Recommendations for Science-Based Safety Assessment of Genetically Modified (GM) Plants for Food and Feed Uses
DOI:
https://doi.org/10.21423/JRS-V09I1WATERSKeywords:
genetically modified plant, food and feed, safety assessment, core studies, risk, problem formulation, supplementary studies, regulationsAbstract
Since the commercial introduction of genetically modified (GM) plants in agriculture over two decades ago, technology developers and regulatory authorities have gained significant experience in assessing their safety based on assessing potential impact to humans, animals and the environment. Over 3500 independent regulatory agency reviews have positively concluded on the safety of GM plants for food and feed. Yet, divergent and increased regulatory requirements have led to delayed and asynchronous approvals, and have restricted access to innovative products for farmers and consumers. With accumulated knowledge from safety assessments conducted so far, an enhanced understanding of plant genomes, and a history of safe use, it is time to re-evaluate the current approaches to the regulation of GM plants used for food and feed. A stepwise approach using weight-of-evidence should be sufficient for the safety assessment of newly expressed proteins in GM plants. A set of core studies including molecular characterization, expression and characterization of the newly expressed proteins (or other expression product), and safety assessment of the introduced protein are appropriate to characterize the product and assess safety. Using data from core studies, and employing a “problem formulation” approach, the need for supplementary hypothesis-driven or case-by-case studies can be determined. Employing this approach for the evaluation of GM plants will remove regulatory data requirements that do not provide value to the safety assessment and provide a consistent framework for global regulation.
doi: 10.21423/jrs-v09i1waters
References
Bisognin, D. A. (2011). Breeding vegetatively propagated horticultural crops. Crop Breeding and Applied Biotechnology, 11, 35-43. Retrieved from http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-70332011000500006&nrm=iso
Brune, P., Chakravarthy, S., Graser, G., Mathesius, C., McClain, S., Petrick, J. S., Sauve-Ciencewicki, A., Schafer, B., Silvanovich, A., Brink, K., Burgin, K., Bushey, D., Cheever, M. L., Edrington, T., Fu, H., Habex, V., Herman, R., Islamovic, E., Lipscomb, E. A., Motyka, S., Privalle, L., Ranjan, R., Roper, J., Song, P., Tilton, G., Zhang, J., Waters, S., Ramos, A., Culler, A. H., Hunst, P., Gast, R., Mahadeo, D., & Goodwin, L. (2021). Core and supplementary studies to assess the safety of genetically modified (GM) plants used for food and feed. Journal of Regulatory Science, 9(1), 45-60. doi: XXX
Codex Alimentarius Commission. (2003, 30 June-5 July). Appendix III, Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants, and Appendix IV, Annex on the Assessment of Possible Allergenicity. Joint FAO/WHO Food Standard Programme, Twenty-fifth session. Food and Agriculture Organization of the United Nations, Rome.
Codex Alimentarius Commission. (2003). Principles for the Risk Analysis of Foods Derived from Modern Biotechnology. Joint FAO/WHO Food Standard Programme. Food and Agriculture Organization of the United Nations, Rome.
Codex Alimentarius Commission. (2009). Foods derived from modern biotechnology, Second edition. Food and Agriculture Organization of the United Nations and World Health Organization, Rome. Retrieved from http://www.fao.org/3/a-a1554e.pdf
Canadian Food Inspection Agency. (1985). Food and Drugs Act. Retrieved September 2019 from https://laws-lois.justice.gc.ca/eng/acts/F-27/FullText.html
Canadian Food Inspection Agency. (2018). Appendix 5: Similar PNTs. Assessment Criteria for Determining Environmental Safety of Plants With Novel Traits, Directive 94-08. Retrieved September 2019 from https://www.inspection.gc.ca/plants/plants-with-novel-traits/applicants/directive-94-08/appendices/eng/1512662253920/1512662254595#app5
Cong, B., Maxwell, C., Luck, S., Vespestad, D., Richard, K., Mickelson, J., & Zhong, C. (2015). Genotypic and Environmental Impact on Natural Variation of Nutrient Composition in 50 Non Genetically Modified Commercial Maize Hybrids in North America. Journal of Agricultural and Food Chemistry, 63(22), 5321-5334. https://www.doi.org/10.1021/acs.jafc.5b01764
Delaney, B., Astwood, J. D., Cunny, H., Conn, R. E., Herouet-Guicheney, C., MacIntosh, S., Meyer, L. S., Privalle, L., Gao, Y., Mattsson, J., Levine, M., & ILSI International Food Biotechnology Committee Task Force on Protein Safety. (2008). Evaluation of protein safety in the context of agricultural biotechnology. Food and Chemical Toxicology, 46(Supplement 2), S71-S97. https://www.doi.org/10.1016/j.fct.2008.01.045
bibitem{faowho1999} Food and Agriculture Organization of the United Nations & World Health Organization. (1999). emph{Principles and Guidelines for the Conduct of Microbiological Risk Assessment}. Retrieved from http://www.fao.org/3/y1579e/y1579e05.htm
Food and Agriculture Organization of the United Nations & World Health Organization. (2001). Definitions for the Purposes of the Codex Alimentarius. Retrieved from http://www.fao.org/3/y2200e/y2200e07.htm
Food Standards Australia New Zealand. (1991). Food Standards Australia New Zealand Act 1991. Retrieved September 2019 from https://www.legislation.gov.au/Details/F2016C00156
Herman, R. A., Chassy, B. M., & Parrott, W. (2009). Compositional assessment of transgenic crops: an idea whose time has passed.Trends in Biotechnology, 27(10), 555-557. https://www.doi.org/10.1016/j.tibtech.2009.07.003
Informa. (2018, May). The Impact of Delays in Chinese Approvals of Biotech Crops. Retrieved from https://croplife.org/wp-content/uploads/2018/05/Impact-of-Delays-in-Chinese-Approvals-of-Biotech-Crops-05-18-FINAL-1.pdf
International Service for the Acquisition of Agri-biotech Applications. (2017). Global Status of Commercialized Biotech/GM Crops in 2017: Biotech Crop Adoption Surges as Economic Benefits Accumulate in 22 Years (Brief 53). International Service for the Acquisition of Agri-biotech Applications. Retrieved from https://www.isaaa.org/resources/publications/briefs/53/download/isaaa-brief-53-2017.pdf
International Service for the Acquisition of Agri-biotech Applications. (2018). Global Status of Commercialized Biotech/GM Crops: 2018 (Brief 54). International Service for the Acquisition of Agri-biotech Applications. Retrieved from https://www.isaaa.org/resources/publications/briefs/54/executivesummary/pdf/B54-ExecSum-English.pdf
James, C., & Krattiger, A. F. (1996). Global Review of the Field Testing and Commercialization of Transgenic Plants: 1986 to 1995, The First Decade of Crop Biotechnology (Brief 1). International Service for the Acquisition of Agri-biotech Applications. Retrieved from https://www.isaaa.org/resources/publications/briefs/01/download/isaaa-brief-01-1996.pdf
National Academies of Sciences, Engineering, and Medicine. (2016). Genetically Engineered Crops: Experiences and Prospects. The National Academies Press.
National Academies of Sciences, Engineering, and Medicine. (2017). Preparing for Future Products of Biotechnology. The National Academies Press.
National Research Council. (2003). Risk Management: The Principles Underlying the Design and Implementation of an Occupational Health and Safety Plan. In Occupational Health and Safety in the Care and Use of Nonhuman Primates. The National Academies Press.
Prado, J. R., Segers, G., Voelker, T., Carson, D., Dobert, R., Phillips, J., Cook, K., Cornejo, C., Monken, J., Grapes, L., Reynolds, T., & Martino-Catt, S. (2014). Genetically engineered crops: from idea to product. Annual Review of Plant Biology, 65, 769-790. https://www.doi.org/10.1146/annurev-arplant-050213-040039
Privalle, L. S., Chen, J., Clapper, G., Hunst, P., Spiegelhalter, F., & Zhong, C. X. (2012). Development of an Agricultural Biotechnology Crop Product: Testing from Discovery to Commercialization. Journal of Agricultural and Food Chemistry, 60(41), 10179-10187. https://www.doi.org/10.1021/jf302706e
Solomon, K. R., Wilks, M. F., Bachman, A., Boobis, A., Moretto, A., Pastoor, T. P., Phillips, R., & Embry, M. R. (2016). Problem formulation for risk assessment of combined exposures to chemicals and other stressors in humans. Critical Reviews in Toxicology, 46(10), 835-844. https://www.doi.org/10.1080/10408444.2016.1211617
U.S. Department of Agriculture. (n.d.). About the SECURE Rule. Retrieved November 2020 from https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/biotech-rule-revision/secure-rule/secure-about
U.S. Department of Agriculture Foreign Agricultural Service. (2015). Japan's regulatory system for GE crops continues to improve. Retrieved March 2019 from https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Agricultural%20Biotechnology%20Annual_Tokyo_Japan_7-13-2015.pdf
U.S. Department of Agriculture Foreign Agricultural Service. (2017). Japan 2017 Agricultural Biotechnology Annual. Retrieved October 2019 from https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Agricultural%20Biotechnology%20Annual_Tokyo_Japan_11-16-2017.pdf
Venkatesh, T. V., Cook, K., Liu, B., Perez, T., Willse, A., Tichich, R., Feng, P., & Harrigan, G. G. (2015). Compositional differences between near‐isogenic GM and conventional maize hybrids are associated with backcrossing practices in conventional breeding. Plant Biotechnology Journal, 13(2), 200-210. https://www.doi.org/10.1111/pbi.12248
Wolt, J. D., Keese, P., Raybould, A., Fitzpatrick, J. W., Burachik, M., Gray, A., Olin, S. S., Schiemann, J., Sears, M., & Wu, F. (2010). Problem formulation in the environmental risk assessment for genetically modified plants. Transgenic Research, 19(3), 425-436. https://www.doi.org/10.1007/s11248-009-9321-9
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Copyright (c) 2021 Stephen Waters, Adela Ramos, Angela Hendrickson Culler, Penny Hunst, Lawrence Zeph, Rachel Gast, Debbie Mahadeo, Jordan Sottosanto, Scott Huber, Guomin Shan, Suma Chakravarthy, Laurie Goodwin
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