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On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. The Coordinated Framework for the Regulation of Biotechnology: Plan for Regulatory Reform under the Coordinated Framework for the Regulation of Biotechnology (the Plan) provides a roadmap for actions the agencies will take,...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Government Accountability Office (GAO) published a “Science & Tech Spotlight” on synthetic biology on April 17, 2023. GAO defines synthetic biology as “a multidisciplinary field of biotechnology that involves engineering the genetic material of organisms — such as viruses, bacteria, yeast, plants, or animals — to have new characteristics.” According to GAO, scientists are currently exploring the use...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on April 10, 2023, that it is inviting public comment on a draft Environmental Assessment (EA) and draft Plant Pest Risk Assessment (PPRA). 88 Fed. Reg. 21602. APHIS states that it produced these documents in response to a petition from Pioneer Hi-Bred International, Inc. seeking deregulation of a corn variety developed using...

On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340: These resources, along with other information on the revised biotechnology regulations, are available on the APHIS website. For additional questions regarding the regulation of modified microorganisms, contact APHIS...

 On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340: These resources, along with other information on the revised biotechnology regulations, are available on the APHIS website. For additional questions regarding the regulation of modified microorganisms, contact APHIS...

By Lynn L. Bergeson and Carla N. Hutton   On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340: “Questions & Answers — Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340”: The questions and answers (Q&A) cover...

By Lynn L. Bergeson On July 16, 2018, the National Science Foundation (NSF) announced a $12 million investment in the Semiconductor Synthetic Biology for Information Processing and Storage Technologies (SemiSynBio) program, a partnership between NSF and Semiconductor Research Corporation (SRC).  Researches expect that integrating biological structures with semiconductor technology could increase current data storage capabilities by 1,000 times, while using less energy than current...

By Lynn L. Bergeson On June 19, 2018, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a press release announcing the availability of a final report entitled Biodefense in the Age of Synthetic Biology.  According to the National Academies, the final report concludes that “[s]ynthetic biology expands the possibilities for creating new weapons — including making existing bacteria and viruses more harmful — while decreasing the...

By Lauren M. Graham, Ph.D. On November 7, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a notice in the Federal Register announcing that it was withdrawing its proposed rule that would have revised the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms.  The proposed rule, which was issued on January 19, 2017, aimed to “update the regulations in response...

By Lauren M. Graham, Ph.D. On August 21, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released their interim report titled A Proposed Framework for Identifying Potential Biodefense Vulnerabilities Posed by Synthetic Biology.  The U.S. Department of Defense (DOD) asked NAS to develop the framework to: Guide an assessment of the security concerns related to advances in synthetic biology; Assess the level of concern warranted for various advances and identify...