Category: Biotechnology/Synthetic Biology

June 26, 2025

NASEM Will Hold Workshop on Synthetic Biology for Biomanufacturing and Predictable Engineering on July 1, 2025

On July 1, 2025, the National Academies of Sciences, Engineering, and Medicine (NASEM) will hold a workshop session on transformative science and technology for the U.S. Department of Defense (DOD), “Synthetic Biology for Biomanufacturing and Predictable Engineering.” NASEM states that “[a]dvances in biotechnology and biomanufacturing are essential for the United States to maintain global leadership as well as for supporting economic and national security interests.” The workshop session...
June 23, 2025

APHIS Announces Updated Pre-Application Questionnaire in APHIS eFile

On June 13, 2025, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that its Biotechnology Regulatory Services (BRS) has launched an updated Pre-Application Questionnaire that will replace the BRS Permitting Assistant in APHIS eFile. According to APHIS, applicants using APHIS eFile will experience: An interface that leads applicants through a series of questions to determine if their application qualifies for a notification or if a permit...
June 16, 2025

NSCEB Roadshow Highlights Biotechnology Across America

The National Security Commission on Emerging Biotechnology (NSCEB) is holding a roadshow to highlight biotechnology across America, including the companies, academic institutions, industry alliances, workforce development programs, and policy initiatives that are driving the future for this rapidly growing industry. Commissioners intend to continue learning about the work being done while engaging on the key findings and recommendations from NSCEB’s recent report to Congress. The first event...
June 6, 2025

Call for Evidence for Impact Assessment of the European Biotech Act Will Close June 11, 2025

The European Commission (EC) began a call for evidence on May 14, 2025, for an impact assessment of the European Biotech Act. The EC states that the overall objective is to improve the size and competitiveness of the biotechnology sector in the European Union (EU) while maintaining high safety standards. The new European Biotech Act will aim to ensure that the EU makes the most of the biotechnology revolution for the benefit of society, the environment, and the economy, while making it easier to...
June 4, 2025

APHIS Begins Public Comment Period on Draft Plant Pest Risk Assessment and Draft Environmental Assessment for Lepidopteran-Protected Maize

On June 3, 2025, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) began a public comment period on a draft plant pest risk assessment (PPRA) and draft environmental assessment (EA) regarding a petition from Bayer U.S.-Crop Science seeking a determination of nonregulated status for maize (corn) event MON 95379 that was developed “using genetic engineering to produce two insecticidal proteins to protect against feeding damage caused by target lepidopteran...
June 3, 2025

House Subcommittees Will Hold Hearing on “Pursuing the Golden Age of Innovation: Strategic Priorities in Biotechnology” on June 5

On June 5, 2025, the House Science and Technology Subcommittees on Energy and on Research and Technology will hold a joint hearing on “Pursuing the Golden Age of Innovation: Strategic Priorities in Biotechnology.” The Subcommittees will hear from the following witnesses: Dr. Drew Endy, Hoover Institution Science and Senior Fellow, Martin Family Fellow in Undergraduate Education for Bioengineering, Stanford University; Ms. Deborah Gracio, Associate Lab Director, National Security Directorate,...
April 30, 2025

National Biotechnology Initiative Act Would Implement Recommendations from NSCEB’s Final Report

As reported in our April 25, 2025, blog item, the National Security Commission on Emerging Biotechnology (NSCEB) announced on April 8, 2025, the availability of its final report and action plan, “urging Congressional action to bring the full weight of American innovation to improve and maintain U.S. global leadership in biotechnology.” On April 9, 2025, Senator Alex Padilla (D-CA), an NSCEB Commissioner, and the other three Congressional Commissioners introduced the bipartisan, bicameral...
April 25, 2025

National Security Commission on Emerging Biotechnology’s Final Report Includes Recommendations to Boost Economy and Protect National Security

The National Security Commission on Emerging Biotechnology (NSCEB) announced on April 8, 2025, the availability of its final report and action plan, “urging Congressional action to bring the full weight of American innovation to improve and maintain U.S. global leadership in biotechnology.” After an extensive study that included “more than 1,800 stakeholder consultations, a holistic review of unclassified and classified material, site visits across the United States, and meetings with...
April 1, 2025

EC Begins Public Consultation on Upcoming EU Bioeconomy Strategy

The European Commission (EC) began a public consultation on March 31, 2025, on the upcoming European Union (EU) Bioeconomy Strategy. The EC states in its March 31, 2025, press release that the Strategy “marks a significant step forward in harnessing the opportunities of the bioeconomy to support European businesses and drive progress towards the EU’s environmental, climate and competitiveness objectives.” According to the call for evidence, the Strategy’s main aims include: Ensuring the...
March 31, 2025

APHIS Evaluates Petitions Reviewed under 2012 Process, Will Use Process Consistent with USDA Biotechnology Regulations Going Forward

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 27, 2025, that it will no longer use the process it outlined in 2012 for reviewing petitions seeking a determination that a modified plant should not be subject to the regulations for the introduction of organisms altered or produced through genetic engineering (modified organisms) that are plant pests or that there is reason to believe are plant pests. On March 6, 2012, APHIS...