Biosafety and Biosecurity Policy

Life sciences research is essential to protecting global health security by helping us to understand the fundamental nature of human-pathogen interactions and informing public health and preparedness efforts, such as the development of vaccines and medical countermeasures. OSP develops policies to preserve the benefits of this research while minimizing its potential misuse.

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FAQs and Fact Sheets

Dual Use Research of Concern

Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. The United States Government’s oversight of DURC is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.

Watch the video “Dual Use Research: A Dialogue”

External Resources

Research Involving Enhanced Potential Pandemic Pathogens (ePPP)

The U.S. Government and the Department of Health and Human Services define enhanced potential pandemic pathogen (ePPP) research as research that may be reasonably anticipated to create, transfer or use potential pandemic pathogens resulting from the enhancement of a pathogen’s transmissibility and/or virulence in humans.

ePPP research can help us prepare for the next pandemic, for example by informing public health and preparedness efforts including surveillance and the development of vaccines and medical countermeasures. However, such research requires strict oversight and may only be conducted with appropriate biosafety and biosecurity measures.

The HHS Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework) was established in 2017 to guide HHS funding decisions on proposed ePPP research and aims to preserve the benefits of life sciences research involving ePPPs while minimizing potential biosafety and biosecurity risks. The HHS P3CO Framework is responsive to and in accordance with the Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight issued by the White House Office of Science and Technology Policy following a three-year, public deliberative process.

Department of Health and Human Services P3CO Framework

Department of Health and Human Services Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens

U.S. Government Policy on Enhanced PPP Research

Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.

Incident Reporting

The NIH Guidelines require that any significant problems, violations, or any significant research-related accidents and illnesses” be reported to OSP within 30 days. Appendix G of the NIH Guidelines specifies certain types of accidents that must be reported on a more expedited basis. Specifically, Appendix G-II-B-2-k requires that spills and accidents in BL2 laboratories resulting in an overt exposure must be immediately reported to the OSP (as well as the IBC). In addition, Appendices G-II-C-2-q and G-II-D-2-k require that spills or accidents occurring in high containment (BL3 or BL4) laboratories resulting in an overt or potential exposure must be immediately reported to OSP (as well as the IBC and BSO).

*Incident reports may be released to the public in full. Please note that incident reports should not include personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in the report.  If it is necessary to include such information, please clearly mark it as such so that it can be considered for redaction in accordance with Freedom of Information Act exemptions.*

IBC RMS and Registration Information

The Institutional Biosafety Committee Registration Management System (IBC-RMS) supports the online submission of IBC registrations and annual registration updates. IBC-RMS users can access the system to keep track of their institution’s registration status, view IBCs currently registered with OSP, and access important compliance guidance relating to the NIH Guidelines. The IBC-RMS also allows users to send policy questions directly to OSP through the Web interface.

IBC Self-Assessment Tool

Investigator Brochure

Biosafety and Biosecurity Innovation Initiative

The Department of Health and Human Services (HHS), in coordination with the U.S. government, launched the Biosafety and Biosecurity Innovation Initiative (BBII) to reduce biological risks associated with advances in biotechnology, biomanufacturing, and the bioeconomy, in accordance with the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy (Bioeconomy EO).

BBII is designed to coordinate and prioritize support for biorisk research and mitigation efforts across the federal government. BBII, at its core, aims to catalyze action across government and society to incentivize biosafety and biosecurity innovation across all sectors that support the bioeconomy and ensure that biotechnology is developed and used responsibly. BBII protects the bioeconomy through funding opportunity, job creation, and knowledge sharing in the areas of biosafety, biosecurity, and biorisk management.

Biosafety and Biosecurity Innovation Initiative Plan for the Bioeconomy

NIH, on behalf of HHS, and the Department of Homeland Security, in coordination with the U.S. government, produced the Biosafety and Biosecurity Innovation Initiative Plan for the Bioeconomy (Plan) in accordance with the Bioeconomy EO, outlining recommendations for U.S. government investment in:

  • Strengthening opportunities for biosafety and biosecurity research and innovation;
  • Incentivizing development and implementation of evidence-based best biological risk management practices, carried out by a competent workforce; and,
  • Fostering a culture of biosafety and biosecurity to encourage trust and norms.

This Plan serves as a framework for U.S. government coordination of BBII, led by NIH.

Read the Plan: Biosafety and Biosecurity Innovation Initiative Plan for the Bioeconomy

Additional Resources

 

Links to Other Biosafety Resources

Additional Resources