National Bio and Agro-defense Facility: DHS and USDA Are Working to Transfer Ownership and Prepare for Operations, but Critical Steps Remain

What GAO Found

The Department of Homeland Security (DHS) and U.S. Department of Agriculture (USDA) have taken steps to plan for and implement the successful transfer of the National Bio and Agro-Defense Facility (NBAF) from DHS to USDA for ownership and operation. (See figure.) The facility is to house state-of-the-art laboratories for research on foreign animal diseases—diseases not known to be present in the United States—that could infect U.S livestock and, in some cases, people. The departments’ steps are consistent with selected key practices for implementation of government reforms. In addition, USDA has taken steps to prepare for NBAF’s operation by identifying and addressing staffing needs; these steps are consistent with other selected key practices GAO examined for strategically managing the federal workforce during a government reorganization.

However, critical steps remain to implement the transfer of ownershp of NBAF to USDA and prepare for the facility’s operation, and some efforts have been delayed. Critical steps include obtaining approvals to work with high-consequence pathogens such as foot-and-mouth disease, and physically transferring pathogens to the facility. DHS estimates that construction of NBAF has been delayed by at least 2.5 months because of the effects of the COVID-19 pandemic. USDA officials stated that, until the full effects of delays to construction are known, USDA cannot fully assess the effects on its efforts to prepare for the facility’s operation. In addition, USDA’s planning efforts were delayed before the pandemic for the Biologics Development Module—a laboratory at NBAF intended to enhance and expedite the transition of vaccines and other countermeasures from research to commercial viability. A November 2018 schedule called for USDA to develop the business model and operating plan for the module in 2019. Officials stated in May 2020 that USDA intends to develop the business model and operating plan by fiscal year 2020’s end.

Construction Site of the National Bio and Agro-Defense Facility (NBAF) as of November 2019 and an Artist’s Rendering of NBAF When Complete

USDA’s efforts to date to collaborate with DHS and other key federal or industry stakeholders on NBAF have included

meeting regularly with DHS officials to define mission and research priorities,

developing written agreements with DHS about DHS’s roles and responsibilities before and after the transfer, and

collaborating with the intelligence community, as well as with relevant international research groups and global alliances, on an ongoing basis.

These efforts are consistent with selected key practices for interagency collaboration, such as including relevant participants and clarifying roles.

Why GAO Did This Study

Foreign animal diseases—some of which infect people—can pose threats to the United States. USDA and DHS have been developing NBAF to conduct research on and develop countermeasures (e.g., vaccines) for such diseases, as part of a national policy to defend U.S. agriculture against terrorist attacks and other emergencies. DHS is constructing NBAF in Manhattan, Kansas.

DHS originally assumed responsibility for owning and operating NBAF. However, USDA will carry out this responsibility instead, following an executive order from 2017 to improve efficiency of government programs. Construction is expected to cost about $1.25 billion.

GAO was asked to review issues related to development of NBAF and USDA’s plans for operating it. This report examines (1) efforts to transfer ownership of NBAF from DHS to USDA and to prepare for the facility’s operation and (2) USDA’s efforts to collaborate with stakeholders.

GAO reviewed DHS and USDA documents and interviewed key department officials and various stakeholders. GAO also compared the departments’ efforts on NBAF with selected key practices for government reforms and collaboration.

For more information, contact Steve D. Morris at (202) 512-3841 or morriss@gao.gov.

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    Based on Federal Aviation Administration (FAA) data and GAO estimates, most U.S. large commercial jet airplanes are certificated at the minimum required stage 3 noise standards, but nearly all of them are able to meet more stringent noise standards. Sixty-three percent of large commercial airplanes in the United States are certificated as meeting the stage 3 standards; however, 87 percent of them were manufactured with technologies that are able to meet more recent and stringent stage 4 or 5 standards as currently configured, according to FAA's 2017 analysis. By analyzing updated data from airlines and aviation manufacturers, GAO estimated that this proportion is even higher: 96 percent of large commercial airplanes are able to meet stage 4 or 5 standards (see figure). According to FAA officials and aviation stakeholders, the primary reason many large commercial airplanes certificated as stage 3 produce lower than stage 3 noise levels is because engine and airframe technology has outpaced the implementation of noise standards. More recently, some airlines have accelerated retirement of certain airplanes, some of which are certificated as stage 3, due to the decrease in travel amid the COVID-19 pandemic. For the generally smaller regional commercial jets (i.e., generally with less than 90 seats), 86 percent are able to meet stage 4 or stage 5 standards, according to manufacturers' data. With regard to general aviation (which are used for personal or corporate flights), 73 percent of the jet airplanes in that fleet are able to meet the more stringent stage 4 or 5 standards, according to manufacturers' data. GAO Estimate of The Number of Large Airplanes in the U.S. Commercial Fleet That Are Able to Meet Stage 3 or Stage 4 and 5 Noise Standards, January 2020 According to stakeholders GAO interviewed, a phase-out of jet airplanes that are certificated as meeting stage 3 standards would provide limited noise reduction and limited other benefits, and could be costly and present other challenges. A phase-out could require recertificating the vast majority of stage 3 airplanes to comply with stage 4 or 5 standards. This process could be costly for operators and manufacturers but would provide little reduction in noise. Further, airplanes currently unable to meet more stringent standards would require modifications or face retirement. For older airplanes that could not be recertificated to meet stage 4 or 5 standards, some operators could incur costs for replacement airplanes sooner than originally planned. Although stakeholders indicated that a phase-out would not substantially reduce noise, they identified other limited benefits newer airplanes generate, such as reduced greenhouse gas emissions and fuel consumption. Although advances in technology have led to quieter aircraft capable of meeting increasingly stringent noise standards, airport noise remains a concern. FAA regulates aircraft noise by ensuring compliance with relevant noise standards. In 1990, federal law required large jet airplanes to comply with stage 3 noise standards by 1999, leading to a phase-out of the noisiest airplanes (stage 1 and 2 airplanes). Later, federal law required smaller airplanes to comply with stage 3 standards by 2016. The FAA Reauthorization Act of 2018 included a provision for GAO to review a potential phase-out of stage 3 airplanes—the loudest aircraft currently operating in the United States. This report describes (1) the proportion of stage 3 airplanes in the U.S. fleet, and what proportion of these stage 3 airplanes are able to meet more stringent noise standards and (2) selected stakeholders' views on the potential benefits, costs, and challenges of phasing out stage 3 airplanes. GAO reviewed FAA's analysis of December 2017 fleet data, analyzed January 2020 fleet data from select airlines and airframe and engine manufacturers, and interviewed FAA officials. GAO also interviewed a non-generalizable sample of 35 stakeholders, including airlines; airframe and engine manufacturers; airports; and industry associations, selected based on fleet and noise data, stakeholder recommendations, or prior GAO knowledge. For more information, contact Heather Krause at (202) 512-2834 or krauseh@gao.gov.
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    Six men were charged in an indictment unsealed on Wednesday for their alleged participation in a nation-wide scheme to defraud dozens of businesses across the United States of luxury goods and services announced Acting Assistant Attorney General Brian C. Rabbitt of the Justice Department's Criminal Division and U.S. Attorney Andrew Lelling of the District of Massachusetts.
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  • Missile Defense: Observations on Ground-based Midcourse Defense Acquisition Challenges and Potential Contract Strategy Changes
    In U.S GAO News
    The Missile Defense Agency (MDA) is developing a system to defend the U.S. from long-range missile attacks. As MDA continues to develop this system, called Ground-based Midcourse Defense (GMD), it has opportunities to incorporate into its approach lessons learned from over 2 decades of system development. MDA has made progress in developing and fielding elements of the GMD system. For example, MDA is constructing a new missile field to expand the fleet of interceptors. However, MDA has also experienced significant setbacks. Most recently, the Department of Defense canceled development of a key GMD element, the Redesigned Kill Vehicle, in 2019 because of fundamental problems with the system's design. Ongoing Construction of a New Ground-based Midcourse Defense Interceptor Field (July 16, 2019) Over the years, GAO has identified practices that MDA could apply to the GMD program to improve acquisition outcomes, such as: Using knowledge-based acquisition practices Involving stakeholders early and often Providing effective oversight Promoting competition Performing robust testing GAO has also made numerous recommendations to improve MDA's acquisition outcomes and reduce risk. As of July 2020, the department has concurred with most of the recommendations GAO made since MDA's inception in 2002. Although the department has implemented many of the recommendations, it has further opportunities to implement the remaining open recommendations and apply lessons learned on a major, new effort to develop a next-generation GMD interceptor. Since the late 1990s, DOD has executed the GMD program through a prime contractor responsible for developing and integrating the entire weapon system. MDA is considering taking over these responsibilities for GMD for the next phase of the program. GAO found that this approach offers potential benefits to the agency, such as more direct control over and greater insight into GMD's cost, schedule, and performance. However, the approach has some challenges that, if not addressed, could outweigh the benefits. For example, MDA may encounter challenges obtaining the technical data and staffing levels necessary to manage this complex weapon system, which could ultimately affect its availability or readiness. As of October 2020, MDA has not yet determined an acquisition strategy for the next phase of the GMD program. The GMD system aims to defend the U.S. against ballistic missile attacks from rogue states like North Korea or Iran. DOD has been developing this system since the 1990s and has spent $53 billion on the system so far. GMD is a complex system that includes interceptors and a ground system, and MDA has largely relied on a contractor, Boeing, to manage development and system integration. MDA is considering moving away from this approach as the program embarks on developing a key element of the GMD, a new interceptor. The House Armed Services Committee included a provision in a report for GAO to assess the GMD contract structure and identify potential opportunities to improve government management and contractor accountability. This report addresses (1) the lessons learned from challenges MDA encountered acquiring the GMD system and (2) the potential benefits and risks of MDA taking over system integration responsibilities for GMD. To conduct this work, GAO reviewed GMD program documentation, prior GAO reports on missile defense, GAO interviews with other DOD components, and expert panel reviews of GMD. GAO also spoke with officials from MDA and other DOD components. GAO has 17 open recommendations aimed at improving missile defense acquisition outcomes and reducing risk. Recently, DOD has taken steps to address some of these open recommendations, but further action is needed to fully implement the remaining recommendations. For more information, contact W. William Russell at (202) 512-4841 or russellw@gao.gov.
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  • Public Health: Federal Programs Provide Screening and Treatment for Breast and Cervical Cancer
    In U.S GAO News
    The Centers for Disease Control and Prevention (CDC) operates the National Breast and Cervical Cancer Early Detection Program (the Early Detection Program) to provide cancer screening and diagnostic services to people who are low-income and uninsured or underinsured. For those screened under the program who require treatment, the Breast and Cervical Cancer Prevention and Treatment Act of 2000 (the Treatment Act) allows states to extend Medicaid eligibility to individuals not otherwise eligible for Medicaid. GAO analysis of CDC data show that the Early Detection Program screened 296,225 people in 2018, a decrease from 550,390 in 2011 (about 46 percent). The largest decrease occurred from 2013 to 2014 (see figure). According to a CDC-funded study, the number of people eligible for the Early Detection Program decreased from 2011 through 2017, by about 48 percent for breast cancer and about 49 percent for cervical cancer. CDC officials attributed these declines in screening and eligibility, in part, to improved access to screening under the Patient Protection and Affordable Care Act (PPACA). For example, PPACA required health plans to cover certain women's preventive health care with no cost sharing. Number of People Screened by CDC's Early Detection Program, 2011-2018 GAO analysis of Centers for Medicare & Medicaid Services' (CMS) data found that, in 2019, 43,549 people were enrolled in Medicaid under the Treatment Act to receive treatment for breast or cervical cancer, a decrease from 50,219 in 2016 (13.3 percent). Thirty-seven states experienced a decrease in Medicaid enrollment under the Treatment Act during this time period, 13 states experienced an increase, and one state had no change. CMS officials noted that Medicaid expansion to adults with incomes at or below 133 percent of the federal poverty level under PPACA (the new adult group) is a key factor that contributed to these enrollment trends. CMS officials said that, in Medicaid expansion states, there were some people who previously would have enrolled in Medicaid based on eligibility under the Treatment Act who instead became eligible for Medicaid in the new adult group. The CMS data show that total enrollment under the Treatment Act in Medicaid expansion states decreased by 25.6 percent from 2016 to 2019. In contrast, total enrollment under the Treatment Act in non-expansion states increased by about 1 percent during this time period. According to the CDC, tens of thousands of people die each year from breast or cervical cancer. Early screening and detection, followed by prompt treatment, can improve outcomes and, ultimately, save lives. Federal programs, like CDC's Early Detection Program, are intended to improve access to these services. GAO was asked to examine the implementation of the Early Detection Program and the states' use of Medicaid under the Treatment Act. This report provides information on the number of people who were 1) screened through the Early Detection Program and 2) enrolled in Medicaid under the Treatment Act. GAO analyzed CDC data on the number of people screened by the Early Detection Program from calendar years 2011 through 2018—the most recent available. GAO also analyzed CMS Medicaid enrollment data from 2016 through 2019—the most recent available. Additionally, GAO reviewed a 2020 study funded by CDC that examines the number of people eligible for the Early Detection Program from 2011 through 2017. Finally, GAO interviewed CDC and CMS officials and reviewed relevant CDC and CMS documents. For more information, contact John E. Dicken, (202) 512-7114, dickenj@gao.gov.
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  • Hanford Cleanup: DOE’s Efforts to Close Tank Farms Would Benefit from Clearer Legal Authorities and Communication
    In U.S GAO News
    The Department of Energy (DOE) has retrieved nuclear waste from all the tanks at C-farm—the first of 18 tank farms (i.e., groupings of tanks) at DOE's Hanford site in southeastern Washington State. The waste is a byproduct of decades of nuclear weapons production and research. DOE is obligated under agreements with the state's Department of Ecology (Ecology) and the U.S. Environmental Protection Agency to move waste from older, single-shell tanks to newer, more durable, double-shell tanks and ultimately to dispose of it. Example of a Tank and of Waste in a Tank at Hanford DOE intends to “close” the C-farm by leaving the nearly empty tanks in place and filling them with grout. However, DOE faces challenges, in part because this approach depends on: (1) DOE's determination under its directives that residual tank waste can be managed as a waste type other than high-level waste (HLW) and (2) Ecology's approval. DOE has started the determination process, but as GAO has previously found, DOE is likely to face a lawsuit because of questions about its legal authority. Ecology has raised concerns that the Nuclear Regulatory Commission (NRC) has not independently reviewed DOE's analysis for this determination. By Congress clarifying DOE's authority at Hanford to determine, with NRC involvement, that residual tank waste can be managed as a waste type other than HLW, DOE would be in a better position to move forward. Another challenge DOE faces in closing C-farm is how to address contaminated soil caused by leaks or discharges of waste from the tanks. DOE and Ecology officials do not agree on a process for evaluating contaminated soil at C-farm or on what role NRC should play in this process. They interpret their agreement differently, particularly regarding whether NRC must review DOE's analysis of contaminated soil. If the two parties cannot resolve this issue, Ecology may deny DOE a permit for C-farm closure. By using an independent mediator to help reach agreement with Ecology on how to assess soil contamination, including NRC's role, DOE would be better positioned to avoid future cleanup delays. DOE has not developed a long-term plan for tank-farm closure, in part, because a plan is not required. However, leading practices in program management call for long-term planning. In addition, DOE faces technical challenges that may take years to address as noted by representatives from various entities or tribal governments. For example, an internal DOE document states there is a 95 percent probability DOE will run out of space in its double shell tanks—space needed to continue retrieval operations. Planning for and building new tanks requires years of work. By developing a long-term plan, DOE could better prepare to address technical challenges. The Hanford site in Washington State contains about 54 million gallons of nuclear waste, which is stored in 177 underground storage tanks. In fiscal years 1997 through 2019, DOE spent over $10 billion to maintain Hanford's tanks and retrieve waste from them. DOE expects to spend at least $69 billion more on activities to retrieve tank waste and close tanks, according to a January 2019 DOE report. Senate Report 116-48, accompanying the National Defense Authorization Act for Fiscal Year 2020, included a provision for GAO to review the status of tank closures at Hanford. GAO's report examines the status of DOE's efforts to retrieve tank waste, challenges DOE faces in its effort to close the C-farm, as well as DOE's approach for closing the remaining tank farms. GAO toured the site; reviewed DOE documents, laws, and regulations; and interviewed officials and representatives from local, regional, and national entities and tribal governments. Congress should consider clarifying DOE's authority at Hanford to determine, with NRC involvement, whether residual tank waste can be managed as a waste type other than HLW. GAO is also making three recommendations, including that DOE (1) use an independent mediator to help reach agreement with Ecology on a process for assessing soil contamination, including NRC's role and (2) develop a long-term plan for its tank waste cleanup mission at Hanford. DOE concurred with all three recommendations. For more information, contact David C. Trimble at (202) 512-3841 or trimbled@gao.gov.
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  • Homelessness: Better HUD Oversight of Data Collection Could Improve Estimates of Homeless Population
    In U.S GAO News
    Data collected through the Point-in-Time (PIT) count—a count of people experiencing homelessness on a single night—have limitations for measuring homelessness. The PIT count is conducted each January by Continuums of Care (CoC)—local homelessness planning bodies that apply for grants from the Department of Housing and Urban Development (HUD) and coordinate homelessness services. The 2019 PIT count estimated that nearly 568,000 people (0.2 percent of the U.S. population) were homeless, a decline from the 2012 count of about 621,500 but a slight increase over the period's low of about 550,000 in 2016. While HUD has taken steps to improve data quality, the data likely underestimate the size of the homeless population because identifying people experiencing homelessness is inherently difficult. Some CoCs' total and unsheltered PIT counts have large year-over-year fluctuations, which raise questions about data accuracy. GAO found that HUD does not closely examine CoCs' methodologies for collecting data to ensure they meet HUD's standards. HUD's instructions to CoCs on probability sampling techniques to estimate homelessness were incomplete. Some CoC representatives also said that the assistance HUD provides on data collection does not always meet their needs. By strengthening its oversight and guidance in these areas, HUD could further improve the quality of homelessness data. To understand factors associated with homelessness in recent years, GAO used PIT count data to conduct an econometric analysis, which found that rental prices were associated with homelessness. To mitigate data limitations, GAO used data from years with improved data quality and took other analytical steps to increase confidence in the results. CoC representatives GAO interviewed also identified rental prices and other factors such as job loss as contributing to homelessness. Estimated Homelessness Rates and Household Median Rent in the 20 Largest Continuums of Care (CoC), 2018 Note: This map shows the 20 largest Point-in-Time counts by CoC in 2018. GAO estimated 2018 homelessness rates because the U.S. Census Bureau data used to calculate these rates were available up to 2018 at the time of analysis. GAO used 2017 median rents (in 2018 dollars) across all unit sizes and types. Policymakers have raised concerns about the extent to which recent increases in homelessness are associated with the availability of affordable housing. Moreover, counting the homeless population is a longstanding challenge. GAO was asked to review the current state of homelessness in the United States. This report examines (1) efforts to measure homelessness and HUD's oversight of these efforts and (2) factors associated with recent changes in homelessness. GAO analyzed three HUD data sources on homelessness and developed an econometric model of the factors influencing changes in homelessness. GAO also conducted structured interviews with 12 researchers and representatives of 21 CoCs and four focus groups with a total of 34 CoC representatives responsible for collecting and maintaining homelessness data. CoCs were selected for interviews and focus groups to achieve diversity in size and geography. GAO also visited three major cities that experienced recent increases in homelessness. GAO recommends that HUD (1) conduct quality checks on CoCs' data-collection methodologies, (2) improve its instructions for using probability sampling techniques to estimate homelessness, and (3) assess and enhance the assistance it provides to CoCs on data collection. HUD concurred with the recommendations. For more information, contact Alicia Puente Cackley at (202) 512-8678 or cackleya@gao.gov.
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  • Defense Health Care: Efforts to Ensure Beneficiaries Access Specialty Care and Receive Timely and Effective Care
    In U.S GAO News
    The Department of Defense (DOD) has a general expectation that its health care beneficiaries, upon receiving an urgent referral to see a specialist, will access that specialty care in 3 days or less. GAO's analysis of 16,754 urgent referrals at military treatment facilities (MTF) shows that DOD beneficiaries accessed specialty care services in 3 days or less for more than half of the urgent referrals. About 9 percent of the urgent referrals involved beneficiaries waiting 3 weeks or longer to be seen. According to DOD officials, some beneficiaries may have waited longer than 3 days due to factors such as patient preference, appointment availability, or waiting for lab results. Time to access care varied by specialty, with beneficiaries urgently referred to ophthalmology generally seeing a specialist the fastest, and those urgently referred to mental health and oncology generally waiting the longest. According to DOD officials, MTFs are responsible for monitoring beneficiaries' access to specialty care through urgent referrals. GAO found that the monitoring processes used varied by MTF and specialty care clinic at the five selected MTFs that GAO reviewed. For example, officials from one MTF told GAO they centrally manage all urgent referrals using a daily report to address any delays, while officials from another MTF told GAO that individual specialty care clinics are responsible for managing their own urgent referrals. DOD officials acknowledged such variation and MTFs have been directed to centralize their referral management and monitoring processes—an effort that is currently underway. GAO found that DOD monitors the rates at which beneficiaries receive timely and effective care, in part, through 10 outpatient health care quality measures. These measures allow DOD to make comparisons to civilian health care systems, and they are reviewed by various DOD groups at least quarterly. However, DOD officials told GAO that since October 2017, they have been unable to monitor nine of the 10 measures for MTFs using Military Health System (MHS) Genesis, DOD's new electronic health record system. According to the officials, DOD's current data warehouse—a system that stores some MHS Genesis data and can be used by MTFs to create reports on quality measures—is not capable of producing accurate reports for those measures. DOD officials told GAO they expect to implement a new data warehouse by the end of 2020. DOD officials also said they are importing data related to quality measures into another system used for quality monitoring; however, DOD does not have a targeted date for completing these data imports. Until these actions are fully implemented, groups responsible for monitoring quality care will continue to lack the data needed to offer assurance that the growing number of MTFs using MHS Genesis are providing beneficiaries with timely and effective care that will lead to better health outcomes. A draft of this report recommended that DOD establish a timeline to complete importing the quality measure-related data from MHS Genesis into DOD's system used for quality monitoring. In its review of the draft, DOD concurred with the recommendation and established a timeline for importing the data, to be available in DOD's system no later than May 2021. After reviewing the information DOD provided, GAO removed the recommendation from the final report. DOD is responsible for ensuring that beneficiaries have access to specialty care for conditions that, while not life-threatening, require immediate attention, as well as for ensuring that beneficiaries receive timely and effective care for certain routine or other services. A report accompanying the National Defense Authorization Act for Fiscal Year 2020 included a provision for GAO to review the quality of health care in the MHS. This report examines (1) the timeliness with which beneficiaries access specialty care at MTFs through urgent referrals and DOD's efforts to monitor access, and (2) DOD's use of quality measures to monitor and improve the rates of timely and effective care received by beneficiaries at MTFs. GAO examined relevant policies, national DOD referral data (a total of 16,754 urgent referrals) for a 1-year period ending August 2019, and the most recent available quality measure data (April 2020). GAO interviewed officials from five MTFs, selected for variation in military services, geography, provision of select specialty services, and use of the electronic health record system. For more information, contact Debra A. Draper at (202) 512-7114 or draperd@gao.gov.
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