animal or microorganism- usually the genes that are believed to encode a distinct biological func-tion - can be isolated in the laboratory and artificially inserted into thechromosomes of another, often unrelated, organism."17 This intentionalcrossing of different genes, which produces a transgenic organism, can cre-ate plants whose characteristics are designed to generate a specific effect. 8

An example is the tomato altered to produce its own anti-freeze to protect itfrom frost.19 A gene from a cold-water fish, containing a natural anti-freeze, was combined with tomato DNA to create the tomato.2°

The "Flavr SavrTM tomato" is another example of genetic manipulation.21

Scientists deactivated the gene that made tomatoes soften when theyripen.22 This allows farmers to ship the tomatoes without bruising.23 Thesegenetic technologies can increase crop yields, produce insect resistantplants, plants that are resistant to herbicides, nutritionally enhanced plants,and create plants that are resistant to climate changes.24 These may appearto be positive innovations, but, there can be numerous adverse effects asso-ciated with the dispersal of GE plants into the environment

15. See Nathan Batalion, 50 Harmful Effects of Genetically Modified Foods (Americansfor Safe Food 2000), available at http://www.cqs.com/50harm.htm (last visited Jan. 25,2002); see also Sophia Kolehmainen, Precaution Before Profits: An Overview of Issues inGenetically Engineered Food and Crops, 20 VA. ENvTL. L.J. 267, 280-81 (2001).

16. See generally LAPPE & BAILEY, supra note 1. The terms genetically engineered,genetically altered, and genetically modified organism are used interchangeably for themanipulating, inserting or removing of genetic material from an organism to create a desiredresult. See generally id.

17. BRIAN TOKAR, Challenging Biotechnology, in REDESIGNING LIFE?: THE WORLDWIDE

CHALLENGE TO GENETIC ENGINEERING 4 (Brian Tokar ed., Zed Books 2001).18. See U.S. CONGRESS, OFFICE OF TECHNOLOGY ASSESSMENT, A NEW TECHNOLOGICAL

ERA FOR AMERICAN AGRICULTURE, OTA-F-474 3 (Washington, D.C.: U.S. GovernmentPrinting Office, Aug. 1992) [hereinafter U.S. Congress].

19. See Joshua M. Stone, Restraints on Competition Through the Alteration of the Envi-ronment at the Genetic Level, 8 N.Y.U. ENVTL. L.J. 704, 715 (2000).

20. See id.21. See David J. Earp, Comment, The Regulation of Genetically Engineered Plants: Is

Peter Rabbit Safe in Mr. McGregor's Transgenic Vegetable Patch?, 24 ENVTL. L. 1633,1652 (1994).

22. See id.23. See id.24. See id.25. See generally June Starr & Kenneth C. Hardy, Note, Not by Seeds Alone: The Bi-

odiversity Treaty and the Role for Native Agriculture, 12 STAN. ENVTL. L.J. 85, 95-96

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Native plant species are adversely affected when GE plants reproducewith other plant life.26 The pesticide and herbicide plant technology in-creases the amount of chemicals that get into watershed, soil, plants, in-sects, birds, animals, and ultimately human systems.2 7 The GE technologyaffects the biodiversity of the ecological systems.28 Human health is alsoaffected through an increased level of antibiotics in our system through theintroduction of antibiotic marker genes used in recombinant DNA.29 GEfoods are often comprised of allergenic material or foreign proteins thathave not been scientifically tested over an extended period of time.3°

Another problem with GE foods is that the Federal Drug Administration("FDA") does not require them to be labeled.3' This infringes upon ourright to know precisely the ingredients in our food so that we can bothprotect ourselves from allergens and choose what type of food we wish toconsume.32 Nuisance law does not provide enough legal protection againstthe above problems with the introduction of GE organisms into the environ-ment.33 Compensation alone is not enough for the organic farmer becausethey also want to preserve their land and continue to farm organically forgenerations to come. The viability of organic farms, the health of the pub-lic, and the preservation of the environment depend upon a new regulatorysystem with enforceable criminal sanctions.

In 2002, the United States Public Interest Research Group ("USPIRG")sued Heritage Salmon, Inc. under the Clean Water Act ("CWA") 34 for inter-fering with wild Atlantic salmon and water quality by growing and releas-ing "non North American strain or species" of salmon. 35 As part of the

(1993). This Note discusses the impact of focusing on crop yields without establishing morebalanced and sustainable agricultural resources. See id. at 86-87.

26. See TEITEL & WILSON, supra note 4, at 115.27. See LAPP & BAILEY, supra note 1, at 96.28. See id. at 97.29. See TEITEL & WILSON, supra note 4, at 114.30. See Jennifer Ferrara & Michael K. Dorsey, Genetically Engineered Foods: A

Minefield Of Safety Hazards, in REDESIGNING LIFE? THE WORLDWIDE CHALLENGE TO GE-NETIC ENGINEERING 57 (Brian Tokar ed., Zed Books 2001).

31. See TEITEL & WILSON, supra note 4, at 61-70.32. See generally id.33. See generally Asiala, 505 N.E.2d at 577.34. 33 U.S.C.A. § 1259 (West 2001).35. Press Release, Federal Court Bans Frankenfish and Antibiotics (July 29, 2002),

available at www.organicconsumers.org/gefood/frankenfishban.cfm (last visited Feb. 18,2003); see also National Environmental Law Center, Judge Bans Future Stocking AtMaine's Largest Salmon Farm Company (Feb. 14, 2003), at http://nelconline.org/nelc.asp?id2=9071&id3=NELCI (last visited Apr. 22, 2003); National Environmental Law Center,Settlement of Environmental Lawsuit Points to New Direction for Salmon Farming, at http://nelconline.org/nelc.asp?id2=7185&id3=NELCI; Settlement Protects Salmon, Coastal Wa-ters, at http://nelconline.org/nelc.asp?id=8688&id3=NELCI (last visited Apr. 22, 2003). Seegenerally United States Pub. Interest Research Group v. Heritage Salmon, Inc., 2002 WL240440 (D. Me. 2002) (ordering Summary Judgment decision prior to the consent decree;


settlement, the United States District Court for the District of Maine entereda Consent Decree against Heritage Salmon, Inc., banning them from grow-ing GE salmon.3 6 There is the potential for the salmon to reproduce withwild Atlantic salmon, thus making the wild Atlantic salmon extinct.37 Sim-

ilarly, the native plants will be bred into extinction while the soil, water,and helpful insect population may deteriorate.3 8 The organic farmer is enti-tled to the same protection for their land that the court has given the riversand ocean through the enforcement of the CWA.3 9

Ideally, there would be a complete ban on GE foods until scientific re-

search and data developed to the point where concrete assessments of theenvironmental and health impacts can be determined. However, consider-

ing the monetary investments already made by many factions of the indus-try this is an unrealistic option.4" In the alternative, a regulatory and

enforcement scheme that specifically targets GE plants and protects organicfarmers is needed.

This Comment will explore the inadequacies of present regulations gov-

erning GE foods and propose a uniform federal regulatory structure with

criminal penalties imposed on those who allow genetic drift and for thosewho do not adhere to the statutory requirements. Part II outlines the propo-

sal of the Federal Organic Protection Act ("OPA") regulated under the En-

the official consent decree is not yet published); United States Pub. Interest Research Groupv. Stolt Sea Farm, Inc., 2002 WL 1552165 (D. Me. 2002).

36. See Federal Court Bans Frankenfish and Antibiotics, supra note 35, at www.organiccinsumers.org/gefood/frankenfish.cfm. The consent decree includes:

[1] Limits on stocking density, to minimize disease outbreaks[,][2] Measures to protect wild salmon from interaction with farmed fish[,][3] Mandatory fallowing, to reduce pollution impacts[,][4] Ban on experimental drugs without environmental review,[and a][5] Moratorium on expansion of Heritage operations into Penobscot Bay[.]

Id.37. See National Environmental Law Center, Settlement Protects Salmon, Coastal Wa-

ters, at http://nelconline.org/nelc.asp?id2=8688&id3=NELCI. See generally George VanCleve, Regulating Environmental and Safety Hazards of Agricultural Biotechnology for aSustainable World, 9 WASH. U. J.L. & POL'Y 245, 291-97 (2002).

38. See Sophia Kolehmainen, Precaution Before Profits: An Overview of Issues in Ge-netically Engineered Foods and Crops, 20 VA. ENVTL. L.J. 267, 280-81 (2001).

39. See ROGER W. FINDLEY & DANIEL A. FARBER, ENVIRONMENTAL LAW IN NuT SHELL

119 (5th Ed. West Group 2000). "In 1972 Congress adopted a totally different approach [toFederal Water Pollution Control]. The 1972 amendments established a system of standards,permits and enforcement aimed at 'goals' of 'fishable and swimmable' waters by 1983 andtotal elimination of pollutants discharges into navigable waters by 1985." Id.

40. See generally Judy J. Kim, Note, Out of the Lab and Into the Field: Harmonizationof Deliberate Release Regulations for Genetically Modified Organisms, 16 FORDHAM INT'L

L.J. 1160, 1160-79 (1993). "In 1990 alone, the U.S. government spent more than US$3.4billion to support research and development in biotechnology-related areas." Id. at 1164.

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vironmental Protection Agency ("EPA").4 ' Part III intersperses the issuesof biodiversity, traditional farming, health risks, and GE plants infused withherbicides and pesticides. In addition, Part III examines the current regula-tory statutes that govern GE foods and shows that because of the segmenta-tion of GE food into various parts, each part governed by a separate agency,there are a multitude of deficiencies and gaps in the standards.

Part IV discusses the current enforceable penalties under the UnitedStates Department of Agriculture ("USDA"), the FDA and the EPA. Part Vdetails the proposed OPA using the Organic Foods Production Act as amodel. The OPA provisions enact a certification process, a genetics stan-dards board, a permit procedure, civil penalties, criminal sanctions for ge-netic drift and criminal sanctions for non-compliance with the statute. Draftlegislation from Maine and Massachusetts are used as a comparison andmodel to incorporate civil penalties.42 The OPA extracts parts of both the

41. See John Charles Kunich, Mother Frankenstein, Doctor Nature, and the Environ-mental Law of Genetic Engineering, 74 S. CAL. L. REV. 807, 863 (2001). Kunich proposes aTransgenic Release Act ("TRA") governed by the EPA which includes a register of trans-genic organisms, an information-flow system, a center for transgenic research and testing,and remediation liability. See id. "This would be a list, or . . . a database, of all [GE]organisms in existence within the jurisdiction of the U.S., including field tests." Id. at 864.The registry dictates that the creators and producers of the GE organisms would be responsi-ble for supplying proof of safety and risk assessment. See id. Kunich retains the FDAprocess under the FFDCA, which classifies GE foods as "substantially equivalent" to non-GE foods. See id. Under the information-flow system, Kunich suggests a system similar toEPCRA, which would "require information flow to and between certain organizations withineach community as the presence of genetically engineered organisms." Id. at 865. Kunichalso borrows from the Biosafety Clearinghouse under the Cartagena Protocol on Biosafety tocreate an organization that gathers and disseminates "information concerning the varieties,locations, effects, and movements of [GE] organisms." Id. at 866. One of the main featuresof the actual Biosafety Clearinghouse is for parties to the convention to state whether theyare willing to accept imports of goods containing GE foods for trade purposes. See id. TheCenter for Transgenic Research and Testing "would conduct basic and applied research on[GE] organisms." Id. at 867. The remediation liability would be "assessed against the pro-ducers, not against the users" and require the EPA "to conduct the remediation action in-house rather than compel the producer to do so." Id. at 869. "As proposed, the TRA wouldnot require prerelease testing or certification" because Kunich believes that "this seems ap-propriate given the evident heavy preponderance of benefits over risks for [GE] organisms inuse up unitl now." Id. at 868. See also Jonathan A. Glass, The Merits of Ratifying andImplementing the Cartagena Protocol on Biosafety, Comment, 21 Nw. J. INT'L L. & Bus.491, 505 (2001). The Protocol operates under the precautionary principle, which "permitsparties to act [by refusing to accept GE organisms] absent clear scientific evidence or basedon non-scientific criteria" as opposed to the U.S. system exemplified by the FDA standardthat requires proof of harm.

42. Compare An Act Relative to the Liability for Genetically Engineered Food, Mass.S.B. 1912 (SN) (2003), and Genetically Engineered Organism Liability Act of 2002, OhioH.R. 4816, and An Act to Protect Against Contamination of Crops and Wild Plant Popula-tions by Genetically Engineered Plants, ME. REV. STAT. ANN. tit. 7, § 1052, available athttp://www.mofga.org/news200l0531.htm (last visited Feb. 18, 2003). See generally Mar-garet Rosso Grossman, Biotechnology, Property Rights and the Environment, 50 AM. J.CoMp. L. 215, 242 (2002).


CWA4 3 and the Resource Conservation and Recovery Act ("RCRA") 44 to

instill criminal sanctions into the Act. The Comment concludes in Part VIby establishing the OPA as a comprehensive regulatory scheme for GEfoods, by holding those responsible for their escape into the environmentcriminally liable.

II. PROPOSAL OF THE FEDERAL ORGANIC PROTECTION ACT

The lack of a comprehensive regulatory system for GE plants and thelack of legal recourse invites the proposal of a statute that regulates GEfarmers and imposes criminal sanctions for the spread of GE plants.4 ' ThisComment proposes a regulatory system to address the gaps left open by theexisting regulatory scheme currently governing GE foods.4 6 The proposedOPA model would consolidate the GE plant into one substance regulated byone agency, the EPA.47 The separate classifications, a chemical (USDA), apesticide (EPA), and an unsafe additive (FDA), currently embraced bythese agencies would be erased.48 The proposal extracts parts of other ex-isting legal doctrines and statutory regulations, but recognizes that piece-meal criminal sanctions would be an inappropriate solution applied to analready disjointed regulatory system.

The proposed certification process would require a GE farmer to undergoa federal inspection of their growing and handling methods and to certifythat appropriate precautions are in place to prevent contamination.49 Thisplaces the burden on the appropriate farmer, since the GE farmer is the oneintroducing a new species into the environment.5" The proposed geneticsstandard board would monitor GE farmer's seed introduction, farming pro-cess, production, and distribution. In order to dispose, store, or treat the GEplants the statute would require that a GE farmer obtain a permit. Civilpenalties would also be imposed on a GE farmer to allow an organic farmerto recoup any losses due to contamination, reduction in the price of sellingnon-organic produce, additional transportation, storage, or handling costs,and recovery of liability due to breach of contract for not being able todeliver the organic product to the buyer due to contamination. Under the

43. 33 U.S.C.A. § 1319.44. 42 U.S.C.A. § 6921.45. See discussion infra Part III.46. See discussion infra Part III.47. See Kunich, supra note 41, at 863.48. See id.49. See generally A Guide to the Recommendations, supra note 2, at http://www.or-

ganic.org/7/guide/ (suggesting inspection of organic farmers growing and handlingmethods).

50. See id. (Organic Crop Production Standard). The National Organics StandardsBoard would mandate that the organic farmer be responsible for maintaining GE free farms.I believe the inverse would be the best practice.

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proposed federal statute, incidents of genetic drift would trigger criminalsanctions for a GE farmer for the spread of GE plants. In addition, any non-compliance with the statute would result in criminal sanctions. The crimi-nal sanctions would provide an incentive for a GE farmer to take appropri-ate precautions with the new technology.

Criminal enforcement of environmental laws is a relatively new concept."Since the early 1990's, both criminal enforcement of environmental lawsand the severity of penalties imposed for violations have increased signifi-cantly."'" Similar to the ad hoc regulations of GE plants, the federal envi-ronmental crimes program was "developed in piecemeal stages, withCongress giving little systematic consideration to the policy goals, the insti-tutional structure, or the elements of the offenses."52 This fractured systemstems from the confusion as to the purpose of environmental enforcement.53

There are three main views as to why there are criminal sanctions forenvironmental crimes.54 The first objective is to promote regulatory com-pliance. Second, criminal sanctions are used to prevent pollution. The thirdgoal is to punish violators in order to deter future environmental crimes.55

The proposed Act considers each of these objectives as valid and importantin maintaining a safe and healthy environment. The proposed model incor-porates all three enforcement purposes.

III. THE REGULATORY FRAMEWORK

The composition of GE foods creates a quandary as to which governmen-tal agency will govern its components, from the growing process to the finalproduct. Governmental safeguards are needed to ensure that the risks tohealth and the environment are protected. "In 1986, the Office of ScienceTechnology Policy issued a policy statement called the Coordinated Frame-work for Regulation of Biotechnology."56 Under this framework GE foodsare managed by three governmental agencies: the USDA, FDA, and EPA.57

51. Margaret Shaw, Note, Criminal Enforcement of Environmental Laws: Relevancy ofthe Public Welfare Doctrine in Determining Culpability, 27 NEW ENG. J. ON CrM. & CIv.CONFINEMENT 337, 337 (2001).

52. JOHN F. COONEY ET AL., ENVIRONMENTAL CRIMES DESKBOOK 5 (EnvironmentalLaw Institute 1996) [hereinafter Environmental Crimes Deskbook].

53. See id.54. See id.55. See id.56. Kim, supra note 40, at 1179.57. See LAPPE & BAILEY, supra note 1, at 73; see also Kim, supra note 40, at 1177.

Other nations follow a process oriented regulatory approach whereby the technique of ge-netic engineering itself is a risk. See id. Conversely, the United States takes a productspecific approach which regulates the end result, such as the pesticide or the produce. Seeid.


The governmental departments within individual states also help regulateGE foods.58

The USDA governs the plant's growth and the geographic locale where itwill be planted.59 The EPA governs the permissible herbicides and pesti-cides released into the environment, and sets the safe levels of pesticide andherbicide residues for food.6" The FDA governs proper labeling of GEfoods in conjunction with the EPA's pesticide tolerance standards.61 Boththe USDA and the EPA fit GE foods into pre-existing statutes dealing withplant pests.62 "Since transgenic plants are not considered pests per se, theymay be exempt from regulation if they do not fall within one of the agen-cies' jurisdictional categories. '"63

Food processors must be in compliance with both FDA and EPA regula-tions. 4 Some legislators have favored fitting GE plants into pre-existingstatutes whenever possible, while others favor creating separate regulations,as they consider GE farming to be fundamentally different from traditionalfarming practices.65 The Organization for Economic Cooperation and De-velopment was instrumental in lobbying for GE foods to fit within the ex-isting framework in order to increase the ease with which biotechnology isaccepted.66

The gaps created by segmenting GE plants into separate categories andthen governing them through three different agencies are a concern forhuman and environmental health.67 Presently, organic farmer's reliance onthe non-cohesive regulatory system puts them at risk of contamination fromGE plants.68 This inadequate approach leaves the organic farmer no re-course if their land is contaminated. 69 The OPA would provide the protec-tion that the organic farmer needs through the enforcement of criminalsanctions for a GE farmer's transgressions.

58. See STEPHEN NOTTINGHAM, EAT YOUR GENES: How GENETICALLY MODIFIED FOODIs ENTERING OUR DIET 123 (Zed Books Ltd. 1998).

59. See LAPPE & BAILEY, supra note 1, at 73.

60. See id.61. See id. at 73-74.62. See Earp, supra note 21, at 1641.63. Id. (emphasis in original).64. See id. at 74.65. See NOTTINGHAM, supra note 58, at 122.66. See id.67. See discussion infra Part IV.68. See discussion infra Part IV; see also Kolehmainen, supra note 38, at 280.69. See discussion infra Part IV; see also Kolehmainen, supra note 38, at 280.

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A. The Need for Biodiversity

Biodiversity is the "variety of plant and animal life on earth or in a par-ticular ecosystem. '"" It is important to "maintain[ ] and preserv[e] the deli-cate balance of each ecosystem" in order to protect the integrity ofbiodiversity. 1 The GE crop threatens to decrease the diverse varieties ofplants currently grown by substituting a limited selection.72 The selectionbecomes limited when the GE plants weed out the native plants.73 Theintegrity of plant species will be compromised as engineered crop acreageincreases and native plants become overloaded with genetic pollen and thenative plant is suppressed.7 4 "One such hazard is that because evolutionaryprocesses are not static, the altered biological products that [GE] farmersintroduce into the environment can further evolve and can cause other orga-nisms in the environment to evolve in harmful ways."75 This new breed ofplant can freely move from farm to farm through wind, insects, birds andcross-pollination.7 6 The movement of genetic pollen from place to place iscalled genetic drift and the resulting altered plants are called genetic falloutor pollution which knows no limits or bounds.77

70. Starr & Hardy, supra note 25, at 87.71. Id. at 85.72. See LAPPE & BAILEY, supra note 1, at 97. In 1997, Pioneer Hi-Bred International

Seed Company pulled out of a deal with Monsanto to carry their roundup ready corn. See id.Pioneer stated in their letter to their customers that the contract terms "'could significantlylimit the number of traits, genes, and technologies.'" Id.; see also Kunich, supra note 41, at860. "The advantages genetic engineers have conferred upon plants and animals could en-able them to out-compete native species and reduce biodiversity, with possible loss of somespecies entirely."

73. See LAPPE & BAILEY, supra note 1, at 97; see also ALEX JACK, AWAKENING TO THE

HAZARDS OF GENETICALLY ALTERED FOODS: IMAGINE A WORLD WITHOUT MONARCH BUT-

TERFLIES 32-35 (One Peaceful World Press 2000).74. See LAPPE & BAILEY, supra note 1, at 96.75. Stone, supra note 19, at 705.76. See ALEX JACK, AWAKENING TO THE HAZARDS OF GENETICALLY ALTERED FOODS:

IMAGINE A WORLD WITHOUT MONARCH BUTTERFLES 32-35 (One Peaceful World Press2000); see also Scott Kilman & Jill Carroll, Monsanto Admits Unapproved Seed May Be inCrops, WALL ST. J., Apr. 15, 2002, at A3.

The biotechnology industry concedes the primary point of its opponents -

that crops mate too freely to keep genetically modified versions entirelyseparate. The wind and insects can carry the pollen of a genetically modi-fied plant great distances to where it isn't wanted: an organic farm, for in-stance. The pollen from a genetically modified corn plant can fertilize cornthat wasn't intended to be bio-engineered. The problem extends to geneti-cally modified crops that are legal but unwanted by a certain segment ofconsumers. A Wall Street Journal laboratory investigation last year of 20products labeled as containing no genetically modified ingredients foundevidence of the material in 16 of them.

77. See Batalion, supra note 15, at http://www.cqs.com/50harm.htm (last visited Jan. 25,2002).


Many of the GE plants are patented and in order to have the technologi-cal patent a company must prove that they "will maintain a uniform prod-uct."78 This requirement of uniformity guarantees that the resultingprogeny will be close to identical from the original seed.79 This is danger-ous because it is important to the environment that a diverse stock of seedsis maintained.8" Diversity ensures that a plant can evolve its different char-acteristics with shifting growing conditions and climate changes.8 Plantsneed to be able to continually adapt to the changing environment in order tosurvive.8" With loss of biological diversity there inevitably develops a fra-gility of agriculture.83

The property rights of organic farmers are being infringed upon by ge-netic pollution because this type of plant dispersal is pervasive and spreadswithout restraint.84 Scientists have not adequately assessed the conse-quences of the long-term affects of GE foods on biodiversity.85 Because ofthe threat to biodiversity there is a need to keep GE crops contained. Inorder to accomplish this result criminal sanctions for those who let themloose upon the environment must be imposed.

Experiments in Germany have shown that engineered oilseed rape can haveits pollen move over 200 meters. As a result German farmers have sued tostop field trials in Berlin. In Thailand, the government stopped field testsfor Monsanto's Bt cotton when it was discovered by the Institute of Tradi-tional Thai Medicine that 16 nearby plants of the cotton family, used bytraditional healers, were being genetically polluted. US research showedthat more than 50% of wild strawberries growing inside of 50 meters of aGM strawberry field assumed GM gene markers[,] . ..wild honey wasfound to be contaminated. This means that bees are likely to pollinate or-ganic plants and trees with transgenic elements.

Id.78. LAPPt & BAILEY, supra note 1, at 97.79. See id.80. See id. at 99.81. See id. at 98.82. See id.83. See LAPPf & BAILEY, supra note 1, at 98; see also Batalion, supra note 15, at http://

www.cqs.com/50harm.htm. "During the Irish potato famine of the 19th century, farmersgrew limited varieties of potatoes. This allowed a crop blight to spread throughout. Bycontrast, there are thousands of varieties of potatoes in Peru - what provides adaptabilityand thus a constant resource for blight resistance."

84. See generally Stone, supra note 19.85. See LAPPE & BAILEY, supra note 1, at 105; see also Batalion, supra note 15, at http:/

/www.cqs.com/50harm.htm. "A study in Denmark (Mikkelsen, 1996) and in the UK (Na-tional Institute of Agricultural Botany) showed superweeds growing nearby in just one gen-eration .... An experiment in France showed a GM canola plant could transfer genes to wildradishes, what persisted in four generations."

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B. Traditional Farming Practices

Traditional farming uses plant breeding practices that work within bi-odiversity, not against it.86 Farmers "have propagated crop plants for mil-lennia by selecting plants that possess desirable characteristics such ashigher yields or better taste, and then using seeds from these plants for thenext year's crop. '"87 Rather than activating or deactivating genes in a plant,time-honored propagation methods work with the plant's inherent genes.88

Traditionally, selective breeding through cross-pollination creates hybridswith different characteristics.89 These selective hybrids "maintain[ ] somelevel of shared evolutionary history. '"90

Traditional breeding, therefore, allows for a gradual evolutionary history,which in turn maintains the natural boundaries between plant species9 andthis helps to protect against random unpredictability. 92 For example, scien-tists studied GE mustard plants and non-GE mustard plants.93 "Typicallythe mustard plant is self-pollinating with low rates of cross pollination,which would lead researchers to assume that if such a plant was geneticallymodified it would have a low chance of cross-pollination with otherplants."9 4 Unpredictably, the scientists discovered that the GE mustardplant was "twenty times more likely to cross-pollinate than the non-geneti-cally modified mustard plant."95 Genetic pollution is a heightened form oftoxic contamination because, unlike an oil spill, there is no way to clean it

86. See Starr & Hardy, supra note 25, at 96.GM crop farming is expanding rapidly around the world. Global acreage ofGM crops has risen 25 fold in four years, from approximately 4.3 millionacres in 1996 to about 100 million acres in 1999. Worldwide sales of GMfoods rocketed from an estimated $75 million in 1995 to a staggering $2.3billion in 1999.

Id.; see also Peter Tyson, Should We Grow GM Crop?, Nova Special Frontline Report:Harvest of Fear, available at http://www.pbs.org/wgbh/harvest/exist/ (last visited Aug. 14,2002).

87. Earp, supra note 21, at 1643; see also Batalion, supra note 15, at http://www.cqs.com/50harm.htm. There has been an increasing trend of large corporations to buy up smallseed companies and require when distributing patented seeds that the farmers sign contractsnot to save their seeds but to replace them yearly with the controlled brands.

88. See Kolehmainen, supra note 38, at 284-85.89. See id. at 285.90. Id.91. See id.92. See id. at 276. Another type of unpredictability has been seen in the experimentation

with laboratory rats. See id. Two groups of rats were fed potatoes, one group was fed GEpotatoes and the other non-GE potatoes. See id. The ones fed GE potatoes "showed stuntedgrowth and suppressed immune systems" while the non-GE fed rats showed none of thesymptoms. Id.

93. See Kohelmainen, supra note 38, at 276.94. Id.95. Id.


up.96 These genetically altered plants cannot be distinguished, as they con-tinually cross-pollinate with other vegetation.97 Organic farmers' propertyrights are being eroded by their inability to rely on the organic seeds theyplant being the same organic crop they harvest. The proposed OPA wouldensure that a GE farmer's plants are contained within their farm's bounda-ries so that there will be no genetic pollution.

C. The United States Department of Agriculture

The USDA's responsibility is to regulate GE plant releases under theFederal Plant Pest Act ("FPPA") and the Plant Quarantine Act ("PQA"). 98

FPPA protects American agriculture from new or unknown plant pests anddiseases and regulates crops that may be injurious to cultivated crops. 99

Although neither the FPPA nor the PQA specifically deal with GE plants, in1987 the USDA issued policy statements to regulate GE plants prior to theirrelease into the environment or movement into commerce under the previ-ous system set up for traditional plant pests. 1°° Under this authority, theUSDA regulates the plants through the Animal Plant Health Inspection Ser-vice ("APHIS") division.1"1

APHIS regulates the "introduction of organisms and products altered orproduced through genetic engineering which are plant pests or which thereis reason to believe are plant pests."1 °2 APHIS defines plant pest as "inver-tebrate animals, bacteria, fungi, other parasitic plants ... which can directlyor indirectly injure or cause disease or damage in or to any plants or partsthereof, or any processed, manufactured, or other products of plants."' 3

GE foods are considered plant pests because there is not enough researchand conclusive evidence available to establish whether or not they will in-terfere with other plants in the ecology."°

APHIS handles the interstate movement, importation, and field-testing ofGE foods through a detailed permit process."0 5 The permit process includes"[a] detailed description of the proposed procedures, processes, and safe-

96. See JACK, supra note 76, at 35; see also TEITEL & WILSON, supra note 4, at 37.97. See JACK, supra note 76, at 76. "In the Netherlands, a natural foods company ran-

domly tested organic corn chips it had imported from the U.S. and discovered that theycontained GM ingredients. Prima Terra, the manufacturer in the U.S.[.], had made the chipsfrom corn obtained from a certified organic farm in Texas." Id. Pollen from a GM corn croplocated six miles away cross-pollinated with the organic com. See id. at 30.

98. See Earp, supra note 21, at 1642 (citing 7 U.S.C. §§ 150aa-150jj (1988 & Supp. V1993)).

99. See id.; see also 7 U.S.C.A. §§ 151-64, 166-67 (West 1999).100. See Kunich, supra note 41, at 839.101. See NO--rINGHAM, supra note 58, at 123; see also Kim, supra note 40, at 1170.102. 7 C.F.R. § 340.0 (2000).103. 7 C.F.R. § 340.1 (2000).104. See NOTrINGHAM, supra note 58, at 123.105. See id.

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guards which will be used to prevent escape and dissemination of the regu-lated article at each of the intended destinations."10 6 The permit process forfield-testing and release into the environment includes details of the GEfood, the genes transformed, the purpose of the proposed release and thesafeguards in place to prevent escape.' °7 APHIS makes an initial risk as-sessment, contacts the department of agriculture in the relevant states, andthen APHIS and the state department work together to ensure proper in-spection, security and operating procedures. 10 8

APHIS must complete an environmental assessment under the NationalEnvironmental Policy Act ("NEPA") °9 of the potential environmental im-pacts on the ecology." 0 NEPA's mission statement, a declaration of con-gressional national policy for the "[c]reation and maintenance of conditionsunder which man and nature can exist in productive harmony" could poten-tially halt the introduction of GE plants into the environment."' The Actmakes it a "[c]ontinuing responsibility of Federal Government to use allpracticable means to improve and coordinate Federal plans, functions, pro-grams, and resources" in compliance with NEPA.'" NEPA requires fed-eral agencies to take environmental factors into consideration when makingsignificant decisions through a mandatory environmental impact statement("EIS"). 1 13

In Barnes v. Shalala,"4 the plaintiff's alleged that the FDA's approval ofthe bovine growth hormone (rBGH, a GE growth hormone injected intocows to increase milk production) failed to take certain environmental im-pacts into consideration in the "environmental assessment" report. The EISassessed these significant environmental impacts, such as: "health impactson dairy cows, shifts in land use patterns, feasible alternatives to rBGHsuch as rotational gazing, the potential health risks to consumers caused byincreased IGF- I and antibiotic residues and the economic impacts on family

106. 7 C.F.R. § 340.4(12) (2000).107. See NOTrINGHAM, supra note 58, at 124.108. See id. at 123. If the GE food to be regulated is considered a trade secret the

applicant must submit two versions of the specified information and the one with the tradesecrets remains with the USDA and the other version is sent to the relevant states. See id.

109. 42 U.S.C.A. § 4331 (West 2001).

110. See Kolehmainen, supra note 38, at 291.111. 42 U.S.C.A. § 4331(a) (West 2001).112. 42 U.S.C.A. § 4331(b) (West 2001).113. See 42 U.S.C.A. § 4332(2)(c) (West 2001); see also Roger C. Cramton & Richard

K. Berg, On Leading a Horse to Water: NEPA and the Federal Bureaucracy, 71 MICH. L.REV. 511, 536 (1973). While NEPA is considered an action forcing statute there are no clearguidelines as to how the information must figure into the final decision; Michael Herz, Par-allel Universes: NEPA Lessons for the New Property, 93 COLUM. L. REV. 1668, 1704(1993).

114. 865 F. Supp. 550 (W.D. Wis. 1994).


dairy farms.""' 5 The court held that the farmers did not have standingunder NEPA because their harm was purely economic and thus did not fallwithin the zone of interest requirement." 6 The consumers, however, didhave standing because the plaintiff's allegations were "sufficient to allegean environmental impact on human health."' 17

Once the consumers re-filed their claim the court deferred to the FDA'sexpertise when it noted that the FDA had made its conclusion despite"scientists, economists, farmers and environmental and animal welfare or-ganizations [who had] questioned the safety and quality of [rBST]-derivedproducts, [and] the thousands of letters from consumers [FDA had received]asking it to deny approval of [rBST] or to require labeling of [rBST]-de-rived products.""' 8

While Barnes relates to a GE dairy product, it exemplifies the failure ofNEPA to protect the organic farmer. Therefore, the proposed federal statuteis needed to ensure that organic farmer's land and consumer health is pro-tected, by ensuring that the GE farmer contains their crops.

Under APHIS, if an applicant is approved for a field-test site permit, thepermit is valid for one year.1 ' 9 The approved permit triggers field site mon-itoring by APHIS personnel before, during, and after the experimental re-lease and any remaining plants, after one year are destroyed.' 20 After initialtest sites are conducted, biotechnology companies seek to grow GE plantson a larger commercial scale.' 2 ' Ultimately, biotechnological companieswant GE plants to enter into the environment without restrictions.122 How-ever, just because the GE plants are grown without problems in a test fieldsite does not mean that the GE plants are ready for unrestricted release.' 23

While the test field sites may be closely monitored, the sites are not rep-resentative of unrestricted environmental release because the purpose of thetest site is to ensure that the GE plant does not interact with the nativeplants.'24 The test site does not show the effects of the interchange betweenthe native plants and the GE plants nor does it show other effects on the

115. Id. at 562; see also Paul S. Naik, Biotechnology Through the Eyes of an Opponent:The Resistance of Activist Jeremy Riflin, 5 VA. J.L. & TECH. 5, 21 (2000).

116. See Barnes, 865 F. Supp. at 563.117. Id.118. Paul S. Naik, Biotechnology Through the Eyes of an Opponent: The Resistance of

Activist Jeremy Ritkin, 5 VA. J.L. & TECH. 5, 112 (2000) (citing Strawber v. Shalala, 895 F.Supp. 1178, 1183 (W.D. Wis. 1995)) (alterations in original).

119. See NOTrINGHAM, supra note 58, at 123.120. See id. at 124.121. See Earp, supra note 21, at 1638.122. See id. at 1638-39.123. See id. at 1639; see also LAPPI & BAILEY, supra note 1, at 74. APHIS must over-

see more than 800 test sites annually and reduces this daunting task by allowing corporationsto field test crops without prior regulatory review.

124. See Earp, supra note 21, at 1654-55.

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environment.12 1 It simply shows that the GE plant can mature in a compa-rable way to the traditional plant. The leap from a test site, where the plantsare closely monitored, to one where the plants are released without restric-tions creates a false sense of security.'2 6 The organic farmer has a right toprotect her land from unwanted organisms. The OPA is a concrete way toensure the organic farmer's business is secure by placing the burden on theGE farmer to contain their plants or face criminal sanctions if they fail to doSO.

Nevertheless, the USDA is streamlining the permit process to allow for asimple notification process, on a case-by-case basis rather than the time-consuming process of the permit application.'2 7 In 1997, APHIS declaredthat the process of notification would be extended to all species considereda common crop.' 28 In 1993, the USDA created new rules that allow anapplicant to petition the agency for exemption of a GE plant as a plant pest,and give the proponent "non-regulated status.' 29 If the petition is granted,the GE plant no longer requires the permit process under the FPPA.13°

A non-regulated status is permitted if the proponent can meet all six re-quirements laid out by APHIS:

(1) . . . any plant species that is not listed as a noxious weed ... [j(2) [tjhe introduced genetic material is 'stably integrated' . . .[;](3) [t]he function of the introduced genetic material is known and... doesnot result in plant disease[;](4) [t]he introduced genetic material does not

(i) [c]ause the production of an infectious entity, or(ii) [e]ncode substances that are . . . toxic to nontarget organismsknown or likely to feed or live on the plant species, or(iii) [e]ncode products intended for pharmaceutical use.

(5) ... the introduced genetic sequences do not pose a significant risk ofthe creation of any new plant virus ... [j(6) [t]he plant has not been modified to contain... genetic material fromanimal or human pathogens. 3

125. See id. at 1655.126. See LAPPf & BAILEY, supra note 1, at 74.127. See Earp, supra note 21, at 1639.128. See NOTrINGHAM, supra note 58, at 124.129. See Earp, supra note 21, at 1634; see also LAPPt & BAILEY, supra note 1, at 74.

Once deregulated, the GE plant does not require any oversight except for pesticide and her-bicide tolerance and can be grown for commercial use. "Crops that are no longer regulated[include] "Monsanto's Roundup ReadyTM corn, AgrEvo herbicide tolerant soybeans, DeKalbherbicide tolerant corn, and DuPont's herbicide tolerant cotton." Id. at 74-75; Environmen-tal Effects of Transgenic Plants: The Scope and Adequacy of Regulation (Feb. 22, 2002),available at http://www.archives.greenpeace.org/-geneng/highlights/gmo.usdareport.htm(last visited Aug. 15, 2002) (containing current status of petitions under 7 C.F.R. § 340APHIS).

130. See No-rINGHAM, supra note 58, at 124.131. 7 C.F.R. § 340.3 (2000).


The notification procedure, while appearing thorough, relies upon theproponent to supply the scientific information and does not require an inde-pendent environmental analysis.' 3 2 Concomitantly, there is simply notenough scientific research to affirmatively establish an answer to the sixcriteria. The OPA's certification process and genetics standards boardwould ensure that the GE farmer was adhering to the regulatory scheme.The board would continually monitor the GE farmer as well as mandatelabeling so that consumers would be able to choose whether the food wassafe for them. Criminal sanctions in the form of fines and/or imprisonmentwould act as a deterrent to irresponsible genetic release.

"The [USDA's] view is that 'the constraints imposed by the eligibilitycriteria and the performance standards effectively eliminate the potential forsignificant impact to the environment that would occasion any case-by-caseanalysis'" by the agency. 133 The shift in procedure shows that the USDAhas grown comfortable with the introduction of GE plants into the environ-ment and that they are anticipating that GE crops will be grown on a grandscale. 134 This clearly leaves the organic farmer's land open tocontamination.

D. The Health Risks

In addition to whether GE foods will disturb the local environment, dis-rupt natural ecological processes and displace native plants is the issue ofthe risks to human health. There are risks of allergic reactions to foreignfoods as well as reactions to known allergens such as peanuts or Brazil nutsthat have been engineered with corn or beans. 135 Antibiotic resistantmarker genes are found within many GE foods. 1 36 These marker genesenable scientists to determine if the gene transference has been success-

132. See Kunich, supra note 41, at 840. "There may be a tendency to defer to thesuperior scientific and technical knowledge of the proponents of transgenic organisms and,in effect, rubber-stamp their assurances that the organisms are safe." Id. at 830.

133. Id. at 840 (citing Genetically Engineered Organisms and Products; NotificationProcedures for the Introduction of Certain Regulated Articles; and Petition for NonregulatedStatutes, 58 Fed. Reg. 17,044, 17,054 (Dep't of Agric. Mar. 31, 1993)).

134. See Earp, supra note 21, at 1639.135. See DR. MICHAEL W. Fox, BEYOND EVOLUTION THE GENETICALLY ALTERED Fu-

TURE OF PLANTS, ANIMALS, THE EARTH ... AND HUMANS 58, 59 (The Lyons Press 1999);see also Batalion, supra note 15, at http://www.cqs.com/50harm.htm (HEALTH). "About25% of Americans have adverse reactions to foods. 8% of children and 2% of adults havefood allergies as tested by blood immunoglobins."

136. See Fox, supra note 135, at 59; see also Batalion, supra note 15, at http://www.cqs.com/50harm.htm (HEALTH). "In 1998, the British Royal Society called for the banning ofthis marker as it threatens a vital antibiotic's use. The resistant qualities of GM bacteria infood can be transferred to other bacteria in the environment and throughout the humanbody."

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ful.'37 Scientists expose the recipient cell to antibiotics after the gene trans-ference and if the antibiotic resistant marker gene survives then thetransferred gene survived as well.' 38 Without markers, the scientists wouldhave to analyze each cell. 139

As a result of these procedures, when an individual consumes GE foodthey are also ingesting antibiotics. 140 Some scientists are concerned thatonce ingested these antibiotic resistant markers could transfer the resistanceto other bacteria found in the intestinal tract. 4 ' This transference couldcause an individual to be resistant to prescribed antibiotics when they areneeded to fight infection.' 4 ' The antibiotic marker DNA can be transferredto human and animal bacteria within the body and the exposure to the an-tibiotic resistant bacteria could gravely affect the control of disease. 14 3

"Even those who minimize the threat of antibiotic resistance transfer rec-ommend against using antibiotic resistant genes in genetically modifiedfoods for antibiotics that are still useful."' 144

Currently, GE foods do not have to be labeled; thus an individual is sus-ceptible to allergic reactions because they cannot determine what is in thefood product.1 45 A GE food can carry the allergen properties of the trans-ferred gene. 14 6 For example in 1996, Pioneer Hi-Bred developed a geneti-cally altered soybean by transferring a Brazil nut gene into a soybean genein order to increase its protein content. 47 The resulting GE soybean con-tained the allergen properties of the Brazil nut whose allergic reactions arecommon and often fatal. 148 GE food labeling would allow consumers tomake informed choices; a vegetarian could avoid foods that contain animal

137. See Kolehmainen, supra note 38, at 277.138. See id.139. See ALAN McHUGHEN, PANDORA'S PICNIC BASKET; THE POTENTIAL AND HAZARDS

OF GENETICALLY MODIFIED FOODS 56 (Oxford University Press 2000).140. See TEITEL & WILSON, supra note 4, at 114.141. See Fox, supra note 135, at 59; see also Batalion, supra note 15, at http://www.cqs.

com/50harm.htm (HEALTH).Several studies have shown bacteria of the mouth, pharynx and intestinescan take up the transgenic DNA in the feed of animals, which in turn can bepassed on to humans. This threatens the hallmark accomplishment of thetwentieth century - the reduction in infectious diseases that critically helpedthe doubling of life expectancy.

142. See Kolehmainen, supra note 38, at 277.143. See id.144. Id. Compare Kolhemainen, supra note 38, at 277, with Steven H. Yoshida, The

Safety of Genetically Modified Soybeans: Evidence and Regulation, 55 FOOD DRUG L.J. 193,203 (2000). Although Mr. Yoshida also recommends against using "antibiotics that are stilluseful," in his article, he expresses reasons why use of antibiotic marker genes "do notappear to pose a problem for GMF safety."

145. See LAPP & BAILEY, supra note 1, at 124.146. See Kolehmainen, supra note 38, at 278.147. See id.148. See id.


genes; international exports of GE foods can be identified for countries whodo not wish to accept them; and those that are allergic to or wish to refrainfrom eating GE foods can do so. 149

E. Food and Drug Administration

Within the USDA and the FDA there are divisions that govern the devel-opment of animal and health products, including those produced throughgenetic engineering. 150 Regardless of whether they are GE or not, the FDAregulates food, food additives, and human drugs while the USDA regulatesplants, seeds, animal biologics, and plant pests. 151 The responsibility ofregulating the marketplace of new foods and food additives falls to theFDA i"2 under the Federal Food Drug and Cosmetics Act ("FDCA"), 1 53

which has the authority to remove products it considers unsafe. 154

The FDCA makes those who produce GE foods legally responsible forthe health and safety of their products 15 5 because GE foods fall within thedefinition of adulterated foods "defined as[:] foods that contain an addedsubstance."' 5 6 If the FDCA has already established through prior scientificevidence that a substance is safe it will not be considered adulterated. 57

This is problematic because a substance may be safe alone but may not betested after it has been combined with another substance, as is the case withcombinant DNA.158

In 1992, the FDA issued a policy statement "that foods developedthrough genetic engineering are not inherently dangerous and, except in rarecases, should not require special premarket testing or regulation."' 5 9 Aspart of the policy the FDA decided that GE foods should be considered nodifferently than traditional methods of cross breeding nor would they beconsidered adulterated foods unless there were special circumstances. 160

Examples of special circumstances are GE foods with proteins known tocause allergic reactions that have altered nutritional content and those foods

149. See McHUGHEN, supra note 139, at 201; see also Fox, supra note 135, at 191. TheUnited States, Australia, Argentina, Canada, Uruguay, and Chile blocked the portion of theUnited Nations international Biosafety Protocol Treaty that included "the right of everycountry to know which seeds, grains, and foods that it imports have been geneticallyengineered."

150. See NOTrINGHAM, supra note 58, at 125.151. See Earp, supra note 21, at 1641.152. See NOTTINGHAM, supra note 58, at 125.153. 21 U.S.C.A. § 301 (West 2000).154. See NOTnNGHAM. supra note 58, at 125; see also 21 U.S.C.A. § 301 (West 2000).155. See NOTTINGHAM, supra note 58, at 125.156. Kolehmainen, supra note 38, at 289.157. See id.158. See id.159. Kunich, supra note 41, at 843.160. See NOTTINGHAM, supra note 58, at 125.

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that contain antibiotic marker genes. 6 ' If a GE food fails to fall into one ofthese special conditions the FDA does not require a safety evaluation re-view.162 "Instead, the FDA established an advisory process, whereby man-ufacturers consult with [and provide the information about the GE food to]the agency about the human health risks of their products."' 163

The reduced scrutiny of the GE foods used in manufacturing means thatwhen companies use GE foods as a component of a finished product theyalone have to guarantee the safety of the ingredient and thus the safety ofthe finished product. 164 Producers of GE foods should bear the burden ofproviding neutral scientific evidence of a GE food's safety, as they do withother foods classified as adulterated foods. 165 Under the OPA, the GE foodmanufacturer would be required to ensure that the GE food is safe forhuman consumption. The GE farmer would be required to obtain the scien-tific data from a neutral source needed to prove that the GE food was safeand failure to comply would result in criminal sanctions.

The FDA does not require mandatory labeling either, leaving consumerswithout a means to know the contents of the foods they are ingesting. 66

"The FDA believes that [GE] foods are 'substantially equivalent' to non-GE foods .... "'1 67 This "equivalence" has not been subjected to long-termtests of the effects to human health and the impacts on the environment. 168

GE foods demand more stringent governmental controls than are presentlyrequired.' 69 The OPA would provide such federal governmental controls.

The FDA can inspect a farm at any time, much like the OccupationalSafety Health Act ("OSHA") inspects a company for safe working condi-tions. However, unlike OSHA's surprise inspections routine, a farmerunder the FDA may preempt the surprise inspection "by conducting a self-

161. See id.; see also Kunich, supra note 41, at 844. Premarket notification was alsomade voluntary, although the FDA indicated that it "'believes that it is in the best interestsof the regulated industry and the agency' for developers to inform the FDA prior to commer-cial distribution, about foods or feed derived from new plant varieties, including those de-rived using genetic engineering." (citing OFFICE OF PREMARKET APPROVAL & OFFICE OF

SURVEILLANCE & COMPLIANCE, FOOD & DRUG ADMIN., GUIDANCE ON CONSULTATION PRO-

CEDURES FOR FOOD DERIVED FROM NEW PLANT VARIETIES (Oct. 1997), at http://vm.cfsan.fda.gov/-lrd/consulpr.html).

162. See NOTTINGHAM, supra note 58, at 125; see also Batalion, supra note 15, at http://www.cqs.coml50harm.htm (General). "The FDA only requests of firms that they conducttheir own tests of new GM products in what Vice President Quale back in 1992 referred to asa 'regulatory relief program.' The FDA makes no review of those tests unless voluntarilyrequested by the company producing the product."

163. Kolehmainen, supra note 38, at 289.164. See id. at 290.165. See id.166. See id.167. Id.168. Kolehmainen, supra note 38, at 290.169. See id.

274


inspection." "70 "This new twist on the fox guarding the hen house has beenmet with great corporate enthusiasm."'' Additionally, environmental auditprivilege laws enable corporations to reduce the potential for an inspectionby promptly divulging any alleged misconducts.' 7 2 The OPA's certificationrequirement ensures yearly compliance with the governmental agency andtesting from seed to marketable product with criminal sanctions enforceablefor non-compliance.

F. Environmental Protection Agency

1. GE Plants Containing Herbicides and Pesticides

Biotechnology has found ways to alter the genetic make-up of a plant'sDNA to include herbicides and pesticides.' 73 FIFRA defines pesticidesbroadly as "any substance or mixture of substances intended for preventing,destroying, repelling, or mitigating any pest.., for use as a plant regulator,defoliant, or desiccant."' 7 4 Genetic engineering can selectively produce in-sect-resistant or insect-tolerant varieties of crops.' 75 Scientists experimentwith ways to code the genetics of a plant with a pesticide that is poisonousto the target pest but safe for other non-threatening pests. 176 These plantsare intrinsically insect resistant through the transference of genes that makethe plant noxious to the insect. 177 These plants are genetically altered bythe insertion of bacteria, known as Bacillus thuringiensis (Bt).' 78

Historically, Bt has been used for pest management because of its "re-markably selective toxicity for the leaf-eating larvae of moth and butterflyspecies. '1'7 However, the pollen from the genetic version of Bt corn hasbeen found to kill non-pest insects.18° Organic farmers use Bt because itprovides a non-chemical choice to control insects.' 8 ' This organically ap-proved pesticide's usefulness is threatened by the abundance of Bt entering

170. LAPPf & BAILEY, supra note 1, at 74.171. Id.172. See id.; see also COONEY, supra note 52, at 34.173. See U.S. Congress, supra note 18, at 44-45.174. 7 U.S.C.A. § 136a(u) (West 1999).175. See U.S. Congress, supra note 18, at 45.176. See id.

177. See LAPPt & BAILEY, supra note 1, at 63.

178. See id.

179. Id.180. See JACK, supra note 76, at 4. "'Most corn pollen remains within the cornfield and

Monarch larvae can choose to avoid feeding on Bt pollen by feeding on the underside ofleaves or on other milkweed leaves with little or no Bt pollen.'" (quoting Monsanto's offi-cial response to evidence that gene-altered corn was killing Monarch larvae).

181. See LAPPI & BAILEY, supra note 1, at 65.

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into the environment.' 82 The influx of Bt will rapidly ensure that the pestswill become resistant to the bacteria.183

This particularly affects the organic farmer because Bt is a pesticide uponwhich they rely.' 84 It is natural and organically approved. 185 The geneti-cally altered plants that contain an herbicide or pesticide have a temporallimit for the GE farmer as the insects evolve very quickly and become resis-tant to pesticides.' 86 An insect-resistant crop will soon be ineffective andwill require different or stronger pesticides. 87

The acceleration of insect pests resistant to B.t. toxin through the increaseduse of GM plants is a legitimate issue of considerable import. Ecologists,population geneticists, statisticians, and many other experts are trying tofigure out not if, but when [the Bt toxin will become ineffective] and howto manage the problem to minimize the threat.' 88

The Monsanto Company produces a Roundup® ultra herbicide that isused in conjunction with their Roundup Ready TM seeds.' 8 9 RoundupReadyTM plants, a variety of Roundup Ready Tm resistant technology, over-produce "the natural levels of the key enzyme normally poisoned by theherbicide." ' A plant producing this enzyme will become resistant to theRoundup ReadyT Ultra herbicide when it is sprayed onto the plant. 9' Inthis way the herbicide resistant plant can withstand a higher dosage of thepesticide than a nearby weed.192 This allows a GE farmer to spray the toxicherbicide more frequently and with a higher potency without doing damage

182. See id.183. See id. at 65-66. Currently pesticide resistance is a problem in the U.S. with over

five hundred anthropod species resistant to at least one pesticide. See id. at 66.184. See id. at 65.185. See id.186. See LAPPE & BAILEY, supra note 1, at 66; see also Batalion, supra note 15, at http:/

/www.cqs.com/50harm.htm (Insects and Larger Animals). "Pests the transgenic cotton wasmeant to kill - cotton bollworms, pink bollworms, and budworms - were once 'secondarypests.' Toxic chemicals killed off their predators, unbalanced nature, and thus made them'major pests.'"

187. See generally LAPPE & BAILEY, supra note 1, at 53-54. See also Batalion, supranote 15, at http://www.cqs.com/50harm.htm (Insects and Larger Animals). "The recent'stink bug' epidemic in North Carolina and Georgia seems linked to bioengineered plantsthat the bugs love. Monsanto, on their Farmsource website, recommended spraying themwith methyl parthion, one of the deadliest chemicals."

188. MCMUGHEN, supra note 139, at 191.189. See LAPPE & BAILEY, supra note 1, at 52-53. As a condition to buying the

Roundup ReadyTM seed the grower "agrees not to supply any of this seed to anyone forplanting and agrees not to save any crop produced from this seed for replanting or supplysaved seed to anyone for replanting." Id. at 53. The grower also agrees to only use theRoundup® branded herbicide. See id. One way that a farmer can save money is to save hisseeds from year to year. See id. at 57. Monsanto requires the farmer to re-buy every yearand to pay a technology fee. See id.

190. Id. at 53.191. See id.192. See id. at 57.


to the harvest crop."' "The Roundup Ready TM technology provides a kindof genetic buffer against the toxic effects of Roundup®" for the harvestcrop.' 94 The genetically altered plant will be immune to the effects of theultra Roundup Ready TM herbicide while the weed will die out. Similar tothe rapidly evolving insect resistant crops, the weeds will soon be equippedwith the same resistance as the GE plant.'95

If the herbicide resistant plant cross-pollinates with nearby weeds, theweeds will be resistant to the herbicide calling for stronger herbicides toprotect the plant and making the Roundup Ready TM seeds ineffective. 96

Both pesticide resistant and herbicide resistant biotechnology has its short-comings.' 97 The fact that the technology quickly becomes ineffective andcalls for stronger pesticides and herbicides will impact the environment innegative ways. 198 The extra herbicides and pesticides will impact the soil,water, non-target insects, and threaten native plants and animals. 99 In ad-dition, it naturally follows that humans may be ingesting increased levels ofherbicides and pesticides into their system.2°°

Spillage of the seeds is another way for GE plants to escape into theenvironment.20' When farmers plant and harvest seeds, the seeds getcaught in the farm equipment, and spill along the road. The seeds are thentransported to another field the next day or week. 2 GE foods can alsoescape into the environment through pollen-based gene flow, that spreadsfrom plant to plant, season to season and through the spillage of seeds. Thetransported seeds will root and grow in the unconfined space.20 3

193. See id.194. LAPPE & BAILEY, supra note 1, at 53.195. See McHUGHEN, supra note 139, at 126. If the GE crop is a close enough relative

to the native weeds there is a problem of interbreeding. See id. The herbicide resistant weedmight compromise the utility of the herbicide on the GE food crops. See id. Then theassurance needed is that there are stronger herbicides still available to control the weed. Seeid. at 126-27; see also Batalion, supra note 15, at http://www.cqs.com/50harm.htm (Plants)."[A]n Alberta Canada farmer began planting three fields of different GM canola seeds in1997 and by 1999 produced not one, but three different mutant weeds - respectively resis-tant to three common herbicides (Monsanto's Roundup, Cyanamid's Pursuit, and Aventis'Liberty)."

196. See Kolehmainen, supra note 38, at 280-81.197. See id.198. See id.199. See Greenpeace, Pharn Crops -A Food Accident Waiting to Happen (Sept. 2001),

available at http://www.archive.greenpeace.org/-geneng/reports/food/pharmrice.pdf (lastvisited Aug. 14, 2002).

200. See Kolehmainen, supra note 38, at 281.201. See McHUGHEN, supra note 139, at 166.202. See id. The ministry of Agriculture, Fisheries, and Food in the UK has said that

they needed to "establish a mandatory monitoring system for seeds, under which a farmerwould have to account for each and every seed at planting and at harvest." Id.

203. See Kolehmainen, supra note 38, at 280; see also McHU HEN, supra note 127, at166.

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2. Federal Insecticide, Fungicide and Rodenticide Act and ToxicSubstance Control Act

The EPA regulates GE foods under the authority of the Federal Insecti-cide, Fungicide and Rodenticide Act ("FIFRA") and Toxic Substance Con-trol Act ("TSCA").2 °4 "FIFRA gives the EPA authority over thedistribution, sale, and use of pesticide products and mandates the registra-tion of pesticides before distribution or use. 2 °5 The TSCA governs theresidue levels of pesticides in food products as well as monitors the adverseeffects pesticides have on native plants in the ecosystem.20 6 Through theseacts, the EPA regulates both pesticides and herbicides in GE plants, includ-ing the GE plants with Bt toxin.20 7 The EPA has the authority to exemptcertain pesticides and herbicides that it considers safe for theenvironment.208

"Under FIFRA and other EPA regulations, developers of plants geneti-cally engineered to produce pesticides must submit raw health and safetytest data to the EPA. '2 9 This data is available to the public for review inthe Federal Register for thirty days during the notice and comment periodbefore the plants are approved.210 While this provides some informationregarding the health and safety of the GE plant, it does not require that theEPA conduct its own evaluation. It merely relies on the information pro-vided by the GE developer. 21' FIFRA regulates the pesticide within theplant as being separate from the plant itself. Thus, the EPA is regulatingthe chemical in the traditional manner, rather than assessing the effects ofthe pesticide found within the plant structure.212 There is no separate EPAregulation for GE plants without internal pesticides or herbicides.

The main function of FIFRA is its regulatory requirement of registrationof all pesticides.213 FIFRA's requirement includes submitting informationas to the "'level and degree' of potential beneficial or adverse effects onhumans and the environment." ' 4 A cost benefit analysis is applied to the

204. See NOTTNGHAM, supra note 58, at 125; see also 7 U.S.C.A. §§ 136a-136y (West1999); 15 U.S.C.A. §§ 2601-2692 (West 1998).205. Kunich, supra note 41, at 831.206. See NOrrINGHAM, supra note 58, at 125-26.207. See id. at 126.208. See id.209. Kolehmainen, supra note 38, at 291.210. See id.211. See id.212. See Kunich, supra note 41, at 831.213. See id. at 832.214. Id.


adverse effects on humans and the environment that considers the eco-nomic, social, and environmental costs and benefits of the pesticide.2" 5

The TSCA has some control over the GE plants. For example, its admin-istrative duties are to test and classify toxic substances for unreasonable riskto the environment before they are produced and distributed into the mar-ketplace.2 6 An individual who intends to manufacture a new chemical sub-stance must detail the substance and the proposed methods of production allthe way to disposal, including the health and environmental implications forthe new substance. 2 7 Nothing in the statute specifically addresses GEproducts.21 8

The EPA's TSCA Biotechnology Program office has asserted authorityover GE microorganisms under TSCA by defining a GE microorganism asa chemical substance.219 Labeling GE plants as chemicals does not accountfor the fact that they are plants that grow, move and reproduce. Theseplants disperse in a different manner than chemical pesticides which seepinto the soil or enter the ground water in the area where they are applied.22°

The regulations of the TSCA have little effect on the spread of GE plants asthe Act is intended to regulate the common definition of chemicals.

Inherent in the Act is a cost benefit analysis that must take into accountthe effects on human health, the environment as well as the benefits of thesubstance and the potential for substitutes and the impact on national econ-omy.22' The recent development of GE plants does not provide enoughdata to establish the effects on human health and the environment.

The TSCA regulations take into account the effects of a chemical spill,but not genetic drift or "superweeds. ' 222 Problems arise when regulatoryprocedures are splintered. First, because the EPA is regulating the pesticideand not the plant, the EPA may be overlooking the fact that some geneticsubstances interact with pesticides and create a new toxic form.z23 Second,the new herbicide resistant plants often require increased levels of herbicideuse and corporations may put pressure on the EPA to increase the safe toler-

215. See id. at 833. "FIFRA contains an important and controversial exemption in thecase of pesticides produced solely for export to a foreign nation. In such instances, thepesticide need only satisfy certain labeling requirements and be produced by a registeredapplicant subject to FIFRA record-keeping mandates." Id. Therefore, we may be eatingpesticides on imported vegetables that do not pass the human health and safe environmenttest in the United States.

216. See 15 U.S.C.A. §§ 2603-2605 (West 1998).217. See 15 U.S.C.A. § 2603 (West 1998).218. See 15 U.S.C.A. §§ 2601-2692 (West 1998).219. See Kunich, supra note 41, at 827.220. See id.221. See 15 U.S.C.A. § 2605(c) (West 1998).222. See 15 U.S.C.A. §§ 2601-2692 (West 1998).223. See LAPPt & BAILEY, supra note 1, at 75.

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ant levels of herbicide residue. 224 Third, the USDA is required to consultwith the EPA before executing a permit for a field test site of GE plants.225

Although the agencies consult each other, they are not viewing the plant,product or environment as a holistic unit. The EPA is regulating the pesti-cide, the USDA is regulating the plant and the FDA is regulating the finalproduct.226

The lack of regulatory safeguards and constraints on GE foods are gearedtowards eventual acceptance of these foods into the marketplace.227 TheUSDA favors unregulated releases of GE plants after initial test sites. 228

These test sites do not show how GE plants interact with native plants orhow the increased pesticides and herbicides affect the soil or ground-water.2 9 The FDA essentially considers GE plants to be the same as non-GE plants, as long as the original gene transferred has already been regu-lated. 23

" The FDA sees no problem with the lack of labeling, the high pro-pensity for allergic reactions, or the lack of studies proving the effects offoreign genes in human bodies.2 11 The EPA regulates the pesticide andherbicide within the plant and if the type of pesticide has previous approval,the GE plant passes the inspection process.232

Government agencies have started to regulate based on the results of acost benefit analysis. 233 These agencies view pollution in terms of whatpercentage is a reasonable standard.2 34 The EPA considers GE foods withpesticides and herbicides as a continuation of existing regulations.235 How-ever, under a cost benefit analysis, the unknown health hazards cannot befactored into the equation. The regulations focus on finding an acceptablestandard of safety based on economic factors rather than human and envi-

224. See id. The EPA supported Monsanto's Roundup Ready technology by increasingthe tolerance level of a pesticide called glyphosate. The levels were increased from 6 partsper million to 20 parts per million. See id. at 75-76.

225. See NOMrNGHAM, supra note 58, at 125.226. See id.227. See LAPPt & BAILEY, supra note 1, at 77-78.228. See Earp, supra note 21, at 1639.229. See generally id. See also Batalion, supra note 15, at http://www.cqs.com/50harm.

htm.In Oregon, scientists found GM bacterium (klebsiella planticola) meant tobreak down wood chips, corn stalks and lumber wastes to produce ethanol -with the post-process waste to be used as compost - rendered the soil ster-ile. It killed essential soil nutrients, robbing the soil of nitrogen and killednitrogen capturing fungi.

230. See NOTTINGHAM, supra note 58, at 125.231. See generally supra Part III.E.232. See NOTTINGHAM, supra note 58, at 126.233. See WILLIAM F. Fox, JR., UNDERSTANDING ADMINISTRATIVE LAW 186-91 (4th ed.

2000).234. See id.235. See NOTTINGHAM, supra note 58, at 126.


ronmental health and safety. Alternatively, the OPA provides a coherentstatute, that takes a precautionary approach to biotechnology, requires ad-herence to measures created to contain genetic drift, and imposes criminalsanctions for non-compliers.

IV. ENFORCEABLE REGULATORY PENALTIES

The three regulatory agencies are focused on plant pests (USDA), humanhealth issues (FDA), and the environment (EPA) respectively. The relativenewness of biotechnology combined with a lack of prolonged scientific dataregarding its release leave the governance in a state of piecemeal regula-tions. 236 None of the current regulations adequately address the concerns ofthe organic farmer. The organic farmer is searching for a way to make alegal boundary between their organic crops and the spread of the GE plants.However, property lines are invisible to the spread of evolutionary ecology.The three regulatory agencies have limited penalties for the improper manu-facturing, planting or spread of GE foods, therefore, a comprehensive stat-ute is needed to protect organic farmers.

A. Penalties Under the USDA

Under the USDA the statutory language of APHIS 7 C.F.R. § 340.0(b)states that:

Any regulated article introduced not in compliance with the requirementsof this part shall be subject to the immediate application of such remedialmeasures or safeguards as an inspector determines necessary to preventthe introduction of such plant pests.2 37

Pursuant to the Plant Protection Act, "the Secretary [of Agriculture] mayhold, seize, quarantine, treat, apply other remedial measures to, destroy, orotherwise dispose of any plant, plant pest, noxious week, biological controlorganism, plant product, [or] article. 23 8

The penalty or remedial consequence only takes effect if the regulatedarticle has not been introduced in compliance with the statute. Once thearticle is introduced in compliance with the notification process, there is nobackup system to regulate the genetic drift or the spreading plant.239 Thestreamlined process of regulating a GE plant through the APHIS process 240

ensures that "once such authorization is issued, there is no control over thelater escape of the modified plants, either in their original form or as even-

236. See Kunich, supra note 41, at 823.237. 7 C.F.R. § 340.0(b) (2000).238. 7 U.S.C.S. § 7714(a) (Law Co-op 2003).239. See Batalion, supra note 15, at http://www.cqs.com/50harm.htm. "We can antici-

pate classic bio-invasions as a result of new GM strains, just as with the invasions of thekutzu vine or purple loosestrife in the plant world." Id.

240. See discussion supra Part III.C.

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tually evolved or cross-pollinated with other varieties."'24 ' The task of theregulators is further confounded by the lack of ability to conduct a riskassessment or to test for the spread of the GE plant.2 4 2 Although the Secre-tary of Agriculture is given the authority to handle any regulated article notin compliance with the process, there lacks measures that deal with the con-tamination of organic crops, soil, or ground water by GE plants. 243 Thepenalties for non-compliance need to be codified in a statute in order to bean effective measure of compliance. The criminal sanctions available in theOPA would ensure compliance and the containment of GE plants.

B. Penalties Under the FDA

There are no penalties per se under the FDA, only an appeals process forthe proponent whose product is turned down. 4 4 The statute outlines thedenial of the petition, which states that if the proponent:

(A) fails to establish that the proposed use of the food additive, under theconditions of use to be specified in the regulation, will be safe: Provided,That no additive shall be deemed to be safe if it is found to induce cancerwhen ingested by man or animal . . . except that this proviso shall notapply with respect to the use of a substance as an ingredient of feed foranimals.

245

For the product to be deemed unsafe there needs to be enough researchand testing to prove its harm. 2 46 The statute requires proof of harm tohuman health rather than proof of safety.2 47 Therefore, the lack of scientificresearch available on GE foods makes it a safe product under the FDAstandards. Further research and testing on the effects of GE foods on ani-mals, humans, and the environment will be necessary before the currentregulatory language of the FDA can be an effective control of GE foods.The OPA takes a precautionary approach to the regulation of GE foods witha focus on containment, oversight, and certification which ensures that con-sumers and organic farmers can choose to live without GE foods.

C. Penalties Under the EPA

There are penalties for unregistered herbicides and pesticides underFIFRA of the EPA. However, they fail to address the particularities of GEplants. The statute states that:

(b) Criminal Penalties

241. Kunich, supra note 41, at 841.242. See id.243. See 7 C.F.R. § 340.0(b) (2000).244. See 21 U.S.C.A. § 348 (West 1999).245. 21 U.S.C.A. § 348(c)(3)(A) (West 1999).246. See id.247. See id.


(1) In general(A) Any registrant, applicant for a registration, or producer who know-ingly violates any provision of this subchapter shall be fined not more than$50,000 or imprisonment for not more than 1 year, or both.248

The provisions of the subchapter provide that itshall be unlawful for any person in any State to distribute or sell to anyperson-(A) any pesticide that is not registered ... [;](B) any registered pesticides if any claims made for it ... differ from anyclaims made for it as a part of the ... registration[;].(C) any registered pesticide the composition of which differs at the time ofits distribution or sale as described in its ... registration ... [,j(E) any pesticide which is adulterated or misbranded; or... (A) to detach,alter, deface, or destroy ... any labeling.249

These criminal penalties are not particularly tailored to the disbursementof GE plants encoded with pesticides. The statute was not written withbiotechnology in mind and therefore neglects to protect organic farmersfrom incidents of genetic drift or the spread of "superweeds." The OPA'spurpose in creating a federal regulatory statute for GE foods falling underthe EPA is to ensure complete governance of GE foods. The EPA is theagency that has the expertise about the environment and can understand thebiodiversity implications for GE foods. The OPA requires that the EPAenforce criminal sanctions for those who do not comply with the statute.

D. Requirements Under the Organic Foods Production Act

Organic farmers, by contrast, are lobbying Congress to pass National Or-ganic Standards ("NOS") that will create concrete regulations with clearramifications for non-adherence °.2 " The Organic Foods Production Act("OFPA") under Title XXI of the Farm Bill's purpose is to regulate theproduction and handling of foods labeled as organic.25" ' OFPA intends toauthorize the formation of the National Organic Program ("NOP") to estab-lish standards, oversee and require a certification process for organic farmsand products.2 52

The NOP in turn created the National Organic Standards Board("NOSB") to assist the Secretary of Agriculture in setting the standardsunder which the USDA's national organic program is based.25 3 The NOS

248. 7 U.S.C.A. § 1361(b)(1) (West 1999).249. 7 U.S.C.A. §§ 136j(a)(l)-(a)(2) (West 1999).250. See A Guide to the Recommendations, supra note 2, at http://www.organic.org/7/

guide/ (National Organic Standard Board).251. See id. (Organic Foods Production Act).252. See id. (National Organic Program).253. See id. (National Organic Standard Board). The Board consists of four farmers,

two handlers/processors, one retailer, one scientist (with expertise in toxicology, ecology or

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are only proposed standards, presently private and state agencies certify or-ganic farmers, producers, and products.25 4

The NOSB defines "[o]rganic agriculture [as] an ecological productionmanagement system that promotes and[sic] enhances biodiversity, biologi-cal cycles and soil biological activity. It is based on minimal use of off-farm inputs and on management practices that restore, maintain and en-hance ecological harmony. '"255 The standards include an approved list ofacceptable as well as prohibited materials for pest control treatments.256

While it is important for organic farmers and consumers to have reliablestandards for organic products, organic farmers cannot control the spread ofGE foods. The responsibility for containment must be placed on the GEfarmers. The preceding outline of the OFPA is used in this Comment as amodel for the proposed OPA statute in order to convey the needed compo-nents of a comprehensive regulatory system.

Organic certification is the cornerstone of the program.257 Under theNOP a farm seeking certification submits an Organic Farm Plan to theUSDA.258 The plan must detail all current growing or handling methods.259

After the plan is accepted, the farm undergoes inspection by an accreditedinspector.26 ° Thereafter, the certification agency conducts yearly on-siteinspections.26'

In order for organic farms to be certified, the crops must be grown onland "which has been free of prohibited substances for three years prior toharvest. '26 2 If a crop becomes infested with GE plants it will take at leastthree years to regain certification. If the GE problem can in fact be re-moved at all.263 "Organic farmers are responsible for establishing adequatebuffer zones or barriers to protect against pesticide or fertilizer drift from

biochemistry), three consumer/public interest advocates, and three environmentalists. Seeid.; see also National Organic Standards Board Members, available at http://www.organic.org/7/guidelist.html (last visited Aug. 15, 2002) (listing the current board members).

254. See A Guide to the Recommendations, supra note 2, at http://www.organic.org/7/guide/. Because there is no national standard there is no guarantee that the same definitionof organic will carry from state to state or region to region. See id. The national standardsfor both producers and consumers is needed to establish consistency and prevent mislabelingor fraud. See id.

255. Id. (National Organic Standard Board).256. See id.257. See id.258. See A Guide to the Recommendations, supra note 2, at http://www.organic.org/7/

guide/act.html (Organic Foods Product Act).259. See id.260. See id.261. See id.262. Id. (Organic Crop Production Standards).263. See A Guide to the Recommendations, supra note 2, at http://www.organic.org/7/

guide/ (Organic Crop Production Standards).


neighboring conventional farms."1264 The contaminated crops cannot besold as organic and the farmer loses his or her certification after a certifyingagent verifies the incident.2 65 The certifier can implement residue testingand make the decision as to when the farmer can be re-certified.266

The NOSB enforcement measures and penalties will require the organicfarmers to monitor their crops and pay the penalty for the intrusion of GEcrops. The NOSB states that:

Any person who knowingly mislabels a product as organic can be fined amaximum of $10,000 and may be disbarred from the Organic Program forfive years. Persons who make false statements to the Secretary of Agricul-ture, a state official or a certifying agent are subject to penalties underFederal law, and may be disbarred from the program for five years.2 67

Once a farm has been infected with a GE substance there is little theorganic farmer can do but stop labeling their product organic. 268 There arealso violations for certifying agencies, "[a] certifying agency that violatesthe provision of the program or falsely or negligently certifies any operationshall lose accreditation and shall not be eligible for re-accreditation forthree years. 26 9

The standards also include a section specifically addressing geneticdrift.2 70 The NOSB's biotechnology policy states that the class of "geneti-cally engineered organisms and their derivatives be prohibited in organicproduction and handling systems."27' The provisions of the Act are pro-spective in that they compel every organic farm to execute residue tests ontheir crops as the technology becomes available.2 72 "Given the brief periodof significant use [of GE plants], and the array of theoretically serious envi-ronmental hazards, there is a need for vigilance backed up with regulatorymuscle. '273 The NOS places the burden of compliance on the organic

264. Id.265. See id.266. See id.267. Id. (Enforcement and Penalties).268. See A Guide to the Recommendations, supra note 2, at http://www.organic.org/7/

guide/ (Organic Crop Production Standards).269. Id. (Enforcement and Penalties).270. See id. (Organic Crop Production Standards).271. Genetically Engineered Foods Not Organic (Oct. 16, 1996), available at http://csf.

Colorado.edu/forums/ecofem/oct96/0099.html (last visited Aug. 15, 2002).Genetically engineered is defined as: Made with techniques that alter themolecular or cell biology of an organism by means that are not possibleunder natural conditions or processes. Genetic engineering includes recom-binant DNA, cell fusion, micro-and macro-encapsulation, gene deletion anddoubling, introducing a foreign gene, and changing the positions of genes.

Id.272. See A Guide to the Recommendations, supra note 2, at http://www.organic.org/7/

guide/ (Organic Crop Production Standards).273. Kunich, supra note 41, at 860.

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farmer even if the breach is not their own. Alternatively, the federal OPAwould compel compliance from the GE farmer who releases GE plants intothe environment.

V. ORGANIC PROTECTION ACT

The OPA is a proposed comprehensive statute that includes a certifica-tion process, a genetics standards board, fines for improper releases, a per-mit process for treatment, storage and disposal of the GE plants andenforceable criminal sanctions for offenders and non-compliers.2 74 TheEPA would be solely responsible for the oversight of the OPA.275 The cur-rent separate classifications of GE plants, as a chemical governed by theUSDA, a pesticide governed by the EPA, and an unsafe additive governedby the FDA would be eliminated.276 GE farmers would have to complywith a certification process to inspect their growing and handling methodsand certify that certain measures are being taken to prevent contaminationof outside resources.2 77 The GE farmer, rather than the organic farmer,would ensure compliance with the newly introduced technology.278 Thegenetics standard board would monitor GE farmer's seed introduction,farming process, production, and distribution. 79 In order to dispose, store,or treat the GE plants the statute would require that the GE farmer obtain apermit."8

Under the federal statute if there were an incident of genetic drift, thecriminal sanctions would be imposed on the GE farmer for the spread of GEplants. Civil penalties would be imposed for the loss of premium prices forthe organic products, as well as additional transportation, storage, or han-dling costs, loss due to breach of contracts, and costs due to loss of organiccertification resulting from the contamination. Any non-compliance withthe statute would result in criminal sanctions providing an incentive for theGE farmer to take appropriate safeguards with the new technology.

274. See generally A Guide to the Recommendations, supra note 2, at http://www.or-ganic.org/7/guide/. See also Resource Conservation and Recovery Act ("RCRA") 42 U.S.C.§ 6921 (1989).

275. See Kunich, supra note 41, at 863.276. See supra Part 1I.277. Cf A Guide to the Recommendations, supra note 2, at http://www.organic.org/7/

guide/.278. See Kunich, supra note 41, at 864. "The proponent [(creators and producers, but

not the farmer)] of any new organism would be responsible for including a risk assessment,describing the best available scientific evidence of the prospects for harm to the environ-ment." Id.

279. Cf A Guide to the Recommendations, supra note 2, at http://www.organic.org/7/guide/ (National Organic Standard Board).

280. See CWA 33 U.S.C. A. § 1319 (West 2000); see also RCRA 42 U.S.C.A. § 6921(West 1989).


A. The Certification Process

A mandatory certification process for each GE farm would be establishedto ensure that the GE farmer was adhering to the regulatory scheme. 28' Thecertification process would take a holistic approach to the GE plants andcover the process from the inception of the GE seed until the plants are soldat market, including disposal of the waste product and potential escapes intothe environment. The certification process would document the type oftransgenic properties of the GE food, the growing and handling methods,the geographic location, and take into consideration the location of organicfarms to GE farms. 282 Non-compliance with the certification process wouldbe a federal offense with monetary fines and a 3-5 year loss of certificationas a civil penalty.283 The loss of certification would essentially stop the GEfarming until re-certification was approved.

Included in the certification process would be a national list 284 of GEfarmers and their current locations, crops, including expected pollination

281. Compare with An Act to Protect Against Contamination of Crops and Wild PlantPopulations by Genetically Engineered Plants, ME. REV. STAT. ANN. tit. 7, § 1052, availableat www.mofga.org/news200lO531.html (last visited Feb. 18, 2002).

Responsibilities of Manufacturer -A manufacturer of genetically engineered plants, planting stock or seedsthat present a risk of cross-contamination and are sold or distributed in thisState is subject to the provisions of this subchapter.1. The manufacturer or seed dealer of the genetically engineered plants,plant parts or seeds shall provide written instructions to all growers onhow to plant the plant parts, seeds or plants and how to grow and harvestthe crop to minimize potential cross-contamination. These instructionsmust be at least as inclusive as guidelines issued by the USDA relative tothe establishment of buffer zones between genetically engineered plants anwild or cultivated plants subject to the risk of cross-contamination. Themanufacturer or seed dealer shall file a copy of these instructions with thecommissioner at least 20 days in advance of any sale of the geneticallyengineered plants, plant parts or seeds in this State.

Id.282. See A Guide to the Recommendations, supra note 2, at http://www.organic.org/7/

guide/ (Organic Crop Production Standards).283. See id. (Enforcement and Penalties).284. See Kunich, supra note 41, at 864. The concept of registering transgenic organisms

comes from Professor Charles Kunich's article. See id.; see also A Guide to the Recommen-dations, supra note 2, at http://www.organic.org/7/guide/ (The National List). The OFPAproposes a National List for which products can be "used in organic production, processingand handling." Id.There are seven criteria that are used for evaluation:

(1) Effect on human health(2) Effect on the farm ecosystem(3) Toxicity and mode of action(4) Availability of gentler alternatives

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and harvest dates. The database would include the genetic makeup of theplant and any current scientific research. This database would alert organicfarmers and the general public of GE farms in their area, as well as, assistthe EPA in enforcing containment procedures. The database would also bea useful tool in the global market by allowing countries that seek to regulateor bar the entrance of GE foods to do so.2 8 5 For example, "Denmark andGermany possess the most stringent laws regarding the release of geneti-cally engineered organisms. ' This transparency would provide informa-tion for farmers and consumers.

B. Genetics Standards Board

The EPA, as an overseer of the OPA, would create a Genetics StandardsBoard that would continually monitor all aspects of GE farming, productionand distribution.287 This would include mandatory labeling of all GE foodsincluding antibiotic markers, pesticides and herbicides, and potentialallergens.

288

The Genetics Standard Board, similar to the NOSB would consist of or-ganic and GE farmers, handlers/processors, retailers, scientists, consumer/public interests advocates, and environmentalists.289 In addition, therewould be positions on the board for international members to advise the

(5) Probability of environmental contamination during manufacture and dis-posal (6) Potential for interactions with other materials used and(7) Overall compatibility with a system of sustainable agriculture.

Id.These seven criteria would be used in the inverse for GE farmers introduction of GE plants.See id.; An Act to Protect Against Contamination of Crops and Wild Plant Populations byGenetically Engineered Plants, ME. REV. STAT. ANN. tit. 7, § 1052, available at www.mofga.org/news (last visited Feb. 18, 2002).

Responsibilities of Manufacturer-2. Record keeping. The manufacture or seed dealer shall identify and main-tain, for at least 2 years after the date of sale, a list of the names and ad-dresses of all growers of its genetically engineered plants, plant parts orseeds in this State. The list is not a public record .... A manufacturer orseed dealer shall permit the commissioner to inspect the list when requestedto facilitate an investigation into a claim of cross-contamination.

285. See Kim, supra note 40, at 1170-71; see also Pilot Phase of the BioSafety Clearing-House, at http://bch.biodiv.org/Pilot/About/Introduction.aspx (last visited Apr. 4, 2003).

286. Kim, supra note 40, at 1170. "Representatives of the biotechnology industries inDenmark and Germany, however, have expressed concern about their continued competi-tiveness in an international forum when other countries are harmonizing their laws to fostertrade." Id. at 1171. Some countries with no genetic regulations have served as test sites forUnited States companies. See id. at 1184. "For example, the Wistar Institute of Philadelphiaconducted tests for a genetically engineered vaccine on cattle in Argentina." Id.

287. Cf A Guide to the Recommendations, supra note 2, at http://www.organic.org/7/guide/ (National Organic Standard Board).

288. See id.289. See id.


United Nations on trade issues and international concerns. The boardwould rotate on a staggered basis and report directly to the EPA. Theboard's reports would be made public, in compliance with the EmergencyPlanning and Community Right-to-Know Act ("EPCRA"). 29 0

The board would be responsible for establishing a regional education andinformation program that would educate the public about GE foods. 29 1 Thisregional educator would disseminate information about the OPA. A majorcomponent of the board's focus would be to encourage public awarenessand participation in the decision making process through lecturing in publicforums and educational institutions.292 The board would also be responsi-ble for implementing the Federal Register's notice requirement and com-ment period.293

C. Permit Requirements for Disposal

The "cradle to grave" model of the RCRA would be incorporated into theOPA preventing contamination by the GE plants, seeds, and potential ge-netic drift.2 94 The GE farmer would be required to obtain a permit for thetreatment, storage and disposal of the GE products. The OPA would out-line the proper methods for each stage of the process and how to recordthese stages for review by the EPA and the certifier. The provisions of theOPA, similar to RCRA would be both prospective and retrospective bythreatening to impose liability for those who may infringe upon the require-ments in the future and attach liability to those who have already releasedGE plants into the environment.295

D. Criminal Sanctions for Genetic Drift

The criminal sanctions for the spread of GE plants would be similar tothe penalties under the CWA. The CWA was designed after the Rivers andHarbors Act ("Refuse Act") and imposed criminal penalties for "depositingany refuse material into 'navigable waters ... or their tributaries.' "296 TheCWA codified in 33 U.S.C. § 1319(c)(2) and altered for the proposal's rele-vance states:Any person who:

290. See 42 U.S.C.A. §§ 11001-11050 (West 2001); see also Kunich, supra note 41, at865.

291. See Kunich, supra note 41, at 865-66. "The TRA should mandate regulary recur-ring public meetings ... including in-person public meetings, periodic press releases on aregional, national and international scale, and a widely publicized web site." Id.

292. See id.293. See Fox, supra note 233, at 163-70.294. See 42 U.S.C.A. § 6921 (West 1989).295. See id.296. Shaw, supra note 51, at 339 (alteration in original).

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violates ... this title, or any permit [or certification] ... issued under...this title .. or ... introduces into . . . [the environment] any [GE sub-stance] .. other than in compliance with all applicable Federal, State, orlocal requirements, [certifications] or permits, which causes [the spread ofGE plants] to violate any . . . permit issued under this title . . . shall bepunished by a fine . . or by imprisonment . or by both.297

The substantial threat of criminal fines and imprisonment would stand todeter non-compliance with the OPA. The implementation of the fines andimprisonment to actual offenders would deter future wrongdoers and helpensure the containment of the GE plants.

E. Civil Penalties

Crop contamination would entitle the organic farmer to recoup civil penal-ties for:(a) Loss of any price premium which would have accrued to a farmer of

non-genetically engineered products by contract or other marketingarrangement, or which would have been otherwise reasonably availa-ble to the farmer through ordinary commercial channels;

(b) Any additional transportation, storage, handling, or related chargesor costs incurred by the farmer which would not have been incurredin the absence of crop contamination; and

(c) Any judgment, charge, or penalty for which the farmer of non-geneti-cally engineered products is liable due to breach of contract includingloss or organic certification, for failure to deliver a crop free of ge-netically engineered material or for delivering a crop exceeding anycontractually agreed tolerances for the presence of genetically engi-neered material.29 8

F. Criminal Sanctions for Noncompliance with the Statute

An important consideration for organic farmers is that a section of theproposed OPA would cover criminal sanctions, for the protection of organicfarms.2 99 Presently, the environmental crimes program under the EPA op-

297. 33 U.S.C.A. § 1319(c)(2) (West 2001). The "knowingly" requirement under thisAct is beyond the scope of this Comment.

298. An Act Relative to the Liability for Genetically Engineered Food, Mass. S.B. 1912(SN) (2003)

299. Compare with An Act to Protect Against Contamination of Crops and Wild PlantPopulations by Genetically Engineered Plants, ME. REV. STAT. ANN. tit 7, § 1052, availableat www.fmofga.org/news200lO531.html (last visited Feb. 18, 2002).

Responsibilities of Manufacturer-3. Violation; Penalty. Failure to comply with this [statute] is a civil viola-tion for which a penalty of not more than $1,500 may be adjudged. Inaccordance with Title 5, chapter 375, the commissioner may suspend orrevoke a license issued under section 1044-A if the holder of the licensefails to comply with this subchapter.


erates under the premise that "(1) some instances of noncompliance areexpected from even the best managed facilities and (2) virtually every act ofnoncompliance may be prosecuted criminally." 3" Given this premise, it isparamount that the criminal sanctions encourage the GE farmer to followthe guidelines and take special care to contain their crops.

The environmental crimes program is limited by the resources availableto the agencies whose mandate it is to enforce the crimes.30 ' Generally,there are five criteria the EPA considers when addressing noncompliancewith an Act's requirements.30 2 First, the scienter requirement considers theprospective defendant's "'guilty knowledge' or intent to violate the law. '" 30 3

Second, the EPA considers the nature and seriousness of the offense interms of environmental and human health safety issues. 3

1 The remainingcriteria, encompasses the need for deterrence, the compliance history of theoffender, and the need for simultaneous civil or administrative enforcementactions.3"5 The criteria weigh the public concern for the particular issue athand against "public sentiment supporting strong enforcement action. ' '306

Independent scientific research may be the best source for the non-biasedinformation.

The proposed criminal sanctions under the OPA would follow the RCRAmodel codified in 42 U.S.C. § 6928(d)(2) and state in an adapted form:

(d) CRIMINAL PENALTIESAny person who-(2) [creates, grows, produces,] treats, stores, or disposes of any [GE sub-stance] identified or listed under this subchapter-

A. without a permit [or certification] .. ;B. violation of any material condition or requirement of such permit [orcertification];C. violation of any material condition or requirement of any applicationinterim status regulations or standards;

(3) omits material information[,labeling] or makes any false statement...shall, upon conviction, be subject to a fine ... or imprisonment ... orboth.307

A criminal enforcement scheme is a necessary tool to encourage compli-ance with the system and to deter future non-compliance. A self-auditingprogram of releases into the environment would reduce any fines, imprison-

300. COONEY, supra note 52, at 12.301. See id. at 35, 63.302. See id. at 13.303. Id.304. See id.305. See COONEY, supra note 52, at 13.306. Id.307. 42 U.S.C.A. § 6928(d)(2) (West 1995). The knowingly requirement is beyond the

scope of this Comment.

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ment, or both.3"' This gives GE farmers an incentive to comply with theregulations. 3" Additionally, it would help alleviate the EPA's financialburden of policing the releases of GE crops. 3 1 °

VI. CONCLUSION

The proposed system addresses the gaps left by the existing regulatoryscheme. It incorporates a certification process, a genetics standards board,fines for improper releases, a permit process for treatment, storage and dis-posal of the GE plants, civil penalties for economic losses to the organicfarmer and enforceable criminal sanctions for offenders. These regulatory

and criminal sanctions need immediate implementation as the spread of GEplants into the environment, across borders, into our supermarkets, and ourbodies is already taking place.

Marcia Ellen DeGeer

308. See COONEY, supra note 48, at 34.309. See generally id. at 35.310. See generally id.

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