About Dual Use Research of Concern

The U.S. Government mandates that federally funded intramural or extramural research falling within the scope of Category 1 or Category 2 of this policy is subject to federal and institutional oversight. The purpose of this oversight is to preserve the benefits of such research while minimizing biosafety and biosecurity risks, including the potential misuse of knowledge, information, products, or technologies in a manner that could harm public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.

Categories of Research

The new policy classifies research into two categories:

Category 1: Includes a list of biological agents or toxins and is reasonably anticipated to result in high-risk outcomes, such as increased transmissibility, virulence, or resistance to medical countermeasures. Examples include Botulinum neurotoxins, Chikungunya virus, and Francisella tularensis.

 

Category 2: Involves research that is expected to result in a Potential Pandemic Pathogen (PPP), the development, use, or transfer of a Pathogen of Enhanced Pandemic Potential (PEPP), or work with an eradicated or extinct PPP that could pose a significant public health threat.