Guidance and Guidelines

Biosafety in Microbiological and Biomedical Laboratories (BMBL): The BMBL is a manual published jointly by the National Institutes for Health (NIH) and the Centers for Disease Control and Prevention (CDC) that lays out the code of practice for biosafety and biocontainment in the U.S. The BMBL is referenced in the Select Agent Regulations and is used in many professional and academic laboratories.

The BMBL 6th Edition was published in June 2020 and can be found online. Updates to the BMBL are published online as necessary.

NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines): The NIH Guidelines outline science-based safety practices for creating and handling recombinant and synthetic nucleic acid molecules, and organisms and viruses containing such molecules. The NIH Guidelines also articulate the responsibilities of institutions, investigators, and Institutional Biosafety Committees. Compliance with the NIH Guidelines is a term and condition of grant awards for recipients of funding from the National Institutes of Health and certain other Federal agencies.

Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA: This guidance sets forth recommended baseline standards for the gene and genome synthesis industry (providers) and for manufacturers of benchtop nucleic acid synthesis devices. It also details best practices for customers of synthetic nucleic acids (i.e., institutions, principal users, end users, and third-party vendors) regarding screening orders for sequences of concern and for responsibly handling the use and transfer of synthetic nucleic acids containing sequences of concern. In addition, this guidance seeks to encourage best practices to address biosecurity concerns associated with the potential misuse of synthetic nucleic acids to bypass existing regulatory controls.

Key Planning Factors and Considerations for Response to and Recovery from a Biological Incident: The document includes strategic and operational issues for consideration when developing response and recovery plans for a biological incident. This guidance directly supports and builds upon the response and recovery efforts described in the Biological Incident Annex to the Response and Recovery Federal Interagency Operational Plan (BIA; FIOP). Key Planning Factors and Considerations for Response to and Recovery from a Biological Incident provides planning guidance and serves as a reference for regional, state, local, tribal, and territorial (SLTT) departments and agencies that are planning for biological incidents.

U.S. Government Policy on Oversight of Life Sciences Dual Use Research of Concern: This policy establishes regular review of U.S. Government funded or conducted research with certain high-consequence pathogens and toxins for its potential to be Dual Use Research of Concern (DURC) in order to mitigate risks as appropriate and collect information needed to inform the development of an updated policy, as needed, for the oversight of DURC. More information on DURC.

United States Government Policy for Institutional Oversight of Life Sciences DURC: The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. addresses institutional oversight of DURC, which includes policies, practices, and procedures to ensure DURC is identified and risk mitigation measures are implemented, where applicable. Institutional oversight of DURC is the critical component of a comprehensive oversight system because institutions are most familiar with the life sciences research conducted in their facilities and are in the best position to promote and strengthen the responsible conduct and communication of DURC. More information on DURC.