All Knowledge & Insights By Date

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 May 12, 2021, from 3:30 p.m. to 5:00 p.m. (EDT), the European Commission (EC) Helpdesk will host a webinar on appropriate Intellectual Property (IP) rights for biotechnology inventions.  The 60-minute webinar will provide an overview of: Relevant IP rights; Product development IP context; IP specifics in biotechnology; IP portfolio development; and IP portfolio management. The webinar is free of charge, but registration is required.  Additional information...

By Lynn L. Bergeson On June 26, 2020, the Biotechnology Innovation Organization (BIO), a Biobased and Renewable Products Advocacy Group (BRAG®) member, announced the winners of its 2020 Start-Up Stadium competition. The competition had 30 finalists that were evaluated during BIO Digital in June, by expert judges with backgrounds in investment, entrepreneurship, start-ups, economic development, capital formation, and academia. Five winners were chosen based on their commercially viable...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. The international standards organization, ASTM International, is seeking additional task group members to further develop the current terminology standard in industrial biotechnology (E3072-19). ASTM International develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. Its sub-committee, E62.91 for Terminology in Industrial Biotechnology, is responsible for suggesting new...

By Lynn L. Bergeson Pennsylvania State University’s (Penn State) Huck Institutes of the Life Sciences’ Center of Excellence in Industrial Biotechnology (CoEIB) is now offering a new round of IMPACT Seed Grants to support interdisciplinary research, curricular development, or educational activities in the broad area of industrial biotechnology. These areas include but are not limited to: biopharmaceutical manufacturing, food biotechnology, and production of biobased chemicals....

By Lynn L. Bergeson On January 1, 2020, U.S. President Donald Trump released a statement recognizing the beginning of National Biotechnology Month and the country’s “enormous potential” of biotechnology to improve lives in the United States and around the globe. Highlighting the benefits of biotechnology in different sectors, President Trump states that for every one job in biotechnology, nearly two other jobs are created in various sectors in the rural United States. In his...

By Lynn L. Bergeson On January 9, 2020, also in recognition of National Biotechnology Month, the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) announced the launch of a unified website for biotechnology regulation. Streamlining information about the three agencies in charge of overseeing agriculture biotechnology products, this website comes, in part, to fulfill President Trump’s Executive Order (EO)...

By Lynn L. Bergeson On April 2, 2019, U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., and Deputy Commissioner for Policy, Legislation and International Affairs, Anna Abram, released a statement on the status of FDA’s Plant and Animal Biotechnology Innovation Action Plan (Action Plan). Focused on FDA’s risk-based regulatory framework, the Action Plan aims at securing confidence in the safety and performance of plant and animal-based products for consumers,...

By Lynn L. Bergeson In a recent statement prepared by U.S. Food and Drug Administration’s (FDA) Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition, and by Dennis Keefe, Ph.D, Director of FDA’s Office of Food Additive Safety, FDA highlights its commitment to assisting plant biotechnology developers to foster innovation and ensure that consumers can confidently trust FDA’s high safety standards.  Plant biotechnology consists of methods...

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...