Florida Medical Doctor Pleads Guilty to Conspiring to Falsify Clinical Trial Data

A Florida medical doctor pleaded guilty to conspiring to falsify clinical trial data regarding an asthma medication, the Department of Justice announced today.

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    In U.S GAO News
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    In U.S GAO News
    Most commercial aircraft undergo voluntary inspections to ensure that galleys and lavatories are constructed and assembled to meet the Food and Drug Administration's (FDA) sanitation standards, according to industry representatives. Twenty-seven percent of the inspections FDA conducted between fiscal years 2015 and 2019 found objectionable conditions. But in nearly all of these instances, the conditions identified, such as the need for additional sealant in areas where there was a gap or seam, were corrected by the airline or aircraft manufacturer during the inspection. However, some regional airline representatives told GAO that their aircraft do not receive these construction inspections, either because larger airlines with which they have contracts told them the inspections were unnecessary or because they did not believe the inspections were relevant to them. FDA provides these inspections free of charge, upon request of aircraft manufacturers or airlines, and aircraft passing inspection receive a certificate of sanitary construction. Representatives of one aircraft manufacturer said they view the certificate as beneficial because their customers see it as a guarantee that the aircraft was constructed in a way that decreases the likelihood of microbial contamination, pests, and insects. While the construction inspections are important, they are not required, and FDA does not proactively encourage airlines to request them. By developing a process for communicating directly to all U.S.-based commercial airlines, including regional airlines, to encourage them to receive construction inspections, FDA could better ensure that aircraft meet FDA sanitation standards to protect passenger health. An Airline Representative Applying Additional Sealant in Response to an FDA Inspection FDA faces several challenges in providing construction inspections and is taking steps to address these challenges. For example, the demand for inspections by manufacturers and airlines is unpredictable, and FDA inspectors are responsible for inspections at multiple locations. To help mitigate these challenges, officials we interviewed from four FDA field offices said they usually request advance notice from industry to allow the agency time to allocate the necessary resources for construction inspections. Voluntary construction inspections are the primary mechanism by which FDA oversees compliance with its required sanitation standards for the construction of aircraft galleys and lavatories. A report accompanying the House 2019 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill included a provision for GAO to review FDA's process for ensuring proper sanitation in aircraft galleys and lavatories. This report (1) examines the extent to which aircraft are inspected to ensure compliance with FDA's sanitation standards, and (2) discusses challenges FDA faces in providing aircraft inspections and how FDA is addressing such challenges. GAO reviewed FDA guidance, interviewed FDA officials in headquarters and four selected field offices with high volumes of construction inspections, conducted site visits to meet with FDA inspectors, and interviewed representatives of selected aircraft manufacturers and airlines. GAO recommends that FDA develop a process for communicating directly with all U.S.-based commercial airlines to encourage them to request construction inspections. FDA generally agreed with our recommendation. For more information, contact Steve Morris (202) 512-3841 MorrisS@gao.gov.
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    In U.S GAO News
    As of December 2019, at least 1,600 homes in Connecticut had confirmed pyrrhotite but the total number of affected homes is likely higher. According to one estimate, 4,000–6,000 more homes in Connecticut could develop crumbling foundations due to pyrrhotite. Affected homeowners may face total remediation costs of $150,000 or more and drops in property values of 25 percent or more. Connecticut established funding to provide homeowners with up to $175,000 towards the cost of foundation replacement, but affected homeowners are typically responsible for about one-third of total repair costs (which can include costs for replacing driveways and porches damaged during foundation replacement). Current funding is expected to assist 1,034 homeowners. Pyrrhotite Damage to a Basement and a Home Being Repaired Due to Pyrrhotite Damage GAO found that highly affected towns lost more than $1.6 million in tax revenue in 2018 due to lost assessment value of the houses affected by pyrrhotite, but town officials told us the losses have not yet significantly affected their budgets. However, officials were concerned that pyrrhotite could have long-term effects on their towns if the number of affected homes increased or homes were not remediated. GAO also found that homes located in highly affected towns and built when pyrrhotite-containing concrete was used sold for significantly less, on average, than similar homes in less-affected towns. Stakeholders told GAO that defaults and foreclosures related to pyrrhotite have been limited to date. Some federal funds have already been used for pyrrhotite testing and GAO identified eight additional federal programs that could be used to help mitigate financial impacts on homeowners. However, most of these programs have eligibility or funding restrictions that limit their potential for this purpose. Stakeholders with whom GAO spoke suggested other federal responses—in particular, declaring pyrrhotite damage a major disaster or establishing a federally backed insurance product. However, the Federal Emergency Management Agency determined that pyrrhotite damage did not qualify as a natural catastrophe, and a federally backed insurance program may not be feasible since it would serve a small population with high expected costs. Certain homes built in northeastern Connecticut and central Massachusetts between 1983 and 2015 have concrete foundations containing the mineral pyrrhotite. Pyrrhotite expands when it is exposed to water and oxygen and, over time, concrete foundations containing pyrrhotite may crack and crumble. The Explanatory Statement accompanying the Consolidated Appropriations Act, 2019 included a provision for GAO to study the financial impact of pyrrhotite. This report describes (1) what is known about the number of homes affected by pyrrhotite in the region; (2) the financial impact of pyrrhotite on homeowners; (3) the financial effects on towns, local housing markets, and the federal government; and (4) federal options to mitigate pyrrhotite's financial impact on affected homeowners. GAO analyzed data from state, local, and private entities about the extent of pyrrhotite in foundations and associated costs, and federal actions taken in response to pyrrhotite. GAO also interviewed federal, state, and local officials; homeowners; and other stakeholders such as banks and real estate agents. For more information, contact John Pendleton at (202) 512-8678 or pendletonj@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
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  • Department of Defense: Actions Needed to Improve Accounting of Intradepartmental Transactions
    In U.S GAO News
    The Department of Defense (DOD) has a long-standing material weakness related to intradepartmental transactions. Intradepartmental transactions occur when trading partners within the same department engage in business activities—such as the Department of the Army as a seller and the Department of the Navy as a buyer within DOD. As part of the standard process of preparing department-wide financial statements, intradepartmental transaction amounts are eliminated to avoid overstating accounts for DOD. For the fourth quarter of fiscal year 2019, DOD eliminated approximately $451 billion of net intradepartmental activity. Auditors continue to report a material weakness related to DOD's processes for recording and reconciling intradepartmental transaction amounts that are necessary to eliminate the transactions and prepare reliable consolidated financial statements. DOD has identified implementation of the Government Invoicing (G-Invoicing) system as its long-term solution to account for and support its intradepartmental activities. In fiscal year 2020, DOD issued a policy requiring all DOD components to use G-Invoicing's General Terms and Conditions (GT&C) functionality for initiating and approving GT&C agreements—a necessary step for using subsequent G-Invoicing functionalities (see figure). GAO found the use of this functionality varied among selected DOD components because of issues such as inconsistency in DOD policies and numerous changes to G-Invoicing system specifications. If DOD components do not implement the GT&C functionality, there is an increased risk of delay in full implementation of G-Invoicing to help remediate the intradepartmental eliminations material weakness. General Terms and Conditions Agreement Process in Government Invoicing Although DOD has identified G-Invoicing as its long-term solution, GAO found that DOD has not implemented an overall department-wide strategy to address its intradepartmental eliminations material weakness in the short term. Further, GAO found that while DOD issued a department-wide policy in May 2019 with new requirements for reconciling intradepartmental transactions, the Defense Finance and Accounting Service and selected DOD components have not updated their policies or implemented several of the new requirements. Without a short-term strategy that includes identifying the causes of issues and consistently implementing department-wide policies across DOD, DOD's efforts to resolve differences in intradepartmental transaction amounts—including its efforts in the long term—will likely be inefficient and ineffective. Since 1995, GAO has designated DOD financial management as high risk because of pervasive weaknesses in its financial management systems, controls, and reporting. DOD's long-standing intradepartmental eliminations material weakness reflects DOD's inability to adequately record and reconcile its intradepartmental transactions, and has affected DOD's ability to prepare auditable financial statements. GAO was asked to evaluate DOD's process for performing intradepartmental eliminations. This report examines the extent to which DOD has (1) identified and taken steps to address issues related to intradepartmental eliminations and (2) established and implemented policies and procedures related to intradepartmental eliminations. GAO interviewed DOD officials about intradepartmental eliminations processes and reviewed DOD policies and procedures to identify the extent to which procedures have been implemented to record and reconcile intradepartmental transactions. GAO is making five recommendations to DOD, including that DOD should (1) take actions to ensure that its components follow its policy for using G-Invoicing's GT&C functionality and (2) develop short-term solutions that address causes for trading partner differences before G-Invoicing is fully implemented. DOD agreed with all five recommendations and cited actions to address them. For more information, contact Kristen Kociolek at (202) 512-2989 or kociolekk@gao.gov.
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  • Unaccompanied Children: Actions Needed to Improve Grant Application Reviews and Oversight of Care Facilities
    In U.S GAO News
    The Office of Refugee Resettlement's (ORR) grant announcements soliciting care providers for unaccompanied children—those without lawful immigration status and without a parent or guardian in the U.S. available to provide care and physical custody for them—lack clarity about what state licensing information is required. Further, ORR does not systematically confirm the information submitted by applicants or document a review of their past performance on ORR grants, when applicable, according to GAO's analysis of ORR documents and interviews with ORR officials. The grant announcements do not specify how applicants without a state license should show license eligibility—a criterion for receiving an ORR grant—or specify what past licensing allegations and concerns they must report. In addition, the extent to which ORR staff verify applicants' licensing information is unclear. In fiscal years 2018 and 2019, ORR awarded grants to approximately 14 facilities that were unable to serve children for 12 or more months because they remained unlicensed. In addition, ORR did not provide any documentation that staff conducted a review of past performance for the nearly 70 percent of applicants that previously held ORR grants. Without addressing these issues, ORR risks awarding grants to organizations that cannot obtain a state license or that have a history of poor performance. State licensing agencies regularly monitor ORR-funded facilities, but according to GAO's survey of these agencies, their information sharing with ORR is limited (see figure). State licensing agencies and ORR staff both said that improved information sharing would benefit their monitoring of facilities. Without such improvements, ORR may lack information about ongoing issues at its facilities. Key Survey Responses on Information-Sharing with the Office of Refugee Resettlement (ORR) by the 23 State Agencies That Licensed ORR-Funded Facilities in Fall 2019 ORR requires grantees to take corrective action to address noncompliance it identifies through monitoring, but ORR has not met some of its monitoring goals or notified grantees of the need for corrective actions in a timely manner. For example, under ORR regulations, each facility is to be audited for compliance with standards to prevent and respond to sexual abuse and harassment of children by February 22, 2019, but by April 2020, only 67 of 133 facilities had been audited. In fiscal years 2018 and 2019, ORR also did not meet its policy goals to visit each facility at least every 2 years, or to submit a report to facilities on any corrective actions identified within 30 days of a visit. Without further action, ORR will continue to not meet its own monitoring goals, which are designed to ensure the safety and well-being of children in its care. ORR is responsible for the care and placement of unaccompanied children in its custody, which it provides through grants to state-licensed care provider facilities. ORR was appropriated $1.3 billion for this program in fiscal year 2020. GAO was asked to review ORR's grant making process and oversight of its grantees. This report examines (1) how ORR considers state licensing issues and past performance in its review of grant applications; (2) state licensing agencies' oversight of ORR grantees, and how ORR and states share information; and (3) how ORR addresses grantee noncompliance. GAO reviewed ORR grant announcements and applications for fiscal years 2018 and 2019. GAO conducted a survey of 29 state licensing agencies in states with ORR facilities, and reviewed ORR monitoring documentation and corrective action reports. GAO also reviewed ORR guidance and policies, as well as relevant federal laws and regulations, and interviewed ORR officials. GAO is making eight recommendations to ORR on improving clarity in its grant announcements, communication with state licensing agencies, and monitoring of its grantees. ORR agreed with all eight recommendations. For more information, contact Kathryn A. Larin at (202) 512-7215 or larink@gao.gov.
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    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.
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    In Crime News
    Doctor’s Choice Home Care, Inc. and its former owners, Timothy Beach and Stuart Christensen, have agreed to pay $5.15 million to resolve allegations that the home health agency provided improper financial inducements to referring physicians through sham medical director agreements and bonuses to physicians’ spouses who were Doctor’s Choice employees, the Department of Justice announced today. 
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  • Cyber Diplomacy: State Should Use Data and Evidence to Justify Its Proposal for a New Bureau of Cyberspace Security and Emerging Technologies
    In U.S GAO News
    The Department of State (State) did not demonstrate that it used data and evidence to develop its proposal for establishing a new Bureau of Cyberspace Security and Emerging Technologies (CSET). In response to GAO requests for such data and evidence, State provided GAO with briefing slides outlining different options for the new bureau and an action memo, approved by the Secretary of State. The memo recommended that CSET focus on cyberspace security and the security aspects of emerging technologies and report to the Under Secretary for Arms Control and International Security, while the Bureau of Economic and Business Affairs (EB) would continue to have responsibility for digital economy issues. However, State did not explain how it would address any challenges associated with the decision on CSET's organizational placement. For example, the memo did not address how State would coordinate internally on the cybersecurity aspects of digital economy policy issues with cyber diplomacy functions split between CSET and EB. The memo also did not specify how State would develop consolidated positions and set priorities for State's international cyberspace efforts, given the separation of these issues. Moreover, neither the briefing nor the action memo contained analyses supporting the additional details laid out in State's 2019 notification to Congress on CSET, including support for proposed resource allocations for the new bureau. Without developing data and evidence to support its proposal for the new bureau, State lacks assurance that its proposal will effectively set priorities and allocate appropriate resources for the bureau to achieve its intended goals. State needs to develop these areas further to better ensure the success of any new organizational arrangement. The United States and its allies are facing expanding foreign cyber threats as international trade, communication, and critical infrastructure become increasingly dependent on cyberspace. State leads U.S. government international efforts to advance the full range of U.S. interests in cyberspace. The Cyber Diplomacy Act of 2019 (H.R. 739, 116th Cong.), co-sponsored by 29 members of Congress, proposed the establishment of a new office within State that would have consolidated responsibility for digital economy and internet freedom issues, together with international cybersecurity issues. While the House Foreign Affairs Committee reported out this bill in March 2019, the full House of Representatives did not consider the bill prior to expiration of the 116th Congress. State subsequently notified Congress in June 2019 of its plan to establish CSET, with a narrower focus on cyberspace security and emerging technologies. On January 7, 2021, State announced that the Secretary had approved the creation of CSET and directed the department to move forward with establishing the bureau. However, as of the date of this report, State had not created CSET. GAO was asked to review State's efforts to advance U.S. interests in cyberspace. This report examines the extent to which State used data and evidence to develop and justify its proposal to establish CSET. GAO reviewed available documentation and interviewed State officials. To determine the extent to which State used data and evidence to develop and justify its proposal to establish CSET, GAO assessed State's documentation against a relevant key practice for agency reforms compiled in GAO's June 2018 report on government reorganization. The Secretary of State should ensure that State uses data and evidence to justify its current proposal, or any new proposal, to establish the Bureau of Cyberspace Security and Emerging Technologies to enable the bureau to effectively set priorities and allocate resources to achieve its goals. While State disagreed with GAO's characterization of its use of data and evidence to develop its proposal for CSET, it agreed that reviewing such information to evaluate program effectiveness can be useful. State commented that it has provided GAO with appropriate material on its decision to establish CSET and has not experienced challenges in coordinating cyberspace security policy across the department while the CSET proposal has been in discussion. State concluded that this provides assurance that CSET will allow the new bureau to effectively set priorities and allocate resources. The documents State provided in response to GAO's requests, including a set of briefing slides and an action memo to the Secretary, did not sufficiently demonstrate that it used data and evidence in developing its proposal. In addition, State's comment that it has not experienced coordination challenges in recent years is not sufficient evidence that the potential for such challenges does not exist. Without evidence to support the creation of the new bureau, State lacks needed assurance that the bureau will effectively set priorities and allocate appropriate resources to achieve its intended goals. For more information, contact Brian M. Mazanec at (202) 512-5130 or MazanecB@gao.gov, or Nick Marinos at (202) 512-9342 or MarinosN@gao.gov.
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  • Science & Tech Spotlight: Tracing the Source of Chemical Weapons
    In U.S GAO News
    Why This Matters Some governments are suspected of using chemical weapons despite international prohibitions under the Chemical Weapons Convention. For example, sarin and VX nerve gas have been identified in attacks. Most recently, Novichok nerve agent was used in 2020. Technologies exist to identify chemical warfare agents and possibly their sources, but challenges remain in identifying the person or entity responsible. The Technology What is it? According to the Global Public Policy Institute, there have been more than 330 chemical weapons attacks since 2012. Such attacks are prohibited under the Chemical Weapons Convention. A set of methods called forensic chemical attribution has the potential to trace the chemical agent used in such attacks to a source. A set of methods called forensic chemical attribution has the potential to trace the chemical agent used in such attacks to a source. For example, investigators could use these methods to identify the geographic sources of raw materials used to make the agent, for example, or to identify the manufacturing process Such information can aid leaders in deciding on whether or how to respond to a chemical weapons attack. Figure 1. Forensic chemical attribution process How does it work? Forensic chemical attribution is a three-step process, though the third step is being developed (see Fig. 1). First, a sample is taken from a victim or the site of an attack. Second, the sample's chemical components are analyzed and identified (see Fig. 2), either at a mobile lab or at one of 18 authorized biomedical labs worldwide. Common identification methods are: Gas chromatography, which separates chemical components of a mixture and quantifies the amount of each chemical. Mass spectrometry, which measures the mass-to-charge ratio of ions (i.e., charged particles) by converting molecules to ions and separating the ions based on their molecular weight. Nuclear magnetic resonance (NMR), which can determine the structure of a molecule by measuring the interaction between atomic nuclei placed in a magnetic field and exposing it to radio waves. NMR works on is the same principle as magnetic resonance imaging (MRI) used in medical diagnostics. In the third step—still under development—investigators use the data from the forensic chemical identification and analysis and identification methods from step two to develop a "chemical fingerprint." The fingerprint can be matched to a database of information on existing methods or known sources to identify chemical agents (i.e., Source A matching Sample 1 of Fig. 2). However, a comprehensive database containing complete, reliable data for known agents does not exist. How mature is it? Forensic chemical analysis and identification (i.e., Step 2 of Fig.1) is mature for known chemical agents. For example, investigators determined the nerve agent sarin was used in an attack on civilians in 2017. The methods can also identify new agents, as when investigators determined the chemical composition of the Novichok nerve agent after its first known use, in 2018. Forensic chemical analysis and identification methods are also mature enough to generate data that investigators could use as a "chemical fingerprint"– that is, a unique chemical signature that could be used in part to attribute a chemical weapon to a person or entity. For example, combining gas chromatography and mass spectrometry can provide reliable information about the chemical components and molecular weight of an agent. To achieve Step 3, scientists could use this these methods in a laboratory experiment to match impurities in chemical feedstocks of the weapon to potentially determine who made it. In an investigation, such impurities could indicate the geographic origin of the starting material and the process used to create the agent. Figure 2. Example of forensic chemical identification and analysis, showing a match between Sample 1 and Source A. Opportunities An effective international system for forensic chemical attribution can open up several opportunities, including: Defense. Knowing the source of a chemical agent could help nations better defend against future attacks and, when appropriate, take military action in response to an attack.  Legal response. Source attribution may provide information to help find and prosecute attackers or to impose sanctions. Deterrence. The ability to trace chemical agents to a source might deter future use of chemical weapons.  Challenges Chemical database. Creating a comprehensive international database of chemical fingerprints would require funding and international collaboration to sample chemicals from around the world. Finding perpetrators. Matching a chemical to its sources does not reveal who actually used it in an attack. Almost all investigations require additional evidence. Samples. Collecting a sufficient sample for attribution can be challenging, as can storing and transporting it using a secure chain of custody—potentially over great distance—to one of the 18 authorized biomedical labs worldwide. International cooperation. Lack of cooperation can delay investigations and may compromise sample quality.  Cooperation is also essential for creating an international database. Standardization. Attribution methods are complex and require standardized, internationally accepted protocols to ensure results are reliable and trusted. Such protocols do not yet exist for attributing a chemical weapons attack. Policy Context and Questions The following questions are relevant to building an effective, trusted system for tracing attacks using forensic chemical attribution: How can federal agencies promote and contribute to the international standardization of scientific methods for forensic chemical attribution? Which agency or agencies should lead this effort? How can the international community create and implement a framework for cooperation and trust in forensic chemical attribution? What actions could promote or incentivize creation of an internationally accepted database of unique chemical fingerprints for attributing chemical agents to their sources? What can be done to fully identify and address the scientific and technological gaps in current capabilities for attributing a chemical agent to its source? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov.
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  • Federalism: Opportunities Exist to Improve Coordination and Consultation with State and Local Governments
    In U.S GAO News
    Federal agencies' intergovernmental affairs activities advance agency objectives that require coordination with state and local governments. Most of the 24 Chief Financial Officers (CFO) Act agencies GAO surveyed reported undertaking similar information-sharing and coordination activities, such as serving as liaisons, conducting outreach, and hosting and attending events. The agencies GAO surveyed also reported taking varied approaches to structuring their intergovernmental affairs operations to conduct these activities. Of the 20 agencies with agency-wide intergovernmental affairs offices, half focused on intergovernmental affairs as their sole function while the other half included multiple functions, such as congressional or legislative affairs. How Agencies Organized Their Intergovernmental Affairs Operations Most agencies also reported that intergovernmental affairs activities and responsibilities were dispersed across their agencies. Regional and program offices perform intergovernmental affairs functions at some agencies, while others have an agency-wide office for them. Responsibilities for consulting with state and local governments under Executive Order (E.O.) 13132 also varied. The order requires that each federal agency designate an official to implement the order. Fourteen agencies reported having such an official; 10 did not report having one. Representatives from state and local associations GAO interviewed reported interacting with federal agency intergovernmental affairs offices for outreach and information-sharing purposes. They also cited coordination and consultation challenges, such as difficulty identifying intergovernmental affairs contacts, limited federal agency knowledge of state and local government, and inconsistent consultation on proposed regulations. The Office of Management and Budget (OMB) has primary responsibility for implementing E.O. 13132 and related implementation guidance, including a requirement for the designation of a federalism official. However, OMB could not identify any oversight steps it had taken to ensure federal agencies' designation of a federalism official consistent with its guidance for implementation of the executive order. Taking steps to ensure federal agencies' designation of a federalism official could help ensure that agencies have an accountable process in place for appropriately consulting with state and local governments. Federal programs fulfilling national goals in education, health care, transportation infrastructure, and homeland security, among other issues, are implemented through a complex partnership between federal, state, and local governments. E.O. 13132, Federalism, outlines principles and criteria to guide the formulation and implementation of policies and the appropriate division of responsibilities between levels of government. GAO was asked to review intergovernmental affairs activities at executive branch agencies. This report (1) identifies intergovernmental affairs offices' key responsibilities and activities at selected federal agencies and how these offices are organized, and (2) assesses state and local government officials' interaction with intergovernmental affairs offices, including their reported strengths and challenges. GAO examined relevant policies and executive orders and surveyed officials from the 24 CFO Act agencies. GAO also interviewed a nongeneralizable sample of individuals from 10 associations representing state and local government officials. GAO is recommending that OMB ensure that federal agencies implement its guidance on agency adherence to E.O. 13132 requirements, particularly related to designating a federalism official. OMB neither agreed nor disagreed with the recommendation. For more information, contact Michelle Sager at (202) 512-6806 or sagerm@gao.gov.
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  • Forced Labor Imports: DHS Increased Resources and Enforcement Efforts, but Needs to Improve Workforce Planning and Monitoring
    In U.S GAO News
    Since 2016, U.S. Customs and Border Protection (CBP), within the Department of Homeland Security (DHS), has increased its resources to enforce a prohibition on importing goods made with forced labor, but has not determined its workforce needs. CBP formed the Forced Labor Division in 2018 to lead its efforts, and increased expenditures for the division from roughly $1 million in fiscal year 2018 to $1.4 million in fiscal year 2019. However, CBP has not assessed and documented the staffing levels or skills needed for the Forced Labor Division. For example, the division suspended some ongoing investigations due to a staff shortage and has plans to expand and train its workforce; however, the division has not assessed the number, type, locations, or specialized skills of positions it needs to achieve programmatic results. Without assessing its workforce needs, the division lacks reasonable assurance that it has the right number of people, with the right skills, in the right places. CBP has increased forced labor investigations and civil enforcement actions, but managers lack complete and consistent data summarizing cases. CBP detained shipments under 13 Withhold Release Orders (WRO) from 2016 through 2019, as shown in the figure below. However, the Forced Labor Division uses incomplete and inconsistent summary data to monitor its investigations. For example, data were missing on the sources of evidence collected for almost all active cases. Incomplete and inconsistent summary data on the characteristics and status of cases may hinder managers' effective monitoring of case progress and enforcement efforts. Figure: U.S. Customs and Border Protection (CBP) Forced Labor Withhold Release Orders, 2016 through 2019 With regard to criminal violations, DHS's U.S. Immigration and Customs Enforcement (ICE) has increased its resources to investigate allegations of forced labor, including those related to U.S. imports. ICE coordinates criminal investigations of forced labor, conducted in the U.S. and abroad. ICE reported spending about $40 million on forced labor investigations in fiscal year 2019, an increase of over 50 percent since 2016. Forced labor investigations often involve a range of criminal violations, including violations that are not related to the importation of goods. As such, reported expenditures include costs for cases on related issues, such as human trafficking. Forced labor is a global problem in which individuals are exploited to perform labor or services. The International Labour Organization estimates that forced labor generates profits of $150 billion a year globally. CBP is responsible for enforcing Section 307 of the Tariff Act of 1930, which prohibits the importation of goods made with forced labor. CBP has authority to detain shipments when information indicates that forced labor produced the goods. ICE is responsible for investigating potential crimes related to forced labor, and importers may be subject to prosecution. GAO was asked to review the status of DHS resources for implementing the Section 307 prohibition on forced labor imports, following an amendment of the law in 2016. This report examines (1) the extent to which CBP assessed agency needs for the enforcement of the prohibition on forced labor imports, (2) the outcome of CBP enforcement activities and monitoring of such efforts, and (3) ICE resources for investigations on forced labor. GAO reviewed CBP and ICE documents and data, and interviewed agency officials. This is a public version of a sensitive report GAO issued in July 2020. Information that CBP deemed sensitive has been omitted. GAO is making three recommendations, including that CBP assess the workforce needs of the Forced Labor Division, and improve its forced labor summary case data. CBP concurred with all three recommendations. For more information, contact Kimberly Gianopoulos at (202) 512-8612 or gianopoulosk@gao.gov.
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