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...
Archives
November 11, 2016
EPA Biotech Review Staff Prepares To Handle Engineered Microorganism TSCA Submissions
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...
October 28, 2016
IBioIC Announces Recipients Of £3 Million In Funding For Synthetic Biology Projects
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:...
July 1, 2016
Agenda Of Biotechnology For Clean Vehicles Session Released; Includes Synthetic Biotechnology, Advan
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...
October 19, 2015
Recorded Webcast Available – Leveraging Synthetic Biology’s Promise and Managing Potential Risk
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...
September 18, 2015
Wilson Center Releases Funding Report On U.S. Synthetic Biology Research
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....
November 7, 2014
Article Explores TSCA Application To Synthetic Biology
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...