KEEPING CONSUMERS IN THE DARK: HOW THE NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARD THREATENS TRANSPARENCY AND FOOD SECURITY

KEEPING CONSUMERS IN THE DARK: HOW THE NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARD THREATENS TRANSPARENCY AND FOOD SECURITY Robin M. Nagele* ABSTRACT: In July 2016, President Barack Obama signed the National Bioengineered Food Disclosure Standard into law. The law creates national labeling standards for genetically engineered foods in an effort to inform consumers, advance food safety, and eliminate a patchwork of state labeling laws. However, because of the law s failure to create clear disclosure requirements, it will be largely ineffective at informing consumers about whether a food contains genetically engineered ingredients, and will shift the costs of the labeling system to consumers who are comfortable purchasing food with genetically engineered ingredients. This comment argues that the National Bioengineered Food Disclosure Standard creates a labeling system for genetically engineered foods that is counterproductive to transparency and equity in the food system, and that a voluntary labeling system is the only way to facilitate transparency and preserve access to a safe and affordable food supply. CITATION: Robin M. Nagele, Comment, How the National Bioengineered Food Disclosure Standard Threatens Transparency and Food Security, 57 Jurimetrics J. 529 554 (2017). In July 2016, President Barack Obama signed the National Bioengineered Food Disclosure Standard into law. 1 The standard creates national labeling criteria for genetically engineered foods 2 in an effort to inform consumers, advance food safety, and eliminate a patchwork of state labeling laws. 3 However, because of the standard s failure to specify clear disclosure requirements, it will be largely ineffective at informing consumers about whether a food contains genetically engineered ingredients. Moreover, the standard shifts the costs of the labeling system to consumers who are comfortable purchasing food with *J.D. Candidate, Sandra Day O Connor College of Law at Arizona State University; B.S., 2011, Animal Science & Agribusiness, Cal Poly San Luis Obispo. The author would like to thank Professor Tamara Herrera for her invaluable input and mentorship in writing this comment. 1. Brandon R. McFadden, The Unknowns and Possible Implications of Mandatory Labeling, 35 TRENDS BIOTECHNOLOGY 1, 1 (2017). 2. National Bioengineered Food Disclosure Standard, Pub. L. No. 114-216, 130 Stat. 834 (2016) (to be codified at 7 U.S.C. 1639). 3. See McFadden, supra note 1, at 1 2. SUMMER 2017 529

Nagele genetically engineered ingredients, and preempts many more effective and popular state labeling laws. 4 This comment argues that a mandatory labeling system for genetically engineered foods is counterproductive to transparency, reliability, and equity in the food system. Part I discusses the development of genetic engineering of food and the prevalence of genetically engineered foods in our food system. Part II explores the regulation of genetically engineered foods in the United States and analyzes the strengths and weaknesses of the National Bioengineered Food Disclosure Standard. Part III considers the utility of mandatory labeling systems in general and the standard s mandatory labeling requirement for genetically engineered foods specifically, ultimately arguing that a voluntary labeling system for genetically engineered foods is the only way to facilitate transparency with respect to genetically engineered foods while ensuring adequate access to a safe and affordable food supply. I. DEVELOPMENT AND REGULATION OF GENETICALLY ENGINEERED FOODS Humans began to use genetic modification to produce desired traits in plants and animals used for food thousands of years ago. 5 To emphasize certain attributes in plants, ancient farmers influenced the genetic material of organisms through selective breeding and artificial selection. 6 This involved choosing organisms with desirable traits and mating them to combine or propagate those traits in the plant s offspring. 7 Repeated use of selection over time produced genetic changes that yielded more productive, reliable crops. 8 Thus, human intervention in the form of genetic modification, in addition to other natural forces, has created food species that are genetically distinct from their ancestors. 9 4. Alan Bjerga & Angela Greiling Keane, Obama Ready to Sign Food-Label Bill Consumer Groups Dislike, BLOOMBERG POL. (July 13, 2016, 7:52 AM), http://www.bloomberg.com/politics/ articles/2016-07-13/obama-ready-to-sign-food-label-bill-consumer-groups-find-suspect [https://web. archive.org/web/20170521115353/https://www.bloomberg.com/politics/articles/2016-07-13/obamaready-to-sign-food-label-bill-consumer-groups-find-suspect]. 5. COMM. ON IDENTIFYING & ASSESSING UNINTENDED EFFECTS OF GENETICALLY ENGINEERED FOODS ON HUMAN HEALTH, INST. OF MED. & NAT L RESEARCH COUNCIL OF THE NAT L ACADS., SAFETY OF GENETICALLY ENGINEERED FOODS: APPROACHES TO ASSESSING UNINTENDED HEALTH EFFECTS 23 (2004) [hereinafter NAT L RESEARCH COUNCIL]. 6. Gabriel Rangel, From Corgis to Corn: A Brief Look at the Long History of GMO Technology, SCI. NEWS (Aug. 9, 2015), http://sitn.hms.harvard.edu/flash/2015/from-corgis-to-corna-brief-look-at-the-long-history-of-gmo-technology/. 7. Id. 8. Id. 9. Cf. NAT L RESEARCH COUNCIL, supra note 5, at 23 (suggesting that natural evolutionary changes have also played a part in the genetic diversity of modern food). 530 57 JURIMETRICS

Keeping Consumers In the Dark One of the earliest examples of genetic modification through artificial selection involves maize. 10 About 10,000 years ago, teosinte, the ancient forebear of modern maize, grew in what is now Mexico. 11 Unlike modern maize, teosinte was a tall grass that produced small ears with few kernels. Ancient farmers discovered that some teosinte stalks produced larger ears with more kernels, and they began to save the kernels from those plants and replant them. 12 Over time, the less productive teosinte evolved into the more productive modern maize. Today, maize crops produce large ears with many rows of kernels. 13 Traditional genetic modification through breeding and selection the method ancient farmers used to cultivate maize from teosinte is imprecise and inefficient; it can take many years to produce crops with a certain desirable trait on a large scale. 14 Accordingly, scientists have developed more efficient processes of altering plant and animal genetics that involve modern technologies. 15 Modern genetic modification involves transforming species by inserting one or more genes from a plant 16 that possesses a desirable characteristic into another plant. 17 Many types of genetic modification, including selection, crossing, interspecies, embryo rescue, somatic hybridization, somaclonal variation, cell selection, and mutation breeding therefore do not involve recombinant DNA (rdna) technology. 18 However, modification techniques that use rdna technologies have become increasingly common because they have the potential to be extremely precise, successful, and introduce fewer unintended mutations. 19 These techniques use rdna technology to create a targeted change in a plant or animal 10. Genetic Sci. Learning Ctr., Evolution of Corn, LEARN.GENETICS, http://learn.genetics. utah.edu/content/selection/corn/ (last visited Dec. 21, 2016). 11. Id. 12. Id. 13. Id. 14. Stella G. Uzogara, The Impact of Genetic Modification of Human Foods in the 21st Century: A Review, 18 BIOTECHNOLOGY ADVANCES 179, 183 (2000). 15. Rangel, supra note 6. 16. While both plants and animals may be genetically modified, the term genetically modified foods generally refers to crop plants created for human or animal consumption using these technologies. Sirkku K. Hellsten, Genetic Modification (GMOs): Food, in ENCYCLOPEDIA OF GLOBAL BIOETHICS 1368, 1369 (Henk ten Have ed., 2016). This paper will largely discuss genetic modification of plants and will not focus on genetic modification of animals. 17. Stephanie Amaru, A Natural Compromise: A Moderate Solution to the GMO & Natural Labeling Disputes, 69 FOOD & DRUG L.J. 575, 575 (2014). 18. NAT L RESEARCH COUNCIL, supra note 5, at 23 28 (defining selection as discarding seeds from unfavorable plants and sowing seeds from superior plants; crossing as brushing pollens of plants on sexually compatible plants; interspecies crossing as transfer of small pieces of DNA from one plant to another; embryo rescue as transfer of hybrid genes to a recipient species; somatic hybridization as fusion of cells to combine genetic material from two plant sources; somaclonal variation as growing plants in vitro for potentially valuable traits; cell selection as isolating certain superior cells, growing them in cultures, and inserting into plants; and mutation breeding as exposing plants or seeds to mutations to introduce changes in DNA sequences). 19. Id. at 28. SUMMER 2017 531

Nagele gene sequence and are often categorized as genetically engineered, a specific type of genetic modification. 20 Crops produced using modern genetic engineering technology became commercially available in the United States for the first time in 1996. 21 Initially, genetically engineered corn, cotton, and soybeans represented a small fraction of the total acres planted of each of those crops. 22 Now, genetically engineered varieties constitute the vast majority of corn, cotton, and soybeans grown in the United States. 23 In fact, ninety-four percent of soybeans, eighty-nine percent of corn, and eighty-nine percent of cotton planted in 2016 were genetically engineered. 24 These crops are engineered to be either herbicide tolerant (HT) or insect resistant (BT). HT crops are designed to withstand treatment with an herbicide that would otherwise kill both the plant and the targeted weeds. 25 BT crops, on the other hand, are engineered to contain Bacillus thuringiensis, a gene commonly found in soil bacteria and that produces a toxin to kill certain insects. 26 Genetic engineering in agriculture has produced valuable results, including increased food production, enhanced nutritional value, and decreased losses due to weather and pests. 27 A. The Genetic Engineering Controversy Despite these benefits, genetic engineering is controversial. Those that oppose the use of genetic engineering assert several arguments in support of their position. 28 One of the central arguments against genetic engineering is based on the belief that inserting rdna into plants can lead to mutations that may unpredictably affect how the genes function in nature. 29 Many opponents of genetic engineering cite the concern that its use may create new allergens or toxins risks that generally do not occur with conventional breeding. 30 Other arguments 20. Id. 21. Recent Trends in GE Adoption, U.S. DEP T AGRIC. ECON. RES. SERV. https://www.ers.usda. gov/data-products/adoption-of-genetically-engineered-crops-in-the-us/recent-trends-in-ge-adoption. aspx (last updated July 12, 2017). 22. Id. In 1996, only seven percent of soybeans, fourteen percent of cotton, and three percent of the total acres of each crop were genetically engineered. Id. 23. Other commercially available GM crops include alfalfa, canola, papaya, squash, and sugar beet. The Case for GMO Labeling, FOOD & WATER WATCH (Jan. 2015) [hereinafter Case for GMO Labeling: Fact Sheet], http://www.foodandwaterwatch.org/sites/default/files/case%20for%20gmo% 20Labeling%20FS%20Jan%202015_0.pdf. 24. Recent Trends in GE Adoption, supra note 21. 25. Id. 26. J. Perez et al., Bacillus Thuringiensis (Bt) General Fact Sheet, NAT L PESTICIDE INFO. CTR. (Feb. 2015), http://npic.orst.edu/factsheets/btgen.html. 27. NAT L RESEARCH COUNCIL, supra note 5, at 23. 28. Amaru, supra note 17, at 579. 29. See id. 30. Id. 532 57 JURIMETRICS

Keeping Consumers In the Dark focus on the environmental impacts associated with the production of genetically engineered crops: genetically engineered crops affect ecosystems by altering soil bacteria, attracting new pests, and increasing reliance on pesticide use. 31 Finally, apart from public health and environmental concerns, many opponents of genetically engineered crops object to genetic engineering for philosophical, religious, or moral reasons. 32 Those who advocate for the continued use of genetic engineering in agriculture note that studies indicate genetically engineered crops are no riskier to human health than their traditional counterparts. 33 Farmers observe that the adoption of genetic engineering has made weed and pest control more efficient and cost effective, and has also contributed to the production of higher yields in some cases. 34 Moreover, genetic engineering enables scientists to gain closer control over crop genetics to produce desirable changes quickly. 35 Genetic engineering thus allows farmers to expediently overcome difficult situations that would otherwise compromise yields, such as extreme climate and pest infestations, by providing drought and pest resistance. 36 Although there is little scientific concern about the safety of genetically engineered foods, polls show the vast majority of Americans support mandatory labeling of foods containing genetically engineered ingredients. 37 Advocates for mandatory labeling argue that consumers have a right to know what is in their food; especially because some consumers worry that genetically engineered foods could potentially contain unexpected toxins and unknown allergens. 38 Without mandatory labeling, advocates argue that there is no way to track adverse health effects of people who consume genetically engineered foods. 39 B. Regulation of Genetically Engineered Foods Genetic engineering technologies are subject to a well-established regulatory process that ensures the technology produces food that is safe for human 31. Lindsay F. Wiley, Deregulation, Distrust, and Democracy: State and Local Action to Ensure Equitable Access to Healthy, Sustainably Produced Food, 41 AM. J.L. & MED. 284, 288 (2015). 32. See id. at 290. See also J. Howard Beales III, Modification and Consumer Information: Modern Biotechnology and the Regulation of Information, 55 FOOD & DRUG L.J. 105, 109 10 (2000). 33. See Biotechnology, CTR. FOR SCI. PUB. INT., https://cspinet.org/protecting-our-health/ biotechnology (last visited Oct. 16, 2016). 34. Graham Brookes & Peter Barfoot, Economic Impact of GM Crops, 5 GM CROPS & FOOD 65, 65 66 (2014). 35. See Amaru, supra note 17, at 581. 36. Id. 37. Liza Gross, Forget GMOs. Pesticides Pose the Real Risk, AM. PROSPECT (Aug. 23, 2016), http://prospect.org/article/forget-gmos-pesticides-pose-real-risk. 38. Beales, supra note 32, at 108. 39. Case for GMO Labeling: Fact Sheet, supra note 23. SUMMER 2017 533

Nagele consumption. 40 Regulatory authority over genetic engineering in agriculture is established through the Coordinated Framework for Regulation of Biotechnology (Coordinated Framework), 41 which was established in 1986 by the Office of Science and Technology Policy. 42 The Coordinated Framework creates roles for the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and United States Department of Agriculture (USDA) in the regulation of genetically engineered crops. 43 Under the Coordinated Framework, the EPA, FDA, and USDA closely evaluate and regulate the permitting of crop biotechnology and ensure genetically engineered food and feed products are as safe as their conventional counterparts. 44 The FDA also maintains the ability to recall any food or ingredient found unsafe for consumption. 45 However, if a genetically engineered product is found to be substantially equivalent to its conventional counterpart, it is not subject to additional extensive safety testing or labeling requirements. 46 C. Regulation of Product Labels for Genetically Engineered Foods Additionally, the Food, Drug, and Cosmetic Act authorizes the FDA to regulate food labeling. 47 The Food, Drug, and Cosmetic Act prohibits false and misleading representations on food labels, but only requires the disclosure of some predetermined material facts on food labels. 48 Passed in 1990, the Nutrition Labeling and Education Act (NLEA) further clarifies food labeling standards by mandating disclosure of certain nutrition facts and providing for regulation of claims about the health effects of foods. 49 By providing intellectual property protection 50 and limited regulatory oversight in the production and marketing of genetically engineered foods, the U.S. 40. Stanley H. Abramson & J. Thomas Carrato, Crop Biotechnology: The Case for Product Stewardship, 20 VA. ENVTL. L.J. 241, 245 (2001). 41. Id. 42. Coordinated Framework for Biotechnology, 51 Fed. Reg. 23,302 (June 26, 1986). 43. See Abramson & Carrato, supra note 40, at 245. 44. Amaru, supra note 17, at 582; see also BIOTECHNOLOGY WORKING GRP., EXEC. OFFICE OF THE PRESIDENT, MODERNIZING THE REGULATORY SYSTEM FOR BIOTECHNOLOGY PRODUCTS: FINAL VERSION OF THE 2017 UPDATE TO THE COORDINATED FRAMEWORK FOR THE REGULATION OF BIOTECHNOLOGY 8 27 (2017). Cf. 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, 377 (2012) ( Multiple scholars have noted that the principles set forth in the Framework seem to presume biotechnology s relative safety and utility. ). 45. Amaru, supra note 17, at 582 n.49. 46. Id. at 583. 47. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 341 (2015). 48. Amaru, supra note 17, at 583. 49. Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, 104 Stat. 2353 (1990). 50. See generally Haley Stein, Intellectual Property and Genetically Modified Seeds: The United States, Trade, and the Developing World, 3 NW. J. TECH. & INTELL. PROP. 160 (2005) (discussing the broad intellectual property protections afforded to crop biotechnology in the United States). 534 57 JURIMETRICS

Keeping Consumers In the Dark government has assisted the development and widespread use of genetic engineering technology. 51 A utilitarian approach to food, scientific optimism, and general support for free markets and trade may have driven the initial acceptance of genetic engineering technology in the United States. 52 Moreover, FDA testing has not found evidence that using biotechnology to insert genes into plants poses food safety problems. 53 Finally, Executive Order 12,866 provides that federal agencies should only promulgate regulations when absolutely necessary for example, to correct a market failure or protect the health and safety of the public or environment. 54 Even if a federal agency has determined a regulation is necessary, Executive Order 12,866 makes it clear that regulation is only appropriate if the benefits justify the costs. 55 Because of the difficulty in quantifying the costs and benefits of a labeling program, 56 some proposed labeling regulations are inherently difficult to justify under this standard. 57 The United States has thus had a hands-off approach with respect to labeling the final genetically engineered product. 58 Furthermore, the FDA has stated that, in general, it will not impose labeling requirements for disclosure that a food has been produced using genetic engineering because it is not material information. 59 Arguably, the FDA s position gave rise to the proliferation of genetically engineered foods and the creation of a strictly voluntary labeling system. Undoubtedly this approach has contributed to the ubiquity of genetically engineered foods in the American diet. 60 Nevertheless, consumer advocates argue that consumers have a right to know whether foods contain genetically engineered ingredients and have demanded mandatory labeling of foods containing such ingredients. 61 Advocates note that consumption of genetically engineered foods may have unintended 51. C. Ford Runge et al., Differing U.S. and European Perspectives on GMOs: Political, Economic, and Cultural Issues, 2 ESTEY CTR. J. INT L L. & TRADE POL Y 221, 221 222 (2001). 52. See id. at 223 25 (contrasting the acceptance of GM technology in the US with a reluctance to do so in Europe). 53. Amaru, supra note 17, at 576. 54. See Exec. Order No. 12,866, C.F.R. 638 (1993), reprinted in 5 U.S.C. 601 (1994). 55. Cass R. Sunstein, On Mandatory Labeling, with Special Reference to Genetically Modified Foods, 165 U. PA. L. REV. 1043, 1046 (2017). See also Elena Kagan, Presidential Administration, 114 HARV. L. REV. 2245, 2285 86 (2001) (noting that a cost-benefit analysis is the basic criterion in assessing regulatory decisions). 56. See infra notes 176 83 and accompanying text. 57. See Sunstein, supra note 55, at 1047. 58. Amaru, supra note 17, at 576. 59. Id. at 584; see also All. for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166, 179 (D.D.C. 2000) (affirming the FDA s determination that genetic engineering does not materially alter food, and that foods produced with genetic engineering do not present a different or greater safety concern than conventionally grown foods, and thus labeling for genetically engineered foods is not appropriate or required). 60. Lars Noah, Genetic Modification and Food Irradiation: Are Those Strictly on a Need-to- Know Basis?, 118 PENN ST. L. REV. 759, 764 (2014). 61. Id. at 784. SUMMER 2017 535

Nagele consequences. 62 They argue that the genetic engineering process may introduce a new allergen into the food supply or a new toxin into the crop. 63 They also express concern that genetic engineering could change the food s nutritional composition so that it may have more or less vitamins. 64 Despite consumer concerns, the FDA has repeatedly declined to require disclosure of products containing genetically engineered ingredients. 65 The nationwide push for mandatory labeling gained traction after Vermont passed a mandatory labeling law for all foods containing genetically engineered ingredients. 66 Several other states, including Alaska, Connecticut, and Maine also enacted mandatory labeling systems, 67 and Virginia and Vermont enacted mandatory labeling systems for genetically engineered seeds. 68 However, each of the state laws varied in requirements and exceptions. 69 Producers pointed out that inconsistency between the state laws needlessly impeded commerce and exposed them to fines for noncompliance. 70 They have also argued for many years that mandatory labeling for genetically engineered foods may spook[] unsophisticated consumers and uneasy retailers, who may have unsubstantiated concerns about genetic engineering. 71 Producers claimed they would be forced to investigate expensive reformulations of products to produce foods 62. Id. 63. Id. 64. Amaru, supra note 17, at 580 81. 65. About GE Food Labeling, CTR. FOR FOOD SAFETY, http://www.centerforfoodsafety.org/ issues/976/genetically-engineered-food-labeling (last visited Oct. 8, 2016) [perma.cc/c9v3-6a9p]. 66. See Carolyn Orr, Proposed Labeling of Genetically Modified Food Gets Passage in First State; Legal Showdowns Likely, STATELINE MIDWEST, June 2014, at 3, 3, http://www.csgmidwest. org/policyresearch/0614-gmo-labeling.aspx [https://perma.cc/9nxd-hwct]. Vermont s labeling law provides that food must be labeled as genetically engineered if it is offered for sale in Vermont and is entirely or partially produced with genetic engineering. The label must clearly read: produced with genetic engineering and cannot be labeled as natural, naturally made, naturally grown, or all natural. Genetically engineered raw commodities that do not have packaging must be identified with a label on the shelf or bin. VT. STAT. ANN. tit. 9, 3043 (West, Westlaw through Law No. 41 of the 1st Sess. of the 2017 2018 Assemb. Gen.). The law provides some exceptions for food that is entirely derived from animals that have been fed genetically engineered products; raw commodities that are produced without knowing or intentional use of genetic engineering; processed foods of which GM ingredients do not make up more than.9 percent of the total weight; medical food; and food served, sold, or provided in a restaurant. Id. 3044. 67. ALASKA STAT. ANN. 17.20.040(a)(4) (West, Westlaw current with chs. from the 1st Reg. Sess. and 2nd Spec. Sess. of the 30th Leg. in effect through Aug. 17, 2017); CONN. GEN. STAT. ANN. 21a-92c (West, Westlaw current with enactments of the 2017 Jan. Reg. Sess. effective on or before Aug. 15, 2017); ME. REV. STAT. ANN. tit. 22 2593 (West, Westlaw current with emergency legis. through ch. 309 of the 2017 1st Reg. Sess. of the 128th Leg.). 68. VA. CODE ANN. 3.2-4008 (West, Westlaw current through end of the 2017 Reg. Sess.); VT. STAT. ANN. tit. 6, 644 (West, Westlaw through Law No. 41 of the 1st Sess. of the 2017 2018 Assemb. Gen.). 69. See Bjerga & Keane, supra note 4. 70. Id. 71. Noah, supra note 60, at 787. 536 57 JURIMETRICS

Keeping Consumers In the Dark without genetic engineering. 72 In response to the increasingly controversial labeling debate, and the concern of food producers and distributors, President Obama signed the National Bioengineered Food Disclosure Standard into law on July 29, 2016. 73 II. THE NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARD The National Bioengineered Food Disclosure Standard creates national food labeling standards for foods containing genetically engineered ingredients. 74 Specifically, the standard creates a national mandatory disclosure standard for foods produced using bioengineering. 75 However, as is discussed below, producers can easily avoid the labeling requirements and the consequences of noncompliance, 76 resulting in a law that lacks regulatory teeth and fails to provide meaningful information to consumers. The standard defines bioengineered foods as those that contain[] genetic material that has been modified through in vitro [rdna] techniques; and... for which the modification could not otherwise be obtained through conventional breeding or found in nature. 77 All foods that must be labeled under the Food, Drug, and Cosmetic Act must contain a disclosure indicating the food is bioengineered. 78 Similarly, any food subject to the labeling requirements of the Federal Meat Inspection Act, 79 Poultry Products Inspection Act, 80 or Egg Products Inspection Act 81 must contain a disclosure indicating the food is bioengineered only if the most predominant ingredient of the food would independently be subject to the labeling requirements under the Food, Drug, and Cosmetic Act; or the most predominant ingredient of the food is broth, stock, water, or a similar solution; and the second most predominant ingredient of the food would independently be subject to the labeling requirements. 82 Foods certified under the Organic Foods Production Act may advertise the absence of bioengineering in the food. 83 72. See Amaru, supra note 17, at 593. 73. McFadden, supra note 1; see also Bjerga & Kane, supra note 4. 74. Bjerga & Kane, supra note 4 (discussing Senate Bill S. 764, which creates the National Bioengineered Food Disclosure Standard). 75. National Bioengineered Food Disclosure Standard, Pub. L. No. 114-216, 130 Stat. 834 (2016) (to be codified at 7 U.S.C. 1639). 76. See supra notes 73 75 and accompanying text; infra notes 77 81 and accompanying text. 77. 291(1)(b), 130 Stat. at 834. 78. Id. 292 (c)(1); see generally Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 399 (2012) (detailing the foods that require labeling). 79. 21 U.S.C. 601 695 (2012). 80. Id. 451 472. 81. Id. 1031 1056. 82. 292, 130 Stat. at 834 35. 83. 296, 130 Stat. at 838 39. SUMMER 2017 537

Nagele The standard gives the Secretary of Agriculture two years to establish a precise disclosure standard and identify requirements and procedures necessary to carry them out. 84 The requirements and procedures must identify the amount of a bioengineered substance that may be present for the food to be bioengineered, and may not require animal products to be considered bioengineered just because the animal consumed feed made from a genetically engineered crop. 85 It must also identify reasonable disclosure options for food in very small packages and provide additional time for small food manufacturers to comply. 86 The standard permits food producers and manufacturers to disclose that a food is genetically engineered with text, a symbol, or an electronic or digital link on the food s packaging. 87 If the manufacturer chooses to use an electronic or digital link, it must include a statement that the link will provide access to a website with more food information. 88 The disclosure must be of sufficient size to be easily and effectively scanned or read by a digital device. 89 The standard authorizes the Secretary of Agriculture to conduct audits for compliance, but does not authorize penalties for noncompliance. Nor does it give the Secretary authority to recall food that is not properly labeled. 90 Finally, the standard contains an express preemption provision for state labeling laws relating to genetically engineered foods and seeds. 91 A. The DARK Act : Consumer Reaction to the Standard Although the National Bioengineered Food Disclosure Standard purports to create a mandatory labeling scheme, many consumer advocates are dissatisfied with it. They highlight the lack of clear disclosure requirements, 92 numerous exceptions, 93 and narrow definition of bioengineering among the standard s shortcomings. 94 Even the FDA has noted that the standard s narrow definition could exempt most current genetically engineered foods from being labeled at all. 95 In addition to preempting popular state labeling laws, the standard also 84. 293 (a) (1) (2), 130 Stat. at 835. This directive to the Secretary of Agriculture effectively circumvents the cost-benefit analysis requirement of Executive Order 12,866, discussed above. See Sunstein, supra note 55, at 1048 n.15. 85. 293 (b) (2) (A) (B), 130 Stat. at 835. 86. 293(a), 130 Stat. at 835 36. 87. 293(d), 130 Stat. at 836 37. 88. Id. 89. Id. 90. 293(g), 130 Stat. at 837. 91. Id. 293(e). 92. Senator Stabenow and Senator Roberts GMO Labeling Legislation, JUST LABEL IT, http:// www.justlabelit.org/dark-act/ (last visited Oct. 8, 2016). 93. Bjerga & Keane, supra note 4. 94. Alexis Baden-Mayer, DARK Act Fact Sheet, ORGANIC CONSUMERS ASS N (June 29, 2016) [hereinafter DARK Act Fact Sheet], https://www.organicconsumers.org/news/dark-act-fact-sheet. 95. Andrew Kimbrell, Obama s GMO Embarrassment: Why the New Labeling Bill Just Signed into Law Is a Sham, SALON (Aug. 7, 2016, 12:30 PM), http://www.salon.com/2016/08/07/ obamas-gmo-embarrassment-why-the-new-labeling-bill-just-signed-into-law-is-a-sham_partner/. 538 57 JURIMETRICS

Keeping Consumers In the Dark prevents states from enacting mandatory labeling laws in the future a prohibition consumer advocates believe impedes transparency. 96 Finally, consumer advocates are displeased that despite being branded as a mandatory labeling system, the standard provides no penalties for noncompliance. 97 Opponents have given the standard the misnomer DARK Act, which stands for Denying Americans the Right to Know. 98 A primary concern regarding the standard relates to transparency: although the standard purports to provide consumers with desired information, it falls short. For example, producers who choose to use an electronic or digital link are not required to expressly state that the product is genetically engineered, just that the link will provide access to more food information. Therefore, because food producers may choose this option, consumers may still find it difficult to ascertain whether foods are genetically engineered. 99 Consumers who are unaware the link will disclose the food is genetically engineered may choose not to scan it, even if they are interested in the information. It could be argued that the only justification for these disclosure options is to hide the information from the public. 100 Other consumers without access to a smart phone or the Internet may be deprived of the information all together. Civil rights activists have criticized the disclosure options as discriminatory. Activist Reverend Jesse Jackson appealed to President Obama to repeal the standard, noting that 100,000,000 Americans, most of them poor, people of color and elderly either do not own a smart phone... to scan the QR code or live in an area of poor internet connectivity. 101 96. Christian Detisch, President Obama Signs DARK Act into Law, FOOD & WATER WATCH (Aug. 1, 2016), http://www.foodandwaterwatch.org/news/president-obama-signs-dark-act-law. 97. DARK Act Fact Sheet, supra note 94. 98. See Bjerga & Keane, supra note 4; Detisch, supra note 96. According to Laura Murphy, Director of the Environmental & Natural Resources Law Clinic at Vermont Law School Reporter, [C]ongress created a mechanism for companies to hide behind QR codes and trample on state efforts to provide their citizens with actual information.... [T]he federal law has a confusing definition of bioengineering that gives USDA the authority to determine how much of a product needs to be bioengineered before a label is required, and prevents even the food companies from certain types of disclosure. Jonathan Greenberg, Obama Expands Monsanto Doctrine by Signing DARK Act and Invalidating Vermont GMO Labeling Law, HUFFINGTON POST (Aug. 11, 2016), http://www. huffingtonpost.com/entry/obama-signs-dark-act-to-invalidate-vermonts-landmark_us_57a644c7e4b0 ccb023727b2d. 99. See Nan Feng, Note, The Recent Enactment of National Mandatory GMO Labeling Law: Superior to a Voluntary Labeling Scheme but Unlikely to End the Labeling Controversy, 40 SEATTLE U. L. REV. 821, 840 (2017). 100. Editorial, A Flawed Approach to Labeling Genetically Modified Food, N.Y. TIMES (July 6, 2016), http://www.nytimes.com/2016/07/07/opinion/a-flawed-approach-to-labeling-geneticallymodified-food.html?_r=0. 101. Rev. Jesse Jackson Calls on President Obama to Reject Discriminatory Labeling Bill, CTR. FOR FOOD SAFETY (July 14, 2016), http://www.centerforfoodsafety.org/press-releases/4432/revjesse-jackson-calls-on-president-obama-to-reject-discriminatory-labeling-bill#. SUMMER 2017 539

Nagele Consumers also argue that because of the standard s many exemptions, some genetically engineered foods are completely excused from labeling requirements. 102 This is because beef, pork, poultry, and eggs are generally exempted from the labeling requirements, 103 and foods that contain a majority of those ingredients are also exempted even if they contain genetically engineered ingredients. 104 Foods produced with genetic engineering technologies that do not involve in vitro rdna are similarly exempted from labeling requirements because of the standard s narrow definition of bioengineering, which includes only genetic engineering technologies that use in vitro recombinant DNA techniques. 105 Thus, foods produced using other forms of genetic modification, 106 several of which involve DNA manipulation, do not have to be labeled. In preempting state labeling laws, the standard strikes down numerous popular regulations, including those in Vermont, Connecticut, Maine, and Alaska, where consumers voted for regulations supporting their right to know. 107 The standard also preempts seed labeling laws in Vermont and Virginia, 108 where farmers have stated that the genetic engineering disclosure on seed packages provides critical information they need to make decisions about which seeds to purchase and plant. 109 Finally, the standard has been branded as creating a mandatory labeling system, but its lack of fines for noncompliance leaves many wondering if producers will choose to comply. 110 Without enforcement mechanisms, the standard effectively maintains a voluntary labeling scheme under the guise of a mandatory system. This will undoubtedly perpetuate consumer confusion about genetically engineered foods and mislead consumers into believing that foods that do not have the required labels do not contain genetically engineered ingredients. In fact, many foods may be genetically engineered and just not labeled. B. Big Agriculture : Big Beneficiary of the Standard Consumers have rallied for mandatory labeling for genetically engineered foods for many years. In fact, some studies show the majority of Americans support mandatory labeling. 111 However, producers of genetically engineered 102. Kimbrell, supra note 95. 103. National Bioengineered Food Disclosure Standard, Pub. L. No. 114-216, 130 Stat. 834, 834 35 (2016) (to be codified at 7 U.S.C. 1639). 104. DARK Act Fact Sheet, supra note 94. 105. 291(1), 130 Stat. at 834. 106. See supra notes 3 10 and accompanying text. 107. Detisch, supra note 96. 108. Kimbrell, supra note 95. 109. 162 CONG. REC. S4841, 4882 (daily ed. July 7, 2016) (statement of Sen. Sanders). 110. See DARK Act Fact Sheet, supra note 94. 111. Gross, supra note 37. 540 57 JURIMETRICS

Keeping Consumers In the Dark crops and the agrochemical industry resisted the push for mandatory labeling. 112 Both groups argued that a mandatory labeling scheme would be costly. 113 It would cause consumers to choose products made without genetic engineering, which are more expensive and less efficient to produce. 114 The National Bioengineered Food Disclosure Standard s exemptions, lack of penalties for noncompliance, and preemption provisions thus provide a benefit to many food producers and agrochemical companies by preventing states from implementing mandatory labeling systems. 115 The standard, which is supported by the Grocery Manufacturers Association and Monsanto, essentially stops the labeling debate at both the state and federal levels. Although the standard has been branded as a requirement for transparency to benefit consumers, in reality, it benefits the food industry and big agriculture while failing to provide any meaningful information to consumers. 116 With its numerous exemptions and lack of penalties, the standard provides mechanisms for many food producers to avoid its requirements. 117 Moreover, the standard, and any labeling effort that does not require complete transparency with respect to genetically engineered foods, helps agrochemical companies maintain control over the food supply, and maintains incentives to plant genetically engineered crops. 118 This is because agrochemical companies that create genetically engineered crop biotechnology create an entire system of food production; companies that produce genetically engineered seeds often produce the chemicals those crops are designed to resist. 119 For example, agrochemical company Monsanto sells genetically engineered soybean seeds that are Roundup-Ready, meaning they are engineered to withstand the application of the herbicide Roundup. Monsanto also produces 112. Editorial, Labels for GMO Foods Are a Bad Idea, SCI. AM. (Sept. 1, 2013), https://www. scientificamerican.com/article/labels-for-gmo-foods-are-a-bad-idea. 113. Id. 114. Id. 115. Food and agriculture companies have invested heavily in lobbying efforts to combat mandatory labeling for GMOs. Rob Coleman, Food Lobby Spends $101 Million in 2015 to Avert GMO Labeling, ENVTL. WORKING GRP. (Feb. 25, 2016), http://www.ewg.org/research/lobbying-antilabeling-groups-tops-100m ( Big food, farm and biotechnology companies and trade associations working to prevent labeling of food containing genetically engineered ingredients reported spending $101.4 million on lobbying [in 2015]. ). 116. See Greenberg, supra note 98. 117. See Bjerga & Keane, supra note 4; see also National Bioengineered Food Disclosure Standard, Pub. L. No. 114-216, 130 Stat. 834, 837 (2016) (to be codified at 7 U.S.C. 1639) (making it a prohibited act to knowingly not make a required disclosure, but assigning no penalty for noncompliance). 118. See Five Things Monsanto Doesn t Want You to Know About GMOs, FOOD & WATER WATCH (May 7, 2015), http://www.foodandwaterwatch.org/news/five-things-monsanto-doesnt-wantyou-know-about-gmos (describing the connection between GMOs and corporations control of the food supply). 119. Id. SUMMER 2017 541

Nagele Roundup. Thus, farmers that purchase and plant Roundup-Ready soybeans from Monsanto also rely on Monsanto to supply the Roundup itself. 120 Because genetically engineered crops are intended to withstand certain herbicides and pesticides, farmers use those chemicals repeatedly. Insects and weeds develop resistance to these chemicals, and the chemicals themselves become less effective at combatting the pests they are designed to eliminate. 121 As the chemicals become less effective, farmers use more of them, and producers of the chemicals are incentivized to develop even harsher products. 122 At a minimum, more genetically engineered crops means more pesticide use, which is beneficial to the producers of those products, but is harmful to the environment and public health. 123 By providing a means for agrochemical companies and food producers of genetically engineered crops to continue to produce and sell those crops without any real disclosure requirement, the standard provides great benefits to producers of genetically engineered crops and agrochemical companies. III. THE NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARD IS BAD FOOD POLICY Despite preexisting close regulation of genetic engineering technologies 124 and the FDA s determination that genetic engineering does not pose food safety problems, 125 consumers and Congress seemingly perceived a need for additional regulation of genetically engineered foods. This decision comes with farreaching implications for consumers and food producers, and rejects the consideration of factors that generally influence labeling decisions. When labeling decisions are left to producers, market forces will drive decisions regarding the extent of information included on a food label. 126 Generally, a producer will add more information to a label if she believes the 120. Id. 121. U.S. ENVTL. PROT. AGENCY, DRAFT PESTICIDE REGISTRATION (PR) NOTICE 2016-X, NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS AND REGISTRANTS OF PESTICIDE PROJECTS (2016), https://www.epa.gov/sites/production/files/2016-05/documents/pr-2016-x-guidancepesticide-registrants-resistance-management.pdf. 122. Id. 123. Id. Numerous studies have demonstrated adverse effects to the environment and public health as a result of repeated, high-volume pesticide use. See, e.g., Robert B. Gunier et al., Prenatal Residential Proximity to Agricultural Pesticide Use and IQ in 7-Year-Old Children, ENVTL. HEALTH PERSP. 1, 5 (July 2016); Virginia Rauh et al., Seven-Year Neurodevelopmental Scores and Prenatal Exposure to Chlorpyrifos, a Common Agricultural Pesticide, in EVERYDAY ENVIRONMENTAL TOXINS: CHILDREN S EXPOSURE RISKS 201, 212 (Areej Hassan ed., 2015). 124. See supra notes 38 43 and accompanying text (discussing the Coordinated Framework and the process for permitting crop biotechnology). 125. Amaru, supra note 17, at 576. 126. See Sunstein, supra note 55, at 1050 53; Julie Caswell, How Labeling of Safety and Process Attributes Affects Markets for Food, 27 AGRIC. & RESOURCE ECON. REV. 151, 156 (1998). 542 57 JURIMETRICS

Keeping Consumers In the Dark additional information will generate more revenue than costs. 127 However, some situations justify mandatory disclosure requirements. For example, a label may be necessary to alert consumers to health and safety concerns. 128 Part III discusses the factors that drive labeling decisions, and examines situations where it may be justified to require producers to include certain information on food labels, ultimately arguing that the justifications for mandatory labeling systems do not support mandatory labeling for genetically engineered foods. Finally, Part III provides several specific alternatives to the mandatory labeling requirements imposed by the standard that would encourage transparency while ensuring adequate access to safe and affordable foods for all consumers. A. A Cost-Benefit Analysis: Voluntary Labeling Decisions Absent a mandatory labeling requirement, producers choose to use certain labels to disclose facts about food products based on a cost-benefit analysis. For producers focused on maximizing profits, the decision to disclose a food s genetically engineered content hinges on the costs and benefits of doing so: producers will add more information to packaging if they believe the additional information will generate more revenue than costs. 129 A producer will therefore label a product if she believes the additional information will cause consumers to purchase her product. 130 On the other hand, consumers will generally maximize utility by choosing products that most closely align with their preferences, and labeling claims can provide consumers with additional choices by providing more information on which to base their decisions. 131 Thus, some labeling decisions may enhance economic efficiency by helping consumers identify and purchase products they want most. 132 A voluntary labeling scheme can similarly enable the development of markets for certain foods without affecting the price and availability of other unlabeled foods. Because voluntary labeling systems allow producers to choose a 127. ELISE GOLAN ET AL., U.S. DEPT. AGRIC. ECON. RESEARCH SERV., ECONOMICS OF FOOD LABELING 7 (2000) [hereinafter ECONOMICS OF FOOD LABELING]. 128. See generally Caswell, supra note 126 (discussing, among other examples, USDA s mandatory labeling policy aimed at ensuring safe handling practices to reduce the risk of foodborne illness). 129. See generally ELISE GOLAN ET AL., U.S. DEP T AGRIC. ECON. RESEARCH SERV., LABELING GENETICALLY MODIFIED FOODS: AN ECONOMIC APPRAISAL (2000) [hereinafter LABELING GENETICALLY MODIFIED FOODS: AN ECONOMIC APPRAISAL]. 130. Id. at 3. 131. Id. at 2; Alison van Eenennaam et al., The Potential Impacts of Mandatory Labeling for Genetically Engineered Food in the United States 8 (Council for Agric. Sci. & Tech., Issue Paper No. 54, 2014), http://www.cast-science.org/download.cfm?publicationid=282271&file=1e30b9edc325b d7238e06b551e4a73f4b712tr. See also ECONOMICS OF FOOD LABELING, supra note 127, at 7 ( Labeling decisions may enhance economic efficiency by helping consumers to target expenditures toward products they most want. ). 132. ECONOMICS OF FOOD LABELING, supra note 127, at 7. SUMMER 2017 543

Nagele production practice and related label to maximize their own return while providing consumers with choices based on their own preferences, they provide consumers with more choices. 133 A voluntary labeling system is especially effective for foods produced using practices or ingredients some consumers wish to avoid, but are nevertheless safe to consume. 134 The voluntary labeling system used for products made with milk from cows not treated with recombinant bovine somatotropin (rbst) highlights the success of a voluntary labeling system for products that are safe, but which some consumers do not want to purchase. Used primarily to increase milk production in dairy cattle, one source defines rbst as a genetically engineered version of a naturally-occurring growth hormone. 135 The FDA approved the use of rbst in 1993 after conducting a scientific review that revealed rbst is safe and effective for dairy cows, that milk from rbst-treated cows is safe for human consumption, and that production and use of the product do not have a significant impact on the environment. 136 The FDA also concluded that there was no significant difference between milk from treated and untreated cows. 137 Nevertheless, soon after milk producers began to use rbst, consumer groups objected and demanded a mandatory labeling system for all products made with milk from cows treated with rbst. 138 In response, producers created a negative label (rbst-free) to indicate that certain products are not made with milk from cows treated with rbst. 139 The FDA affirmed the use of the rbst-free label, provided producers include a disclaimer on the product noting that [n]o significant difference has been shown between milk derived from rbst-treated and non-rbst-treated cows to prevent the rbst-free claim from being misleading. 140 The FDA s insistence that producers include the disclaimer was based on the idea that, without context, an rbst-free label could erroneously imply that milk from untreated cows is safer or of higher quality. 141 Studies indicate that the use of the rbst-free label has affected total milk sales little, if any. 142 While some producers and consumers benefit from increased sales as a result of the rbst-free label, the negative label 133. Caswell, supra note 126. 134. See, e.g., C. Ford Runge & Lee Ann Jackson, Negative Labeling of Genetically Modified Organisms (GMOs): The Experience of rbst, 3 AGBIOFORUM 58, 60 (2000) (discussing the evolution of a voluntary negative labeling strategy within the U.S. dairy sector). 135. Id. 136. Interim Guidance on the Voluntary Labeling of Milk and Milk Products from Cows That Have Not Been Treated with Recombinant Bovine Somatotropin, 59 Fed. Reg. 6279, 6279 80 (Feb. 10, 1994). 137. Id. 138. Runge & Jackson, supra note 134. 139. Id. 140. Interim Guidance on the Voluntary Labeling of Milk and Milk Products from Cows That Have Not Been Treated with Recombinant Bovine Somatotropin, 59 Fed. Reg. at 6280. 141. Id. 142. Runge & Jackson, supra note 134. 544 57 JURIMETRICS

Keeping Consumers In the Dark ensures two important things: (1) information is provided to assist consumers in making a well-informed purchasing decision, and (2) in general, an adequate supply of milk is readily available at an affordable price. Voluntary labeling systems can likewise alert consumers to social welfare concerns that may affect their purchasing decisions. 143 Dolphin-safe tuna labeling is an example. 144 In the late 1980s, consumers became aware of tuna-fishing practices that resulted in hundreds of thousands of dolphin deaths each year. 145 In response to a worldwide tuna boycott, tuna companies began purchasing from fishermen who did not kill dolphins, and began advertising that fact through product labels. 146 Today, ninety-five percent of the world s tuna companies are committed to dolphin-safe practices, and the dolphin-safe label is used on tuna sold throughout the world. 147 Providing a greater number of choices for consumers and minimizing the use of certain harmful production techniques are examples of social benefits that may result from changes in consumer purchasing decisions as a result of voluntary labeling. Voluntary labeling may thus contribute to enhanced net social benefits of increasing or decreasing consumption of foods with certain traits without affecting overall markets. 148 B. Health and Safety: Justifications for Mandatory Labeling Systems Despite the potential advantages of adding additional information to a product label, market forces are unlikely to motivate producers to disclose all information relevant to consumer purchasing decisions, even if that information is vital to decisions regarding consumer health and welfare. 149 For example, information that a food is high in fat and cholesterol is capable of influencing consumer decisions, but a producer is unlikely to voluntarily advertise that fact. In situations where the market does not provide enough information to allow consumers to consider information that could adversely affect individual health or safety, mandatory labeling is appropriate to increase informed consumption. 150 An example of a mandatory labeling scheme designed to improve consumer health and increase informed consumption involves food nutrition labels. The NLEA requires food producers to include nutrition information on the packages 143. See Sunstein, supra note 55, at 1051 52 (explaining that disclosure of information may influence purchasing decisions which may in turn reduce risks to third parties, animals, or the environment). 144. Jani Actman, Dolphin-Safe Tuna Rules Just Got Tougher, NAT L GEOGRAPHIC: WILDLIFE WATCH (Mar. 25, 2016), http://news.nationalgeographic.com/2016/03/160325-dolphinsafe-tuna-label-mexico-world-trade-organization/. 145. Id. 146. Id. 147. Dolphin Safe Fishing, INT L MARINE MAMMAL PROJECT, http://savedolphins.eii.org/ campaigns/dsf (last visited July 7, 2017) [https://perma.cc/c3jk-a6jc]. 148. See ECONOMICS OF FOOD LABELING, supra note 127, at 7 8. 149. See id. at 7 8. 150. Id. at 19. SUMMER 2017 545