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Genetic Technology and Food Security: A View from the United States

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Genetic Technology and Food Safety

Part of the book series: Ius Comparatum - Global Studies in Comparative Law ((GSCL,volume 14))

Abstract

Genetic technology has produced new varieties of crops, primarily corn, soy, and cotton, that resist insects and tolerate herbicides. Many producers in the United States have cultivated genetically modified crops, and in 2014, GM crops were grown on millions of hectares in 28 countries. Legal requirements for authorization in the United States, implemented by the US Department of Agriculture, Environmental Protection Agency, and Food and Drug Administration, are designed to ensure that genetically modified crops are safe to grow, safe for the environment, and safe to eat. GM crops have raised significant issues: labeling, not currently required in the US; liability for possible damage caused by cultivation and sale; and regulatory barriers and asynchronous approvals. In light of current food insecurity, the growing world population, and the uncertainties of climate change, GM crops may help to satisfy global food demands.

An earlier, condensed version of this Chapter was published at 62(supp.) Am. J. Comp. L. 273–302 (2014). This Chapter is based on work supported by USDA, National Institute of Food and Agriculture, Hatch Project No. ILLU-470-309. The Chapter was last updated in February 2015. © 2016, M.R. Grossman

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Notes

  1. 1.

    Pamela Ronald, Plant Genetics, Sustainable Agriculture and Global Food Security, 188 Genetics 11, 12 (May 2011).

  2. 2.

    Id. at 12. On biotechnology, see generally ISAAA, Agricultural Biotechnology (A Lot More than Just GM Crops) (2014), http://www.isaaa.org.

  3. 3.

    Gary Marchant et al., Impact of the Precautionary Principle on Feeding Current and Future Generations, at 11 (Issue Paper No. 52, CAST, Ames, Iowa, 2013).

  4. 4.

    Ronald, supra note 1, at 12. For a list of 610 scientific papers that evaluate the safety of GM food and feed, see http://chilebio.cl/documentos/Publicaciones.pdf (June 2013). A European organization recently indicated that “the potential benefits of crop genetic improvement technologies are very significant,” and recommended improvements in EU policy to capture those benefits. European Academies Science Advisory Council (EASAC), Planting the Future: Opportunities and Challenges for Using Crop Genetic Improvement Technologies for Sustainable Agriculture, at 2 (2013).

  5. 5.

    Andrew Pollack, Executive at Monsanto Wins Global Food Honor, NY Times, 19 June 2013.

  6. 6.

    Gurdev S. Khush, Genetically modified crops: the fastest adopted crop technology in the history of modern agriculture, 1(14) Ag. & Food Security 1, 2 (2012) (noting a “moral imperative to make GM technology available for public good” and an “urgent need for appropriate science-based, cost-effective and time-effective regulatory systems that are responsible and rigorous but not onerous for small and poor developing countries”).

  7. 7.

    Clive James, ISAAA Brief 49, Global Status of Commercial Biotech/GM Crops: 2014, Executive Summary (2015), http://www.isaaa.org/resources/publications/briefs/49/executivesummary/pdf/B49-ExecSum-English.pdf.

  8. 8.

    Id., Table 1 (listing production by country). EU production in 2014 was 3 % lower than in 2013.

  9. 9.

    NASS, USDA, Acreage 25–27 (2014). In 2013, GM varieties made up 90 % of all corn, 93 % of soy, and 90 % of upland cotton. Id.

  10. 10.

    James, supra note 7; see Table 1.

  11. 11.

    Id. GM events are approved for release into the environment, cultivation, food, and feed. For a comprehensive overview, see Jorge Fernandez-Cornejo et al., Genetically Engineered Crops in the United States (ERS, USDA, ERR 162, 2014).

  12. 12.

    James, supra note 7.

  13. 13.

    Id.

  14. 14.

    Clive James, ISAAA Brief 49–2014: Top Ten Facts, Fact 7 (ISAAA, 2014).

  15. 15.

    Graham Brookes & Peter Barfoot, Economic impact of GM crops: The global income and production effects 1996–2012, 5(1) GM Crops & Food: Biotec. Agric. & Food Chain 65, 69 (2014). The authors acknowledge that “[o]ver-reliance on the use of glyphosate and the lack of crop rotation … has [sic] contributed to the development of weed resistance.” Id. at 70.

    A 2013 survey in the United Kingdom indicated that 61 % of British farmers would grow GM crops, if possible, and 64 % believed GM foods were safe to eat. Survey results: What farmers really think about GM, Farmers Weekly, 12 June 2013, http://www.fwi.co.uk/arable/survey-results-what-farmers-really-think-about-gm.htm.

  16. 16.

    See Margaret Rosso Grossman, The Coexistence of GM and Other Crops in the European Union, 16 Kan. J.L. & Pub. Pol’y 324 (2007).

  17. 17.

    7 U.S.C. §§ 6501–6523; 7 C.F.R. part 205. For current versions of U.S.C. and C.F.R., link from http://www.gpo.gov/fdsys/.

  18. 18.

    7 C.F.R. § 205.105. The unintentional presence of a detectable GM residue may not affect organic status, if the operator did not used genetic modification and took reasonable steps to avoid contacts with GMOs.

  19. 19.

    7 U.S.C. § 6508; 7 C.F.R. §§ 205.236, 205.237.

  20. 20.

    Council Regulation 834/2007, arts. 9, 23(3), 2007 O.J. L189, at 1. See Regulations 1829/2003 and 1830/2003, as amended, with thresholds (0.9 %) established in Directive 2001/18, as amended, art. 21(3).

  21. 21.

    See AMS, USDA, National Organic Program, Final Rule 34 (1990), http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3004452:

    When we are considering drift issues, it is particularly important to remember that organic standards are process based. Certifying agents attest to the ability of organic operations to follow a set of production standards and practices that meet the requirements of the Act and the regulations. This regulation prohibits the use of excluded methods in organic operations. The presence of a detectable residue of a product of excluded methods alone does not necessarily constitute a violation of this regulation. As long as an organic operation has not used excluded methods and takes reasonable steps to avoid contact with the products of excluded methods as detailed in their approved organic system plan, the unintentional presence of the products of excluded methods should not affect the status of an organic product or operation.

  22. 22.

    Michael Cardwell, Public Participation in the Regulation of Genetically Modified Organisms: A Matter of Substance or Form?, 12 Envtl L. Rev. 12, 12–13 (2010). On public protests and vandalism of GM crops in the UK and France, see id. at 25–35. See also David Zilberman et al., Continents divided: Understanding differences between Europe and North America in acceptance of GM crops, 4(3) GM Crops & Food: Biotec. Agric. & Food Chain 202 (2013).

    One scholar argued that EU policy on GMOs imposes externalities, including “the negative impact on investment in research and development … [leading to] a reduction in global food security through a reduction in the potential productivity gains which investments in biotechnology can be expected to provide. In other words, a reduction in potential global food supply.” William A. Kerr, Food Security and Trade: Some Supply Conundrums for 2050, 15(2) Estey Centre J. Int’l L. & Trade Pol’y 115, 127 (2014).

  23. 23.

    Alan McHughen, Public Perceptions of Biotechnology, 2 Biotec. J. 1105, 1106 (2007) (quoting survey results indicating that fewer than half of consumers knew that GM foods were in US supermarkets or that eating GM fruit would not alter that person’s genes). See also Patrick F. Byrne, Safety and Public Acceptance of Transgenic Products, 46 Crop Sci. 113, 113–114 (2006).

  24. 24.

    Pew Research Center, Public and Scientists’ Views on Science and Society (2015), www.pewresearch.org. Of those with a college education, 49 % believe that GM foods are safe to eat.

  25. 25.

    William K. Hallman et al., Public Perceptions of Labeling Genetically Modified Foods, at 2–5 (Rutgers School of Environmental and Biological Sciences, 2013).

  26. 26.

    See, e.g., Dorothy Du, Note, Rethinking Risks: Should Socioeconomic and Ethical Considerations Be Incorporated into the Regulation of Genetically Modified Crops?, 26 Harv. J. L. & Tech. 375, 379–387 (2012). For discussion of the reasons for US opposition, see Brooke Glass-O’Shea, The History and Future of Genetically Modified Crops: Frankenfoods, Superweeds, and the Developing World, 7 J. Food L. & Pol’y 1, 16–22 (2011).

  27. 27.

    On consumer initiatives, for labeling see infra text accompanying notes 223–226.

  28. 28.

    International Food Information Council (IFIC), Consumer Perceptions of Food Technology Survey, Executive Summary, at 3 (2012). In 2012, US consumers expressed concern about biopharming (production of pharmaceuticals and industrial chemicals in crops). On pharming, see generally Eckard Rehbinder et al., Legal problems of pharming, in Pharming, at 213–289 (Springer, Berlin, 2009). Maine, for example, prohibited open-air production of genetically engineered pharmaceutical crops. Maine Rev. Stat. Ann. tit. 7, §§ 1051, 1055.

  29. 29.

    International Food Information Council (IFIC), Consumer Perceptions of Food Technology Survey (2014) [no page numbers]. Fewer consumers were favorable toward biotech foods than in 2012 (38 %), but more were neutral (26 % in 2012) and unfavorable (20 %). Changes in 2014 may reflect state labeling initiatives and publicity. In 2014, only about 11 % of consumers surveyed had read or heard “a lot” about food biotechnology, and 89 %, only a little or nothing. Thirty-seven percent believed that biotech foods were available in US supermarkets, but with some inaccurate beliefs about what foods.

  30. 30.

    Id. Consumers were more likely to buy GM foods that offer health benefits (about 70 %), improve taste (58 %), or come from crops that reduced pesticide use (69 %). Scientists in Europe found that consumers would pay a premium for GM foods with health benefits (biofortified crops), but would purchase GM foods with benefits for producers only with a discount. Hans De Steur et al., Status and market potential of transgenic biofortified crops, 33(1) Nature Biotec. 25, 27 (2015).

  31. 31.

    IFIC, supra note 29. About 29 % of consumers were unfavorable; 25 % were neutral; and 15 % didn’t have enough knowledge. Only 7 % of consumers had a lot of information about animal biotechnology; 45 %, a little; and 48 %, none.

  32. 32.

    FAS, USDA, Joint Statement (2013), http://www.fas.usda.gov/joint-statement-innovative-agricultural-production-technologies-particularly-plant-biotechnologies. Other supporting governments are Australia, Brazil, Canada, Argentina, and Paraguay.

  33. 33.

    See Codex Alimentarius, Foods derived from modern biotechnology (2d ed., 2009) (collecting principles and guidelines), ftp://ftp.fao.org/docrep/fao/011/a1554e/a1554e00.pdf.

  34. 34.

    Food & Water Watch, Biotech Ambassadors: How the U.S. State Department Promotes the Seed Industry’s Global Agenda, at 2 (2013).

  35. 35.

    Id. at 3. Food and Water Watch analyzed 926 cables discussing biotechnology released by Wikileaks in 2010, but did not use secret cables. The NGO identified four goals of biotech diplomacy: to promote business interests of biotech companies, to encourage foreign governments to weaken rules for biotechnology (opposing labeling), to protect biotech exports, and to encourage the developing world to adopt GM crops. Id. at 8, 11.

  36. 36.

    Id. at 16.

  37. 37.

    FAO, Voluntary Guidelines to support the progressive realization of the right to adequate food in the context of national food security, at 5, para. 15 (27th Session of the FAO Council, Nov. 2004).

  38. 38.

    World Food Summit, Declaration of the World Summit on Food Security, at 1, n. 1 (FAO, WSFS 2009/2, Rome, 16–18 Nov. 2009), http://www.fao.org/fileadmin/templates/wsfs/Summit/Docs/Final_Declaration/WSFS09_Declaration.pdf.

  39. 39.

    FAO, IFAD & WFP, The State of Food Insecurity in the World 2014: Strengthening the Enabling Environment for Food Security and Nutrition, at 8–9 (FAO, Rome, 2014) (indicating that with more effort the Millennium Development Goal – to reduce by half the proportion of undernourished – for 2015 may be within reach, but the World Food Summit goal of reducing by half the number of undernourished cannot be achieved).

  40. 40.

    World Food Summit, supra note 38, at 2, para. 4.

  41. 41.

    Id. at 2, para. 5.

  42. 42.

    Stacey Rosen et al., International Food Security Assessment, 2014–2024, at 2 (USDA, GFA-25, 2014).

  43. 43.

    Id. at 2.

  44. 44.

    Id. at 1, 3, Table 2a. In 2000, more than 1 billion people, 37 % of the population, were food insecure; the distribution gap was 24 million tons. Birgit Meade & Stacey Rosen, International Food Security Assessment, 2013–2023, at 14 (USDA, GFA-24, 2013), citing World Food Programme statistics.

  45. 45.

    Rosen et al., supra note 42, at 1, 3, Table 1. In 2024, food insecurity in Sub-Saharan Africa is projected to affect 31.2 % of the population. Id. at 5. In West Africa, the ebola virus will increase food insecurity, at least in the short term. See Anne-Claire Thomas et al., European Commission, Impact of the West African Ebola Virus Disease Outbreak on Food Security (Joint Research Centre, Ispra, Italy, 2014).

  46. 46.

    ERS, USDA, Definitions of Food Security, http://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-us/definitions-of-food-security.aspx (last updated 3 Sept. 2014).

  47. 47.

    Id. (all quotations).

  48. 48.

    Richard Volpe, Price Inflation for Food Outpacing Many Other Spending Categories, Amber Waves (Aug. 2013), link from http://www.ers.usda.gov/amber-waves/2013-august/.

  49. 49.

    Alisha Coleman-Jensen et al., Household Food Security in the United States in 2013 (ERS, USDA, ERR 173, 2014). Food insecure households “were, at times, unable to acquire adequate food … because they had inadequate money and other resources for food.” Id. at 8.

  50. 50.

    Id. at 8. Nearly 20 % of those households with children were food-insecure. In 9.6 % of those households, parents provided food for their children first, so only adults were food insecure.

  51. 51.

    Id. at 12.

  52. 52.

    Id. at 14.

  53. 53.

    Id. at 29. Three major programs are Supplemental Nutrition Assistance Program (SNAP, earlier called food stamps), National School Lunch Program, and Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Id. at 27.

  54. 54.

    Economist Intelligence Unit, Global Food Security Index 2013, at 6 (2013). The US, Norway, and France are the most food secure. Developing countries improved their food security between 2012 and2013.

  55. 55.

    USAID, The Future of Food Assistance: U.S. Food Aid Reform (Fact Sheet, 2013). See Food for Peace Act, 7 U.S.C. §§ 1691–1738r.

  56. 56.

    Chicago Council on Global Affairs, Advancing Global Food Security: The Power of Science, Trade, and Business, at 75 (Catherine Bertini & Dan Glickman, co-chairs, 2013). US Food Aid is not part of Feed the Future, discussed below. Id. at 39.

  57. 57.

    U.S. Gov’t Accountability Office (GAO), Foreign Assistance: Various Challenges Impede the Efficiency and Effectiveness of U.S. Food Aid, at 15, 37–38 (GAO-07-560, 2007). See also GAO, International Food Aid: Prepositioning Speeds Delivery of Emergency Aid, but Additional Monitoring of Time Frames and Costs is Needed (GAO-14-277, 2014).

  58. 58.

    See Noah Zerbe, Feeding the famine? American food aid and the GMO debate in Southern Africa, 29 Food Pol’y 593 (2004) (arguing that US food aid policy was designed to promote adoption of GM crops, rather than to alleviate famine).

  59. 59.

    Chicago Council, supra note 56, at 75.

  60. 60.

    USAID, supra note 55. President Obama’s 2014 budget proposed reforms to make US food aid programs more flexible and efficient. Although food aid with US commodities would continue when appropriate, aid would also include vouchers, cash, and locally-sourced food for emergencies. The President also proposed to end monetization, making more food aid available. Id.

  61. 61.

    Title III of the Agricultural Act of 2014, Pub. L. 113–79, 128 Stat. 649 (2014), signed into law in February 2014.

  62. 62.

    Ralph M. Chite, Coordinator, The 2014 Farm Bill: A Comparison of the Conference Agreement with the Senate-Passed (S. 954) and House-Passed (H.R. 2642) Bills, at 9–10 (CRS R43076, 2014).

  63. 63.

    Jean C. Buzby et al., The Estimated Amount, Value, and Calories of Postharvest Food Losses at the Retail and Consumer Levels in the United States, at 11 (ERS, USDA, EIB 121, 2014). Consumer losses were 21 % and retail losses, 10 % of the food supply. The study did not consider losses earlier in the food chain (e.g., postharvest loss of produce). Not all food loss can be prevented, due to “technical and spatial factors; consumers’ tastes, preferences, and food habits; and economic factors.” Id. at 22.

  64. 64.

    Press Release, USDA, USDA and EPA Launch U.S. Food Waste Challenge (No. 0112.13, 4 June 2013). In the US, 30–40 % of food is wasted.

  65. 65.

    USDA, http://www.usda.gov/oce/foodwaste/index.htm# (format changed).

  66. 66.

    Tim Searchinger et al., Creating a Sustainable Food Future: A Menu of Solutions to Sustainably Feed More Than 9 Billion People by 2050, at 28 (World Resources Institute Report, 2013); Brian Lipinski et al., Reducing Food Loss & Waste, at 5 (World Resources Institute Working Paper, 2013) (relying on FAO data). See also House of Commons, International Development Committee, Global Food Security (HC 176, 2013) (recommending targets to reduce food waste, with sanctions).

  67. 67.

    Lipinski et al., supra note 66, at 9. Food loss also wastes water and land, increases CO2 emissions, and releases methane in landfills. For strategies to reduce food loss see Searchinger et al., supra note 66, at 28–33.

  68. 68.

    See generally FAO, Food Wastage Footprint: Impacts on Natural Resources, Summary Report (FAO, Rome, 2013).

  69. 69.

    Deepak K. Ray et al., Yield Trends Are Insufficient to Double Global Crop Production by 2050, 8(6) PLOS/One 1, 1 (June 2013), http://www.plosone.org.

  70. 70.

    Id. at 2 (using about 2.5 million statistics from about 13,500 political units, between 1961 and 2008, with focus on the last two decades). Recent research has found evidence of “yield plateaus or abrupt decreases in rate of yield gain” between 1990 and 2010 and suggests that farmers have already achieved maximum yields for some cereal crops. Patricio Grassini et al., Distinguishing between yield advances and yield plateaus in historical crop production trends, 4 Nature Comm., art. 2918, DOI:10.1038/ncomms3918 (2013).

  71. 71.

    Ray et al., supra note 69, at 6. On sustainable intensification, see T. Garnett et al., Sustainable Intensification in Agriculture: Premises and Policies, 341 Sci. 33 (5 July 2013).

  72. 72.

    H. Charles J. Godfray et al., Food Security: The Challenge of Feeding 9 Billion People, 327 Sci. 812, 813–17 (12 Feb. 2010).

  73. 73.

    Brookes & Barfoot, supra note 15, at 72, Table 7.

  74. 74.

    Id. at 69.

  75. 75.

    American Council on Science and Health, Feeding the World with Modern Agricultural Biotechnology, at 20 (2013), http://www.acsh.org. See generally Nina V. Fedoroff & Drew L. Kershen, Agricultural Biotechnology – An Opportunity to Feed a World of Ten Billion, 118(4) Penn State L. Rev. 859 (2014).

  76. 76.

    World Food Summit, supra note 38, at 5, para. 26 (emphasis added). As the FAO noted in 2013, little additional land is available for agriculture, because potential cropland is forest, environmentally protected, or in urban uses. FAO, FAO Statistical Yearbook 2013: World Food and Agriculture, at 10 (FAO, Rome, 2013). See UN Environment Programme, Assessing Global Land Use: Balancing Consumption with Sustainable Supply (2014) (indicating that a global expansion of cropland to meet food demand in 2050 raises issues of sustainability).

  77. 77.

    G-8, L’Aquila Joint Statement on Global Food Security (July 2009), http://www.g8.utoronto.ca/summit/2009laquila/2009-food.pdf, expanded by the G-20 in Pittsburgh, Leaders’ Statement: The Pittsburgh Summit, para. 39 (Sept. 2009), https://g20.org/wp-content/uploads/2014/12/Pittsburgh_Declaration_0.pdf.

  78. 78.

    Feed the Future is part of the New Alliance for Food Security and Nutrition, an association of donors, global and African companies, and African governments. Among the global companies are biotech seed and agribusiness companies, including Monsanto, DuPont, Cargill, and Syngenta. Feed the Future, Progress Report: Boosting Harvests, Fighting Poverty, at 28 (2012).

  79. 79.

    Id. at 6.

  80. 80.

    Id. at 23. See also Feed the Future, Global Food Security Research Strategy, at 42, 43 (2011). A World Resources Institute report accepts a role for genetic engineering, along with conventional breeding in sustainable food production:

    Genetic engineering can play a role, particularly because improved techniques now allow insertion of genes in particular locations, reducing the amount of trial and error necessary to produce crops with improved traits (such as pest or drought resistance). In the short run, genetic engineering can most help by enabling faster breeding responses to new pests. More fundamental crop improvements from genetic engineering, such as improved uptake of nutrients and reduced losses of water, are uncertain and will take decades to come to fruition.

    Searchinger et al., supra note 66, at 6.

  81. 81.

    Godfray et al., supra note 72, at 816 (noting, at 815, that GM technology “should neither be privileged nor automatically dismissed”). For the conclusions that GM crops “have a significant role to play in agriculture development in African countries south of the Sahara” and that some crops could benefit African smallholder farmers, see José Falck-Zepeda, Genetically Modified Crops in Africa: Economic and Policy Lessons from Countries South of the Sahara, at 224–225 (IFPRI, Washington DC, 2013).

  82. 82.

    On the global significance of reducing greenhouse gas emissions while increasing production, see Searchinger et al., supra note 66, at 83–93.

  83. 83.

    See generally L. Val Giddings et al., Feeding the Planet in a Warming World: Building Resilient Agriculture through Innovation (ITIF, Washington DC & LSE, London, 2013) (asserting, at 21–23, that global regulatory regimes for GMOs stifle innovation).

  84. 84.

    US Census Bureau, The 2012 Statistical Abstract, National Data Book, at 548, Table 852.

  85. 85.

    Paul C. Wescott & Michael Jewison, Weather Effects on Expected Corn and Soybean Yields, at 9 (ERS, USDA, FDS-13g-01, 2013). See also ERS, USDA, U.S. Drought 2012: Farm and Food Impacts, http://www.ers.usda.gov/topics/in-the-news/us-drought-2012-farm-and-food-impacts.aspx. Accessed 13 Feb. 2015.

  86. 86.

    Monsanto, Genuity DroughtGard Hybrids, http://www.monsanto.com/products/Pages/droughtgard-hybrids.aspx. US producers planted only 50,000 ha of DroughtGard in 2013 and 275,00 ha in 2014. James, supra note 7.

  87. 87.

    James, supra note 7. On WEMA, a private/public sector partnership, see http://wema.aatf-africa.org/.

  88. 88.

    See Gret O. Edmeades, Progress in Achieving and Delivering Drought Tolerance in Maize – An Update (ISAAA, 2013).

  89. 89.

    ISAAA, Biotechnology and Climate Change, Pocket K No. 43 (2013), link from http://www.isaaa.org/kc. GM crops also help to mitigate climate change by decreasing emission of greenhouse gases (lower pesticide application) and sequestering carbon (no-till farming). Id. at 2.

  90. 90.

    Bruce Alberts et al., Editorial, Standing Up for GMOs, 341 Sci. 1320 (20 Sept. 2013). See also Editorial, Fight the GM Food Scare: Mandatory labels for genetically modified foods are a bad idea, Sci. Am., Sept. 2013, at 10: “Greenpeace and other anti-GMO organizations have used misinformation and hysteria to delay the introduction of Golden Rice to the Philippines, India and China.”

  91. 91.

    Daniel Cressey, A New Breed, 497 Nature 29 (2 May 2013). Recent research suggests that orange plants engineered with a spinach gene can resist citrus greening, a disease that threatens Florida citrus production. Venessa Wong, Can Genetically Modifying an Orange With a Spinach Gene Save Florida’s Crop?, Bloomberg Businessweek, 17 Dec. 2013.

  92. 92.

    Drew L. Kershen, Health and Food Safety: The Benefits of Bt Corn, 61 Food & Drug L.J. 197, 197–206 (2006) (explaining the science of neural tube defects and the effect of Bt corn on fumonisin concentrations).

  93. 93.

    ISAAA, Nutritionally-Enhanced GM Feed Crops, Pocket K No. 41 (2012), link from http://www.isaaa.org/kc. Other advantages may follow. For example, improved phosphorus availability in GM crops with the phytase enzyme can help to reduce excretion of phosphorus and the resulting pollution.

  94. 94.

    Id. at 1–2. These include corn with increased lysine; rice with elevated free tryptophan, used for chicken feed; soybeans enriched with more digestible amino acids; lupin with increased methionine for broiler chickens.

  95. 95.

    Id. at 4.

  96. 96.

    Olivier de Schutter, Right to Food, http://www.srfood.org/en/right-to-food. De Schutter served from 2008 to 2014, and the quotation is no longer at this web address.

  97. 97.

    UN General Assembly, Universal Declaration on Human Rights, art. 25(1) (Doc. 217 A (III), 10 Dec. 1948), http://www.un.org/en/documents/udhr.

  98. 98.

    UN General Assembly, International Covenant on Economic, Social and Cultural Rights, art. 11(1),(2) (16 Dec. 1966, in force 3 June 1976), 993 U.N.T.S. 3, 7 (1976). Article 2, id. at 5, sets out the concept of “progressive realisation,” requiring parties to take steps to realize the rights recognized in the Covenant. See also UN Economic and Social Council, Committee on Economic, Social and Cultural Rights, General Comment No. 12 (Doc. E/C.12/1999/5, 12 May 1999) (discussing issues concerning art. 11). In August 2013, the Covenant had 160 Parties and 70 Signatories.

  99. 99.

    FAO, Rome Declaration on World Food Security, World Food Summit, Rome, 13–17 Nov. 1996, http://www.fao.org/docrep/003/w3613e/w3613e00.HTM.

  100. 100.

    UN General Assembly, Millennium Declaration (Doc. A/Res/55/2, 18 Sept. 2000), http://www.un.org/millennium/declaration/ares552e.pdf.

  101. 101.

    FAO, Voluntary Guidelines, supra note 37 (a “soft-law” document, adopted by consensus).

  102. 102.

    UN Office of High Commissioner for Human Rights & FAO, The Right to Adequate Food (Fact Sheet No. 34, 2012).

  103. 103.

    President Jimmy Carter signed the Covenant, 5 Oct. 1977, but the US has not ratified it. See also the Protocol of San Salvador (1988) to the OAS American Convention on Human Rights in the Area of Economic, Social and Cultural Rights (1969), signed but not ratified by the US. Art. 12(1) of the San Salvador Protocol: “Everyone has the right to adequate nutrition which guarantees the possibility of enjoying the highest level of physical, emotional and intellectual development.”

  104. 104.

    US Mission to the UN, Explanation of Position by the United States of America on Resolution: The Right to Food, UN Human Rights Council, 19th Session (Geneva, Switzerland, 22 Mar. 2012) (joining the consensus document, albeit with reservations). See UN General Assembly, Human Rights Council, The Right to Food, in Report of the Human Rights Council on its nineteenth session 22 (Doc. A/HRC/19/2, 24 May 2013), http://www.ohchr.org/EN/HRBodies/HRC/RegularSessions/Session19/Pages/19RegularSession.aspx.

  105. 105.

    International Human Rights Clinic (IHRC), Nourishing Change: Fulfilling the Right to Food in the United States, at 3 (NYU School of Law, 2013) (describing US programs). Fifteen federal food assistance programs exist. Requirements (e.g., income thresholds) limit eligibility, and Congress must appropriate funds. See also Molly D. Anderson, Beyond food security to realizing food rights in the US, 29 J. Rural Stud. 113, 114 (2013).

  106. 106.

    This section on authorization of GMOs is condensed from Margaret Rosso Grossman, Genetically Modified Crops and their Products in the United States: A Review of the Regulatory System, in José Martinez, ed., XI Jahrbuch des Agrarrechts, at 69–95 (Nomos, Baden-Baden, 2012).

  107. 107.

    See Phillips McDougall, The Cost and Time Involved in the Discovery, Development and Authorization of a New Plant Biotechnology Derived Trait (Study for CropLife International, 2011). The cost of traits introduced between 2008 and 2012 is $136 million, over an average of 13.1 years from initiation to commercial sale. Registration and regulatory issues consume about 5.5 years.

  108. 108.

    Office of Science and Technology Policy (OSTP), Coordinated Framework for Regulation of Biotechnology Products, 51 Fed. Reg. 23,302 (26 June 1986) (drafted in cooperation with administrative agencies). See also OSTP, Exercise of Federal Oversight Within Scope of Statutory Authority: Planned Introductions of Biotechnology Products into the Environment, 57 Fed. Reg. 6753 (27 Feb. 1992) (describing a “risk-based, scientifically sound approach to the oversight,” id. at 6753).

  109. 109.

    FDA, Guidance for Industry 187: Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (2011), http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM113903.pdf.

  110. 110.

    7 U.S.C. §§ 7701–7772 (replacing the Plant Pest and Plant Quarantine Acts). Section 7711 authorizes regulation of plant pests.

  111. 111.

    7 C.F.R. § 340.1; 7 U.S.C. § 7702(14).

  112. 112.

    7 C.F.R. part 340. In 2008, USDA proposed regulatory amendments to expand its oversight, but by February 2015, these amendments had not been promulgated. APHIS, Importation, Interstate Movement, and Release into the Environment of Certain Genetically Engineered Organisms: Proposed Rule, 73 Fed. Reg. 60,008 (9 Oct. 2008), corrected at 73 Fed. Reg. 66,563 (10 Nov. 2008), to be codified at 7 C.F.R. part 340. Beginning in March 2012, APHIS provided more opportunities for public comment about petitions for nonregulated status. See APHIS, Enhancements to Public Input, link from http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/biotechnology. For criticism of USDA regulation, see, e.g., Emily Montgomery, Genetically Modified Plants and Regulatory Loopholes and Weaknesses under the Plant Protection Act, 37 Vt. L. Rev. 351 (2012).

  113. 113.

    A regulated article is an “organism which has been altered or produced through genetic engineering, if the donor organism, recipient organism, or vector or vector agent … meets the definition of plant pest.” 7 C.F.R. § 340.1.

  114. 114.

    42 U.S.C. §§ 4321–4370 f. NEPA requires preparation of an environmental impact statement for “major Federal actions significantly affecting the quality of the human environment.” Id. § 4332(2)(C).

    APHIS’ failure to prepare environmental impact statements has engendered litigation, and a case involving Monsanto’s Roundup Ready alfalfa reached the US Supreme Court. Monsanto Co. v. Geertson Seed Farms, 561 U.S. 139, (2010). See Margaret Rosso Grossman, Monsanto Co. v. Geertson Seed Farms: US Supreme Court Decides GM Alfalfa Case, 5(4) Eur. Food & Feed L. Rev. 216–221 (2010).

  115. 115.

    7 C.F.R. §§ 340.4 (permits), 340.3 (notifications). USDA proposed to eliminate the notification procedure and require permits for all field trials. APHIS, supra note 112.

  116. 116.

    Statistics on permits, notifications, and petitions, as well as APHIS documents related to applications, are available at APHIS, USDA, Biotechnology, http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml (updated daily). In 2013, the agency approved 602 releases, and in 2014, 534. Information Systems for Biotechnology, Summary data, http://www.isb.vt.edu/release-summary-data.aspx. See also Fernandez-Cornejo et al., supra note 11.

  117. 117.

    7 U.S.C. §§ 136–136y.

  118. 118.

    21 U.S.C. §§ 301–399d, supplemented by the Food Safety Modernization Act, Pub. L. 111–353, 124 Stat. 3885 (2011), codified at 21 U.S.C. §§ 2201–2252.

  119. 119.

    40 C.F.R. parts 152 & 174; EPA, Pesticide Registration (PR) Notice 2007–2: Guidance on Small-Scale Field Testing and Low-Level Presence in Food of Plant-Incorporated Protectants (PIPs) (Docket EPA-HQ-OPP-2007-0654-0001, 2007), http://www.epa.gov/PR_Notices/pr2007-2.htm.

  120. 120.

    7 U.S.C. § 136(u). The EPA defines PIP as “a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for [its] production.” 40 C.F.R. § 174.3.

  121. 121.

    7 U.S.C. § 136a(c)(5). Unreasonable adverse effects are defined at id. § 136(bb).

  122. 122.

    7 U.S.C. § 136c; 40 C.F.R. part 172. Some small-scale field tests do not require permits. 40 C.F.R. § 172.3; EPA, Notice 2007–2, supra note 119.

  123. 123.

    7 U.S.C. § 136c(b). A food tolerance is a legal limit on the maximum amount of a substance in or on a food.

  124. 124.

    PIPs, which are produced and used in living plants, are different from other pesticides, so PIPs present unique regulatory issues. The EPA planned to promulgate regulations with data requirements designed for PIPs, but those regulations had not been adopted by February 2015. EPA, Notification, 76 Fed. Reg. 14,358 (16 Mar. 2011) (Docket EPA-HQ-OPP-2009-0499, to amend 40 C.F.R. parts 152, 158, 174).

  125. 125.

    21 U.S.C. § 346a.

  126. 126.

    Until 1996, pesticide residues were considered food additives and subject to the Delaney Clause, 21 U.S.C. § 348(c)(3)(A), that prohibited approval of substances that contain carcinogens. They are now governed separately, id. § 346a.

  127. 127.

    21 U.S.C. § 346a(a)(1). Scientific data must support requests for tolerances or exemptions. See also EPA, Notice 2007–2, supra note 119, at 3, 6–7.

  128. 128.

    21 U.S.C. § 346a(b)(2)(A)(i). Safe means “a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” Id. § 346a(b)(2)(A)(ii).

  129. 129.

    Id. § 346a(c)(2)(A)(i),(ii).

  130. 130.

    Exemptions are codified 40 C.F.R. §§ 174.501–174.533 (2013).

  131. 131.

    FDA, Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. 22,984, 23,005 (29 May 1992) (FDA, 1992 Policy). The FDA has authority to regulate substances intended to enhance plant resistance to chemical herbicides (e.g., glyphosate).

  132. 132.

    Id. at 22,988.

  133. 133.

    Id. at 22,986–22,990, citing 21 U.S.C. § 342(a)(1). At the developer’s request, the FDA reviewed the Flavr Savr tomato (FDA Docket No 91A-0330) to determine whether it was as safe as other tomatoes and concluded that no significant safety differences existed. See FDA, Calgene, Inc; Availability of Letter Concluding Consultation, 59 Fed. Reg. 26,647 (23 May 1994).

  134. 134.

    See FDA, 1992 Policy, supra note 131, at 22,990.

  135. 135.

    Id. at 22,984–22,985. A National Academy of Sciences report agreed that a “policy to assess products based exclusively on their method of breeding is scientifically unjustified.” NAS, Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects, at 9 (NAS, Washington DC, 2004).

  136. 136.

    21 U.S.C. §§ 342, 348.

  137. 137.

    FDA, 1992 Policy, supra note 131, at 22,992 (referring to OECD and FAO/WHO documents). Substantial equivalence is a comparative approach, rather than a safety assessment.

  138. 138.

    Council for Biotechnology Information, Substantial Equivalence in Food Safety Assessment, at 1 (2001). In analyzing gene products, the first step is evaluation for allergenicity, acute toxicities, and major “compositional components.” If the protein is safe, the second step focuses on substantial equivalence.

  139. 139.

    For criticism, see Thomas O. McGarity, Seeds of Distrust: Federal Regulation of Genetically Modified Foods, 35 Univ. Mich. J.L. Reform 403, 426–432, 484 (2002).

  140. 140.

    FDA, Premarket Notice Concerning Bioengineered Foods, 66 Fed. Reg. 4706, 4711 (18 Jan. 2001). Because consultation is successful and protects public health, the FDA indicated that the rule may not be needed. U.S. Gov’t Accountability Office, Genetically Engineered Crops: Agencies Are Proposing Changes to Improve Oversight, But Could Take Additional Steps to Enhance Coordination and Monitoring, at 44 (GAO-09-60, 2008).

  141. 141.

    21 U.S.C. § 342(a) (defining adulterated food). Any substance that is not “an inherent constituent of food or whose level in food has been increased by human intervention” is “added” under 21 U.S.C. § 342(a)(1). FDA, 1992 Policy, supra note 131, at 22,989.

  142. 142.

    21 U.S.C. § 348(a). The Food Additives Amendment, enacted in 1958, did not address foods from new plant varieties, which had been regulated under § 342(a)(1).

  143. 143.

    21 C.F.R. § 170.3(i). See 21 U.S.C. § 348(b),(c) (requirements for petition and approval).

  144. 144.

    21 U.S.C. § 342(a)(2)(C). “The term ‘safe’ … has reference to the health of man or animal.” Id. § 321(u).

  145. 145.

    See Fred H. Degnan, The GRAS Concept: Ensuring Food Safety and Fostering Innovation, in FDA’s Creative Application of the Law: Not Merely a Collection of Words, at 15–35 (FDLI, Washington DC, 2006). The FDA has applied different interpretations to the GRAS provisions, but GRAS is considered “a tool capable of more flexibility, thus permitting realistic food safety decisions and fostering new technology and innovation.” Id. at 15.

  146. 146.

    The regulatory definition of GRAS, 21 C.F.R. § 170.30, reads in part:

    (a) General recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. … General recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food.

  147. 147.

    A food additive is a substance that is “not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures … to be safe under the conditions of its intended use.” 21 U.S.C. § 321(s).

  148. 148.

    FDA, 1992 Policy, supra note 131, at 22,989. The current GRAS list is published in 21 C.F.R. parts 182, 184, 186.

  149. 149.

    21 C.F.R. § 170.30(b). See Degnan, supra note 145, at 26–28 (reviewing litigation on the standard for GRAS determination).

  150. 150.

    FDA, 1992 Policy, supra note 131, at 22,990. The agency did not expect “any serious question about the GRAS status of transferred genetic material,” unless the substance (e.g., protein, carbohydrate, fat, oil) differed “significantly in structure, function, or composition from substances found currently in food.”

  151. 151.

    Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166, 177 (D. D.C. 2000), citing 21 C.F.R. § 170.30(a),(b).

  152. 152.

    See, e.g., Alison Peck, Leveling the Playing Field in GMO Risk Assessment: Importers, Exporters and the Limits of Science, 28 B.U. Int’l L.J. 241, 252–63 (2010).

  153. 153.

    See Thomas G. Neltner et al., Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe, JAMA Internal Med. (7 Aug. 2013), DOI:10.1001/jamainternmed. 2013.10559 (analyzing financial conflicts of interest and questioning the independence of GRAS determinations).

  154. 154.

    See 21 U.S.C. § 348; McGarity, supra note 139, at 455. See also 21 C.F.R. § 170.35 (voluntary petition for affirmation of GRAS status, to be replaced by notification).

  155. 155.

    FDA, Substances Generally Recognized as Safe, 62 Fed. Reg. 18,938 (17 Apr. 1997). Any person can notify the FDA of a claim that a particular use of a substance is exempt from premarket approval as GRAS.

  156. 156.

    See FDA, Guidance for Industry: Frequently Asked Questions about GRAS, Q 15 (2004). Since 1998, FDA received 550 GRAS notices. Although most notifiers received “no questions” letters, some notifiers withdrew GRAS notices, and other notices remain pending. FDA, GRAS Notice Inventory, http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.htm (last updated 31 Oct. 2014).

  157. 157.

    FDA, Substances Generally Recognized as Safe; Reopening of the Comment Period, 75 Fed. Reg. 81,536 (28 Dec. 2010); FDA, supra note 155.

  158. 158.

    Erica Seiguer & John J. Smith, Perception and Process at the Food and Drug Administration: Obligations and Trade-Offs in Rules and Guidances, 60 Food & Drug L.J. 17, 20 (2005).

  159. 159.

    FDA, 1992 Policy, supra note 131, at 22,991.

  160. 160.

    FDA, Guidance on Consultation Procedures – Food Derived from New Plant Varieties (1997), http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Biotechnology/ucm096126.htm.

  161. 161.

    See FDA, Notice, Agency Information Collection Activities, 76 Fed. Reg. 9,020 (16 Feb. 2011). The form is FDA 3665, available on the FDA website.

  162. 162.

    See FDA, Completed Consultations on Bioengineered Foods (updated 28 Nov. 2014), http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=bioListing.

  163. 163.

    FDA, Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use, at parts II, III.C. (2006), http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatory Information/Biotechnology/ucm096156.htm. As discussed above, the EPA regulates PIPs.

  164. 164.

    Id. part III.C.3. See FDA, Inventory of New Protein Consultations (updated 27 Mar. 2013), http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/Submissions/ucm222595.htm.

  165. 165.

    For information about European restrictions, see GMO-free Europe, http://www.gmo-free-regions.org/.

  166. 166.

    To protect intellectual property (a subject beyond the scope of this report), seed developers prohibit saving and replanting seeds. Bowman v. Monsanto Co., 569 U.S. __, 133 S. Ct. 1761 (2013) (without permission of the patent holder, a farmer cannot reproduce patented seeds by planting and harvesting).

  167. 167.

    See US HHS, USDA, USEPA, Memorandum of Understanding (Doc. 10-2000-0058-MU, 2011), http://www.epa.gov/opp00001/biopesticides/pips/biotech-mou.pdf.

  168. 168.

    See Margaret Rosso Grossman, Genetically Modified Crops and Food in the United States: The Federal Regulatory Framework, State Measures, and Liability in Tort, in Luc Bodiguel & Michael Cardwell, eds., The Regulation of Genetically Modified Organisms: Comparative Approach, at 299, 317–321 (OUP, Oxford, 2010). For a list of state biotechnology laws, see National Conference of State Legislatures, State Biotech Statutes (2011), http://www.ncsl.org/research/agriculture-and-rural-development/state-biotech-statutes.aspx.

  169. 169.

    E.g., Michigan Organic Products Act of 2000, Mich. Comp. Laws § 286.907(d) (excluding use of GM organisms from definition of organic agriculture). On federal restrictions, see supra text accompanying notes 17–21.

  170. 170.

    California A.B. 504, Chap. 444, Statutes of 2014, codified in the Cal. Fish & Game Code, chap. 3, div. 3. Researchers could grow GE fish in closed systems (tanks).

  171. 171.

    Cal. Food & Ag. Code §§ 55000–55123; see § 55009 (characteristics of commercial impact); §§ 55080–55083 (commercial impact rice).

  172. 172.

    Id. §§ 55052, 55051, 55040.

  173. 173.

    Ark. Code Ann. §§ 2-15-201 to -208; see § 2-15-204(b)(1).

  174. 174.

    Id. § 2-15-205(a). On the California and Arkansas laws, see Thomas P. Redick & Donald L. Uchtmann, Coexistence Through Contracts: Export-Oriented Stewardship in Agricultural Biotechnology vs. California’s Precautionary Containment, 13 Drake J. Agric. L. 207, 227–229 (2008).

  175. 175.

    Mo. Rev. Stat. § 261.256 (2012).

  176. 176.

    Id. § 261.259.

  177. 177.

    Redick & Uchtmann, supra note 174, at 238. By 2008, no district had been created,

  178. 178.

    AgrEvo LLRice 06, LLRice 62. See USDA, Petitions for Determination of Nonregulated Status, http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml.

  179. 179.

    Redick & Uchtmann, supra note 174, at 229, 232–33. LL601, similar to varieties already approved, was deregulated in 2006, 71 Fed. Reg. 70,360 (4 Dec. 2006). On the Bayer incident, see infra notes 272–276.

  180. 180.

    Brassica Seed Production Districts, Wash. Admin. Code §§ 16-326-010 to 16-326-060 (2012).

  181. 181.

    Idaho Admin. Code 02.06.13, authorized by Idaho Code § 22-108(2). Oregon also authorizes canola control areas. Or. Rev. Stat. §§ 570.405, 570.450 and Senate Bill 207 (introduced, Jan. 2015).

  182. 182.

    See e.g., Marin County, CA Code, ch. 6.92, Prohibition of Growing of Genetically Modified Crops (passed, 2004) (making cultivation of GM organisms a public nuisance).

  183. 183.

    Redick & Uchtmann, supra note 174, at 229–231.

  184. 184.

    McHughen, supra note 23, at 1109.

  185. 185.

    Jackson County, Oregon, The Genetically Engineered Plant Ordinance (chap. 635, 2013). Josephine County, Oregon also approved a ban, but a state law (Or. Rev. Stat. § 633.738 (2013), enacted after Jackson County’s ban was on the ballot) preempts local governments from governing GM crops. Farmers who produce GM alfalfa have challenged the ordinance. Schulz Family Farms LLC v. Jackson County, Case 1:2014cv01975 (D. Ct. Ore.).

  186. 186.

    Kauai County, Hawaii Ordinance 960; Maui County, Hawaii, Ballot Initiative (Nov. 2014), codified at Maui County Code, chap. 20.39. Kauai has appealed to the 9th Circuit. The same judge has also invalidated the restriction on GM crops on the Big Island (Hawaii County Ordinance 13–121). Jennifer Sinco Kelleher, Federal judge rules against Big Island GMO law, Washington Times, 26 Nov. 2014.

  187. 187.

    FDCA, supra note 117. The discussion of labeling is adapted in part from a book chapter to be published in Italy.

  188. 188.

    21 C.F.R. part 101, Food Labeling.

  189. 189.

    FDA, 1992 Policy, supra note 131, at 22,991.

  190. 190.

    21 U.S.C. § 343(a).

  191. 191.

    Id. § 321(n).

  192. 192.

    FDA, 1992 Policy, supra note 131, at 22,991.

  193. 193.

    Legal commentators suggest that Congress should require GM food to be labeled. See, e.g., Margaret Sova McCabe, Superweeds and Suspect Seeds: Does the Genetically-Engineered Crop Deregulation Process Put American Agriculture at Risk?, 1 U. Balt. J. Land & Dev. 109, 153–54 (2012); Debra M. Strauss, The Role of Courts, Agencies, and Congress in GMOs: A Multilateral Approach to Ensuring the Safety of the Food Supply, 48 Idaho L. Rev. 267, 315 (2012).

  194. 194.

    Alliance for Bio-Integrity, supra note 151, at 179.

  195. 195.

    Id. at 178.

  196. 196.

    Id. at 179.

  197. 197.

    FDA, Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Draft Guidance (2001), http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm059098.htm.

  198. 198.

    Id. (all quotations).

  199. 199.

    See Council for Agricultural Science and Technology (CAST), The Potential Impacts of Mandatory Labeling for Genetically Engineered Food in the United States (Issue Paper 54, CAST, Ames, Iowa, 2014) (analyzing legal and economic implications of mandatory labeling and recommending against mandatory labeling).

  200. 200.

    American Medical Assoc., Policy H-480.958: Bioengineered (Genetically Engineered) Crops and Foods (June 2012) (all quotations). But see American Public Health Association, Policy Statement 2001–11, 92(3) Am. J. Pub. Health 451, 463 (2002) (“any food product containing genetically modified organisms [should] be so labeled”).

  201. 201.

    AAAS, Statement by the AAAS Board of Directors on Labeling of Genetically Modified Foods (2012), http://www.aaas.org/news/releases/2012/media/AAAS_GM_statement.pdf. The AAAS statement engendered controversy and disagreement. See also Editorial, Fight the GM Food Scare, supra note 90.

  202. 202.

    Cass Sunstein, Don’t Mandate Labeling for Gene-Altered Foods, Bloomberg, 12 May 2013. See Gary E. Marchant & Guy A. Cardineau, The labeling debate in the United States, 4(3) GM Crops & Food: Biotec. Agric. & Food Chain 126,133 (2013): “The GM labeling debate is one of the most important battlefields in the country pitting science- and evidence-based public policy against a populist social movement funded and manipulated by pseudoscientific, unaccountable and self-interested forces.”

  203. 203.

    IFIC, 2014, supra note 29.

  204. 204.

    Id. Of millennials (ages 18–34), 39 % wanted additional information; 37 % wanted nutritional information, and 22 % wanted information about biotechnology.

  205. 205.

    Allison Kopicki, Strong Support for Labeling Modified Foods, NY Times, 27 July 2013.

  206. 206.

    Hallman et al., supra note 25, at 4. The 7 % response was to the question, “What information would you like to see on food labels that is not already there?”

  207. 207.

    Genetically Engineered Food Right-to-Know Act, S. 809 & H.R. 1699, 113th Congress; Safe and Accurate Food Labeling Act of 2014, H.R. 4432, https://www.congress.gov/bill/113th-congress/house-bill/4432

  208. 208.

    The 2014 bill would have required premarket biotechnology notification before a GM food is introduced into interstate commerce. Both soybean and corn growers supported the 2014 bill, because it would “protect consumers and ensure the safety of food ingredients using solid science-based information by providing a consistent, informative GMO labeling solution that eliminates confusion and advances food safety.” Press Release, National Corn Growers Association NCGA Announces Support [for] Federal GMO Labeling Legislation (9 Apr. 2014).

  209. 209.

    FDA, Docket FDA-2011-P-0723-0001, http://www.regulations.gov. The FDA received comments on the petition, but had not responded by February 2015. In January 2014, 2000 food groups and others wrote to the President, demanding labels for GM foods.

  210. 210.

    E.g., Vt. Stat. Online, tit. 6, §§ 611(c), 644(a)(4). Virginia’s requirement, Va. Code § 3.1-275.4, was repealed in 2008.

  211. 211.

    Alaska Stat. § 17.20.040(a)(14) (GM fish are misbranded unless conspicuously labeled).

  212. 212.

    Me. Rev. Stat. tit 7 § 530-A (effective 1 Jan. 2002).

  213. 213.

    Right to Know GMO, State Map, http://www.righttoknow-gmo.org/states (map with links to information about state legislation). For the status of GM labeling initiatives in various states, see CAST, supra note 199, at 11–13.

  214. 214.

    E.g., California SB 1381; New Hampshire HB 660, http://legiscan.com/NH/bill/HB660/20134.

  215. 215.

    William Lesser, Costs of Labeling Genetically Modified Food Products in N.Y. State (2014), http://dyson.cornell.edu/people/profiles/docs/LabelingNY.pdf.

  216. 216.

    Pub. L. 13–183, effective 1 Oct. 2013, http://www.cga.ct.gov/2013/ACT/pa/pdf/2013PA-00183-R00HB-06527-PA.pdf.

  217. 217.

    Id. § 3.

  218. 218.

    Id. § 1.

  219. 219.

    LD 718, 126th Maine Legislature, codified as Me. Rev. Stat. tit. 22, chap. 565.

  220. 220.

    Act 120, codified at Vt. Stat. Ann. tit.9, chap. 82A. In October 2014, the state asked for public comment on draft rules to implement the law. The attorney general was to recommend whether milk or milk products must be labeled under the law. See International Dairy Foods Association v Amestoy, 92 F.3d 67 (2d Cir. 1996).

  221. 221.

    Grocery Mfrs Ass’n v. Sorrell, No. 5:14-CV-117 (D. Vt.).

  222. 222.

    Lester M. Crawford, FDA Deputy Commissioner, Letter to Oregon Governor John A. Kitzhaber, 4 Oct. 2002, http://www.bio.org/sites/default/files/Kitzhaber_0.pdf.

  223. 223.

    The California Constitution, art. II, § 8, allows ballot initiatives under which the people of the state enact laws. The text of Proposition 37 is available in Text of Proposed Laws 110, http://vig.cdn.sos.ca.gov/2012/general/pdf/text-proposed-laws-v2.pdf (2012).

  224. 224.

    Washington, Initiative Measure No. 522 (filed June 29, 2012), http://sos.wa.gov/_assets/elections/initiatives/FinalText_285.pdf.

  225. 225.

    Colorado, Proposition 105 (filed Nov. 22, 2013) (70 % of voters opposed), http://www.sos.state.co.us/pubs/elections/Initiatives/titleBoard/filings/2013-2014/48Final.pdf; Oregon, Measure 92 (filed 3 Jan 2014), http://ballotpedia.org/Oregon_Mandatory_Labeling_of_GMOs_Initiative,_Measure_92_(2014),_Full_text_of_measure.

  226. 226.

    See Margaret Rosso Grossman, California Proposition 37: Voters Reject Mandatory Labeling of GM Food, 8(1) Eur. Food & Feed L. Rev. 73 (2013). See generally Laura Murphy et al., More than Curiosity: The Constitutionality of State Labeling Requirements for Genetically Engineered Foods, 37 Vt. L. Rev. 477–553 (2013) (drawn from a memorandum to support GM labeling legislation in Vermont).

  227. 227.

    U.S. Const. amend. X: “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.”

  228. 228.

    State labeling laws may affect international trade and may violate WTO Agreements. For a detailed analysis see Drew L. Kershen, Would State-Mandated Labels for Biotech Foods Violate World Trade Agreements? (Washington Legal Foundation, 2012).

  229. 229.

    U.S. Const. art. I, § 8, cl. 3.

  230. 230.

    Pike v. Bruce Church, Inc., 397 U.S. 137, 142 (1970). See John S. Harbison, The War on GMOs: A Report from the Front, at 13–16 (2004), link from http://www.NationalAgLawCenter.org.

  231. 231.

    U.S. Const. amend. I: “Congress shall make no law … abridging the freedom of speech.” See generally Pamela A. Vesilind, Emerging Constitutional Threats to Food Labeling Reform, 17 Nexus: Chap. J. L. & Pol’y 5 (2012).

  232. 232.

    States can regulate misleading commercial speech or speech that concerns unlawful activity. Central Hudson Gas & Elec. Corp. v. Public Serv. Comm’n, 447 U.S. 557, 566 (1980). The prohibition of claims that GE foods are natural, as in the Connecticut and Maine laws, may violate the First Amendment. See Lauren Handel, Labeling of Genetically Engineered Foods: A Constitutional Analysis of California’s Proposition 37, at 4–7 (2012), http://ssrn.com/abstract=2169440.

  233. 233.

    Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985).

  234. 234.

    Amestoy, supra note 220.

  235. 235.

    Id. at 73, 74.

  236. 236.

    Zauderer, supra note 233, at 651. See Handel, supra note 232, at 7–10.

  237. 237.

    U.S. Const. art. VI, cl. 2: “This Constitution, and the Laws of the United States … shall be the supreme Law of the Land.”

  238. 238.

    Handel, supra note 232, at 10–13 (analyzing preemption provisions that apply to FDA and USDA regulation).

  239. 239.

    21 U.S.C. § 343–1 (preempting some types of labeling required by 21 U.S.C. § 343).

  240. 240.

    E.g., GM canola oil, for which FDA labeling standards exist. See Briseno v. ConAgra Foods, Inc., 2011 U.S. Dist. Lexis 154750 (C.D. Cal.) (dismissing plaintiff’s demand for disclosure of GM ingredients in canola labeled “100 % Natural”).

    The National Corn Growers Association opposes state labeling mandates and supports “FDA having federal preemption of individual state labeling laws.” NCGA, Biotechnology, in 2013 Policy and Position Papers 8, 10 (No. 1-A-1, 2013).

  241. 241.

    Federal Meat Inspection Act, 21 U.S.C. §§ 601–692, at § 678; Poultry Products Inspection Act, 21 U.S.C. §§ 451–471, at § 467e.

  242. 242.

    FDA, Food Labeling: Nutrient Content Claims, 58 Fed. Reg. 2302, 2407 (6 Jan. 1993). See also id. at 2397: “FDA has decided not to define the term ‘natural’ or to prohibit its use.” See Erik Benny, Essay, “Natural” Modifications: The FDA’s Need to Promulgate an Official Definition of “Natural” that Includes Genetically Modified Organisms, 80 Geo. Wash. L. Rev. 1504, 1521–1525 (2012) (asserting that GM food meets FDA’s informal definition of natural, because it has no synthetic or artificial ingredients).

    The USDA has a policy on use of the term natural on labels for meat and poultry. An applicant for labeling must show that the product does not contain artificial or synthetic ingredients and that the product and its ingredients are “not more than minimally processed.” FSIS, USDA, Food Standards and Labeling Policy Book, at 116 (2005).

  243. 243.

    Holk v. Snapple Beverage Corp., 575 F.3d 329, 342 (3d Cir. 2009) (holding that state consumer fraud class action challenging “all natural” for beverages made with high fructose corn syrup is not preempted).

  244. 244.

    E.g., a California district court issued an order that preliminarily certified a $4 million settlement in a case involving snack items, cereals, and other foods marked “all natural” but containing GM, artificial, and synthetic ingredients. Trammell v. Barbara’s Bakery, Inc., No. 12–2664 (N.D. Cal., 26 June 2013). A $9 million settlement resolved five class action suits concerning juice with GM ingredients. Pappas v. Naked Juice Co., No. LA CV 11-08276-JAK (PLAx) (C.D. Cal., 7 Aug. 2013). See http://www.nakedjuiceclass.com. Parties have settled other cases.

  245. 245.

    E.g., In re Wesson Oil Marketing and Sales Practices Litigation, 818 F. Supp. 2d 1383 (J.P.M.L. 2011) (consolidating six cases); In re Conagra Foods, Inc., 2013 WL 4259467 (C.D. Cal.) (denying stay pending outcome of referral to FDA).

  246. 246.

    Krzykwa v. Campbell Soup Co., 2013 WL 2319330 (S.D. Fla.).

  247. 247.

    E.g., Cox v. Gruma Corp., 2013 WL 3828800 (N.D. Cal.). The Organic Consumers Association petitioned the FDA to prohibit the use of the term natural for products with GM ingredients. Press Release, Organic Consumers Association, OCA Asks FDA to Prohibit Use of the Word ‘Natural’ in Products Containing GMOs (14 Aug. 2013), link from http://www.organicconsumers.org. The Grocery Manufacturers Association planned to petition the FDA to allow GM foods to be labeled natural. Letter from Karin F.R. Moore, GMA, to Elizabeth H. Dickinson, FDA, 5 Dec. 2013; Stephanie Strom, Group Seeks Special Label for Food: ‘Natural,’ NY Times, 19 Dec. 2013.

  248. 248.

    Letter from Leslie Kux, FDA Assistant Commissioner for Policy, to the Honorable Yvonne Gonzalez Rogers et al., 6 Jan. 2014.

  249. 249.

    Cookson Beecher, Whole Foods to Require Labeling of GM Foods, Food Safety News, 15 Mar. 2013, http//www.foodsafetynews.com.

  250. 250.

    Version 11 of the Standard (ratified May 2014) is at http://www.nongmoproject.org/wp-content/uploads/2014/06/Non-GMO-Project-Standard-v11.pdf. Since 2010, the Non-GMO Project has certified almost 25,000 products See Stephanie Strom, Many G.M.O.-Free Labels, Little Clarity Over Rules, N.Y. Times, 30 Jan. 2015.

  251. 251.

    Stephanie Strom, U.S. Approves a Label for Meat From Animals Fed a Diet Free of Gene-Modified Products, N.Y. Times, 20 June 2013.

  252. 252.

    Chipotle, Ingredients Statement, GMOs, link from http://www.chipotle.com (“Our goal is to eliminate GMOs from Chipotle’s ingredients.”).

  253. 253.

    Chuck Jolley, McDonald’s says No to GMOs (19 Nov. 2014) link from http://feedstuffsfoodlink.com. USDA authorized the potato, developed by J.R. Simplot, in 2014.

  254. 254.

    This discussion does not consider cases (e.g., alfalfa, bentgrass) that allege failure of USDA to prepare an environmental impact statement under the National Environmental Policy Act. See supra note 114.

  255. 255.

    See Debra M. Strauss, Liability for Genetically Modified Food: Are GMOs a Tort Waiting to Happen?, SciTech Law. 8, 9 (Fall 2012) (discussing Monsanto’s patent infringement cases).

  256. 256.

    Damage from cross-pollination is not theoretical. “The scientific evidence of the propensity of GM genes to wander – and to wander further than initially thought – is piling up.” Jane Matthews Glenn, Footloose: Civil Responsibility for GMO Gene Wandering in Canada, 43 Washburn L.J. 547, 547 (2004).

  257. 257.

    See Grossman, supra note 168, at 330–331.

  258. 258.

    E.g., In re StarLink Corn Prods. Liab. Litig., 212 F. Supp. 2d 828 (N.D. Ill. 2002).

  259. 259.

    For more detailed discussion, see Grossman, supra note 168, at 321–331. See also Paul J. Heald & James Charles Smith, The Problem of Social Cost in a Genetically Modified Age, 58 Hastings L.J. 87 (2006). See also In re StarLink Corn Prods., supra note 258.

  260. 260.

    A nuisance is an activity or condition that is harmful, annoying, offensive, unpleasant, disagreeable, or inconvenient to another. Restatement (Second) of Torts § 821A cmt. b (1979).

  261. 261.

    Id. § 822 cmts. c & d.

  262. 262.

    Zygmunt J.B. Plater et al., Environmental Law and Policy: Nature, Law, and Society, at 75 (4th ed. 2010).

  263. 263.

    For a detailed discussion, see Margaret Rosso Grossman, Anticipatory Nuisance and the Prevention of Environmental Harm and Economic Loss from GMOs in the United States, 18 J. Envtl L. & Prac. 107–167 (2008).

  264. 264.

    Drew L. Kershen, Legal Liability Issues in Agricultural Biotechnology, 10 Envtl Liab. 203, 205–207 (2002). Trespass by GM pollen may not meet an old requirement of a “direct and immediate” invasion because of the passage of time (pollination occurs long after planting) and the intervening force of wind. Heald & Smith, supra note 259, at 135.

  265. 265.

    See Kershen, supra note 264, at 208–210, for a discussion of negligence.

  266. 266.

    Restatement (Second) of Torts § 520 & cmt. f (1977).

  267. 267.

    American Soybean Association, Policy Resolution on Biotechnology Approvals and Minimum Requirement for Attempted Identity-Preserved Production, Harvesting, and Utilization of Biotechnology-enhanced Varieties/Hybrids that are Unapproved for Export to Major Markets (2000).

  268. 268.

    NCGA, Know Before You Grow (2013), http://www.ncga.com/for-farmers/know-before-you-grow/trait-table (listing GM corn varieties and their approval status in the EU and Japan). See also NCGA, Biotechnology, supra note 240.

  269. 269.

    212 F. Supp. 2d 828 (N.D. Ill. 2002).

  270. 270.

    Aventis voluntarily cancelled the registration for StarLink. Aventis formed a corporation to monitor corn to contain the GM protein; these efforts succeeded, and monitoring ended in 2008. US EPA, White Paper Concerning Dietary Exposure to Cry9c Protein Produced by StarLink Corn and the Potential Risks Associated with Such Exposure (2008). For more detail see Grossman, supra note 168, at 331–333.

  271. 271.

    Federation of American Scientists, The Prodigene Incident, http://www.fas.org/biosecurity/education/dualuse-agriculture/2.-agricultural-biotechnology/prodigene-incident.html.

  272. 272.

    The USDA deregulated the rice, but farmers and others had already suffered damages. APHIS, Notice, 71 Fed. Reg. 70,360 (4 Dec. 2006).

  273. 273.

    Joe Whittington & Andrew M. Harris, Bayer Must Pay Farmers for Contaminated Rice Crop, Bloomberg, 4 Dec. 2009. The judge had granted defendant Bayer’s motion for summary judgment on public nuisance, negligence per se, and other claims, but held that the economic loss doctrine did not bar plaintiffs’ tort claims. In re Genetically Modified Rice Litigation, 666 F. Supp. 2d 1004, 1015–1017 (E.D. Mo. 2009) (motions for summary judgment).

  274. 274.

    E.g., Ruling compensates farmers for GM rice contamination, Greenwire, Feb. 8, 2010; Jury Tells Bayer to Pay Ark. Rice Farmers $48 M, Bloomberg, 15 Apr. 2010.

  275. 275.

    In re Genetically Modified Rice Litigation, 2010 WL 716190 (E.D. Mo. 2010) (memorandum and order concerning proposed trust fund).

  276. 276.

    Andrew Harris & David Beasley, Bayer Agrees to Pay $750 Million to End Lawsuits Over Gene-Modified Rice, Bloomberg, 1 July 2011.

  277. 277.

    Press Release, USDA, Update on the Detection of Genetically Engineered (GE) Glyphosate-Resistant Wheat Plants (29 July 2013). In September 2013, a low level of GM alfalfa was discovered in a Washington farmer’s non-GM alfalfa. USDA planned no government action, calling the contamination a “commercial issue.” Carey Gillam, USDA will not take action in case of GMO alfalfa contamination, Reuters, 17 Sept. 2013.

  278. 278.

    E.g., Center for Food Safety v. Monsanto, No. 13–213 (E.D. Wash., filed 5 June 2013). See http://www.centerforfoodsafety.org.

  279. 279.

    Agrisure Viptera was approved in China in December 2014. See Syngenta’s website, http://www.syngenta-us.com/Agrisure/agrisure-viptera.aspx.

  280. 280.

    David Pitt, Farmers File More Than 360 Corn Lawsuits Against Syngenta, Associated Press, 6 Feb. 2015, http://abcnews.go.com/US/wireStory/farmers-file-360-corn-lawsuits-syngenta-28777413. Farmers who did not plant Viptera, but whose corn could not be exported to China, sued, as did large exporting companies.

  281. 281.

    Transfer Order, In Re Syngenta AG MIR 162 Corn Litigation – MDL No. 2591 (11 Dec. 2014).

  282. 282.

    Lara Khoury & Stuart Smyth, Reasonable Foreseeability and Liability in Relation to Genetically Modified Organisms, 27 Bul. Sci. Tech. & Soc. 215, 221 (2007). Harms to human health have not been identified.

  283. 283.

    Cases involving GM components of foods labeled “natural” have already raised the fraud issue. See supra text accompanying notes 242–248.

  284. 284.

    N.V. Federoff et al., Radically Rethinking Agriculture for the 21st Century, 327 Sci. 833 (12 Feb. 2010).

  285. 285.

    Id. at 833.

  286. 286.

    Chicago Council, supra note 56, at 11 (defining sustainable intensification as agriculture that is “productive, sustainable, nutritious, and resilient to setbacks”).

  287. 287.

    Id. at 26. Private-sector biotechnology research is unlikely to develop crops that do not offer significant profit.

  288. 288.

    Id. at 5.

  289. 289.

    See Judith A. Chambers, et al., GM Agricultural Technologies for Africa: A State of Affairs (African Development Bank & IFPRI, 2014) (recognizing the potential of GM technology for Africa, but raising critical issues including capacity, regulatory policy, intellectual property rights, trade and markets, and environmental issues).

  290. 290.

    Christopher J.M. Whitty et al., Africa and Asia need a rational debate on GM crops, 497 Nature 31, 32 (2 May 2013). See generally Hossein Azadi & Peter Ho, Genetically modified and organic crops in developing countries: A review of options for food security, 28 Biotechnology Advances 160, 166 (2010).

  291. 291.

    Sven Ove Hanson & Karin Joelsson, Crop Biotechnology for the Environment?, 26 J. Agric. Envtl Ethics 759, 767 (2013): “Therefore, today, the issue is no longer yes or no to crop biotechnology, but what direction it should take.” Id.

  292. 292.

    Whitty et al., supra note 290, at 33. See the recommendation of Federoff & Kershen, supra note 75, at 875:

    If modern science is to contribute to the agricultural productivity increases required in coming decades as the climate warms and the human population continues to grow, it is imperative to get beyond the cultural and political biases against molecular crop modification, acknowledge the safety record of GM crops, and ease the regulatory barriers to their development and deployment.

  293. 293.

    Federoff et al., supra note 284, at 833. See also Alessandro Nicolia et al., An overview of the last 10 years of genetically engineered crop safety research, Critical Rev. in Biotec. (2013), DOI: 10.3109/07388551.2013.823595: “The scientific research conducted so far has not detected any significant hazards directly connected with the use of GE crops.”

  294. 294.

    Federoff et al., supra note 284, at 833. (recommending assessment of data on GM crop safety and reevaluation of the existing regulatory framework in the United States). See also EASAC, supra note 4, at 2 (2013): “The [European Union] regulatory framework must be reformulated appropriately to be science-based, transparent, proportionate and predictable, taking into account the extensive experience gained and good practice implemented worldwide.” The EU chief scientist endorsed the conclusions of the EASAC report, a joint statement of EU scientific academies. EU chief scientist: ‘It is unethical not to use GM technology,’ EurActiv, 26 Sept. 2013, http://www.euractiv.com.

  295. 295.

    Federoff et al., supra note 284, at 834.

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    Margaret Rosso Grossman

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    Roland Norer

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Grossman, M.R. (2016). Genetic Technology and Food Security: A View from the United States. In: Norer, R. (eds) Genetic Technology and Food Safety. Ius Comparatum - Global Studies in Comparative Law, vol 14. Springer, Cham. https://doi.org/10.1007/978-3-319-23995-8_9

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