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Biodefense: Actions Needed to Address Long-Standing Challenges

GAO-23-106476 Published: Mar 09, 2023. Publicly Released: Mar 09, 2023.
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Fast Facts

The National Biodefense Strategy outlines how the federal government should prepare for and respond to biological incidents. The pandemic exposed shortcomings in federal response efforts.

This snapshot highlights federal biodefense challenges and opportunities for improvement that we've identified. For instance, agencies have developed response plans and conducted interagency exercises to prepare for biological threats. However, they don't routinely work together to monitor exercise results in order to identify potential problems. Doing so would help to ensure that the nation is better prepared to respond to the next biological threat.

First responders in hazmat suits practicing in a BioWatch safety drill

two first responders wearing khaki colored hazmat suits in a building

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The Big Picture

Biodefense consists of actions to counter biological threats, reduce biological risks, and prepare for, respond to, and recover from biological incidents. The complexity of these efforts requires a whole-of-government approach. For over a decade, GAO has evaluated federal biodefense efforts related to implementation of the National Biodefense Strategy, biodefense preparedness and technology challenges, and federal biosurveillance efforts, among others and identified challenges and opportunities for improvement.

What GAO’s Work Shows

1. National Biodefense Strategy Challenges

In 2018, the White House issued the National Biodefense Strategy, which outlined five high-level goals and functions. It was designed to strengthen federal biodefense capabilities to address naturally occurring, accidental, and deliberate biological threats. An accompanying Presidential memorandum set up a governance structure to guide its implementation, coordinate federal biodefense activities, and assess the effectiveness of goals and objectives. However, in 2020, GAO found a lack of clear procedures and planning to analyze data in a way that leveraged resources and advanced national biodefense capabilities, among other findings.

➢ We recommended that the Secretary of Health and Human Services direct the interagency biodefense body to clearly document guidance and methods for analyzing the data collected.

Further, GAO has reported on broad issues related to leadership, coordination, and collaboration as a result of fragmentation throughout the biodefense enterprise. In October 2022, the White House updated the National Biodefense Strategy. The new strategy changed the biodefense governance structure, underscoring the need for institutionalized leadership to assess, prevent, prepare for, respond to, and recover from biological threats.

Five National Biodefense Strategy Goals and Functions

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2. Biodefense Preparedness Activities Need Strengthening

Key federal agencies have developed response plans and conducted interagency exercises to prepare for and respond to biological threats. In 2021, GAO's analysis of these exercises—and the federal response to the COVID-19 pandemic and other incidents—revealed long-standing biodefense challenges. These included challenges in coordinating response capabilities, managing information, and in planning and conducting exercise efforts. GAO further found that there was no interagency process to assess and communicate exercise priorities, or monitor results from exercises and incidents.

➢ We recommended that key federal agencies take steps to address these gaps, including assessing exercise priorities and monitoring the results of exercises and incidents to identify patterns of challenges and root causes.

SARS-CoV-2 coronaviruses

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3. DHS Faces Biodefense Technology Challenges

The Department of Homeland Security (DHS)'s BioWatch program, begun in 2003, is designed to provide early indication of a biological weapons attack using a system of aerosol collectors and laboratory facilities. In 2021, GAO reported on DHS's effort to replace BioWatch with a new system. This project faces risks, such as the possibility of increased false alarm rates, due to technology limitations and uncertainties with combining technologies for use in biodetection. DHS plans to reduce risk using technology readiness assessments, but GAO found that DHS's guidance for these assessments lacked sufficient detail to ensure objectivity and independence, among other findings.

➢ We recommended that DHS conduct technology readiness assessments that follow our best practices before making acquisition decisions.

4. Challenges Exist with DHS's Biosurveillance Efforts

DHS's National Biosurveillance Integration Center (NBIC) integrates, analyzes, and distributes key information about health and disease events to help ensure the nation's responses are well informed, save lives, and minimize economic impact. However, in 2015, GAO found that NBIC faced several challenges that limited its ability to fulfill its mission, such as limited access to federal agency data and other coordination challenges.

➢ We presented Congress with several options to address NBIC's challenges, such as providing NBIC with additional authorities or assigning NBIC's mission to other agencies.

GAO has ongoing work reviewing NBIC and we plan to report its findings in fall 2023.

NBIC analysts review biosurveillance data

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Challenges and Opportunities

The COVID-19 pandemic has brought into sharp focus the shortcomings of the nation's current preparation to respond to a nationally significant biological incident. GAO identified actions that federal agencies could take to prepare for and respond to future biological incidents. As of March 2023, 21 of 29 recommendations made remain unimplemented. We continue to monitor agencies' progress in implementing these recommendations.

For more information, contact Christopher P. Currie at (404) 679-1875 or

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Biological warfareBiological weaponsBiosurveillanceFederal agenciesHomeland securityHealth carepandemicsFirst respondersInformation managementAerosols