Risk-appropriate regulations for gene-editing technologies

References

• Royal Society (undated) What are genetic technologies. The Royal Society. London (UK). [accessed 2023 Dec 4]. https://royalsociety.org/topics-policy/projects/genetic-technologies/.
   Google Scholar
• Convention on Biological Diversity. 2022. Kunming-Montreal global biodiversity framework. [accessed 2023 Oct 10]. https://www.cbd.int/doc/decisions/cop-15/cop-15-dec-04-en.pdf.
   Google Scholar
• Agroecology Now. 2022. Agroecology – a promising alternative to the biodiversity crisis in agriculture and industrial food systems. [accessed 2023 Dec 1]. https://www.agroecologynow.com/agroecology-alternative-to-biodiversity-crisis/
   Google Scholar
• Desertif’actions 2022. Agroecology Brought to the COP 15. [accessed 2023 Dec 1]. https://desertif-actions.org/en/homepage/desertifactions-2022/agroecology-brought-to-the-cop-15/.
   Google Scholar
• Balmford A. Concentrating vs spreading our footprint: how to meet humanity’s needs at least cost to nature. J Zool. 2021;315(2):79–109. doi:10.1111/jzo.12920.
   Web of Science ®Google Scholar
• Feniuk C, Balmford A, Green R, et al. Land sparing to make space for species dependent on natural habitats and high nature value farmland. Proc Biological Sci. 2019 Aug 28;286(1909):20191483. Epub. doi:10.1098/rspb.2019.1483
   PubMed Web of Science ®Google Scholar
• Finch T, Green R, Masomino D, Peach N, Balmford A, Tulloch A. Optimising nature conservation outcomes for a given region-wide level of food production. J Appl Ecol. 2020 [22 Feb 2020];57(5):985–94. doi:10.1111/1365-2664.13594.
   Web of Science ®Google Scholar
• Balmford A, Bateman I. Current conservation policies risk accelerating biodiversity loss, Comment, Nature 21st June 2023. Nature. 2023a;618(7966): 671–74. Current conservation policies risk accelerating biodiversity loss (nature.com). 10.1038/d41586-023-01979-x
   PubMed Web of Science ®Google Scholar
• Balmford A, Bateman I. Current land use policies risk accelerating farming’s environmental impact. BalmfordBateman | SSA: Science for Sustainable Agriculture, UK; 2022. scienceforsustainableagriculture.com.
   Google Scholar
• European Commission. Directorate-general for research and innovation. A decade of EU-funded GMO research (2001-2010). 2010 [accessed 2023 Oct, 10]. https://data.europa.eu/doi/10.2777/97784.
   Google Scholar
• Klümper W, Qaim M, Albertini E. A meta-analysis of the impacts of genetically modified crops. PLoS ONE. 2014;9: 11(11):e111629. doi:10.1371/journal.pone.0111629.
   Web of Science ®Google Scholar
• National Academies of Science, Engineering and Medicine. 2016. Genetically engineered crops. [accessed 2023 Oct, 10]. https://nap.nationalacademies.org/catalog/23395/genetically-engineered-crops-experiences-and-prospects.
   Google Scholar
• Smyth SJ, Webb SR, Phillips PWB. The role of public-private partnerships in improving global food security. Global Food Security. 2021;3:100588. doi:10.1016/j.gfs.2021.100588.
   Google Scholar
• Organisation for Economic Cooperation and Development. making better policies for food systems. Paris: OECD; 2021. doi:10.1787/ddfba4de-en.
   Google Scholar
• Conway G, Toenniessen G. Feeding the world in the 21st century. Nature. 1999;403(suppl 6761): 402, c55–c58. doi:10.1038/35011545.
   Google Scholar
• Smyth SJ, Gusta M, Belcher K, Phillips PWB, Castle D. Changes in herbicide use following the adoption of HR canola in Western Canada. Weed Technol. 2011;25:3(3):492–500. doi:10.1614/WT-D-10-00164.1.
   Web of Science ®Google Scholar
• Carpenter JE. Impact of GM crops on biodiversity. GM Crops Food. 2011;2:1(1):7–23. doi:10.4161/gmcr.2.1.15086.
   Google Scholar
• Brookes G. Genetically modified crop use 1996-2020: impacts on carbon emissions. GM Crops Food. 2022a;13(1):242–61. Full article: Genetically Modified (GM) Crop Use 1996–2020: Impacts on Carbon Emissions (tandfonline.com). doi:10.1080/21645698.2022.2118495
   PubMed Web of Science ®Google Scholar
• Brookes G. Farm income and production impacts from the use of GM crop technology 1996-2020. 2022b. Full article: Farm income and production impacts from the use of genetically modified (GM) crop technology 1996-2020 (tandfonline.com). 10.1080/21645698.2022.2105626
   Google Scholar
• National Geographic. Invasive species. National Geographic Society, Washington DC. 2022 [accessed 2032 Oct 12]. https://education.nationalgeographic.org/resource/invasive-species/.
   Google Scholar
• United Nations Environmental Programme. Invasive alien species report. 2023 [accessed 2023 Oct 12]. https://www.unep.org/resources/report/invasive-alien-species-report.
   Google Scholar
• Champer J, Buckman A, Akbari OS. Cheating evolution: engineering gene drives to manipulate the fate of wild populations. Nat Rev Genet. 2016;17(3):146–59. doi:10.1038/nrg.2015.34.
   PubMed Web of Science ®Google Scholar
• European Commission. Farm to fork strategy. 2020. [accessed 2023 Oct 12]. https://food.ec.europa.eu/horizontal-topics/farm-fork-strategy_en.
   Google Scholar
• Lika E, Sutherland C, Gleim S, Smyth SJ. Quantifying changes in the environmental impact of herbicide use in Saskatchewan. Weed Technology; Forthcoming a.
   Google Scholar
• Brookes G. Genetically modified crop use 1996-2020: environmental impacts associated with pesticide use change. GM Crops Food. 2022c;13(1). Full article: Genetically Modified (GM) Crop Use 1996–2020: Environmental Impacts Associated with Pesticide Use Change (tandfonline.com). doi:10.1080/21645698.2022.2118497
   Google Scholar
• MNP. Implications of a total emissions reduction target on fertilizer. 2021 [accessed 2023 Dec 2] https://mma.prnewswire.com/media/1635963/Fertilizer_Canada_New_Report_Warns_of_Potential_for__48_Billion.pdf?p=original/.
   Google Scholar
• Lika E, Sutherland C, Gleim S, Smyth SJ. Comparative study on fertilizer application trends in Saskatchewan and their implications. Plant Nutrition; Forthcoming b.
   Google Scholar
• Nordhaus T, Shah S. In Sri Lanka, organic farming went catastrophically wrong – a nationwide experiment is abandoned after producing only misery. 2022. https://www.tbsnews.net.thoughts/sri-lanka-organic-farming-went-catastrophically-wrong-381010
   Google Scholar
• Lebedev VG, Popova AA, Shestibratov KA. Genetic engineering and genome editing for improving nitrogen use efficiency in plants. Cells. 2021;10: 12(12):3303. doi:10.3390/cells10123303.
   Web of Science ®Google Scholar
• Miller H, Hefferon K. Reduce synthetic fertilizers and improve yields? The microbiome revolution comes to agriculture. Genetic Literary Project. August 23 2023.
   Google Scholar
• Wen A, Havens KL, Bloch SE, Shah N, Higgins DA, Davis-Richardson AG, Sharon J, Rezaei F, Mohiti-Asli M, Johnson A, et al. enabling biological nitrogen fixation for cereal crops in fertilized fields. ACS Synth Biol. 2021;10(12):3264–77. doi:10.1021/acssynbio.1c00049.
   PubMed Web of Science ®Google Scholar
• Sutherland C, Gleim S, Smyth SJ. Correlating genetically modified crops, glyphosate use, and increased carbon sequestration. Sustainability. 2021;13(21):11679. doi:10.3390/su132111679.
   Web of Science ®Google Scholar
• Sathee L, Jagadhesan B, Pandesha PH, Barman D, Adavi BS, Nagar S, Krishna GK, Tripathi S, Jha SK, Chinnusamy V. Genome editing targets for improving nutrient use efficiency and nutrient stress adaptation. Front Genetics. 2022:13. doi:10.3389/fgene.2022.900897.
   Web of Science ®Google Scholar
• Głowacka K, Kromdijk J, Kucera K, Xie J, Cavanagh AP, Leonelli L, Leakey ADB, Ort DR, Niyogi KK, Long SP. Photosystem II subunit S overexpression increases the efficiency of water use in a field-grown crop. Nat Commun. 2018;9(1):868. doi:10.1038/s41467-018-03231-x.
   PubMedGoogle Scholar
• Smyth SJ. Contributions of genome editing technologies towards improved nutrition, environmental sustainability and poverty reduction. Front. Genome Editing. 2022;4:1–9. doi:10.3389/fgeed.2022.863193.
   Google Scholar
• Nature Biotechnol. Japan Embraces CRISPR-Edited Fish. Nature Biotechnol. 2021;40:10. doi:10.1038/s41587-021-01197-8.
   Web of Science ®Google Scholar
• Blix TB, Dalmo RA, Wargelius A, Myhr AI. Genome editing on finfish: current status and implications for sustainability. Revi Aquacult. 2021;13:4(4):2344–63. doi:10.1111/raq.12571.
   Web of Science ®Google Scholar
• Government of Canada. Mountain pine beetle. Natural Resources. 2022 [accessed 2023 Oct 17]. https://natural-resources.canada.ca/our-natural-resources/forests/wildland-fires-insects-disturbances/top-forest-insects-and-diseases-canada/mountain-pine-beetle/13381.
   Google Scholar
• Blind K. The influence of regulation on innovation: a quantitative assessment for OECD countries. Research Policy. 2012;41:391–400. doi:10.1016/j.respol.2011.08.008.
   Web of Science ®Google Scholar
• Phillips P, Williams A (2023). A meta-analysis of GM crops regulatory approval costs. Johnson shoyama centre for the study of science and innovation policy working paper series 2023-1. Canada: University of Saskatchewan. https://www.schoolofpublicpolicy.sk.ca/csip/.
   Google Scholar
• MacDougall P. The cost and time involved in the discovery, development and authorisation of a new plant biotechnology derived trait. 2011. Edinburgh (Scotland): Report for Crop Life International. Getting-a-Biotech-Crop-to-Market-Phillips-McDougall-Study.pdf(croplife.org).
   Google Scholar
• Bayer J, Norton G, Falck-Zepeda J. Cost of compliance with biotechnology regulation in the Philippines: implications for developing countries. AgBioforum 2010.13:53-62 cost of compliance with biotechnology regulation in the. Philippines: Implications for Developing Countries – AgBioForum; 2010.
   Google Scholar
• AgBioinvestor. Time and Cost to develop a new GM trait. 2022. Edinburgh (Scotland): Report for Crop Life International. AgbioInvestor-Trait-RD-Branded-Report-Final-20220512.pdf (croplife.org).
   Google Scholar
• Smyth S, McDonald J, Falck-Zepeda J. Investment, regulation and uncertainty: managing new plant breeding techniques. GM Crops Food: biotechnol agric food chain. 2014;5(1):1–14. doi:10.4161/gmcr.27465.
   PubMedGoogle Scholar
• Lassoued R, Phillips PWB, Smyth SJ, Hesseln H. Estimating the cost of regulating genome edited crops: expert judgment and overconfidence. GM Crops Food. 2019;10(1):44–62. doi:10.1080/21645698.2019.1612689.
   PubMed Web of Science ®Google Scholar
• Brookes G, Downes C. Can the EU regulatory environment help deliver food innovation? AgroFood Industry Hi Tech. 2017 July August;28(4):38–40. Drawing on the findings of a study undertaken for the EU specialty food ingredient industry association ‘Economic impact assessment for EU food related regulations on research, innovation and competitiveness in the food speciality sector. https://www.specialityfoodingredients.eu/uploads/news.documents/Brookes.innovation_report_June_2016.pdf
   Google Scholar
• Kalaitzandonakes N, Giddings V, McHughen A, Zahringer K. The impact of asynchronous approvals for biotech crops on agricultural sustainability, trade and innovation. CAST Commentary QTO 2016/2 December 2016. QTA20162_Asynchronous_Approvals_Eng_1A2341477D0E2.pdf (cast-science.org). 2016.
   Google Scholar
• Brookes G, Kayhan S. Economic impacts of the biosafety law and implementing regulations in Turkey on the Turkish importing and user sectors. Report (unpublished) for the United Soybean Board and the American Soybean Association-International Marketing. 2021. www.united-soybean.org
   Google Scholar
• DG Agriculture, European Commission. Study on the implications of asynchronous GMO approvals for EU imports of animal feed products. 2010. Study executed by the Agricultural Economics Research Institute (LEI), Wageningen University, Economics and Management of Agrobiotechnology Center (EMAC), University of Missouri, and Plant Research Institute (PRI), Wageningen, Netherlands Study on the implications of asynchronous GMO approvals for EU imports of animal feed products - Publications Office of the EU (europa.eu)
   Google Scholar
• Bertioli D, Miller H. The inhibition of innovation. CATO Institute. Washington DC: The Inhibition of Innovation | Cato Institute. Fall 2023.
   Google Scholar
• Entine J, Felipe MSS, Groenewald J-H, Kershen DL, Lema M, McHughen A, Nepomuceno AL, Ohsawa R, Ordonio RL, Parrott WA, et al. Regulatory approaches for genome edited agricultural plants in select countries and jurisdictions around the world. Transgenic Res. 2021;3:e96. doi:10.1007/s11248-021-00257-8.
   Google Scholar
• Kalaitzandonakes N, Willig C, Zahringer K. The economics and policy of genome editing in crop improvement. The Plant Genome. 2022;16(2):e20248. doi:10.1002/tpg2.20248.
   PubMed Web of Science ®Google Scholar
• Bullock D, Wilson W, Neadeau J. Gene editing versus genetic modification in the research and development of new crop traits: an economic comparison. Am J Eco. 2021;103(5):1700–19. doi:10.1111/ajae.12201.
   Web of Science ®Google Scholar
• Whelan A, Gutti P, Lema M. Gene editing regulation and innovation economics. Front Bioeng Biotechnol Policy Practice Rev. 2020 Apr;15(8):303. eCollection 2020. doi:10.3389/fbioe.2020.00303.
   Google Scholar