兰德-识别并缩小联邦特工计划中的差距-新兴生物技术时代的改进机遇（英）-2025_57页_1mb

Summary

The Federal Select Agent Program (FSAP) regulates biological select agents and toxins to safeguard public health and security. However, emerging biotechnologies, such as recombinant DNA technology and artificial intelligence, pose new challenges by enabling the creation of engineered pathogens that may evade current oversight. Key gaps identified in FSAP include:

1. Identification of New Agents: The list-based approach fails to capture novel pathogens or engineered threats with functional similarities to select agents.
2. Speed of Response: The regulatory amendment process is slow, delaying responses to emergent threats like novel viruses.
3. Transparency in Designation: Criteria for selecting agents are not quantitative or publicly accessible, hindering clarity.
4. Security vs. Safety Balance: FSAP prioritizes security over biosafety, potentially discouraging transparency and incident reporting.

Proposed Mitigations:

• Functional Criteria: Transitioning to function-based designations instead of taxonomy-based lists to address novel agents.
• Risk-Based Framework: Implementing more nuanced and transparent functional criteria for select agent additions.
• Near-Miss Reporting: Enhancing incident reporting systems to improve transparency and learning.
• Nucleic Acid Restrictions: Regulating genetic sequences of select agents to curb unauthorized synthesis.

Obstacles:

• Mitigations may burden research, restrict international collaboration, and require frequent regulatory updates.

Conclusion: FSAP must adapt to address emerging threats while balancing security with scientific progress.