Strengthening and Modernizing Biosafety Oversight: Region 1 Listening Session

On September 30, 2025, the National Institutes of Health (NIH), in collaboration with the New England Biological Safety Association, the Northeast Biological Safety Association, the Mid-Atlantic Biological Safety Association, and the Chesapeake Area Biological Safety Association, will host the first in a series of public regional listening sessions aimed at strengthening and modernizing biosafety oversight.

This Region 1 session will take place virtually from 2:00–5:00 PM ET and will prioritize participation from stakeholders located in Maine, New Hampshire, Vermont, Massachusetts, Connecticut, Rhode Island, New York, Pennsylvania, New Jersey, Delaware, West Virginia, Maryland, and Washington, D.C..

Purpose and Objectives

The initiative reflects NIH’s commitment to updating its biosafety framework in light of evolving research practices and new challenges in global health security. The listening session is designed to:

• Gather Stakeholder Input: Solicit feedback on the scope of NIH’s biosafety policy, including whether it should continue to focus on recombinant and synthetic nucleic acids or expand to encompass wild-type biological agents, proteins (e.g., toxins, prions), infectious microbes, and other hazardous biological materials.
• Assess Oversight Needs: Identify categories of research that may warrant reduced local or NIH oversight, such as non-biomedical research under USDA or EPA purview, FDA-regulated clinical research, or low-risk projects involving RG1 agents or certain transgenic organisms.
• Promote Transparency and Engagement: Provide a platform for scientists, biosafety professionals, and other stakeholders to share their perspectives on creating a more modern, risk-based biosafety oversight system.

Format and Participation

The session will be webcast live via NIH Videocast, ensuring accessibility for participants across the region. Pre-registration is required, and attendees are encouraged to indicate if they wish to provide oral comments. Requests to make comments must be submitted by September 29, 2025.

All oral contributions, as well as written feedback, will be considered as NIH and its partners refine the direction of biosafety modernization. Importantly, the session is free and open to the public, reinforcing the initiative’s emphasis on inclusivity and diverse stakeholder engagement.

Who Should Attend

This session is particularly relevant to:

• Public health and global health security professionals
• Biosafety officers and laboratory managers
• Academic and government researchers conducting life sciences or biomedical research
• Regulatory and compliance officials working with NIH, USDA, EPA, or FDA frameworks
• Epidemiologists and infectious disease experts interested in policy intersections with research oversight

Looking Ahead

The Region 1 event represents just the beginning of NIH’s nationwide effort. By engaging local and regional stakeholders, NIH aims to shape a modern, flexible biosafety oversight framework that balances scientific innovation with safety and public trust.

For more information, including the draft agenda, registration link, and participation details, please visit the NIH Office of Science Policy’s event webpage.