Synthetic biology is an emerging, interdisciplinary research field with much promise for biomedicine. Broadly defined as “the design and construction of new biological systems to perform specific tasks,” researchers and clinicians are using synthetic biology to develop targeted treatments for cancer, coronaviruses, and so forth. Because of the experimental nature of synthetic biology, regulation is necessary. Current federal frameworks, such as the Food, Drug, and Cosmetics Act, The Toxic Substances Act of 1976, Institutional Review Boards, and self-regulation are not enough. As a result, states have a unique opportunity to develop statutory and regulatory frameworks to develop a pathway for regulating synthetic biology. In developing legislation, state lawmakers should look to build a comprehensive framework that addresses businesses selling technology for synthesizing DNA codes, monitors orders for synthetic DNA, and develops statewide documentation systems. Additionally, public health information on treatments using synthetic biology can help to educate the public and reduce the prevalence of misconceptions about the technology. In the absence of federal regulation, states should step into the synthetic biology regulatory space to ensure that their citizens are not harmed by therapies developed using synthetic biology.

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合成生物学：生物医学背景下的国家监管

合成生物学是一个新兴的跨学科研究领域，在生物医学领域前景广阔。广义上定义为“设计和构建新的生物系统来执行特定任务”，研究人员和临床医生正在使用合成生物学来开发针对癌症、冠状病毒等的靶向治疗方法。由于合成生物学的实验性质，监管是必要的。目前的联邦框架，如《食品、药品和化妆品法》、1976 年《有毒物质法》、机构审查委员会和自我监管是不够的。因此，各州有独特的机会来制定法规和监管框架，以制定监管合成生物学的途径。在制定立法时，州立法者应该着眼于建立一个全面的框架，解决企业销售合成 DNA 代码技术的问题，监控合成 DNA 的订单，并开发全州范围的文件系统。此外，关于使用合成生物学进行治疗的公共卫生信息可以帮助教育公众并减少对该技术的普遍误解。在没有联邦监管的情况下，各州应进入合成生物学监管领域，以确保其公民不会受到使用合成生物学开发的疗法的伤害。关于使用合成生物学进行治疗的公共卫生信息有助于教育公众并减少对该技术的普遍误解。在没有联邦监管的情况下，各州应进入合成生物学监管领域，以确保其公民不会受到使用合成生物学开发的疗法的伤害。关于使用合成生物学进行治疗的公共卫生信息有助于教育公众并减少对该技术的普遍误解。在没有联邦监管的情况下，各州应进入合成生物学监管领域，以确保其公民不会受到使用合成生物学开发的疗法的伤害。