The Obama Administration today announced that it will overhaul the program that governs U.S. research involving dangerous pathogens and toxins such as anthrax, which are collectively known as select agents. An executive order issued by the White House this afternoon says the government will put the most dangerous of the 82 items currently on the select agent list into a high-risk category and require tougher security measures such as greater physical security and more rigorous screening for researchers working with those agents.
The stratification into higher and lower risk categories could increase headaches for some biomedical researchers and university administrators. But it may reduce the regulatory burden for those who work with relatively less hazardous agents, while making the rules clearer for all.
The departments of Health and Human Services and Agriculture—the two agencies responsible for oversight of the select agent program—will put together this list of high-risk (called Tier 1) agents over the next 18 months by identifying those pathogens and toxins that present “the greatest risk of deliberate misuse with most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence.” In addition, the two agencies will “consider reducing the overall number of agents and toxins on the Select Agent List.” The order also mandates creation of a panel of federal security and scientific experts who will advise the select agent program.
The idea of separating select agents by risk is part of a biosecurity bill (H.R. 5498) pending in the House of Representatives. The executive order appears to guarantee that tiering will happen if that legislative effort stalls. It’s as yet unclear whether the government plans to relax rules for agents outside of the Tier 1 subset.
This is the biggest proposed change to the select agent program since it assumed its current form 7 years ago.