August 30, 2018

From GMO Litigation to GMO Disclosure Regulation: What’s Ahead for Disputes over Genetically Engineered Crops?

Andrew R. Varcoe

Genetically engineered (GE) crops—sometimes called genetically modified organisms (GMOs)—have been common in the United States for about 20 years. They are not universally accepted, though. Indeed, GE crops have been a recurring focus of public litigation since they began to be widely adopted. A pending U.S. Department of Agriculture (USDA) food disclosure rulemaking will bring new challenges for GE crops and, perhaps, some high-profile litigation.

A note about terminology: I use the term “genetically engineered” in this article “to describe the use of modern biotechnology”—that is, “the application of in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection of plants.” U.S. Food and Drug Administration (FDA), Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants (Nov. 2015), https://goo.gl/C1FReN. GE plants are often colloquially described as GMOs. FDA’s “longstanding position” is that using the term “genetic modification” (or GMO) to refer to modern biotechnology “is less accurate because the term encompasses the broad spectrum of genetic alterations that can be made in plants.” Id. Nonetheless, many members of the U.S. public, and some other countries, use these terms interchangeably. See USDA, Agricultural Biotechnology Glossary, www.usda.gov/topics/ biotechnology/biotechnology-glossary. I do so here as well.

U.S. farmers have adopted GE crops at a remarkable rate over the past two decades. GE seed varieties were commercially introduced in the United States in 1996. Currently, over 90 percent of U.S. corn, soybeans, upland cotton, canola, and sugar beets are produced using GE varieties. These varieties have traits that farmers have found beneficial—particularly herbicide tolerance and resistance to insects or disease. See USDA Econ. Research Serv. (ERS), Biotechnology: Overview, www.ers.usda.gov/topics/farm-practices-management/biotechnology. According to a leading industry trade group, 70 to 80 percent of U.S. food is GE or has GE ingredients. Grocery Manufacturers Association (GMA) Position on GMOs, http://bit.ly/2Dm0usk (available at GMA, National Biotech Disclosure Law Protects U.S. Food System, http://bit.ly/2BYaBY2). And countries on six continents—including Argentina, Canada, China, India, and Pakistan—grow considerable quantities of GE crops, with the United States as the global leader, followed by Brazil. See Int’l Serv. for the Acquis’n of Agri-biotech Applic’ns (ISAAA), ISAAA Brief 52-2016: Executive Summary (2016), http://bit.ly/2qMu6LY. Thanks in large part to research by public-sector scientists, the supply of available GE crops and of GE or GE-derived foods seems likely to increase, and to become more diverse, in the near future. Id.

Scientists’ understandings of the safety and benefits of genetic engineering in agriculture differ significantly from overall public perceptions. A recent National Academies of Sciences (NAS) study, for example, “found no substantiated evidence of a difference in risks to human health between currently commercialized [GE] crops and conventionally bred crops, nor did it find conclusive cause-and-effect evidence of environmental problems from the GE crops.” NAS, Report in Brief, Genetically Engineered Crops: Experiences and Prospects 1, 3 (May 2016), www.nap.edu/resource/23395/GE-crops-report-brief.pdf. Similarly, the board of directors for the American Association for the Advancement of Science (AAAS) stated in 2012 that “the science is quite clear: crop improvement by the modern molecular techniques of biotechnology is safe.” AAAS, Statement by the AAAS Board of Directors on Labeling of Genetically Modified Foods (Oct. 20, 2012), http://goo.gl/82vY0A. “GM crops are the most extensively tested crops ever added to our food supply.” Id.; see also World Health Org., Frequently Asked Questions on Genetically Modified Foods (May 2014), http://goo.gl/5L9k1K; Mitch Daniels, Avoiding GMOs Isn’t Just Anti-Science. It’s Immoral., Washington Post (Dec. 27, 2017), http://wapo.st/2Ci8xY5.

Although the gap may be narrowing, polls suggest that members of the public are generally less confident than scientists in the safety of foods derived from GE crops. The Pew Research Center reported in late 2016 that “14% of U.S. adults say that almost all scientists agree GM foods are safe to eat, and another 28% say more than half of scientists agree about this.” Brian Kennedy & Cary Funk, Many Americans Are Skeptical About Scientific Research on Climate and GM Foods, Pew Research Ctr. (Dec. 5, 2016), https://goo.gl/AgX7cY; see also Cary Funk & Lee Rainie, Public and Scientists’ Views on Science and Society, Pew Research Ctr. (Jan. 29, 2015), http://pewrsr.ch/1wF3R2h (37 percent of members of general public, but 88 percent of AAAS scientists, thought that GM foods were generally safe to eat).

The Federal Regulatory Framework Governing GE Crops

In the United States, regulatory review of GE plants is performed by three federal agencies under a division of labor known as the Coordinated Framework. See Executive Office of the President, Office of Sci. & Tech. Pol’y, Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302 (June 26, 1986). To simplify slightly, USDA regulates plant health, FDA regulates food safety, and the U.S. Environmental Protection Agency (EPA) regulates pesticides (whether used on a GE plant or generated by the plant). See generally Ctr. for Food Safety v Vilsack, 718 F.3d 829, 833–36 (9th Cir. 2013) (Alfalfa II). USDA historically has played a leading role under the Coordinated Framework and has been subjected to considerable litigation for its regulatory decisions in this area.

USDA, through the Animal and Plant Health Inspection Service (APHIS), regulates GE plants under the Plant Protection Act (PPA), 7 U.S.C. §§ 7701–7772. USDA’s authority under the current regulatory scheme, 7 C.F.R. Part 340, is limited to regulating GE plants that are plant pests (a term of art under the statute) or are developed using plant pests. See 7 U.S.C. § 7702(14) (defining plant pests as “any living stage of any of [eight enumerated categories of organisms or other articles] that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product”). Plant pests (for example, soil bacteria) have been used as donors of, or vectors for transmission of, genetic material that is transferred to (and thus used to alter the genetic makeup of) plants. Under USDA’s regulatory scheme, it is this use of plant pests to genetically engineer plants that provides the justification for asserting Part 340 regulatory authority over those plants. See 7 C.F.R. § 340.1 (defining “regulated article” to include “[a]ny 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”).

Using permitting processes, 7 C.F.R. §§ 340.3, 340.4, USDA regulates a GE plant under Part 340 unless and until USDA concludes, after considering a detailed petition, that the plant is not a plant pest because it does not cause physical harm to plants. See 7 C.F.R. § 340.6; Alfalfa II, 718 F.3d at 835, 840–41; APHIS, Permits, Notifications, and Petitions (Mar. 16, 2016), https://goo.gl/8o1F9V. At that point, the organism is “deregulated,” terminating the agency’s regulatory jurisdiction over the organism under Part 340. Deregulation is the trigger (for USDA purposes) for commercialization of GE plants. See generally id. at 834–35; APHIS, Petitions for Determination of Nonregulated Status, http://goo.gl/poyuHm (listing all deregulated GE plants).

Many new plant breeding techniques use innovative technologies, including forms of genome editing, that do not require the use of plant pests. They thus fall outside the existing Part 340 regulatory scheme for GE plants. USDA uses an abbreviated “letter of inquiry” process to allow parties to confirm whether their organism falls under Part 340. See APHIS, Am I Regulated Under 7 CFR Part 340?, www.aphis.usda.gov/aphis/ourfocus/biotechnology/am-i-regulated. There is considerable debate over whether and to what extent special regulation should apply to plants bred using these newer techniques. See, e.g., Paul Enríquez, Genetically Modified Food is Too Advanced for Its Out-of-Date Regulations, The Hill, July 8, 2017, http://bit.ly/2u5EDVm; Alison Abbott, European Court Suggests Relaxed Gene-Editing Rules, Nature (Jan. 19, 2018), www.nature.com/articles/d41586-018-01013-5.

At the very end of the Obama administration, USDA issued a proposed rule to revise Part 340 that, in its view, tried to address such questions and to better align regulation with risk. APHIS, Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms, 82 Fed. Reg. 7008 (Jan. 19, 2017). The USDA proposal would have subjected a wider class of plants, including some plants developed using new technologies, to initial regulatory review. 82 Fed. Reg. 7014. The proposal also would have exempted some categories of plants from premarket regulation, including organisms that could have been produced using traditional breeding or chemical or radiation-based mutagenesis (which has never been considered genetic engineering). See id. at 7015–16, 7018 n.6, 7029. Under the proposal, the agency would subject a nonexempt organism to an initial risk assessment, and then determine whether the organism presents risks requiring ongoing regulation. Id. at 7014. (At the same time, FDA solicited public input on the use of genome editing techniques in plants. FDA, Genome Editing in New Plant Varieties Used for Foods; Request for Comments, 82 Fed. Reg. 6564 (Jan. 19, 2017); see also Robert M. Califf & Ritu Nalubola, FDA’s Science-based Approach to Genome Edited Products, FDA Voice (Jan. 18, 2017), http://bit.ly/2khApGO. FDA has neither proposed nor taken any action in response to the comments that it has received.) The USDA proposal attracted some praise, but also attracted criticism from a diverse array of parties. In late 2017, USDA withdrew the proposal, stating that it would “begin a fresh stakeholder engagement aimed at exploring alternative policy approaches.” 82 Fed. Reg. 51,582 (Nov. 7, 2017).

Early this year, an interagency task force recommended that the U.S. government continue efforts initiated by the Obama administration to modernize the U.S. biotechnology regulatory system. USDA, Report to the President of the United States from the Task Force on Agriculture and Rural Prosperity 33–34 (Jan. 8, 2018), http://bit.ly/2qC3NKE; see id. at 31 (“Globally, the biotechnology sector is a driver of the ‘fourth industrial revolution,’ and presents an incredible opportunity for American farmers and rural communities to thrive at the forefront of innovation.”); Remarks by President Trump to the American Farm Bureau [Federation] Annual Convention (Jan. 8, 2018), https://www.whitehouse.gov/briefings-statements/remarks-president-trump-american-farm-bureau-annual-convention-nashville-tn/ (“We’re streamlining regulations that have blocked cutting-edge biotechnology, setting free our farmers to innovate, thrive, and to grow.”). Later that month, Agriculture Secretary Sonny Perdue and FDA Commissioner Scott Gottlieb signed a memorandum of understanding underscoring their agencies’ “commit[ment] to modernizing the Coordinated Framework . . . and the U.S. agricultural biotechnology regulatory system to develop efficient, science-based regulatory practices” by working with other agencies on a strategy issued by the Obama administration in 2016. FDA, Formal Agreement between USDA and FDA Relative to Cooperation and Coordination (Jan. 30, 2018), http://bit.ly/2EyzJFt; see also Executive Office of the President, National Strategy for Modernizing the Regulatory System for Biotechnology Products (Sept. 2016), http://bit.ly/2EhGpEn.

This March, Secretary Perdue released a statement “providing clarification” on USDA’s oversight of plants produced through genome editing and other new breeding techniques. The bottom line: “USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests.” APHIS, Secretary Perdue Issues USDA Statement on Plant Breeding Innovation (Mar. 28, 2018), https://bit.ly/2GiVbQw. “With this approach, USDA seeks to allow innovation when there is no risk present[.]” Id. (quoting Secretary Perdue).

Early this summer, USDA issued a notice of intent to prepare an environmental impact statement concerning the possibility of “amending its biotechnology regulations to address advances in biotechnology and various issues previously raised by stakeholders.” APHIS, USDA Seeks Comment on Notice of Intent to Prepare Draft Programmatic EIS on Its Biotechnology Regulations (June 29, 2018), https://bit.ly/2N97SwM; APHIS, Notice of Intent to Prepare an Environmental Impact Statement; Movement and Outdoor Use of Certain Genetically Engineered Organisms, 83 Fed. Reg. 30,688 (June 29, 2018). The 30-day public comment period will end on July 30, 2018. It would not be surprising if this process were to result in a proposed Part 340 rule that differs in significant respects from the Obama administration’s proposed rule that USDA withdrew in late 2017.

Litigation Challenging Federal Regulatory Decisions Concerning GE Crops

Until recently, nongovernmental organizations (NGOs) relied on the National Environmental Policy Act (NEPA) and the Endangered Species Act (ESA) to bring lawsuits challenging USDA regulatory decisions concerning GE crops intended for widespread use. One of the themes of these suits was that widespread cultivation and use of certain GE crops could lead to the overuse of pesticides to which those crops were engineered to be resistant, and that USDA had failed adequately to consider the potential impacts of such pesticide use. These suits have resulted in several significant, and sometimes colorful, court decisions.

In 2007, for instance, a federal district court held that APHIS had violated NEPA by failing to prepare an environmental impact statement (EIS) before it deregulated Roundup Ready alfalfa (RRA). Geertson Seed Farms v. Johanns, No. C06-01075, 2007 WL 518624, at *10–12 (N.D. Cal. Feb. 13, 2007) (Alfalfa I). That decision led to Monsanto Co. v. Geertson Seed Farms, 561 U.S. 139, 144, 164–66 (2010), in which the Supreme Court held, without addressing the NEPA merits, that the district court had abused its discretion in entering a permanent injunction that simultaneously forbade the planting of RRA and forbade APHIS from partially deregulating RRA while preparing an EIS.

In a similarly complex, long-running dispute over GE sugar beets, a district court at one phase entered a preliminary injunction requiring the destruction of certain juvenile beets that were subject to APHIS permitting restrictions. The Ninth Circuit vacated that injunction, reasoning that the plaintiffs had not shown even a possibility that the beets would cause irreparable harm. Ctr. for Food Safety v. Vilsack, 636 F.3d 1166, 1173 (9th Cir. 2011). As then-Judge (now Chief Judge) Sidney Thomas, writing for the court, memorably put it, “[t]he alleged irreparable harms are little more than an expression that ‘life finds a way.’” Id. at 1174 (quoting Michael Crichton, Jurassic Park 159 (Ballantine 1990)). “However, an invocation to chaos theory is not sufficient to justify a preliminary injunction. . . . Biology, geography, field experience, and permit restrictions make irreparable injury unlikely.” Id.

In the Alfalfa II case, decided in 2013, the Ninth Circuit sharply curtailed parties’ ability to bring NEPA and ESA challenges to APHIS decisions deregulating GE crops. On remand from the district court’s decision in Alfalfa I, vacating the agency’s initial deregulation of the same plant, APHIS again deregulated RRA. See Alfalfa II, 718 F.3d at 838. New litigation was brought challenging APHIS’s decision as inconsistent with the PPA, the Administrative Procedure Act (APA), NEPA, and the ESA. After a federal district court upheld the agency’s decision, the Ninth Circuit affirmed, concluding that once APHIS has determined that a GE plant is not a plant pest and has deregulated it, APHIS lacks regulatory jurisdiction over the plant under the PPA. In particular, APHIS lacked the “power to regulate the adverse economic effects that could follow RRA’s deregulation” or “the use of herbicides like glyphosate.” 718 F.3d at 841. EPA, not USDA, was tasked with regulating herbicide use. Id. APHIS’s lack of authority “obviated the need for the agency to consult with the [Fish and Wildlife Service] under the ESA and to consider alternatives to unconditional deregulation under NEPA.” Id. at 833.

In concluding that the agency’s lack of discretion truncated its NEPA and ESA obligations, the court relied on a substantial body of case law indicating that those obligations turn on the nature and limits of an agency’s legal discretion. See id. at 839, 842 (citing, e.g., Karuk Tribe of Calif. v. U.S. Forest Serv., 681 F.3d 1006, 1020 (9th Cir. 2012) (en banc); Nat’l Ass’n of Home Builders v. Defenders of Wildlife, 551 U.S. 644, 655 (2007)). A leading case in this area is Department of Transportation v. Public Citizen, 541 U.S. 752, 770 (2004), which holds that “where an agency has no ability to prevent a certain effect due to its limited statutory authority over the relevant actions,” the agency need not consider such effects when “determining whether its action is a ‘major Federal action’” under NEPA.

Litigation Challenging Local Ordinances Banning GE Crops

Before and after Alfalfa II, a small number of U.S. localities enacted ordinances that banned or restricted GE crops. In Atay v. County of Maui, 842 F.3d 688 (9th Cir. 2016), and other decisions, the Ninth Circuit held that three such ordinances, all enacted by Hawaii counties, were preempted by a combination of state and federal law. First, the court held that federal law expressly preempted the county ordinances to the extent that they pertained to GE plants regulated by USDA as plant pests, which triggered the PPA’s express preemption provision (7 U.S.C. § 7756(b)). Second, the court held that federal law did not impliedly preempt the ordinances to the extent that they pertained to deregulated GE plants, which were outside USDA’s regulatory authority (and thus did not trigger express preemption). Third, the court held that Hawaii law (a “comprehensive state statutory scheme for the regulation of potentially harmful plants”) impliedly preempted the ordinances insofar as they pertained to deregulated GE plants. See Atay, 842 F.3d at 691; Hawaii Papaya Indus. Ass’n v. County of Hawaii, 666 Fed. Appx. 631, 634 (9th Cir. 2016); Syngenta Seeds, Inc. v. County of Kauai, 664 Fed. Appx. 669, 671 (9th Cir. 2016); Syngenta Seeds, Inc. v. County of Kauai, 842 F.3d 669, 681 (9th Cir. 2016).

Of course, the Ninth Circuit’s state-law holdings are not directly applicable outside Hawaii, as is shown by two recent decisions based on peculiarities of Oregon law. See Schultz Family Farms LLC v. Jackson County, No. 1:14-cv-01975, 2015 WL 3448069, *5–6 (D. Or. May 29, 2015) (ordinance not preempted by right-to-farm law; ordinance had been grandfathered in separate state law preempting local regulation of seeds); White v. Josephine County, No. 15-CV-23592 (Josephine Cty. (Or.) Cir. Ct. May 16, 2016) (ordinance preempted by seed law), aff’d without opinion, 287 Or. App. 888 (2017). But the Ninth Circuit’s federal-law holdings are the law in the nine states within the circuit. After Atay, localities cannot simply ban the growing of GE crops in any of those states.

Labeling and Disclosure: Vermont’s Now-Preempted GE Food Labeling Law

As Atay and other cases were unfolding, legislative efforts were in motion to change the regulatory status quo concerning the disclosure of information to consumers about the use of genetic engineering in producing food. Those efforts have borne fruit.

Under the Food, Drug, and Cosmetic Act (FDCA), FDA’s long-standing position has been that, as a general matter, whether a food is produced using genetic engineering is not a fact that must appear on a food’s label. Indeed, a statement containing such information on a label could be false or misleading, and thus illegal, “if, when considered in the context of the entire label or labeling,” the statement suggests “that a food product or ingredient is safer, more nutritious, or otherwise has different attributes than other comparable foods because the food was not genetically engineered.” FDA, Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from [GE] Plants (Nov. 2015); cf. Amy Harmon, How Square Watermelons Get Their Shape, and Other G.M.O. Misconceptions, N.Y. Times, July 12, 2016, at D1.

In 2014, Vermont passed a law that departed from FDA’s long-held presumption. Vt. Stat. Ann. tit. 9 § 3043 (2014). Vermont’s new law required special labeling on the packages of many GE or GE-derived foods offered for sale in the state after July 1, 2016. Trade groups sued Vermont, asserting First Amendment, dormant Commerce Clause, and preemption arguments. The federal district court denied their motion for a preliminary injunction, concluding that the law’s core mandatory disclosure requirement was likely consistent with the First Amendment. Grocery Manufacturers Ass’n v. Sorrell, 102 F. Supp. 3d 583, 635–36 (D. Vt. 2015). (The court concluded that the law was likely unconstitutional insofar as it prohibited the use of “natural” and similar terms to refer to GE food products, but found no likelihood of irreparable harm as to those issues. Id. at 636, 641–42, 645–48.) The plaintiffs appealed to the Second Circuit—which heard argument, but never decided the appeal, as explained below.

Labeling and Disclosure: A New Federal Statute Requires Bioengineering Disclosure—and Preempts State Labeling and Disclosure Laws

In July 2016, President Obama signed bipartisan disclosure legislation that preempted the Vermont law, prompting the plaintiffs in the Vermont litigation to dismiss their appeal and the underlying suit. Pub. L. No. 114–216, § 1, July 29, 2016, 130 Stat. 834, codified as 7 U.S.C. §§ 1639–1639c, 1639i–1639j. The law is directed to USDA, not to FDA, on the ground that it is a food marketing law, not a food safety law. The law thus amends the Agricultural Marketing Act of 1946, not the FDCA, and does not alter FDA’s preexisting authority over food safety. 7 U.S.C. § 1639c(b)(1). The law requires USDA to issue a final rule by July 2018 to create and implement a mandatory disclosure standard for food intended for human consumption that is or may be bioengineered. Id. §§ 1639b(a)(1), 1639(2). USDA’s Agricultural Marketing Service (AMS), which also administers the National Organic Program, is responsible for implementing the new law. See https://www.ams.usda.gov/rules-regulations/gmo.

Although a comprehensive analysis is beyond the scope of this article, three aspects of the new law warrant mention here. First, the law defines the term bioengineering as referring to a food “(A) that contains genetic material that has been modified through in vitro recombinant DNA techniques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature.” 7 U.S.C. § 1639(1). This definition (which seems potentially narrower than “genetic engineering”—a term used in a preemption provision of the statute) is subject to various exclusions. For example, there are exclusions for food served in restaurants or similar establishments; for food derived from animals that consumed bioengineered feed; and for certain foods containing USDA-regulated meat, poultry, and egg products. Id. §§ 1639a(c)(2), 1639b(b)(2)(A),(G)(i). USDA-certified organic food is also exempt. Id. § 6524. The law leaves several issues to be resolved by regulation, such as the meaning of such terms as “conventional breeding” and the amount of a bioengineered substance needed for a food to qualify as “bioengineered food.” See, e.g., id. § 1639b(b)(1), (2)(B).

Second, the disclosure law requires USDA to allow food manufacturers three options for disclosure on food packages: text; symbols; and an electronic or digital link (e.g., a QR code). 7 U.S.C. § 1639b(b)(2)(D), (d). On-package labeling is thus allowed, but not required.

Finally, the disclosure law contains two preemption provisions, plus a savings clause. The first provision preempts disclosure or labeling requirements that are not identical to the national standard. 7 U.S.C. § 1639b(e). The second provision preempts “any requirement relating to the labeling of whether a food . . . or seed is genetically engineered (which shall include such other similar terms as determined by [USDA]) or was developed or produced using genetic engineering.” Id. § 1639i(b). The savings clause preserves “any remedy created by a State or Federal statutory or common law right” against preemption. Id. § 1639j.

Labeling and Disclosure: As a Deadline Looms, USDA Issues Proposed Regulations Implementing the New Statute

In May 2018, USDA AMS released proposed regulations to implement the disclosure law. It seems unlikely that final regulations will issue by the statutory deadline of late July. AMS, National Bioengineered Food Disclosure Standard, 83 Fed. Reg. 19,860 (May 4, 2018) (proposed rule); see USDA, USDA Seeks Comments on Proposed Rule for National Bioengineered Food Disclosure Standard (May 3, 2018), https://bit.ly/2KKFlwE (60-day comment period will not be extended); Food Labeling Law Delayed, Feedstuffs (Apr. 30, 2018), https://bit.ly/2K6VJ9z. As with the statute, this article does not attempt a comprehensive overview of the proposed rule. Here are a few highlights:

First, AMS offered alternative proposals and invited comments on several key issues, such as whether highly refined foods and ingredients are bioengineered food. See 83 Fed. Reg. 19,862–63; id. at 19,863 (inviting comment “on whether to consider intellectual property law as one potential method of determining whether a genetic modification could be found in nature”); id. at 19,865 (inviting comment on whether enzymes and yeast should be included on AMS lists of bioengineered foods); id. at 19,865–67 (discussing approaches to incidental additives and undetectable recombinant DNA); id. at 19,868–69 (discussing alternative approaches for determining amounts of bioengineered substances that may be present in food without disclosure); id. at 19,872–75 (describing and portraying alternative proposals for on-package symbols). The proposal makes no explicit reference to foods developed using genome editing, but the narrowness of the statutory definition of bioengineering tends to weigh against the notion that, as a general matter, such foods would be subject to disclosure. See 7 U.S.C. § 1639(1).

Second, AMS proposed to distinguish between bioengineered (BE) foods, commercially available in the United States, that have a “high” U.S. “adoption rate” (85 percent or more) and commercially available BE foods that are “not highly adopted.” 83 Fed. Reg. 19,864; see also id. at 19,871–72. AMS would compile and regularly revise lists of foods in both categories. For products containing a food on either list, a disclosure would be presumptively required. The presumption could be overcome by “documented verification” of non-BE status. Id. at 19,871; see also id. at 19,878. For foods and ingredients on the first list, disclosure could be made using the terms “Bioengineered food” and ‘‘Contains a bioengineered food ingredient” (or an analogous symbol). Id. at 19,871–72. For foods and ingredients on the second list, the terms ‘‘May be bioengineered food” and “May contain a bioengineered food ingredient” (or their analogous symbols) could also be used. Id. at 19,872.

Finally, AMS indicated that pursuant to executive orders that require cost-benefit analysis of regulatory alternatives and the maximization of net benefits, the proposed rule would impose substantial costs on society, but is “not expected to have any benefits to human health or the environment.” 83 Fed. Reg. 19,881. The only clear benefit of the proposed rule, as described by AMS, appears to be that it preempts state laws, thus “eliminat[ing] costly inefficiencies of a state-level approach to BE disclosure.” Id. (also noting that “[a]ny benefits to consumers . . . are difficult to measure”). AMS’s discussion of this topic seems to suggest that the White House Office of Management and Budget (OMB) has expressed considerable interest in ensuring that AMS promulgates “the least costly rule” that complies with statutory requirements. Id.

A Few Predictions

As Yogi Berra and Niels Bohr are each said to have observed, it’s tough to make predictions—especially about the future. Nonetheless:

First, USDA’s forthcoming final regulations will likely be challenged in court, whether by parties who regard the regulations as too onerous or by parties who regard them as too weak. One might expect challenges based on the disclosure statute itself and on the APA. At least one NGO has suggested that there will be constitutional challenges, which presumably would be harder to mount. See, e.g., Andrew Kimbrell, Why the GMO “Labeling” Bill Obama Just Signed into Law Is a Sham––and a National Embarrassment, Ctr. for Food Safety (Aug. 4, 2016), https://goo.gl/uc7VMf (suggesting that law is “blatantly discriminatory and unconstitutional”); see also Baylen Linnekin, Why a Bad GMO Law Makes Good GMO Regulations Impossible, Reason (May 5, 2018), https://bit.ly/2K2Qibw.

Second, the specifics of the preemption provisions of the new law will be vigorously disputed in litigation. The intent of these overlapping provisions appears to be to ensure broad, immediate preemption—a kind of belt-and-suspenders approach. See Sen. Rep. No. 114-403, at 1, 3, 6, 7, 10 (Dec. 9, 2016). Yet the savings clause, construed to harmonize with the two preemption provisions, may present significant questions in some contexts. See Robin Kundis Craig, Labeling Genetically- Engineered Foods: An Update from One of the Front Lines of Federalism, 47 Env. Law. 609, 641–45 (2017); Kim Bousquet, New Rules Coming for GMO Labeling, Thompson Coburn LLP (Mar. 27, 2018), https://bit.ly/2v4I1Bg (discussing recent decisions interpreting preemption language).

Third, disclosure issues aside, it seems unlikely that controversy over GE crops will dissipate soon. Localities, or even some states, may seek to explore the limits on their powers to regulate GE crops in the wake of the Ninth Circuit’s decision in Atay. And national groups are likely to advocate vigorously for their competing positions as USDA moves forward on its now-resumed efforts to review and consider updating the Part 340 scheme for regulating GE plants.

In closing, it is reasonable to expect that disagreements and debate will surround the use of any major technology related to the cultivation of crops or the production of food. Agriculture has always had, and presumably will always have, environmental impacts. Technology can mitigate such impacts, but can also enhance or focus them. Moreover, the very novelty of some technologies can draw public attention to impacts that might otherwise seem familiar or natural. It might be suggested that a technology’s very success in penetrating agricultural practices is likely to enhance the likelihood that interested parties will consider ways to regulate or control the technology to mitigate its potential effects.

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    Andrew R. Varcoe

    Mr. Varcoe is a partner at Boyden Gray & Associates PLLC in Washington, D.C. Between 2007 and 2014, he was an attorney at the U.S. Department of Agriculture (USDA), where he took part in some of the USDA cases described in this article. Between 2014 and 2017, he was deputy general counsel at the Biotechnology Innovation Organization, where he took part in some of the other cases. Any views herein are solely his own. He may be reached at avarcoe@boydengrayassociates.com.