All Knowledge & Insights By Date

The Law Library of Congress published a November 2023 report entitled Selected Issues in Biotechnology Regulation: Australia, Belgium, Brazil, Canada, China, England, European Union, Germany, India, Japan, Mexico, New Zealand, Singapore, South Africa, South Korea, Taiwan that provides an overview of the main statutes and policies governing selected issues on the development of biotechnology products, particularly those derived from genetically modified organisms (GMO) and genetic engineering....

On November 13, 2023, the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) posted the following documents on the Unified Website for Biotechnology Regulation: As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative to accelerate biotechnology innovation and grow America’s...

The European Commission (EC) announced on October 3, 2023, that it adopted a Recommendation on critical technology areas for the European Union’s (EU) economic security, for further risk assessment with EU member states. According to the EC, the Recommendation relates to the assessment of technology risk and technology leakage. The EC states that the risk assessment “will be objective in character, and neither its results nor any follow-up measures can be anticipated at this stage.”...

By Lynn L. Bergeson and Carla N. Hutton   The July 2023 issue of the Organization for Economic Cooperation and Development’s (OECD) Chemical Safety and Biosafety Progress Report includes a summary of the April 2023 meeting of the Party on the Harmonization of Regulatory Oversight in Biotechnology (WP-HROB). During the meeting, WP-HROB agreed on next steps for preparing several consensus documents: “Environmental Considerations for Risk/Safety Assessment for the Release of...

By Lynn L. Bergeson and Carla N. Hutton   On June 27, 2023, the Office of Science and Technology Policy (OSTP) announced the release of a new action plan intended to “rapidly and equitably expand biotechnology and biomanufacturing education and job training programs in the United States.” According to OSTP, biomanufacturing “is a critical aspect of advanced manufacturing that can drive new, sustainable alternatives across industries” and “can unlock new...

By Lisa R. Burchi, James V. Aidala, and Heather F. Collins, M.S. 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...

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...

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...

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...

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...