Select Agent Program

Definition

The Select Agent Program is a regulatory framework established by the U.S. Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) to oversee the possession, use, and transfer of select agents and toxins that pose a severe threat to public health and safety. This program aims to ensure that research involving these high-risk biological materials is conducted safely and securely, preventing misuse or accidental release.

5 Must Know Facts For Your Next Test

1. The Select Agent Program classifies select agents and toxins into two categories: Tier 1 agents, which pose the highest risk, and other select agents that are less dangerous.
2. Facilities that handle select agents must register with the CDC or APHIS and comply with strict security and safety requirements.
3. Personnel working with select agents must undergo background checks and training to ensure they understand the risks associated with these materials.
4. The program mandates regular inspections of facilities that work with select agents to verify compliance with regulations.
5. Failure to adhere to the Select Agent Program's regulations can result in severe penalties, including fines and loss of research funding.

Review Questions

• How does the Select Agent Program contribute to biosafety and biosecurity in research involving hazardous biological materials?
  • The Select Agent Program enhances biosafety and biosecurity by establishing stringent guidelines for the handling of dangerous biological agents. It requires facilities to implement strict security measures, conduct regular inspections, and ensure personnel are properly trained. By regulating who can access these materials and how they can be used, the program helps mitigate risks associated with potential misuse or accidental release of harmful pathogens.
• What are the main responsibilities of facilities that work with select agents under the Select Agent Program?
  • Facilities that work with select agents are responsible for registering with the CDC or APHIS, maintaining compliance with security protocols, ensuring personnel undergo background checks, and implementing biosafety measures. They must also keep detailed records of the possession and transfer of select agents. Regular audits are conducted to ensure adherence to safety regulations, which is essential for protecting public health.
• Evaluate the impact of the Select Agent Program on public health and safety in relation to bioterrorism threats.
  • The Select Agent Program plays a critical role in safeguarding public health by addressing potential bioterrorism threats posed by dangerous biological agents. By closely monitoring and regulating these materials, the program minimizes the risk of them being misused for malicious purposes. The stringent security measures and oversight help ensure that research involving select agents is conducted responsibly while also enhancing national preparedness against biological threats.

Related terms

Biosafety Level: A set of biocontainment precautions required to isolate dangerous biological agents in an enclosed laboratory facility.

Biosecurity: Measures taken to protect against the loss, theft, misuse, or intentional release of biological materials.

Biological Weapons Convention:

An international treaty that aims to prevent the development, production, and stockpiling of biological weapons.