Select Agent

Select Agent

A Select Agent is a biological agent or toxin that has been determined by the United States government to have the potential to pose a severe 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 to prevent their misuse, particularly in the context of bioterrorism or biological warfare.

History

The concept of Select Agents was formalized in the United States with the passage of the Antiterrorism and Effective Death Penalty Act of 1996, which required the Centers for Disease Control and Prevention (CDC) to establish a list of biological agents and toxins that could pose a threat to public health and safety. This list has been updated periodically to reflect new scientific knowledge and emerging threats.

Regulatory Framework

The regulation of Select Agents is primarily governed by the Federal Select Agent Program, which is jointly managed by the CDC and the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA). The program oversees the possession, use, and transfer of Select Agents and toxins, ensuring that facilities handling these agents comply with stringent security, safety, and reporting requirements.

Registration and Security

Entities that wish to work with Select Agents must register with the Federal Select Agent Program and undergo a rigorous approval process. This includes background checks for personnel, security risk assessments, and the implementation of comprehensive security plans to prevent unauthorized access or theft.

Biosafety and Containment

Facilities handling Select Agents must adhere to strict biosafety and containment protocols to prevent accidental release or exposure. This includes the use of biosafety level (BSL) laboratories, with BSL-3 and BSL-4 being the most secure and used for the most dangerous agents.

List of Select Agents

The list of Select Agents includes a wide range of bacteria, viruses, fungi, and toxins. Some notable examples include:

• Bacillus anthracis (the causative agent of anthrax)
• Yersinia pestis (the causative agent of plague)
• Francisella tularensis (the causative agent of tularemia)
• Ebola virus
• Marburg virus
• Botulinum neurotoxin

Research and Public Health

Research involving Select Agents is crucial for developing medical countermeasures, such as vaccines and therapeutics, to protect against potential outbreaks or bioterrorism events. However, due to the risks associated with these agents, research is conducted under strict regulatory oversight to ensure public safety.

Controversies and Challenges

The regulation of Select Agents has been subject to debate, particularly regarding the balance between security and scientific research. Some researchers argue that overly stringent regulations can hinder scientific progress, while others emphasize the need for robust security measures to prevent misuse.

Also see

• Bioterrorism
• Biosafety level
• Biological warfare
• Centers for Disease Control and Prevention
• United States Department of Agriculture