Select agents

Select Agents

Select agents are a group of biological agents and toxins that have been identified by government agencies as posing a significant threat to public health and safety, to animal or plant health, or to animal or plant products. These agents are subject to strict regulations and oversight due to their potential to be used in bioterrorism or biowarfare.

Definition

Select agents are defined by the Centers for Disease Control and Prevention (CDC) and the United States Department of Agriculture (USDA) as biological agents and toxins that could potentially pose a severe threat to public health and safety. The list of select agents is regularly reviewed and updated based on emerging threats and scientific advancements.

Regulatory Framework

The regulation of select agents in the United States is governed by the Federal Select Agent Program (FSAP), which is jointly managed by the CDC and the USDA's Animal and Plant Health Inspection Service (APHIS). The FSAP oversees the possession, use, and transfer of select agents and toxins to ensure that they are handled safely and securely.

Registration

Entities that wish to possess, use, or transfer select agents must register with the FSAP. This process involves a thorough review of the entity's facilities, security measures, and personnel. Only registered entities are legally permitted to work with select agents.

Security Measures

Due to the potential risks associated with select agents, entities must implement stringent security measures. These include:

• Access Control: Limiting access to select agents to authorized personnel only.
• Inventory Management: Maintaining accurate records of select agent quantities and locations.
• Personnel Reliability: Conducting background checks and ensuring that personnel are trustworthy and competent.

Examples of Select Agents

Select agents include a variety of bacteria, viruses, fungi, and toxins. Some notable examples are:

• Bacillus anthracis (the causative agent of anthrax)
• Yersinia pestis (the causative agent of plague)
• Botulinum toxin
• Ebola virus

Research and Development

Research involving select agents is crucial for developing medical countermeasures, such as vaccines and therapeutics. However, such research must be conducted under high-level biosafety conditions, typically in Biosafety Level 3 (BSL-3) or Biosafety Level 4 (BSL-4) laboratories.

Ethical Considerations

The dual-use nature of select agents, where they can be used for both beneficial and harmful purposes, raises significant ethical concerns. Researchers and policymakers must balance the need for scientific advancement with the potential risks of misuse.

Also see

• Bioterrorism
• Biosafety level
• Pathogen
• Public health