Optimizing the Security of Biological Select Agents and Toxins in the United States

Jul 8, 2010
Jul 8, 2010

Summary

Creates a new system to secure dangerous germs and poisons based on their risk level, protecting national security without stopping important science.

What problem does this solve?

The rules for securing dangerous biological materials were confusing and inconsistent, which could make important research too difficult. This order creates a clear, risk-based system to protect these materials from misuse while still supporting scientific work.

What does this order do?

Creates a tiered list of dangerous agents
Requires the government to create a list of biological agents and toxins sorted by risk. A special group, called Tier 1, will include the agents that pose the greatest threat of misuse or could cause mass harm.
Establishes a new security advisory panel
Creates the Federal Experts Security Advisory Panel, made up of people from many government agencies. This panel will give advice on how to best secure dangerous biological materials.
Develops new security standards for high-risk agents
Orders the creation of new, specific security rules for the Tier 1 agents. This includes rules for physical security at labs and cybersecurity to protect information.
Coordinates federal oversight
Requires federal agencies to create a plan to work together on inspections and security practices. This helps make sure the rules are consistent and reduces confusion for labs.
Considers reducing the number of regulated agents
Asks agencies to think about removing some agents and toxins from the official list. This would focus security efforts on the materials that are truly the most dangerous.

Who does this affect?

  • Scientists and research institutions
  • Federal oversight agencies
  • Public health officials

What is the real world impact?

Balances national security with scientific progress
Ensures that dangerous biological materials are kept safe from terrorists or accidental release. At the same time, it tries to avoid making the rules so strict that they stop important research on diseases and public health threats.

When does this start?

This order sets several deadlines for federal agencies, starting from July 2, 2010.
Designation of Tier 1 Agents
Within 18 months of the order (by January 2, 2012), the Secretaries of Health and Human Services and Agriculture must designate the Tier 1 list of the most dangerous agents.
Proposal of New Security Rules
Within 15 months of the order (by October 2, 2011), the Secretaries of Health and Human Services and Agriculture must propose new security rules for Tier 1 agents.
Finalization of New Security Rules
Within 27 months of the order (by October 2, 2012), the Secretaries of Health and Human Services and Agriculture must publish the final rules and guidance for securing Tier 1 agents.
Plan for Coordinated Oversight
Within 6 months of the order (by January 2, 2011), federal agencies must develop a plan to coordinate their security oversight and inspection activities.
Initial Panel Recommendations
Within 4 months of the order (by November 2, 2010), the new Federal Experts Security Advisory Panel must provide its first recommendations.