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Highlights

The anthrax attacks of 2001 and more recent national reports have raised concerns that the United States is vulnerable to attacks with chemical, biological, radiological, and nuclear (CBRN) agents. Because of the potential consequences of such attacks, members of Congress have expressed the need for the Departments of Homeland Security (DHS) and Health and Human Services (HHS) to coordinate in assessing risks posed by CBRN agents. GAO was asked to examine how DHS and HHS coordinate on the development of CBRN risk assessments and the extent to which they have institutionalized such efforts. GAO examined relevant laws, presidential directives, collaboration best practices, and internal control standards; analyzed DHS and HHS CBRN risk assessments; and interviewed DHS and HHS officials.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Homeland Security To ensure that DHS senior officials are able to monitor progress on the development of the proposed strategic and implementation plans for DHS's CBRN risk assessment efforts, the Secretary of Homeland Security should develop and document interim time frames and milestones as part of a plan to develop, finalize, and obtain interagency agreement on the written procedures for interagency development of the TRAs and MTAs that DHS intends to issue as strategic and implementation plans.
Closed - Implemented

Recommendation status is Closed - Implemented.

On October 10, 2012, the DHS Under Secretary for Science and Technology signed the document titled Strategic Implementation Plan for Conducting Material Threat Assessments (MTAs) and Issuance of Material Threat Determinations (MTDs). On November 15, 2012, the HHS Assistant Secretary for Preparedness and Response (ASPR) also signed the same document, finalizing it as guidance for both DHS and HHS in developing future MTAs and MTDs. This document outlines the roles, responsibilities, policies, and procedures for DHS and HHS to collaborate in conducting MTAs and issuing MTDs. Finalization of this guidance document addresses the spirit of our recommendation and we therefore consider the recommendation to be implemented by this action. In addition, in May 2013, DHS's Science and Technology Directorate's Chemical and Biological Defense Division (S&T CBD) and HHS's Biomedical Advanced Research and Development Authority--within the office of ASPR--jointly signed a memorandum of agreement (MOA). The MOA is designed to provide a framework for coordination to meet mutual requirements for modeling public health emergency responses, including with medical countermeasures, for incidents involving chemical, biological, radiological, or nuclear (CBRN) materials. Such modeling is used in S&T CBD's development of DHS's CBRN terrorism risk assessments. The MOA is intended to promote collaboration, the provision of subject matter expertise, and facilitate data and information exchange between DHS and HHS experts. Finalization of this MOA addresses the spirit of our recommendation and we therefore consider the recommendation to be implemented by this action. On October 24, 2013, the DHS Acting Under Secretary for Science and Technology signed the September 2013 document titled CBRN Terrorism Risk Assessments (TRAs) Engagement Strategy. DHS developed this document in direct response to our recommendation. It outlines DHS's strategy for engaging relevant stakeholders at other federal departments and agencies in the production and use of DHS's CBRN TRAs, as well as establishes three overarching goals for DHS's engagement with other federal stakeholders in the development of TRAs: Goal 1: Establish a clear path to guide engagement of strategic partners in the development of the TRAs. Goal 2: Identify policies and procedures for prioritizing future efforts to continually improve the evidence-base, utility, and communication of TRA products. Goal 3: Provide guidance and support for stakeholders in the appropriate use and interpretation of TRA results in support of U.S. national preparedness efforts. On February 4, 2014, the HHS Assistant Secretary for Preparedness and Response also signed the same document, finalizing it as guidance for both DHS and HHS. Finalization of this guidance document addresses the spirit of our recommendation and we therefore consider the recommendation to be implemented by this action.
Department of Health and Human Services To ensure that HHS and its federal partners are fully aware of and agree with the processes for developing the public health and medical consequence modeling reports and that consistent and effective interagency coordination continues, the Secretary of Health and Human Services should develop written procedures for obtaining, evaluating, and incorporating interagency input into the development and review of the modeling reports, to supplement the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) memorandum of understanding (MOU) and working group charters.
Closed - Implemented

Recommendation status is Closed - Implemented.

On June 29, 2012, the Assistant Secretary for Preparedness and Response (ASPR) noted that "HHS continues to work with DHS on an improved process for consensus regarding the types of threat scenario(s) used to produce medical and public health consequences assessments and civilian medical countermeasure requirements, which we anticipate will be completed in the coming months. Once completed these improvements will be incorporated into any written templates for medical countermeasure requirements generation." In September 2014, ASPR officials noted that HHS had developed written procedures for obtaining, evaluating, and incorporating interagency input into the development and review of the modeling reports. HHS cited the Department of Homeland Security's November 2012 Strategic Implementation Plan to Conduct Material Threat Assessments as evidence of these procedures.
Department of Health and Human Services To ensure that HHS and its federal partners are fully aware of and agree with the processes for developing the public health and medical consequence modeling reports and that consistent and effective interagency coordination continues, the Secretary of Health and Human Services should determine whether to renew the MOU or whether alternate coordination mechanisms, such as the PHEMCE senior council charter, are sufficient to confirm federal departments' agreement to work collaboratively.
Closed - Implemented

Recommendation status is Closed - Implemented.

On June 29, 2012, the Assistant Secretary for Preparedness and Response provided documentation that indicated it had finalized the interagency memorandum of understanding between the Department of Health and Human Services, the Centers for Disease Control, the National Institutes of Health, and the Food and Drug Administration. As a result, this recommendation is closed as implemented.

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