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Consuming (F)ears of Corn: Public Health and Biopharming

Published online by Cambridge University Press:  06 January 2021

Rebecca M. Bratspies
Rebecca M. Bratspies*
Affiliation:
CUNY School of Law
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Extract

I’m convinced that physical containment is overrated and, while reassuring to the psyche, is hardly the line of defense one would like to put the greatest reliance upon.

So what you have to keep asking yourself is: Suppose the worst happens, what are the consequences?

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Article
Information
American Journal of Law & Medicine , Volume 30 , Issue 2-3 , June 2004 , pp. 371 - 404
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Copyright © American Society of Law, Medicine and Ethics and Boston University 2004

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References

1 Letter from Dr. Paul Berg, Chair of the National Institutes of Health Advisory Committee Concerning Recombinant DNA Technology, to Dewitt Stetten; see also MICHAEL ROGERS, BIOHAZARD 151 (1977) (reflecting on the relaxed adherence to safety protocols for biotechnology research).

2 Michael Specter, The Pharmageddon Riddle, NEW YORKER, Apr. 10, 2000, at 58, 67 (quoting Robert B. Shapiro, former Chief Executive Officer and Chair of Monsanto, Inc.).

3 Article 2 of the Convention on Biological Diversity defines biotechnology as any technological application that uses biological systems, living organisms or derivatives thereof to make or modify products or processes for specific use. CONVENTION ON BIOLOGICAL DIVERSITY, art. 2, USE OF TERMS, at http://www.biodiv.org/convention/articles.asp?lg=0&a=cbd-02 (last updated Dec. 6, 2003). The United States defines biotechnology as the use of modern scientific techniques, including genetic engineering, to improve or modify plants, animals, and microorganisms. U.S. DEPARTMENT OF STATE, FREQUENTLY ASKED QUESTIONS ABOUT BIOTECHNOLOGY, at http://usinfo.state.gov/ei/economic_issues/biotechnology/biotech_faq.html (last visited June 26, 2004). The U.S. State Department and the U.S. Department of Agriculture (USDA) also provide useful glossaries of biotechnology. See U.S. DEPARTMENT OF STATE, GLOSSARY OF BIOTECHNOLOGY TERMS, at http://usinfo.state.gov/journals/ites/0903/ijee/glossary.htm (last visited June 26, 2004); ECONOMIC RESEARCH SERVICE, U.S. DEPARTMENT OF AGRICULTURE, HARMONY BETWEEN AGRICULTURE AND THE ENVIRONMENT: CURRENT ISSUES, at http://www.ers.usda.gov/Emphases/Harmony/issues/genengcrops/terms.htm (last updated July 9, 2002). The USDA site also refers users to the more complete the United Nations Food and Agriculture Organization Glossary of Biotechnology for Food and Agriculture which defines biopharming as [t]he use of genetically transformed crop plants and livestock animals to produce valuable compounds, especially pharmaceuticals. A. ZAID ET AL., GLOSSARY OF BIOTECHNOLOGY FOR FOOD AND AGRICULTUREA REVISED AND AUGMENTED EDITION OF THE GLOSSARY OF BIOTECHNOLOGY AND GENETIC ENGINEERING (2001), available at http://www.fao.org/DOCREP/004/Y2775E/y2775e07.htmbm07.1. The biotechnologies discussed in this article are all rooted in insights developed through molecular biology and genetics.

4 See Chris, R. Somerville & Daroi, Bonetta, Plants as Factories for Technical Materials, 125 PLANT PHYSIOLOGY 168 (2001)Google Scholar.

5 Biopharming involves inserting novel genes into crop plants, like corn, in order to make the plants manufacture proteins that may be used as drugs, vaccines, enzymes, antibodies, hormones, or industrial chemicals. Essentially biopharming converts plants into a living factory for chemical or pharmaceutical production. Although biopharming uses food crops as its production vehicle, biopharm crops are not food and are not intended for human consumption. See STATE PIRGS, STATE PIRGS CAMPAIGN ON GENETICALLY ENGINEERED FOODS, at http://pirg.org/ge/GE.asp?id2=10570&id3=ge& (last visited June 26, 2004).

6 See ANIMAL AND PLANT HEALTH INSPECTION SERVICE, USDA, BIOTECHNOLOGY REGULATORY SERVICES, CURRENT STATUS OF RELEASE PERMITS, at http://www.aphis.usda.gov/brs/status/relday.html (last visited July 23, 2004) (listing test plots all around the country.)

7 There are generally three types of biobased products in various stages of planning or production: commodity chemicals (e.g., ethanol or oil-based inks), specialty chemicals (e.g., pharmaceuticals and plastics), and materials (e.g., wood and paper). Biobased commodity and materials production will largely be outside the scope of this article because the various proposals being floated do not typically involve plants bioengineered to express novel, non-food compounds.

8 Henry, Daniell, Environmentally Friendly Approaches to Genetic Engineering, 35 IN VITRO CELLULAR DEV. BIOLOGY-PLANT 361, 361 (1999)Google Scholar (citing other sources).

9 Somerville & Bonetta, supra note 4, at 169; Christine, Nawrath et al., Targeting the Polyhydroxy-butyrate Biosythetic Pathways to the Plastids of Arabidopsis Thaliana Results in High Levels of Polymer Accumulation, 91 PROC. NATL ACAD. SCI. U.S. 12760 (1994)Google Scholar.

10 COMMITTEE ON BIOBASED INDUSTRIAL PRODUCTS, NATIONAL RESEARCH COUNCIL, BIOBASED INDUSTRIAL PRODUCTS: RESEARCH AND COMMERCIALIZATION PRIORITIES (2000).

11 Farming already raises a host of environmental issues, many of which are addressed by existing environmental laws, albeit poorly. For example, factories must comply with environmental statutes, including the Clean Water Act (CWA). However, environmental harms, such as agricultural run-off, are not regulated under the CWA. Biopharm crops will require tremendous inputs of fertilizer and pesticides, and runoff will likely introduce toxins and pollutants into the environment.

12 Biopharming may reduce U.S. dependence on foreign oil. See, e.g., Melvin Calvin, New Sources for Fuels and Materials, 219 SCIENCE 24 (1983) (speculating that gene transfer could be used to develop new fuels). For current developments in biofuels and bioenergy, see OFFICE OF ENERGY EFFICIENCY AND RENEWABLE ENERGY, U.S. DEPARTMENT OF ENERGY, BIOFUELS FOR SUSTAINABLE TRANSPORTATION, at http://www.ott.doe.gov/biofuels/ (last updated May 14, 2004).

13 See Memorandum for the President's Council on Food Safety, Aug. 25, 1998, available at http://www.foodsafety.gov/~dms/fs-wh13.html (describing national expectations of food safety). This article focuses on human health questions raised by the likelihood of commingling biopharm crops with conventional crops destined for use as food or feed. The ethical considerations, additional human health implications and environmental effects of biopharming, while significant, are beyond the scope of this Article.

14 COMMITTEE ON ENVIRONMENTAL IMPACTS ASSOCIATED WITH COMMERCIALIZATION OF TRANSGENIC PLANTS, NATIONAL RESEARCH COUNCIL, ENVIRONMENTAL EFFECTS OF TRANSGENIC PLANTS: THE SCOPE AND ADEQUACY OF REGULATION 246 (2002) [hereinafter ENVIRONMENTAL EFFECTS].

15 Id.

16 For a description of some of these requirements, see Rebecca, Bratspies, The Illusion of Care: Regulation, Uncertainty and Genetically Modified Food Crops, 10 N.Y.U. ENVTL. L.J. 297, 310-14 (2002)Google Scholar; see also GREGORY N. MANDEL, GAPS, INEXPERIENCE, INCONSISTENCIES, AND OVERLAPS: CRISIS IN THE REGULATION OF GENETICALLY MODIFIED PLANTS AND ANIMALS, available at http://www.ssrn.com/abstract=418221 (June 19, 2003).

17 APHIS, USDA, BIOTECHNOLOGY REGULATORY SERVICES, COMPLIANCE AND ENFORCEMENT, at http://www.aphis.usda.gov/brs/compliance.html (last visited June 26, 2004). Although the Animal and Plant Health Inspection Service (APHIS) characterizes this as a low number of violations, and therefore a success story, others are far less sanguine about the conclusions to be drawn from this number. See, e.g., THE PEW INITIATIVE ON FOOD AND BIOTECHNOLOGY, ACADEMIA/INDUSTRY VIOLATED USDA RULES, at http://pewagbiotech.org/buzz/display.php3?StoryID=114 (last visited June 26, 2004).

18 Indeed, in 2002, the Office of Science and Technology Policy acknowledged the significance of this risk. For proposed federal actions to update field test requirements for biotechnology derived plants and to establish early food safety assessments for new proteins produced by such plants, see 67 Fed. Reg. 50,578, 50,587 (Aug. 2, 2002) (As the number and diversity of field tests increase, the likelihood that cross-pollination due to pollen drift from field tests to commercial fields and commingling of seeds produced under field tests with commercial seeds or grain may also increase. This could result in intermittent, low-levels of biotechnology-derived genes, and gene products occurring in commerce that have not gone through all applicable regulatory reviews.).

19 In the context of first-generation genetically modified (GM) crops, industry trade groups acknowledge that cross-pollination, adventitious commingling, and other causes make it virtually impossible to assure that any U.S. corn shipment is 100% non-GM. See VALUE ENHANCED GRAIN (VEG) SOLUTIONS, COMMENTARY: INTRODUCING VEG TO THE WORLD BIOTECH CONTROVERSY, at http://www.vegrains.org/cgi-bin/english/Commentary%200802.cfm (Aug. 22, 2002). Over and above any human health impacts, biopharm contamination of the food supply will likely have dramatic ramifications for the U.S. share of the global commodities market. Id.

20 For this reason, opponents of biopharming refer to the practice as pharmageddon. See, e.g., MAE-WAN HO, INSTITUTE OF SCIENCE IN SOCIETY, PHARMAGEDDON, at http://www.i-sis.org.uk/ Pharmageddon.php (Dec. 2, 2002). Although this characterization is sensational, even those scientists closely affiliated with biopharm companies acknowledge that precautionary measures should be taken when biopharmaceuticals are likely to persist in the environment or bioaccumulate. See, e.g., Henry, Daniell et al., Medical Molecular Farming: Production of Antibodies, Biopharmaceuticals and Edible Vaccines in Plants, 6 TRENDS PLANT SCI. 219 (2001)Google Scholar.

21 An allergic reaction is an abnormal response of the body's immune system to an otherwise safe compound. Some reactions are life threatening, such as anaphylactic shock. Some of the biopharm products currently under development have been engineered to produce trypsin. See, e.g., U.S. Patent No. 6,087,558 (issued July 11, 2000) (claiming invention of a transgenic plant that produces trypsinogena precursor of trypsin). Trypsin has a history of eliciting allergic responses in exposed populations. For allergy information, see Harvey, R. Colten et al., Immediate Hypersensitivity to Hog Trypsin Resulting from Industrial Exposure, 292 NEW ENG. J. MED. 1050 (1975)Google Scholar; Peter, R. Shewry et al., Plant Protein Families and Their Relationships to Food Allergy, 30 BIOCHEMICAL SOC. TRANSACTIONS 906 (2002)Google Scholar (identifying trypsin as an allergen). The poster child for inadvertent creation of allergenic products through genetic engineering involved the experimental transfer of a Brazil nut protein to soybeans. See Julie, A. Nordlee et al., Identification of a Brazil-nut Allergen in Transgenic Soybeans, 334 NEW ENG. J. MED. 688 (1996)Google Scholar.

22 A toxic reaction in humans is a response to a poisonous substance. Unlike allergic reactions, all humans are subject to toxic reactions. The Codex Alimentarius considers evaluations of allergenicity, toxicity, and anti-nutrient potential to be integral components of any food safety risk assessment process. FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, CODEX PRINCIPLES AND GUIDELINES ON FOODS DERIVED FROM BIOTECHNOLOGY, at ftp://ftp.fao.org/codex/ standard/en/CodexTextsBiotechFoods.pdf (last visited June 26, 2004).

23 Anti-nutrients are naturally occurring compounds that interfere with absorption of important nutrients in digestion. For example, avidin, the first commercialized biopharm crop has a well-known ability to interfere with vitamin B absorption. U.S. Patent No. 5,767,379 (issued June 16, 1998) (claiming invention of a transgenic plant that produces avidin); see also MARK H. BEERS ET AL., MERCK MANUAL OF DIAGNOSIS AND THERAPY, sec. 1, ch. 3 (17th ed., John Wiley & Sons 1999), available at http://www.merck.com/mrkshared/mmanual/section1/chapter3/3o.jsp; Gianni, Bregola et al., Biotin Deficiency Facilitates Kindling Hyperexcitability in Rats, 7 NEUROLOGICAL REPORT 1745 (1996)Google Scholar (inducing biotin deficiency by controlling avidin consumption); Claudia, J. Carey & James, G. Morris, Biotin Deficiency in the Cat and the Effect on Hepatic Propionyl CoA Carboxylase, 107 J. NUTRITION 330 (1977)Google Scholar; Donald, M. Mock et al., Marginal Biotin Deficiency Is Teratogenic in ICR Mice, 133 J. NUTRITION 2519 (2003)Google Scholar; Toshiaki, Watanabe, Dietary Biotin Deficiency Affects Reproductive Function and Prenatal Development in Hamsters, 123 J. NUTRITION 2101 (1993)Google Scholar.

24 In November 2003, a coalition of public interest groups filed suit in Hawaii District Court requesting an injunction barring future biopharm field tests until these questions are answered. Center for Food Safety v. Veneman, No. 03-1-1509 (D. Haw. Nov. 12, 2003), at http://64.78.7.168/pubs/ComplaintHawaii11.12.2003.pdf.

25 See infra Part II.B.

26 Even Biotechnology Industry Organization (BIO), an industry trade and lobbying group, concedes that there is no United States policy on industrial biotechnology. See BIOTECHNOLOGY INDUSTRY ORGANIZATION, EXTERNAL RESOURCES, at www.bio.org/ind/links.asp (last visited June 26, 2004) (identifying four key publications that represent, as close as you will find, a U.S. policy on industrial biotechnology). In 2003, APHIS published interim guidelines for industrial biotechnology. Introductions of Plants Genetically Engineered to Produce Industrial Compounds, 68 Fed. Reg. 46,434 (Aug. 6, 2003). For the first time, these new regulations require that any such introductions be pursuant to a permit. At least 10 industrial biopharm field tests had already been conducted under a less stringent notification procedure. Id. at 46,435.

27 See, e.g., Scott Kilman, Food, Biotech Industries Feud: Crops Bred to Produce Medicines Raise Contamination Worries, WALL ST. J., Nov. 5, 2002, at B7; Aaron Zitner, Fields of Gene Factories, L.A. TIMES, June 4, 2001, at A1; Biomass R&D Technical Advisory Committee, VISION FOR BIOENERGY & BIOBASED PRODUCTS IN THE UNITED STATES, at http://www.bioproductsbioenergy.gov/pdfs/BioVision_03_Web.pdf (Oct. 2002).

28 Indeed, in 2003, USDA found that about 20% of farmers growing existing genetically modified (GM) crops failed to comply with planting regulations intended to prevent contamination of conventional crops. Emily Gersema, USDA Survey Shows Biotech Rules Breaches, ASSOCIATED PRESS, Sept. 10, 2003, available at 2003 WL 63460812. Given these high levels of non-compliance with existing requirements and relaxed regulatory oversight, there is no reason to believe that farmers behavior will be any different with regard to biopharm crops. In addition, evidence of contamination is mounting. For example, after just two years of Canadian cultivation, GM canola has crosspollinated so extensively that a new, triply herbicide resistant, feral canola has emerged. JIM ORSEN, GENE STACKING IN HERBICIDE TOLERANT OILSEED RAPE: LESSONS FROM THE NORTH AMERICAN EXPERIENCE, ENGLISH NATURE RESEARCH REPORTS NO. 443 (2002), available at http://www.englishnature.org.uk/pubs/publication/PDF/enrr443.pdf. In light of these findings, any regulatory decisions about these crops must assume that commingling will occur.

29 The U.S. Environmental Protection Agency (EPA) was advised to test transgenic plants producing pharmaceutical compounds for their biological effects at dietary concentrations which, at a minimum, will likely be encountered in the transgenic plant itself. See FIFRA SCIENTIFIC ADVISORY PANEL, MAMMALIAN TOXICITY ASSESSMENT GUIDELINES FOR PROTEIN PLANT PESTICIDES, SAP REPORT NO. 2000-03B (2000), available at http://www.epa.gov/oscpmont/sap/2000/index.htm. USDA does not require any such testing before permitting biopharm crops to be field-tested.

30 Physical containment measures involve using planting distances or timing to prevent contamination of conventional crops with GM crops. Unfortunately, for existing GM crops, physical contamination measures have largely been ineffectual, either because the requirements are too lenient or because they are not being implemented. Indeed, a 2003 USDA survey found that about 20% of farms growing GM crops failed to comply with planting regulations intended to ensure physical containment. Gersema, supra note 28.

31 There is a zero tolerance level for unapproved genetically modified organisms. Corn is the largest U.S. crop, typically between 9-10 billion bushels annually. See CORN REFINERS ASSOCIATION, U.S. CORN PRODUCTION: 1999-2001, at http://www.corn.org/web/uscprod.htm (last visited June 26, 2004). Iowa, Illinois, Nebraska, and Minnesota alone produce more than 50% of the U.S. corn crop. U.S. GRAINS COUNCIL, WORLD CORN PRODUCTION AND TRADE, at http://www.grains.org/grains/corn.html (last visited June 26, 2004). Other major corn-producing states include Indiana, Wisconsin, South Dakota, Michigan, Missouri, Kansas, Ohio, and Kentucky. Id. In 2000, the United States grew 43% of the world's corn and is the single largest corn exporter, providing 64% of corn sold in the international corn market. Id.

32 The text of the CARTAGENA PROTOCOL ON BIOSAFETY is available at http://www.biodiv.org/biosafety/protocol.asp (last visited June 26, 2004). The Protocol entered into force on September 11, 2003 following the fiftieth ratification, by Palau. There are currently sixty members of the Protocol, including the European Union and other significant U.S. trading partners like Mexico. CARTAGENA PROTOCOL ON BIOSAFETY, STATUS OF RATIFICATION AND ENTRY INTO FORCE, Sept. 11, 2003, available at http://www.biodiv.org/biosafety/signinglist.aspx?sts=rtf&ord=dt.

33 CARTAGENA PROTOCOL ON BIOSAFETY, supra note 32, at art. 10.

34 For either the original text or an English translation, see ROGER B. BLUMBERG, TABLE OF CONTENTS FOR MENDEL's PAPER AT MENDELWEB, at http://www.mendelweb.org/MWpaptoc.html (last visited June 26, 2004).

35 For an excellent introduction to the basics of genetics from Mendel to modern biotechnology intended for high school students, see DNA FROM THE BEGINNING, at http://www.dnaftb.org/dnaftb/ (last visited July 16, 2004). For further information on Mendel's role in modern genetics, geared to non-scientists, see MARANTZ HENIG, THE MONK IN THE GARDEN: THE LOST AND FOUND GENIUS OF GREGOR MENDEL, THE FATHER OF GENETICS (2000); MATT RIDLEY, GENOME: THE AUTOBIOGRAPHY OF A SPECIES IN 23 CHAPTERS (2000).

36 J. D., Watson & F. H. C., Crick, Molecular Structure of Nucleic Acids: A Structure for Deoxyribose Nucleic Acid, 171 NATURE 737 (1953)Google Scholar. Watson and Crick were awarded the 1962 Nobel Prize for this discovery. For a first-hand, and somewhat scandalous account of this discovery, see JAMES WATSON, THE DOUBLE HELIX: A PERSONAL ACCOUNT OF THE DISCOVERY OF THE STRUCTURE OF DNA (1968).

37 No discussion of molecular genetics is complete without an acknowledgement of this groundbreaking work. See, e.g., Barbara, R. Jasny & Leslie, Roberts, Building on the DNA Revolution: Introduction, 300 SCIENCE 277 (2003)Google Scholar (stating that [i]mages of Watson and Crick personified molecular biology to the general public in a way that has never been equaled); Elizabeth, Pennisi, Building on the DNA Revolution: A Hothouse of Molecular Biology, 300 SCIENCE 278 (2003)Google Scholar (discussing the work of Watson and Crick and later molecular genetics at the Laboratory of Molecular Biology at the University of Cambridge).

38 See, e.g., Elizabeth, Pennisi, Building on the DNA Revolution: DNA's Cast of Thousands, 300 SCIENCE 282 (2003)Google Scholar (discussing the landmark research on DNA and the genetic code after Watson and Crick).

39 See, e.g., Stanley, N. Cohen et al., Construction of Biologically Functional Bacterial Plasmids In Vitro, 70 PROC. NATL ACAD. SCI. U.S. 3240 (1973)Google Scholar.

40 See id. at 3244.

41 Stanley, N. Cohen, The Manipulation of Genes, 233 SCI. AM. 25, 32 (1975)Google Scholar.

42 See, e.g., Maxine, Singer & Dieter, Stoll, Letter: Guidelines for DNA Hybrid Molecules, 181 SCIENCE 1114 (1974)Google Scholar.

43 Paul, Berg et al., Letter: Potential Biohazards of Recombinant DNA Molecules, 185 SCIENCE 303 (1974)Google Scholar.

44 For a recent account of that historic meeting, see Marcia, Barinaga, Asilomar Revisited: Lessons for Today?, 287 SCIENCE 1584, 1585 (2000)Google Scholar.

45 Paul, Berg et al., Asilomar Conference on Recombinant DNA Molecules, 188 SCIENCE 991, 991 (1975)Google Scholar ( the evaluation of potential biohazards has proved to be extremely difficult. It is this ignorance that has compelled us to conclude that it would be wise to exercise considerable caution in performing this research.) [hereinafter Berg et al., Asilomar Conference]. For an interesting account of the self-regulatory project, see Judith, P. Swazey et al., Risks and Benefits, Rights and Responsibilities: A History of the Recombinant DNA Research Controversy, 51 S. CAL. L. REV. 1019 (1978)Google Scholar.

46 Berg et al., Asilomar Conference, supra note 45, at 991; see also Paul, Berg et al., Summary Statement of the Asilomar Conference on Recombinant DNA Molecules, 72 PROC. NATL ACAD. SCI. U.S. 1981, 1982 (1975)Google Scholar [hereinafter Berg et al., Summary Statement].

47 See Recombinant DNA Research Guidelines, 41 Fed. Reg. 27,902, 27,903 (July 7, 1976). The guidelines, as updated, are still applicable to research funded by the National Institutes of Health (NIH) or conducted at NIH and compliance with the guidelines is a condition for continued NIH funding. The 1976 guidelines prohibited six types of rDNA experiments until more could be learned, allowed other rDNA experiments to proceed only under strict safety standards, required the physical or biological containment of rDNA recombinants in the laboratory, and prohibited the deliberate release of rDNA organisms into the outside environment until more could be learned. Peer review was the primary means to ensure that these guidelines were carried out. Id. at 27,902-21.

48 Found. on Econ. Trends v. Heckler, 756 F.2d 143, 151 (D.C. Cir. 1985) (describing the evolution of the guidelines and upholding an injunction barring deliberate release of a genetically modified organism known as ice-minus until NIH completed an adequate environmental impact statement).

49 Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302 (June 26, 1986).

50 For a thorough description of the Framework and its development, see D. L., Uchtmann, StarLinkTMA Case Study of Agricultural Biotechnology Regulation, 7 DRAKE J. AGRIC. L. 159 (2002)Google Scholar.

51 Id. at 169.

52 Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq. (2000).

53 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 121 et seq. (2000).

54 Plant Protection Act (PPA), 7 U.S.C. 7701 et seq. (2000).

55 Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. at 23,302 (June 26, 1986).

56 Jozef, St. Schell, Transgenic Plants as Tools to Study the Molecular Organization of Plant Genes, 237 SCIENCE 1176, 1176-83 (1987)Google Scholar.

57 There are three primary means to transform, or genetically modify, plants. The most common takes advantage of the unique properties of Agrobacterium tumefaciens, a soil bacteria that infects plants by transferring a plasmid of its own DNA into the target plant. By modifying the genes contained in this plasmid, A. tumefaciens infection can be a means to deliver desirable genes into plant cells instead of the bacteria's own infective genes, which cause Crown Gall disease. Because A. tumefaciens is a known plant pest, these transformations fall neatly within USDA's regulatory authority as outlined in the PPA, 7 U.S.C. 7701-7772. By contrast, USDA authority over the other primary methods of transforming plants, the biolistics or gene gun method and electroporation are less clear. These are the various techniques that I will refer to as genetic engineering, bioengineering, genetic modification, or biotechnology.

58 For a lay description of this process, complete with pictures, see, PARTNERSHIP FOR PLANT GENOMICS EDUCATION, UNIVERSITY OF CALIFORNIA, DAVIS, PLANT TRANSFORMATION, at http://ceprap.ucdavis.edu/Transformation/transform1.htm (last updated Apr. 29, 2003).

59 There are plant DNA libraries for more than thirty important crops. U.S. NATIONAL AGRICULTURE LIBRARY, USDA, PLANT DNA LIBRARY, at http://www.nal.usda.gov/pgdic/dnalibr/ (last visited June 26, 2004). There are almost one hundred plant DNA mapping projects around the world. U.S. NATIONAL AGRICULTURE LIBRARY, USDA, PLANT GENOME MAPPING PROJECTS, at http://www.nal.usda.gov/pgdic/Map_proj/ (last visited June 26, 2004). In 2000, the entire Arabidopsis genome (a plant widely used as a model plant organism) was sequenced. THE ARABIDOPSIS INFORMATION RESOURCE, at http://www.arabidopsis.org/ (last updated Mar. 30, 2004).

60 Proposed Federal Actions to Update Field Test Requirements for Biotechnology Derived Plants and to Establish Early Food Safety Assessments for New Proteins Produced by Such Plants, 67 Fed. Reg. at 50,587 (Aug. 2, 2002).

61 Id. The increases are most dramatic in the United States, but Canada, Argentina, and China have also experienced significant growth in the development and use of biotechnology-derived crops.

62 See ECONOMIC RESEARCH SERVICE, USDA, ADOPTION OF GENETICALLY ENGINEERED CROPS IN THE U.S., at http://www.ers.usda.gov/Data/BiotechCrops/adoption.htm (last updated Sept. 10, 2003).

63 See 67 Fed. Reg. at 50,587.

64 See BILL FREESE, MANUFACTURING DRUGS AND CHEMICALS IN CROPS: BIOPHARMING POSES NEW THREATS TO CONSUMERS, FARMERS, FOOD COMPANIES AND THE ENVIRONMENT (2002), available at http://www.foe.org/safefoods/BIOPHARM_FACTSHEET.doc. Between 1989 and July 2003, APHIS considered 170 permit applications162 permits were issued, 7 were withdrawn, and 1 is still pending. No applications were denied.

65 A complete sequence of the human genome was announced in April 2003. NATIONAL HUMAN GENOME RESEARCH INSTITUTE, at http://www.genome.gov (last visited June 26, 2004).

66 For information about the human genome project, see OFFICE OF SCIENCE, DOE, BIOLOGICAL & ENVIRONMENTAL RESEARCH, HUMAN GENOME RESEARCH, at http://www.science.doe.gov/ober/hug_top.html (last visited June 26, 2004).

67 Id.

68 Stephan Herrera, Protein Therapy Could Heal Agbio, RED HERRING, Sept. 15, 2001, available at http://www.agbioworld.org/biotech_info/articles/interviews/protein_therapy.html.

69 Id.

70 See C.L., Cramer et al., Transgenic Plants for Therapeutic Proteins: Linking Upstream and Downstream Strategies, 240 CURR. TOP. MICROBIOL. IMMUNOL. 95 (1999)Google Scholar.

71 All of the production figures in this paragraph come from RONALD A. RADER, BIOPHARMA: BIOPHARMACEUTICAL PRODUCTS IN THE U.S. MARKET 17 (2d ed. 2003).

72 Id.

73 Id.

74 Introductions of Plants Genetically Engineered to Produce Industrial Compounds, Interim Rule, 68 Fed. Reg. at 46,434 (Aug. 6, 2003) (indicating that roughly half of the entities are private companies and half are research institutes).

75 For example, avidin is expressed at 1.5-3% of total soluble protein in corn seeds. Elizabeth, E. Hood et al., Commercial Production of Avidin from Transgenic Maize: Characterization of Transformant, Production, Processing, Extraction and Purification, 3 MOLECULAR BREEDING 291, 292 (1997)Google Scholar. Chloroplast transformation could potentially increase that yield by an order of magnitude. See Daniell, supra note 8.

76 Stephen, J. Streatfield et al., Plant-based Vaccines: Unique Advantages, 19 VACCINE 2742 (2001)Google Scholar; Takeshi, Arakawa et al., Expression of Cholera Toxin B Subunit Oligomers in Transgenic Potato Plants, 6 TRANSGENIC RESEARCH 403, 412 (1997)Google Scholar (describing biopharming as safer and more cost effective).

77 FREESE, supra note 64; see also James, W. Larrick et al., Production of Secretory IgA Antibodies in Plants, 18 BIOMOLECULAR ENGINEERING 87, 90, 92 (2001)Google Scholar.

78 For a description of the state of the industry, and a detailed assessment of the advantages of plant-based production of therapeutics, see Cramer, supra note 70.

79 Id. at 97 (putting forth a partial list of biopharm products under development).

80 See Henriette, Horvath et al., The Production of Recombinant Proteins in Transgenic Barley Grains, 97 PROC. NATL ACAD. SCI. U.S. 1914 (2000)Google Scholar. For a detailed description of the transformation, see Diter von Wettstein, Application for Permit 00-334-01R Renewal under 7 C.F.R. 340 (Apr. 30, 2002) (on file with author). Currently this protein is available in limited supply from human blood plasma. If biopharming successfully increases the supply, 1-antitrypsin could be used to treat a wide range of disorders more effectively. Id. at 5.

81 von Wettstein, supra note 80, at 5.

82 Daniell et al., supra note 20, at 221, fig. 1 (2001) (describing current human and mammalian trials of these plantibodies).

83 Arakawa et al., supra note 76.

84 Jozef, Kapusta et al., A Plant-derived Edible Vaccine Against Hepatitis B Virus, 13 FASEB J. 1796 (1999)Google Scholar.

85 Carol, O. Tacket et al., Human Immune Responses to a Novel Norwalk Virus Vaccine Delivered in Transgenic PotatoesConcise Communication, 182 J. INFECTIOUS DISEASES 302, 302-05 (2000)Google Scholar.

86 Carol, O. Tacket et al., Immunogenicity in Humans of a Recombinant Bacterial Antigen Delivered in a Transgenic Potato, 4 NATURE MED. 607 (1998)Google Scholar.

87 Id.; Kapusta et al., supra note 84. For a discussion of another experiment with a biovaccine, see Anna Modelska et al., Immunization Against Rabies With Plant-Derived Antigen, 95 PROC. NATL ACAD. SCI. U.S. 2481 (1998).

88 See BIOEXCHANGE, EPICYTE PHARMACEUTICAL ADVANCES PRODUCTION OF HUMAN HIV ANTIBODIES IN PLANTS (Jan. 28, 2003), available at http://www.bioexchange.com/news/news_page.cfm?id=16071; see generally Biolex, Inc., at http://www.biolex.com (Biolex, Inc. acquired Epicyte Pharmaceutical Inc.).

89 Larry, Zeitlin et al., A Humanized Monoclonal Antibody Produced in Transgenic Plants for Immunoprotection of the Vagina Against Genital Herpes, 16 NATURE BIOTECHNOLOGY 1361 (1998)Google Scholar.

90 Alison, A. McCormick et al., Rapid Production of Specific Vaccines for Lymphoma by Expression of the Tumor-derived Single-chain Fv Epitopes in Tobacco Plants, 96 PROC. NATL ACAD. SCI. U.S. 703 (1999)Google Scholar.

91 Elizabeth E. Hood, et al, Commercial Production of avidin from transgenic maize: characterization of transformant, production, processing, extraction and purification, 3 MOLECULAR BREEDING 291-306 (1997).

92 See Topical Application of Antibodies for Contraception and for Prophylaxis Against Sexually Transmitted Diseases, U.S. Patent No. 6,355,235 (issued Mar. 12, 2002) (describing the antibodies as extremely effective in small doses), available at http://www.pharmcast.com/Patents/040400OG/6045786_sexuallyTran040400.htm.

93 See FREESE, supra note 64.

94 Id. (reporting that 134 of USDA's 198 biopharm field trial notifications or permits were for corn).

95 For an explanation of corn's reproductive behavior, see U.S. ENVIRONMENTAL PROTECTION AGENCY, PESTICIDE FACT SHEET: BACILLUS THURINGIENSIS SUBSPECIES CRY1F PROTEIN AND THE GENETIC MATERIAL NECESSARY FOR ITS PRODUCTION (PLASMID INSERT PHI 8999) IN CORN, at http://www.epa.gov/pesticides/biopesticides/ingredients/factsheets/factsheet_006481.pdf (last visited July 23, 2004).

96 ENVIRONMENTAL EFFECTS, supra note 14, at 11 (noting that the extent of confidential business information claimed by registrants hampers external review and transparency of the decision-making process).

97 See FREESE, supra note 64 .

98 GENET, HOW THE BIOTECH INDUSTRY CAPTURED WASHINGTON's ATTENTION, at http://www.gene.ch/genet/2003/Jul/msg00049.html (July 9, 2003).

99 Biomass Research and Development Act, Title III of the Agricultural Risk Protection Act, Pub. L. No. 106-224 (2000).

100 Id.

101 See BIOMASS RESEARCH AND DEVELOPMENT TECHNICAL ADVISORY COMMITTEE, DOE, VISION FOR BIOENERGY & BIOBASED PRODUCTS IN THE UNITED STATES, at http://www.bioproductsbioenergy.gov/pdfs/FinalBiomassRoadmap.pdf (Oct. 2002) [hereinafter DOE VISION FOR BIOENERGY]; BIOMASS RESEARCH AND DEVELOPMENT TECHNICAL ADVISORY COMMITTEE, DOE, ROADMAP FOR BIOMASS TECHNOLOGIES IN THE UNITED STATES, at http://www.bioproductsbioenergy.gov/pdfs/FinalBiomassRoadmap.pdf (Dec. 2002) [hereinafter DOE BIOMASS ROADMAP].

102 DOE VISION FOR BIOENERGY, supra note 101, at ¶ 3.

103 Id. at ¶ 5.

104 Pub. L. No. 106-224.

105 DOE VISION FOR BIOENERGY, supra note 101; DOE BIOMASS ROADMAP, supra note 101.

106 The potential for these non-food proteins to render otherwise unidentifiable foods either allergenic or toxic to consumers is the most prominent of these public health concerns. Because biopharm crops look exactly like conventional crops, a consumer will have no way to know if she is inadvertently consuming dangerous compounds.

107 For example, the National Research Council (NRC) has suggested that large-scale biobased production would necessitate withdrawing half the land currently fallow under the Conservation Reserve Program. See COMMITTEE ON BIOBASED INDUSTRIAL PRODUCTS, supra note 10, at 4.

108 DOE, AGRICULTURE COMPACT, at http://www.oit.doe.gov/agriculture/compact.shtml (last updated Jan. 30, 2004).

109 OFFICE OF INDUSTRIAL TECHNOLOGIES, DOE, PLANT/CROP BASED RENEWABLE RESOURCES 2020, at http://www.oit.doe.gov/agriculture/pdfs/ag_vision.pdf.

110 OFFICE OF INDUSTRIAL TECHNOLOGIES, DOE, TECHNOLOGY ROADMAP FOR PLANT/CROPBASED RENEWABLE RESOURCES 2020, DOE/GO 10099-385, 27 (1999), at http://www.oit.doe.gov/agriculture/pdfs/technology_roadmap.pdf [hereinafter DOE TECHNOLOGY ROADMAP].

111 Id. at 10. Despite being available from the DOE website and various other indicia of government sanction (including participation of DOE and USDA officials), DOE describes the Technology Roadmap as a process initiated by the National Corn Growers Association, and produced by organizations representing the U.S. agricultural, forestry, and chemical companies. DOE, VISIONS AND ROADMAPS, at http://www.oit.doe.gov/agriculture/visions.shtml (last updated Jan. 30, 2004) [hereinafter DOE VISIONS AND ROADMAPS].

112 Id.

113 DOE, INDUSTRIAL TECHNOLOGIES PROGRAM: AGRICULTURE, at http://www.oit.doe.gov/agriculture (last updated Jan. 30, 2004).

114 Id. DOE VISIONS AND ROADMAPS, supra note 111.

115 DOE TECHNOLOGY ROADMAP, supra note 110.

116 Id. at app. 5.

117 The Agricultural Research Service (ARS) is the in-house research agency of the U.S. Department of Agriculture. ARS conducts extensive biopharm research focusing on:

developing feedstocks and industrial products, including biofuels and bioenergy, that expand markets for agricultural materials, replace imports and petroleum-based products, and offer opportunity to meet environmental needs. This includes developing, modifying and utilizing new and advanced technologies to convert plant and animal commodities and by-products to new products and by developing energy crops as well as new crops to meet niche market opportunities.

This description of ARS is available at USDA, BBCC MEMBER AGENCIES, AGRICULTURAL RESEARCH SERVICE, at http://www.ars.usda.gov/Bbcc/usda_BBCC.htm (last updated Sept. 11, 2003). Given ARS's mandate, it is difficult to imagine the agency as a voice for caution in the Roadmap process.

118 Introduction of Plants Genetically Engineered to Produce Industrial Compounds, 68 Fed. Reg. 46,434 (Aug. 6, 2003).

119 Hood et al., supra note 75.

120 See FREESE, supra note 64.

121 ENVIRONMENTAL EFFECTS, supra note 14, at 180-82.

122 See Press Release, Genetically Engineered Food Alert Campaign Center, EPA Gears Up to Approve Controversial Bt Corn Without Conducting Human Health Studies (Oct. 11, 2001), available at http://www.gefoodalert.org/library/admin/uploadedfiles/EPA_Gears_Up_to_Approve_Controversial_Bt_Corn_.htm.

123 See id.

124 See The New Farm, U.S. Not Prepared to Monitor Approved Biotech, ENVIRONMENTAL NEWS SERVICE, April 25, 2003, available at http://www.newfarm.com/news/050103/0501/biotech_monitor.shtml.

125 Drugs produced through biopharming are, however, subject to the same regulatory regime as drugs produced by conventional means.

126 For USDA's regulatory plan, see 7 C.F.R. 340.4 (2003); Field Testing of Plants Engineered to Produce Pharmaceutical and Industrial Compounds, 68 Fed. Reg. 11,337 (Mar. 10, 2003).

127 See Rebecca, M. Bratspies, Myths of Voluntary Compliance: Lessons from the StarLink Corn Fiasco, 27 WM. & MARY ENVTL. L. & POLY REV. 593, 628-33 (2003)Google Scholar; MANDEL, supra note 16.

128 StarLink corn was genetically engineered to contain two novel genesone conveying herbicide tolerance and one conveying insect resistance. Uchtmann, supra note 50, at 160. The herbicide tolerance gene was the product of an earlier approval process. It was the addition of a gene derived from the bacterial species Bacillus thuringiensis (Bt), coding for an insecticidal protein called Cry9C, that triggered the StarLink crisis. Id. at 160, 174-75.

129 Lepidoptera is a large order of insects, comprised of butterflies and moths. For a description of the biological mechanism by which Bt kills Lepidopteran pests, see INTERNATIONAL LIFE SCIENCE INSTITUTE, AN EVALUATION OF INSECT RESISTANCE MANAGEMENT IN BT FIELD CORN: A SCIENCE BASED FRAMEWORK FOR RISK ASSESSMENT AND RISK MANAGEMENT 9-10 (1998), available at http://www.ilsi.org/file/h5_IRM.pdf.

130 Cry9C, the Bt protein incorporated into StarLink corn, shared properties with some known food allergens. See NATIONAL CENTER FOR ENVIRONMENTAL HEALTH, CDC, INVESTIGATION OF HUMAN HEALTH EFFECTS ASSOCIATED WITH POTENTIAL EXPOSURE TO GENETICALLY MODIFIED CORN, at http://www.cdc.gov/nceh/ehhe/Cry9cReport (June 11, 2001) [hereinafter CDC REPORT].

131 Marc Kaufman, Biotech Critics Cite Unapproved Corn in Taco Shells: Gene-Modified Variety Allowed Only for Animal Feed Because of Allergy Concerns, WASH. POST, Sept. 19, 2000, at A2.

132 Approval of Pesticide Product Registrations, 63 Fed. Reg. 28,258 (May 22, 1998).

133 Matt Crenson, Rules for Genetically Modified Corn Broke Down Between Seed Plant, Farm, ST. LOUIS POST-DISPATCH, Dec. 15, 2000, at A10.

134 StarLink Corn: How it Reached the Food Supply, ASSOCIATED PRESS, Dec. 4, 2000, available at http://archive.showmenews.com/2000/dec/20001204busi011.asp; see also, Rebecca M. Bratspies, Myths of Voluntary Compliance: Lessons from the StarLink Corn Fiasco, 27 WM. & MARY ENVTL. L. & POLY REV. 593, 628-33 (2003

135 See, e.g., Associated Press, Biotech Corn Recall Expands in Stores, Restaurants, WASH. POST, Nov. 3, 2000, at A5; Mark Kaufman, Corn Woes Prompt Kellogg Plant Shutdown, WASH. POST, Oct. 21, 2000 at A2; Western Family Recalls Products with Altered Corn, PORTLAND OREGONIAN, Oct. 26, 2000, at A2.

136 U.S. FOOD & DRUG ADMINISTRATION, ENFORCEMENT REPORT, at http://www.fda.gov/bbs/topics/ENFORCE/ENF00666.html (Nov. 1, 2000). Millions of bushels of StarLink corn had been commingled with food corn in at least 350 grain elevators. Kurt Eichenwald, New Concerns Rise on Keeping Track of Modified Corn, N.Y. TIMES, Oct. 14, 2000, at A1.

137 News Release, USDA, Statement by the U.S. Departmentt of Agriculture and the Environmental Protection Agency, Release No. 0345.00 (Sept. 29, 2000), available at http://www.usda.gov/news/releases/2000/09/0345.htm (citing that [a]t the urging of the U.S. Department of Agriculture and the Environmental Protection Agency, Aventis will purchase this year's crop of StarLink corn to prevent the current crop of StarLink corn from being used in processed foods).

138 AVENTIS, AVENTIS CROPSCIENCE STATUS REPORT ON STARLINK (Nov. 9, 2000), available at http://www.aventis.com/main/page.asp?pageid=63336185872770551170&lang=en (citing that recalls of food companies have removed [products containing DNA from StarLink corn] from the food supply).

139 See CDC REPORT, supra note 130. Blood tests failed to find signs of antibodies to the protein in the genetically engineered corn. Thus, the federal Centers for Disease Control and Prevention (CDC) concluded that although the study participants may have experienced allergic reactions, based upon the results of their study alone, CDC could not conclude that a reported illness was a [StarLink] allergic reaction. Id. CDC also cautioned that they could not rule out the possibility because food allergies may occur without detectible serum antibodies to the antigen. Id.

140 Bratspies, supra note 127, at 628, 645.

141 NATIONAL CENTER FOR ENVIRONMENTAL HEALTH, CDC, INVESTIGATION FOR HUMAN HEALTH EFFECTS ASSOCIATED WITH POTENTIAL EXPOSURE TO GENETICALLY MODIFIED CORN, at http://www.cdc.gov/nceh/ehhe/Cry9cReport/ (June 11, 2001); see also EPA, ADVISORY PANEL REPORT ASSESSES SCIENTIFIC INFORMATION CONCERNING STARLINK CORN, at http://www.epa.gov/scipoly/sap/2000/november/starlinkpress.pdf (Dec. 5, 2000).

142 The presence of StarLink corn in human food was unambiguously unlawful, rendering the foods in question adulterated under the Food, Drug, and Cosmetic Act, and violating the corn's Plant Incorporated Pesticide Registration. See Bacillus Thuringiensis subspecies tolworthi Cry9C Protein and the Genetic Material Necessary for its Production in Corn: Exemption From the Requirement of a Tolerance, 63 Fed. Reg. 28,258 (May 22, 1998). This exemption eliminated the need to establish a maximum permissible level for residues of this plant pesticide in, or on, corn used for feed, as well as in meat, poultry, milk, or eggs resulting from animals fed such feed. The exemption specifically did not permit human consumption of the StarLink corn itself.

143 For a full exploration of the StarLink crisis, see Bratspies, supra note 127, at 594-98.

144 PRODIGENE, PLANT BIOTECHNOLOGY INTRO, at http://www.prodigene.com/0201.htm (Mar. 23, 2004).

145 PRODIGENE, OUR TECHNOLOGY PLATFORM, at http://www.prodigene.com/0202.htm (Mar. 23, 2004).

146 APHIS, USDA, BIOTECHNOLOGY REGULATORY SERVICES, WHAT IS THE COMPLIANCE HISTORY WITH APHIS BIOTECHNOLOGY REGULATIONS?, at http://www.aphis.usda.gov/brs/compliance9.html (Nov. 17, 2003).

147 Press Release, APHIS, USDA, USDA Investigates Biotech Company for Possible Permit Violations (Nov. 13, 2002), at http://www.aphis.usda.gov/lpa/news/2002/11/prodigene.html.

148 Id.

149 Emily Gersema, Agriculture Department Fines ProdiGene for Biotech Mishaps, ASSOCIATED PRESS, Dec. 7, 2002, at http://earthboundfarm.com/news-world/GMOfine.html; CNN NEWS, FEDS PROBE BIOTECH FIRM FOR CROP MIXING, at http://www.cnn.com/2002/US/11/14/biotech.contamination (Nov. 14, 2002).

150 Philip Brasher, Biotech Corn May Have Tainted Soybeans, DES MOINES REG., Nov. 13, 2002, at A1.

151 Id.; see also Corn Near Gene-Altered Site to be Destroyed, N.Y. TIMES, Nov. 14, 2002, at C10.

152 Brasher, supra note 150; Corn Near Gene-Altered Site to be Destroyed, supra note 151.

153 Brasher, supra note 150; Corn Near Gene-Altered Site to be Destroyed, supra note 151; Press Release, APHIS, supra note 147.

154 Press Release, USDA, USDA Announces Actions Regarding Plant Protection Act Violations Involving ProdiGene, Inc. (Dec. 6, 2002), available at http://www.usda.gov/news/releases/2002/12/0498.htm. ProdiGene was assessed a 250,000 fine and required to pay more than 3 million to repurchase the soybeans and to clean the silo. See CHRISTOPHER DOERING, PRODIGENE TO SPEND MILLIONS ON BIO-CORN TAINTING, at http://www.planetark.org/avantgo/dailynewsstory.cfm?newsid=18935 (Sept. 12, 2002). USDA also required Prodigene to post a 1 million bond and to comply with additional compliance standards, including additional approvals before field testing and harvesting genetically modified material. Press Release, USDA, supra. The company will be required to develop a written compliance program designed to ensure future compliance with the Plant Protection Act, federal regulations, and permit conditions. Id.

155 Brasher, supra note 150.

156 For an explanation of the violations and their consequences, see TOM ZINNER, NEBRASKA CROP CONTAMINATION ISSUE BRIEFING, at http://www.biotech.wisc.edu/Education/prodigene.html (Nov. 14, 2002).

157 Justin Gillis, EPA Fines Biotechs for Corn Violations, WASH. POST, Dec. 13, 2002, at E3 [hereinafter Gillis, EPA Fines]; Justin Gillis, Corn Growing Far Afield? A Mishap with Gene-altered Grain Spotlights the Odds of Contamination, WASH. POST, Nov. 16, 2002, at E1 [hereinafter Gillis, Corn]. Because the experimental GM corn involved in these incidents was engineered to produce a pesticide, the field test fell under EPA's FIFRA authority.

158 Gillis, Corn, supra note 157. On a related note, FDA is investigating whether genetically modified pigs were improperly sold into the human food supply. Aaron Zitner, Pigs in Genetic Study May Have Ended Up as Food, L.A. TIMES, Feb. 6, 2003, at A17. This incident underscores the very real possibilities that any GM products might wind up in the human food supply. The likely effects of a failure to segregate must be considered at the approval stage.

159 Gillis, EPA Fines, supra note 157; see also Stephen Tvedten, Two Biotech Companies Fined for Violations, at http://safe2use.com/ca-ipm/02-12-18e.htm (Dec. 16, 2002).

160 Justin Gillis, Firm Fined for Spread Of Altered Corn Genes: Government Wasn't Told Soon Enough, WASH. POST, Apr. 24, 2003, at E4.

161 Randy Fabi, USDA Reports 115 Infractions of Biotech Rules, REUTERS, Oct. 20, 2003, available at http://www.calgefree.org/news/sept2003.shtml.

162 Judy Steed, Seeds of Conflict, TORONTO STAR, Nov. 12, 2003, available at http://www.mindfully.org/GE/2003/Percy-Schmeiser-Monsanto12nov03.htm. This discovery was reminiscent of Garth seed's discovery in 2000 that StarLink transgenes had contaminated other hybrid corn varieties.

163 See DANILA ODER, IS BIOPHARMING WORTH THE RISK?, at http://www.inquisitoronline.com/news/0306gm.html (June 1, 2003).

164 See COMMITTEE ON BIOBASED INDUSTRIAL PRODUCTS, supra note 10, at 4 (emphasizing that such co-production could minimize conflicts with use of land for food production); Glynis, Giddings et al., Transgenic Plants as Factories for Biopharmaceuticals, 18 NATURE BIOTECHNOLOGY 1151 (2000)Google Scholar (suggesting that the costs of purifying specialty chemicals could be defrayed by selling the food components of the crop).

165 See Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302 (June 26, 1986).

166 FDA regulates biotechnology products under statutes relating to food (except for meat, poultry, and egg products, which are regulated by the USDA), feed, drugs, and medical devices. See 21 U.S.C. 301, 395 (2000); 21 C.F.R. 171.1-571.1 (2003). In May 1992, FDA published a policy statement regarding food derived from new plant varieties. In this statement, FDA concluded that food and feed derived from genetically modified organisms should be regulated in the same manner as food and feed derived from traditionally bred plants, which leaves the responsibility of assuring the safety of the food with the producer. See Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. 22,984 (May 29, 1992).

167 USDA regulates biotech crops under the PPA, 7 U.S.C. 7701-7772 (2000), which consolidated several previous statutes that APHIS used to regulate genetically engineered organisms, including the Federal Plant Pest Act, 7 U.S.C. 150aa-150jj, and the Plant Quarantine Act, 7 U.S.C. 151-164a, 166-167. The Secretary of Agriculture has delegated her authority under the PPA to APHIS, and I will use APHIS and USDA interchangeably in this discussion. Because no new regulations have yet been issued pursuant to the PPA, APHIS continues to regulate biotechnology products according to the regulations issued under the old statutes. For USDA's Internet site on biotechnology, see http://www.aphis.usda.gov/brs/index.html.

168 EPA regulates genetically modified organisms primarily under statutes relating to toxic substances and pesticides. See Toxic Substances Control Act (TSCA), 15 U.S.C. 2601-2629 (2000) (regulating toxic substances); FIFRA, 7 U.S.C. 136-136y (regulating pesticides). Under TSCA, EPA regulates GM microorganisms, and under FIFRA it regulates so-called plant incorporated protectorants (like Bt crops) and pesticidal microorganisms. EPA also has responsibilities under the FFDCA, 21 U.S.C. 346a(a)-(o) (regulating tolerances or exemptions for the requirement of a tolerance for pesticide residues in foods). Relevant regulations may be found at 40 C.F.R. 152.1- .500, 2172.1-.59, 180.1-.1206, 725.1 .1000 (2003).

169 APHIS, USDA, UNITED STATES REGULATORY OVERSIGHT IN BIOTECHNOLOGY: RESPONSIBLE AGENCIESOVERVIEW, at http://www.aphis.usda.gov/brs/usregs.html (last visited June 26, 2004).

170 PPA, 7 U.S.C. 7701.

171 See Bratspies, supra note 127, at 602-03.

172 Agriculture Secretary Ann M. Veneman ordered the establishment of the Biobased Products and Bioenergy Coordination Council in 2002. USDA, DEPARTMENTAL REGULATION 9600-002, at http://www.ars.usda.gov/Bbcc/DR9600-002.htm (Aug. 26, 2002) [hereinafter USDA DEPARTMENTAL REGULATION].

173 Id.

174 USDA, STRATEGIC PLAN FOR BIOBASED PRODUCTS THROUGH THE BIOBASED PRODUCTS AND BIOENERGY COORDINATION COUNCIL, at http://www.ars.usda.gov/Bbcc/BBCC_strateg.htm (June 1999).

175 USDA DEPARTMENTAL REGULATION, supra note 172.

176 Id.

177 For a discussion of the flawed regulation of genetically modified crops, see Bratspies, supra note 127.

178 See id. at 604-05.

179 Field Testing of Plants Engineered to Produce Pharmaceutical and Industrial Compounds, 68 Fed. Reg. 11,337 (Mar. 10, 2003). For a commentary on this APHIS response to the misuse of genetically engineered crops, see KARIL KOCHENDERFER, COMMENTS SUBMITTED RE: DOCKET NO. 03-031-1, at http://www.gmabrands.com/publicpolicy/docs/comment.cfm?DocID=1135 (last visited June 26, 2004).

180 APHIS, USDA, HIGHLIGHTS OF THE FEDERAL REGISTER NOTICE: CHANGES IN THE PERMIT CONDITIONS FOR 2003, at http://www.usda.gov/news/releases/2003/03/aphisfactsheet030603.pdf (last visited Apr. 7, 2004).

181 68 Fed. Reg. at 11,337.

182 Id. at 11,338-39. Under the new regulations, every test site will be inspected during critical times in the biopharm production cycle. Up to five site visits might be made during the growing season, with another two for assessing volunteer plants the following year. Under the old rules, plots were rarely inspected.

183 Id. at 11,338.

184 Id.

185 Id.

186 Id.

187 Id.

188 Id.

189 Press Release, APHIS, USDA, USDA Strengthens 2003 Permit Conditions for Field Testing Genetically Engineered Plants (Mar. 6, 2003), available at http://www.usda.gov/news/releases/2003/03/aphis030603.htm (statement of Bobby Acord, APHIS Administrator).

190 Id.

191 Introductions of Plants Genetically Engineered to Produce Industrial Compounds, 68 Fed. Reg. 46,434 (Aug. 6, 2003).

192 Id.

193 Id.

194 Id. at 46,435.

195 Id. at 46,434.

196 Id. at 46,435.

197 Id. In March of 2003, APHIS published proposed rules for field testing plant-made pharmaceuticals and industrial chemicals. See Field Testing of Plants Engineered to Produce Pharmaceutical and Industrial Compounds, 68 Fed. Reg. 11,337 (Mar. 10, 2003). These proposed rules indicated that APHIS was considering extending permit requirements to plant-made industrials. Id. at 11,338. In a press release that accompanied publication of the proposed rules, APHIS indicated that the agency intended to publish an interim final rule that will require a permit for the field testing of industrials for the 2003 growing season, and strongly encouraged any 2003 applicants to request a permit for field testing industrials. Press Release, APHIS, USDA, USDA To Require Permits for All Industrial Biotech Plants (Aug. 5, 2003), available at http://www.aphis.usda.gov/brs/industrial_biotech.html. Accordingly, those entities submitting proposals in 2003 submitted permit applications rather than notifications. See 68 Fed. Reg. at 46,435.

198 Id.

199 Id.

200 Id.

201 ENVIRONMENTAL EFFECTS, supra note 14 at 182.

202 Id.

203 Id.

204 Id.

205 See Field Testing of Plants Engineered to Produce Pharmaceutical and Industrial Compounds, 68 Fed. Reg. 11,337 (Mar. 10, 2003).

206 ENVIRONMENTAL EFFECTS, supra note 14 at 1.

207 Id. at 11.

208 THE CAMPAIGN TO LABEL GENETICALLY ENGINEERED FOODS, GE FOODS TUTORIAL: STARLINK FIASCO INCREASES PRESSURE FOR REGULATION, at http://www.thecampaign.org/education/brochure_starlink.htm (last visited May 6, 2004).

209 See EPA, BIOPESTICIDES REGISTRATION ACTION DOCUMENT: BACILLUS THURINGIENSIS PLANT-INCORPORATED PROTECTANTS, at II.B.5, at http://www.epa.gov/pesticides/biopesticides/pips/bt_brad.htm (Oct. 16, 2001).

210 Id.

211 AGRICULTURAL BIOTECHNOLOGY STEWARDSHIP TECHNICAL COMMITTEE, INSECT RESISTANCE MANAGEMENT GROWER SURVEY FOR 2002 BT FIELD CORN GROWING SEASON, at http://www.ncga.com/index.shtml (Dec. 19, 2002).

212 GREGORY JAFFE, PLANTING TROUBLE: ARE FARMERS SQUANDERING BT CORN TECHNOLOGY?, at http://cspinet.org/new/pdf/bt_corn_report.pdf (June 19, 2003).

213 Emily Gersema, USDA Survey Shows Biotech Rules Breaches, TALLAHASSEE DEMOCRAT, Sept. 10, 2003, available at http://www.tallahassee.com/mld/tallahassee/news/politics/6739974.htm.

214 See AMERICAN ASSOCIATION OF INSURANCE SERVICES, BREAKING NEW GROUND: HARMFUL OR NOT, GENETICALLY ENGINEERED FOOD COULD LEAD TO KNOTTY PROBLEMS, at http://www.aaisonline.com/Viewpoint/01fall2.html (last visited June 26, 2004).

215 Aventis had not developed any such tests for StarLink corn prior to the StarLink fiasco. One recommendation made in the aftermath of that incident was that the government ensure that such tests are developed prior to the release of any genetically engineered crop. See ASSESSMENT OF ADDITIONAL SCIENTIFIC INFORMATION CONCERNING STARLINK CORN, FIFRA SCIENTIFIC ADVISORY PANEL, SAP REPORT NO. 2001-09, 39, at http://www.epa.gov/scipoly/sap/2001/july/julyfinal.pdf (July 17, 2001).

216 Bratspies, supra note 127, at 624-25, 630.

217 See FDA, GUIDANCE FOR INDUSTRY: DRUGS, BIOLOGICS, AND MEDICAL DEVICES DERIVED FROM BIOENGINEERED PLANTS FOR USE IN HUMANS AND ANIMALS, 67 Fed. Reg. 57828 (Sept. 12, 2002).

218 Fields used to grow biopharm plants are subject to USDA inspection under 7 C.F.R. 340.

219 Id.

220 ENVIRONMENTAL EFFECTS, supra note 14, at 181. This NRC comment referred to field testing under notification. On August 6, 2003, APHIS issued an interim rule requiring that plants genetically modified to produce industrial compounds be field-tested only under a more rigorous permit system. Introductions of Plants Genetically Engineered to Produce Industrial Compounds, Interim Rule, 68 Fed. Reg. 46,434 (Aug. 6, 2003). For the 2003 growing season, APHIS had similarly decided that plants engineered to produce pharmaceutical compounds should be administered under permit rather than notification. See 7 C.F.R. 340.3(b)(4)(iii) (2003). APHIS identified rationale for this shift was its lack of regulatory experience or scientific familiarity with the non-food, non-feed nature of biopharming. 68 Fed. Reg. 46,435.

221 USDA, STATEMENT OF BERNARD A. SCHWETZ, ACTING PRINCIPAL DEPUTY COMMISSIONER, FDA, BEFORE THE SENATE GOV't AFFAIRS SUBCOMM. ON OVERSIGHT OF GOV't MGMT., RESTRUCTURING, AND THE DIST. OF COLUMBIA, at http://www.fda.gov/ola/2001/foodsafety1010.html (Oct. 10, 2001).

222 ENVIRONMENTAL EFFECTS, supra note 14, at 229.

223 Going with the Flow, 20 NATURE BIOTECHNOLOGY 527 (2002).

224 Berg et al., Asilomar Conference, supra note 45.

225 See id.

226 Id.

227 One critical difference between biopharm research at the time of the Asilomar Conference and research today is that most biopharm research is industry funded, and thus subject to commercial pressures from investors that Asilomar scientists did not have to face.

228 INSTITUTE OF MEDICINE, ENSURING SAFE FOOD FROM PRODUCTION TO CONSUMPTION 91- 93 (1998), available at http://books.nap.edu/books/0309065593/html/index.html.

229 Id.

230 See 21 U.S.C. 331, 332, 342(a)(1) (2000); 21 C.F.R. 109.4, 109.6 (2003).

231 Cf. Daniel, A. Farber, Taking Slippage Seriously: Noncompliance and Creative Compliance in Environmental Law, 23 HARV. ENVTL. L. REV. 297, 307-09 (1999)Google Scholar (describing creative enforcement in the context of the Endangered Species Act).

232 Berg et al., Summary Statement, supra note 46, at 1982.

233 Id.

234 In addition to contamination of the food supply, biopharming also raises questions about the environmental effects of gene flow to wild relatives. Twelve of the world's thirteen most important crops are known to hybridize with wild relatives somewhere in their agricultural range. Ralph, Haygood et al., Consequences of Recurrent Gene Flow from Crops to Wild Relatives, 270 PROC. R. SOC. LOND. B. 1879, 1879 (2003)Google Scholar. Indeed, of the top sixty crop plants, only eleven do not hybridize with wild relatives somewhere in the world, and a majority has wild relatives in the United States. Daniell, supra note 8, at 361. These questions would not be resolved by restricting biopharming to non-food crops, though, because it would reduce the likelihood of contaminated pollen, chloroplast transformation would certainly reduce the environmental impacts these crops will have on natural ecosystems.

235 See Margot Roosevelt, Cures on the Cob, TIME, May 26, 2003, at 56; see also Jonathan Nevit et al., Participatory Assessment of the Social and Economic Impacts of Biotechnology (2003) (unpublished working paper, Virginia Tech), at http://www.agecon.vt.edu/biotechimpact/tobacco/WP20031.pdf.

236 See Justin Gillis, Biotech Industry Adopts Precaution: Altered Plants Banned Near Major Food Crops, WASH. POST, Oct. 22, 2002, at E1, E4 (quoting Michael H. Pauley executive director of biotechnology for Epicyte Pharmaceutical Inc., which is testing a herpes drug grown in corn as saying I think we can all agree that this industry cannot afford StarLink II . One incident like that is unacceptable. It's going to require a certain standard of behavior from the entire industry.).

237 Philip Brasher, Biotech Firm Under Fire Has Links to Iowa, DES MOINES REG., Nov. 14, 2002, available at http://desmoinesregister.com/business/stories/c4789013/19735220.html.

238 Press Release, Grocery Manufacturers of America, GMA Urges the Use of Non-Food Crops for Biotech Drugs (Nov. 14, 2002), available at http://www.gmabrands.com/news/docs/NewsRelease.cfm?DocID=10298.

239 Simon, Geir Moller et al., The Topological Specificity Factor AtMinE1 Is Essential for Correct Plastid Division Site Placement in Arabidopsis, 31 PLANT J. 269 (2002)Google Scholar.

240 Henry, Daniell, GM Crops: Public Perceptions and Scientific Solutions, 4 TRENDS IN PLANT SCI. 467, 468 (1999)Google Scholar; Henry, Daniell et al., Containment of Herbicide Resistance Through Genetic Engineering of the Chloroplast Genome, 16 NATURE BIOTECHNOLOGY 345 (1998)Google Scholar; Susan E. Scott & Mike J. Wilkinson, Low Probability of Chloroplast Movement from Oilseed Rape (Brassica napus) Into Wild Brassica rapa, 17 NATURE BIOTECHNOLOGY 390 (1999).

241 S. Milius, The Green Genes Don't Get Out Much, SCIENCE NEWS, April 10, 1999, available at http://www.findarticles.com/cf_dls/m1200/15_155/54492437/p1/article.jhtml.

242 Some researchers believe that, because of their prokaryotic nature, chloroplasts are ideal for biopharming therapeutics that are currently produced in E.coli systems, including vaccines and antibodies. See Daniell, supra note 8, at 366.

243 See, e.g., M., Schneider et al., The In Vivo Pattern of Firefly Luciferase Expression in Transgenic Plants, 14 PLANT MOL. BIOL. 935 (1990)Google Scholar; Stephen, J. Howell, Transient and Stable Expression of the Firefly Luciferase Gene in Plant Cells and Transgenic Plants, 234 SCIENCE 856 (1986)Google Scholar.

244 Brian, K. Harper et al., Green Fluorescent Protein As A Marker for Expression of A Second Gene in Transgenic Plants, 17 NATURE BIOTECHNOLOGY 1125 (1999)Google Scholar; Staci Leffel et al., Tracking Transgenic Plants Using Green Flourescent Protein, at http://www.isb.vt.edu/brarg/brasym96/leffel96.htm (last visited June 26, 2004). The most famous use of this marker is the well-known photo of a glow-in-the-dark rabbit.

245 Some industry estimates are that biopharmaceutical production may be a 12-14 billion industry by 2005. See Iowa State Response to the BIO Guidance Concerning Plants Intended Not to Be Used for Food or Feed, at http://www.grassley.senate.gov/releases/2002/p02r11-04a.htm (last visited May 6, 2004) (objecting to BIO's moratorium on the ground that it would exclude Iowa from lucrative biopharming opportunities).

246 See, e.g., Philip Brasher, Iowa Denied New Drug Corn, DES MOINES REG., Oct. 23, 2002, at A1.

247 Voluntary moratorium on planting some biotech crops in certain regions, FOOD INSTITUTE REP., Oct. 28, 2002; Justin Gillis, Biotech Industry Adopts Precaution: Altered Plants Banned Near Major Food Crops, Wash. Post, Oct. 22, 2002 at E.1, E.4.

248 Iowa's Senator Chuck Grassley led the campaign to get this commitment revoked stating: BIO is responding to the demands of special interest, not the demands of science. Ill continue to work to ensure that Iowa is not unjustly left out of corn-based pharmaceutical crop production. Press Release, Grassley Continues Efforts to Support Biotech Crop Production in Iowa (Nov. 4, 2002), available at http://www.grassley.senate.gov/releases/2002/p02r11-04.htm.

249 Philip Brasher, Biotech Group Lifts Corn Ban, DES MOINES REG., Dec. 4, 2002, at A1.

250 For example, FDA has expressed its intent to regulate transgenic salmon as an animal drug under the FFDCA. Aside from the problem that this claim of regulatory authority contorts the statutory language past all reasonable limits, this interpretation leaves gaping regulatory holes. For example, it is unclear whether FDA has authority to consider ecosystem harms. See PEW INITIATIVE ON FOOD AND BIOTECHNOLOGY, FUTURE FISH: ISSUES IN SCIENCE AND REGULATION OF TRANSGENIC FISH (2003), available at http://pewagbiotech.org/research/fish/ (examining the ambiguity surrounding FDA's authority to consider environmental risks imposed by transgenic fish).

251 For different perspectives on the measures necessary to cure these regulatory ills, see Marcia, Ellen DeGeer, Comment: Can Roundup Ready TM Seeds Ever Be Corralled?: Restraining Genetic Drift Through Criminal Sanctions, 29 NEW ENG. J. CRIM. & CIV. CONFINEMENT 255 (2003)Google Scholar (arguing for use of criminal penalties to deter genetic drift); Thomas, P. Redick, Biopharming, Biosafety & Billion Dollar Debacles: Preventing Liability for Biotech Crops, 8 DRAKE J. AGRIC. L. 115 (2003)Google Scholar (proposing contract based stewardship regime in lieu of new regulations). I respectfully disagree and would suggest that, in light of the signal failure of criminal and tort regimes to prevent contamination to date, they are a slender reed upon which to balance food safety and the fate of the U.S. multi-billion dollar commodity export business.

252 For example, the NRC unambiguously concluded that, with regard to producing human monoclonal antibodies in plants, [i]t would be essential to grow these plants in restricted locations, meaning isolated from food crops. COMMITTEE ON BIOBASED INDUSTRIAL PRODUCTS, supra note 10, at 228.

253 See, e.g., Giddings, supra note 164, at 1152-54 (noting that many biotech companies use corn because of the economics of production).

254 RALPH E. NEILD & JAMES E. NEWMAN, NATIONAL CORN HANDBOOK: GROWING SEASON CHARACTERISTICS AND REQUIREMENTS IN THE CORN BELT, at http://www.agcom.purdue.edu/AgCom/Pubs/NCH/NCH-40.html (last visited June 26, 2004).

255 See, e.g., JOS FALCK ZEPEDA ET AL., BIOTECHNOLOGY, BIOSAFETY, AND REGULATORY COSTS, at http://www.economia.uniroma2.it/conferenze/icabr2003/abstract/ (linking to Public Perception of Biotechnology) (last visited June 26,, 2004).

256 For a general description of food safety decision-making, see Vern, R. Walker, Some Dangers of Taking Precautions Without Adopting the Precautionary Principle: A Critique of Food Safety Regulation in the United States, 31 ENVTL. L. REP. 10040 (2001)Google Scholar.

257 See Christopher, H. Schroeder, Deliberative Democracy's Attempt to Turn Politics into Law, 65 LAW & CONTEMP. PROBS. 95 (2002)Google Scholar (discussing the hurdles to having such a conversation).

258 For a discussion of how such decision-making could, or ought to take place, see DANIEL A. FARBER, ECO-PRAGMATISM: MAKING SENSIBLE ENVIRONMENTAL DECISIONS IN AN UNCERTAIN WORLD 39-42 (1999).

259 Cost benefit analyses are now de rigueur for almost all agency decision-making. See Exec. Order No. 12,866, 58 Fed. Reg. 51,735 (Oct. 4, 1993). As a tool, cost-benefit analysis can be extremely informative. For questions like the ones posed in this Article, where the benefits are inchoate and the risks are probabilistic, the tool of risk benefit analysis is too often distorted or manipulated in the hands of ideologically or economically interested actors. For a recent critique of what passes for reasoned analysis in the world of cost-benefit balancing, see Frank, Ackerman & Liza, Heinzerling, Pricing the Priceless: Cost Benefit Analysis of Environmental Protection, 150 U. PA. L. R. 1553 (2002)Google Scholar.

260 For an point-by-point refutation of this portrayal, and an argument that regulation of GM crops should be precautionary, See John, S. Applegate, The Prometheus Principle: Using the Precautionary Principle to Harmonize the Regulation of Genetically Modified Organisms, 9 IND. J. GLOBAL LEGAL STUD. 207, 234 (2001)Google Scholar.

261 Steven, J. Streatfield et al., Plant Based Vaccines: Unique Advantages, 19 VACCINE 2742, 2747 (2001)Google Scholar.

262 See, e.g., Chris Clayton, U.S. Cattle Industry Calls For Renewal of Ban on Canadian Beef, OMAHA WORLD HERALD, May 27, 2004.

263 Streatfield, supra note 261.

264 See Peter, W.B. Phillips & Heather, McNeill, A Survey of National Labeling Policies for GM Foods, 3 J. AGROBIOTECHNOLOGY MGMT. & ECON. 219 (2000)Google Scholar, available at http://www.agbioforum.org/v3n4/v3n4a07-phillipsmcneill.htmT1.

265 CARTAGENA PROTOCOL ON BIOSAFETY, supra note 32.

266 Id. at art. 10.