The USDA’s Animal and Plant Health Inspection Service (APHIS) is one of three agencies that govern the importation, interstate movement, or environmental release of certain genetically engineered (GE) organisms. APHIS regulations are in 7 CFR part 340, originally issued in 1987 (https://www.aphis.usda.gov/biotechnology/downloads/7_cfr_340.pdf) and based on the premise that a GE crop could pose a plant pest risk. A major revision was proposed June 6, 2019 (https://www.aphis.usda.gov/brs/fedregister/BRS_20190606.pdf), with public comments accepted for 60 d. Members of the Society for In Vitro Biology (SIVB)—especially within the plant section—are impacted by the current rules and will be impacted by changes. Therefore, the public policy committee studied the changes and prepared a response that was reviewed by the board of directors and submitted to APHIS. APHIS received 6186 comments overall. In general, the SIVB welcomes the proposed revisions, which recognize established scientific guidelines and principles for plant pest risk assessment. In addition, they recognize the safety record accumulated over multiple decades of current GE mechanisms of action (MOA), so the proposed rules include an exemption for new events with established MOA’s in a previously reviewed crop. Further, the proposed rules focus on DNA function and impact rather than its source organism with regulatory review triggered by potential for increased plant pest risk. Most importantly, the proposed revisions codify a light regulatory approach for many applications of genome editing, because these applications result in plants that could otherwise have been developed through traditional breeding techniques or found in nature. If implemented appropriately in the final rule, we find these changes remove many current barriers, and thus are likely to stimulate university and business “startup” innovation. The SIVB recognizes the need for exemption for further model species and gene delivery organisms. Such concerns were adequately expressed by the submitted response. Remaining hurdles for innovative plant incorporated protectants are still problematic. Nevertheless, the SIVB applauds the efforts to update APHIS rules in a scientifically defensible manner. The detailed response is shared below.

USDA的动植物健康检查服务（APHIS）是管理某些基因工程（GE）生物的进口，州际转移或环境释放的三个机构之一。APHIS法规在最初于1987年发布的7 CFR第340部分中（https://www.aphis.usda.gov/biotechnology/downloads/7_cfr_340.pdf），并且基于GE作物可能构成植物有害生物风险的前提。提议于2019年6月6日进行重大修订（https://www.aphis.usda.gov/brs/fedregister/BRS_20190606.pdf），并在60天内接受了公众意见。体外学会会员生物学（SIVB），尤其是在工厂区域内，受当前规则的影响，并将受到变化的影响。因此，公共政策委员会研究了这些变化并准备了一份回应，并由董事会进行了审查并提交给APHIS。APHIS共收到6186条评论。总的来说，SIVB欢迎提议的修订，该修订承认了植物有害生物风险评估的既定科学指南和原则。此外，他们认识到数十年来在当前GE行动机制（MOA）上积累的安全记录，因此拟议规则包括对先前审查过的作物中已建立MOA的新事件进行豁免。进一步，拟议的规则侧重于DNA的功能和影响，而不是其来源生物，其监管审查是由可能增加植物有害生物风险引发的。最重要的是，拟议的修订为许多基因组编辑应用编纂了一种轻型调节方法，因为这些应用所产生的植物原本可以通过传统育种技术开发或在自然界发现。如果在最终规则中适当实施，我们会发现这些变化消除了许多当前的障碍，因此很可能会刺激大学和企业“创业”的创新。SIVB认识到需要豁免其他模型物种和基因传递生物。所提交的答复充分表达了这些关切。创新性植物结合保护剂的剩余障碍仍然存在问题。尽管如此，SIVB赞赏以科学辩护的方式更新APHIS规则的努力。详细回复在下面共享。