All Knowledge & Insights By Date

On October 16, 2015, the U.S. Food and Drug Administration (FDA), along with the Office of Science and Technology Policy (OSTP), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA), announced in the Federal Register a public meeting to be held on October 30, 2015, to discuss Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the...

On October 16, 2015, the U.S. Food and Drug Administration (FDA), along with the Office of Science and Technology Policy (OSTP), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA) announced in the Federal Register a public meeting Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology. The meeting is...

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 October 6, 2015, the National Science and Technology Council, Science and Technology Policy Office published a notice of request for information (RFI) on "Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (CF) and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology" in the Federal Register. The purpose of the RFI is to obtain relevant data that will be used to update the CF...

"Legal, Regulatory & Political Considerations In Commercializing Algal Products" Panel Presented At ABO, October 1, 2015 Hear BRAG's Richard E. Engler, Ph.D., and other panelists on Thursday, October 1, at the Algae Biomass Summit, which runs September 29 – October 2, 2015, in Washington, D.C. This is where leading producers of algae products go to network with industry suppliers and technology providers, where project developers converse with utility executives, and...

On August 25, 2015, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing a Public Meeting and Opportunity for Public Comment on Considerations for Risk Assessment of Genetically Engineered Algae. The public meeting, entitled "Workshop for Public Input on Considerations for Risk Assessment of Genetically Engineered Algae," is intended to receive public input and comments on the data needs of EPA to support risk assessments of biotechnology...

The Expert Workshop focusing on technical questions for the U.S. Environmental Protection Agency's (EPA) development of a biotechnology algae considerations document is drawing near. The workshop will be open to the public and is scheduled for September 30, 2015, from 8:00 a.m. to noon. More details, including instructions on how to register for the workshop, will be made available in a Federal Register notice. More information regarding the biotechnology algae project is available in...

On August 12, 2015, the U.S. Environmental Protection Agency (EPA) announced three webinars to review the new features of the updated online Premanufacture Notifications (PMN) Submission System. The new web-based submission system for the Toxic Substances Control Act (TSCA) Section 5 submissions is replacing the ePMN reporting software that is currently in use. The first webinar is on August 26, 2015, from 1:00 p.m. – 4:00 p.m., and will cover the process of registering with...

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....

In a bit of a surprise announcement, 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 released a memorandum on July 2, 2015, directing three federal agencies with jurisdiction over products of biotechnology, 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...