Copyright © 2025 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

@article{180354,
        author = {G K KAVIN ADITHYA and Ajeet Kumar Shrivasta and Samarth mahekar and Gurushant and S Mouny Gagan},
        title = {Perspectives on Genetically Engineered Microorganisms and Their Regulation in the United States},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {1},
        pages = {1158-1163},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=180354},
        abstract = {Genetically engineered microorganisms (GEMs) offer a new way to respond to the needs of a growing, changing world. GEMs are being used in agriculture, food production and additives, manufacturing, and commodity and non-commodity products, environmental remediation, etc., and there are further applications in development. Coupled with modern advances in genome manipulating technologies, new manufacturing processes, markets and attitudes are propelling a boom of new products containing or made from GEMs. As a result, researchers and developers are on track to interact with biotechnology regulatory policies that have been in place for decades, and are out of sync with fast-paced scientific advances and knowledge. In the United States, biotechnology regulation is done by multiple agencies with overlapping jurisdictions, which is difficult for both regulators and developers, as they must simultaneously ensure a burgeoning innovation and product market, along with safety/efficacy for the public and environment. This article aims to provide clarity on the factors that interact between regulatory policy and the development of GEMs in the United States, with thoughts from regulators and developers. We will provide summaries of a workshop held at the University of California, Berkeley in 2022, where regulators from U.S. regulatory agencies and industry were convened.},
        keywords = {microorganisms, genetic engineering, biotechnology, synthetic biology, regulations, science policy,},
        month = {June},
        }