White House overhauls rules for risky pathogen studies

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New policies for gain-of-function and “dual-use” research will cover broader swath of experiments

Certain kinds of experiments with the H5N1 avian flu virus would see tighter reviews under a new U.S. policy on potentially risky research.The White House is tightening federal oversight of so-called gain-of-function studies that could enhance risky viruses in ways that increase their ability to cause a pandemic. It is also overhauling rules for a broader category of federally funded research on dangerous pathogens that is considered “dual use,” because the results could be used as bioweapons.

The new policy, which will take effect in May 2025, replaces decade-old rules governing “dual-use research of concern” crafted in the wake of the 2001 anthrax attacks. The DURC rules require additional oversight of seven types of experiments that involve 15 high-risk human and animal viruses and bacteria from a longer U.S. government list of dangerous human, animal, and plant pathogens and toxins known as select agents.

Under the new rules for GOF studies, now called Category 2 research, even certain experiments with less lethal agents such as seasonal flu could fall under the policy. That’s because it includes any pathogen that, when manipulated in the lab, could become what the policy calls a"pathogen with enhanced pandemic potential" that severely threatens public health or national security.

 

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