To be commercialized and grown in the US, genetically engineered (GE) crops typically go through an extensive food, feed, and environmental safety assessment process which, in certain instances, requires complex consultations with three different US regulatory agencies. Many small market, niche, and specialty crops have been genetically engineered using the modern tools of recombinant DNA but few have been commercialized due to real or perceived regulatory constraints. This workshop discussed the practical aspects of developing dossiers on GE specialty, niche, or small-market crops/products for submission to US regulatory agencies. This workshop focused on actual case studies, and provided an opportunity for public or private sector scientists and crop developers to spend time with regulatory officials to learn the specifics of compiling a dossier for regulatory approval. The objective of the workshop was to explain and demystify data requirements and regulatory dossier compilation by small companies, academics, and other developers.

中文翻译：

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关于SCRA螺母和螺栓研讨会II的报告：柑桔绿化，超低棉酚和耐病性低丙烯酰胺马铃薯的案例研究。

为了在美国商业化和种植，转基因作物通常要经过广泛的食品，饲料和环境安全评估过程，在某些情况下，需要与美国三个不同的监管机构进行复杂的协商。使用重组DNA的现代工具对许多小型市场，利基市场和特产作物进行了基因工程改造，但由于实际或公认的监管限制，很少有人将其商业化。该研讨会讨论了开发有关GE特产，利基市场或小规模农作物/产品的档案的实际问题，以提交给美国监管机构。该研讨会的重点是实际案例研究，并为公共或私营部门的科学家和农作物开发商提供了一个与监管官员一起度过时间的机会，以了解编写有关档案的详细信息以获取监管批准。研讨会的目的是解释和解密小公司，学者和其他开发人员的数据要求和法规文档汇编。