Guidance and Guidelines

S3: Science Safety Security

Biorisk Management

The U.S. Government published guidance, guidelines, and policies to clarify regulations or suggest voluntary actions. These documents can be called a variety of names, such as guidance, policy and procedures, memorandum, points to consider, or current thinking.

Guidance and Guidelines may:

Clarify the language in a regulation,
Explain how a Department interprets a regulation, and/or
Suggest voluntary actions to be taken by entities outside the Federal Government.

Some Guidance and Guidelines may be published in the Federal Register for public comment, if the agency wishes to seek public comment on the guidance through this formal process. Guidance and Guidelines may be referenced in regulations, but the final versions do not have to be published in the Federal Register, such as Biosafety in Microbiological and Biomedical Laboratories (BMBL).

Compliance with Guidance and Guidelines is voluntary unless the Guidance or Guidelines are incorporated into a regulation, or become a term and condition of an agreement, such as a condition of funding for a grant awarded to an institution. Guidance and Guidelines are also frequently adopted by organizations as best practices, even if they are not required to do so.

For more information on what is published in the Federal Register, please see the National Archive’s Drafting Handbook.

Guiding Principles for Biosafety Governance: Ensuring Institutional Compliance with Biosafety, Biocontainment, and Laboratory Biosecurity Regulations and Guidelines

Guiding Principles for Biosafety Governance: Ensuring Institutional Compliance with Biosafety, Biocontainment, and Laboratory Biosecurity Regulations and Guidelines: The Federal Experts Security Advisory Panel (FESAP) has developed a document articulating a number of guiding principles and best practices for biosafety and biosecurity governance. The document Guiding Principles for Biosafety Governance: Ensuring Institutional Compliance with Biosafety, Biocontainment, and Laboratory Biosecurity Regulations and Guidelines also provides an overview of the Federal regulations, requirements, and guidelines that pertain to biosafety and biosecurity in the U.S. and a description of some of the voluntary laboratory accreditation systems. Finally, this document provides a description of the biosafety and biosecurity oversight frameworks that are in place at the institutional level for ensuring compliance with federal requirements and guidelines.

Biosafety in Microbiological and Biomedical Laboratories (BMBL)

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)

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 (2010)

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.

Planning Guidance for Recovery Following Biological Incidents (Draft) (May 2009)

Planning Guidance for Recovery Following Biological Incidents (Draft) (May 2009): This guidance describes a risk management framework for government and nongovernmental decision-makers who work in emergency planning for responding to a biological incident in a domestic, civilian setting. The goal of this guidance is to provide Federal, State, local and tribal decision makers with consistent Federal Guidance on protecting the public, emergency responders, and surrounding environments during a biological incident. It also focuses on ensuring that local and Federal first responders can prepare for and recover from an incident involving biological contamination.

U.S. Government Policy on Oversight of Life Sciences Dual Use Research of Concern

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

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.

Department of Health and Human Services Framework on H5N1 DURC Research

Department of Health and Human Services Framework on H5N1 DURC Research: In February 2013, HHS developed a Framework for Guiding Funding Decisions about Research Proposals with the Potential for Generating Highly Pathogenic Avian Influenza H5N1 Viruses that are Transmissible among Mammals by Respiratory Droplets to guide funding decisions on proposals for research anticipated to generate HPAI H5N1 viruses that are transmissible by respiratory droplets among mammals. The new Framework outlines a robust review process that takes into account the scientific and public health benefits, the biosafety and biosecurity risks, and the appropriate risk mitigation measures pertinent to the proposed research.

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