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2019 | OriginalPaper | Buchkapitel

2. Regulation of Genome Editing in Plant Biotechnology: Argentina

verfasst von : Agustina I. Whelan, Martin A. Lema

Erschienen in: Regulation of Genome Editing in Plant Biotechnology

Verlag: Springer International Publishing

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Abstract

Argentina is a world leader in regards to regulation and adoption of GM crops. As a consequence, the regulatory aspects of gene editing applied to agriculture were considered proactively, and a simple but sound pioneer regulation was developed.
At present, the Argentine regulatory system is fully able to establish if a gene-edited crop should be classified (and handled) either as a GM crop or a conventional new variety. To this end, the concept of “novel combination of genetic material” derived from the Cartagena Protocol is of paramount importance.
After some pilot cases that have been handled under the new regulation, applicants appreciate the ease, speed and predictability of this regulation. Moreover, it has been considered by other countries in developing their own regulations, thus acting also as a harmonization factor for the safe and effective insertion of these technologies in the global market.
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Fußnoten
1
ISAAA (2016).
 
2
ASA (2018).
 
3
INDEC (2018).
 
4
COMTRADE (2018).
 
5
MINAGRO (2018).
 
6
ISAAA (2016).
 
7
Barfoot and Brookes (2014).
 
8
Trigo (2016).
 
9
Penna and Lema (2003).
 
10
Bustamante (2018).
 
11
Whelan and Lema (2015).
 
12
Burachik (2012) and Burachik and Traynor (2002).
 
13
INFOLEG (1973).
 
14
INFOLEG (2015).
 
15
INFOLEG (1992). Noteworthy, there is also a National Law 20.270 on the Promotion of the Development and Production of Modern Biotechnology—see INFOLEG (2007). However, it does not play any role in regulatory aspects, since it is focused on granting funding and tax incentives to biotechnology-Based Innovative Enterprises—see Rosada (2018).
 
16
INFOLEG (2011a).
 
17
INFOLEG (2011b).
 
18
WTO (2018).
 
19
CBD (2000).
 
20
CBD (2018a).
 
21
CBD (2018b).
 
22
FAO (2014a).
 
23
SENASA (2018).
 
24
INFOLEG (2011c).
 
25
Ishii and Araki (2017).
 
26
EFSA (2012).
 
27
Lusser et al. (2011).
 
28
WHO (2018).
 
29
INFOLEG (2004).
 
30
INFOLEG (2012a).
 
31
INFOLEG (2013a).
 
32
INFOLEG (2013b).
 
33
INFOLEG (2002a).
 
34
INFOLEG (2011d).
 
35
INFOLEG (2018).
 
36
Not to be confused with the National Register of Property of Plant varieties, which is a different register also under the National Seed Institute but devoted to the protection of intellectual property rights on a plant variety.
 
37
Cascardo et al. (1998).
 
38
INFOLEG (2017a).
 
39
FAO (2014b).
 
40
It has been argued elsewhere—see OECD (2015)—that detection of gene-edited products may be more challenging compared to GMOs currently on the market, based on reasons of both technical and human nature. However, from a technical viewpoint, even the slightest mutations obtained by gene editing can be easily detected by molecular techniques currently available, such as those applied in marker-assisted breeding programs to detect Single-Nucleotide Polymorphism (SNPs). Of course, this assertion is true as long as the mutation is known but the same is also valid for GMOs, where the introduced gene or protein must be known in order to design a detection method. In regards to “human nature”, considerations relate to the fact that gene editing may lead to mutations that could be generated spontaneously (or using physical or chemical techniques for mutagenesis); this has been presented as a potential temptation for concealing the method used for obtaining the trait. However, such covering would be very difficult in reality since biotech developers employ several people to generate such products (who should be accomplice of the plot for an indefinite time), and they forcedly leave a trace of patents, papers, presentations to regulatory frameworks of third countries and other public information.
 
41
AOSCA (2018).
 
42
OECD (2018).
 
43
Schiavone et al. (2013).
 
44
H. Cámara de Diputados de la Nación (2010, 2013).
 
45
Berto (2018).
 
46
INFOLEG (2017b).
 
47
FAO (2011).
 
48
Phillips and Smyth (2002).
 
49
FAO (2000).
 
50
Pensel et al. (2007).
 
51
INFOLEG (2012b).
 
52
Valor Soja (2017).
 
53
Co-Extra (2005).
 
54
Ghezan and Tapia (2006).
 
55
Ghezan et al. (2006).
 
56
INFOLEG (1999).
 
57
INFOLEG (1995).
 
58
INFOLEG (2002b).
 
59
INFOLEG (2009).
 
60
Rumi (2018).
 
61
Whelan and Lema (2017).
 
62
Preciado (2015), Biz (2017), Ingrassia (2017), Roman (2017) and Longoni (2017).
 
63
MINCYT (2015) and Trigo et al. (2002).
 
64
Whelan and Lema (2017).
 
65
Lusser et al. (2011).
 
66
SAG (2017).
 
67
CTNBIO (2018).
 
68
ISF (2018), Gepts and Hancock (2006) and Sprink et al. (2016).
 
69
ICA (2018).
 
Literatur
Zurück zum Zitat Burachik M (2012) Regulation of GM crops in Argentina. GM Crops Food 3(1):48–51 CrossRef Burachik M (2012) Regulation of GM crops in Argentina. GM Crops Food 3(1):48–51 CrossRef
Zurück zum Zitat Burachik M, Traynor PL (2002) Analysis of a national biosafety system: regulatory policies and procedures in Argentina. ISNAR, The Hague. (No. 660.6/B945) Burachik M, Traynor PL (2002) Analysis of a national biosafety system: regulatory policies and procedures in Argentina. ISNAR, The Hague. (No. 660.6/B945)
Zurück zum Zitat Cascardo R, Gianni C, Piana JA (1998) Variedades vegetales en Argentina: El comercio de semillas y el derecho de obtentor (No. D50/39). Latín Gráfica, Buenos Aires Cascardo R, Gianni C, Piana JA (1998) Variedades vegetales en Argentina: El comercio de semillas y el derecho de obtentor (No. D50/39). Latín Gráfica, Buenos Aires
Zurück zum Zitat Gepts P, Hancock J (2006) The future of plant breeding. Crop Sci 46(4):1630–1634 CrossRef Gepts P, Hancock J (2006) The future of plant breeding. Crop Sci 46(4):1630–1634 CrossRef
Zurück zum Zitat Ghezan G, Tapia C (2006) Technical visit report - experiences of traceability: Non-GM Maize in Argentina’, INTA. CO-ExTra Project Ghezan G, Tapia C (2006) Technical visit report - experiences of traceability: Non-GM Maize in Argentina’, INTA. CO-ExTra Project
Zurück zum Zitat Ghezan G, Iriarte L, Tapia C, D’Annunzio J (2006) Argentine non-GMO Soybean Chain, INTA Ghezan G, Iriarte L, Tapia C, D’Annunzio J (2006) Argentine non-GMO Soybean Chain, INTA
Zurück zum Zitat Ishii T, Araki M (2017) A future scenario of the global regulatory landscape regarding genome-edited crops. GM Crops Food 8(1):44–56 CrossRef Ishii T, Araki M (2017) A future scenario of the global regulatory landscape regarding genome-edited crops. GM Crops Food 8(1):44–56 CrossRef
Zurück zum Zitat Penna JA, Lema MA (2003) Adoption of herbicide tolerant soybeans in Argentina: an economic analysis in the economic and environmental impacts of Agbiotech. Springer, Berlin, pp 203–221 Penna JA, Lema MA (2003) Adoption of herbicide tolerant soybeans in Argentina: an economic analysis in the economic and environmental impacts of Agbiotech. Springer, Berlin, pp 203–221
Zurück zum Zitat Pensel N, Gargiulo G, Barrios M (2007) Traceability, coexistence systems and practices in Argentina. INTA Pensel N, Gargiulo G, Barrios M (2007) Traceability, coexistence systems and practices in Argentina. INTA
Zurück zum Zitat Phillips PWB, Smyth S (2002) Product differentiation alternatives: identity preservation, segregation, and traceability. AgBioforum 5(2):30–42 Phillips PWB, Smyth S (2002) Product differentiation alternatives: identity preservation, segregation, and traceability. AgBioforum 5(2):30–42
Zurück zum Zitat Sprink T, Metje J, Schiemann J, Hartung F (2016) Plant genome editing in the European Union to be or not to be a GMO. Plant Biotechnol Rep 10(6):345–351 CrossRef Sprink T, Metje J, Schiemann J, Hartung F (2016) Plant genome editing in the European Union to be or not to be a GMO. Plant Biotechnol Rep 10(6):345–351 CrossRef
Zurück zum Zitat Trigo E, Chudnovsky D, Cap E, López A (2002) Los transgénicos en la agricultura argentina. Una historia con final abierto. Libros Del Zorzal, Buenos Aires Trigo E, Chudnovsky D, Cap E, López A (2002) Los transgénicos en la agricultura argentina. Una historia con final abierto. Libros Del Zorzal, Buenos Aires
Zurück zum Zitat Whelan AI, Lema MA (2015) Regulatory framework for gene editing and other new breeding techniques (NBTs) in Argentina. GM Crops Food 6:253–265 CrossRef Whelan AI, Lema MA (2015) Regulatory framework for gene editing and other new breeding techniques (NBTs) in Argentina. GM Crops Food 6:253–265 CrossRef
Zurück zum Zitat Whelan AI, Lema MA (2017) A research program for the socioeconomic impacts of gene editing regulation. GM Crops Food 8(1):74–83 CrossRef Whelan AI, Lema MA (2017) A research program for the socioeconomic impacts of gene editing regulation. GM Crops Food 8(1):74–83 CrossRef
Metadaten
Titel
Regulation of Genome Editing in Plant Biotechnology: Argentina
verfasst von
Agustina I. Whelan
Martin A. Lema
Copyright-Jahr
2019
DOI
https://doi.org/10.1007/978-3-030-17119-3_2

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