Irtiqa Imini Pishgiri Masdumiyat (Safety Promotion and Injury Prevention)

1. Jinek M, Chylinski K, Fonfara I, Hauer M, Doudna JA, Charpentier E. A programmable dual-RNA–guided DNA endonuclease in adaptive bacterial immunity. science. 2012;337(6096):816-21. https://doi.org/10.1126/science.1225829

2. Belhaj K, Chaparro-Garcia A, Kamoun S, Nekrasov V. Plant genome editing made easy: targeted mutagenesis in model and crop plants using the CRISPR/Cas system. Plant methods. 2013;9(1):39. https://doi.org/10.1186/1746-4811-9-39

3. Bortesi L, Fischer R. The CRISPR/Cas9 system for plant genome editing and beyond. Biotechnology advances. 2015;33(1):41-52. https://doi.org/10.1016/j.biotechadv.2014.12.006

4. Waltz, E. (2016). Gene-edited CRISPR mushroom escapes US regulation. nature. 2016;523:293. https://doi.org/10.1038/nature.2016.19754

5. Kagale S, Koh C, Nixon J, Bollina V, Clarke WE, Tuteja R, Spillane C, Robinson SJ, Links MG, Clarke C, Higgins EE. The emerging biofuel crop Camelina sativa retains a highly undifferentiated hexaploid genome structure. Nature Communications. 2014;5(1):3706. https://doi.org/10.1038/ncomms4706

6. Berti M, Gesch R, Eynck C, Anderson J, Cermak S. Camelina uses, genetics, genomics, production, and management. Industrial crops and products. 2016;94:690-710. https://doi.org/10.1016/j.indcrop.2016.09.034

7. Zubr J. Oil-seed crop: Camelina sativa. Industrial crops and products. 1997;6(2):113-119. https://doi.org/10.1016/S0926-6690(96)00203-8

8. Abramovic H, Abram V. Physico-chemical properties, composition and oxidative stability of Camelina sativa oil. Food technol. biotechnol. 2005;43(1):63-70.

9. Knutsen HK, Alexander J, Barregård L, Bignami M, Brüschweiler B, Ceccatelli S, et al. Erucic acid in feed and food. EFSA Journal. 2016;14(11):e04593. https://doi.org/10.2903/j.efsa.2016.4593

10. Ebadi AG, Kahrizi D, Ahmadvandi HR. Production and Biochemical Evaluation of Camelina [Camelina sativa (L.) Crantz] Doubled Haploid Lines. Journal of Medicinal Plants & By-Products. 2024;13(2). https://doi.org/10.22034/jmpb.2023.359588.1489

11. Zhang XH, Tee LY, Wang XG, Huang QS, Yang SH. Off-target effects in CRISPR/Cas9-mediated genome engineering. Molecular therapy Nucleic acids. 2015;4:e264. https://doi.org/10.1038/mtna.2015.37

12. Organisation for Economic Co-operation and Development (OECD). Consensus Document on the Biology of Camelina sativa (L.) Crantz. OECD Publishing, Paris, 2024.

13. James Jr DW, Dooner HK. Isolation of EMS-induced mutants in Arabidopsis altered in seed fatty acid composition. Theoretical and Applied Genetics. 1990 Aug;80(2):241-5. https://doi.org/10.1007/BF00224393

14. Kunst L, Samuels AL. Biosynthesis and secretion of plant cuticular wax. Progress in lipid research. 2003;42(1):51-80. https://doi.org/10.1016/S0163-7827(02)00045-0

15. Jiang W, Zhou H, Bi H, Fromm M, Yang B, Weeks DP. Demonstration of CRISPR/Cas9/sgRNA-mediated targeted gene modification in Arabidopsis, tobacco, sorghum and rice. Nucleic acids research. 2013;41(20):e188. https://doi.org/10.1093/nar/gkt780

16. Liu Y, Du Z, Lin S, Li H, Lu S, Guo L, Tang S. CRISPR/Cas9-targeted mutagenesis of BnaFAE1 genes confers low-erucic acid in Brassica napus. Frontiers in plant science. 2022;13:848723. https://doi.org/10.3389/fpls.2022.848723

17. Ricroch AE, Martin-Laffon J, Rault B, Pallares VC, Kuntz M. Next biotechnological plants for addressing global challenges: The contribution of transgenesis and new breeding techniques. New Biotechnology. 2022;66:25-35. https://doi.org/10.1016/j.nbt.2021.09.001

18. Kleinstiver BP, Pattanayak V, Prew MS, Tsai SQ, Nguyen NT, Zheng Z, Joung JK. High-fidelity CRISPR–Cas9 nucleases with no detectable genome-wide off-target effects. Nature. 2016;529(7587):490-495. https://doi.org/10.1038/nature16526

19. Anzalone AV, Randolph PB, Davis JR, Sousa AA, Koblan LW, Levy JM, Chen PJ, Wilson C, Newby GA, Raguram A, Liu DR. Search-and-replace genome editing without double-strand breaks or donor DNA. Nature. 2019;576(7785):149-157. https://doi.org/10.1038/s41586-019-1711-4

20. Naegeli H, Bresson JL, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, et al. Applicability of the EFSA Opinion on site-directed nucleases type 3 for the safety assessment of plants developed using site-directed nucleases type 1 and 2 and oligonucleotide-directed mutagenesis. EFSA Journal. 2020;18(11):e06299. https://doi.org/10.2903/j.efsa.2020.6299

21. Food and Drug Administration. Guidance for Industry: Regulation of Intentionally Altered Genomic DNA in Animals. 2024.

22. Gelinsky E, Hilbeck A. European Court of Justice ruling regarding new genetic engineering methods scientifically justified: a commentary on the biased reporting about the recent ruling. Environmental Sciences Europe. 2018;30(1):52. https://doi.org/10.1186/s12302-018-0182-9

23. PRISMA Statement Group. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021; 372:n71. https://doi.org/10.1136/bmj.n71

24. Millar AA, Clemens S, Zachgo S, Giblin EM, Taylor DC, Kunst L. CUT1, an Arabidopsis gene required for cuticular wax biosynthesis and pollen fertility, encodes a very-long-chain fatty acid condensing enzyme. The Plant Cell. 1999;11(5):825-838. https://doi.org/10.1105/tpc.11.5.825

25. Ozseyhan ME, Kang J, Mu X, Lu C. Mutagenesis of the FAE1 genes significantly changes fatty acid composition in seeds of Camelina sativa. Plant Physiology and Biochemistry. 2018;123:1-7. https://doi.org/10.1016/j.plaphy.2017.11.021

26. Modrzejewski D, Hartung F, Sprink T, Krause D, Kohl C, Wilhelm R. What is the available evidence for the range of applications of genome-editing as a new tool for plant trait modification and the potential occurrence of associated off-target effects: a systematic map. Environmental Evidence. 2019;8(1):27. https://doi.org/10.1186/s13750-019-0171-5

27. European Food Safety Authority (EFSA) Panel on Genetically Modified Organisms (GMO). Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA Journal. 2012;10(2):2561. https://doi.org/10.2903/j.efsa.2012.2561

28. Delaney B, Goodman RE, Ladics GS. Food and feed safety of genetically engineered food crops. Toxicological Sciences. 2018;162(2):361-371. https://doi.org/10.1093/toxsci/kfx249

29. Organisation for Economic Co-operation and Development (OECD). Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles. Paris: OECD; 1993.

30. Codex Alimentarius Commission. Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants. CAC/GL. 2003;45(2003):1-3.

31. Ghanevati M, Jaworski JG. Active-site residues of a plant membrane-bound fatty acid elongase β-ketoacyl-CoA synthase, FAE1 KCS. Biochimica et Biophysica Acta (BBA)-Molecular and Cell Biology of Lipids. 2001;1530(1):77-85. https://doi.org/10.1016/S1388-1981(00)00168-2

32. Ladics GS. Current codex guidelines for assessment of potential protein allergenicity. Food and Chemical Toxicology. 2008;46(10):S20-S23. https://doi.org/10.1016/j.fct.2008.07.021

33. Food Allergy Research & Resource Program (FARRP), University of Nebraska–Lincoln. AllergenOnline database documentation. Lincoln, NE: University of Nebraska. 2024.

34. Health and Environmental Sciences Institute (HESI). Comprehensive Protein Allergen Resource (COMPARE) Database: 2024 update. Washington, DC: HESI; 2024. https://db.comparedatabase.org/

35. Codex Alimentarius Commission (FAO/WHO). Foods Derived from Modern Biotechnology. Second Edition. Rome: Food and Agriculture Organization of the United Nations / World Health Organization; 2009.

36. Food and Agriculture Organization of the United Nations / World Health Organization (FAO/WHO). Evaluation of Allergenicity of Genetically Modified Foods: Report of a Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology. Rome, Italy: FAO/WHO; 2001.

37. Miccoli A, Marx‐Stoelting P, Braeuning A. The use of NAMs and omics data in risk assessment. EFSA Journal. 2022;20:e200908. https://doi.org/10.2903/j.efsa.2022.e200908

38. Tang X, Lowder LG, Zhang T, Malzahn AA, Zheng X, Voytas DF, Zhong Z, Chen Y, Ren Q, Li Q, Kirkland ER. A CRISPR–Cpf1 system for efficient genome editing and transcriptional repression in plants. Nature Plants. 2017;3(3):17018. https://doi.org/10.1038/nplants.2017.18

39. Zong Y, Wang Y, Li C, Zhang R, Chen K, Ran Y, Qiu JL, Wang D, Gao C. Precise base editing in rice, wheat and maize with a Cas9-cytidine deaminase fusion. Nature Biotechnology. 2017;35(5):438-40. https://doi.org/10.1038/nbt.3811

40. Vakulskas CA, Dever DP, Rettig GR, Turk R, Jacobi AM, Collingwood MA, Bode NM, McNeill MS, Yan S, Camarena J, Lee CM. A high-fidelity Cas9 mutant delivered as a ribonucleoprotein complex enables efficient gene editing in human hematopoietic stem and progenitor cells. Nature Medicine. 2018;24(8):1216-1224. https://doi.org/10.1038/s41591-018-0137-0

41. Ellstrand NC. Dangerous liaisons?: when cultivated plants mate with their wild relatives. Johns Hopkins University Press; 2003.

42. Hilbeck A. European Court of Justice ruling regarding new genetic engineering methods scientifically justified: a commentary on the biased reporting about the recent ruling. Environmental Sciences Europe. 2018;30:52. https://doi.org/10.1186/s12302-018-0182-9

43. Morineau C, Bellec Y, Tellier F, Gissot L, Kelemen Z, Nogué F, Faure JD. Selective gene dosage by CRISPR‐Cas9 genome editing in hexaploid Camelina sativa. Plant Biotechnology Journal. 2017;15(6):729-739. https://doi.org/10.1111/pbi.12671

44. Lee K, Zhang Y, Kleinstiver BP, Guo JA, Aryee MJ, Miller J, Malzahn A, Zarecor S, Lawrence‐Dill CJ, Joung JK, Qi Y. Activities and specificities of CRISPR/Cas9 and Cas12a nucleases for targeted mutagenesis in maize. Plant Biotechnology Journal. 2019;17(2):362-372. https://doi.org/10.1111/pbi.12982

45. Kawall K. The generic risks and the potential of SDN-1 applications in crop plants. Plants. 2021;10(11):2259. https://doi.org/10.3390/plants10112259

46. Organisation for Economic Co-operation and Development (OECD). Safety Assessment of Transgenic Organisms in the Environment. Volume 10: OECD Consensus Document on Environmental Considerations for the Release of Transgenic Plants. Paris: OECD Publishing; 2023. https://doi.org/10.1787/62ed0e04-en