ABSTRACT

Despite over 25 years of safe deployment of genetically engineered crops, the number, complexity, and scope of regulatory studies required for global approvals continue to increase devoid of adequate scientific justification. Recently, there have been calls to further expand the scope of study and data requirements to improve public acceptance. However, increased regulation can actually generate consumer distrust due to the misperception that risks are high. We believe risk-disproportionate regulation as a means to advocate for acceptance of technology is counterproductive, even though some regulatory authorities believe it part of their mandate. To help avoid public distrust, the concept of regulatory transparency to demystify regulatory decision-making should be extended to clearly justifying specific regulatory requirements as: 1) risk-driven (i.e., proportionately addressing increased risk compared with traditional breeding), or 2) advocacy-driven (i.e., primarily addressing consumer concerns and acceptance). Such transparency in the motivation for requiring risk-disproportionate studies would: 1) lessen over-prescriptive regulation, 2) save public and private resources, 3) make beneficial products and technologies available to society sooner, 4) reduce needless animal sacrifice, 5) improve regulatory decision-making regarding safety, and 6) lessen public distrust that is generated by risk-disproportionate regulation.

摘要

尽管基因工程作物的安全部署已超过 25 年，但在缺乏足够科学依据的情况下，全球批准所需的监管研究的数量、复杂性和范围不断增加。最近，有人呼吁进一步扩大研究范围和数据要求，以提高公众的接受度。然而，由于对风险很高的误解，加强监管实际上会引起消费者的不信任。我们认为，风险不成比例的监管作为倡导接受技术的手段会适得其反，尽管一些监管机构认为这是其职责的一部分。为帮助避免公众不信任，应将监管透明度的概念扩展到为监管决策揭开神秘面纱，以明确证明特定监管要求的合理性，例如：1) 风险驱动（即，与传统育种相比，按比例解决风险增加），或 2) 倡导驱动（即，主要解决消费者的担忧和接受度）。这种要求风险不成比例研究动机的透明度将：1) 减少过度规范的监管，2) 节省公共和私人资源，3) 更快地向社会提供有益的产品和技术，4) 减少不必要的动物牺牲，5)改进有关安全的监管决策，以及 6) 减少因风险不成比例的监管而产生的公众不信任。