George Dalton R, Hornstein Eli D, Clower Carrie A, Coomber Allison L, Dillard DeShae, Mugwanya Nassib, Pezzini Daniela T, Rozowski Casey
Department of Forestry and Environmental Resources, College of Natural Resources, North Carolina Sate University, Raleigh, NC, United States.
Genetic Engineering and Society Center, North Carolina State University, Raleigh, NC, United States.
Front Bioeng Biotechnol. 2022 May 2;10:886765. doi: 10.3389/fbioe.2022.886765. eCollection 2022.
Regulation of next-generation crops in the United States under the newly implemented "SECURE" rule promises to diversify innovation in agricultural biotechnology. Specifically, SECURE promises to expand the number of products eligible for regulatory exemption, which proponents theorize will increase the variety of traits, genes, organisms, and developers involved in developing crop biotechnology. However, few data-driven studies have looked back at the history of crop biotechnology to understand how specific regulatory pathways have affected diversity in crop biotechnology and how those patterns might change over time. In this article, we draw upon 30 years of regulatory submission data to 1) understand historical diversification trends across the landscape and history of past crop biotechnology regulatory pathways and 2) forecast how the new SECURE regulations might affect future diversification trends. Our goal is to apply an empirical approach to exploring the relationship between regulation and diversity in crop biotechnology and provide a basis for future data-driven analysis of regulatory outcomes. Based on our analysis, we suggest that diversity in crop biotechnology does not follow a single trajectory dictated by the shifts in regulation, and outcomes of SECURE might be more varied and restrictive despite the revamped exemption categories. In addition, the concept of confidential business information and its relationship to past and future biotechnology regulation is reviewed in light of our analysis.
在美国，新实施的“安全与持续更新环境法规”（SECURE）对下一代作物的监管有望使农业生物技术创新多样化。具体而言，SECURE有望增加符合监管豁免条件的产品数量，支持者认为这将增加参与作物生物技术开发的性状、基因、生物体和开发者的多样性。然而，很少有数据驱动的研究回顾作物生物技术的历史，以了解特定的监管途径如何影响作物生物技术的多样性，以及这些模式如何随时间变化。在本文中，我们利用30年的监管申报数据来：1）了解过去作物生物技术监管途径的格局和历史中的历史多样化趋势；2）预测新的SECURE法规可能如何影响未来的多样化趋势。我们的目标是应用实证方法来探索作物生物技术监管与多样性之间的关系，并为未来对监管结果进行数据驱动的分析提供依据。基于我们的分析，我们认为作物生物技术的多样性并不遵循由监管变化所决定的单一轨迹，尽管豁免类别有所调整，但SECURE的结果可能更加多样和具有限制性。此外，根据我们的分析，对商业机密信息的概念及其与过去和未来生物技术监管的关系进行了审视。
