Policy and Procedures for Managing Dual Use Research of Concern
All EPA life science researchers, extramural research institutions and their procurement personnel are now subject to EPA Order 1000.19 Policy and Procedures for Managing Dual Use Research of Concern. This web page describes what they must know and do to comply with this Order.
Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. EPA defines life sciences research as a systematic investigation designed to develop or contribute to generalizable knowledge involving living organisms (e.g., microbes, human beings, animals, and plants) and their products* (EPA Order 1000.19, 5.h). Pursuant to Executive Order 13546, Optimizing the Security of Biological Select Agents and Toxins in the United States (PDF) (6pp, 190K, About PDF) the U.S. Government issued two policies to address risks associated with DURC.
The United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (4 pp, 111 K, About PDF)(DURC Policy, March 2012) established regular review by federal agencies of U.S. government-funded or conducted research with certain high-consequence pathogens and toxins for its potential to be dual use research of concern. In collaboration with nongovernmental institutions or researchers conducting U.S. government-funded DURC, federal departments and agencies must conduct a risk assessment and develop a risk mitigation plan to apply any necessary and appropriate risk mitigation measures to ensure the research is properly conducted and communicated.
The United States Government Policy for Institutional Oversight of Dual Use Research of Concern (19 pp, 604 K, About PDF) (iDURC Policy, effective September 24, 2015) applies to institutions within the United States that receive funding for life sciences research from the U.S. government. The iDURC Policy requires these institutions to review all life sciences research projects at their institutions and determine whether any such research involves the agents or toxins identified in the iDURC Policy, regardless of the funding source. Institutions conducting life sciences research using one or more of the listed select agents or toxins must have an Institutional Review Entity in place, train their research personnel in managing DURC and maintain records of such training. In addition, they must report to NIH any DURC that is being funded by non-government sources.
Such research is subject to additional institutional review and oversight to determine whether it also involves any of the seven categories of experiments listed in the iDURC Policy and if so, whether it meets the definition of dual use research of concern (see above). Research meeting this definition is subject to risk mitigation measures to ensure the research is properly conducted and communicated. Institutions outside the U.S. must also conduct this review and oversight if the U.S. government directly funds research that involves any of the agents or toxins in the iDURC Policy.
The DURC and iDURC Policies require all federal departments and agencies that conduct life sciences research implement their provisions. EPA Order 1000.19, Policy and Procedures for Managing Dual Use Research of Concern, implements both policies at EPA.
* EPA does not consider the following activities to be research: routine product testing, quality control, mapping, collection of general-purpose statistics, routine monitoring and evaluation of an operational program, observational studies, and the training of scientific and technical personnel.