All Knowledge & Insights By Date

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...

The attorneys, scientists, policy experts, and regulatory advisors of Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) endeavor year-round to keep you informed on key developments as they happen, and prepared for looming changes and deadlines, to help you maintain compliance and competitive advantage as you market your products throughout the world. As the new year begins, we offer you this look back at the top stories of...

On November 9, 2016, Inside EPA published “ New TSCA Requirements Raise Challenges To EPA Biotech Review Staff” (subscription required), outlining what EPA has done to adapt to revised Toxic Substances Control Act (TSCA) requirements for engineered microorganisms.   Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®), was quoted in the article discussing what to expect from approaching biotechnology regulations:   Richard Engler, a...

On October 17, 2016, the Industrial Biotechnology Innovation Centre (IBioIC) announced over £3 million in investments over six synthetic biology projects.  IBioIC was founded by Ingenza Ltd, GlaxoSmithKline plc (GSK), and INEOS to connect academic expertise in synthetic biology with industrial capabilities from businesses in the area.  IBioIC focuses on biotechnology in health, industrial, agriculture, and marine areas.  Recipients of the £3 million in funding are:...

On June 22, 2016, DOE released the detailed agenda for the Biotechnology for Clean Vehicles: Harnessing Synthetic Biology To Enable Next-Generation Biomaterials And Biofuels session at the Sustainable Transportation Summit. The session is hosted by DOE's Office of Energy Efficiency and Renewable Energy (EERE) and will focus on how novel biomaterials and renewable fuels can be used to improve vehicle efficiency and sustainability. The session will also discus the role of synthetic biology in...

On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) hosted “Leveraging Synthetic Biology’s Promise and Managing Potential Risk,” a panel discussion featuring Lynn L. Bergeson, Sheryl Lindros Dolan, and Richard E. Engler, Ph.D., of B&C, and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center.  The event coincided with the release of “The DNA of...

On September 16, 2015, the Woodrow Wilson International Center for Scholars (Wilson Center) released a funding report on U.S. Trends in Synthetic Biology Research Funding. The Wilson Center found that the U.S. invested approximately $820 million in synthetic biology research between 2008 and 2014, with nearly 60 percent of the funding coming from the Defense Advanced Research Projects Agency (DARPA). The National Science Foundation (NSF) has also been funding synthetic biology research,...

The U.S. Environmental Protection Agency (EPA) announced last week that it is developing a project intended to support public dialog concerning the development and use of synthetic biology (Synbio) algae. EPA has oversight responsibility for the production and use of intergeneric microorganisms, including cyanobacteria, eukaryotic microalgae (genetically modified (GM) algae), and their products by application of genetic engineering approaches, including those called Synbio. EPA's recently...

With little fanfare or advanced notice to the general public, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology....

The October 2014 issue of Industrial Biotechnology features the article Creative Adaptation: Enhancing Oversight of Synthetic Biology Under the Toxic Substances Control Act (TSCA), written by Lynn L. Bergeson, Of Counsel with the Biobased and Renewable Products Advocacy Group (BRAG®), Charles M. Auer, former Director of the U.S. Environmental Protection Agency's (EPA) Office of Pollution Prevention and Toxics (OPPT), and Oscar Hernandez, former Director of the Risk Assessment Division...

On May 28, 2014, policy researchers from the J. Craig Venter Institute (JCVI), the University of Virginia, and EMBO released a report on challenges faced by regulators with the increased use of more sophisticated synthetic biology technologies to engineer plants and microbes. According to the press release on the report, "[t]he authors conclude that while the United States governmental agencies tasked with oversight of products derived through synthetic biology have adequate legal...