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1 1 (February 15, 2023)

handle is hein.crs/govekpn0001 and id is 1 raw text is: Congressional ____ Sa Research Service ~ inforrming the Iegislative debate since 1914 Improved Oversight of Pathogen Research: Recent Recommendations February 15, 2023 Introduction The United States has multiple, overlapping policies that guide oversight of pathogen research. These include, among others: Biosafety in Microbiological and Biomedical Laboratories (BMBL) guidelines; Federal Select Agent Program (FSAP); U.S. Government Policy for the Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC); and Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO). Many of these policies and guidelines are framed around biosafety and biosecurity. According to a recent U.S. Government Accountability Office (GAO) report, biosafety includes the practices and equipment that ensure that lab workers, the community, and the environment are protected from infectious pathogens and biological hazards, while biosecurity includes practices to ensure the protection and control of biological materials in laboratories to protect them from theft, loss, or misuse. While some oversight mechanisms are required by law and apply to certain pathogen research conducted in the United States or by U.S. researchers, others are guidance issued by federal agencies and apply only to research and researchers they fund. Privately funded research, or research conducted outside the United States, may therefore not be covered by certain U.S. oversight mechanisms. Two recent reports, one from GAO and a draft report from the National Science Advisory Board for Biosecurity (NSABB), evaluated current U.S. polices related to research with enhanced potential pandemic pathogens (ePPP) and broader biosafety/biosecurity issues related to life-sciences research. While each report provided a separate set of recommendations based on its findings, when considered together, three broad focus areas emerge: Congressional Research Service https://crsreports.congress.gov IN12109 CRS INSIGHT Prepared for Members and Committees of Congress

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