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Published in:
Introduction: Regulation of Plants Derived from Genome Editing—What Lessons To Be Learned from Other Countries? Read chapter Read first chapter

2019 | OriginalPaper | Chapter

7. Genetic Engineering in the United States: Regulation of Crops and Their Food Products

Author : Margaret Rosso Grossman

Published in: Regulation of Genome Editing in Plant Biotechnology

Publisher: Springer International Publishing

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Abstract

In the United States, federal administrative agencies, including the US Department of Agriculture (USDA), implement statutes and regulations that govern genetically engineered plants and their products. US regulatory measures were developed in light of genetic modification using rDNA, before the advent of new technologies, including gene editing, that offer simple, elegant paths to genetic improvement in plants. After a brief review of global and US production of GE crops, this Chapter analyzes US policy and regulation of these crops and their food products, with emphasis on the role of USDA. The Chapter addresses significant issues raised by GE crops: coexistence of GE and non-GE crops, low-level presence, tort liability, and the new US labeling law for bioengineered foods. Recent policy statements encourage modernized science-based regulation, but some uncertainty applies to regulation of crops developed with new genetic technologies. The Chapter analyzes USDA’s governance of new crop varieties with a focus on the “Am I Regulated?” process, which determines whether new organisms are subject to USDA regulation. The USDA has declined regulatory jurisdiction for a number of products of gene editing and has indicated its intention not to regulate crops developed with certain new technologies. Finally, the Chapter outlines some regulatory challenges posed by advances in biotechnology.

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previous chapter Regulation of Genome Editing in Plant Biotechnology: Japan
next chapter Comparative Analysis: The Regulation of Plants Derived from Genome Editing in Argentina, Australia, Canada, the European Union, Japan and the United States
Footnotes
1
NASEM (2016a), pp. 5–6. These crops are referred to as genetically engineered (GE) or, in the European Union, genetically modified (GM) or genetically modified organisms (GMOs). USDA documents use the term genetic engineering, so this Chapter often refers to GE (rather than GM) crops. The term gene editing applies to technologies such as CRISPR.
 
2
NASEM (2017), p. 172. Scope refers to new types biotechnology products not yet seen by regulators; scale, to the number of products and variants of products; complexity, to the number of traits in a single product and interactions between elements in a product. NASEM (2017), p. 139.
 
3
Jaffe (2017). See Enríquez (2017a) for a summary of types of genome editing and their applications in agricultural and other fields. See also Schaart et al. (2015), pp. 3–17 (explaining new breeding techniques).
 
4
Jaffe (2017). Jaffe noted that farmers grow a gene-edited canola variety developed by Cibus.
 
5
NASEM (2016b), p. 1, n.1. NASEM (2017), p. 187 defines CRISPR: “A naturally occurring mechanism of immunity to viruses found in bacteria that involves identification and degradation of foreign DNA. This natural mechanism has been manipulated by researchers to develop genome-editing techniques.” Cas9 refers to CRISPR associated protein 9. Another definition from Jaffe (2017): CRISPR is “a molecule that identifies the location where the DNA should be cut, and Cas 9 is the enzyme that cuts the DNA at the identified location.”
 
6
Baumann (2016), p. 139.
 
7
NASEM (2016b), pp. 1, 5, 12–13 (noting that these organisms may pose environmental risks).
 
8
NASEM (2016b), p. 3. Gene drives are beyond the scope of this Chapter.
 
9
Hicklin (2014), p. 2. CRISPR has been used to modify human embryos, raising numerous ethical and other issues beyond the scope of this Chapter. Baumann (2016).
 
10
Zhang (2014), p. 3.
 
11
NAS (2018) ($100,000 prize to Rodolphe Barrangou, North Carolina State University). Other scientists, including Jennifer Doudna and Emmanuelle Charpentier, have received awards that recognize significant contributions to CRISPR research.
 
12
Enríquez (2017a), p. 608.
 
13
Enríquez (2017a), pp. 608–609.
 
14
USDA, AC21 (2016), p. 32. US regulatory agencies and others refer to the “product” of biotechnology. In many instances the term “resulting organism” would be more appropriate. Professor Pieter van der Meer, Ghent University and Free University Brussels, Belgium, provided this helpful distinction.
 
15
NASEM (2017), p. 172. A comparator is a “known nonbiotechnology organism that is similar to the engineered organism except for the engineered trait” (p. 187).
 
16
USDA, AC21 (2016), p. 32.
 
17
Task Force (2018), p. 33. Genetic engineering of livestock is beyond the scope of this Chapter. For a discussion of GE animal and cloning, see Grossman (2018), pp. 348–357.
 
18
Bergeson (2017), p. 33.
 
19
ISAAA (2018c), pp. 3–5. Brazil, Argentina, Canada, and India planted more than 10 million hectares; other countries planted fewer hectares. Eighteen countries, including 14 developing countries in Latin America, Asia and Africa, grew 50,000 ha or more.
 
20
Gleim et al. (2016), p. 112.
 
21
ISAAA (2018c), p. 101. Other GE crops were squash, potato, eggplant, and apple.
 
22
ISAAA (2018c), pp. 122–123. GE seeds cost more than conventional seeds, but “farmers realize economic benefits from growing GE crops through higher crop yields, and/or lower pesticide costs, and management time savings.” Fernandez-Cornejo et al. (2014), p. 47.
 
23
ISAAA (2018c), p. 108 (excluding ornamentals). See ISAAA (2018a), a global database of approvals.
 
24
Gleim et al. (2016), p. 102. A study of corn found more approvals for import, often for feed, than for cultivation (pp. 108–109).
 
25
NASEM (2016a), p. 5.
 
26
ISAAA (2018c), p. 9 (using 2017 data).
 
27
APHIS, USDA (2018d). In 2016, “food, feed and cultivation approvals were made for apple (1 event), maize (2) and potato (3).” ISAAA (2017), p. 8.
 
28
Smart et al. (2017), pp. 183, 187, 192. In the EU, the mean approval time for authorized organisms from 1995 to 2015 was 1758 days.
 
29
NASS (2017), pp. 29–31; NASS (2018), pp. 31–33.
 
30
ISAAA (2018c), pp. 11–12.
 
31
Fernandez-Cornejo et al. (2016), pp. 4–6. See Monsanto Co. (2010).
 
32
Greene et al. (2016), p. 12; ISAAA (2018c), pp. 12–14.
 
33
NASEM (2016a), p. 21. See also Smyth (2017), pp. 79–81.
 
34
Brookes and Barfoot (2018), p. 71.
 
35
Brookes and Barfoot (2017a), pp. 9–10.
 
36
Developing country farmers gained $96 billion through 2016. Brookes and Barfoot (2018), p. 71. The US level of benefits was followed by benefits to Argentina, India, China, and Brazil. The EU gained relatively little: $251.3 million in Spain; $23.6 million in a few other EU countries. Brookes and Barfoot (2017a), pp. 10–11.
 
37
Brookes and Barfoot (2017c), p. 163.
 
38
Brookes and Barfoot (2017a), p. 13.
 
39
Brookes and Barfoot (2017a), pp. 13–15. See Brookes and Barfoot (2017b), for data on environmental benefits in individual countries, including the United States.
 
40
Kniss (2017), p. 1. No GE wheat is approved for cultivation.
 
41
Resistance occurs where producers do not follow management strategies, including refuges of non-GM crops and high-dose applications to kill partially-resistant insects. NASEM (2016a), p. 13.
 
42
Brookes and Barfoot (2017a), pp. 16–17. Although a global ban on GE crops is unlikely, it could affect land use and increase greenhouse gas emissions, adding more than a billion tons of carbon dioxide to the atmosphere. A ban would also increase food prices and impose other significant welfare losses. Mahaffey et al. (2016).
 
43
ISAAA (2017), pp. 104–105. In addition to the American Association for the Advancement of Science, the National Academy of Science, and the American Medical Association, others include the World Health Organization, European Commission, UK Royal Society of Medicine, French Academy of Science, Food Standards Australia and New Zealand, Union of German Academics of Sciences and Humanities, and 7 other world academies of sciences. In 2010, the European Commission concluded that “biotechnology, and in particular GMOs, are not per se more risky” than conventional crops. European Commission (2010), p. 16.
 
44
AAAS (2012): “[T]he science is quite clear: crop improvement by the modern molecular techniques of biotechnology is safe,” and GM varieties are the “most extensively tested crops ever added to our food supply,” and pose no special risk.
 
45
AMA (2012).
 
46
NASEM (2016a), pp. 2, 19.
 
47
NASEM (2016a), p. 19.
 
48
Gleim et al. (2016), p. 99.
 
49
ISAAA (2017), p. 1.
 
50
This section relies in part on Grossman (2018, 2016b), pp. 306–314, and Grossman (2012).
 
51
OSTP (1986, 1992). A 2002 policy document led to stronger regulation and enhanced oversight. OSTP (2002). The 2017 Update to the Coordinated Framework is discussed below.
 
52
OSTP (1986), pp. 23,303–23,304.
 
53
USDA (1986).
 
54
USDA (1991), p. 4134.
 
55
NIH (2016). An earlier version of NIH guidelines predated the Coordinated Framework.
 
56
NIH (2016), pp. 105–116. Appendix Q pertains to animals.
 
57
NASEM (2017), pp. 69–70; NASEM (2016b), pp. 153, 170.
 
58
OSTP (1992), p. 6753. See generally Biology Fortified (2018), a database of peer-reviewed research on the risks of GE crops.
 
59
NASEM (2016a), p. 467. Although US regulation focuses on the product, whether USDA and EPA regulate is based in part on process (p. 25). The US approach has been characterized as “category-based,” somewhere between product-based and process-based. For USDA, regulation focuses on varieties that contain a plant pest; for EPA, insecticidal properties; for FDA, food additives. Peck (2017), p. 332.
 
60
NASEM (2016a), pp. 472–473.
 
61
7 United States Code [USC] §§ 7701–7772 (replacing the Plant Pest and Plant Quarantine Acts).
 
62
7 USC § 7711. Pests are defined at 7 Code of Federal Regulations [CFR] § 340.1 and listed in § 340.2.
 
63
7 CFR part 340.
 
64
7 CFR § 340.1:
Regulated Article. Any organism which has been altered or produced through genetic engineering, if the donor organism, recipient organism, or vector or vector agent belongs to any genera or taxa designated in §340.2 [listing organisms that are plant pests] and meets the definition of plant pest, or is an unclassified organism and/or an organism whose classification is unknown, or any product which contains such an organism, or any other organism or product altered or produced through genetic engineering which the Administrator, determines is a plant pest or has reason to believe is a plant pest. Excluded are recipient microorganisms which are not plant pests and which have resulted from the addition of genetic material from a donor organism where the material is well characterized and contains only non-coding regulatory regions.
 
65
A policy document from 2002 focused on principles for field testing. The level of confinement should be consistent with the level of risk to health and environment. Strict confinement measures should apply to GE traits that carry unknown or unacceptable risks. Though out-crossing and commingling should be minimized, low levels of GE gene presence from field tests might be acceptable. OSTP (2002). See also APHIS (2007) on low-level presence.
 
66
7 CFR § 340.3. Other limitations on use of notification apply. USDA proposed regulations, withdrawn in November 2017, would have ended the notification procedure.
 
67
7 CFR § 340.4. Interstate movement and import also require permits.
 
68
42 USC §§ 4321–4370f.
 
69
42 USC § 4332(2)(C). Not all experts agree that GE approvals should be subject to NEPA. Conko et al. (2016), p. 497.
 
70
If the environmental assessment finds no significant impact, the agency does not prepare an EIS. APHIS’s failure to prepare an EIS for a GM alfalfa resulted in extensive litigation that reached the US Supreme Court in Monsanto Co. (2010). For details see Grossman (2010).
 
71
BRS (2017c).
 
72
APHIS (2018a).
 
73
7 CFR § 340.6.
 
74
7 CFR § 340.6(c)(4).
 
75
APHIS (2018d). Other petitions were pending (6), withdrawn (32), or incomplete (1). The number on the APHIS website differs from the information from ISAAA (2018c) cited in note 26 above. Since March 2018, APHIS has made several more determinations of nonregulated status.
 
76
NASEM (2017), p. 15 (stating that USDA did not have authority to reassess products with nonregulated status); NASEM (2016a), p. 471. The National Academies recommended that regulatory agencies have authority to require monitoring of GE crops after approval. NASEM (2016a), p. 507.
 
77
7 CFR § 340.6(e).
 
78
BRS (2016), p. 4.
 
79
Conko et al. (2016), p. 497 (suggesting that APHIS decisions are designed in part “to prepare a paper trail to safeguard against abusive, harassing procedural lawsuits under NEPA”).
 
80
7 USC §§ 136-136y.
 
81
21 USC §§ 301–399f; 21 USC §§ 2201–2252 (Food Safety Modernization Act of 2011).
 
82
PIPs are considered pesticides because they are introduced in plants as way of “preventing, destroying, repelling, or mitigating any pest.” 7 USC § 136(u). EPA regulations define 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 CFR § 174.3.
 
83
40 CFR part 154 (pesticide registration), part 172 (experimental use permits), and part 174 (PIPs). Under 40 CFR part 155 (registration review process), the EPA is expected to re-evaluate registered pesticides every 15 years. NASEM (2017), p. 153.
 
84
EPA (2001). In May 2018, EPA withdrew 1994 and 2001 regulatory proposals affecting PIPs, noting that possible new proposals would take account of more current science and recent developments in biotechnology. EPA (2018), pp. 20,006–20,008.
 
85
7 USC § 136a(c)(5). Unreasonable adverse effects are defined in § 136(bb).
 
86
7 USC § 136(bb). See NASEM (2016a), pp. 474–477 (details of risk assessment).
 
87
See Conko et al. (2016), p. 501 (asserting that the PIP category is “too artificial and contrived” and that no data or experience suggests that genetic modifications should be regulated “as if they were pesticides sprayed on crops”).
 
88
40 CFR § 172.3.
 
89
EPA (2007). EPA may require an experimental use permit or a temporary food tolerance.
 
90
NASEM (2016a), pp. 471–472. The EPA requires warning labels on PIP crops. CAST (2018), p. 13.
 
91
21 USC § 346a. Until 1996, pesticide residues were considered food additives and were subject to the Delaney clause that prohibits approval of substances that contain carcinogens. 21 USC § 348(c)(3)(a).
 
92
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.” 21 USC § 346a(b)(2).
 
93
40 CFR §§ 174.501–174.538 (listing permanent and temporary exemptions from the requirement of a tolerance).
 
94
21 USC §§ 342, 343, 348.
 
95
FDA (1992), pp. 22,984–22,985.
 
96
FDA (1992), p. 22,992 (citing to documents on substantial equivalence from the Organisation for Economic Co-operation and Development, the UN Food and Agriculture Organization, and the World Health Organization). On the substantial equivalence of GE and non-GE crops, see ISAAA (2018b).
 
97
21 USC § 342(a), defining as adulterated any food that contains an additive unsafe under § 348.
 
98
21 USC § 348; 21 CFR part 170.
 
99
21 USC § 321(s): “The term ‘food additive’ means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food … if such substance 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.” Pesticide chemical residues in raw or processed agricultural foods are not defined as food additives.
 
100
FDA (1992), p. 22,990. See Alliance for Bio-Integrity (2000), p. 177, which upheld FDA’s presumption of GRAS status for GM foods.
 
101
FDA (2016) and Grossman (2017).
 
102
21 CFR §§ 170.203–170.285 (GRAS regulations).
 
103
FDA (1992), p. 22,991.
 
104
FDA (1997).
 
105
FDA (2006).
 
106
FDA (2018c) (evaluations); FDA (2018a) (consultations).
 
107
Obama (2011), pp. 1–2.
 
108
Holdren et al. (2011), p. 1.
 
109
Holdren et al. (2011), p. 2.
 
110
Holdren et al. (2015), p. 1.
 
111
Holdren et al. (2015), p. 1.
 
112
Holdren et al. (2015), pp. 4–5.
 
113
The analysis was intended to survey the “future landscape” of biotechnology products. A report from the National Academies of Science, Engineering, and Medicine fulfilled this requirement. NASEM (2017).
 
114
US White House (2016), p. 13.
 
115
US White House (2016), p. 8.
 
116
US White House (2016), pp. 16–18.
 
117
See Peck (2017), p. 324.
 
118
US White House (2017). In 2015, the Executive Office of the President had directed the agencies to update the Coordinated Framework (p. 5).
 
119
US White House (2017), p. 8.
 
120
US White House (2017), Table 1, pp. 9–10.
 
121
US White House (2017), Table 2, pp. 28–35.
 
122
US White House (2017), pp. 39–51.
 
123
Peck (2017), p. 324.
 
124
Kuzma (2016), p. 1211.
 
125
Kuzma (2016), pp. 1212–1213.
 
126
CAST (2018), p. 7. See the quotation from Holdren et al. (2015), p. 1, cited at note 111 above.
 
127
APHIS (2016) (referring to regulations at 7 CFR part 340). See APHIS (2017a), pp. 2–36, which presented three alternatives, including regulations to facilitate coexistence through its authority over noxious weeds: “incorporate the noxious weed authority under the PPA as inclusive of GE plants that cause economic harms due to the mere presence of GE plant material in non-GE crops or crop products, regardless of whether this occurs as a result of cross-pollination, or commingling of GE plant material with non-GE crops or their products during harvest, post-harvest shipping and processing, or other means.” That is, economic harms from mere presence would trigger regulation. The Draft EIS alternatives differed from the APHIS proposed regulations that were withdrawn.
 
128
APHIS (2016), p. 6227:
Biotechnology. Laboratory-based techniques to create or modify a genome that result in a viable organism with intended altered phenotypes. Such techniques include, but are not limited to, deleting specific segments of the genome, adding segments to the genome, directed altering of the genome, creating additional genomes, or direct injection and cell fusion beyond the taxonomic family that overcomes natural physiological reproductive or recombination barriers. This definition does not include and is intended not to include traditional breeding, marker assisted breeding, or chemical or radiation-based mutagenesis.
 
129
APHIS (2016), p. 6227. “Product of biotechnology. An organism developed using biotechnology.” APHIS requested public comments on these definitions, in light of “the potential, or lack of potential” of products of biotechnology to pose risks as plant pests or noxious weeds.
 
130
APHIS (2016), p. 6227 (italics omitted). This alternative would eliminate notification, because many products would not be regulated, and also eliminate the petition for nonregulated status.
 
131
APHIS (2017b), proposing to amend 7 CFR part 340 (Docket APHIS-2015-0057). The 2017 proposed rule responds to a request from the USDA Office of the Inspector General and a directive from Congress to amend some aspects of APHIS regulations.
 
132
APHIS (2017c).
 
133
APHIS (2017b), pp. 7009–7011.
 
134
APHIS (2017c), p. 51,582.
 
135
APHIS (2017b), p. 7018.
 
136
APHIS (2017b), p. 7018.
 
137
APHIS (2017b), pp. 7014–7015.
 
138
BRS (2017a).
 
139
One comment included a petition signed by 10,261 members of the Organic Consumers Association, with 2741 unique comments. See documents collected at www.​regulations.​gov under Docket APHIS-2015-0057.
 
140
APHIS (2017c). APHIS provided no time frame for developing a new regulatory proposal.
 
141
Task Force (2018), p. 34. The Task Force, established in April 2017 by Executive Order 13790, Trump (2017), was asked “to identify key legislative, regulatory, and policy changes to achieve rural prosperity in seven areas,” including technological innovation.
 
142
Task Force (2018), p. 34 (capital letters removed from quotations).
 
143
FDA (2017).
 
144
FDA (2017), p. 6565.
 
145
American Soybean Association (2017).
 
146
American Soybean Association (2017). The Association acknowledged that “gene editing techniques used for transgenic varieties could result in novel functional gene(s)” that may pose food safety risks; FDA’s voluntary consultation process has mitigated these risks.
 
147
Greene et al. (2016), pp. 11–13, 29.
 
148
NASEM (2016a) p. 474. EPA has authority to require monitoring.
 
149
US GAO (2016).
 
150
USDA, AC21 (2016). Coexistence is “the concurrent cultivation of conventional, organic, IP, and GE crops consistent with underlying consumer preferences and farmer choices” (p. 13).
 
151
NASEM (2016a), p. 501. Indeed, adventitious presence has been considered normal. Farming “is practiced in the open air” subject to the vagaries of nature, and “100% purity is impossible.” Grossman (2007), p. 329.
 
152
Greene et al. (2016), pp. 27–28. Even if organic producers meet USDA organic process standards for certification, crops with GE material may fail to meet stricter private industry standards for purity.
 
153
For example, EPA (2007) (guidance for avoiding low-level presence from field tests).
 
154
CAST (2016), pp. 3, 5. Greater asynchronies between pairs of countries result in less trade.
 
155
GAABT (2015), p. 6.
 
156
APHIS (2007), p. 14,469 (referring to existence of “low-level mixing of genes and gene products from unintended plant sources. This is true for both conventionally bred plants as well as biotechnology-derived plants. These occurrences can result from natural processes such as the movement of seeds or pollen, or human-mediated processes associated with field testing, plant breeding, or seed production”).
 
157
7 USC § 7714 (authorizing remedial measures for plant pests and weeds, including seizure or destruction of regulated materials).
 
158
APHIS (2007), p. 14,651.
 
159
FAS (2012). Countries are Australia, Argentina, Brazil, Canada, Chile, Costa Rica, Mexico, Paraguay, Philippines, Russia, United States, Uruguay, and Vietnam.
 
160
FAS (2012). The statement defined low-level presence as “low levels of recombinant DNA plant materials that have passed a food safety assessment according to Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA plants (CAC/GL 45-2003) in one or more countries but may on occasion be present in food in importing countries in which the safety of the relevant recombinant-DNA plants has not yet been determined.”
 
161
Agriculture and Agri-Food Canada (2017). The policy model refers to organisms modified by rDNA technology.
 
162
GAABT (2015), p. 4. See CAC (2003a, b).
 
163
Grossman (2016b), p. 328.
 
164
CAST (2016), p. 5.
 
165
For certified seed, the normal purity level is 99.5% (allowing 0.25% weed seed and 0.25% other crop varieties). Grain contracts often allow 3–5% impurity. Smyth (2017), pp. 82–83.
 
166
CAST (2016), p. 8.
 
167
For details on the Syngenta cases, see Redick (2017), pp. 45–54. China approved Viptera® in 2014, but not for cultivation.
 
168
Feeley and Fisk (2017).
 
169
Tidgren (2018).
 
170
Smyth (2017), p. 83.
 
171
Smyth (2017), p. 83. See Grossman (2012), pp. 93–95 for a discussion of LibertyLink® (LL601) rice and StarLink™ corn, an earlier incident.
 
172
For more details on labeling see Grossman (2016a) and references therein.
 
173
21 USC § 343(a).
 
174
21 USC § 321(n).
 
175
Alliance for Bio-Integrity (2000).
 
176
Grossman (2016b), pp. 317–318.
 
177
FDA (2015).
 
178
7 USC §§ 1639-1639c, 1639i-1639j.
 
179
7 USC § 1639(1).
 
180
21 USC § 321(f): “The term ‘food’ means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” Small manufacturers face less burdensome obligations and a later compliance date, and very small manufacturers and restaurant foods are exempt. 7 USC § 1639b.
 
181
For an analysis of mandatory labeling, with special reference to GM foods, and the conclusion that “it will not be easy for the USDA to show that the benefits of the [labeling] mandate justify the costs,” see Sunstein (2017), p. 1069.
 
182
Deloitte (2017). Although many Americans own a smartphone and nearly all national and regional grocery chains provide Wi-Fi in stores, not all small and rural retailers provide Wi-Fi, which would impose costs. Moreover, scanning QR codes or digital links is difficult for many consumers. Results of the study may have influenced AMS’s addition of text message as an alternative method of disclosure.
 
183
AMS (n.d.).
 
184
AMS (2018a).
 
185
AMS requested comments on three possible thresholds. Two alternatives would have exempted “[f]ood in which an ingredient contains a bioengineered substance that is inadvertent or technically unavoidable,” with thresholds of no more than 5%, or alternatively 0.9%, by weight of that specific ingredient. The third alternative would exempt food from labeling if ingredients containing a bioengineered substance are no more than 5% “total weight of the food in final form.” AMS (2018a), p. 19,886.
 
186
AMS (2018b). AMS failed to meet the 29 July 2018 statutory deadline for final regulations.
 
187
66 CFR § 66.1, with analysis and recordkeeping requirements for detectability at 66 CFR § 66.9.
 
188
AMS (2018b), p. 65,835.
 
189
66 CFR § 66.5.
 
190
66 CFR § 66.6. The List, to be updated annually, currently includes the following foods: “Alfalfa, apple (Arctic™ varieties), canola, corn, cotton, eggplant (BARI Bt Begun varieties), papaya (ringspot virus-resistant varieties), pineapple (pink flesh varieties), potato, salmon (AquAdvantage®), soybean, squash (summer), and sugarbeet.” Non-BE varieties of these foods (and foods with nondetectable modified genetic material) are not subject to disclosure. AMS (2018b), p. 65,826. Foods not on the list are subject to disclosure if the manufacturer has actual knowledge that the food or an ingredient is bioengineered. 66 CFR § 66.109.
 
191
66 CFR § 66.102.
 
192
66 CFR § 66.104.
 
193
66 CFR §§ 66.106, 66.108.
 
194
AMS (2018b), p. 65,825. US exports must meet requirements of import countries.
 
195
66 CFR § 66.13. Small food manufacturers have annual receipts of at least $2.5 million but less than $10 million. Provisions for voluntary disclosure may apply. 66 CFR § 66.116.
 
196
66 CFR § 66.13; AMS (2018b), pp. 65,861–65,862.
 
197
Grossman (2016a), pp. 504–507.
 
198
66 CFR §§ 66.400–66.406. After an investigation and a hearing (if requested by the food producer), the results of an investigation of possible violations will be made public.
 
199
21 USC §§ 331–337a.
 
200
Greene et al. (2016), pp. 25–28.
 
201
For details on liability, see Grossman (2016b), pp. 326–330.
 
202
StarLink (2000). The court decision in StarLink indicated that the economic loss doctrine often precludes recovery for damages unrelated to injury to property or physical loss (called pure economic loss).
 
203
European Union law also poses uncertainties. See Kahrmann et al. (2017).
 
204
NASEM (2016a), p. 26.
 
205
See, for example Kerr (2017), p. 69: “Genomics and its associated techniques should not raise the issues pertaining to risks to the environment that arose in the case of transgenic crops. … There is no need for a special regulatory regime, nor for special international trade rules such as those associated with the creation of plants with transgenic gene combinations.” Moreover, “food safety implications should be no different than with food products arising from conventional breeding.”
 
206
Wolt et al. (2016), p. 514.
 
207
7 CFR § 340.1. At the time of the 1986 Coordinated Framework, GE plants were produced with rDNA technology using agrobacterium tumefaciens, a plant pathogen. NASEM (2016a), p. 498.
 
208
7 CFR part 360.
 
209
NASEM (2016a), p. 498.
 
210
FDA (1992).
 
211
See Enríquez (2017b), p. 538.
 
212
NASEM (2016a), p. 493.
 
213
Peck (2017), p. 321.
 
214
7 USC § 1639(1).
 
215
NASEM (2016a), p. 493.
 
216
Conko et al. (2016), p. 502.
 
217
NASEM (2016a), p. 494.
 
218
Smyth (2017), p. 81.
 
219
BRS (2017b).
 
220
BRS (2011).
 
221
APHIS (2018b).
 
222
7 CFR part 340; Wolt et al. (2016), pp. 511, 515, Tables 1, 3.
 
223
Waltz (2016), p. 293 (mentioning 30 products); NASEM (2016a), p. 495. Other techniques include cisgenesis and intragenesis, developed in part because of “legislative, regulatory, marketing, and public-perception concerns.” NASEM (2016a), p. 357. Cisgenesis involves modification of an organism with a gene from a different variety of a crop or a sexually compatible species. Intragenesis recombines plant DNA from the crop itself or its sexually compatible relatives into a genetic construct introduced into the new plant. Simplot’s Innate potato, approved for cultivation in the US, is intragenic.
 
224
Gregoire (2010).
 
225
Gregoire (2012). ZFN products involving plant pests will be regulated, and insertions of genetic material must be evaluated on a case-by-case basis.
 
226
APHIS (2018b). Simplot had followed USDA’s petition process for other potatoes and received nonregulated status. The USDA APHIS database includes Am-I-Regulated? inquiries and Biotechnology Regulatory Services responses since 2011. Citations to APHIS (2018b) link to these documents for each variety.
 
227
APHIS (2018b).
 
228
APHIS (2018b) (also considering the potential for weediness).
 
229
In both 2016 and 2018, BRS confirmed that biolistically derived maize, created by direct physical gene transfer, included no plant pests and posed no threat of weediness. Therefore, the varieties are not regulated. APHIS (2018b). In March 2018, APHIS declined to regulate a salinity-tolerant cisgenic rice, developed with biolistics, as a plant pest, but planned to consider weediness in more detail. The agency also did not regulate a fragrant moss created with PEG-mediated transformation and in May 2018 declined to regulate two biolistic soybeans. APHIS (2018b).
 
230
APHIS (2018b). Erwinia amylovora, modified for application to apple trees, remained a plant pathogen, which is a plant pest.
 
231
Waltz (2016), p. 582. The corn may be commercialized within 5 years; plans for commercialization of the mushroom are uncertain.
 
232
7 CFR part 340; 7 CFR part 360.
 
233
APHIS (2018b). Okanagan Specialty Fruits’ Arctic apples, which do not brown when cut, were also developed by gene silencing, which shut down genes for the browning enzyme. USDA granted nonregulated status to Arctic Golden and Granny apples in 2015, and later extended that status to Arctic Fuji apples. The nonbrowning trait can be characterized as a “loss of function” trait, in contrast to other GE crops with “gain of function” traits (for example, herbicide tolerance or insecticide resistance). NASEM (2016a), p. 272.
 
234
APHIS (2018b).
 
235
APHIS (2018b).
 
236
APHIS (2018b), Waltz (2018), p. 6. The USDA-ARS Plant Science Research Unit that developed the crop is located in St Paul, Minnesota.
 
237
APHIS (2018b).
 
238
NASEM (2016a), p. 509.
 
239
APHIS (2018c).
 
240
APHIS (2018c) explains: “the change to the plant solely introduces nucleic acid sequences from a compatible relative that could otherwise cross with the recipient organism and produce viable progeny through traditional breeding.”
 
241
APHIS (2018c) explains: “off-spring of a genetically engineered plant that does not retain the change of its parent.”
 
242
APHIS (2018c), referring to recommendations in Task Force (2018), discussed above, Sect. 7.4.2.1.
 
243
USDA (2018).
 
244
USDA (2018).
 
245
Giddings (2018).
 
246
FDA (1992), p. 22,982. The definition of modification continues, “Modifications may be minor, such as a single mutation that affects one gene, or major alterations of genetic material that affect many genes. Most, if not all, cultivated food crops have been genetically modified.”
 
247
Peck (2017), p. 322.
 
248
See FDA (2018a).
 
249
Keefe (2015). The biotechnology consultation was completed soon after USDA had granted nonregulated status.
 
250
NASEM (2017).
 
251
NASEM (2017), p. 141.
 
252
NASEM (2017), p. 11.
 
253
NASEM (2017), p. 6. Other agencies may also have jurisdiction over some new products, but the 2017 Coordinated Framework does not outline the roles of those agencies.
 
254
NASEM (2017), p. 11.
 
255
NASEM (2017), pp. 8, 172. Risk assessment for GE crops often uses a nonbiotechnology comparator. With new technology (for example, a product with only synthetic DNA), however, finding a nonbiotech comparator may be difficult, so “the idea of ‘comparator’ may need to expand to include similar existing biotechnology products with which regulatory agencies already have experience” (p. 155). One commentator suggested that in the future regulators could require “omics” data to prove substantial equivalence of crops developed with innovative biotechnology to traditional crops. Enríquez (2017b), pp. 533–534.
 
256
NASEM (2017), p. 11.
 
257
NASEM (2017), p. 11.
 
258
NASEM (2017), pp. 171–185.
 
259
NASEM (2017), pp. 174–175.
 
260
NASEM (2017), pp. 176–177.
 
261
NASEM (2016a), pp. 26–27, 513. The National Academies also recommended that policymakers address socio-economic, as well as scientific, issues and facilitate communication with the public.
 
262
NASEM (2016a), pp. 48, 303.
 
263
IFIC (2017). Only about 5% of consumers ranked biotechnology as their first food safety concern; about 13%, their second or third concern.
 
264
IFIC (2014).
 
265
FDA (2018b).
 
266
Podevin et al. (2012), p. 1057.
 
267
Podevin et al. (2012), pp. 1058–1060.
 
268
Conko et al. (2016), p. 498.
 
269
Conko et al. (2016), pp. 498–499. Risk is “an arithmetic function of the likelihood that the genetic modification will lead to harm and the magnitude of the resulting harm, conventionally stated as: Risk = Hazard × Exposure” (p. 499).
 
270
Conko et al. (2016), p. 501. Most regulatory systems, including the US, “are neither scientifically defensible nor justifiable: all too often, they lead to the plants of lowest risk being subject to the highest degree of scrutiny. The result is a massive waste of limited resources, huge disincentives to innovation in a time of great need and no increase in public or environmental safety.”
 
271
Peck (2017), pp. 328–329.
 
272
Peck (2017), p. 333. Peck recommended creation of a Biosafety Clearinghouse to help developers identify the appropriate regulatory agency for their product and to facilitate agency consultations; EPA environmental monitoring of risky varieties; and federally-funded research to encourage innovation and ensure health and safety (pp. 335–339).
 
273
Indeed, a recent criticism characterized regulation of GE crops as “a scientifically unjustified barrier to agricultural innovation.” CAST (2018), p. 16.
 
274
See CAST (2018), pp. 2–3, 11–12, 15.
 
275
CAST (2018), p. 16. Small-market, specialty, and perennial crops are particularly affected by high costs and data demands of the regulatory process (p. 12).
 
276
Conko et al. (2016), pp. 501–502. These large crops are often annual field crops. CAST (2018), p. 12.
 
277
See Conko et al. (2016), p. 502. See also Bergkamp (2017), pp. 62–63: “[R]egulators should think twice before regulating the risks associated with new technologies. Innovation is important to any society, and innovation requires risk-taking.” Instead, regulators should ask “whether we are better off without the proposed restrictions, or with a more modest regime. Not all risks can and should be regulated; some risks are well worth taking.”
 
278
Kerr (2017), pp. 67, 72 (quotation, p. 67).
 
279
Statutes and regulations are cited in footnotes and not included here.
 
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Metadata
Title
Genetic Engineering in the United States: Regulation of Crops and Their Food Products
Author
Margaret Rosso Grossman
Copyright Year
2019
Book
Regulation of Genome Editing in Plant Biotechnology

Print ISBN: 978-3-030-17118-6

Electronic ISBN: 978-3-030-17119-3

Copyright Year: 2019

DOI
https://doi.org/10.1007/978-3-030-17119-3_7