DOI QR코드

DOI QR Code

외래 DNA단편이 잔존하지 않는 유전자교정식물에 대한 GMO규제 범위의 제외에 관한 국제 동향

Current status on the modification of the scope for GMO regulation on the gene edited plants with no remnants of inserted foreign DNA fragments

  • 이신우 (국립경남과학기술대학교 생명과학대학 농학.한약자원학부)
  • Lee, Shin-Woo (Gene Edited Crops with No Remnants of Inserted Foreign DNA Fragments Should be Exempted From GMO Regulation)
  • 투고 : 2019.08.09
  • 심사 : 2019.09.15
  • 발행 : 2019.09.30

초록

유전자교정작물은 공여 DNA의 사용 여부와 돌연변이의 크기에 따라 SDN-1, SDN-2, SDN-3 작물로 분류한다. 특히 SDN-1과 SDN-2 작물들은 이들을 창출하기 위하여 사용한 운반체 DNA 단편 또는 guide RNA가 잔존 하지 않는 100% transgene-free 작물의 개발이 가능하다. 따라서 이들은 기존의 전통교배육종기술을 이용하거나 자연 상태에서도 창출이 가능한 작물들이다. 그러므로 기존의 GMO 법령에 따라 이들 유전자교정작물을 판별하거나 표시제에 근거한 관리 감독을 수행하기가 어렵다. 이러한 과학적 사실에 근거하여 호주는 SDN-1 작물은 GMO 규제에서 제외하도록 하였다. 또한, 아르헨티나, 브라질, 일본 등은 외래유전자가 최종산물에 잔존 하지 않는 유전자교정작물은 GMO 규제에서 제외하도록 하여 SDN-1은 물론 SDN-2 작물도 GMO에 포함되지 않을 수도 있도록 하였다. 이러한 추세에 따라 우리나라도 외래유전자가 잔존 하지 않는 유전자교정작물은 GMO 규제에서 제외하도록 하여 유전자교정기술을 이용한 다양한 작물 육종 계통 육성이 널리 이용되어 우수 품종 육성에 기여되길 기대한다.

Gene edited crops can be classified as SDN-1, SDN-2 and SDN-3 group depending on their mutation's range and the usage of donor DNA. The SDN-1 and SDN-2 crops, in particular, could be developed as 100% transgene-free, which do not contain any DNA fragment of the vector or guide RNA used for gene editing such as CRISPR Cas9 system. Therefore, there are no scientific methods available for the detection of these crops and differentiation with the one produced by conventional cross breeding techniques. Additionally, it would be impossible to properly implement the existing GMO regulation law, in particular, the national legislation for "GMO labelling". In this regard, Australia has announced that SDN-1 crops will not be subjected to the existing GMO regulation. Furthermore, Argentina and Brazil have established a new policy that GE crops with no transgene (100% transgene-free crops) should be exempted from the scope of the GMO. In addition, Japan has also announced that "an organism that has no remnants of inserted nucleic acid processed extracellularly is not subjected to the Cartagena Act". It means that SDN-2 crops can also be exempted from the scope of GMO. In this trend, in South Korea, I suggested that gene edited crops with no remnants of inserted foreign DNA fragments should be excluded from the existing GMO regulation. Thus, I expect that diverse elite crop lines should be developed by using advanced gene editing technologies

키워드

참고문헌

  1. Abbott A (2015) Europe's genetically edited plants stuck in legal limbo, Scientists frustrated at delay in deciding if GM regulations apply to precision gene editing. Nature 528:319-320 https://doi.org/10.1038/528319a
  2. ACRE (2018) Advice on genome-edited Camelina plants with increased levels of oleic acid. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/708560/gmo-Camelina-oleic-acre-advice.pdf.pdf
  3. Araki M, Ishii T (2015) Towards social acceptance of plant breeding by genome editing. Trends Plant Sci 20(3):145-149 https://doi.org/10.1016/j.tplants.2015.01.010
  4. Duensing N, Sprink T, Parrott WA, Fedorova M, Lema MA, Wolt JD, Bartsch D (2018) Novel features and considerations for ERA and regulation of crops produced by genome editing. Front Bioeng Biotechnol 6:79-95 https://doi.org/10.3389/fbioe.2018.00079
  5. Eckerstorfer MF, Dolezel M, Heissenberger A, Miklau M, Reichenbecher W, Steinbrecher RA, Wassmann F (2019a) An EU perspective on biosafety considerations for plants developed by genome editing and other new genetic modification techniques (nGMs). Front Bioeng Biotechnol 7:31-52 https://doi.org/10.3389/fbioe.2019.00031
  6. Eckerstorfer MF, Engelhard M, Heissenberger A, Simon S, Teichmann H (2019b) Plants developed by new genetic modification techniques-comparison of existing regulatory frameworks in the EU and Non-EU countries. Front Bioeng Biotechnol 7(26):1-16 https://doi.org/10.3389/fbioe.2019.00001
  7. European Academies Science Advisory Council [EASAC] (2015) EASAC Statement on New Breeding Techniques. Available at: http://www.epsoweb.org/file/2105
  8. European Court of Justice [ECJ] (2018a) Judgement of the court in case C-528/16 available at: http://curia.europa.eu/juris/documents.jsf?num=C-528/16
  9. European Court of Justice [ECJ] (2018b) Opinion of advocate general Bobek in Case C-528/16. Available at: http://curia.europa.eu/juris/documents.jsf?num=C-528/16
  10. Faure J-D, Napier JA (2019) Europe's first and last field trial of gene-edited plants? eLife 2018;7:e42379. DOI:https://doi.org/10.7554/eLife. 42379
  11. Hajiahmadi Z, Movahedi A, Wei H, Li D, Orooji Y, Ruan H, Zhuge Q (2019) Strategies to increase on-target and reduce off-target effects of the CRISPR/Cas9 system in plants. Int J Mol Sci 20:3719-3738 https://doi.org/10.3390/ijms20153719
  12. Hilscher J, Burstmayr H, Stoger E (2017) Targeted modification of plant genomes for precision crop breeding. Biotechnol J 12:1-4
  13. Jones HD (2015) Regulatory uncertainty over genome editing. Nat Plants 1:14011 https://doi.org/10.1038/nplants.2014.11
  14. Jouanin A, Boyd L, Visser RGF, Smulders MJM (2018) Development of wheat with hypoimmunogenic gluten obstructed by the gene editing policy in Europe. Front Plant Sci 9:1523-1531 https://doi.org/10.3389/fpls.2018.01523
  15. Jung YJ, Kim JM, Park SC, Cho YG, Kang KK (2018) Current status of new plant breeding technology and its efforts toward social acceptance. J Plant Biotechnol 45:299-305 https://doi.org/10.5010/JPB.2018.45.4.299
  16. Kang J, Snapp AR, Lu C (2011) Identification of three genes encoding microsomal oleate desaturases (FAD2) from the oilseed crop Camelina sativa. Plant Physiol Biochem 49:223-229 https://doi.org/10.1016/j.plaphy.2010.12.004
  17. Kim H, Kim ST, Ryu J, Kang BC, Kim JS, Kim SG (2017) CRISPR/ Cpf1-mediated DNA-free plant genome editing. Nature Commun 8:14406-14412 https://doi.org/10.1038/ncomms14406
  18. Komor AC, Kim YB, Packer MS, Zuris JA, Liu DR (2016) Programmable editing of a target base in genomic DNA without double-stranded DNA cleavage. Nature 533:420-424 https://doi.org/10.1038/nature17946
  19. Lawler M (2015) Silencing the voice of scientific reason. Lancet Oncol 16:4-5 https://doi.org/10.1016/S1470-2045(14)71174-X
  20. Lee SW (2018) Strengthening the competitiveness of agricultural biotechnology through practical application of gene editing technology. J Plant Biotechnol 45:155-170 https://doi.org/10.5010/JPB.2018.45.3.155
  21. Lusser M, Parisi C, Plan D, Rodriguez-Cerezo E (2011) New plant breeding techniques, State-of-the-art and prospects for commercial development. EUR 24760 EN, JRC European Commission
  22. Morineau C, Bellec Y, Tellier F, Gissot L, Kelemen Z, Nogue F, Faure JD (2017) Selective gene dosage by CRISPR-Cas9 genome editing in hexaploid Camelina sativa. Plant Biotechnol J 15:729-739 https://doi.org/10.1111/pbi.12671
  23. Nguyen HT, Silva JE, Podicheti R, Macrander J, Yang W, Nazarenus TJ, Nam JW, Jaworski JG, Lu C, Scheffler BE, Mockaitis K, Cahoon EB. (2013) Camelina seed transcriptome: a tool for meal and oil improvement and translational research. Plant Biotechnol J 11:759-769 https://doi.org/10.1111/pbi.12068
  24. OECD (2018) Conference on genome editing: Applications in agriculture, Paris, http://www.oecd.org/environment/genome-editing-agriculture/
  25. OECD (2019) 33rd meeting of the OECD working group on the harmonisation of regulatory oversight in biotechnology. OECD headquarters, Paris, 9-11, April, 2019
  26. OGTR (2018) Technical review of the Gene Technology Regulations 2001-2017-18 Amendment proposals consultation. Office of the Gene Technology Regulator, http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/amendment%20proposals-1
  27. Panella F, Steinbrecher R, Ferrante A, Schimpf M, Wallace H, Richartz S, Then C (2015) Open letter to the commission on new genetic engineering methods. http://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/New_Breeding_Techniques___Open_Letter_27_Jan_2015.pdf
  28. Qin L, Li J, Wang Q, Xu Z, Sun L, Alariqi M, Manghwar H, Wang G, Li B, Ding X, Rui H, Huang H, Lu T, Lindsey K, Daniell H, Zhang X, Jin X (2019) High-efficient and precise base editing of C.G to T.A in the allotetraploid cotton (Gossypium hirsutum) genome using a modified CRISPR/Cas9 system. Plant Biotechnol J, in press, https://doi.org/10.1111/pbi.13168
  29. Smyth SJ (2017) Canadian regulatory perspectives on genome engineered crops. GM Crops & Food 8:35-43 https://doi.org/10.1080/21645698.2016.1257468
  30. Sprink T, Metje J, Hartung F (2015) Plant genome editing by novel tools: TALEN and other sequence specific nucleases. Curr Opin Biotechnol 32:47-53 https://doi.org/10.1016/j.copbio.2014.11.010
  31. Sprink T, Eriksson D, Schiemann J, Hartung F (2016a) Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts. Plant Cell Rep 35:1493-1506 https://doi.org/10.1007/s00299-016-1990-2
  32. Sprink T, Metje J, Schiemann J, Hartung F (2016b). Plant genome editing in the European Union-to be or not to be-a GMO. Plant Biotechnol Rep 10:345-351 https://doi.org/10.1007/s11816-016-0418-3
  33. USDA-APHIS (2018) Am I regulated under 7 CFR part 340. Available online at: https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/am-i-regulated
  34. Waltz E (2018) With a free pass, CRISPR-edited plants reach market in record time. Nat Biotechnol 36:6-7 https://doi.org/10.1038/nbt0118-6b
  35. Whelan 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
  36. Wolt JD, Wang K, Yang B (2016) The regulatory status of genome edited crops. Plant Biotechnol J 14:510-518 https://doi.org/10.1111/pbi.12444
  37. Zhang Y, Liang Z, Zong Y, Wang Y, Liu J, Chen K, Qiu JL, Gao C (2016) Efficient and transgene-free genome editing in wheat through transient expression of CRISPR/Cas9 DNA or RNA. Nat. Commun. 7:12617-12619 https://doi.org/10.1038/ncomms12617