• Possession, Use, and Transfer of Select Agents and Toxins; Final Rule

Summary of Requirements

• Entities possessing select agents must appoint a Responsible Official (RO). An Alternate Responsible Official (ARO) may also be appointed.
• Entities possessing select agents must register with either the CDC or USDA/APHIS, depending on the select agents possessed.
• Individuals with a legitimate need to work with select agents must undergo a security risk assessment.
• Only approved individuals may have access to select agents.
• Non-approved individuals must be escorted by an approved person at all times while in the laboratory.
• The facility must develop and implement a Biosafety and Security Plan.
• Security systems and procedures must be designed according to a site-specific risk assessment and must provide graded protection in accordance with the threat posed by the select agent.
• Select agents may only be transferred to registered entities.
• Either the CDC or USDA/APHIS must approve all transfers of select agents prior to the transfer.

Training

• The RO must provide training in biosafety, containment, and security procedures to individuals with access to select agents.
• The RO must provide annual refresher training.
• Visitors must be informed of the security requirements and procedures.

Reporting

• Suspected loss or theft of select agents must be reported to the US Department of Agriculture immediately upon discovery.
• Changes in circumstances must be reported by the RO to the agency that issued the certificate of registration.

Inspections

• Prior to issuing a certificate of registration, APHIS or CDC may inspect and evaluate a facility.
• The RO may inspect the facility at least annually.

Recordkeeping

The RO must keep records including:

• The Biosafety and Security Plan;
• Current list of individuals with access to select agents;
• Training records for individuals with access to select agents;
• Accurate and current inventory records;
• Permits and transfer documents;
• Security records (e.g., transactions from automated access control systems, testing and maintenance of security systems, visitor logs);
• Biosafety, containment, and security incident reports;

All records must be kept for 3 years.

Written Program

A Biosafety and Security Plan must be prepared for each entity possessing select agents or toxins. The University has prepared a Biosafety and Security Plan for its laboratories possessing select agents and toxins.

• CDC Select Agent Program
• USDA Agricultural Select Agent Program