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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...

The summer of 2015 was surprisingly busy in the industrial biotechnology policy and regulatory arenas with three important announcements regenerating lots of buzz.  On July 2, 2015, the White House Office of Science and Technology Policy, the Office of Management and Budget, the US Trade Representative, and the Council on Environmental Quality issued a memorandum directing EPA, FDA, and USDA to update and modernize the Coordinated Framework for the Regulation of Biotechnology.  A few...

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 the U.S. Regulatory...

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 the U.S. Regulatory...

In a memorandum dated October 15, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) stated that it plans to begin preliminary research on the lifecycle impacts of EPA’s renewable fuel standard (RFS).  The stated objectives from the memorandum are to determine whether EPA:  (1) complied with the reporting requirements of laws authorizing the RFS; and (2) updated the lifecycle analysis supporting the RFS with findings from the...

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...

Panel Discussion to Be Held Wednesday, October 15, 2015, from 12:00 p.m. - 2:00 p.m. (EDT) On October 15, 2015, the Woodrow Wilson International Center for Scholars (Wilson Center) will host "Leveraging Synthetic Biology's Promise and Managing Potential Risk," a panel discussion featuring Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center. The event coincides with...

Panel Discussion to Be Held Wednesday, October 15, 2015, from 12:00 p.m. - 2:00 p.m. (EDT) On October 15, 2015, the Woodrow Wilson International Center for Scholars (Wilson Center) will host "Leveraging Synthetic Biology's Promise and Managing Potential Risk," a panel discussion featuring Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center. The event coincides with...

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 to...

On October 6, 2015, the White House Office of Science and Technology Policy (OSTP) issued a Request for Information (RFI) to solicit relevant data and information, including case studies that may assist in the development of the proposed update to the Coordinated Framework for the Regulation of Biotechnology (CF). The RFI will assist OSTP in clarifying the current roles and responsibilities of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and...

On September 30, 2015, the U.S. Environmental Protection Agency (EPA) held a workshop on genetically engineered (GE) algae to give stakeholders an opportunity to hear about EPA's plans for improving its risk assessments of GE algae under the Toxic Substances Control Act (TSCA). Dr. Jeff Morris, Deputy Director of Programs for the Office of Pollution Prevention and Toxics (OPPT), welcomed participants and laid out the scope of the meeting: to assist EPA in understanding the questions it needs...

On September 7, 2015, Clean Technica published a conversation with Novozymes CEO Peder Holk Nielsen about opportunities for growth coming from the upcoming COP 21 Paris climate talks. Nielsen expressed a desire for a form of taxation or limits on carbon emissions to be put in place over the next 10 or 15 years. In the future, Nielsen sees biofuel production becoming more sustainable as people turn to waste biomass rather than producing biomass. The increasing use of waste biomass is an...

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...

A September 3, 2015, Inside EPA article regarding EPA’s efforts to improve how it reviews companies’ proposals to develop synthetic biology products, and specifically biotech algae, featured quotes from Bergeson & Campbell, P.C.: In a recent memo to clients, the law firm Bergeson & Campbell calls the announcement of the algae guide update "hugely important for the industrial biotechnology communities," adding that "EPA's announcement suggests a broader Agency initiative is...

The U.S. Environmental Protection Agency (EPA) published a notice in the August 25, 2015, Federal Register announcing a public meeting on September 30, 2015, to receive public input and comments on EPA's data needs to support risk assessments of biotechnology products subject to oversight under the Toxic Substances Control Act (TSCA) that make use of genetically engineered algae and cyanobacteria. The notice states that the workshop will inform an update to an EPA...

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 the Central Data...

On July 29, 2015, a bill to amend the Internal Revenue Code of 1986 to provide credits for the production of renewable chemicals and investments in renewable chemical production facilities, and for other purposes (H.R. 3390) was introduced in the House. The bill would expand production and investment tax credits that are currently available to renewable energy producers to apply also to renewable chemical manufacturers. The program allows manufactures to choose either: (1) a 15 cents per pound...

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...