PUBLIC HEALTH AND PREPAREDNESS
National Institute of Health Launches Biosafety Modernization Initiative
By Michael Marsico, MS, program manager, Public Health Preparedness and Response
In September 2025, the National Institutes of Health( NIH) launched the Biosafety Modernization Initiative, a comprehensive effort to modernize and strengthen biosafety policies and practices. This effort aims to ensure that NIH’ s biosafety framework keeps pace with evolving biological risks posed by advances in science and technology since the creation of the original NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules( NIH Guidelines) in 1976.
Throughout this initiative, NIH is seeking input from across the biosafety community, including academic and research institutions, biosafety professionals, policymakers and members of the public. Their goal across 2025 – 2026 is to collaborate across the community to create a revised biosafety framework addressing current risks.
APHL Biosafety and Biosecurity Committee members share their perspectives on how the initiative can affect state and local public health laboratories:
Peter Iwen, MS, PhD, D( ABMM), F( AAM)
Director, Nebraska Public Health Laboratory
The announcement of a new Biosafety Modernization Institute by the federal government is designed to strengthen biosafety practices with an apparent goal to update the NIH Guidelines. The main function of this document is to provide regulatory control for institutes that engage in NIH-sponsored research. Although most public health laboratories do not participate in NIH-sponsored research, they do handle high consequence pathogens that fall under the oversight of the Federal Select Agent Program( FSAP). Since FSAP uses the NIH Guidelines as one means for regulatory guidance, PHLs will subsequently need to be prepared to address any changes that are made to modernize biosafety practices in the laboratory.
Marian Downing, RBP, CBSP, SM( NRCM)
Biosafety Consultant
There are many questions about how the NIH Biosafety Modernization Initiative may affect biological research, the oversight / funding of Institutional Biosafety Committees( IBCs) and its relevance to private industry and non-research entities such as public health and clinical laboratories. Hopefully, any new guidelines will harmonize with current biosafety standards including the Biosafety in Microbiological and Biomedical Laboratories( BMBL), employ biosafety best practices, protect proprietary information, and utilize peerreviewed research for policy decisions.
David Hill, MEM, CIH
Director of Safety, New York State Department of Health
For any public health laboratories currently conducting federally funded research activities that require oversight by Institutional Biosafety Committees( IBCs), there is likely to be both a change in the scope of biosafety oversight for existing recombinant and synthetic nucleic acid research technologies, as well as an expansion of oversight to include certain wild-type pathogens. However, it will be important for APHL and its members to monitor the progress of this initiative to determine if the proposed future scope will remain limited to federally funded research activities, or if they will look to expand their biosafety oversight beyond that previous boundary to include any biological risks associated with public health laboratory settings.
While not all public health laboratories fall under NIH guidelines, APHL still encourages public health laboratory professionals to participate throughout this process. The APHL Biosafety and Biosecurity Committee will continue to collaborate with NIH and public health partners on the creation of updated guidelines. For more information and announcements, visit the NIH website. g
32 LAB MATTERS Spring 2026 PublicHealthLabs @ APHL. org
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