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2019 | OriginalPaper | Buchkapitel

8. Comparative Analysis: The Regulation of Plants Derived from Genome Editing in Argentina, Australia, Canada, the European Union, Japan and the United States

verfasst von : David Hamburger

Erschienen in: Regulation of Genome Editing in Plant Biotechnology

Verlag: Springer International Publishing

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Abstract

A comparison of the cultivation of genetically modified organism (GMOs) and consumption of their products (Sect. 8.2) reveals the distinctness of each examined country’s approach towards GMOs. Not surprisingly, this finds its continuation in diverging and differing legal frameworks for their regulation. The diversity of approaches is not only reflected in different regulatory triggers and point of entries into the regulatory regime (Sect. 8.3), but also by varying labelling (Sect. 8.5) and coexistence provisions (Sect. 8.6). When taking a closer look at the regulatory status of genome edited plant varieties and the products derived from them, it becomes apparent that the differences of the regulatory frameworks manifest in the legal classification of those plants and their produce. Consequently, genome edited organisms (GEOs) are treated vastly differently by the examined legal regimes (Sect. 8.4). However, it should be borne in mind that some of the examined countries are currently working on a revision of their regulations (Sect. 8.7).

Vorheriges Kapitel Genetic Engineering in the United States: Regulation of Crops and Their Food Products

In the following any abstract reference to countries also includes the EU, even though strictly speaking it does not constitute a nation state.

Cf. Blair and Regenstein (2015), p. 85; Newton (2014), p. 202; Kuntz (2018), p. 183; Spielman and Zambrano (2013), p. 184; Juma (2016), p. 245; Capalbo and Suzuki (2017), p. 270.

Cf. International Service for the Acquisition of Agri-biotech Applications (2018d). This website gives an overview of the changes made to the database since July 2014. However, only new approvals are listed here. On the individual website for each event it is, however, indicated if the approval is still in force.

Those are seven events regarding ornamental flowers (carnations), MON810, Liberty Link Maize (T25) and the Amflora Potato; cf. International Service for the Acquisition of Agri-biotech Applications (2018e).

The database indicates that ornamental carnations with the event ‘Moonlight’ (event code 123.2.38) were approved for cultivation in 2007; International Service for the Acquisition of Agri-biotech Applications (2014). However, the corresponding decision of the European Commission states clearly that ‘[t]he product may be put to ornamental use only, with the exception of cultivation’; European Commission (2007), Art.3. The ‘Moonberry’ (event code IFD-25958-3) and ‘Moonvelvet’ event (event code IFD-264Ø7-2) are listed as approved for cultivation and only on the website of the specific event, it is indicated that they have only been approved for import.

International Service for the Acquisition of Agri-biotech Applications (2016), p. 5.

The less extensive cultivation of GM plant varieties in Canada could be explained with a smaller agricultural area. However, the total area of arable land in Canada was in 2015 even slightly higher than that of Argentina (43.6 million ha compared to 39.2 million ha); cf. Food and Agricultural Organization of the United Nations (2018), Section Land Use—arable land.

International Service for the Acquisition of Agri-biotech Applications (2016), p. 73.

See Chap. 3 (Country Report on Australia), Sect. 3.3.1.1.

Cf. International Service for the Acquisition of Agri-biotech Applications (2016), p. 2.

In detail, these are: alfalfa, apple, bean, canola, carnation, chicory, cotton, creeping bentgrass, eggplant, eucalyptus, flax, maize, melon, papaya, petunia, plum, poplar, potato, rice, rose, soybean, squash, sugar beet, sugarcane, sweet pepper, tobacco, tomato, wheat. Cf. International Service for the Acquisition of Agri-biotech Applications (2018b).

Australian Government Department of Health and Office of the Gene Technology Regulator (2018).

280,422 ha cotton seed and 2,357,000 ha canola (rapeseed); cf. Food and Agricultural Organization of the United Nations (2018), Section Crops—Australia—area harvested.

International Service for the Acquisition of Agri-biotech Applications (2018a). The non-approval of this glyphosate-resistant wheat variety is explained on the one hand by the lack of acceptance by the public; cf. Rao (2015), p. 343. On the other hand, however, it is also due to the fact that the pollen of wheat drifts much further than, for example, that of maize; cf. Gustafson (2014), p. 96. Detailed on this, using Canada as an example, Magnan (2016), pp. 151–157; Eaton (2013).

In 2016 the total harvested area of agricultural crops in Argentina amounted to 36,826,764 ha; cf. Food and Agricultural Organization of the United Nations (2018), Section Crops—Argentina—area harvested.

Office of the Gene Technology Regulator (2008).

International Service for the Acquisition of Agri-biotech Applications (2016), p. 90.

Cf. International Service for the Acquisition of Agri-biotech Applications (2018c).

In the EU GM soybean is not approved for cultivation. In the case of Japan GM soybeans are approved for cultivation but currently not cultivated. Cf. International Service for the Acquisition of Agri-biotech Applications (2018c).

It is estimated that about 70–90% of the worldwide harvested GM crops are consumed as feedstock by food-producing animals; Flachowsky et al. (2012), p. 180; Lucht (2015), p. 4255.

However, on the national level voluntary negative labelling exist. In the case of Germany, the Federal Ministry of Food and Agriculture introduced the label “ohne Gentechnik” (engl. “without gene technology”), which indicates that - in the case of a food or food ingredient of animal origin—no genetically modified feed has been administered to the animal from which the food was obtained; cf. § 3a (4) EG-Gentechnik-Durchführungsgesetz (EGGenTDurchfG). However, it is still possible to feed such animals with genetically modified feed. For example, in the case of poultry, pigs or cattle, it is sufficient for the labelling “without gene technology” if they have not received any genetically modified feed 10 weeks, 4 months or 12 months respectively before slaughter. Cf. Appendix to § 3a (4) Sentence 2 EGGenTDurchfG.

Cf. La Capital (2018).

Calyxt, Inc. (2016).

For further details see Chap. 2 (Country Report on Argentina), Sect. 2.5.

For further details see Chap. 3 (Country Report on Australia), Sect. 3.5.

See for example PlantForm (2015).

Cf. For example Canadian Food Inspection Agency (2013). The second approved genome edited plant variety has never been tested in Canada, but the results of field trials conducted in the USA have been used during the approval procedure, cf. Canadian Food Inspection Agency (2014).

For further details see Chap. 4 (Country Report on Canada), Sect. 4.5.

Ayers (2018), Pratt (2018) and Cibus (2018).

For further details see Chap. 5 (Country Report on the EU), Sect. 5.5.

For further details see Chap. 6 (Country Report on Japan), Sect. 6.4.

Cf. Ricroch et al. (2017), p. 178; Lusser et al. (2012), p. 233.

For further details see Chap. 7 (Country Report on the USA), Sect. 7.8.2.2.

Calyxt (2018a).

Cibus (2018) and Pratt (2018).

Calyxt (2018b).

Dewey (2018).

Calyxt (2019a).

Calyxt (2019b).

For this section see Chap. 2 (Country Report on Argentina), Sect. 2.3.1.

Ministerio de Agroindustria (2011).

Servicio Nacional de Sanidad y Calidad Agroalimentaria (2011).

For this section see Chap. 3 (Country Report on Australia), Sect. 3.3.1.

Gene Technology Act 2000, Para. 32.

Pursuant to Para. 10 Gene Technology Act 2000 “deal with, in relation to a GMO, means the following: (a) conduct experiments with the GMO; (b) make, develop, produce or manufacture the GMO; (c) breed the GMO; (d) propagate the GMO; (e) use the GMO in the course of manufacture of a thing that is not the GMO; (f) grow, raise or culture the GMO; (g) import the GMO; (h) transport the GMO; (i) dispose of the GMO; and includes the possession, supply or use of the GMO for the purposes of, or in the course of, a dealing mentioned in any of paragraphs (a) to (i).”

Gene Technology Act 2000, Para. 10.

For a detailed illustration of the Australian GMO definition, which considers exceptions as well, see Chap. 3 (Country Report on Australia), Sect. 3.3.1.1.

See Standard 1.5.2 of the Australia New Zealand Food Standards Code and the further explanations in Chap. 3 (Country Report on Australia), Sect. 3.3.1.2.

Cf. Section 3 of Standard 1.5.2 of the Australia New Zealand Food Standards Code.

Cf. Standard 1.1.2 of the Australia New Zealand Food Standards Code.

For this section see Chap. 4 (Country Report on Canada), Sect. 4.3.1.

The Seeds Act, R.S.C., 1985, c. S-8 and the Seeds Regulations, C.R.C.,c. 1400 refer only to seeds and not to plants. However, seed is very broadly defined as “any plant part of any species belonging to the plant kingdom, represented, sold or used to grow a plant”; Seeds Act, R.S.C., 1985, c. S-8, Para.2. Therefore, the corresponding plant is considered to be covered as well.

Seeds Act, R.S.C., 1985, c. S-8, Para. 3 (1) (b) in conjunction with Seeds Regulations, C.R.C.,c. 1400, Part V, Para 109 (1).

This is a rather simplified description of the exemption rules. For the detailed specification of exempted seeds see Seeds Regulations, C.R.C.,c. 1400, Part V, Para.108.

Cf. Seeds Regulations, C.R.C.,c. 1400, Para.110 (d).

Directive 94-08, Assessment Criteria for Determining Environmental Safety of Plants With Novel Traits, Sec.1. This is, however, not the legal definition used in Seeds Regulations, C.R.C.,c. 1400, Para.107 (1).

Food and Drug Regulations, C.R.C., c. 870, Para. B.28.002.

Food and Drug Regulations, C.R.C., c. 870, Para. B.28.001.

“genetically modify” is defined as “to change the heritable traits of a plant, animal or microorganism by means of intentional manipulation”; Food and Drug Regulations, C.R.C., c. 870, Para. B.28.001.

Food and Drug Regulations, C.R.C., c. 870, Para. B.28.001.

For this section see Chap. 5 (Country Report on the EU), Sect. 5.3.1.

Cf. Art.4 (1) Directive 2001/18/EC; Art.3 (1) Regulation 1829/2003. Strictly speaking Directive 2009/41/EC, which is regulating the contained use, does, pursuant to Art.2 (b), not apply to GMOs but to genetically modified micro-organisms (so called GMMs). While every GMM is also a GMO within the meaning of the EU regulatory framework, not every GMO is at the same time a GMM.

For a detailed illustration of the European GMO definition see Chap. 5 (Country Report on the EU), Sect. 5.3.1.

This aspect is further explained in see Chap. 5 (Country Report on the EU), Sect. 5.3.2.

ECJ, Case C-528/16 Confédération paysanne and Others (2018), ECLI:EU:C:2018:583, para. 29.

ECJ, Case C-528/16 Confédération paysanne and Others (2018), ECLI:EU:C:2018:583, para. 28.

For this section see Chap. 6 (Country Report on Japan), Sect. 6.3.1.

Cf. Cartagena Law 2003, Art.4 and Art.12. The English translation of the official title of the Cartagena Law is “Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (Act No. 97 of 2003)”. This is commonly referred to as “Cartagena Law 2003”. The Cartagena Law uses the term “living modified organism” instead of “genetically modified organism”, as it is an act of implementation of the Cartagena Protocol which uses the term LMO instead of GMO.

Cartagena Law 2003, Art.2 (3).

Cartagena Law 2003, Art.2 (2).

Ministry of Health, Labour and Welfare (2018, 2019).

Ministry of Health and Welfare (2000a).

Ministry of Health and Welfare (2000b).

For this section see Chap. 7 (Country Report on the USA), Sect. 7.3.2.

Plant Protection Act, 7 U.S.C. §§ 7701–7786, § 7712 (a).

7 CFR Part 340.

7 CFR Part 340, § 340.0 (a).

7 CFR Part 340, § 340.1.

7 CFR Part 340, § 340.1. This is a significantly shortened version of the definition. For the full definition, see the legal text or Chap. 7 (Country Report on the USA), Sect. 7.3.2.1, fn.64.

“Genetic engineering” is in that context defined as “genetic modification of organisms by recombinant DNA techniques”; 7 CFR Part 340, § 340.1.

Federal Insecticide, Fungicide, and Rodenticide Act, 7 USC §§ 136-136y, §136a (a).

“Plant-incorporated protectant” is defined 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 production of such a pesticidal substance. It also includes any inert ingredient contained in the plant, or produce thereof”; 40 C.F.R. Part 174, § 174.3.

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 - 399h, § 331 (a).

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 - 399h, § 342 (a) (2) (A).

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 - 399h, § 342 (a) (2) (C) (i). The definition has been shortened considerably. For the complete definition, see the legal text.

“Food additive” is defined as “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 […] to be safe under the conditions of its intended use”; Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 - 399h, § 321 (s).

Cf. Food and Drug Administration (1992), p. 22990.

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 - 399h, § 348 (a).

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 - 399h, § 321 (s).

Food and Drug Administration (1992), p. 22990.

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 - 399h, § 342 (a) (2) (B).

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 - 399h, § 346 (a).

Cf. Sect. 8.2.

Cf. Fig. 8.4 (Sect. 8.2.1.2), Fig. 8.6 (Sect. 8.2.1.2) and Fig. 8.7 (Sect. 8.2.1.2).

For this section see Chap. 2 (Country Report on Argentina), Sect. 2.3.2.

For this section see Chap. 3 (Country Report on Australia), Sect. 3.3.2.

For this section see Chap. 4 (Country Report on Canada), Sect. 4.3.2.

100

“Genetically modify” is defined as “to change the heritable traits of a plant, animal or microorganism by means of intentional manipulation”; Food and Drug Regulations, C.R.C., c. 870, Sec. B.28.001.

101

For this section see Chap. 5 (Country Report on the EU), Sect. 5.3.2.

102

ECJ, Case C-528/16 Confédération paysanne and Others (2018), ECLI:EU:C:2018:583.

103

Strictly speaking, only herbicide-resistant plants created via ODM or SDN-1 have been subject to the ruling of the ECJ. The ruling of the ECJ refers to “techniques/methods of mutagenesis such as those at issue in the main proceedings”; ECJ, Case C-528/16 Confédération paysanne and Others (2018), ECLI:EU:C:2018:583, Para. 28. In the main proceedings it is only referred to ODM and SDN-1; Conseil d’État, n°388649 Confédération paysanne et autres (2016), Para. 23. It should be noted, however, that ODM and SDN-1 are here only mentioned as examples for modern directed mutagenesis using genetic engineering techniques (cf. the use “notamment”; engl. “including” or “in particular”). The opinion of the Advocate General referred also only exemplary (“such as”) to ODM and SDN-1; Opinion of the Advocate General Bobek, Case C-528/16 Confédération paysanne and Others (2018), Para. 46. Therefore, it can be argued that SDN-2 is directly covered as well by the judgment since SDN-2 can also be understood as a mutagenesis technique due to its close resemblance to ODM (both cause small changes to the DNA based on a template without incorporating foreign DNA into the genome).

104

Cf. the general assessment of the EU’s GMO definition above (Sect. 8.3.4). Since the ECJ ruled in paragraph 29 of the judgment in the case 528/16 that at least SDN-1 and ODM “alter the genetic material of an organism in a way that does not occur naturally” just based on the process used, the same is true a fortiori for SDN-2 and SDN-3 when applying the Court’s reasoning.

105

For this section see Chap. 6 (Country Report on Japan), Sect. 6.3.2.

106

Sato (2018a, 2018b).

107

Kurai and Sato (2018).

108

Sato (2019a).

109

Sato (2019a), p. 2.

110

Cf. Chap. 6 (Country Report on Japan), Sect. 6.2.

Sato (2018c, d, e).

Sato (2019b).

Sato (2019c), p. 3.

Sato (2019c), pp. 3–4.

115

Sato (2019c), p. 5.

116

For this section see Chap. 7 (Country Report on the USA), Sect. 7.8.

117

7 CFR Part 340, § 340.1.

118

Wolt et al. (2016), p. 511.

119

Cf. Li et al. (2018), pp. 209–212; Lino et al. (2018), p. 1241; Li et al. (2015), pp. 453–458.

120

Ma et al. (2017).

121

United States Department of Agriculture (2018a).

122

United States Department of Agriculture (2018c).

123

United States Department of Agriculture (2018c).

124

United States Department of Agriculture (2018c).

125

Otherwise, the EPA could have regulatory competences. Cf. Chap. 7 (Country Report on the USA), Sect. 7.8.1.

126

However, foreign genetic material is present in the plant in the intermediate steps.

127

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 - 399h, § 342 (a) (2) (B).

128

Cf. Fig. 8.4.

129

For this section see Chap. 2 (Country Report on Argentina), Sect. 2.8.

130

For this section see Chap. 3 (Country Report on Australia), Sect. 3.8.

131

Australia New Zealand Food Standards Code, Standard 1.5.2, Sec. 4 (5).

132

For this section see Chap. 4 (Country Report on Canada), Sect. 4.8.

133

For this section see Chap. 5 (Country Report on the EU), Sect. 5.8.

134

Cf. Regulation (EC) No 1829/2003, Art.12 (1) in conjunction with Art.2.

135

For this section see Chap. 6 (Country Report on Japan), Sect. 6.6.

136

For a list of the crops and the processed products made out of them that are subject to mandatory GMO labelling see Sato (2016), p. 23.

137

For this section see Chap. 7 (Country Report on the USA), Sect. 7.6.

138

United States Department of Agriculture and Agricultural Marketing Service (2018).

139

National Bioengineered Food Disclosure Standard, 7 USC §§ 1639-1639c, § 1639 (1).

140

Since part B refers explicitly to “the modification” described in part A, it is clear that both parts of the definition must be read together.

141

United States Department of Agriculture and Agricultural Marketing Service (2018), p. 65816.

142

For the distinction between “detection,” “identification,” and “traceability” see Hamburger (2018), section “Coexistence Measures and Identity Preservation Systems”. Nonetheless, a genetic alteration might be no longer detectable if the produce is processed or refined in a certain way. However this is not an issue that is specifically linked to genome edited plants but applies to all genetically modified crops and their products.

143

United States Department of Agriculture and Agricultural Marketing Service (2018), p. 65818.

144

Voigt and Klima (2017), p. 321.

145

United States Department of Agriculture and Agricultural Marketing Service (2018), p. 65872.

146

There exist, however, indicators that a higher threshold of 5% has only a rather small impact on the number of products which are requiring labelling. Cf. Viljoen and Marx (2013), p. 389; Oh and Ezezika (2014), p. 11.

147

Schenkelaars and Wesseler (2016), pp. 6–8; Lee (2014), p. 244; Beckmann et al. (2014), p. 376.

148

Kumar and Sopory (2008), p. 306; Smyth et al. (2004), p. 140; Wiseman (2009), p. 257. This and the previous paragraph was taken from Hamburger (2018).

149

For this section see Chap. 2 (Country Report on Argentina), Sect. 2.9.

150

For this section see Chap. 3 (Country Report on Australia), Sect. 3.9.

151

Crothers (2017), p. 20.

152

For this section see Chap. 4 (Country Report on Canada), Sect. 4.9.

153

Danielson and Watters (2017), pp. 15–16.

154

For this section see Chap. 5 (Country Report on the EU), Sect. 5.9.

155

Ministry of Agriculture, Forestry and Fisheries (2008) (in Japanese only).

156

For an overview over the different regional requirements see Sato (2016), pp. 17–21.

157

For this section see Chap. 7 (Country Report on the USA), Sect. 7.5.

158

Lee (2014), p. 244.

159

Schenkelaars and Wesseler (2016), p. 9; Falck-Zepeda (2006), p. 1204; Gabriel and Menrad (2015), pp. 482, 484.

160

Venus et al. (2017), p. 421.

161

For this section see Chap. 2 (Country Report on Argentina), Sect. 2.6.

162

Gene Technology Amendment (2019 Measures No. 1) Regulations 2019. https://www.legislation.gov.au/Details/F2019L00573/. Accessed 7 June 2019.

163

Strictly speaking this is to some degree an oversimplification. Under certain circumstances an exempted organism could still be regarded as GMO and an organism here classified as GMO could be exempted by a different provision. For more details on this see Explanatory Statement: Select Legislative Instrument 2019 No. XX. Gene Technology Amendment (2019 Measures No. 1) Regulations 2019. https://www.legislation.gov.au/Details/F2019L00573/. Accessed 7 June 2019, pp. 8–9.

164

Gene Technology Amendment (2019 Measures No. 1) Regulations 2019. https://www.legislation.gov.au/Details/F2019L00573/. Accessed 7 June 2019, Sect. 25.

165

Gene Technology Amendment (2019 Measures No. 1) Regulations 2019. https://www.legislation.gov.au/Details/F2019L00573/. Accessed 7 June 2019, Sect. 26

166

European Food Safety Authority (2012), p. 13.

167

Ata et al. (2018).

168

For this section see Chap. 4 (Country Report on Canada), Sect. 4.6.

169

For this section see Chap. 5 (Country Report on the EU), Sect. 5.6.

170

Cf. European Commission (2017).

171

Similar Lappin (2018), p. 3.

172

Cf. Chap. 6 (Country Report on Japan), Sect. 6.5.

173

Cf. Sect. 8.4.5.

174

Sato (2019d).

175

United States Department of Agriculture (2019).

176

United States Department of Agriculture (2019), p. 26514.

177

United States Department of Agriculture (2019), p. 26537.

178

United States Department of Agriculture (2019), p. 26520.

179

United States Department of Agriculture (2019), p. 26519.

180

Cf. Chap. 7 (Country Report on the USA), Sect. 7.9.

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Titel: Comparative Analysis: The Regulation of Plants Derived from Genome Editing in Argentina, Australia, Canada, the European Union, Japan and the United States
verfasst von: David Hamburger
Verlag: Springer International Publishing
Buch: Regulation of Genome Editing in Plant Biotechnology
Print ISBN: 978-3-030-17118-6

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

Copyright-Jahr: 2019
DOI: https://doi.org/10.1007/978-3-030-17119-3_8

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8. Comparative Analysis: The Regulation of Plants Derived from Genome Editing in Argentina, Australia, Canada, the European Union, Japan and the United States

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