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By Lynn L. Bergeson On October 30, 2018, the U.S. Food and Drug Administration (FDA) published a statement by FDA Commissioner Scott Gottlieb, M.D., and FDA Deputy Commissioner Anna Abram regarding FDA’s new action plan to advance plant and animal biotechnology innovation.  Aimed at ensuring the safety of plant and animal biotechnology products and avoiding unnecessary barriers to future innovation, the Action Plan focuses on three key priorities: Advancing public health by promoting...

By Lynn L. Bergeson On August 2, 2018, the Trump Administration’s Principal Deputy Director of the U.S. Fish and Wildlife Service, Gregory J. Sheehan, reversed an Obama era 2014 policy on the use of biotechnology on wildlife refuges. On July 17, 2014, the Obama Administration issued a memorandum prohibiting the use of genetically modified biotechnology crops to feed wildlife and the use of neonicotinoid pesticides in agricultural practices. This ban was issued in response to...

By Lynn L. Bergeson On March 28, 2018, Secretary of the U.S. Department of Agriculture (USDA) Sonny Perdue issued a statement providing clarification on USDA’s oversight of plants produced through innovative new breeding techniques that include techniques called genome editing.  The announcement states that under its biotechnology regulations, USDA “does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding...

By Lauren M. Graham, Ph.D. On January 8, 2018, U.S. Secretary of Agriculture Sonny Perdue presented to President Donald Trump the findings of the Interagency Task Force on Agriculture and Rural Prosperity.  The Task Force was established in 2017 following an Executive Order by President Trump to ensure the informed exercise of regulatory authority that impacts agriculture and rural communities.  According to the report, over 100 actions organized around five key topic areas,...

By Kathleen M. Roberts On November 8, 2017, the U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) issued a statement soliciting applications for its Biotechnology Risk Assessment Research Grants Program.  The program aims to support the generation of new information that will assist federal regulatory agencies in making science-based decisions about the effects of introducing genetically engineered (GE) organisms, including microorganisms,...

By Lauren M. Graham, Ph.D. Industrial Biotechnology recently published a special issue to highlight the advances and challenges in algae-based products and applications.  The article, written by B&C® Consortia Management, L.L.C. (BCCM) affiliate Bergeson & Campbell, P.C. (B&C®) Managing Partner, Lynn L. Bergeson; B&C Senior Chemist, Richard E. Engler, Ph.D.; and BCCM Manager, Lauren M. Graham, Ph.D., examines the complex regulatory domain and discusses the...

By Lauren M. Graham, Ph.D. On October 17, 2017, Congressman Jimmy Panetta (D-CA), Congressman Neal Dunn, M.D. (R-FL), and 77 additional House members sent a bipartisan letter to the U.S. Department of Agriculture (USDA), U.S. Food and Drug Administration (FDA), and U.S. Environmental Protection Agency (EPA) to urge the agencies to work together to promote innovative new technologies aimed at increasing crop yields and reducing the cost of production.  According to Congressman Panetta,...

By Lauren M. Graham, Ph.D. On October 12, 2017, the U.S. Food and Drug Administration (FDA) announced two public meetings regarding its Agricultural Biotechnology Education and Outreach Initiative.  The meetings will be held in Charlotte, North Carolina, on November 7, 2017, from 8:00 a.m. to 1:00 p.m. (EST) and in San Francisco, California, on November 14, 2017, from 8:00 a.m. to 1:00 p.m. (PST).  FDA states the purpose of the public meetings is “to provide the...

On October 4, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of final guidance that helps to clarify FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those produced through the use of biotechnology.  The notice was published in the Federal Register on October 5, 2017.  82 Fed. Reg. 46500.  Guidance for Industry #236,...

By Lauren M. Graham, Ph.D. On June 30, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released the final version of its report Preparing for Future Products of Biotechnology, which is the result of a collaboration by a committee of experts convened by NAS.  The report provides an overview of the committee’s discussion on “the future products of biotechnology that are likely to appear on the horizon, the challenges that the regulatory agencies...

By Lynn L. Bergeson and Margaret R. Graham On June 30, 3017, the National Academies of Sciences, Engineering, and Medicine (NAS) released its final version of its report Preparing for Future Products of Biotechnology, which it states “analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making [and] … identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the...

By Lynn L. Bergeson and Margaret R. Graham On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) announced the release (pre-publication version) of a new report:  Preparing for Future Products of Biotechnology.  Pursuant to the White House Office of Science and Technology Policy's (OSTP) July 2, 2015, memorandum, “Modernizing the Regulatory System for Biotechnology Products,” NAS was tasked with looking into the future and describing the...

Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Charles M. Auer, Senior Regulatory and Policy Advisor with B&C, have published “An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders,” in Industrial Biotechnology. This article discusses how the “New [Toxic Substances Control Act (TSCA)] fundamentally changes the U.S. Environmental Protection Agency's (EPA) approach to evaluating and managing...

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for...

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update).  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with...

By Lynn L. Bergeson and Carla N. Hutton On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update).  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology...

As previously reported in the Biobased and Renewable Products Advocacy Group’s (BRAG®) Biobased and Renewable Products Update of September 22, 2016, Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (Update to the Coordinated Framework) was published in the Federal Register .  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental...

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 October 25, 2016, Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®), presented “Under-appreciated Regulatory Barriers to Commercialization of Algae and Algal Products” at the Algae Biomass Summit in Phoenix, Arizona. Dr. Engler’s presentation was part of the Legal, IP and Regulatory Issues — Challenges and Opportunities track of the summit, and explored how algae processing and use is regulated by the Federal Food, Drug, and...

On October 11, 2016, Microvi Biotechnologies Inc. (Microvi) announced that it had been awarded a grant by the U.S. Department of Energy (DOE) for work on new biocatalytic technology that converts the methane and carbon dioxide (CO2) found in biogas into valuable liquid chemicals.  This technology utilizes the biogas created at landfills and wastewater treatment plants that is usually burned off into the atmosphere due to the current burdensome conversion process.  Microvi’s...