January 20, 2022

News

News Network

Laboratory Safety: FDA Should Strengthen Efforts to Provide Effective Oversight

11 min read
<div>The Food and Drug Administration (FDA) has taken steps intended to improve safety at its laboratories, including those that work with hazardous biological agents. Specifically, FDA created the Office of Laboratory Safety (OLS) in 2017 as a safety oversight body for all FDA laboratories. Establishment of FDA's Office of Laboratory Safety (OLS) Note: Prior to March 2019, OLS was referred to as the Office of Laboratory Science and Safety. In coordination with FDA's operating divisions—known as centers—OLS has standardized safety policies, incident reporting, inspections, and safety training. However in creating OLS, FDA did not implement key reform practices that could have helped ensure OLS's effectiveness. For example, FDA's centers and OLS did not reach a shared understanding of OLS's roles and responsibilities—a key practice for effective agency reforms. Although senior agency leaders were involved in developing OLS's strategic plan, disagreements about OLS's role raised by center directors at that time still remain. For example, center directors told GAO that OLS's mission should not include science, laboratory quality management, or inspections. Conversely, the director of OLS said OLS remains committed to its mission as envisioned in the strategic plan, which includes these areas of responsibility. FDA officials said they plan to update the plan in 2021, which presents an opportunity for FDA to address areas of disagreement. In its current form, FDA's laboratory safety program also does not meet the key elements of effective oversight identified in GAO's prior work. For example, The oversight organization should have clear authority to ensure compliance with requirements. However, as part of a 2019 reorganization, FDA placed the OLS director at a lower level than the center directors. Also, OLS does not directly manage the center safety staff responsible for ensuring the implementation of safety policies that OLS develops. As a result, OLS has limited ability to access centers' laboratories—in part because they cannot inspect them unannounced—or to ensure compliance with safety policies. The oversight organization should also be independent from program offices to avoid conflict between program objectives and safety. However, OLS depends on the centers for much of its funding and has had to negotiate with the centers annually for those funds, which can allow center directors to influence OLS priorities through the funding amounts they approve. FDA has not assessed potential independence risks from using center funds for OLS. Without taking steps to do so, FDA's laboratory safety program will continue to compete with the centers' mission objectives and priorities. In 2014, FDA discovered improperly stored boxes of smallpox virus, posing a risk to individuals who might have been exposed. This raised concerns about the oversight of FDA's laboratories that conduct research on hazardous biological agents. In 2016, GAO made five recommendations to improve FDA's laboratory safety, four of which the Department of Health and Human Services (HHS) had not fully implemented as of July 2020. GAO was asked to examine FDA's efforts to strengthen laboratory safety. This report examines FDA's efforts since GAO's 2016 report to improve safety in its laboratories that work with hazardous biological agents. To conduct this work, GAO reviewed FDA documents; assessed FDA's safety oversight practices against key reform practices and oversight elements GAO identified in prior work; and interviewed FDA officials, including staff and senior leaders at OLS and the three centers that work with hazardous biological agents. GAO is making five recommendations to FDA, including to resolve disagreements over roles and responsibilities, to provide OLS with the authority and access to facilities necessary to oversee laboratory safety, and to take steps to assess and mitigate any independence risks posed by how OLS is funded. HHS agreed with all five recommendations. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov.</div>

What GAO Found

The Food and Drug Administration (FDA) has taken steps intended to improve safety at its laboratories, including those that work with hazardous biological agents. Specifically, FDA created the Office of Laboratory Safety (OLS) in 2017 as a safety oversight body for all FDA laboratories.

Establishment of FDA’s Office of Laboratory Safety (OLS)

Note: Prior to March 2019, OLS was referred to as the Office of Laboratory Science and Safety.

In coordination with FDA’s operating divisions—known as centers—OLS has standardized safety policies, incident reporting, inspections, and safety training. However in creating OLS, FDA did not implement key reform practices that could have helped ensure OLS’s effectiveness. For example, FDA’s centers and OLS did not reach a shared understanding of OLS’s roles and responsibilities—a key practice for effective agency reforms. Although senior agency leaders were involved in developing OLS’s strategic plan, disagreements about OLS’s role raised by center directors at that time still remain. For example, center directors told GAO that OLS’s mission should not include science, laboratory quality management, or inspections. Conversely, the director of OLS said OLS remains committed to its mission as envisioned in the strategic plan, which includes these areas of responsibility. FDA officials said they plan to update the plan in 2021, which presents an opportunity for FDA to address areas of disagreement.

In its current form, FDA’s laboratory safety program also does not meet the key elements of effective oversight identified in GAO’s prior work. For example,

  • The oversight organization should have clear authority to ensure compliance with requirements. However, as part of a 2019 reorganization, FDA placed the OLS director at a lower level than the center directors. Also, OLS does not directly manage the center safety staff responsible for ensuring the implementation of safety policies that OLS develops. As a result, OLS has limited ability to access centers’ laboratories—in part because they cannot inspect them unannounced—or to ensure compliance with safety policies.
  • The oversight organization should also be independent from program offices to avoid conflict between program objectives and safety. However, OLS depends on the centers for much of its funding and has had to negotiate with the centers annually for those funds, which can allow center directors to influence OLS priorities through the funding amounts they approve. FDA has not assessed potential independence risks from using center funds for OLS. Without taking steps to do so, FDA’s laboratory safety program will continue to compete with the centers’ mission objectives and priorities.

Why GAO Did This Study

In 2014, FDA discovered improperly stored boxes of smallpox virus, posing a risk to individuals who might have been exposed. This raised concerns about the oversight of FDA’s laboratories that conduct research on hazardous biological agents. In 2016, GAO made five recommendations to improve FDA’s laboratory safety, four of which the Department of Health and Human Services (HHS) had not fully implemented as of July 2020.

GAO was asked to examine FDA’s efforts to strengthen laboratory safety. This report examines FDA’s efforts since GAO’s 2016 report to improve safety in its laboratories that work with hazardous biological agents.

To conduct this work, GAO reviewed FDA documents; assessed FDA’s safety oversight practices against key reform practices and oversight elements GAO identified in prior work; and interviewed FDA officials, including staff and senior leaders at OLS and the three centers that work with hazardous biological agents.

What GAO Recommends

GAO is making five recommendations to FDA, including to resolve disagreements over roles and responsibilities, to provide OLS with the authority and access to facilities necessary to oversee laboratory safety, and to take steps to assess and mitigate any independence risks posed by how OLS is funded. HHS agreed with all five recommendations.

For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov.

News Network

  • Vermont Man Pleads Guilty to Hiring A Person to Kidnap and Kill an Individual in a Foreign Country and Child Pornography Charges
    In Crime News
    A Vermont man pleaded guilty today to hiring a woman in Venezuela to kidnap an adult male and make a video of the man being beaten, tortured, and suffocated to death, and to conspiracy to produce child pornography and possession of child pornography.
    [Read More…]
  • Hospice Administrator Sentenced for Role in Hospice Fraud Scheme
    In Crime News
    The administrator of a Southern California hospice was sentenced Thursday to 30 months in prison for his role in a multimillion dollar hospice fraud scheme.
    [Read More…]
  • Former Priest and ‘Shelter Home’ Operator Indicted for Illicit Sexual Conduct Against Minors
    In Crime News
    A federal grand jury in Washington, D.C., returned an indictment today charging a U.S. citizen and resident of Timor Leste with seven counts of engaging in illicit sexual conduct in a foreign place.
    [Read More…]
  • Honoring International Migrants Day
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • Briefing with Senior State Department Official on the Secretary’s Upcoming Travel to Jerusalem, Ramallah, Cairo, and Amman
    In Crime Control and Security News
    Office of the [Read More…]
  • Imposing Sanctions on CAR Militia Leader
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • Transit-Oriented Development: DOT Should Better Document Its Rationale for Financing Decisions and Evaluate Its Pilot Program
    In U.S GAO News
    What GAO Found Transit agencies and local governments have looked to increase transit ridership and revenues by encouraging growth along transit corridors with transit-oriented development. Such projects generally comprise mixed-use residential and commercial real estate near transit. In 2015, the Fixing America's Surface Transportation Act expanded eligibility under two federal financing programs administered by the Department of Transportation's (DOT) Build America Bureau (Bureau) to transit-oriented development projects. While the Bureau has provided information on these programs to many potential project sponsors, it has not approved financing for any transit-oriented development projects since 2016 or clearly documented all project eligibility decisions. Specifically, the Bureau received 29 inquiries from project sponsors—mostly joint ventures by developers and local agencies—about financing such projects. All but seven inquiries were in early stages of development and not ready for the Bureau to assess their eligibility for financial assistance. Of the seven more developed projects, the Bureau determined that six were ineligible for financing and that one project is preliminarily eligible. However, we found the Bureau did not clearly document its rationale for five of the six declared ineligible, in part because it did not follow its procedures for conducting these reviews and implemented new procedures without documenting the changes. Without a clearly documented rationale for eligibility decisions and procedures for making decisions, sponsors lack reasonable assurance that the Bureau is reviewing projects consistently. Transit-Oriented Development Project Inquiries to the Build America Bureau since 2016 The Federal Transit Administration (FTA) awards grants through a pilot program to help transit agencies and communities plan for transit-oriented development. While FTA has invested almost $80 million through this pilot program since FTA made its first awards in 2015, it has not documented a plan to evaluate the pilot or identify lessons learned in line with leading practices. Without such an evaluation, FTA will not be able to understand whether the pilot program is fulfilling its goals to help communities develop strategies to facilitate transit-oriented development. Further, FTA will lack information to inform congressional decisions about the pilot program's future. Why GAO Did This Study U.S. transit agencies face fiscal challenges and rely heavily on local, state, and federal funding to operate rail and bus systems. Transit-oriented development projects could help transit agencies increase ridership and revenues, and Congress has sought ways to support these projects. A 2012 statute established a pilot program for FTA to provide grants to communities to plan for transit-oriented development, and a 2015 statute expanded eligibility under the Transportation Infrastructure Finance and Innovation Act program and the Railroad Rehabilitation Improvement and Financing program to include transit-oriented development projects. GAO was asked to review DOT's transit-oriented development efforts. This report, among other things, examines: (1) the status of the Bureau's reviews of transit-oriented development projects since 2016 and the extent to which it documented decisions, and (2) how FTA has evaluated the pilot program for transit-oriented development planning. GAO reviewed Bureau documents, surveyed applicants for the Bureau's financing, and interviewed transit agencies in the pilot program selected by ridership, location, and other factors.
    [Read More…]
  • Just the Facts: Trends in Pro Se Civil Litigation from 2000 to 2019
    In U.S Courts
    Most federal pro se cases are civil actions filed by persons serving time in prison. Pro se prisoner petitions spiked in 2016 after a pair of Supreme Court rulings made it possible for certain prisoners to petition to have their sentences vacated or remanded. Non-prisoners who file pro se actions most often raise civil rights claims.
    [Read More…]
  • Sheriff of Franklin County, Arkansas Found Guilty of Assaulting Two Individuals in Custody
    In Crime News
    A federal jury convicted the Sheriff of Franklin County, Arkansas today on two counts of deprivation of rights under color of law.
    [Read More…]
  • Switzerland Travel Advisory
    In Travel
    Reconsider travel to [Read More…]
  • Grenada Travel Advisory
    In Travel
    Exercise increased [Read More…]
  • Issuance of New Executive Order Establishing Sanctions Related to the Crisis in Ethiopia
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • The United States and the Holy See: Promoting Religious Freedom and Defending Human Dignity
    In Crime Control and Security News
    Office of the [Read More…]
  • OCA Directorates
    In Travel
    OCA’s four [Read More…]
  • Law Enforcement: Federal Agencies Should Improve Reporting and Review of Less-Lethal Force
    In U.S GAO News
    What GAO Found Less-lethal force includes tactics and weapons that are neither likely nor intended to cause death or serious injury such as physical tactics, batons, chemical spray and munitions (e.g., pepper spray and tear gas), and kinetic impact munitions (e.g., rubber bullets). Most of the 10 federal agencies that GAO reviewed have less-lethal force policies that apply to demonstrations. All 10 agencies provide their personnel with less-lethal force training that varied by the agencies' mission. The agencies reported that they equip their personnel on various types of less-lethal force. Further, all 10 agencies have policies and training related to ensuring that their use of less-lethal force minimizes unintended injuries. Examples of Less-Lethal Force The Bureau of Prisons (BOP) is the only agency without a less-lethal force policy that applies to demonstrations. Its policy focuses exclusively on inmates in federal institutions. However, in recent years, BOP deployments beyond its institutions have occurred more often in response to civil disturbances and natural disasters. Updating its policy to address such situations will help ensure that their policy addresses all potential use of force situations facing its personnel. As shown in the photographs below, federal personnel responded to the demonstrations in Washington, D.C., and Portland, Oregon. Federal Personnel in Washington, D.C. (left), and Portland, Oregon (right) Eight of the 10 agencies used less-lethal force during the selected deployments. For those eight agencies, reporting requirements varied and reports often did not include basic information. Reporting requirements varied among agencies within the Departments of Homeland Security (DHS) and Justice (DOJ). This variance impairs departmental oversight. For example, while some agencies require personnel to report their use of a baton in all cases, others in the same department required doing so only if there were serious injury. Most agencies' less-lethal force reporting was missing information that would be useful for determining if the force was applied in accordance with agency policy. Specifically, reports from six agencies— Federal Protective Service, U.S. Customs and Border Protection, U.S. Immigration and Customs Enforcement (ICE), U.S. Secret Service (USSS), U.S. Marshals Service (USMS), and U.S. Park Police (USPP)—were missing basic information, such as time, location, type of munition used, or circumstances surrounding the use of force. For example, some reports provided a high-level summary of the day but did not identify which officers used force or the types of force each officer used. Further, DHS's oversight over the quality and consistency of use of force reporting was impaired because the department has not established a body to monitor use of force reporting across all of its component agencies, as required by DHS policy. All 10 agencies had processes to determine if less-lethal force was applied in accordance with agency policy, but some of the eight agencies that reported using less-lethal force during selected deployments did not explicitly document their determinations. Specifically, USMS, ICE, and USSS did not document if force was used in accordance with policy. Documenting such reviews will help ensure that they review all reportable uses of less-lethal force. The remaining five agencies that did document less-lethal force determinations—Federal Protective Service, U.S. Customs and Border Protection; BOP; Bureau of Alcohol, Tobacco, Firearms, and Explosives; and USPP—found that nearly all of their incidents were in accordance with policy. The remaining incidents were referred to the relevant Offices of the Inspector General or were pending further administrative actions as of July 2021. Demonstrators in Washington, D.C. (left), and Portland, Oregon (right) Several federal agencies deployed personnel to Washington, D.C., and Portland, Oregon, in response to the demonstrations. Washington, D.C. At least 12 federal agencies deployed, collectively, up to about 9,300 personnel per day in response to the demonstrations from May 26, 2020, through June 15, 2020. Of these, six agencies reported a total of over 120 less-lethal force incidents during this period, including physical tactics, batons, chemical spray, and chemical and kinetic impact munitions. Three of these agencies (BOP, USPP, and USSS) reported using force as part of the effort to clear Lafayette Square on June 1, 2020. Portland, Oregon. At least five federal agencies deployed, collectively, up to about 325 personnel per day in response to the demonstrations from June 26, 2020, through September 30, 2020. Four agencies reported a total of over 700 less-lethal force incidents during this period, including batons, chemical spray, chemical and kinetic impact munitions, diversionary devices, and electronic control devices. Why GAO Did This Study Federal agencies deployed personnel and used less lethal force during demonstrations in response to the death of Mr. George Floyd and others. Two of the largest deployments were in Washington, D.C., and Portland, Oregon. This report examines the extent to which federal agencies (1) developed policies, procedures, and training on the use of less-lethal force during demonstrations; (2) reported their use of such force during deployments to Washington, D.C., and Portland, Oregon; and (3) took action to review their use of less-lethal force for these deployments. GAO also presents information on the federal roles and activities during these deployments. To address these objectives, GAO identified 10 federal agencies that used less-lethal force or deployed large numbers of personnel in Washington, D.C., and Portland, Oregon, from May through September 2020. Specifically, GAO identified four agencies within DHS, four agencies within DOJ, the U.S. Park Police within the Interior, and the National Guard within the Department of Defense. GAO reviewed agency guidance on less-lethal force; analyzed use of force reports and determinations on whether the force was used in accordance with policy; and interviewed agency officials.
    [Read More…]
  • Secretary Michael R. Pompeo Briefing with the Traveling Press
    In Crime Control and Security News
    Michael R. Pompeo, [Read More…]
  • Defense Management: Opportunities Exist to Improve DOD’s Reform Efforts
    In U.S GAO News
    What GAO Found The Department of Defense (DOD) has long sought to reform its enterprise business operations—such as its processes to manage contracts, finances, and supply chain— but faces challenges in improving department-wide management. DOD has taken some actions to improve its business operations data, but remains limited by the lack of reliable cost data, affecting its ability to monitor and inform its reform efforts. Having reliable data to identify baseline costs of the department's business and management functions and to measure progress has been a key challenge facing DOD, but one the department is trying to address. As GAO reported in November 2020, DOD has made progress in setting baseline costs of certain activities, such as logistics and real estate management. Further, DOD has ongoing efforts to develop baselines for all of the department's enterprise business operations that should enable it to better monitor reform progress. However, DOD needs better data about how it performs its business functions. For example, in September 2018, GAO reported that DOD's efforts to reduce inefficiencies in human resources services were hampered by inconsistent performance data across the six organizations that provide these services. DOD has ongoing efforts to address GAO's recommendations. DOD still needs clear roles, responsibilities, authorities and dedicated resources to support reform. GAO has found that demonstrating sustained leadership commitment—including through ensuring that those responsible for leading change have clearly defined and documented roles, responsibilities, and authorities—is imperative for successful business transformation. GAO has assessed many of DOD's organizational structures over the decades, including the recently eliminated Chief Management Officer (CMO) position. GAO found that, while Congress had given the CMO both significant responsibilities and authorities, DOD had not resolved unanswered questions about how those authorities would be carried out, nor communicated the CMO's roles and responsibilities department-wide. GAO also identified instances where CMO reforms were hampered by a lack of resources. As DOD moves to an organization without the CMO position, which was eliminated in 2021, clarifying the roles and responsibilities of those tasked with managing business reform remains important. DOD could also improve its efforts to reliably demonstrate progress toward meaningful reform. DOD has reported achievements from some of its department-wide efforts, such as its reported $37 billion in savings from fiscal years 2017 to 2021. However, GAO reported in November 2020 that while DOD's reported savings were largely reflected in its budget materials, the underlying analyses were not always well documented and the savings were not always consistent with the department's definitions of reform. For example, one reform initiative was based on delaying military construction projects that, according to DOD officials, allowed DOD to fund higher priorities. If a delayed project is still planned, however, the costs will likely be realized in a future year and are not a reflection of business process reform. DOD concurred with GAO's recommendations to establish a process to standardize development and documentation of such cost savings, and ensure that reported savings are consistent with the department's definitions of reform. Why GAO Did This Study DOD spends billions of dollars each year to maintain key business operations and defense-wide agencies and programs intended to support the warfighter, including systems and processes related to the management of contracts, finances, the supply chain, support infrastructure, and weapon systems acquisition. The department's approach to transforming these business operations is linked to its ability to perform its overall mission, directly affecting the readiness and capabilities of U.S. military forces. This testimony summarizes GAO's past work related to DOD's efforts to improve the management of its business operations. Specifically, this testimony discusses DOD's efforts to (1) improve data and baselines to monitor and inform reform efforts; (2) establish clear roles, responsibilities, and authorities for leading reform efforts, and dedicate resources to these efforts; and (3) reliably demonstrate progress in its reform efforts. This statement is based on GAO's body of work issued from 2017 through 2020 on DOD management and business reform issues.
    [Read More…]
  • Employee of Government Contractor Pleads Guilty to Fraud and Kickback Charges
    In Crime News
    An employee of a government contractor pleaded guilty today to his involvement in a scheme to overbill a contract administered by the General Services Administration (GSA) by approximately $1.25 million, and solicit and receive kickbacks from a subcontractor in exchange for providing that subcontractor valuable contract modifications.
    [Read More…]
  • Social Security and Medicare: Improving the Timeliness of Trust Fund Reports
    In U.S GAO News
    What GAO Found Treasury took some steps to improve its management of the schedule for developing the Social Security and Medicare Trustees reports but the boards of trustees did not meet the statutory deadline of April 1 for the reports due in 2020 and 2021. In 2019, GAO issued two recommendations to try to improve the timeliness of the reports. Consistent with GAO's first recommendation in 2019, Treasury developed schedules for preparing the annual reports that included the planned and actual dates for meeting intermediate goals and the statutory deadline of April 1. Other than tracking the planned and actual dates of each reporting cycle, however, Treasury has not told GAO about any other steps it took to better manage the schedule, as GAO recommended. Therefore the recommendation has not been fully implemented. GAO also recommended that Treasury inform Congress of reporting delays. Treasury reported that the working group—agency officials involved in the preparation of the reports— established a policy in December 2020 to notify Congress if the trustees anticipate issuing the reports after the April 1 statutory deadline. The policy states that the chairperson will "assess the need to notify Congress of the reports' timing." The policy does not specify how they would make that assessment, nor does it mention including the reasons for the delay. A Treasury official stated that they did not interpret our recommendation to mean that the policy itself had to address communicating the reasons for delayed reports—only that those reasons be included in the information communicated to Congress. This policy does not fully address GAO's recommendation because it implies that notifying Congress should be discretionary and does not call for any explanation of the delays and updated timeframes. The policy should serve as a prompt for subsequent working groups to provide timely updates and address all of the information we recommended communicating to Congress. There are potential actions Treasury, in consultation with the boards of trustees, could take to help address GAO's prior recommendations. For example, Treasury, in its role as chairperson of the boards, could prioritize meeting the statutory deadline, review progress in developing the reports, obtain buy-in on timeliness goals from key officials, learn from past reporting cycles, and strengthen the policy to inform Congress of delays. In addition, the boards of trustees could amend their bylaws to state explicitly the goal of meeting the April 1 statutory deadline, and require that Congress be informed of report issuance delays, the reasons for delays, and the updated issuance date estimates. Finally, if Congress does not believe sufficient progress has been made to address GAO's recommendations, it could codify GAO's 2019 recommendations to Treasury with explicit requirements for reporting and communication. In commenting on a draft of this report, Treasury emphasized the unique circumstance and challenge that the COVID-19 pandemic presented to completing the modeling underlying the Trustees reports. They explained that the working group made a deliberate decision to take additional time to prepare the reports in order to accurately incorporate the effects of the pandemic and that this was necessary in order to ensure a high-quality report. Why GAO Did This Study Boards of trustees manage the trust funds that largely provide funding for benefits paid under the Social Security and Medicare programs. The Social Security Act requires the trustees to report on the trust funds' financial status to Congress each year by April 1. In 2019, GAO reported that the trustees issued the reports after this statutory deadline in 17 of the 25 years from 1995 to 2019, and were more than 2 months late in 6 years from 2010 to 2019. GAO's report recommended two actions to the Secretary of the Treasury, in their capacity as the chairperson of the boards. The first recommendation was that Treasury work with the other trustees, in consultation with the chief actuaries of Social Security and the Center for Medicare & Medicaid Services, to improve the management of the report development schedules in order to provide the Trustees reports to Congress by the April 1 statutory deadline. The second recommended that Treasury work with other trustees to establish a policy to inform congressional committees of jurisdiction when the reports are expected to miss this deadline; we recommended that this outreach include the factors contributing to the delay and the updated expected dates. Treasury concurred with these recommendations. GAO was asked about additional actions to better ensure the timely issuance of the Trustees reports, including considering changes to the trustees' bylaws and Congressional action. This report (1) describes Treasury's progress in addressing GAO's 2019 recommendations, and (2) offers potential actions, consistent with GAO's recommendations, that could help ensure timely completion of the Trustees reports. GAO reviewed the 2019 report, relevant documentation from the reporting cycles for the 2020 and 2021 Trustees reports, and information Treasury provided about actions it has taken to implement GAO's recommendations from the 2019 report. For more information, contact Elizabeth Curda at (202) 512-7215 or curdae@gao.gov.
    [Read More…]
  • Uranium Management: Actions to Mitigate Risks to Domestic Supply Chain Could Be Better Planned and Coordinated
    In U.S GAO News
    Federal agencies, including the Department of Energy (DOE) and the separately organized National Nuclear Security Administration (NNSA) within DOE, and uranium industry representatives have identified risks to the commercial supply chain for uranium needed for defense purposes. Such uranium may need to be mined domestically and enriched using U.S. technology to be free of obligations for the peaceful use of uranium and certain technology imported under international agreements. Identified risks to the unobligated uranium supply chain include (1) possible loss of domestic uranium mining capabilities and (2) possible challenges in re-starting the only facility in the United States for converting natural uranium into a form suitable for use in enrichment operations. Further, the U.S. has not had an operating enrichment capability that uses U.S. technology since 2013. Idle Domestic Plant for Converting Uranium to a Form Suitable for Enrichment DOE and NNSA have initiated actions officials believe will mitigate such risks to the unobligated uranium supply chain. For example, DOE and NNSA have both taken steps to reestablish a domestic enrichment capability with U.S. technology. In addition, DOE has proposed creation of a domestic uranium reserve to help support the domestic uranium mining and conversion industries until market conditions improve. DOE's fiscal year 2021 budget request includes $150 million for the reserve. However, we cannot conclude that the estimate is reasonable because it is unclear how the funding needs for the reserve were determined. By providing a more complete analysis to support future funding requests for the reserve, DOE could better provide assurance that such requests would achieve objectives. The Nuclear Fuel Working Group's strategy to mitigate risks to the domestic uranium industry does not fully incorporate all desirable characteristics GAO has identified for a national strategy. For example, it does not identify (1) the level of resources needed to support proposed actions or (2) an interagency coordinating mechanism. DOE is developing an implementation plan for the strategy, but DOE officials provided conflicting statements about the extent to which the agency will coordinate interagency implementation. NNSA has several defense needs for enriched uranium, including low-enriched uranium to produce tritium for nuclear weapons. To meet these needs, NNSA relies on commercial sectors of the domestic uranium industry, such as uranium mining or enrichment, which make up a supply chain for unobligated uranium. However, this industry faces commercial viability risks. In April 2020, the President's Nuclear Fuel Working Group released a strategy to mitigate risks to the domestic uranium industry. This working group includes DOE, the Department of Defense, and other agencies. Senate Report 115-262 included a provision that GAO review NNSA's planning for the future supply of unobligated enriched uranium. This report examines (1) risks agencies and others have identified to the unobligated uranium supply chain and agency actions to mitigate those risks, and (2) the extent to which the Nuclear Fuel Working Group's risk mitigation strategy incorporates desirable characteristics of a national strategy. GAO analyzed key NNSA and DOE planning documents and interviewed NNSA and other agency officials and industry representatives. GAO is making three recommendations, including that DOE improve its cost estimate to support future funding requests for the proposed uranium reserve and ensure its implementation plan for the strategy addresses each of the desirable characteristics of a national strategy. DOE concurred with GAO's recommendations. For more information, contact at (202) 512-3821 or bawdena@gao.gov.
    [Read More…]

Crime

Network News © 2005 Area.Control.Network™ All rights reserved.