Journal of Applied Biological Chemistry

The Korean Society for Applied Biological Chemistry (한국응용생명화학회)
권호 표지
DOI QR코드

DOI QR Code

Trends in the global regulation of new breeding techniques and perspective

신육종기술의 규제 전망 및 문제점

  • Kim, Donghern (Green Bio Consulting) ;
  • Suh, Seung-Man (Institute of Life Sciences and Resources, Department of Food Science & Biotechnology, Kyung Hee University) ;
  • Kim, Ji-Yeong (Institute of Life Sciences and Resources, Department of Food Science & Biotechnology, Kyung Hee University) ;
  • Kim, Hae-Yeong (Institute of Life Sciences and Resources, Department of Food Science & Biotechnology, Kyung Hee University)
  • Received : 2018.11.12
  • Accepted : 2018.11.18
  • Published : 2018.12.31
Download PDF
⟨ Previous Next ⟩

Abstract

'New Breeding Techniques (NBTs)' have been one of hot issues, since their future will be affected profoundly by national as well as international regulatory landscapes. In this review, we compare characteristics of NBTs with conventional and genetic modification, and analyze genetically modified organism (GMO) regulatory systems in the context of possible regulation of NBTs. NBTs are very heterogeneous in terms of principles, methodologies, and final products. As Living Modified Organisms (LMO) is defined in the Cartagena Protocol on Biosafety (CPB) as an organism containing novel combination of genetic materials obtained by the use of modern biotechnology, CPB as well as other national legislations locate itself somewhere in the middle between product-based and process-based regulations. It is also noted that jurisdictions with regulatory systems more oriented to product-based one tend to be more productive and decide or may decide to exempt site-directed nucleases-1 from GMO regulation. In this context, Korean legislations are reviewed to clarify the commons and differences in GMO definitions. Act on Transboundary Movement of LMO Act, Food Sanitation Act and Agricultural and Fishery Products Quality Control Act are three major acts to regulate GMOs. It is noted that there are differences in the definition of LMO or GM food/products especially between the LMO Act and the Food Sanitation Act. Such differences may cause conflicts between Acts when policy-decision regarding the regulation of NBTs is made. Therefore, it is necessary to reorganize legislations before policies regarding the regulation of any techniques from biotechnology are made.

Keywords

References

  1. ISAAA (2017) Global status of commercialized biotech/GM crops in 2017: Biotech crop adoption surges as economic benefits accumulate in 22 years. ISAAA Brief No. 53. ISAAA, Ithaca
  2. Schurman L (2004) Fighting “frankenfoods”: Industry opportunity structures and the efficacy of the anti-biotech movement in western Europe. Social Problems 51: 243-268 https://doi.org/10.1525/sp.2004.51.2.243
  3. COGEM (2006) New techniques in plant biotechnology, COGEM report CGM/061024-02
  4. European Commission (2008) Working group on the establishment of a list of techniques falling under the scope of directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment and directive 90/219/EEC on the contained use of genetically modified micro-organisms. ENV B3/AA/D
  5. Lusser M, Parisi C, Plan D, Rodriguez-Cerezo E (2011) New plant breeding techniques: state-of-the-art and prospects for commercial development. EC JRC Reference Report EUR 24760 EN
  6. Lusser M, Parisi C, Plan D, Rodriguez-Cerezo E (2012) Deployment of new biotechnologies in plant breeding. Nat Biotech 30: 231-239 https://doi.org/10.1038/nbt.2142
  7. European Commission (2017) New techniques in agricultural biotechnology. Scientific Advisory Mechanism, High Level Group of Scientific Advisors. Explanatory Note 02/2017
  8. Atanassova A, Keiper F (2018) Plant breeding innovation: A global perspective. Cereal Chem 95: 8-16 https://doi.org/10.1002/cche.10021
  9. Schaart JG, van de Wiel CCM, Lotz LAP, Smulders MJM (2016) Opportunities for products of new plant breeding techniques. Trends Plant Sci 21: 438-449 https://doi.org/10.1016/j.tplants.2015.11.006
  10. CBGP UPM-INIA (2018) Regulating genome edited organisms as GMOs has negative consequences for agriculture, society and economy http://www.cbgp.upm.es/files/Position_paper_on_the_ECJ_ruling_on_CRISPR22_Oct_2018_CONFIDENTIAL.pdf
  11. Steinbrecher RA (2015) Genetic engineering in plants and the "new breeding techniques (NBTs)", Inherent risks and the need to regulate. EcoNexus Briefing December 2015. http//nuffieldbioethics.org/wpcontent/uploads/genome-editing-evidence-EcoNexus.pdf. Accessed 30 October 2018
  12. Koh HJ (2018) Management measures of plant varieties by the application of genome editing techniques. Proceedings of Joint Symposium on Genome Editing, Kosid and Kor Soc Breeding Sci 71-96
  13. Nuijten E, Messmer MM, Lammerts van Bueren ET (2017) Concepts and strategies of organic plant breeding in light of novel breeding techniques. Sustainability 9: 18
  14. USDA (2018) Secretary Perdue issues USDA statement on plant breeding innovation. Press Release No 0070.18 https://www.usda.gov/media/press-releases/2018/03/28/secretary-perdue-issues-usda-statementplant-breeding-innovation
  15. Court of Justice of the European Union (2018) Organisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive. Press Release No 111/18 https://curia.europa.eu/jcms/upload/docs/application/pdf/2018-07/cp180111en.pdf
  16. Wight AJ (2018) Strict EU ruling on gene-edited crops squeezes science. Nature 563: 15-16 https://doi.org/10.1038/d41586-018-07166-7
  17. Lassoued R, Smyth SJ, Phillips PWB, Hesseln (2018) Regulatory uncertainty around new breeding techniques. Frontiers in Plant Sci 9: 1-10 https://doi.org/10.3389/fpls.2018.00001
  18. Kim JY (2018) Recent progress in CRISPR-based genome editing techniques and domestic research status. Proceedings of Joint Symposium on Genome Editing, Kosid and Kor Soc Breeding Sci 31-54
  19. Kim YG, Cha J, Chandrasegaran S (1996) Hybrid restriction enzymes: zinc finger fusions to FokI cleavage domain. Proc Natl Acad Sci USA 93: 1156-1160 https://doi.org/10.1073/pnas.93.3.1156
  20. Carrol D (2011) Genome engineering with zinc-finger nucleases. Genetics 188: 773-782 https://doi.org/10.1534/genetics.111.131433
  21. Gaj T, Gerbach Ca, Barbas III CF (2013) ZFN, TALEN and CRISPR/Cas-based methods for genome engineering. Trends Biotechnol 31: 397-405 https://doi.org/10.1016/j.tibtech.2013.04.004
  22. Kamburova VS, Nikitina EV, Shermatov SE, Buriev ZT, Kumpatla SP, Emani C, Abdurakhmonov I (2017) Genome editing in plants: An overview of tools and application. Int'l J Agronomy https://doi.org/10.1155/2017/7315351
  23. Gupta RM, Musunuru K (2017) Expanding the genetic editing tool kit: ZFNs, TALENs and CRISPR-Cas9. J Clin Invest 124: 4154-4161
  24. Malzahn A, Lowder L, Qi Y (2017) Plant genome editing with TALEN and CRISPR. Cell Biosci DOI 10.1186/s13578-017-0148-4
  25. Haft DH, Selengut J, Mongodin EF, Nelson KE (2014) Aguild of 45 CRISPR-associated (Cas) protein families and multiple CRISPR/Cas subtypes exist in prokaryotic genomes. PLoS Comput Biol 1: 474-483
  26. Perkin IC, Adrianos SI, Oppert B (2016) Gene disruption technologies have the potential to transform stored product insect pest control. Insects 7: 46 doi:10.3390/insects7030046
  27. USDA APHIS (2018) Regulated article letters of inquiry https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/am-i-regulated/Regulated_Article_Letters_of_Inquiry
  28. Clasen BM, Stoddard TJ, Luo S, Demorest ZL, Li J, Cedrone F, Tibebu R, Davison S, Ray EE, Daulhac A, Coffman A, Yabandith A, Retterath A, Haun W, Baltes NJ, Mathis L, Voytas DF, Zhang F (2016) Improving cold storage and processing traits in potato through targeted gene knockout. Plant Biotech J 14: 169-176 https://doi.org/10.1111/pbi.12370
  29. Demorest Z, Coffman A, Baltes NJ, Stoddard TJ, Clasen BM, Luo S, Retterath A, Yabandith A, Gamo ME, Bissen J, Mathis L, Voytas DF, Zhang F (2016) Direct stacking of sequence-specific nuclease-induced mutations to produce high oleic and low linolenic soybean oil. BMC Plant Biol 16:225 DOI 10.1186/s12870-016-0906-1
  30. Bomgardner MM (2017) CRISPR: A new toolbox for better crops. Chemical and Engineerin News 95: 30-34
  31. Hall SS (2016) Editing the mushroom. Scientific America https://www.aaas.org/sites/default/files/Stephan%20Hall%20-Gene-EditedMushroom%20(SciAm)%20(3).pdf
  32. Wang Y, Cheng X, Shan Q, Zhang Y, Liu J, Gao C, Qui YL (2014) Simultaneous editing of three homeoalleles in hexaploid bread wheat confers heritable resistance to powdery mildew. Nature Biotech 32: 947-951 https://doi.org/10.1038/nbt.2969
  33. Petolino JF (2015) Genome editing in plants via designed zinc finger nucleases. In Vitro Cell Dev Biol 51: 1-8
  34. Sauer NJ, Mozoruk J, Miller RB, Warburg ZJ, Walker KA, Beetham PR, Schopke CR, Gocal GFW (2016) Oligonucleotide-directed mutagenesis for precision gene editing. Plant Biotech J 2016 14: 496-502
  35. Espinoza c, Schlechter R, Herrera D, Torres E, Serrano A, Medina C, Arce-Johnson P (2013) Cisgenesis and intragenesis: New tools for improving crops. Biol Res 46: 323-331 https://doi.org/10.4067/S0716-97602013000400003
  36. Jo K-W, Kim C-J, Kim S-J, Kim T-Y, Bergervoet M, Jongsma MA, Visser RGF, Jacobsen E, Vossen JH (2014) Development of late blight resistant potatoes by cisgene stacking. BMC Biotech 14: 50 https://doi.org/10.1186/1472-6750-14-50
  37. Kost TD, Gessler C, Jansch M, Flachowsky H, Patocchi A, Broggini GAL (2015) Development of the first cisgenic apple with increased resistance to fire blight. PLoS ONE 10: e0143980. doi:10.1371/journal.pone.0143980
  38. Schaart JG, Kjellsen TD, Mehli L, Heggem R, Iversen T-H, Schouten HJ, Krens FA (2011) Towards the production of genetically modified strawberries which are acceptable to consumers. Genes, Genomes & Genomics 5: 102-107
  39. EPSO (2016) Reverse breeding. Meet the parent. Crop Genetic Improvement Techniques Fact Sheet http://www.epsoweb.org/file/2183
  40. Kumari P, Nilanjaya, Singh NK (2018) Reverse breeding: Accelerating innovation in plant breeding. J Pharmacognosy Phytochem SP1: 1811-1813
  41. Dirks R, van Dun K, de Snoo CB, van den Berg M, Lelivelt CLC, Voermans W, Woudenberg L, de Wit JPC, Reinink K, Schut JW, van der Zeeuw E, Vogelaar A, Freymark G, Gutterling EW, Keppel MN, van Drongelen P, Kieny M, ELLUL P, Touraev A, Ma H, de Jong H, Wijnker E (2009) Reverse breeding: a novel breeding approach based on engineered meiosis. Plant Biotech J 7: 837-845 https://doi.org/10.1111/j.1467-7652.2009.00450.x
  42. Lee RWH, Strommer J, Hodgins D, Shewen PE, Niu YQ, Lo RYC (2001) Towards development of an edible vaccine against bovine pneumonic pasteurellosis using transgenic white clover expressing a Mannheimia haemolytica A1 leukotoxin 50 fusion protein. Infection and Immunity 69: 5786-5793 https://doi.org/10.1128/IAI.69.9.5786-5793.2001
  43. Lusser M, Davies HV (2013) Comparative regulatory approaches for groups of new plant breeding techniques. News Biotech 30: 437-446 https://doi.org/10.1016/j.nbt.2013.02.004
  44. Goldschmidt EE (2014) Plant grafting: new mechanisms, evolutionary implication. Frontiers in Plant Sci. doi: 10.3389/fpls.2014.00727
  45. Liu Z-W, Zhou J-X, Huang H-W, Li Y-Q, Shao C-R, Li L, Cai T, Chen S, He X-J (2016) Two components of the RNA-directed DNA methylation pathway associated with MORC6 and silence loci targeted by MORC6 in Arabidopsis. PLoS Genet 12: e1006026. doi:10.1371/journal.pgen.1006026
  46. Smyth SJ (2017) Canadian regulatory perspectives on genome engineered crops. GM Crops & Food 8:35-41 https://doi.org/10.1080/21645698.2016.1257468
  47. SAGP (2015) Secretaria de agricultura ganaderia Y pesca, resolution 173/2015 https://boletinoficial.gob.ar/#!DetalleNotmativa/1095531/null
  48. Whelen AI, Lema MA (2015) Regulatory framework for gene editing and other new breeding techniques (NBTs) in Argentina. GM Crops & Food 6: 253-265 https://doi.org/10.1080/21645698.2015.1114698
  49. Schmidt S (2018) To regulate or not to regulate: Current legal status for gene-edited crops. http://www.global-engage.com/agricultural-biotechnology/to-regulate-or-not-to-regulate-current-legal-status-for-gene-edited-crops/
  50. Kahrmann J (2018) Regulation of genome editing in Europe and Germany. Proceedings of Second Asia Forum on Genome Editing, Korean Biosafety Clearing House, 59-71
  51. UK (2018) Evidence check: GM and gene editing-Government statement. https://www.parliament.uk/documents/commons-committees/science-technology/evidence-tests/GM-and-Gene-Editing.pdf.
  52. Fritsche S, Poovaiah C, MacRae E, Thoriby G (2018) A New Zealand perspective on the application and regulation of gene editing. Frontiers in Plant Sci 9: 1323. doi: 10.3389/fpls.2018.01323
  53. Mitchell H (2018) Australian regulation, risk assessment and genome edited organisms. Proceedings of Second Asia Forum on Genome Editing, Korean Biosafety Clearing House, 261-276
  54. Bunge J, Craymer L (2018) Scientists in China race to edit crop genes, sowing unease in US. Wall Street Journal https://www.wsj.com/articles/scientists-in-china-race-to-edit-crop-genes-sowing-unease-in-u-s-1525611601
  55. USDA FAS (2017) Israel agricultural biotechnology annual 2017. https://gain.fas.usda.gov/Recent%20GAIN%20Publications/ Agricultural%20Biotechnology%20Annual_Tel%20Aviv_Israel_12-1-2017.pdf
  56. Tachikawa M (2018) Regulatory discussions and consumer perceptions on genome editing in Japan. Proceedings of Second Asia Forum on Genome Editing, Korean Biosafety Clearing House, 239-255
  57. Abdullah MFF (2018) Regulatory issues on genome editing in Malaysia. Proceedings of Second Asia Forum on Genome Editing, Korean Biosafety Clearing House, 91-103
  58. Rahman SJ (2018) Genome editing technologies: Existing monitoring and compliance protocols for confined field trials of GE crops in India. Proceedings of Second Asia Forum on Genome Editing, Korean Biosafety Clearing House,131-142
  59. Biosafety Clearing House (2018) Cartagena protocol on biosafety. https://bch.cbd.int/protocol/
  60. Ishii T, Araki M (2017) A future scenario of the global regulatory landscape regarding genome-edited crops. GM Crops & Food 8: 44-56 https://doi.org/10.1080/21645698.2016.1261787
  61. WIPO (2014) Republic of Korea. Act on transboundary movement, etc., of living modified organisms (Act No.6448 of March 28, 2001, as amended up to Act No. 12833 of November 19, 2014). http://www.wipo.int/wipolex/en/details.jsp?id=15643
  62. KFDA (2017) Food sanitation act (Act No. 15277, December 19, 2017). https://elaw.klri.re.kr/kor_mobile/viewer.do?hseq=46429&type=sogan&key=31
  63. MAFRA (2016) Agricultural and fishery products quality control act (Act No 14483, December 27, 2016). https://elaw.klri.re.kr/kor_mobile/viewer.do?hseq=42239&type=sogan&key=7