Opportunities and Challenges with Early Implementation (GAO-20-483T)
Summary
GAO testimony, GAO-20-483T, before the Committee on Oversight and Reform of the House of Representatives, for release on March 11, 2020. It is the statement of Chris P. Currie, Director, Homeland Security and Justice, and Mary Denigan-Macauley, Director, Health Care, on GAO's work on the National Biodefense Strategy and its early implementation. The statement describes biological threats that are naturally occurring, intentional or accidental, including bioterrorism and safety and security lapses at facilities that house biological threat agents. It notes that as of March 5, 2020 COVID-19 had spread from China to nearly 80 countries, including the United States, which had over 150 cases.
Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used
Full text
United States Government Accountability Office
Testimony
Before the Committee on Oversight and
Reform, House of Representatives
NATIONAL BIODEFENSE
For Release on Delivery
Expected at 9:30 a.m. ET
March 11, 2020
STRATEGY
Opportunities and
Challenges with Early
Implementation
Statement of Chris P. Currie, Director,
Homeland Security and Justice
and
Mary Denigan-Macauley, Director,
Health Care
GAO-20-483T
Letter
Chairwoman Maloney, Ranking Member Jordan, and Members of the
Committee:
We are pleased to be here today to discuss our recently issued work on
the National Biodefense Strategy. 1 Catastrophic biological threats
highlight the inextricable link between security and public health
concerns. These threats—whether naturally-occurring, intentional, or
accidental—have the potential to cause loss of life and sustained damage
to the economy, societal stability, and global security. The vast and
evolving biological threat landscape includes threats of naturally-occurring
infectious diseases, bioterrorism, and safety and security lapses at
facilities that house biological threat agents. For example, the
unpredictable nature of naturally-occurring disease, such as the novel
coronavirus (COVID-19), poses a threat to humans. As of March 5, 2020,
COVID-19 has spread from China to nearly 80 countries, including the
United States, which has over 150 cases and nearly a dozen deaths
associated with the virus. This novel virus poses a public health and
economic threat, and may eventually be declared a pandemic, as seen
with severe acute respiratory syndrome (SARS) in 2003. Infectious
diseases, such as coronaviruses, can be transmissible from animals to
humans, demonstrating how our relationships with animals may increase
the risk of disease transmission among people, pets, livestock, and
wildlife.
Since March 2011, we have called for a more strategic approach to
guiding the systematic identification of risks, assessing resources needed
to address those risks, and prioritizing and allocating investments across
the biodefense enterprise. 2 At that time, we said the biodefense
enterprise would benefit from institutionalized leadership with sufficient
time, responsibility, authority, and resources needed to promote efficiency
and accountability. Similarly, so that leadership can help to ensure that
federal programs are well coordinated, and that gaps and duplication in
capabilities are avoided, we called for a strategy that would help ensure
1GAO, National Biodefense Strategy: Additional Efforts Would Enhance Likelihood of
Effective Implementation, GAO-20-273 (Washington, D.C.: Feb. 19, 2020).
2The nation’s biodefense capabilities consist of all efforts to counter biological threats,
reduce risks, and prepare for, respond to, and recover from biological incidents that could
have catastrophic consequences. GAO, Opportunities to Reduce Potential Duplication in
Government Programs, Save Tax Dollars, and Enhance Revenue, GAO-11-318SP
(Washington, D.C.: Mar. 1, 2011).
Page 1 GAO-20-483T National Biodefense Strategy
that plans and actions across various biodefense functions are cohesive,
compatible, and mutually reinforcing.
Signed into law in December 2016, the National Defense Authorization
Act for Fiscal Year 2017 (NDAA) required the departments of Defense
(DOD), Health and Human Services (HHS), Homeland Security (DHS),
and Agriculture (USDA) to jointly develop a national biodefense strategy
and associated implementation plan. 3 In September 2018, the White
House issued the National Biodefense Strategy (Strategy) and
characterized it as a new direction to protect the nation against biological
threats, stating that its implementation would promote a more efficient,
coordinated, and accountable biodefense enterprise. At the same time,
the President issued the Presidential Memorandum on the Support for
National Biodefense/National Security Presidential Memorandum-14
(NSPM-14), which details a governance structure and implementation
process to achieve the Strategy’s goals. For example, it established two
governing bodies: the Biodefense Steering Committee—chaired by the
Secretary of HHS—and the Biodefense Coordination Team to support the
efforts of the Steering Committee. 4
Our testimony today highlights key findings from our February 2020
report, which analyzed the extent to which the Strategy and related
implementation efforts are designed to allow an enterprise-wide
approach. 5 We made four recommendations to HHS in our report, aimed
at improving the Strategy’s implementation. HHS concurred with our
recommendations.
For our February 2020 report, we evaluated the early Strategy
implementation efforts of HHS, DOD, USDA, and DHS; the departments
of State, Justice (specifically the FBI), and Veterans Affairs (VA); and the
3 See Pub. L. No. 114-328, § 1086, 130 Stat. 2000, 2423 (2016) (codified at 6 U.S.C. §
104).
4The Biodefense Steering Committee is chaired by the Secretary of HHS and consists of
the Secretaries of DOD, USDA, DHS, and the Departments of State and Veterans Affairs
(VA); the Attorney General; and the Administrator of the Environmental Protection Agency
(EPA). The Biodefense Coordination Team members include representatives from: HHS
(including the Office of the Assistant Secretary for Preparedness and Response, the
Centers for Disease Control and Prevention, the National Institutes of Health, and the
Food and Drug Administration), DOD, DHS, EPA, USDA, Department of Justice (including
the FBI), Department of State, VA, the Office of the Director of National Intelligence, the
U.S. Agency for International Development, and the Departments of Commerce, Energy,
Treasury, Interior, Transportation, and Labor.
5GAO-20-273.
Page 2 GAO-20-483T National Biodefense Strategy
Environmental Protection Agency (EPA). We analyzed the Strategy and
associated plans, reviewed agency products created in response to
requirements set forth in NSPM-14, and solicited perspectives from key
officials in the eight agencies named above. More information on our
scope and methodology can be found in the report. The work on which
this statement is based was performed from October 2018 to February
2020 in accordance with generally accepted government auditing
standards.
We found that the National Biodefense Strategy and associated plans
The Biodefense bring together all the key elements of federal biodefense capabilities,
Strategy Provides which presents an opportunity to identify gaps and consider enterprise-
wide risk and resources for investment trade-off decisions. 6 However,
Opportunity to Create challenges with planning to manage change; limited guidance and
an Enterprise-Wide methods for analyzing capabilities; and lack of clarity about decision-
making processes, roles, and responsibilities while adapting to a new
Approach, but enterprise-wide approach could limit the success of the Strategy’s
Implementation implementation.
Challenges Remain
Framework Created to The National Biodefense Strategy and its associated plans bring together
Assess Enterprise-Wide the efforts of federal agencies with significant biodefense roles,
responsibilities, and resources to address naturally-occurring, accidental,
National Biodefense
and intentional threats. The Strategy and plans also provide processes for
Capabilities collecting and analyzing comprehensive information across the
enterprise, an important step toward the kind of enterprise-wide strategic
decision-making we have called for. The Strategy defines the term
“biothreat” broadly to include all sources of major catastrophic risk,
including naturally-occurring biological threats, the accidental release of
pathogens, and the deliberate use of biological weapons. Officials we
interviewed noted that this is the first time that the federal government
has identified activities across the whole biodefense enterprise and
assessed resources and gaps to address multiple sources of threat
regardless of source.
The Strategy also outlines high-level goals and objectives to help define
priorities. NSPM-14, which was issued to support the strategy,
6“Associated plans” refers to the implementation plan, which was included as Annex I in
the National Biodefense Strategy, and NSPM-14, which accompanied the release of the
Strategy and provides a governance structure to guide the Strategy’s implementation.
Page 3 GAO-20-483T National Biodefense Strategy
established a structure and process by which federal agencies can
assess enterprise-wide biodefense capabilities and needs, and
subsequently develop guidance to help inform agency budget
submissions. NSPM-14 lays out, in broad strokes, a process to identify
biodefense efforts and assess how current resources support the
Strategy, how existing programs and resources could better align with the
Strategy, and how additional resources, if available, could be applied to
support the goals of the Strategy. As shown in figure 1, this process
begins through a data call with participating agencies documenting all
biodefense programs, projects, and activities within their purview in a
biodefense memorandum.
Figure 1: Process to Identify and Assess Biodefense Activities to Inform Budget Submissions
a
National Security Presidential Memorandum-14 identifies the heads of these agencies as “Covered
Officials.”
b
National Security Presidential Memorandum-4, issued in 2017, describes the National Security
Council’s organization. It assigns the role of managing the development and implementation of
national security policies by multiple executive departments and agencies to policy coordination
committees. These committees are designed to provide policy analysis for consideration by the more
senior committees of the national security system and ensure timely responses to the President’s
decisions.
In interviews, officials from participating agencies stated that the NSPM-
14 processes constitute a new approach to identifying gaps and setting
budget priorities for biodefense, and that they viewed the approach as
generally well designed. Additionally, agency officials said that the
Page 4 GAO-20-483T National Biodefense Strategy
assessment and joint policy guidance development process outlined in
NSPM-14 offered some promise for helping agencies identify the
resources necessary to achieve the Strategy’s goals. Nevertheless,
officials from all of the agencies we interviewed, even those with the most
optimistic views on the leadership and governance structure design,
tempered their responses with the caveat that implementation is in such
early stages that it remains to be seen how effective these structures will
actually be once tested.
Implementation In our February 2020 report, we also identified challenges that if not
Challenges Remain addressed could hinder enterprise-wide biodefense efforts. Specifically,
although the Strategy and associated plans establish the foundation for
enterprise risk management, we and biodefense agency officials
identified multiple challenges that could affect the Strategy’s
implementation. 7 These include challenges individual agencies faced
during the initial data collection process as well as a lack of planning and
guidance to support an enterprise-wide approach. In our analyses and
interviews, we found that parts of the process in the first year were
underdeveloped, raising questions about (1) the plans to support change
management practices and ensure that early-implementation limitations
do not become institutionalized in future years’ efforts; (2) guidance and
methods for meaningfully analyzing the data; and (3) the clarity of
decision-making processes, roles, and responsibilities.
Challenges adapting to new procedures. During our interviews, agency
officials reported challenges they faced in the first-year’s data collection
effort. These challenges may have led to incomplete data collection, but
are not wholly unexpected given they occurred in the context of the
individual agencies and officials adapting to new procedures and a
broader cultural shift from how they have approached their biodefense
missions in the past. Officials told us that because of the learning involved
the first time through the process, agencies may not have submitted
complete or detailed information about their biodefense programs. Some
officials we interviewed voiced concern that this first-year effort could set
a poor precedent for these activities in future years if the challenges are
7Enterprise risk management is a strategy for helping policymakers make decisions about
assessing risks, allocating resources, and taking actions under conditions of uncertainty.
For some areas, like biodefense, where activities cut across multiple federal and
nonfederal entities, applying enterprise risk management principles becomes more
challenging, but equally important to help ensure the responsible parties can make
decisions that help to ensure effectiveness and maximize opportunities to better manage
risk.
Page 5 GAO-20-483T National Biodefense Strategy
not acknowledged and addressed. For example, an official noted that
committing to the first-year’s results as the “baseline” for future years of
the Strategy’s implementation could compound or institutionalize the
issues encountered in the first year. Officials from HHS and Office of
Management and Budget staff stressed that this process will be iterative,
with the first year being primarily about outlining the existing biodefense
landscape.
Our prior work on organizational transformations states that incorporating
change management practices improves the likelihood of successful
reforms and notes that it is important to recognize agency cultural factors
that can either help or inhibit reform efforts. 8 However, the agencies
involved in implementing the Strategy do not have a plan that includes
change management practices that can help prevent these challenges
from being carried forward into future efforts, and help reinforce
enterprise-wide approaches, among other things. To address this issue,
we recommended the Secretary of HHS direct the Biodefense
Coordination Team to establish a plan that includes change management
practices—such as strategies for feedback, communication, and
education—to reinforce collaborative behaviors and enterprise-wide
approaches and to help prevent early implementation challenges from
becoming institutionalized. HHS concurred with this recommendation.
Guidance and methods for analyzing data. We found a lack of clear
procedures and planning to help ensure that the Biodefense Coordination
Team is prepared to analyze the data, once it has been collected, in a
way that leads to recognition of meaningful opportunities to leverage
resources in efforts to maintain and advance national biodefence
capabilities. In particular, HHS (1) has not documented guidance and
methods for analyzing the data, including but not limited to methods and
guidance for how to account for the contribution of nonfederal capabilities;
and (2) does not have a resource plan for staffing and sustaining ongoing
efforts. Specifically, we found that the processes for the Biodefense
Coordination Team to analyze the results of all the individual agency data
submissions and identify priorities to guide resource allocation were not
agreed upon or documented prior to the agency efforts and continue to
lack specificity and transparency. In our interviews, officials from four
agencies said they were uncertain about fundamental elements of the
8GAO, Government Reorganization: Key Questions to Assess Agency Reform Efforts,
GAO-18-427 (Washington, D.C.: June 13, 2018) and Results-Oriented Cultures:
Implementation Steps to Assist Mergers and Organizational Transformations,
GAO-03-669 (Washington, D.C.: Jul. 2, 2003).
Page 6 GAO-20-483T National Biodefense Strategy
implementation process, including how information gathered will be used
to identify gaps and set priorities. Additionally, the initial effort to collect
information on all programs, projects, and activities focused on existing
federal activities and did not include a complete assessment of
biodefense capabilities at the nonfederal level ̶ capabilities needed to
achieve the goals and objectives outlined in the Strategy.
Officials we interviewed also expressed concern about the resources that
the Biodefense Coordination Team had available to it, both in the first
year and on an ongoing basis. The officials told us that not all agencies
were able to provide a full-time detailee to help support the team. We
have previously reported that agencies need to identify how interagency
groups will be funded and staffed. 9 However, officials from multiple
agencies told us that the initial planning for the staffing and
responsibilities for the Biodefense Coordination Team had not been
finalized. Without a plan to help ensure sufficient resources and mitigate
resource challenges for ongoing efforts, the Biodefense Coordination
Team risks not having the capacity it needs to conduct meaningful
analysis, which would undermine the vision created by the Strategy and
NSPM-14. To address these issues, we recommended the Secretary of
HHS direct the Biodefense Coordination Team to (1) clearly document
guidance and methods for analyzing the data collected from the agencies,
including ensuring that nonfederal resources and capabilities are
accounted for in the analysis, and (2) establish a resource plan to staff,
support, and sustain its ongoing efforts. HHS concurred with both
recommendations.
Roles and responsibilities for joint decision-making. The governing
bodies overseeing the National Biodefense Strategy’s implementation—
the Biodefense Steering Committee and Biodefense Coordination
Team—did not clearly document key components of the assessment
process and roles and responsibilities for joint decision-making in the first
year of NSPM-14 implementation. This raises questions about how these
bodies will move from an effort to catalog all existing activities to decision-
making that accounts for enterprise-wide needs and opportunities. For
example, officials from multiple agencies were not certain how the
governing bodies would make joint decisions regarding priority-setting
and the allocation of resources, how they would assign new biodefense
9GAO, Managing for Results: Implementation Approaches Used to Enhance Collaboration
in Interagency Groups, GAO-14-220 (Washington, D.C.: Feb. 14, 2014) and Managing for
Results: Key Considerations for Implementing Interagency Collaborative Mechanisms,
GAO-12-1022 (Washington, D.C.: Sept. 27, 2012).
Page 7 GAO-20-483T National Biodefense Strategy
responsibilities if gaps were identified, and to what extent the Biodefense
Steering Committee could enforce budgetary priorities, if at all.
We also found a lack of shared understanding and agreement about how
the interagency process would work to align resources toward any
identified gaps and reconfigure resources for any identified redundancies
or inefficiencies. Additionally, we found that Presidential memorandums
guiding the process did not detail specific decision-making principles or
steps for reaching consensus or even for raising decision points about
how to best leverage or direct resources across the enterprise in
response to any gaps or inefficiencies. Similarly, agency officials we
interviewed were not clear how this process would work, how decisions
would be made, or how agencies would agree to take on new
responsibilities to bridge gaps to achieve the Strategy’s goals.
Further, the governing bodies have not fully defined the roles and
responsibilities for making enterprise-wide decisions that affect individual
agency budgets and for enforcing enterprise-wide budget priorities. As
with other parts of the NSPM-14 implementation process, the details
regarding specific roles and responsibilities for directing and enforcing
budget decisions lack detail and specificity. Additionally, officials from four
agencies stated that the charter for the Biodefense Coordination Team
has not been finalized, further delaying the articulation of roles and
responsibilities and the ability to establish a shared agenda and common
operating picture. As a result, some officials remain skeptical of the
effectiveness of any decisions made.
We previously reported that effective national strategies should help
clarify implementing organizations’ relationships in terms of leading,
supporting, and partnering. 10 In the context of the Strategy, that includes
how enterprise-wide decisions about leveraging or directing resources to
fill gaps and reduce inefficiency will be made and by whom. Similarly, our
previous work has found that articulating and agreeing to a process for
making and enforcing decisions and clarifying roles and responsibilities
can improve the clarity surrounding a shared outcome, and that
articulating these agreements in formal documents can strengthen
agency commitment to working collaboratively and provide the overall
framework for accountability and oversight. 11 Uncertainty around the
10GAO, Combating Terrorism: Evaluation of Selected Characteristics in National
Strategies Related to Terrorism, GAO-04-408T (Washington, D.C.: Feb. 3, 2004).
11GAO-12-1022.
Page 8 GAO-20-483T National Biodefense Strategy
mechanisms to identify enterprise-wide priorities along with the lack of
clearly documented and agreed upon processes, roles, and
responsibilities for joint decision-making jeopardize the Strategy’s ability
to enhance efficiency and effectiveness of the nation’s biodefense
capabilities. To address this issue, we recommended that the Secretary
of HHS direct the Biodefense Coordination Team to clearly document
agreed upon processes, roles, and responsibilities for making and
enforcing enterprise-wide decisions. HHS concurred.
In conclusion, the current COVID-19 outbreak demonstrates that
responding to the ever-changing nature and broad array of biological
threats is challenging. The National Biodefense Strategy calls for the
need to improve state, local, tribal, territorial, private sector, federal,
regional, and international surveillance systems and networks to contain,
control and respond to biological incidents. As the current coronavirus
outbreak continues to cross regional and international borders, the federal
government must take necessary steps to protect the American public.
At the same time, we must not lose sight of the next threat. The National
Biodefense Strategy and NSPM-14 put in place a framework to be able to
assess threats and make difficult decisions about how to apply limited
resources to achieve the best benefit. However, the Strategy is only as
good as its implementation. Taking the necessary steps to address the
recommendations we have made regarding managing this cultural
change, analyzing data, ensuring sufficient resources to maintain
implementation efforts, and clearly articulating roles and responsibilities
for joint decision-making will better position our nation for the threats we
face today and in the future.
Chairwoman Maloney, Ranking Member Jordan, and Members of the
Committee, this concludes our prepared statement. We would be happy
to respond to any questions you may have at this time.
Page 9 GAO-20-483T National Biodefense Strategy
If you or your staff has any questions concerning this testimony, please
GAO Contact and contact Christopher P. Currie at (404) 679-1875, CurrieC@gao.gov or
Staff Mary Denigan-Macauley at (202) 512-7114,
DeniganMacauleyM@gao.gov. Contact points for our Offices of
Acknowledgments Congressional Relations and Public Affairs may be found on the last page
of this statement. Individuals making key contributions to this statement
include Kathryn Godfrey (Assistant Director), Susanna Kuebler (Analyst-
In-Charge), Michele Fejfar, Eric Hauswirth, Tracey King, and Jan
Montgomery. Key contributors for the previous work that this testimony is
based on are listed in each product.
(104141)
Page 10 GAO-20-483T National Biodefense Strategy
This is a work of the U.S. government and is not subject to copyright protection in the
United States. The published product may be reproduced and distributed in its entirety
without further permission from GAO. However, because this work may contain
copyrighted images or other material, permission from the copyright holder may be
necessary if you wish to reproduce this material separately.
The Government Accountability Office, the audit, evaluation, and investigative
GAO’s Mission arm of Congress, exists to support Congress in meeting its constitutional
responsibilities and to help improve the performance and accountability of the
federal government for the American people. GAO examines the use of public
funds; evaluates federal programs and policies; and provides analyses,
recommendations, and other assistance to help Congress make informed
oversight, policy, and funding decisions. GAO’s commitment to good government
is reflected in its core values of accountability, integrity, and reliability.
The fastest and easiest way to obtain copies of GAO documents at no cost is
Obtaining Copies of through our website. Each weekday afternoon, GAO posts on its website newly
GAO Reports and released reports, testimony, and correspondence. You can also subscribe to
GAO’s email updates to receive notification of newly posted products.
Testimony
Order by Phone The price of each GAO publication reflects GAO’s actual cost of production and
distribution and depends on the number of pages in the publication and whether
the publication is printed in color or black and white. Pricing and ordering
information is posted on GAO’s website, https://www.gao.gov/ordering.htm.
Place orders by calling (202) 512-6000, toll free (866) 801-7077, or
TDD (202) 512-2537.
Orders may be paid for using American Express, Discover Card, MasterCard,
Visa, check, or money order. Call for additional information.
Connect with GAO on Facebook, Flickr, Twitter, and YouTube.
Connect with GAO Subscribe to our RSS Feeds or Email Updates. Listen to our Podcasts.
Visit GAO on the web at https://www.gao.gov.
Contact FraudNet:
To Report Fraud,
Website: https://www.gao.gov/fraudnet/fraudnet.htm
Waste, and Abuse in
Automated answering system: (800) 424-5454 or (202) 512-7700
Federal Programs
Orice Williams Brown, Managing Director, WilliamsO@gao.gov, (202) 512-4400,
Congressional U.S. Government Accountability Office, 441 G Street NW, Room 7125,
Relations Washington, DC 20548
Chuck Young, Managing Director, youngc1@gao.gov, (202) 512-4800
Public Affairs U.S. Government Accountability Office, 441 G Street NW, Room 7149
Washington, DC 20548
James-Christian Blockwood, Managing Director, spel@gao.gov, (202) 512-4707
Strategic Planning and U.S. Government Accountability Office, 441 G Street NW, Room 7814,
External Liaison Washington, DC 20548
Please Print on Recycled Paper.
File and source
- File
- gao-20-483t.pdf
- Size
- 323,177 bytes
- SHA-256
- c1e9bfd5eee2bfdb04e53fd2ae9478868553c4fcb54e021459bfb0ddc097f7dd
- Our copy
- gao-20-483t.pdf
- Original
- www.gao.gov