Category: Biotechnology/Synthetic Biology

May 31, 2023

EPA Issues Final Rule to Accelerate Use of Plant-Incorporated Biotechnologies

On May 31, 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting a class of plant-incorporated protectants (PIP) created using genetic engineering, from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. PIPs are pesticidal substances produced by plants and the genetic material...
May 3, 2023

APHIS Releases New Strategic Plan for 2023-2027, Includes Biotechnology Objectives

By Lynn L. Bergeson and Carla N. Hutton   On April 25, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it published a new five-year strategic plan. According to APHIS, it incorporates input it received from stakeholders on the strategic framework, a summarized version of the plan that it published in June 2022. The plan includes six strategic goals that focus on working to: Protect agriculture from plant and animal...
May 1, 2023

OMB Seeks Input on Bioeconomy-Related Industries and Products

By Lynn L. Bergeson and Carla N. Hutton   The Office of Management and Budget (OMB) published a request for information (RFI) on April 27, 2023, seeking public input on existing or potential bioeconomy-related industries and products that are established, emerging, or currently embedded in existing industry/manufacturing processes. 88 Fed. Reg. 25711. As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a...
April 24, 2023

GAO Science and Tech Spotlight Describes Benefits of Synthetic Biology and Challenges Ahead

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Government Accountability Office (GAO) published a “Science & Tech Spotlight” on synthetic biology on April 17, 2023. GAO defines synthetic biology as “a multidisciplinary field of biotechnology that involves engineering the genetic material of organisms -- such as viruses, bacteria, yeast, plants, or animals -- to have new characteristics.” According to GAO, scientists are currently exploring the use of...
April 6, 2023

DOC’s Bureau of Economic Analysis Releases Report on Developing a National Measure of the Economic C

By Lynn L. Bergeson and Carla N. Hutton   President Joseph Biden’s September 12, 2022, Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative directs the U.S. Department of Commerce’s (DOC) Bureau of Economic Analysis (BEA) to assess “the feasibility, scope, and costs of developing a national measurement of the economic contributions of the bioeconomy.” As reported in our March 30, 2023, blog item, BEA released a March 2023 report on...
April 5, 2023

DOD Publishes Biomanufacturing Strategy and RFI on Biomanufactured Products and Process Capabilities

By Lynn L. Bergeson and Carla N. Hutton   As part of the National Biotechnology and Biomanufacturing Initiative, the U.S. Department of Defense (DOD) announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. As reported in our March 30, 2023, blog item, on March 22, 2023, DOD released its Biomanufacturing Strategy to guide these...
April 3, 2023

White House OSTP Outlines Goals for U.S. Biotechnology and Manufacturing

By Lynn L. Bergeson and Carla N. Hutton As reported in our March 30, 2023, blog item, on March 22, 2023, the White House Office of Science and Technology Policy (OSTP) released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals. The report includes five sections, each presenting goals that highlight what could be possible with the power of biology. The goals set ambitious national targets for the next two decades to...
March 30, 2023

Biden Administration Announces New Goals and Priorities to Advance Biotechnology and Biomanufacturin

By Lynn L. Bergeson and Carla N. Hutton   As reported in our September 13, 2022, blog item, President Joseph Biden signed an Executive Order (EO) on September 12, 2022, creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” On March 22, 2023, the White House Office of Science and Technology Policy (OSTP) published a fact sheet announcing “new bold goals and priorities...
March 9, 2023

USDA Celebrates Inaugural National Biobased Products Day, Announces 2022 Award Winners for BioPrefer

By Lynn L. Bergeson and Carla N. Hutton   On March 8, 2023, the U.S. Department of Agriculture (USDA) announced the kickoff of the inaugural National Biobased Products Day and highlighted the accomplishments of people and organizations working to improve sustainability within the federal government. USDA notes that its ongoing work includes the National Institute of Food and Agriculture’s (NIFA) Agriculture and Food Research Initiative programs, which fund research that advances...
March 6, 2023

EPA Announces Both EPA and FDA to Conduct Virtual Public Meeting and Request Comments on Modernizing Their Approach to Oversight of Certain Products

On February 22, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced that it will co-host a virtual public meeting with the U.S. Food and Drug Administration’s (FDA) Center of Veterinary Medicine (CVM) on March 22, 2023. As stated in our February 17, 2023, blog, EPA and FDA are considering how best to update their respective oversight responsibilities for specific products in an efficient and...