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Published Regulations

S3: Science Safety Security

Biorisk Management 

Regulations are issued by U.S. Federal government Departments and Agencies to interpret and implement laws passed by Congress. When Congress passes a law directing an agency to perform an action, the Department may issue a regulation further interpreting the language in the law. Not all laws require regulations. Agencies generally can issue, modify, or amend regulations without seeking additional action from Congress.

For more information on when issuing regulations is necessary, please see The Administrative Procedure Act (5 U.S.C. 552).

Issuing a regulation requires several steps:

  • First, the agency publishes a proposed regulation in the Federal Register for public comment, so that any member of the public can suggest changes or ask questions for clarification.
  • Second, after the comment period closes, the agency considers comments and questions it received, and makes changes to the proposed regulation as it thinks necessary to address the comments and questions submitted.
  • Finally, once those changes are made, the agency publishes the final regulation in the Federal Register.

The final published regulation holds the force and effect of law, and establishes requirements. If an agency wants to update or change a regulation, it must go through the steps above to do so. Some agencies might have additional steps for issuing a regulation. Agencies may issue an interim regulation or more than one proposed version of a regulation, but all agencies must go through these basic steps to publish a regulation.

All regulations are published in the Federal Register, and then codified annually in the Code of Federal Regulations or CFR. The CFR is categorized into broad subject areas, called titles. Titles are divided into parts, subparts, sections, and subsections. When referencing the CFR, usually only the title and the part or section is referenced. The format is written like this:

Biorisk Management 

The annual CFR provides the most recent version of a rule as of the date the volume is published. Rules issued during the year that have not yet been codified into the CFR may be found in the Federal Register. The federal register notice also usually provides the agency’s explanation of the final regulation, its response to public comments, and any changes the agency made to the regulation from prior versions in response to comments.

If you want to see regulations that have been issued in the current year, or the agencies explanation of the rule, you should consult the federal register.

Select Agent Final Rule: Department of Health and Human Services (42 CFR Part 73) (DHHS): This is the Department of Health and Human Services regulation implementing Title II, Subtitle A of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.