Federal Rulemaking: Selected EPA and HHS Regulatory Analyses Met Several Best Practices, but CMS Should Take Steps to Strengthen Its Analyses

What GAO Found

GAO reviewed 11 Executive Order (EO) 13771 rules—five significant Environmental Protection Agency (EPA) rules and six economically significant Department of Health and Human Services (HHS) rules. Seven of the 11 rules modified (i.e. repealed, amended, or delayed) existing rules (see table). GAO found that analyses for most of the seven rules monetized the same types of benefits and costs as analyses for the rules they modified, an indicator of consistency in the regulatory analyses. For example, one EPA rule modified an earlier rule that had established requirements for chemical risk management programs. EPA monetized anticipated changes to industry compliance costs for both rules. Where agencies monetized similar types of benefits and costs for both reviewed rules and modified rules, the value of some estimates differed, in part, because agencies had updated analytical assumptions, such as the number of entities subject to requirements or relevant wage data.

Topics and Characteristics of 11 Environmental Protection Agency (EPA) and Department of Health and Human Services (HHS) Rules Selected for Review

Agency

Topics

Modified existing rule(s)

Monetized costs exceeded benefits

EPA

Risk management programs

 

Railroad ties as non-waste fuels

 

Chemical data reporting

 

Mercury reporting

 

Effluent from dental offices

HHS, FDA

Food labeling

 

Agricultural water requirements

HHS, CMS

End-stage renal disease treatment

 

Home health quality reporting

 

Patient discharge planning

 

Diabetes prevention and appropriate use of imaging services

Legend: ● = Yes; ○ = No

Source: GAO analysis of EPA, Food and Drug Administration (FDA), and Centers for Medicare & Medicaid Services (CMS) data. | GAO-21-151

Regulatory analyses for eight of the 11 rules GAO reviewed projected that monetized costs would exceed monetized benefits, though each identified other factors that may have led decision makers to determine that the total benefits justified the total costs, such as important, non-quantified effects. These eight analyses met about half of the selected best practices for economic analysis. However, some analyses developed by HHS’s Centers for Medicare & Medicaid Services (CMS) did not fully meet best practices associated with analyzing regulatory alternatives, assessing important effects, and providing transparency. It is particularly important that agencies develop quality analyses for economically significant rules, such as those finalized by CMS. By meeting these best practices, CMS could help the public and other parts of government provide effective feedback and mitigate potential conflict with entities affected by rules. It could also help CMS assess whether a rule’s benefits justify the costs.

Why GAO Did This Study

EO 13771 generally requires executive agencies to identify two rules for repeal for each new rule issued. Since EO 13771 went into effect in 2017, executive agencies have taken regulatory actions expected to generate over $50 billion in savings to society. Quality regulatory analysis provides agency decision makers and the public with a thorough assessment of the benefits and costs of different regulatory options.

GAO was asked to review regulatory analyses for rules finalized under EO 13771. For selected agencies, this report examines (1) how the calculated economic effects of selected rules differed, if at all, from those of rules they modified; and (2) the extent to which agencies met best practices in analyzing the economic effects of selected rules for which monetized costs exceed monetized benefits.

GAO reviewed analyses for 11 rules—and the rules they modified— finalized by EPA and HHS, the two agencies that finalized the most economically significant EO 13771 rules through fiscal year 2019. GAO compared analyses to selected best practices in GAO’s Assessment Methodology for Economic Analysis .

What GAO Recommends

GAO recommends that CMS take steps to ensure its future regulatory analyses are consistent with best practices for analyzing alternatives, assessing important effects, and providing transparency. EPA said it appreciated GAO’s findings. HHS generally agreed with the report, and CMS agreed with the recommendation directed to it.

For more information, contact Yvonne D. Jones at (202) 512-6806 or jonesy@gao.gov.

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    Good morning and thank you for that kind introduction. It is an honor to be here with you today, even if only virtually. Just a year ago, addressing a conference of this size and importance via video would have seemed unthinkable. Today, it is — unfortunately — normal. I look forward to the time — hopefully, soon — when we can gather again in person. In the meantime, I am grateful for this opportunity to speak with you, and I look forward to my discussion with Kim after my remarks conclude.
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  • Construction Company Owners Pleaded Guilty to Defrauding Federal Program Intended for Service-Disabled Veteran-Owned Small Businesses
    In Crime News
    Two Texas construction company owners have pleaded guilty in a long-running scheme to defraud the United States.
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  • Virginia Man Pleads Guilty to Enticement, Child Pornography Charges
    In Crime News
    A Virginia man who used an online chat website to engage in sexually explicit conversations with a 12-year-old minor female and later induced the victim to engage in sexually explicit behavior over video chat, pleaded guilty today in U.S. District Court in the Western District of Virginia to a pair of federal charges, announced Acting Assistant Attorney General Brian C. Rabbitt of the Justice Department’s Criminal Division and U.S. Attorney Thomas T. Cullen for the Western District of Virginia.
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  • Michigan Based Wire Fraud Conspiracy and Tax Offenses Charged
    In Crime News
    A federal grand jury in Detroit, Michigan, returned an indictment today charging Michigan businessmen John Angelo from Royal Oak, Cory Justin Mann from West Bloomfield, Michael Daneshvar from Bingham Farms, Glenn Franklin from Harrison Township, and Brent Sitto, from Bloomfield Township with one count each of conspiracy to commit wire fraud and further charging John Angelo and bookkeeper Rosina Angelo, also known as Rosina Caruvana, from Mountainside, New Jersey, with one count of conspiracy to defraud the IRS. John Angelo and Rosina Angelo were also each charged with three counts of aiding in the preparation of a false tax return and Cory Mann was charged with two additional counts of aiding in the preparation of a false tax return.
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  • Troubled Asset Relief Program: Treasury Continues Winding Down Housing Programs
    In U.S GAO News
    The Department of the Treasury (Treasury) continues to wind down housing assistance programs funded by the Troubled Asset Relief Program (TARP). Treasury has extended one program to assist certain program participants who have been affected by the COVID-19 pandemic, although limited program funds remain at this point. As of September 30, 2020, Treasury had disbursed $30.85 billion (95 percent) of the $32.56 billion TARP funds obligated to the three housing programs (see figure). The Making Home Affordable program allowed homeowners to apply for loan modifications to avoid foreclosure. Treasury will continue to provide incentive payments for loan modifications through 2023. The Housing Finance Agency Innovation Fund for the Hardest Hit Housing Markets provided funds to 18 states and the District of Columbia to help struggling homeowners through programs tailored to the state. Treasury extended this program through June 2021 because of the COVID-19 pandemic's negative economic effects on some program participants. The Federal Housing Administration (FHA) Short Refinance program allowed eligible homeowners to refinance into an FHA-insured loan. Under this program, Treasury made TARP funds available to provide additional coverage to lenders for a share of potential losses on these loans for borrowers who entered the program by December 31, 2016. Status of Troubled Asset Relief Program Housing Programs, as of September 2020 aAccording to the Department of the Treasury (Treasury), these funds have been committed to future financial incentives for existing Making Home Affordable transactions, as of September 30, 2020. bRepresents the amount of funds that states and the District of Columbia have drawn from Treasury. cIncludes about $11.6 million in administrative expenses and $10 million of reserve funds, as of September 30, 2020. Treasury will be reimbursed for unused reserve amounts. dAmounts do not add up due to rounding. In response to the 2008 housing crisis, Treasury established TARP-funded housing programs to help struggling homeowners avoid foreclosure and preserve homeownership. Since 2009, Treasury has obligated $32.56 billion for such housing programs. The Emergency Economic Stabilization Act of 2008 provided GAO with broad oversight authorities for actions taken related to TARP. This report provides an update on the status of TARP-funded housing programs, as of September 30, 2020. GAO reviewed Treasury program data and documentation, and interviewed Treasury officials. This report contains the most recently available public data at the time of GAO's review, including obligations, disbursements, and program participation. For more information, contact John H. Pendleton at (202) 512-8678 or pendletonj@gao.gov.
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  • Imposter Nurse Sentenced to Prison for Fraud and Tax Evasion
    In Crime News
    A nurse formerly employed by an Ann Arbor, Michigan, health care consultancy was sentenced to 65 months in prison for defrauding employers of over $2.2 million and evading more than $697,000 in taxes, announced Principal Deputy Assistant Attorney General Richard E. Zuckerman of the Justice Department’s Tax Division and U.S. Attorney Matthew J. Schneider for the Eastern District of Michigan.
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  • Defense Reform: DOD Has Made Progress, but Needs to Further Refine and Formalize Its Reform Efforts
    In U.S GAO News
    The Department of Defense (DOD) has made progress in establishing valid and reliable cost baselines for its enterprise business operations and has additional efforts ongoing. DOD's January 2020 report responding to section 921 of the John S. McCain National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2019 addressed most of the key requirements from that section but also had some limitations, which DOD acknowledged. For example, the baselines included only labor and information technology costs because DOD's financial data do not attribute costs to other specific activities required under section 921. However, DOD officials told GAO they have developed and are continuing to refine baselines for all of the department's enterprise business operations, such as financial and human resource management, to enable DOD to better track the resources devoted to these operations and the progress of reform. While still in progress, this effort shows promise in addressing the weaknesses in DOD's section 921 report and in meeting the need for consistent baselines for DOD's reform efforts that GAO has previously identified. GAO found that DOD's reported savings of $37 billion from its reform efforts and a Defense-Wide Review to better align resources are largely reflected in its budget materials; however, the savings were not always well documented or consistent with the department's definitions of reform. Specifically: DOD had limited information on the analysis underlying its savings estimates, including (1) economic assumptions, (2) alternative options, and (3) any costs of taking the actions to realize savings, such as opportunity costs. Therefore, GAO was unable to determine the quality of the analysis that led to DOD's savings decisions. Further, some of the cost savings initiatives were not clearly aligned with DOD's definitions of reform, and thus DOD may have overstated savings that came from its reform efforts rather than other sources of savings, like cost avoidance. For example, one initiative was based on the delay of military construction projects. According to DOD officials, this was done to fund higher priorities. But if a delayed project is still planned, the costs will likely be realized in a future year. Without processes to standardize development and documentation of savings and to consistently identify reform savings based on reform definitions, decision makers may lack reliable information on DOD's estimated reform savings. In coordinating its reform efforts, DOD has generally followed leading practices for collaboration, but there is a risk that this collaboration may not be sustained in light of any organizational changes that Congress or DOD may make. This risk is increased because the Office of the Chief Management Officer (OCMO) and other offices have not formalized and institutionalized these efforts through written policies or agreements. Without written policies or formal agreements that define how organizations should collaborate with regard to DOD's reform and efficiency efforts, current progress may be lost, and future coordination efforts may be hindered. DOD spends billions of dollars each year to maintain key business operations. Section 921 of the NDAA for FY 2019 established requirements for DOD to reform these operations and report on their efforts. DOD has also undertaken additional efforts to reform its operations in recent years. Section 921 called for GAO to assess the accuracy of DOD's reported cost baselines and savings, and section 1753 of the NDAA for FY 2020 called for GAO to report on the OCMO's efficiency initiatives. This report assesses the extent to which DOD has (1) established valid and reliable baseline cost estimates for its business operations; (2) established well-documented cost savings estimates reflecting its reforms; and (3) coordinated its reform efforts. GAO assessed documents supporting costs, savings estimates, and coordination efforts; interviewed DOD officials; observed demonstrations of DOD's reform tracking tools; and assessed DOD's efforts using selected criteria. GAO is making three recommendations—specifically, that DOD establish formal processes to standardize development and documentation of cost savings; ensure that reported savings are consistent with the department's definition of reform; and formalize policies or agreements on its reform efforts. DOD concurred with GAO's recommendations. For more information, contact Elizabeth Field at (202) 512-2775 or fielde1@gao.gov.
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  • Michigan Man Pleads Guilty to Conspiring to Defraud the IRS and to Steal Crash Reports from the Detroit Police Department
    In Crime News
    A Birmingham, Michigan, resident pleaded guilty today to conspiring to defraud the IRS and to steal from an organization receiving federal funds, announced Acting Deputy Assistant Attorney General Stuart M. Goldberg of the Justice Department’s Tax Division.
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  • Facial Recognition: CBP and TSA are Taking Steps to Implement Programs, but CBP Should Address Privacy and System Performance Issues
    In U.S GAO News
    U.S. Customs and Border Protection (CBP) has made progress testing and deploying facial recognition technology (FRT) at ports of entry to create entry-exit records for foreign nationals as part of its Biometric Entry-Exit Program. As of May 2020, CBP, in partnership with airlines, had deployed FRT to 27 airports to biometrically confirm travelers' identities as they depart the United States (air exit) and was in the early stages of assessing FRT at sea and land ports of entry. Facial Recognition Technology in Use at an Airport CBP has taken steps to incorporate some privacy principles in its program, such as publishing the legislative authorities used to implement its program, but has not consistently provided complete information in privacy notices or ensured notices were posted and visible to travelers. Ensuring that privacy notices contain complete information and are consistently available would help give travelers the opportunity to decline to participate, if appropriate. Further, CBP requires its commercial partners, such as airlines, to follow CBP's privacy requirements and can audit partners to assess compliance. However, as of May 2020, CBP had audited only one of its more than 20 airline partners and did not have a plan to ensure all partners are audited. Until CBP develops and implements an audit plan, it cannot ensure that traveler information is appropriately safeguarded. CBP has assessed the accuracy and performance of air exit FRT capabilities through operational testing. Testing found that air exit exceeded its accuracy goals—for example, identifying over 90 percent of travelers correctly—but did not meet a performance goal to capture 97 percent of traveler photos because airlines did not consistently photograph all travelers. A plan to improve the photo capture rate would help CBP better fulfill the program's mission of creating biometrically confirmed traveler departure records. Further, while CBP monitors air exit's performance, officials are not alerted when performance falls short of minimum requirements. The Transportation Security Administration (TSA) has conducted pilot tests to assess the feasibility of using FRT but, given the limited nature of these tests, it is too early to fully assess TSA's compliance with privacy protection principles. Within the Department of Homeland Security (DHS), CBP is charged with the dual mission of facilitating legitimate travel and securing U.S. borders, and TSA is responsible for protecting the nation's transportation system. For both CBP and TSA, part of their inspection and screening responsibilities includes reviewing travel identification documents and verifying traveler identities. Beginning in 1996, a series of federal laws were enacted to develop and implement an entry-exit data system, which is to integrate biographic and, since 2004, biometric records for foreign nationals. This report addresses (1) the status of CBP's deployment of FRT, (2) the extent to which CBP has incorporated privacy protection principles, (3) the extent to which CBP has assessed the accuracy and performance of its FRT, and (4) the status of TSA's testing and deployment of FRT and how TSA has incorporated privacy protection principles. GAO conducted site visits to observe CBP's and TSA's use of FRT, which were selected to include all three travel environments—air, land, and sea; reviewed program documents; and interviewed DHS officials. GAO is making five recommendations to CBP to (1) ensure privacy notices are complete, (2) ensure notices are available at locations using FRT, (3) develop and implement a plan to audit its program partners for privacy compliance, (4) develop and implement a plan to capture required traveler photos at air exit, and (5) ensure it is alerted when air exit performance falls below established thresholds. DHS concurred with the recommendations. For more information, contact Rebecca Gambler at (202) 512-8777 or gamblerr@gao.gov.
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  • Antitrust Division Announces Updates To Civil Investigative Demand Forms And Deposition Process
    In Crime News
    Assistant Attorney General Makan Delrahim of the Justice Department's Antitrust Division announced today that the Antitrust Division has implemented two uniform updates to its Civil Investigative Demand (CID) forms and deposition process: 
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  • Ohio Man Pleads Guilty to Paying Co-Conspirator to Illegally Dump Drums of Hazardous Waste
    In Crime News
    An Ohio man pleaded guilty in the Southern District of Ohio before U.S. District Judge Edmund A. Sargus Jr. to conspiring to illegally transport and dispose of hazardous waste at several area apartment complexes.
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  • The Importance of Diversity and Inclusion in Diplomacy: A Conversation with Security Engineering Officer Rahim Theriot
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  • Man Sentenced to 97 months in Prison for Role in International Credit Card Fraud and Money Laundering Conspiracy
    In Crime Control and Security News
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  • Chief Justice Roberts Issues 2020 Year-End Report
    In U.S Courts
    Chief Justice John G. Roberts, Jr., has issued his 2020 Year-End Report on the Federal Judiciary.
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  • Veteran Suicide: VA Needs Accurate Data and Comprehensive Analyses to Better Understand On-Campus Suicides
    In U.S GAO News
    The Department of Veterans Affairs' (VA) process for identifying on-campus suicides does not include a step for ensuring the accuracy of the number of suicides identified. As a result, its numbers are inaccurate. VA's Veterans Health Administration (VHA) first started tracking on-campus veteran suicides in October 2017, and uses the results to inform VA leadership and Congress. GAO reviewed the data and found errors in the 55 on-campus veteran suicides VHA identified for fiscal years 2018 and 2019, including 10 overcounts (deaths that should not have been reported but were) and four undercounts (deaths that should have been reported but were not).   Examples of Errors on the Department of Veterans Affairs' (VA) List of 55 On-Campus Veteran Suicides for Fiscal Years 2018 and 2019 (as of September 2019) VA has taken some steps to address on-campus veteran suicides, such as issuing guidance and staff training. However, GAO found that the analyses informing these efforts are limited. Specifically, VHA requires root cause analyses—processes to determine what can be done to prevent recurrences of incidents—for some but not all on-campus veteran suicides. According to VHA officials, only 25 percent of on-campus suicides from October 2017 to April 2019 met the criteria for a root cause analysis. does not make use of all relevant information VA collects about these deaths, such as clinical and demographic data collected through other VA suicide prevention efforts. VHA officials said they could not link the different sources of information, but GAO found that selected medical facilities could do so. Without accurate information on the number of suicides and comprehensive analyses of the underlying causes, VA does not have a full understanding of the prevalence and nature of on-campus suicides, hindering its ability to address them. VA established suicide prevention as its highest clinical priority. In recent years, there have been reports of veterans dying by suicide on VA campuses—in locations such as inpatient settings, parking lots, and on the grounds of cemeteries. GAO was asked to review veteran deaths by suicide on VA campuses. This report examines (1) VA's process to track the number of veterans that died by suicide on VA campuses, and (2) steps VA has taken to address these types of suicides. GAO reviewed the sources of information VHA uses to identify and analyze on-campus veteran suicides, VA and VHA strategic plans and policies related to suicide prevention and reporting, and federal internal control standards. GAO also interviewed VA and VHA central office officials, and officials from three medical facilities that GAO selected because they reportedly had on-campus veteran suicides between fiscal years 2018 and 2019. GAO is making three recommendations, including that VA improve its process to accurately identify all on-campus veteran suicides and conduct more comprehensive analyses of these occurrences. VA did not concur with one of GAO's recommendations related to conducting root cause analyses. GAO continues to believe that this recommendation is valid, as discussed in the report. For more information, contact Debra A. Draper at (202) 512-7114 or draperd@gao.gov.
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  • Businessman Sentenced for Foreign Bribery and Money Laundering Scheme Involving PetroEcuador Officials
    In Crime News
    An Ecuadorian businessman living in Miami was sentenced today to 35 months in prison for his role in a $4.4 million bribery and money laundering scheme that funneled bribes to then-public officials of Empresa Pública de Hidrocarburos del Ecuador (PetroEcuador), the state-owned and state-controlled oil company of Ecuador.
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  • Three Tribal Officials Charged in Bribery Scheme
    In Crime News
    Two current tribal government officials and one former tribal government official of the Three Affiliated Tribes of the Mandan, Hidatsa, and Arikara Nation (MHA Nation) were charged by criminal complaint unsealed today for their alleged acceptance of bribes and kickbacks from a contractor providing construction services on the Fort Berthold Indian Reservation (FBIR), which is the home of the MHA Nation.
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  • Puerto Rico: Perspectives on the Potential to Expand Air Cargo Operations
    In U.S GAO News
    Cargo was flown by air between more than 97 countries within the selected regions of Africa, Europe, Latin America, and the U.S. that may affect air cargo expansion in Puerto Rico. However, according to Department of Transportation (DOT) and European Union data, most international air cargo transportation was concentrated at a handful of countries and at airports in these regions. For example, four countries in Europe accounted for 72 percent of the U.S.-European Union air cargo transported, by weight. Likewise for airports, Miami International Airport accounted for 70 percent of air cargo transported between the U.S. and Latin America. Worldwide, cargo-only carriers transported on average 13.8 billion pounds of air cargo to and from the U.S. from 2016 through 2018. Of that cargo, two of the selected regions—Latin America and Europe—when combined accounted for 46 percent. Air Cargo Transported by Cargo-Only Airlines between the U.S. and Global Regions, Average Weight in Millions of Pounds, 2016 through 2018 Based on interviews with industry stakeholders and studies reviewed. GAO identified four factors that are generally associated with an airport's ability to attract air cargo traffic: (1) an airport's geographical location; (2) its proximity to transportation networks; (3) its supporting airport infrastructure and resources; and (4) the governmental and regulatory environments. For example, an airport located near businesses that generate large volumes of both inbound and outbound cargo that could be transported by air may be an important geographic factor for air carriers. Puerto Rican government and industry stakeholders GAO spoke with said that increased air cargo would benefit its airports and lead to positive effects on the Puerto Rican economy. For example, officials noted that expansion of air cargo operations could increase the use of underutilized airports and create opportunities for existing industry—such as the pharmaceutical, medical device, and aerospace industries—and help develop new ones. Puerto Rican and industry stakeholders had varying perspectives on the potential for Puerto Rico's expanding its air cargo operations. For example, some stakeholders said Puerto Rico's geographic location may allow it to serve as a refueling and cargo distribution point, particularly for flights between Europe and Latin America, while others said the island may be too close to some Latin American destinations to serve that purpose. Whether and to what extent Puerto Rico can increase air cargo operations depends on how air carriers weigh the various factors discussed above. Puerto Rico's economy has been in decline for much of the last 15 years and was devastated by hurricanes in 2017. Puerto Rico has sought to increase air cargo and passenger traffic at its international airports as a means to bolster and diversify its economy. Specifically, Puerto Rico seeks to serve as a transshipment point for transferring cargo between air carriers flying from Europe to Latin America. Air cargo, whether carried in the holds of passenger aircraft or by cargo-only aircraft, is an important component of global trade. The FAA Reauthorization Act of 2018 includes a provision for GAO to study the international air cargo transportation services among the United States and the African, Latin American, and European regions and the potential expansion of air cargo operations in Puerto Rico. This report addresses (1) what is known about air cargo operations between these world regions; (2) factors affecting the development of air cargo markets; and (3) Puerto Rican officials' and selected industry stakeholders' views on the economic effect and potential of expanding air cargo operations in Puerto Rico. GAO analyzed DOT and European air cargo data for flights between the U.S. and the selected regions for 2016 through 2018 (the latest available data). GAO also interviewed officials from DOT, and stakeholders from Puerto Rico and the air-cargo industry, selected based on prior GAO work and stakeholder mission. For more information, contact Heather Krause at (202) 512-2834 or krauseh@gao.gov.
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  • Afghan National Arrested for 2008 Abduction of American Journalist
    In Crime News
    The Department of Justice announced the unsealing of a federal indictment charging Haji Najibullah, a/k/a “Najibullah Naim,” a/k/a “Abu Tayeb,” a/k/a “Atiqullah” with six counts related to the 2008 kidnapping of an American journalist and two Afghan nationals. Najibullah, 44, was arrested and transferred to the United States from Ukraine to face the charges in the indictment. Najibullah will be presented today before U.S. Magistrate Judge Ona T. Wang. The case is assigned to U.S. District Judge Katherine Polk Failla.
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  • Acting Assistant Attorney General Brian Rabbitt Delivers Remarks at the PPP Criminal Fraud Enforcement Action Press Conference
    In Crime News
    Over the course of the past six months, the COVID-19 pandemic has wreaked havoc across our country and presented unprecedented challenges for ordinary Americans from all walks of life. 
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  • Restaurant Chain Manager Pleads Guilty to Employment Tax Fraud
    In Crime News
    The manager of the San Diego Home Cooking restaurant chain pleaded guilty today to employment tax fraud, announced Principal Deputy Assistant Attorney General Richard E. Zuckerman of the Justice Department’s Tax Division and U.S. Attorney Robert S. Brewer Jr. for the Southern District of California.
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