Abstract
Biotechnology has played an increasingly important role in agriculture since the commercialization of genetically engineered crops, now planted globally on 185 million hectares. Animal applications of biotechnology include transgenic and cloned animals. In the US and the EU, legislative measures described in this chapter govern authorisation of GE crops, with a focus on food and feed safety and protection of the environment; transgenic and cloned animals are also subject to regulation. The US and the EU share some regulatory priorities, including scientific risk assessment, and face similar issues (a lengthy regulatory process and coexistence of GE and other crops). Significant differences in regulation, particularly in risk management, exist. Moreover regulatory barriers caused by asynchronous approvals of GE crops have reduced trade between the US and EU. Innovative genetic technologies, which may escape regulation under current laws, may require amendments to US and EU regulatory measures. This chapter suggests that despite differences in approach, regulatory systems should facilitate the development of new products of biotechnology and help to make these products available to global producers and consumers.
This Chapter is based on work supported by USDA, National Institute of Food and Agriculture, Hatch Project No. ILLU-470-348.
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Notes
- 1.
NAS (2004), p. 17.
- 2.
NAS (2002), p. 4.
- 3.
- 4.
NAS (2002), p. 4.
- 5.
NASEM (2016), p. 1.
- 6.
ISAAA (2017), p. 2. These crops are termed genetically engineered (GE) or, especially in the EU, genetically modified (GM). This Chapter will use both terms.
- 7.
ISAAA (2017), pp. 1–4. In 1996, total plantings were 1.7 million hectares. The US grew sugar beets, alfalfa (8.46 million hectares), and small amounts of papaya, squash, and potato.
- 8.
ISAAA (2017), pp. 12–13.
- 9.
ISAAA (2017), pp. 2–4.
- 10.
Gliem et al. (2016), p. 112.
- 11.
ISAAA (2017), p. 10. The 3768 separate approvals do not include GM flowers. There were 1238 approvals for feed, 1777 for food, and 753 for cultivation.
- 12.
Gliem et al. (2016), p. 102. A study of corn found more approvals for import, often for feed, than for cultivation (pp. 108–109).
- 13.
NASEM (2016), p. 5.
- 14.
See discussion of AquAdvantage salmon below and Grossman (2016b).
- 15.
See ISAAA (2017), pp. 15–16.
- 16.
NASEM (2016), pp. 493–494.
- 17.
- 18.
Fernandez-Cornejo et al. (2014), p. 47.
- 19.
Brookes and Barfoot (2017), pp. 9–10.
- 20.
In 2017, biotech varieties were 92% of corn, 94% of soy, and 96% of upland cotton. NASS (2017), pp. 29–31. Most corn and cotton seeds have stacked traits that provide both insect resistance and herbicide tolerance. Producers planted significant amounts of GE canola and sugar beets, with fewer acres of GE alfalfa, sweet corn, squash, and papaya. Greene et al. (2016). By 2013, about 98% of US sugar beets and 95% of canola were GE (herbicide tolerant) varieties. Only 13% of harvested alfalfa acres were GE; alfalfa is planted every 6–7 years, and (after litigation beginning in 2007) deregulation occurred only in 2011. Fernandez-Cornejo et al. (2016).
- 21.
Brookes and Barfoot (2017), pp. 10–11.
- 22.
Brookes and Barfoot (2017), p. 13.
- 23.
- 24.
Kniss (2017), p. 1.
- 25.
NASEM (2016), pp. 2, 19.
- 26.
- 27.
Gliem et al. (2016), p. 99.
- 28.
ISAAA (2017), p. 1. As commentators noted, a global ban on GE crops (although unlikely) would increase food prices and impose other significant welfare losses; a ban is also likely to affect land use and to increase greenhouse gas emissions, adding more than a billion tons of carbon dioxide to the atmosphere. Mahaffey et al. (2016).
- 29.
- 30.
- 31.
OSTP (1992), p. 6753.
- 32.
NASEM (2016), p. 467. Although US regulation focuses on the product, whether USDA and EPA regulate is based in part on process (p. 25).
- 33.
For more detail, see Grossman (2012).
- 34.
7 USC §§ 7701–7772 (replacing the Plant Pest and Plant Quarantine Acts).
- 35.
7 USC § 7711.
- 36.
7 CFR part 340.
- 37.
APHIS regulations required a permit for trials that posed special risks; other trials required only notification and compliance with APHIS performance standards. The 2017 proposed regulation would require permits for regulated organisms. See discussion below.
- 38.
NEPA, 42 USC § 4332(2)(C), requires federal agencies to prepare an environmental impact statement for “major federal actions significantly affecting the quality of the human environment.”
- 39.
APHIS, USDA (2017a) (data base of petitions).
- 40.
7 USC §§ 136-136y.
- 41.
PIPs are considered pesticides because they are introduced in plants as way of “preventing, destroying, repelling, or mitigating any pest.” 7 USC § 136(u). The EPA defines PIP as “a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for [its] production.” 40 CFR § 174.3.
- 42.
7 USC § 136a(c)(5). Unreasonable adverse effects are defined in § 136(bb).
- 43.
21 USC §§ 301–399f.
- 44.
21 USC § 346a.
- 45.
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).
- 46.
40 CFR §§ 174.501–174.535 (listing permanent and temporary exemptions from the requirement of a tolerance).
- 47.
FDA (1992).
- 48.
21 USC §§ 342, 348.
- 49.
FDA (1992), p. 22,992 (referring to OECD and FAO/WHO documents on substantial equivalence).
- 50.
21 USC § 342(a), defining as adulterated any food additive that is unsafe under § 348.
- 51.
21 USC § 321(s). A GRAS determination requires the same level of scientific evidence required for approval of a food additive.
- 52.
FDA (1992), pp. 22,990.
- 53.
- 54.
FDA (2017a) (Biotechnology Consultations).
- 55.
NASEM (2016), pp. 472–473.
- 56.
7 USC 136(bb). See NASEM (2016), pp. 474–477 (details of risk assessment).
- 57.
The discussion is guided by Grossman (2016c) and the references therein.
- 58.
21 USC § 343(a).
- 59.
21 USC § 321(n).
- 60.
A federal district court decision upheld the FDA’s conclusion. Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166 (D DC 2000).
- 61.
FDA (2015a) (Guidance, Voluntary Labeling).
- 62.
National Bioengineered Food Disclosure Standard (2016), Public Law 114–216.
- 63.
7 USC § 1639(1).
- 64.
A study of technological challenges that affect electronic or digital access to disclosure, required by law, identified obstacles for retailers and consumers. Deloitte (2017).
- 65.
7 USC § 1639b.
- 66.
AMS, USDA (2017).
- 67.
Grossman (2016c), pp. 504–507.
- 68.
Obama (2011), pp. 1–2.
- 69.
OSTP (2011), p. 1. The memorandum distinguished risk assessment and risk management: “Federally mandated risk management actions should be appropriate to, and commensurate with, the degree of risk identified in the assessment” (p. 2).
- 70.
Language in the National Strategy is similar. The policy of the US government is to adopt regulatory approaches “to protect health and the environment while reducing regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.” US White House (2016), p. 13.
- 71.
US White House (2016), p. 8.
- 72.
US White House (2016), pp. 16–18.
- 73.
US White House (2017). In 2015, the Executive Office of the President had directed the agencies to update the Coordinated Framework (p. 5).
- 74.
US White House (2017), p. 8.
- 75.
US White House (2017), Table 1, pp. 9–10.
- 76.
US White House (2017), Table 2, pp. 28–35.
- 77.
US White House (2017), pp. 39–51.
- 78.
APHIS, USDA (2017b), proposing to amend 7 CFR part 340 (Docket APHIS-2015-0057). The 1987 rule had been amended several times, and in 2015 APHIS withdrew its 2008 proposed amendment. 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.
- 79.
APHIS, USDA (2017c).
- 80.
APHIS, USDA (2017b), pp. 7009–7011. APHIS is developing a Weed Risk Assessment System for Genetically Engineered Plants.
- 81.
APHIS, USDA (2017b), p. 7018.
- 82.
APHIS, USDA (2017b), p. 7018.
- 83.
APHIS, USDA (2017b), pp. 7014–7015.
- 84.
APHIS, USDA (2017c). APHIS provided no time frame for developing a new regulatory proposal.
- 85.
FDA (2017b) (Notification, Genome editing).
- 86.
FDA (2017b), p. 6565.
- 87.
- 88.
ISAAA (2017), p. 9.
- 89.
Contained use is now governed by Directive 2009/41.
- 90.
- 91.
Directive 2001/18, preamble (47). See de Sadeleer (2015), pp. 535–537.
- 92.
Regulation 178/2002, preamble (112); see also preamble (20), Articles 6, 7.
- 93.
Regulation 178/2002, preamble (19).
- 94.
For detail on these measures, see Grossman (2009), pp. 280–295.
- 95.
On the role of EFSA, see de Sadeleer (2015), pp. 539–541.
- 96.
An October 2016 draft proposal (SANTE/11248/2016 Annex) would amend Annexes II and III of Directive 2001/18 to strengthen environmental risk assessment, making it “needlessly more burdensome.” FAS, USDA (2016), p. 19 (referring to SANTE/11248/2016).
- 97.
- 98.
EFSA (2011), 3.1.3.
- 99.
EFSA (2011), 3.3.3. A similar process applies to feed. If a product will be used as both food and feed, a single decision is made. Regulation 1829/2003, art. 27.
- 100.
Regulation 1829/2003; Regulation 1830/2003.
- 101.
European Commission (2015b) (Memo/15/4779).
- 102.
FAS, USDA (2016), p. 23 (GAIN FR1624). In the US and Brazil, the average is 25 months.
- 103.
EU Ombudsman (2016).
- 104.
Regulation 1829/2003, Article 7(1) imposes a time limit of within 3 months after the EFSA decision.
- 105.
EU Ombudsman (2016), para 20–21.
- 106.
FAS, USDA (2016), pp. 17–18, 32–33. The EU threshold for labelling is 0.9%. See below.
- 107.
Commission Regulation 619/2011, Article 2 and preamble (14). Some private operators set a 0.01 threshold for seed. See ICF-GHK (2013), pp. 33–34. In 2009, according to the Foreign Agricultural Service, “the EU denied the entry of 180,000 metric tons of U.S. soy because the shipment contained traces of three biotech corn types that the EU had not approved for food, feed, or import, although these products were allowed for use in the United States.” This event led to the 2011 regulation. FAS, USDA (2016), p. 32.
- 108.
For example Directive 2001/18, Article 23.
- 109.
de Sadeleer (2015), pp. 543–545.
- 110.
Directive 2001/18, Article 26a, added by Regulation1829/2003, art. 43. On early coexistence measures in the EU, see Grossman (2007).
- 111.
European Commission (2010), repealing Recommendation 2003/556/EC.
- 112.
See Bodiguel (2016).
- 113.
Directive 2015/412, preamble (6).
- 114.
Directive 2015/412, preamble (16).
- 115.
Directive 2015/412, Article 1, amending 2001/18, Article 26a.
- 116.
Directive 2001/18, Article 26b(1)-(2). See European Commission (2017b) (Member State demands).
- 117.
Directive 2001/18, Article 26b(3).
- 118.
See Directive 2015/412, preamble (15). Socio-economic impacts, both quantitative and qualitative impacts, include “costs of coexistence, the lack of benefit, and consumer protection.” Winter (2016), p. 127.
- 119.
Directive 2001/18, Article 26b(3) (enumeration omitted).
- 120.
Directive 2001/18, preamble (14): Member State grounds can include “the maintenance and development of agricultural practices which offer a better potential to reconcile production with ecosystem sustainability, or maintenance of local biodiversity, including certain habitats and ecosystems, or certain types of natural and landscape features, as well as specific ecosystem functions and services.”
- 121.
Directive 2001/18, Article 26b(8).
- 122.
FAS, USDA (2016), pp. 9–10.
- 123.
Winter (2016), p. 121.
- 124.
Salvi (2016), pp. 209–210.
- 125.
- 126.
Salvi (2016), p. 210.
- 127.
European Commission (2015c), COM (2015) 177 final.
- 128.
Salvi (2016), pp. 208–209.
- 129.
FAS, USDA (2016), p. 18.
- 130.
European Commission (2017c), COM (2017) 85.
- 131.
Products were GMOs and glyphosate. European Commission (2017a) (Memo/17/273).
- 132.
- 133.
Commission Regulation 65/2004.
- 134.
Regulation 1829/2003, Article 12. Labelling must also mention characteristics of food that is different from its conventional counterparts or that may “give rise to ethical or religious concerns” (Article 13).
- 135.
Regulation 1830/2003, Article 4 (traceability); Directive 2001/18, Article 21; Regulation 1829/2003, Article 12.
- 136.
CAST (2009), p. 12.
- 137.
CAST (2009), pp. 5–12.
- 138.
Economist (2017), p. 19.
- 139.
CAST (2009), p. 4.
- 140.
CAST (2009), p. 5.
- 141.
NAS (2002), p. 4.
- 142.
NAS (2002), p. 2.
- 143.
- 144.
- 145.
NAS (2002), pp. 9–11 and chap. 5. Fitness in the environment will determine whether a GE animal—for example, GE salmon—will become established in the wild. The report noted the lack of regulatory framework to govern biotechnology in arthropods (p. 14).
- 146.
- 147.
CVM, FDA (2015), p. 3 (Guidance 187). Guidance 187 focuses on animals with heritable rDNA constructs, including food animals. Nonheritable modifications include, for example, gene therapy, and may be addressed in a later FDA guidance.
- 148.
21 USC § 360b; 21 CFR parts 510, 514. In 2002 the NAS indicated some lack of clarity about the meaning of the FDCA new animal drug provisions in the context of transgenic animals. Policy questions existed about the meaning of safe, environmental impacts, degree of precaution, application of new animal drug regulatory standards. NAS (2002), p. 111.
- 149.
The FDCA defines drugs as “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” A new animal drug is “any drug intended for use in animals other than man, including any drugs intended for use in animal feed … the composition of which is such that such drug is not generally recognized [among experts] as safe and effective.” 21 USC §§ 321(g), 321(v).
- 150.
- 151.
NEPA, 42 USC § 4332(2)(C).
- 152.
- 153.
FDA (2015c) (Draft Guidance on Labeling).
- 154.
Consolidated Appropriations Act 2016, § 761(a).
- 155.
In Canada, 4.5 tons of AquAdvantage salmon were sold for consumption, with no label requirement, in August 2017. Waltz (2017).
- 156.
The “regulated article” is the “intentionally altered genomic DNA of the animal.” CVM, FDA (2017), pp. 4–5 (Draft Guidance 187).
- 157.
CVM, FDA (2017), p. 3.
- 158.
Miller (2017), including quotation in prior sentence. Miller suggests that the FDA could avoid lengthy pre-market review by using the GRAS concept to GE animals; “adding a GRAS gene to a GRAS organism is likely to yield a GRAS outcome,” thus eliminating some pre-market review.
- 159.
FAS (2016), pp. 42–43.
- 160.
FAS (2016), pp. 45–46.
- 161.
EFSA (2012a).
- 162.
EFSA (2013). The document focuses on risk assessment under both Regulation 1829/2003 and Directive 2001/18.
- 163.
EFSA (n.d.).
- 164.
Regulation 2015/2283, Articles 2(2)(a), 3(2)(a)(v).
- 165.
Regulation 178/2002, Article 2. Live animals are not defined as food unless they are intended for human consumption (Article 2(b)).
- 166.
Regulation 1829/2003, Article 2(5); Regulation 2001/18, Article 2(2) and Annex IA.
- 167.
Regulation 1829/2003; Regulation 1830/2003.
- 168.
CAST (2009), p. 3.
- 169.
BIO (2010).
- 170.
CVM, FDA (2015) (Guidance 187), p. 2.
- 171.
CVM, FDA (2008a), pp. 9–10.
- 172.
CVM, FDA (2008a), p. 15.
- 173.
CVM, FDA (2008a), p. 16.
- 174.
- 175.
CVM, FDA (2008b) (Guidance 179), p. 3.
- 176.
CVM, FDA (2008b) (Guidance 179), p. 3.
- 177.
Knight (2008).
- 178.
FAS (2011) (Argentina, Brazil, New Zealand, Paraguay).
- 179.
EFSA (2008).
- 180.
- 181.
EFSA (2012b), p. 2.
- 182.
EFSA (2012b), p. 18.
- 183.
European Commission (2013e), COM (2013) 894 final (Novel Foods proposal).
- 184.
European Commission (2013c), COM (2013) 892 final, p. 2. A Commission impact assessment accompanying the proposals set out several policy options: no change (continue use of Novel Foods Regulation); pre-market approval of food from clones and their progeny; labelling of food from clones and their progeny (requiring identification and traceability of animals); and temporary suspension of cloning and import of clones. European Commission (2013b), SWD (2013) 519 final, pp. 28–47.
- 185.
European Commission (2013a) (Memo/13/1169), p. 3.
- 186.
European Commission (2013c), COM (2013) 892 final. The legal basis for the Directive was Article 43 TEFU (agriculture), and would have been enacted under the co-decision procedure, with both Parliament and Council reaching agreement. Another objective was “to ensure uniform conditions of production for farmers” (p. 2).
- 187.
Council Directive 98/58/EC protects the welfare of farm animals.
- 188.
European Commission (2013d), COM (2013) 893 final. The legal basis was Article 352(1) Lisbon Treaty and would have required consent of Parliament and unanimous decision of the Council.
- 189.
- 190.
See Eur-Lex (n.d.).
- 191.
Under Regulation 258/97, Member State food assessment agencies reviewed new foods first. Regulation 2015/2283 introduces a more efficient centralized procedure, with an EFSA risk assessment.
- 192.
Regulation 2015/2283, preamble (14); Article 1(2)(e).
- 193.
Regulation 2015/2283, Article 3(2)(a)(v). See also Article 3(2)(a)(vi), defining novel food as “food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae.” Like some procedures in the US, the Regulation indicates that food operators should determine if their product must comply with the regulation. In case of uncertainty, operators should consult the relevant Member State, which may consult other States and the Commission (Article 4(1)-(3)).
- 194.
Regulation 2015/2283, Articles 10–13. Articles 14–20 set out a procedure to facilitate use of traditional food with a 25-year history of safe consumption in third countries.
- 195.
For example, Regulation 1169/2011.
- 196.
Regulation 2015/2283, preamble (33) and Article 9(2)(c), (3)(b).
- 197.
European Commission (2015a), p. 1.
- 198.
European Commission (2015a), pp. 1–6. See also ICF GHK (2012). Requirements for an effective system could resemble identification and tracking of individual animals in the National Animal Identification System, developed to monitor animal health and eventually abandoned by the US Department of Agriculture. Grossman (2006).
- 199.
NASEM (2016), p. 455.
- 200.
- 201.
NASEM (2016), p. 492.
- 202.
See NASEM (2016), p. 502.
- 203.
Stapleton (2016), p. 531.
- 204.
Stapleton (2016), pp. 530–531. Stapleton believes that Directive 2015/412, which allows Member States to opt out of cultivation, helps to resolve the deadlock.
- 205.
Gliem et al. (2016), pp. 110–112.
- 206.
Smart et al. (2017), p. 183.
- 207.
Smart et al. (2017), p. 183 (references omitted).
- 208.
Smart et al. (2017), p. 192.
- 209.
Smart et al. (2017), pp. 187, 192. The US study included 95 observations; EU, 65 observations of completed applications.
- 210.
Smart et al. (2017), pp. 192–193. In the EU, developers’ scientific investigations can use data submitted by other notifies.
- 211.
CAST (2009), p. 12.
- 212.
Smyth et al. (2016), p. 189.
- 213.
- 214.
USDA, AC21 (2016).
- 215.
US Government Accountability Office (2016).
- 216.
- 217.
Greene et al. (2016), pp. 25–28.
- 218.
The Canadian Parliament defeated a GM labelling law in May 2017.
- 219.
The Codex Alimentarius Commission has no rules for labelling, but listed a number of relevant Codex texts. CAC (2011).
- 220.
Young (2003), pp. 461–466.
- 221.
NASEM (2016), pp. 455–456.
- 222.
United Nations (1992), principle 15.
- 223.
United Nations (2000), preamble and Article 1.
- 224.
For comparison of US and EU approaches to precaution, see Anker and Grossman (2009).
- 225.
Regulation 178/2002, Articles 6, 7, which do not mention consumer preferences. Preamble (112) refers to “a risk to life or health.”
- 226.
“Traceability should also facilitate the implementation of risk management measures in accordance with the precautionary principle.” Regulation 1830/2003, preamble (3). See European Commission (2000).
- 227.
Regulation 2015/2283, Article 12(1)(B), referring to Regulation 178/2002 (General Food Law), Article 7. “Novel foods should be safe and if their safety cannot be assessed and scientific uncertainty persists, the precautionary principle may be applied.” Regulation 2015/2283, preamble (20).
- 228.
Anker and Grossman (2009), p. 21. One European lawyer commented that “[b]ehind the concept of a precautionary system … , there is a rigid political choice on the part of the European legislator which rather encourages suspicion regarding the application of biotechnologies in agriculture, in a manner that is very different from that of other countries.” Lucifero (2016), p. 155.
- 229.
- 230.
CAST (2013), pp. 12–13.
- 231.
NAS (2002), p. 116.
- 232.
Phillipson (2016), p. 92.
- 233.
Binimelis and Myhr (2015), pp. 61–62.
- 234.
NASEM (2016), p. 464. Trade agreements discourage consideration of socioeconomic concerns.
- 235.
United Nations (2000), Article 26(1), Socio-Economic Considerations.
- 236.
Smyth (2017), p. 82. Smyth argues that the Cartagena Protocol undermines agriculture research in developing countries. Moreover, he asserts that the EU offers preferred tariff rates to developing countries that ratify the Protocol and discourages developing countries from adopting GE crops by threating loss of access to EU markets (pp. 82–84). His rather draconian recommendations are to help developing countries to leave the Cartagena Protocol and to “develop a means of fencing Europe out of global commodity trade” (p. 85).
- 237.
Regulation 178/2002, preamble (19).
- 238.
Regulation 2015/2283, preamble (1).
- 239.
Regulation 2015/2283, Article 12(1)(d).
- 240.
ISAAA (2017), p. 112.
- 241.
- 242.
Smyth et al. (2016), p. 189.
- 243.
Smyth et al. (2016), pp. 189–190.
- 244.
Smyth et al. (2016), p. 190.
- 245.
Phillipson (2016), pp. 94–95.
- 246.
NASEM (2016), p. 461.
- 247.
Smyth (2017), p. 82.
- 248.
NASEM (2016), p. 461 (citing the 2006 Panel Report in WTO Dispute DS291). The moratorium dated from 24 June 1999. The last GE approval (carnations) before the moratorium was in October 1998; last food approval, in April 1998.
- 249.
NAS (2002), p. 13.
- 250.
NAS (2002), p. 14.
- 251.
COGEM (2011), p. 106.
- 252.
COGEM (2011), p. 103.
- 253.
ISAAA (2017), pp. 112–113.
- 254.
FAS, USDA (2014).
- 255.
CAST (2016), p. 3.
- 256.
For certified seed, the normal purity level is 99.5% (allowing.25% weed seed and.25% other crop varieties). Grain contracts often allow 3–5% impurity. Smyth (2017), pp. 82–83.
- 257.
CAST (2016), pp. 3, 5.
- 258.
Smyth (2017), p. 83.
- 259.
- 260.
- 261.
Tidgren (2017). Syngenta planned to appeal the verdict.
- 262.
Feeley and Fisk (2017).
- 263.
GAABT (2015), p. 6.
- 264.
Commission Regulation 619/2011.
- 265.
CAST (2016), p. 8.
- 266.
CAST (2016), p. 8.
- 267.
GAABT (2015), p. 4. If requested by the importing government, a safety dossier should be submitted for unauthorized GE events.
- 268.
Grossman (2016a), p. 328.
- 269.
CAST (2016), p. 5.
- 270.
Bradford (2012), p. 35. Requirements for the Brussels Effect include market power, regulatory capacity and preference for strict rules, inelastic targets of regulation (no relocation possible), and legal, technical, and economic nondivisibility of standards (pp. 11–19).
- 271.
CAST (2016), p. 3.
- 272.
NASEM (2016), p. 26. For an explanation and comparison of new techniques in agricultural biotechnology see High Level Group of Scientific Advisors 2017.
- 273.
NASEM (2016), p. 493.
- 274.
Smyth (2017), p. 81. Some technologies, considered mutagenesis, are not regulated as GM crops in the US.
- 275.
Firko (2016). Arctic apples, which do not brown when cut, were developed by gene silencing, which shut down genes for the browning enzyme.
- 276.
Waltz (2016). Other techniques include cisgenesis and intragenesis, which are faster and more precise than genetic engineering and perhaps more acceptable to consumers. Miraglia and Brera (2016), p. 312. Cisgenesis involves modification of an organism with a gene from a sexually compatible species and does not change the DNA sequence in the recipient organism. It is especially useful for organisms, like trees, with a long reproduction cycle. Miraglia and Brera (2016), pp. 309–310. Intragenesis is a modification “that leads to a combination of different gene fragments from donor organism(s) of the same or a sexually compatible species as the recipient.” Miraglia and Brera (2016), p. 310, quoting EFSA. Simplot’s Innate potato, approved for cultivation in the US, is intragenic.
- 277.
Miraglia and Brera (2016), pp. 316–317.
- 278.
Regulation 2015/2283, Articles 2, 3.
- 279.
Lusser et al. (2011), pp. 8, 49–50.
- 280.
Member States have mixed views about innovative genetic technologies. Some States are open to new techniques; others are uncertain; most have no official position. Little public awareness of innovative biotechnologies exists. FAS, USDA (2016), p. 41.
- 281.
European Commission (n.d.).
- 282.
- 283.
Bergeson (2017), p. 33.
- 284.
- 285.
NASEM (2017).
- 286.
NASEM (2017), p. 11.
- 287.
NASEM (2017), p. 6. Other agencies may also have jurisdiction, but the Coordinated Framework does not provide specific details.
- 288.
NASEM (2017), p. 11.
- 289.
NASEM (2017), p. 8.
- 290.
NASEM (2017), p. 11.
- 291.
NASEM (2016), pp. 26–27. A European expert on risk regulation may agree with this approach: “Safe GMOs are subject to onerous prior risk assessment and approval regimes, as well as reporting and labelling requirements.” Bergkamp (2017), p. 61. He asserted that generally “regulators should think twice before regulating the risks associated with new technologies. Innovation is important to any society, and innovation requires risk-taking” (p. 62). He suggested that regulators 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” (p. 63).
- 292.
NASEM (2016), p. 26.
- 293.
Podevin et al. (2012), p. 1057.
- 294.
Podevin et al. (2012), pp. 1058–1060.
- 295.
ISAAA (2017), p. 2.
- 296.
ISAAA (2017), p. 115.
- 297.
ISAAA (2017), p. 113.
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Grossman, M.R. (2018). Agricultural Biotechnology: Regulation in the United States and the European Union. In: Bremmers, H., Purnhagen, K. (eds) Regulating and Managing Food Safety in the EU. Economic Analysis of Law in European Legal Scholarship, vol 6. Springer, Cham. https://doi.org/10.1007/978-3-319-77045-1_15
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