Requirements for facilities transferring or receiving select agents. Final rule

Area of Science:

• Public Health
• Biosafety Regulations
• Infectious Disease Control

Background:

• The Centers for Disease Control and Prevention (CDC) regulates the transfer of biological agents and toxins, known as select agents.
• Current regulations mandate registration and adherence to the Third Edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL) for entities handling select agents.

Purpose of the Study:

• To revise existing biosafety standards for facilities handling select agents.
• To introduce new biosecurity standards for facilities working with select agents.
• To update the incorporated guidelines from the Third Edition to the Fourth Edition of the BMBL.

Main Methods:

• Publication of a Notice of Proposed Rulemaking (NPRM) on October 28, 1999.
• Proposal to incorporate the Fourth Edition of the BMBL by reference, replacing the Third Edition.
• Review of public comments on the proposed rulemaking.

Main Results:

• No comments were received in response to the Notice of Proposed Rulemaking.
• The CDC is proceeding with amending its regulations as proposed.

Conclusions:

• The CDC is officially amending its regulations to incorporate the Fourth Edition of the BMBL.
• This update will enhance biosafety and biosecurity standards for facilities handling select agents and toxins.