On September 9, 2025, the National Institutes of Health (NIH) launched a new Biosafety Modernization Initiative. According to a Statement from NIH Director Dr. Jay Bhattacharya, the Agency is committed to ensuring that “gold-standard science is conducted under gold-standard biosafety conditions.” The initiative is a comprehensive effort to modernize and strengthen biosafety policies, practices, and oversight to keep pace with the evolving risks posed by today’s rapidly advancing science and technology.
Almost 50 years ago, NIH introduced the Guidelines for Research Involving Recombinant DNA Molecules, which was most recently updated in 2024, and now includes synthetic nucleic acid molecules. This publication has established the biosafety framework for much of the biology-related research that has been conducted since it was introduced. However, the NIH acknowledges that “the increasingly multi-disciplinary, cross-sector, and global nature of modern science calls for a paradigm shift.”
For the next several months, the Agency will be working closely with the research community and other stakeholders to create what they are referring to as “the biosafety framework of the 21st century.” The goal is to develop a risk-based system that focuses on NIH-relevant biomedical laboratory research. They are proposing various components to the initiative to revamp biosafety oversight as summarized below:
- Expand guidance beyond recombinant DNA and synthetic nucleic acid technologies to potentially include wild type biological agents, proteins (e.g., toxins, prions), and infectious microorganisms.
- Reduce management of certain low-risk recombinant technologies (e.g., Risk Group 1 agents, some transgenic organisms, certain expression plasmids) that, based on historical safety data, are generally considered low risk and may no longer warrant the oversight once deemed necessary.
- Harmonize the new NIH policies with existing guidance found in the Centers for Disease Control and Prevention (CDC)/NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition.
- Remove certain types of research overseen by other federal agencies from coverage. This includes clinical research under the purview of the Food and Drug Administration (FDA), non-biomedical research with plants and agricultural animals regulated by the U.S. Department of Agriculture (USDA), and work with certain microbes that fall under the jurisdiction of the Environmental Protection Agency (EPA).
- Strengthen Institutional Biosafety Committees (IBCs) to reinforce their position as the front line of biosafety oversight. This includes ensuring they receive resources comparable to other oversight bodies such as Institutional Review Boards (IRBs) and Institutional Animal Care of Use Committees (IACUCs).
The NIH is taking a phased approach, with the goal of introducing the final updated policy in the Fall of 2026. The four phases of the initiative are outlined below:
- Phase I (Fall 2025): Build awareness and encourage maximum public feedback. This includes hosting stakeholder events and conducting regional listening sessions with the opportunity to provide comments. The first stakeholder meeting, a virtual Region 1 Listening Session, was held on September 30, 2025. Future engagement opportunities will be listed on NIH’s Biosafety and Biosecurity Policy webpage.
- Phase II (Winter 2025 – Spring 2026): Synthesize information gathered during stakeholder events and listening sessions. Publish a draft Policy for public comment.
- Phase III (Spring – Summer 2026): Assess feedback on the draft Policy, refine it, and evaluate guidance needs.
- Phase IV (Fall 2026): Publish the final Policy, release community-driven guidance, and launch rigorous outreach and education efforts.
The NIH encourages stakeholders to stay informed and share their feedback on the Biosafety Modernization Initiative at any time. Comments can be provided by email at [email protected] or on the NIH commenting portal. ABSA International also has information on how you can get involved to help shape the future of biosafety oversight. For additional information about the NIH initiative, please contact us!
This blog was written by Beth Graham, Safety Partners’ Director of Quality, Research, and Training.
