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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: 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.