DataSheet1_Lessons for a SECURE Future: Evaluating Diversity in Crop Biotechnology Across Regulatory Regimes.PDF

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，依据新近实施的“SECURE”规则对下一代农作物进行监管，预示着农业生物技术领域创新将呈现多样化趋势。具体而言，“SECURE”规则承诺扩大可申请监管豁免的产品数量，支持者认为这将增加涉及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，鲜有基于数据的驱动研究回顾作物生物技术的历史，以了解特定监管途径如何影响生物技术领域的多样性以及这些模式可能随时间如何变化。在本文中，我们借鉴了30年以来的监管提交数据，旨在1）理解过去作物生物技术监管途径在历史背景和景观中的多样化趋势，以及2）预测新的SECURE规则可能如何影响未来的多样化趋势。我们的目标是采用实证方法来探究监管与作物生物技术多样性之间的关系，并为未来基于数据的监管结果分析提供基础。基于我们的分析，我们认为作物生物技术的多样性并非遵循由监管变革所决定的单一轨迹，而SECURE的后果可能更为多样化和限制性，尽管豁免类别的调整。此外，在分析的基础上，我们还审视了商业机密信息概念及其与过去和未来生物技术监管的关系。