Notice of EPA Implementation of the United States Government Policy on Institutional Oversight of Life Sciences Dual Use Research of Concern for Assistance Agreements
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On September 24, 2014, the Federal Government released the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (iDURC Policy). Institutions and Federal Government funding agencies have one year, until September 24, 2015, to establish the necessary procedures to comply with the iDURC Policy. The purpose of this Notice is to alert institutions of the iDURC Policy’s issuance and to describe EPA’s intended implementation of the iDURC Policy regarding EPA’s research grants and cooperative agreements.
Dual use research of concern (DURC) is defined as 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. Despite its value and benefits, some products of this research may be misused for harmful purposes. The fundamental aim of this oversight policy is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.
The iDURC Policy applies to all research projects, regardless of funding source, that involve one or more of 15 listed agents and toxins and are conducted at or sponsored by an organization that receives Federal financial support for life sciences research. The iDURC Policy requires that institutions review research involving these agents to determine whether it can be anticipated to result in specified experimental effects, and if so, whether these projects constitute DURC. The iDURC Policy specifies the responsibilities of Principal Investigators (PI), the Institutional Contact for Dual Use Research of Concern (IC for DURC), the Institutional Review Entity (IRE), and the recipient institution with respect to research subject to the iDURC Policy.
Intended EPA Policy and Implementation
EPA’s iDURC policy will apply to all research awards issued on or after October 1, 2015. EPA recipient institutions and their principal investigators conducting life sciences research subject to the iDURC Policy have a number of responsibilities. This Notice does not summarize all of them, but highlights a few. EPA recommends institutions reference the actual policy, available at Dual Use Research of Concern, for a comprehensive list of all requirements.
Notably, by September 24, 2015, institutions must establish a standing Institutional Review Entity (IRE). The IRE will be required to identify DURC as described by the scope of the iDURC Policy and assess such research for the benefits and risks associated with its conduct and communication. This assessment must be performed when research, regardless of the source of funding, is identified that involves one or more of the 15 agents and toxins listed in the iDURC Policy and are conducted at or sponsored by an organization that receives Federal financial assistance for life sciences research.
If research funded by EPA is assessed by the IRE for DURC potential, the institution will be required to notify the Project Officer listed on the Notice of Award of the results of the IRE review process within 30 days. In instances when the research is determined to be DURC, EPA Homeland Security will work with the institutions and investigators conducting the research to develop an appropriate risk mitigation plan to minimize the risk of misuse of the knowledge, information, products, or technologies generated by the research. This may be implemented through a term and condition of the award. If, during the course of conducting research, the research becomes DURC, the recipient will be required to inform EPA immediately of the change in DURC status and to develop a risk mitigation plan as outlined above. The institution will be responsible for ensuring that DURC is conducted in accordance with the approved risk mitigation plan. Within 30 calendar days of identifying non-compliance, the institution will have to report to EPA any instances of noncompliance with the iDURC Policy, as well as measures undertaken by the institution to prevent recurrences of similar situations of noncompliance.
If an institution subject to the iDURC policy identifies any non-US Government (USG) funded research as DURC, notification should be made within 30 days to the NIH Program on Biosecurity and Biosafety Policy (See contact details listed below). Failure of EPA recipients to comply with the iDURC Policy and any special award terms and conditions may result in an enforcement action as outlined in 2 CFR 200.338, remedies for non-compliance.
To assist institutions in implementing the iDURC Policy, the USG has developed A Companion Guide to the USG Policies for Oversight of Life Sciences Dual Use Research of Concern (Companion Guide)(77 pp, 880 K, About PDF). The Companion Guide offers tools that promote the understanding and identification of DURC, risk assessment and development of risk mitigation plans and risk management processes, the responsible communication of DURC, and training and education on the DURC issue.
Additional educational tools and resources can be found on the U.S. Government Science, Safety, Security (S3) website - Dual Use Research of Concern.
Inquires about this notice should be directed to:
Environmental Protection Agency
Office of Grants and Debarment
National Policy, Training and Compliance Division
Inquiries regarding specific grant applications or projects that may be subject to the iDURC policy should be directed to the assigned Project Officer of the relevant EPA Program Office.
General inquiries about the DURC and iDURC Policy should be directed to:
White House Office of Science and Technology