Kavli Center for Ethics, Science, and the Public, University of California─Berkeley, Berkeley, California 94720, United States.
United States Department of Agriculture, Washington, D.C. 20250, United States.
ACS Synth Biol. 2024 May 17;13(5):1412-1423. doi: 10.1021/acssynbio.4c00048. Epub 2024 Apr 26.
Genetically engineered microorganisms (GEMs) represent a new paradigm in our ability to address the needs of a growing, changing world. GEMs are being used in agriculture, food production and additives, manufacturing, commodity and noncommodity products, environmental remediation, etc., with even more applications in the pipeline. Along with modern advances in genome-manipulating technologies, new manufacturing processes, markets, and attitudes are driving a boom in more products that contain or are derived from GEMs. Consequentially, researchers and developers are poised to interact with biotechnology regulatory policies that have been in effect for decades, but which are out of pace with rapidly changing scientific advances and knowledge. In the United States, biotechnology is regulated by multiple agencies with overlapping responsibilities. This poses a challenge for both developers and regulators to simultaneously allow new innovation and products into the market while also ensuring their safety and efficacy for the public and environment. This article attempts to highlight the various factors that interact between regulatory policy and development of GEMs in the United States, with perspectives from both regulators and developers. We present insights from a 2022 workshop hosted at the University of California, Berkeley that convened regulators from U.S. regulatory agencies and industry developers of various GEMs and GEM-derived products. We highlight several new biotechnologies and applications that are driving innovation in this space, and how regulatory agencies evaluate and assess these products according to current policies. Additionally, we describe recent updates to regulations that incorporate new technology and knowledge and how they can adapt further to effectively continue regulating for the future.
基因工程微生物（GEM）代表了我们应对不断发展和变化的世界需求的一种新范式。GEM 正在农业、食品生产和添加剂、制造业、商品和非商品产品、环境修复等领域得到应用，更多的应用正在酝酿之中。随着基因组操作技术的现代进步，新的制造工艺、市场和态度正在推动更多含有或源自 GEM 的产品的繁荣。因此，研究人员和开发者准备好与已经实施了几十年的生物技术监管政策进行互动，但这些政策已经跟不上科学进步和知识的快速变化。在美国，生物技术由多个机构监管，各机构的职责存在重叠。这给开发者和监管者都带来了挑战，他们既要同时允许新的创新和产品进入市场，又要确保这些产品对公众和环境的安全性和有效性。本文试图从监管者和开发者的角度，突出美国监管政策与 GEM 发展之间相互作用的各种因素。我们从 2022 年在加州大学伯克利分校举办的一次研讨会中介绍了来自美国监管机构的监管者和各种 GEM 及其衍生产品的行业开发者的观点。我们强调了一些推动这一领域创新的新技术和应用，以及监管机构如何根据现行政策评估和评估这些产品。此外，我们还描述了最近对法规的更新，这些更新纳入了新技术和知识，以及它们如何进一步适应未来的有效监管。
