You are given two reports by the government agency.  

Report 1:
Title IV of the Higher Education Act (HEA; P.L. 89-329), as amended, authorizes programs that provide financial assistance to students to attend certain institutions of higher education (IHEs). In academic year (AY) 2016-2017, 6,760 institutions were classified as Title IV eligible IHEs. Of these IHEs eligible to participate in Title IV programs, approximately 29.4% were public institutions, 27.8% were private nonprofit institutions, and 42.9% were proprietary (or private, for-profit) institutions. It is estimated that $122.5 billion was made available to students through Title IV federal student aid in FY2017. To be able to receive Title IV assistance, students must attend an institution that is eligible to participate in the Title IV programs. IHEs must meet a variety of requirements to participate in the Title IV programs. First, an IHE must meet basic eligibility criteria, including offering at least one eligible program of education. In addition, an IHE must satisfy the program integrity triad, under which it must be legally authorized to provide a postsecondary education in the state in which it is located; accredited or preaccredited by an agency recognized by the Department of Education (ED) for such purposes, and certified by ED as eligible to participate in Title IV programs. The state authorization and accreditation components of the triad were developed independently to address the issues of quality assurance and consumer protection, and the federal government (ED specifically) generally relies on states and accrediting agencies to determine standards of educational program quality. The federal government's only direct role in determining Title IV eligibility is through the process of certification of eligibility and ensuring IHEs meet some additional Title IV requirements. Certification, as a component of the program integrity triad, focuses on an institution's fiscal responsibility and administrative capacity to administer Title IV funds. An IHE must fulfill a variety of other related requirements, including those that relate to institutional recruiting practices, student policies and procedures, and Title IV program administration. Finally, additional criteria may apply to an institution depending on its control or the type of educational programs it offers. For instance, proprietary institutions must derive at least 10% of their revenues from non-Title IV funds (also known as the 90/10 rule). Failure to fulfill some of these requirements does not necessarily end an IHE's participation in the Title IV programs, but may lead to additional oversight from ED and/or restrictions placed an IHE's Title IV participation. This report provides a general overview of HEA provisions that affect a postsecondary institution's eligibility for participation in Title IV student aid programs. It first describes general eligibility criteria at both the institutional and programmatic level and then, in more detail, the program integrity triad. Next, it discusses several issues that are closely related to institutional eligibility: Program Participation Agreements, campus safety policies and crime reporting required under the Clery Act, the return of Title IV funds, and distance education. To be eligible to participate in HEA Title IV student aid programs, institutions must meet several criteria. These criteria include requirements related to programs offered by the institutions, student enrollment, institutional operations, and the length of academic programs. This section discusses the definition of an eligible IHE for the purposes of Title IV participation and program eligibility requirements. The HEA contains two definitions of institutions of higher education. Section 101 provides a general definition of IHE that applies to institutional eligibility for participation in HEA programs other than Title IV programs. The Section 102 definition of IHE is used only to determine institutional eligibility to participate in HEA Title IV programs. Section 101 of the HEA provides a general definition of IHE. This definition applies to institutional participation in non-Title IV HEA programs. Section 101 IHEs can be public or private nonprofit educational institutions. Section 101 specifies criteria both public and private nonprofit educational institutions must meet to be considered IHEs. Neither the HEA nor regulations specifically define a public institution of higher education. However, in general, public institutions can be described as those whose educational programs are operated by states or other government entities and are primarily supported by public funds. Regulations define a nonprofit IHE as one that (1) is owned and operated by a nonprofit corporation or association, with no part of the corporation's or association's net earnings benefiting a private shareholder or individual, (2) is determined by the Internal Revenue Service to be a tax-exempt organization under Section 501(c)(3) of the Internal Revenue Code (IRC), and (3) is legally authorized to operate as a nonprofit organization by each state in which it is physically located. To be considered a Section 101 IHE, public and private nonprofit educational institutions must admit as regular students only individuals with a high school diploma or its equivalent, individuals beyond the age of compulsory school attendance, or individuals who are dually or concurrently enrolled in both the institution and in a secondary school; be legally authorized to provide a postsecondary education within the state in which they are located; offer a bachelor's degree, provide a program of at least two-years that is acceptable for full credit toward a bachelor's degree, award a degree that is accepted for admission to a graduate or professional program, or provide a training program of at least a one-year that prepares students for gainful employment in a recognized occupation; and be accredited or preaccredited by an accrediting agency recognized by ED to grant accreditation or preaccreditation status Section 102 of the HEA defines IHE only for the purposes of Title IV participation. The Section 102 definition includes all institutions included in the Section 101 definition (i.e., public and private nonprofit IHEs) and also includes proprietary institutions, postsecondary vocational institutions, and foreign institutions that have been approved by ED. Section 102 specifies that proprietary and postsecondary vocational institutions must meet many of the same Section 101 requirements that are applicable to public and private nonprofit institutions. In addition, Section 102 specifies other criteria that all types of educational institutions must meet to be considered Title IV eligible IHEs. HEA Section 102 specifies that a proprietary IHEs is an institution that is neither a public nor a private nonprofit institution. In addition to the basic Title IV eligibility criteria that all IHEs must meet (e.g., state authorization, accreditation by an ED-recognized accrediting agency), proprietary IHEs must meet additional criteria to be considered Title IV eligible. Specifically, a proprietary IHE must (1) provide an eligible program of training "to prepare students for gainful employment in a recognized occupation" or (2) provide a program leading to a baccalaureate degree in liberal arts that has been continuously accredited by a regional accrediting agency since October 1, 2007, and have provided the program continuously since January 1, 2009. Additionally, it must have been legally authorized to provide (and have continuously been providing) the same or a substantially similar educational program for at least two consecutive years. HEA Section 102 defines a postsecondary vocational institution as a public or private nonprofit institution that provides an eligible program of training "to prepare students for gainful employment in a recognized occupation," and has been legally authorized to provide (and has continuously been providing) the same or a substantially similar educational program for at least two consecutive years. It is possible for a public or private nonprofit IHE that offers a degree program (e.g., an associate's or bachelor's degree) to also qualify as a postsecondary vocational institution by offering programs that are less than one academic year and that lead to a nondegree recognized credential such as a certificate. Institutional participation in Title IV student aid programs allows students from the United States to borrow through the federal Direct Loan program to attend postsecondary institutions located outside of the United States. In general, a foreign institution is eligible to participate in the Direct Loan program if it is comparable to an eligible IHE (as defined in HEA Section 101) within the United States, is a public or private nonprofit institution, and has been approved by ED. Foreign graduate medical schools, veterinary schools, and nursing schools are also eligible to participate in Title IV student aid programs, but must meet additional requirements. Freestanding foreign graduate medical schools, veterinary schools, and nursing schools may be proprietary institutions. Additional requirements for foreign institutions to participate in Title IV student aid programs are beyond the scope of this report and, generally, will not be discussed hereinafter. The definitions of proprietary institutions and postsecondary vocational institutions contained in Section 102 have several overlapping components with the Section 101 definition of IHE. For instance, both proprietary and postsecondary vocational institutions must (1) admit as regular students only those individuals with a high school diploma or its equivalent, individuals beyond the age of compulsory school attendance, or individuals who are dually or concurrently enrolled in both the institution and in a secondary school; (2) be legally authorized to provide a postsecondary education by the state in which they are located; and (3) be accredited or preaccredited by an accrediting agency recognized by ED to grant such statuses. In addition, all types of institutions (including public and private nonprofit institutions) must meet requirements related to the course of study offered at the institution and student enrollment to be considered Title IV eligible under Section 102. In general, any type of institution is considered ineligible to participate in Title IV programs if more than 25% of its enrolled students are incarcerated, or if more than 50% of the its enrolled students do not have a secondary school diploma or equivalent and the institution does not provide a two-year associate's degree or a four-year bachelor's degree. Also, in general, an institution is ineligible if more than 50% of the courses offered are correspondence courses or if 50% or more of its students are enrolled in correspondence courses. These "50% rules" are discussed in more detail in the distance education section of this report. Finally, an institution is considered ineligible to participate in Title IV programs if the institution has filed for bankruptcy or the institution (or its owner or chief executive officer) has been convicted of or pled no contest or guilty to a crime involving the use of Title IV funds. While the above-described criteria generally apply to most types of Section 102 institutions, specific criteria apply to individual types of Section 102 institutions. The following sections provide information on Title IV eligibility criteria that apply to those additional types of IHEs not specified in Section 101, but specified in Section 102: proprietary IHEs, postsecondary vocational institutions, and foreign institutions. Hereinafter, unless otherwise noted, the term "institution of high education (IHE)" only refers to Section 102 institutions. To qualify as an eligible institution for Title IV participation, an institution must offer at least one eligible program, but overall institutional eligibility does not necessarily extend to all programs offered by the institution. Not all of an institution's programs must meet program eligibility requirements for an IHE to participate in Title IV, but, in general, students enrolled solely in ineligible programs cannot receive Title IV student aid. To be Title IV eligible, a program must lead to a degree (e.g., an associate's or bachelor's degree) or certificate or prepare students for gainful employment in a recognized occupation. Before awarding Title IV aid to students, an IHE must determine that the program in which a student is participating is Title IV eligible, ensure that the program is included in its accreditation notice, and ensure that the the IHE is authorized by the appropriate state to offer the program. In addition to the general criteria for all types of institutions, a program must meet specific eligibility requirements depending on whether the institution at which it is offered is a public or private nonprofit IHE, a proprietary IHE, or a postsecondary vocational IHE. At a public or private nonprofit IHE, the following types of programs are Title IV eligible: (1) programs that lead to an associate's, bachelor's, professional, or graduate degree; (2) transfer programs that are at least two academic years in length and for which the institution does not award a credential but that are acceptable for full credit toward a bachelor's degree; (3) programs that lead to a certificate or other recognized nondegree credential, that prepare students for gainful employment in a recognized occupation, and that are at least one academic year in length; (4) certificate or diploma training programs that are less than one year in length, if the institution also meets the definition of a postsecondary vocational institution; and (5) programs consisting of courses required for elementary or secondary teacher certification in the state in which the student intends to teach. For all of these, an academic year must also require an undergraduate course of study to contain an amount of instructional time in which a full-time student is expected to complete at least 24 semester or trimester credit hours, 36 quarter credit hours, or 900 clock hours. In general, eligible programs at proprietary and postsecondary vocational institutions must meet a specified number of weeks of instruction and must provide training that prepares students for gainful employment in a recognized occupation (described below). At proprietary and postsecondary vocational institutions, the following types of programs are Title IV eligible: undergraduate programs that provide at least 600 clock hours, 16 semester or trimester hours, or 24 quarter hours of instruction offered over a minimum of at least 15 weeks ; such programs may admit, as regular students, individuals who have not completed the equivalent of an associate's degree; programs that provide at least 300 clock hours, 8 semester hours, or 12 quarter hours of instruction offered over a minimum of 10 weeks; such programs must be graduate or professional programs or must admit as regular students only individuals who have completed the equivalent of an associate's degree; short-term programs that provide between 300 and 600 clock hours of instruction over a minimum of 10 weeks ; such programs must have been in existence for at least one year, have verified completion and placement rates of at least 70%, may not last more than 50% longer than the minimum training period required by the state or federal agency for the occupation for which the program is being offered, and must admit as regular students some individuals who have not completed the equivalent of an associate's degree; and programs offered by accredited proprietary IHEs that lead to a bachelor's degree in liberal arts; the school must have been continuously accredited by an ED-recognized accrediting agency since at least October 1, 2007 and must have provided the program continuously since January 1, 2009. Most nondegree programs offered by public and private nonprofit IHEs must prepare students for "gainful employment in a recognized occupation." Gainful employment requirements also apply to almost all programs offered by proprietary and postsecondary vocational institutions, regardless of whether they lead to a degree. In response to concerns about the quality of programs that prepare students for gainful employment and the level of student debt assumed by individuals who attend these programs, ED issued final rules on gainful employment on October 31, 2014. The regulations require that educational programs subject to gainful employment requirements offered by IHEs meet minimum performance standards to be considered offering education that prepares students for gainful employment in a recognized occupation. They also require IHEs to disclose specified information about each of its gainful employment programs to enrolled or prospective students. Finally, the gainful employment rules require IHEs to report information to ED necessary to calculate the debt-to-earnings ratios. Although the gainful employment regulations became effective July 1, 2015, various aspects of them have not yet been fully implemented or have been delayed in implementation. For example, ED delayed until July 1, 2019, some portions of the rule relating to certain disclosure requirements. Additionally, to enable ED to calculate whether an IHE's programs meet the minimum performance standards (discussed below), regulations specify that ED obtains data from the Social Security Administration (SSA). However, a memorandum of understanding relating to data sharing between ED and SSA lapsed in 2018. In August 2018, ED issued a Notice of Proposed Rulemaking that proposes to rescind the gainful employment rules in their entirety. Based on HEA requirements relating to the implementation date for Title IV regulations, the earliest possible date the proposed rules could go into effect is July 1, 2020. The gainful employment regulations establish a framework within which educational programs offered by IHEs must meet minimum performance standards to be considered offering education that prepares students for gainful employment in a recognized occupation. Under the framework, ED annually calculates two debt-to-earnings (D/E) rates for each gainful employment program offered by an IHE, the discretionary income rate and the annual earnings rate. These rates measure a gainful employment program's completers' debt (their annual loan payments) as a percentage of their post-completion earnings. Using these measures, institutions will be determined to be "passing," "in the zone," or "failing." Thresholds for each category are as follows: Passing : Programs whose completers have annual loan payments less than or equal to 8% of annual earnings (the annual earnings rate) or less than or equal to 20% of discretionary income (the discretionary income rate). In the zone: Programs whose completers have annual loan payments greater than 8% but less than or equal to 12% of annual earnings or greater than 20% but less than or equal to 30% of discretionary income. Failing : Programs whose completers have annual loan payments greater than 12% of annual earnings and greater than 30% of discretionary income. Programs that are failing in two out of any three consecutive years or that are in the zone for four consecutive years will be ineligible for Title IV participation for three years. The gainful employment rules also contain several disclosure requirements. For any year in which ED notifies an IHE that a gainful employment program could become ineligible in the next year based on its debt-to-earnings ratios (i.e., one year of failure or three years in the zone), the IHE must provide a warning to current and prospective students that the program does not meet the gainful employment standards and that if the program does not meet the gainful employment standards in the future, students would not be able to receive Title IV aid. In addition, an IHE must disclose specified information about each of its gainful employment programs to enrolled and prospective students. Information to be disclosed includes the following: the primary occupation that the program prepares students to enter; whether the program satisfies applicable educational prerequisites for professional licensure or certification in each state within the institution's metropolitan statistical area (MSA); program length and number of clock or credit hours, or equivalent, in the program; the program's completion rates for full-time and less-than-full-time students and the program's withdrawal rates; Federal Family Education Loan (FFEL) and Direct Loan program loan repayment rates for all students who entered repayment on Title IV loans and who enrolled in the program, for those who withdrew from the program, and for those who completed the program; the program tuition, fees, and additional costs incurred by a student who completes the program within the program's published length; the job placement rate for the program, if otherwise required by the institution's accrediting agency or state; the percentage of enrolled students who received Title IV or private loans for enrollment in the program; the median loan debt and mean or median earnings of students who completed the program, of students who withdrew from the program, and of both groups combined; the program cohort default rate; and the annual earnings rate for the program. Institutions must also certify that each of their gainful employment programs is included in the IHE's accreditation, meets any state or federal entity accreditation requirements, and meets any state licensing and certification requirements for the state in which the IHE is located. Title IV of the HEA sets forth three requirements to ensure program integrity in postsecondary education, known as the program integrity triad. The three requirements are state authorization, accreditation by an accrediting agency recognized by ED, and eligibility and certification by ED. This triad is intended to provide a balance in the Title IV eligibility requirements. The states' role is to provide consumer protection, the accrediting agencies' role is to provide quality assurance, and the federal government's role is to provide oversight of compliance to ensure administrative and fiscal integrity of Title IV programs at IHEs. The state role in the program integrity triad is to provide legal authority for an institution to operate a postsecondary educational program in the state in which it is physically located. There are two basic requirements for an IHE to be considered legally authorized by a state: 1. the state must authorize the IHE by name to operate postsecondary educational programs, and 2. the state must have in place a process to review and address complaints concerning IHEs, including enforcing applicable state law. An IHE can be authorized by name through a state charter, statute, constitutional provision, or other action by an appropriate state agency (e.g., authorization to conduct business or operate as a nonprofit organization). Additionally, an institution must also comply with any applicable state approval or licensure requirements. The state agency responsible for the authorization of postsecondary institutions must also perform three additional functions: upon request, provide the Secretary with information about the process it uses to authorize institutions to operate within its borders; notify the Secretary if it has evidence to believe that an institution within its borders has committed fraud in the administration of Title IV programs; and notify the Secretary if it revokes an institution's authorization to operate. On December 19, 2016, ED issued final regulations related to state authorization for IHEs offering postsecondary distance or correspondence education (discussed later in this report). The regulations would require an IHE offering postsecondary distance or correspondence education to students residing in a state in which the IHE is not physically located to meet any requirements within the student's state of residence. Under the rules, an IHE may meet this requirement if it participates in a state authorization reciprocity agreement. These regulations were scheduled to become effective July 1, 2018. However, on July 3, 2018 (and effective June 29, 2018), the Secretary of Education (Secretary) issued a final rule delaying the implementation of these requirements until July 1, 2020. The second component of the program integrity triad is accreditation by an ED-recognized accrediting agency or association. In higher education, accreditation is intended to help ensure an acceptable level of quality within IHEs. For Title IV purposes, an institution must be accredited or preaccredited by an ED-recognized accrediting agency. Each accrediting agency must meet HEA-specified standards to be recognized by ED. From its inception, accreditation has been a voluntary process. It developed with the formation of associations that distinguished between IHEs that merited the designation of college or university from those that did not. Since then, accreditation has been used as a form of "external quality review ... to scrutinize colleges, universities and programs for quality assurance and quality improvement." In 1952, shortly after the passage of the Veterans' Readjustment Act of 1952 (the Korean GI Bill; P.L. 82-550), the federal government began formally recognizing accrediting agencies. This was done as one means to assess higher education quality and link it to determining which institutions would qualify to receive federal aid under the Korean GI Bill. Rather than creating a centralized authority to assess quality, the federal government chose to rely in part on the existing expertise of accrediting agencies. Today, ED's formal recognition of accrediting agencies is important, because an IHE's Title IV eligibility is conditioned upon accreditation from an ED-recognized accreditation organization. As part of the accreditation system's development, three types of accrediting agencies have emerged: Regional accrediting agencies. These operate in six regions of the United States, with each agency concentrating on a specific region. Generally, these accredit entire public and private nonprofit degree-granting IHEs. National accrediting agencies. These operate across the United States and also accredit entire institutions. There are two types of national accrediting agencies: faith-based agencies that accredit religiously affiliated or doctrinally based institutions, which are typically private nonprofit degree-granting institutions, and career-related agencies that typically accredit proprietary, career-based, degree- and nondegree-granting institutions. Specialized or programmatic accrediting agencies. These operate throughout the United States and accredit individual educational programs (e.g., law) and single-purpose institutions (e.g., freestanding medical schools). Specific educational programs are often accredited by a specialized accrediting agency, and the institution at which the program is offered is accredited by a regional or national accrediting organization. Generally, an institution must be accredited by an ED-recognized accrediting agency that has the authority to cover all of the institution's programs. Alternatively, a public or private nonprofit IHE may be preaccredited by an agency recognized by ED to grant such preaccreditation, and a public postsecondary vocational institution may be accredited by a state agency that ED determines is a reliable authority. Proprietary institutions must be accredited by an ED-recognized accrediting agency. The accreditation process begins with an institution or program requesting accreditation. Institutional accreditation is cyclical, with a cycle ranging from every few years up to 10 years. Initial accreditation does not guarantee subsequent renewal of the accredited status. Typically, an institution seeking accreditation will first perform a self-assessment to determine whether its operations and performance meet the basic standards required by the relevant accrediting agency. Next, an outside group of higher education peers (e.g., faculty and administrators) and members of the public conduct an on-site visit at the institution during which the team determines whether the accrediting organization's standards are being met. Based on the results of the self-assessment and site visit, the accrediting organization determines whether accreditation will be awarded, renewed, denied, or provisionally awarded to an institution. Educational programs within institutions can be accredited by programmatic accrediting agencies; however, a program is not required to be accredited by a programmatic accrediting agency for Title IV purposes. Rather, it only needs to be covered by the IHE's primary accrediting agency. Frequently, programmatic accrediting agencies review a specific program within an IHE that is accredited by a regional or national accrediting agency. An institution that has had its accreditation revoked or terminated for cause cannot be recertified as an IHE eligible to participate in Title IV programs for 24 months following the loss of accreditation, unless the accrediting agency rescinds the loss. The same rules apply if an institution voluntarily withdraws its accreditation. The Secretary can, however, continue the eligibility of a religious institution whose loss of accreditation, whether voluntary or not, is related to its religious mission and not to the HEA accreditation standards. If an institution's accrediting agency loses its recognition from ED, it has up to 18 months to obtain accreditation from another ED-recognized agency. Although the federal government does not set specific standards for institutional or programmatic accreditation, generally, it does require that institutions be accredited or preaccredited by a recognized accrediting organization to be eligible for Title IV participation. ED's primary role in accreditation is to recognize an accrediting agency as a "reliable authority regarding the quality of education or training offered" at IHEs through the processes and conditions set forth in the HEA and federal regulations. For ED recognition, Section 496 of the HEA specifically requires that an accrediting agency be a state, regional, or national agency that demonstrates the ability to operate as an accrediting agency within the relevant state or region or nationally. Additionally, agencies must meet one of the following criteria: IHE membership with the agency must be voluntary, and one of the primary purposes of the agency must be accreditation of the IHEs. The agency must be a state agency approved by the Secretary as an accrediting agency on or before October 1, 1991. The agency must either conduct accreditation through a voluntary membership of individuals in a profession, or it must have as its primary purpose the accreditation of programs within institutions that have already been accredited by another ED-recognized agency. Agencies that meet the first or third criterion listed above must also be administratively and financially separate and independent of any related trade association or membership organization. For an agency that meets the third criterion and that was ED-recognized on or before October 1, 1991, the Secretary may waive the requirement that the agency be administratively and financially independent of any related organization, but only if the agency can show that the existing relationship with the related organization has not compromised its independence in the accreditation process. All types of accrediting agencies must show that they consistently apply and enforce standards that ensure that the education programs, training, or courses of study offered by an IHE are of sufficient quality to meet the stated objectives for which the programs, training, or courses are offered. The standards used by the accrediting agencies must assess student achievement in relation to the institution's mission; this may include course completion, job placement rates, and passage rates of state licensing exams. Agencies must also consider curricula, faculty, facilities, fiscal and administrative capacity, student support services, and admissions practices. Accrediting agencies must also meet requirements that focus on the review of an institution's operating procedures, including reviewing an institution's policies and procedures for determining credit hours, the application of those policies and procedures to programs and coursework, and reviewing any newly established branch campuses. They must also perform regular on-site visits that focus on the quality of education and program effectiveness. The final component of the program integrity triad is eligibility and certification by ED. Here, ED is responsible for verifying an institution's legal authority to operate within a state and its accreditation status. ED also evaluates an institution's financial responsibility and administrative capability to administer Title IV student aid programs. An institution can be certified to participate in Title IV for up to six years before applying for recertification. ED determines an IHE's financial responsibility based on its ability to provide the services described in its official publications, to administer the Title IV programs in which it participates, and to meet all of its financial obligations. A public IHE is deemed financially responsible if its debts and liabilities are backed by the full faith and credit of the state or another government entity. A proprietary or private nonprofit IHE is financially responsible if it meets specific financial ratios (e.g., equity ratio) established by ED, has sufficient cash reserves to make any required refunds (including the return of Title IV funds), is meeting all of its financial obligations, and is current on its debt payments. Even if an institution meets the above requirements, ED does not consider it financially responsible if the IHE does not meet third-party financial audit requirements or if the IHE violated past performance requirements, such as failing to satisfactorily resolve any compliance issues identified in program reviews or audits. Alternatively, if an institution does not meet the above standards of financial responsibility, ED may still consider it financially responsible or give it provisional certification, under which it may operate for a time, if it qualifies under an alternative standard. These alternative standards include submitting an irrevocable letter of credit to ED that is equal to at least 50% of the Federal Student Aid (FSA) program funds that the IHE received during its most recently completed fiscal year, meeting specific monitoring requirements, or participating in the Title IV programs under provisional certification. Along with demonstrating financial responsibility, an institution must demonstrate its ability to properly administer the Title IV programs in which it participates and to provide the education it describes in public documents (e.g., marketing brochures). Administrative capability focuses on the processes, procedures, and personnel used in administering Title IV funds and indicators of student success. Administrative capability standards address numerous aspects of Title IV administration. For example, to administer Title IV programs an institution must use ED's electronic processes and develop a system to identify and resolve discrepancies in Title IV information received by various institutional offices. The IHE must also refer cases of Title IV student fraud or criminal misconduct to ED's Office of Inspector General for resolution, and it must provide all enrolled and prospective students financial aid counseling. Finally, the IHE must have an adequate internal system of checks and balances that includes dividing the functions of authorizing payments and disbursing funds between two separate offices. Institutions are required to have a capable staff member to administer Title IV programs and coordinate those programs with other aid received by students. This person must also have an adequate number of qualified staff to assist with aid administration. Before receiving Title IV funds, an IHE must certify that neither it nor its employees have been debarred or suspended by a federal agency; similar limitations apply to lenders, loan servicers, and third-party servicers. Relating to indicators of student success, an institution must have satisfactory academic progress (SAP) standards for students receiving Title IV funds. In general, IHEs must develop SAP standards that establish a minimum grade point average (or its equivalent) for students and a maximum time frame in which students must complete their educational programs. A student who fails to meet the SAP requirements becomes ineligible to receive Title IV funds. Also related to student success indicators, an institution that seeks to participate in Title IV programs for the first time may not have an undergraduate withdrawal rate for regular students that is greater than 33% during its most recently completed award year. An institution may be deemed administratively incapable if it has a high cohort default rate (CDR). In general, the CDR is the number of an IHE's federal loan recipients who enter repayment in a given fiscal year (the cohort fiscal year) and who default within a certain period of time after entering repayment (cohort default period; CDP), divided by the total number of borrowers who entered repayment in the cohort fiscal year. Since 2014, ED has used a three-year CDP in calculating an institution's CDR. An IHE will be found administratively incapable if one of the following conditions is met: 1. an institution's CDR is greater than 40% in one year for loans made under the FFEL and Direct Loans programs; 2. an institution's CDR is 30% or greater for each of the three most recent fiscal years for loans made under the FFEL and Direct Loans programs; or 3. an institution's CDR is 15% or greater in any single year for loans made under the Federal Perkins Loan Program. When an IHE is determined to be administratively incapable due to a high CDR, it may become ineligible to participate in the Direct Loan, Pell Grant, and/or Perkins Loan programs (but not other Title IV programs). ED may grant provisional certification for up to three years to an institution that would be deemed administratively capable except for its high cohort default rates. If an institution is seeking initial certification, ED can grant it up to one year of provisional certification. ED can also grant an institution provisional certification for up to three years if ED is determining the IHE's administrative capacity and financial responsibility for the first time, if the IHE has experienced a partial or total change in ownership, or if ED determines that the administrative or financial condition of the IHE may hinder its ability to meet its financial responsibilities. Additionally, if an accrediting agency loses its ED recognition, any institution that was accredited by that agency may continue to participate in Title IV programs for up to 18 months after ED's withdrawal of recognition. To ensure that an institution is conforming to eligibility requirements, ED can conduct program reviews. During a program review, ED evaluates an institution's compliance with Title IV requirements and identifies actions the IHE must take to correct any problem(s). Review priority is given to those institutions with high cohort default rates; IHEs with significant fluctuations in Pell Grant awards or Direct Loan volume that are not accounted for by changes in programs offered; IHEs that are reported to have deficiencies or financial aid problems by their state or accrediting agency; IHEs with high annual dropout rates; and IHEs determined by ED to pose a significant risk of failing to comply with the administrative capability or financial responsibility requirements. If, during a review, ED determines that an institution is not administratively capable or financially responsible or is violating Title IV program rules, ED may grant it provisional certification, take corrective actions, or impose sanctions. ED has the authority to impose a variety of sanctions and corrective actions on an institution that violates Title IV program rules, a Program Participation Agreement (discussed later in this report) or any other agreement made under the laws or regulations, or if it substantially misrepresents the nature of its educational programs, financial charges, or graduates' employability. Sanctions include fines, limitations, suspensions, emergency actions, and terminations. ED can also sanction third-party servicers performing tasks related to the institution's Title IV programs. ED may impose several types of sanctions on institutions for statutory and regulatory violations, including fines, limitations, and suspensions. ED can fine an institution up to $55,907 for each statutory or regulatory violation it commits, depending on the size of the IHE and the seriousness of the violation. Under a limitation, ED imposes specific conditions or restrictions on an institution related to its administration of Title IV funds. A limitation lasts for at least 12 months, and if an institution fails to abide by the limitation, ED may initiate a termination proceeding. Finally, under a suspension, an institution is not allowed to participate in Title IV programs for up to 60 days. Each of these sanctions may require an institution to take corrective actions as well, which may include repaying illegally used funds or making payments to eligible students from the IHE's own funds. ED can take emergency action to withhold Title IV funds from an institution if it receives reliable information that an IHE is violating applicable laws or regulations, agreements, or limitations. ED must determine that the institution is misusing federal funds, that immediate action is necessary to stop misuses, and that the potential losses outweigh the importance of using established procedures for limitation, suspension, or termination. An emergency action suspends an institution's participation in Title IV programs and prohibits it from disbursing such funds. Typically, the emergency action may not last more than 30 days. The final action ED can take is the termination of an institution's participation in Title IV programs. Generally, an institution that has had its participation terminated cannot reapply to be reinstated for at least 18 months. To request reinstatement, an institution must submit a fully completed application to ED and demonstrate that it has corrected the violation(s) for which its participation was terminated. ED may then approve, approve subject to limitations, or deny the institution's request. Several other requirements affect institutional eligibility for Title IV programs. Some of these requirements include institution Program Participation Agreements, which include provisions related to incentive compensation and campus crime reporting requirements; return of Title IV funds; and distance education. The failure to meet the requirements for any of these may result in the loss of Title IV eligibility or other sanctions. HEA Section 487 specifies that each institution wanting to participate in Title IV student aid programs is required to have a current Program Participation Agreement (PPA). A PPA is a document in which the institution agrees to comply with the laws, regulations, and policies applicable to the Title IV programs; it applies to an IHE's branch campuses and locations that meet Title IV requirements, as well as its main campus. It also lists all of the Title IV programs in which the IHE is eligible to participate, the date on which the PPA expires, and the date on which the IHE must reapply for participation. By signing a PPA, an institution agrees that it will act as a fiduciary responsible for properly administering Title IV funds, will not charge students a processing fee to determine a student's eligibility for such funds, and will establish and maintain administrative and fiscal procedures to ensure the proper administration of Title IV programs. The PPA reiterates many provisions required for institutional eligibility and ED certification discussed earlier in this report and contains several additional notable requirements that may affect an IHE's Title IV eligibility, which are described below. Along with the general participation requirements with which an institution must comply, a PPA may also contain institution-specific requirements. As part of their PPAs, domestic and foreign proprietary IHEs must agree to derive at least 10% of their revenue from non-Title IV funds (i.e., no more than 90% of their revenue can come from Title IV funds). This is known as the 90/10 rule. Examples of non-Title IV funds include private education loans and some military and veterans' benefits, such as benefits provided under the Post-9/11 GI Bill program. If an IHE violates the 90/10 rule in one year, it does not immediately lose its Title IV eligibility. Rather, it is placed on a provisional eligibility status for two years. If the IHE violates the 90/10 rule for two consecutive years, it loses its eligibility for at least two years. In a PPA, an IHE must agree it will not provide any commission or incentive compensation to individuals based directly or indirectly on their success in enrolling students or the enrolled students' obtaining financial aid; however, some exceptions apply to this general rule. For instance, IHEs can provide incentive compensation to individuals for the recruitment of foreign students who are ineligible to receive Title IV funds or they can provide incentive compensation through a profit-sharing plan. The ban on incentive compensation only applies to the activities of securing enrollment (recruitment) and securing financial aid. Other activities are not banned, and ED draws a distinction between activities that involve directly working with individual students and policy-level determinations that affect recruitment and financial aid awards. For instance, an individual who is responsible for contacting potential student applicants or assisting students in filling out an enrollment application cannot receive incentive compensation, but an individual who conducts marketing activities, such as the broad dissemination of informational brochures or the collection of contact information, can receive incentive compensation. HEA Section 485(f), referred to as the Clery Act, requires domestic Title IV participating IHEs (1) to report to ED campus crime statistics and (2) establish and disseminate campus safety and security policies. Both the campus crime statistics and campus safety and security policies must be compiled and disseminated to current and prospective students and employees in an IHE's annual security report (ASR). Campus crime statistics required to be reported to ED and included in an ASR include data on the occurrence on campus of a range of offenses specified in statute, including murder, burglary, robbery, domestic violence, rape, and other forms of sexual violence. In addition to campus crime statistics, ASRs must include statements of campus safety and security policies regarding, for example, procedures and facilities for students and others to report criminal actions or other emergencies occurring on campus and an IHE's response to such reports; security and access to campus facilities; campus law enforcement, including the law enforcement authority of campus security personnel, and the working relationship between campus security personnel and state and local law enforcement; programs designed to inform students and employees about the prevention of crimes; and the possession, use, and sale of alcoholic beverages and illegal drugs; enforcement of state underage drinking laws; enforcement of federal and state drug laws; and any drug or alcohol abuse education programs required under the HEA. An ASR must also include statements of policies specifically relating to incidence of domestic and sexual violence. For example, an ASR must include statements of policy regarding programs to prevent such incidents; procedures a victim should follow if such an incident as occurred; procedures an IHE will follow once such an incident has been reported and procedures for institutional disciplinary actions in cases of alleged incidents (including a statement of the standard of evidence that will be used in any school proceeding arising from the incident report); and possible sanctions and protective measures that an IHE may impose following a final determination in an institutional proceeding regarding such incidences. The Clery Act prohibits the Secretary of Education from requiring IHEs to adopt particular policies, procedures, or practices; and prohibits retaliation against anyone exercising his or her rights or responsibilities under the act. HEA Section 484B specifies that when a Title IV aid recipient withdraws from an IHE before the end of the payment or enrollment period for which funds were disbursed, Title IV funds must be returned to ED according to a statutorily prescribed schedule. In general, when a student withdraws from an IHE, an IHE first determines the portion of Title IV aid considered to be "earned" by the student while enrolled and the portion considered to be "unearned." Unearned aid must be returned to ED. Up to the 60% point of a payment or enrollment period, unearned funds must be returned on a pro rata schedule. After the 60% point of a payment or enrollment period, the total amount of funds awarded is considered to have been earned by the student and no funds are required to be returned. Whether an IHE and/or the student is required to return the funds to ED depends on a variety of circumstances, including whether Title IV funds have been applied directly to a student's institutional charges. Unearned funds must be returned to their respective programs in a specified order, with loans being returned first, followed by Pell Grants, and then other Title IV aid. In some instances, a student may have earned more aid than has been disbursed, and the difference is disbursed to the student after the student withdraws. Generally, distance education and correspondence education refers to educational instruction with a separation in time, place, or both between the student and instructor. It is a way in which institutions can increase student access to postsecondary education by offering alternatives to traditional on-campus instruction. Recently, due to the greater availability of new technologies, there has been substantial growth in the amount and types of courses institutions offer. Section 103(7)(A) and (B) of the HEA and the accompanying regulations define distance education as instruction that uses "(1) the internet; (2) one-way and two-way transmissions through open broadcast, closed circuit, cable, microwave, broadband lines, fiber optics, satellite, or wireless communications devices; [or] ... (3) audio conferencing" to deliver instruction to students separated from the instructor. A course taught through a video cassette, DVD, or CD-ROM is considered a distance education course if one of the above-mentioned technologies is used to support student-instructor interaction. Regardless of the technology used, "regular and substantive interaction between the students and the instructor" must be ensured. Correspondence courses are expressly excluded from the definition of distance education. A correspondence course is one for which an institution provides instructional materials and exams for students who do not physically attend classes at the IHE, but does not include those courses that are delivered with "regular and substantive interaction between the students and the instructor" via one of the above-described technologies. In 1992, partially in response to cases of some correspondence institutions' fraudulent and abusive practices used to attract unqualified students to enroll in programs of poor or questionable quality, Congress incorporated provisions referred to as the "50% rules" into the HEA. The rules affected both the eligibility of institutions offering correspondence courses and their students' eligibility for Title IV aid. In general, under the rules, an institution is ineligible for Title IV aid if more than 50% of its courses are offered by correspondence, or if 50% or more of its students are enrolled in correspondence courses. As discussed earlier in this report, rules promulgated in 2016 would have required an IHE offering postsecondary distance or correspondence education in a state in which it is not physically located to meet any state authorization requirements within that state. Under the regulations, an IHE could meet this requirement if it participates in a state authorization reciprocity agreement. These regulations were scheduled to become effective July 1, 2018. However, on July 3, 2018 (and effective June 29, 2018), the Secretary of Education issued a final rule delaying the implementation of these requirements until July 1, 2020. The distinction between distance education and traditional instruction is also important for the purposes of Title IV program eligibility. Distance education programs provided by domestic IHEs are eligible for Title IV participation if they have been accredited by an accrediting agency recognized by ED to evaluate distance education programs. A program offered by a foreign IHE, in whole or in part, through distance education (including telecommunications) or correspondence is ineligible for Title IV participation.

 

 Report 2:
This section provides an overview of FMD, as well as information on the potential impact of an outbreak in the United States; USDA activities to respond to outbreaks of diseases, including FMD; federal, state, tribal, and industry roles in FMD control; and FMD vaccines. FMD is a highly contagious viral disease that causes fever and painful lesions on cloven-hoofed animals’ hooves, mouths, and udders (see fig. 1). These debilitating effects, rather than high mortality rates, are responsible for severe productivity losses associated with FMD. The disease generally does not infect humans and is not considered a public health or food safety threat. Young animals may die from the virus, while most adult animals recover. However, livestock infected with FMD have severely diminished meat and milk production. FMD virus can be found in all secretions and excretions from infected animals, including in breath, saliva, milk, urine, feces, and semen, as well as in the fluid from the lesions. Animals can release the virus for up to 4 days before showing visible signs of infection, and FMD can spread from one animal species to another. The virus itself can survive in the environment for many months and can spread when healthy animals come into contact with infected animals or via contaminated vehicles, equipment, clothes, feed, or animal products, as shown in figure 2. The United States has not had an FMD outbreak since 1929, but the disease could be introduced here from countries in Africa, Asia, Eastern Europe, or South America where it is present. The United States is vulnerable to FMD transmission, given the large size and mobility of the U.S. livestock sector. In 2018, the United States had about 94 million head of cattle, 74 million swine, 5 million sheep, and more than 2 million goats. Many of these livestock are concentrated in major livestock- producing states such as Texas and Iowa, but livestock are present in every state. (See figs. 3 and 4 for the populations of cattle and swine by state.) According to USDA documents, a large percentage of livestock in the United States are kept on large farms, ranches, or feedlots (i.e., areas or buildings where livestock are fed and fattened up), some with capacity for 50,000 to 100,000 or more animals. Livestock are transported daily to feeding facilities, markets, slaughter plants, and other farms or ranches. For example, swine are often moved among multiple premises at different stages of their life spans to accommodate their growth in size, among other things. According to the swine industry, approximately 1 million swine are on the road every day in transit to various stages of the production process. An FMD outbreak in the United States could have serious economic consequences. A 2001 outbreak of FMD in the United Kingdom, for example, resulted in the killing of more than 6 million animals, with direct costs of more than $3 billion to the public sector and more than $5 billion to the private sector. The extent of economic damage in the United States would depend primarily on the duration and geographic extent of the outbreak, the extent of trade disruptions, and how consumers reacted to the disease and associated control measures, according to USDA. In a large and long-lasting outbreak, control measures such as killing animals and halting the transportation of animals could cause significant losses for livestock operations. In addition, trade disruptions could have an enormous impact because U.S. exports of livestock, meat, and dairy products—together valued at more than $19 billion in 2017 based on estimates from the U.S. Meat Export Federation and the U.S. Dairy Export Council—would likely stop or be sharply reduced. In addition, domestic consumers might be reluctant to purchase meat and animal products such as milk during an FMD outbreak, even though the products would be safe for people to consume, according to USDA. Partly to protect the economic interests of the U.S. livestock industry, the Animal Health Protection Act authorizes USDA to detect, control, and eradicate diseases in livestock. USDA’s Animal and Plant Health Inspection Service (APHIS) is the lead agency for responding to outbreaks of foreign animal diseases, including FMD. According to APHIS, in responding to an outbreak of FMD or any foreign animal disease, APHIS, in coordination with state and industry partners, would conduct the following activities, among others: Surveillance. Observing animals for visible signs of disease and analyzing data on locations and numbers of disease cases to detect premises with the disease, determine the size and extent of an outbreak, and determine whether outbreak control measures are working. Epidemiologic tracing. Gathering and analyzing data on cases of a disease, premises with such cases, movement of infected animals, and their potential contact with uninfected animals to locate other animals or premises with the disease, understand the outbreak’s rate and direction of spread, and investigate the source of the outbreak. Diagnostic testing. Conducting approved and validated assessments of samples taken from animals to identify infected animals or to demonstrate that healthy animals are free of disease. Applying quarantines and stop-movement orders. Restricting the movement of infected or potentially infected animals, animal products, and contaminated items to prevent the virus from spreading to healthy animals. Biosecurity Biosecurity measures, which help minimize disease spread, include the following: placing signs indicating precautions personnel and visitors must follow; establishing sign-in procedures at entry points; removing dirt from boots and disinfecting them prior to entering a facility; using disposable personal protective equipment, such as Tyvek suits, gloves, masks, and boots, when entering premises; disposing of contaminated items properly; designating “clean” and “dirty” storage areas in vehicles; and controlling movement on and off premises. Employing biosecurity measures. Taking steps, such as cleaning and disinfecting trucks that travel between premises, to contain the virus on infected premises and prevent it from spreading via objects or equipment that can carry infection. Stamping out and vaccination. Killing infected animals and vaccinating uninfected animals—for example in buffer zones around infected premises—to limit the spread of the virus. Compensating owners. Paying owners fair market value for animals and equipment that the government determines must be destroyed to limit disease spread. To help prepare for a potential FMD outbreak, APHIS and its partners conduct preparedness exercises in which officials practice responding to simulated FMD outbreaks. Such exercises range from small-scale, narrowly scoped exercises to full-scale, broadly scoped exercises. For example, some exercises focus on specific response tasks such as electronic messaging between laboratories or shipping response supplies to the field, and involve relatively few people for less than a day. Other exercises simulate a wide range of response activities that APHIS and its partners would use in an FMD outbreak, involve dozens of people from different agencies and industry organizations in locations across the country, and last for multiple days. Multiple units within APHIS carry out these preparedness and response activities at the agency’s headquarters in Maryland; field offices in 27 states and Puerto Rico; and the National Veterinary Services Laboratories in Ames, Iowa, and on Plum Island, New York. APHIS’s Foreign Animal Disease Diagnostic Laboratory on Plum Island, New York, develops and performs diagnostic tests for foreign animal diseases, including FMD. APHIS also works with federal agencies within and outside of USDA, along with states, tribes, and academic and industry partners—all of which have roles related to FMD control, as discussed below. USDA’s Food Safety and Inspection Service is responsible for the safety of meat, poultry, and egg products. Agency officials assigned to slaughter establishments examine animals before processing to look for visible symptoms of FMD, among other things. USDA’s Agricultural Research Service conducts research on agricultural problems of high national priority, including the FMD virus and FMD vaccine. USDA’s National Institute of Food and Agriculture invests in and conducts agricultural research, education, and extension to help solve national challenges in agriculture, food, the environment, and communities. The agency has funded modeling of FMD spread and research on potential economic impacts. DHS has funded research on FMD vaccine and development of response decisions tools, training, and equipment; sponsored preparedness exercises; and developed emergency plans, among other things. In an FMD outbreak, DHS may assume the lead for coordination of federal resources if the Secretary of Agriculture requests assistance from DHS. The Secretary of Homeland Security, in coordination with the Secretaries of Agriculture, Health and Human Services, the Attorney General, and the Administrator of the Environmental Protection Agency, is to ensure that the combined federal, state, and local response capabilities are adequate to respond quickly and effectively to a major disease outbreak, among other things, affecting the national agriculture or food infrastructure. The Department of the Interior carries out disease surveillance of wild animals and coordinates surveillance activities with state fish and wildlife agencies, among other things. The Department of the Interior’s U.S. Geological Service conducts research on wildlife diseases, including FMD, and if needed in an FMD outbreak, would administer diagnostic tests for wildlife. The Federal Bureau of Investigation coordinates the federal investigation of criminal activities through the Joint Terrorism Task Force. If animals, livestock, or poultry are suspected targets of a terrorist attack, or if any evidence suggests a foreign animal disease may have been or could be intentionally introduced, USDA notifies the Federal Bureau of Investigation to investigate. State governments prepare plans for foreign animal diseases, including FMD; conduct preparedness exercises; and would play a key role in a response effort. In an FMD outbreak, a state animal health official and an APHIS field official would co-lead initial response efforts. For example, state governments might take immediate actions, such as applying quarantines and stop-movement orders. Tribal governments, like state governments, would play a key role in initial response efforts and conduct activities similar to those of state governments. The National Animal Health Laboratory Network is a partnership of 59 federal, state, and university-associated animal health laboratories throughout the United States, of which 45 are approved to administer diagnostic tests for FMD. Livestock industry organizations support communication and education efforts with their members and the public, participate in FMD preparedness exercises, and have helped develop some FMD planning documents. As part of its response to an FMD outbreak, APHIS may access vaccine through the North American Foot-and-Mouth Disease Vaccine Bank (vaccine bank), which is jointly administered by the United States, Mexico, and Canada. Because finished vaccines have a short shelf life, the vaccine bank manages a supply of vaccine concentrate, which can be stored at extremely cold temperatures for about 5 years. Some of the concentrate is stored at the Foreign Animal Disease Diagnostic Laboratory on Plum Island, New York, and some at the manufacturer’s facilities in Lyon, France. During an FMD outbreak, the manufacturer would convert the concentrate into finished vaccine and ship it to the United States. For the concentrate stored in the United States, the vaccine bank would need to first ship it to the manufacturer overseas. APHIS’s National Veterinary Stockpile coordinates logistics planning, particularly for catastrophic outbreaks, and would be responsible for delivering the finished vaccine to affected states, according to USDA planning documents. The FMD virus has seven distinct variations, or serotypes, and more than 60 subtypes within the serotypes, according to USDA documents. FMD vaccine should be as closely matched to the outbreak subtype as possible to provide more effective protection, according to USDA officials and a document on FMD vaccination. A vaccine for one FMD subtype may also provide good or partial immunity to other closely related subtypes, but it would not generally protect against other serotypes. The vaccine bank has concentrate for a number of FMD subtypes that pose the greatest risk to North American livestock based on recommendations from the World Reference Laboratory for FMD. We have previously reported on APHIS’s management of foreign animal diseases, including FMD. For example, in May 2015, we recommended that USDA assess and address its veterinarian workforce needs for emergency response to an outbreak of an animal disease such as FMD. USDA agreed, in part, with the recommendation, and in 2017 hired additional veterinarians. The agency is currently building a model to develop workforce estimates for a large-scale FMD outbreak, according to agency officials. USDA’s planned approach for responding to an FMD outbreak relies on several different strategies emphasizing stamping out, vaccination, or both, depending on factors such as the size of the outbreak. To aid agency officials in implementing the strategies, USDA has developed overarching guidance for responding to animal disease outbreaks and detailed procedures for many response activities. USDA’s APHIS has developed several different, but not mutually exclusive, outbreak response strategies that the agency will consider to control and eradicate FMD in an outbreak as part of its planned approach, according to USDA documents and officials. These strategies rely on stamping out—killing and disposing of—infected and susceptible animals, vaccination of uninfected animals, or both. For strategies involving vaccination, options include killing and disposing of vaccinated animals (vaccinate-to-kill), allowing the animals to be slaughtered and their meat processed (vaccinate-to-slaughter), or allowing the animals to live out their useful lifespan (vaccinate-to-live). Response strategies would likely change as an outbreak unfolds, and might also vary by region or type of animal affected, according to APHIS planning documents. Over time, USDA’s FMD planned approach has evolved from relying solely on stamping out to including vaccination strategies as it became apparent that in many potential scenarios, reliance on stamping out alone would not be effective or feasible. Specifically, in 2010, USDA’s Foot-and- Mouth Disease Response Plan: The Red Book (Red Book) first stated that APHIS would consider vaccination strategies such as vaccinate-to- slaughter and vaccinate-to-live. In 2014 APHIS updated the Red Book with the addition of a vaccinate-to-kill strategy to better distinguish what would happen to animals if they were not eligible for slaughter. By 2016, USDA had determined that complete stamping out of anything beyond a small FMD outbreak was not a viable, effective, or sustainable response strategy for the United States, according to USDA’s FMD vaccination policy. Experiences in preparedness exercises and foreign outbreaks of FMD influenced a shift in USDA’s planned approach toward vaccination strategies. In 2010, Japan and South Korea both experienced FMD outbreaks and initially relied on stamping out combined with strict movement restrictions. Japan stamped out about 300,000 cattle and swine, and South Korea stamped out about 150,000 cattle and 3 million swine—a third of the country’s total swine population. Despite these efforts, FMD continued to spread in both countries until they implemented vaccination strategies, according to USDA documents. A 2007 FMD preparedness exercise, sponsored by the Texas Animal Health Commission and USDA, found that killing and disposing of infected animals in a livestock-dense area like the Texas panhandle would not be feasible in a timely manner because of the large number of animals on infected premises (e.g., 50,000 to 75,000 head of cattle on large cattle feedlots). USDA learned that having vaccination strategies in place would be necessary to effectively respond to an FMD outbreak. If an FMD outbreak occurred, APHIS would select a response strategy or multiple strategies, or it would modify strategies to achieve its FMD response goals based on the unique circumstances of the outbreak, according to agency planning documents. APHIS would do so in consultation with affected states and tribes, and if the agency chose to use vaccine, states would request it from USDA. According to agency planning documents we reviewed, APHIS would consider a number of factors when deciding on its approach, including the following: FMD vaccine availability; consequences of the outbreak (e.g., trade restrictions or loss of valuable genetic stock); public acceptance of response strategy or strategies; scale of the outbreak (i.e., number and size of infected premises); rate of outbreak spread; location of initial outbreak (e.g., isolated ranch versus livestock- producing area); movement of animals (number of locations that infected or potentially infected animals have traveled to or through); and federal and state resources available to implement response strategies. Resource needs vary among strategies and generally increase with the scale of an outbreak, according to USDA planning documents. Having the necessary resources available to implement a stamping-out response strategy would include having qualified personnel to kill animals in accordance with accepted protocols and having appropriate disposal facilities. To implement strategies involving vaccination, APHIS would need a sufficient quantity of vaccine, the resources for distributing and administering the vaccine, and the diagnostic tests necessary to distinguish between vaccinated and infected animals, according to USDA’s FMD vaccination policy. If the scale of an outbreak were small, and APHIS had access to sufficient resources, agency officials would likely implement a stamping-out strategy in an attempt to quickly stop the production of virus in infected animals and limit the outbreak’s spread, according to agency planning documents. However, these planning documents indicate that if the outbreak grew to a moderate regional, large regional, national, or catastrophic scale, the resources required for killing all infected and potentially infected animals, disposing of carcasses, and paying compensation to livestock owners would quickly multiply, and APHIS policy calls for strategies focused on vaccination, according to USDA documents. Over time, USDA’s APHIS has developed various documents to guide its response to FMD, including overarching guidance for responding to FMD and other foreign animal diseases, procedures with in-depth operational details, and plans to secure the nation’s food supply. To aid agency officials in implementing FMD response strategies broadly, APHIS has developed FMD response plans and guidance for responding to foreign animal disease outbreaks more generally. For example, the Red Book describes USDA’s FMD response strategies; identifies the capabilities needed to respond to an FMD outbreak; and provides guidance on the critical activities required during the response, including time frames for these activities. The Red Book is intended for responders at all levels of government and industry partners. For example, if a state official or a livestock owner wanted to know the steps to test and confirm a positive case of FMD, the Red Book explains the process and has a flowchart to illustrate the steps. APHIS also has developed response manuals that provide guidance relevant to foreign animal disease outbreaks, including FMD. For example, a manual on roles and coordination provides an overview of USDA’s framework for incident management, funding, communication strategies, relationships, and authorities during a foreign animal disease outbreak, including an FMD outbreak. APHIS also has produced ready reference guides that condense guidance material from these broader documents into short summary documents for training and education purposes. In addition, APHIS has developed standard operating procedures (SOP) for many response activities. Some SOPs are specific to an FMD outbreak, and others provide more general instruction on activities to respond to foreign animal diseases. The FMD biosecurity SOP, for example, describes steps responders at all levels of government and industry partners can take to help prevent the spread of the virus, such as protocols for putting on and taking off personal protective equipment (e.g., coverall suits, boots, and gloves); standards for separating “clean” and “dirty” zones in vehicles and on premises; and instructions for cleaning and disinfecting vehicles before arrival at and after departure from different premises. Many of the more general SOPs have proven useful during outbreaks of other animal diseases and exercises simulating FMD outbreaks, according to APHIS and state government officials, and APHIS has revised them to incorporate lessons learned. For example, one state animal health official said that during the 2014 avian influenza outbreak, the SOP for disposing of poultry carcasses through composting was initially insufficient because the poultry industry had not previously been composting in all states. To improve consistency across states, APHIS updated protocols during the outbreak and created composting protocols for avian influenza-infected flocks and livestock to supplement the agency’s disposal SOP, which addresses carcass disposal for foreign animal diseases generally. These composting protocols expanded on and clarified guidance to be used in subsequent outbreaks. In addition, APHIS held training on composting procedures for birds and on large animal composting, which could be part of an FMD response. USDA, in coordination with industry, state, federal, and academic representatives, has also developed supply plans to secure the nation’s food supply and keep businesses operating during an FMD outbreak while managing the risk of spreading the virus, which would decrease the economic impact of an outbreak. To date, USDA and its industry and university partners have developed Secure Milk Supply and Secure Pork Supply plans and have partially completed a Secure Beef Supply plan. These plans guide industry on managing uninfected premises and uninfected animals during an FMD or other foreign animal disease outbreak. For example, the Secure Milk Supply plan has guidance on what producers can do to continue moving shipments of milk during an outbreak, including how to implement enhanced biosecurity plans to prevent the spread of FMD to their facilities. The sheep industry is currently developing its own secure food and wool supply plan, according to industry representatives. USDA would likely face significant challenges in pursuing its FMD response goals of detecting, controlling, and containing FMD as quickly as possible; eradicating FMD using strategies that seek to stabilize animal agriculture industries and the economy; and facilitating continuity of commerce in uninfected animals. We identified 11 challenge areas, based on our review of USDA documents, interviews with agency officials and others with expertise with FMD, and 29 responses to our questionnaire. A majority of respondents indicated that in 10 of the 11 areas USDA would face challenges that are significant—that is, important enough to be worthy of USDA action. (See app. I, fig. 7, for a summary of the responses.) For the 11th area, which is communication and coordination, opinions were split on whether the area would present significant challenges. The 11 challenge areas, which sometimes overlap or fall outside of USDA’s direct control, are described below. Examples of actions USDA is taking to address these challenges are described later in this report. USDA would likely face surveillance challenges that could delay detection of the first cases in an FMD outbreak. A majority (22 of 29) of respondents to our questionnaire indicated that USDA would face significant challenges in this area. FMD can spread without detection for the following reasons: there is no active surveillance for FMD, animals may not have visible signs until up to 4 days after becoming signs can be difficult to notice in some species, and infected wild animals could go undetected and spread the virus. For initial detection of an FMD outbreak, USDA relies on passive surveillance, waiting for producers or veterinarians to notice and report visible signs. In contrast, for initial detection of other diseases, such as bovine spongiform encephalopathy (commonly known as mad cow disease), USDA has active surveillance programs in which animals are routinely tested regardless of visible signs. According to USDA officials, the cost and resources required to conduct active surveillance for initial detection of an FMD outbreak would not be justified because the United States has not had an FMD outbreak for decades and there is a risk that false positives could create unnecessary disruptions. However, the officials said the agency would likely use active surveillance during an outbreak. Passive surveillance, however, may not allow for timely detection of the initial cases of FMD, particularly in sheep. FMD infection in sheep often causes only mild signs or symptoms, such as an elevated temperature or loose stool, and in some cases will not cause any overt signs or symptoms at all, even though the animal may be spreading the virus, according to representatives of the sheep industry. Therefore, an FMD outbreak could become widespread before USDA detects the first cases. Even if responders are able to detect FMD in domesticated animals before an outbreak becomes widespread, wild animals may become infected and spread the virus, posing additional challenges for USDA and its partners. For example, the U.S. population of feral swine, which are susceptible to FMD, is estimated at 6 million and is rapidly expanding, according to APHIS. Detecting and controlling infected wild animals could be extremely difficult, according to agency officials, and if not controlled, these populations could serve as carriers for the disease. In addition, limitations in diagnostic capabilities, discussed below, could hamper the availability of data needed for surveillance, such as accurate information on new cases of FMD. USDA would likely face challenges related to its capability to diagnose FMD. Such challenges include the lack of validated population-level diagnostic tests and potentially insufficient resources to collect samples and perform diagnostic testing in a large outbreak. A majority (24 of 29) of respondents to our questionnaire indicated that USDA would face significant challenges in this area. Currently, during an FMD outbreak, USDA would rely on individual animal testing, given that it has not validated any diagnostic tests that can be used for a group or population of animals, according to USDA’s surveillance SOP. If an FMD outbreak expands, the ability to test a large number of animals quickly with minimal resources would be useful for USDA. In a 2017 study of the potential uses of a bulk milk test for FMD in dairy cattle, for example, USDA found that 720 bulk milk tests could replace over 35,000 individual animal tests with the same level of confidence in disease status. However, the study identifies additional work needed to implement bulk milk tests. USDA and state officials investigate suspected cases of FMD on previously uninfected premises, according to USDA documents. To do so, USDA or state officials travel to the suspected premises—sometimes over long distances—collect samples from the animal or animals, and send them to a qualified laboratory for diagnostic testing. During an outbreak, massive quantities of diagnostic testing may need to be conducted, straining the capacity of federal and state laboratories that are qualified to investigate suspected cases of FMD, and potentially causing delays in detecting infected premises, according to both an after-action report for a preparedness exercise and agency officials. In addition, USDA officials we interviewed expressed concern that diagnostic kits used for these individual animal tests would be in short supply during an outbreak and said that they do not currently know how much time it would take for manufacturers to produce more. In the event of a large FMD outbreak, delays in getting diagnostic results could slow USDAs ability to detect, control, and contain an outbreak. USDA would likely face challenges in the area of information management during an outbreak, including incompatible data systems at the state and federal levels or between diagnostic laboratories and USDA and responders who lack familiarity with USDA data systems. A majority (20 of 29) of respondents to our questionnaire indicated that USDA would face significant challenges in this area. USDA and state data systems track information on registered livestock premises and animals. In addition, USDA has an emergency response database for collecting and analyzing data on disease outbreaks and managing response resources. However, state data systems cannot always communicate directly with USDA’s data systems because they use different software, according to two state animal health officials. Such impediments to communication could delay information sharing about the location of infected and susceptible animals. One industry representative said that such delays could prolong decisions about permits for uninfected animals to move, disrupting industries’ continuity of business. According to an academic researcher, interruptions in movement of animals could cause processing facilities to either close, operate at a diminished capacity, or be overwhelmed by a backlog of animals once movement is restarted, leading to animal welfare concerns. These disruptions could present challenges for USDA to facilitate continuity of commerce in uninfected animals, one of its response goals. USDA’s ability to control an outbreak could also be impaired if responders lack familiarity with USDA data systems. For example, according to a USDA after-action report, during the 2014 avian influenza outbreak, some responders were unfamiliar with USDA’s system for entering outbreak response information, resulting in incorrect usage or underutilization of the system. As a result, USDA’s overall response was slower than it would have been if timely information had been available. USDA would likely face challenges related to the traceability of animals (i.e., the ability to trace their locations and movements) after an outbreak was detected. We found that these challenges result from insufficient use of identification numbers for livestock premises (such as farms and ranches) and individual animals to enable tracing of infected, exposed, and susceptible animals, and from identification numbers that cannot be easily read (e.g., because they are not electronic). A majority (25 of 29) of respondents to our questionnaire indicated that USDA would face significant challenges in this area. In an outbreak, responders would use premises and animal identification numbers, if available, to trace the location and movements of infected animals to identify other animals that may have been exposed. They would also use the identification numbers to locate all susceptible animals in the region, in order to notify owners about the outbreak and any response measures in place, such as stop- movement orders. These activities would be hampered without the identification numbers. For example, Iowa and Texas regulations do not require producers to register all of their animals with the state. Also, record keeping varies at individual farms and ranches, where some producers have electronic records, but others have no written records or rely on hand-written paper documents, according to USDA documents. Searching through records by hand at individual farms could take days rather than the hours that it would take if the records were electronic, according to a USDA planning document. Without timely and accurate tracing through the use of premises and animal identification numbers, USDA may face challenges controlling and containing an FMD outbreak and facilitating continuity of commerce in uninfected animals. In addition, some animals have identification numbers on ear tags that must be read visually, which could slow USDA’s efforts to control and contain an outbreak. In an outbreak, responders would need to inspect animals with such ear tags to manually read and record the identification numbers for individual animals. In contrast, for animals with electronic tags, responders could use electronic readers, which can accurately read identification numbers for a group of animals from a distance of up to 12 feet, according to a 2016 USDA study on electronic identification for livestock. One industry representative said that the beef cattle industry has not widely implemented electronic identification because it is difficult for many operators to justify the added cost of purchasing and attaching an electronic tag for each animal. In an FMD outbreak, USDA would likely face biosecurity challenges including lack of sufficient biosecurity on some premises, difficulty in implementing biosecurity measures for certain species, and lack of documentation (such as a written plan) specifying what measures are currently in place. A majority (20 of 29) of respondents to our questionnaire indicated that USDA would face significant challenges in this area. If sufficient biosecurity measures are not consistently in place on farms, ranches, and feedlots, people and vehicles may inadvertently spread the FMD virus when they travel among premises, impeding USDA’s ability to control and contain an outbreak. For example during the 2001 FMD outbreak in the United Kingdom, poor biosecurity and livestock owners’ movements between scattered farms led to the introduction of FMD in previously uninfected areas, according to a 2002 report by the United Kingdom’s National Audit Office. Some livestock owners have not implemented extensive biosecurity measures on their premises, in part because they have not experienced a recent animal disease outbreak and measures may be difficult or expensive to implement, according to an industry representative. In addition, it may be difficult to implement biosecurity measures for certain species. For example, cattle feedlots operate outdoors and may have unrestricted points of entry and exit, so it can be more difficult and costly to control access and implement other biosecurity measures. In addition, even if producers have biosecurity measures in place, these measures may not be sufficiently documented to facilitate continuity of commerce in uninfected animals. According to USDA guidance documents, during an FMD outbreak, premises in areas with movement restrictions will be required to obtain permits to move any animals or animal products. To obtain such a permit, producers must show that they are not contributing to the spread of disease or putting their animals at risk of exposure, and producers without documented biosecurity plans may face delays moving their animals. According to swine industry representatives, even swine farms with biosecurity procedures do not always document such procedures or the steps they have taken. USDA would likely face depopulation challenges during an FMD outbreak, including limited capability for killing large numbers of animals in a timely manner and difficulties owing to the large size of some animals affected by FMD. A majority (22 of 29) of respondents to our questionnaire indicated that USDA would face significant challenges in this area. For example, USDA officials said killing animals in large feedlots—which can hold 50,000 or more animals—would quickly overwhelm resources, such as the staff and equipment required to kill animals. USDA policy calls for depopulating infected premises within 24 hours, but this may not be feasible on large livestock operations because the animals have to be killed individually, which would be time-consuming according to an industry representative. If infected premises are not quickly depopulated, animals will continue producing the virus and increase the risk of infecting animals on additional premises, hampering USDA’s ability to control and contain an outbreak. Rapid depopulation of infected swine is particularly critical to containing the spread of an outbreak because swine are known as amplifiers of FMD virus, producing and excreting 3,000 times more virus than cattle or sheep, according to USDA documents. USDA would likely face disposal challenges during an FMD outbreak, including the feasibility and logistics of disposing of a large number of animal carcasses, public concern about disposal options, and the environmental impacts of disposal. A majority (25 of 29) of respondents to our questionnaire indicated that USDA would face significant challenges in this area. In a large FMD outbreak, millions of cattle could be affected. It is possible that FMD can survive for several months on a frozen carcass, according to USDA documents, so if such carcasses are not disposed of properly, they could pose a risk for spreading FMD, hampering USDA’s efforts to control and contain an outbreak. Disposing of the carcasses of a 50,000- head herd of cattle from a large feedlot would be a massive effort: the total weight for disposal could be as much as 30,000 tons, or about 1,500 dump truck loads to move all the animals to disposal sites, according to an industry representative. One state animal health official stated that disposal of one or two herds may be possible, but if an outbreak were more widespread, the state would quickly run out of options. In addition, certain disposal strategies, such as incinerating large piles of carcasses, may cause a negative public reaction, according to an industry representative, USDA’s disposal SOP, and state animal health officials. Figure 5 illustrates carcass disposal during a 2001 FMD outbreak in the United Kingdom, where the government implemented a policy of stamping out all susceptible animals within 3 kilometers of known FMD cases. In reaction to the policy, the public staged protests, and businesses in rural areas lost customers who stayed away because of the striking images in the media, according to a 2002 report by the University of Newcastle. Finally, carcass disposal can create environmental impacts, such as when a burial site contaminates the groundwater or incineration contaminates the air. In general, states regulate disposal, including such things as the timing (e.g., within 24 hours of an animal’s death) and the method of disposal (e.g., prohibiting outdoor incineration or specifying that up to 7 cattle may be buried per acre per year). In an FMD outbreak, large numbers of carcasses could make it difficult to comply with such regulations. USDA would likely face resource challenges in pursuing its FMD response goals, including insufficient numbers of incident responders to effectively implement USDA strategies in a medium or large outbreak, as well as insufficient resources devoted to preparedness planning in some states. A majority (23 of 29) of respondents to our questionnaire indicated that USDA would face significant challenges in this area. During the 2014 avian influenza outbreak, there were difficulties quickly providing response resources, such as personnel and equipment, to rapidly stamp out affected flocks, according to a USDA after-action report. According to an academic researcher, an FMD outbreak would be significantly more difficult to handle than recent avian influenza outbreaks. One state official noted that in his state there is not enough of a workforce to adequately respond to an outbreak, and there is no assigned workforce at the local level. For example, this official noted that his state employed only two veterinarians and a few animal health technicians to collect samples for testing in the event of an FMD outbreak. Other state animal health officials expressed concern that states and counties will have difficulty fielding adequate workforces to inspect animal transport vehicles and implement stop-movement orders. Insufficient preparedness planning in some states could also hamper response efforts, according to a response to our questionnaire from an academic researcher with expertise in FMD preparedness. Some states have not allocated resources to develop FMD response plans, including, for example, the conditions that would trigger a stop-movement order. States typically control intrastate movement under the state’s authority, and if states delay issuing stop-movement orders, it may be more difficult for USDA to control and contain an outbreak. Communication and coordination may be an area where USDA could face challenges during an FMD outbreak because of ineffective external or internal communications and unclear roles and responsibilities. Responses to our questionnaire in all categories (federal and state government officials, industry representatives, and academic researchers) were mixed about whether communication and coordination was an area with significant challenges. Specifically, 11 respondents said it was an area with significant challenges, 12 said it was not, and 6 were unsure. One industry respondent who said that the area was not a challenge cited a team of industry representatives that is working with USDA and states to prepare for an FMD outbreak. On the other hand, during a 2016 FMD preparedness exercise in Texas, coordination between USDA and other participants was at times inadequate. For example, during the exercise USDA and the Texas Animal Health Commission shared leadership of the response effort, and some respondents cited frustration with this top-down leadership structure because they were accustomed to emergency management practices and protocols designed for incidents such as natural disaster response efforts, which are generally initiated at the local level. Participants commented that they were confused about who did what and said that coordination needs to be improved between USDA and local governments, according to an after-action report. Also, communication across participating agencies broke down. For example, information from USDA on stop-movement orders, the size of the quarantine zone, and the number of sites quarantined did not reach all stakeholders in a timely manner, according to an after-action report. Compensating livestock owners for animals or equipment that the government determines must be destroyed to limit the spread of FMD would likely pose various challenges for the agency. USDA would provide the owners with up to 100 percent of the expenses of purchase, destruction, and disposition of animals or materials required to be destroyed, based on the agency’s appraisal of the fair market value. Doing so would likely pose various challenges for the agency, according to USDA and state government officials. A majority (19 of 29) of respondents to our questionnaire indicated that USDA would face significant challenges in this area. Such challenges include uncertainties about fair appraisal methods (especially when an outbreak has caused livestock prices to decline), owners resisting killing their animals if compensation rates are too low, and the potentially massive scale of compensation payments. According to USDA economists, if trade restrictions were imposed during an FMD outbreak, the fair market value of animals and their products would likely drop as a result of oversupply. USDA’s response to the outbreak could be slowed if producers brought legal challenges to stop the stamping out of their herds because they were not satisfied with compensation levels, a scenario that took place in a 2018 USDA-led exercise simulating the first few days of an FMD outbreak. Moreover, in a widespread FMD outbreak, the scale of federal compensation payments could be substantial. For example, in the 2001 United Kingdom FMD outbreak, compensation costs were estimated at over $1 billion for the killing of about 6 million animals. Given the larger size of the livestock industry in the United States, federal compensation costs could be much higher, depending on the number of animals killed as part of the response. USDA would likely face challenges related to vaccination, an area of particular importance given vaccination’s central role in USDA’s strategies for pursuing its response goals. All 29 respondents to our questionnaire agreed that the challenges USDA faces related to vaccination are significant. In particular, USDA does not have access to sufficient vaccine to achieve its response goals under many potential outbreak scenarios, and there is not consensus about how to allocate the limited supply, according to USDA officials and documents. Other challenges in this area relate to the timing and logistics of obtaining, distributing, and administering vaccine and to scientific, procedural, and infrastructure issues in vaccine production. Supplies of FMD vaccine concentrate in the vaccine bank may be sufficient to help control and eradicate a small, localized outbreak, but it is unlikely that they would be sufficient to stop a larger outbreak, according to USDA planning documents and officials. With a vaccine that is matched to the appropriate FMD subtype, a single dose can protect cattle for 6 months, and two doses are required to provide the same protection to swine. APHIS’s 2016 FMD vaccination policy states that 25 million doses for each of 10 subtypes of the virus is an appropriate minimum target to have available. However, the United States currently has access to only 1.75 million doses of each subtype available in the vaccine bank, according to USDA documents. In the United States, there are 24 states in which the number of livestock exceeds the doses available in the vaccine bank, according to USDA documents. In a 2016 report to Congress, USDA stated that the cost to reach its target of 25 million doses would be about $125 million, which would be about 10 percent of APHIS’s budgetary resources in fiscal year 2016. In addition, because the vaccine concentrate has a 5-year shelf life, USDA would incur costs to routinely replace the supply of concentrate, according to agency officials. The Agriculture Improvement Act of 2018 contains a provision that directs the Secretary of Agriculture to establish a national animal vaccine and veterinary countermeasures bank, and to prioritize the acquisition and maintenance of sufficient quantities of FMD vaccine and accompanying diagnostic products. The need for additional FMD vaccine was reinforced by a 2016 survey of states by USDA and Iowa State University. On the basis of responses from 32 state animal health officials, the authors estimated that in a widespread or national outbreak, states would plan to use on average 4.2 million doses during the first 14 weeks of the outbreak. Based on these estimates, a vaccine request from a single state could greatly exceed the 1.75 million doses available per subtype in the vaccine bank’s supply. Moreover, if an FMD outbreak occurred in Texas or Iowa, the states with the largest cattle and swine populations, respectively, the available vaccine supply would provide a single dose for about 14 percent of Texas’s 12.3 million cattle or the required two doses for about 4 percent of Iowa’s 22.8 million swine. Texas’s and Iowa’s cattle and swine populations together make up about 24 percent of the combined population of cattle and swine nationwide. Figure 6 illustrates the vaccine doses needed to protect cattle and swine in Texas and Iowa compared with the currently available FMD vaccine bank supply of 1.75 million doses per subtype. In addition, because of the large number of FMD subtypes present around the world, and because the FMD virus is constantly mutating, it is possible that an FMD subtype could be introduced in the United States that is not covered by vaccines currently in the vaccine bank. According to a representative from an FMD vaccine manufacturer, producing a vaccine for a new subtype of FMD could take from 6 to 18 months, depending on whether the subtype was known and other factors. Because of the limited supply of vaccine and the potentially high demand for it, USDA would likely face the challenge of deciding how to allocate it in an FMD outbreak. In a 2016 survey of 13 industry veterinarians, there was no consensus within the beef, dairy, and swine industries about priorities for the vaccine. Specifically, USDA and Iowa State University asked the veterinarians to rank the importance of vaccinating various populations (e.g., bull studs, lactating cows, and boar studs) within the beef, dairy, and swine industries, assuming there was only enough vaccine to vaccinate 25 to 50 percent of animals in a specified area. The responses varied widely, with high and low rankings for nearly every population of animals. The timing and logistics of obtaining, distributing, and administering the FMD vaccine could also pose challenges. The timing to reformulate the banked vaccine would pose challenges for USDA in an outbreak, according to respondents to our questionnaire. In addition, in March 2005, we found that USDA would not be able to deploy vaccines rapidly enough to contain a widespread FMD outbreak. After USDA requests FMD vaccine from the vaccine bank, vaccine manufacturers could take from 4 to 13 days to finish and ship all of the requested vaccine to the United States, during which time the virus could spread within the livestock population, according to USDA documents. If the vaccine bank’s supply of concentrate is exhausted during an outbreak and more is needed, manufacturers may take several months to produce it, according to a vaccine manufacturer. After obtaining the vaccine, USDA would distribute it to affected states, and the states would distribute it to veterinarians, producers, or others who would be responsible for administering vaccine, according to USDA and state FMD vaccination documents. Many states do not currently have vaccination plans in place and may not have identified the warehousing locations, staff needs, and tracking required to efficiently distribute FMD vaccine, according to agency and state government officials, which could slow USDA’s efforts to contain and control an outbreak. States with vaccination plans may be able to more quickly and effectively distribute and administer FMD vaccine during an outbreak. For example, California has a vaccination plan that details how it would receive, distribute, and administer FMD vaccine while maintaining the appropriate temperatures and documentation. The plan includes details such as the supplies needed for administering FMD vaccine to cattle. USDA faces challenges in obtaining vaccine and using it in a response effort because of scientific, procedural, and infrastructure challenges related to the vaccine and its production. There are very few vaccine manufacturers in the world with the capacity to produce most of the FMD vaccine subtypes and meet the quality standards required by the United States, according to agency officials. Further, there is currently no production capacity for FMD vaccine in the United States because dedicated infrastructure is not in place to produce vaccines without live virus. There is a statutory prohibition against working with live FMD virus on the U.S. mainland, absent a permit granted by the Secretary of Agriculture, and live virus is needed to produce conventional vaccines. To work within this constraint, USDA’s Agricultural Research Service (ARS) and DHS developed new technologies to produce vaccine using modified versions of the virus that are unable to cause or transmit disease. The agencies transferred these technologies to vaccine companies that are investing in their development, according to USDA officials. In 2018, the Secretary of Agriculture announced that vaccine companies could apply for permits to work with a specific modified, noninfectious version of the FMD virus on the mainland. One company has exclusive rights to use this modified version, which was developed and patented by ARS. The company plans to produce FMD vaccine in the United States, but it could take several years to license the initial product, complete the necessary permitting procedures, and build manufacturing infrastructure, according to USDA documents and a company official. Using FMD vaccine to respond to an outbreak presents additional challenges that are related to limitations of FMD vaccines. Specifically, animals may take up to 28 days after vaccination to develop protective immunity to FMD, depending on the species, potency of vaccine, and other factors. Even after 28 days, some vaccinated animals may not be fully immune to FMD and may continue spreading the virus despite having no visible signs of infection, according to USDA documents. To mitigate challenges in responding to potential FMD outbreaks, USDA’s APHIS has identified corrective actions through preparedness exercises, surveys, and lessons learned in other outbreaks, as called for in its SOPs. However, APHIS generally does not follow its SOPs for prioritizing or monitoring the completion of these actions. A USDA SOP outlines a process for identifying corrective actions to improve the agency’s preparedness for outbreaks of foreign animal diseases. According to the SOP, APHIS is to identify corrective actions after preparedness exercises and animal disease incidents. Consistent with this SOP, APHIS identifies corrective actions for FMD preparedness through exercises simulating FMD outbreaks, surveys of agency officials and others, and lessons learned from outbreaks of other diseases. More specifically, see the following: APHIS sponsors FMD preparedness exercises and participates in some such exercises that other federal or state agencies sponsor. After an exercise, the sponsoring agency generally prepares an after- action report that specifies corrective actions, and may include a responsible party for and a date for completing each action. APHIS has after-action reports for more than 40 FMD preparedness exercises that it sponsored or participated in from 2007 through 2018, which include corrective actions for USDA and APHIS. APHIS conducts annual surveys of its staff and others—including state government officials, industry representatives, and academics— to identify corrective actions related to preparedness and response training needs. APHIS identifies corrective actions for FMD preparedness based on lessons learned after outbreaks of other diseases. For example, some of the actions that APHIS identified after outbreaks of avian influenza, such as improving a database used for emergency response, could also help the agency mitigate challenges it would face in an FMD outbreak, according to agency officials. APHIS has identified dozens of corrective actions in all 11 of the areas where we identified challenges for USDA in pursuing its FMD response goals. APHIS has taken corrective actions in each area. For example, to help mitigate the challenge of insufficient biosecurity on some premises, the agency partnered with Iowa State University to offer producers across the nation training on developing enhanced biosecurity plans for implementation during a foreign animal disease outbreak. However, APHIS has not yet taken some other corrective actions that it has identified. According to agency officials and experts we interviewed, these corrective actions can help mitigate, but may not completely resolve, the challenges identified. Some challenges may be outside USDA’s control to fully resolve. For example, the logistical challenges of carcass disposal could be overwhelming in a large-scale outbreak, which could generate thousands of tons of carcasses. A corrective action calling for training on carcass management may help educate FMD responders about disposal methods or preventing environmental impacts; however, such training may not fully resolve the challenge. Table 1 shows examples of corrective actions identified by USDA in after- action reports, planning documents, other agency documents, or interviews, which the agency has taken or not yet taken for the 11 challenge areas we identified. Some of the corrective actions that USDA has identified and taken relate to the challenge area of vaccination. For example, to help speed access to vaccine, in 2018, the Secretary of Agriculture announced that vaccine companies could apply for permits to enable them to develop and produce certain types of FMD vaccine in the United States in the future, thereby avoiding delays from producing the vaccine overseas and shipping it here. Also, APHIS officials have used an FMD predictive model to evaluate the effectiveness of different vaccination schemes at the state level, and they told us that they plan to conduct a similar analysis at the national level. The results could help inform USDA’s vaccine prioritization decisions in advance of an outbreak, according to the officials. USDA has also begun implementing other corrective actions that have been identified related to FMD vaccination, although more work remains. For example, in February 2009, we recommended—and USDA agreed— that it should detail in a contingency response plan how a response using vaccines would be implemented. Similarly, after-action reports for 2013 and 2016 preparedness exercises highlighted the need for procedures to guide the implementation of FMD vaccination strategies. APHIS has taken or planned several steps to help address this need: In 2009, APHIS began drafting vaccine implementation procedures but realized that the national procedures needed to be developed in collaboration with states because of variation among states in their predominant industries, agriculture infrastructure, and government resources. When more states have developed vaccination implementation procedures, APHIS may revise and finalize the national procedures originally drafted in 2009, according to agency officials. APHIS’s National Veterinary Stockpile developed plans in 2009 and 2011 outlining how some aspects of a vaccination strategy would be implemented. Specifically, in 2009 it developed a template that states and tribes can use to develop their own plans, and in 2011 it prepared a logistical plan for distributing FMD vaccine to the field. The National Veterinary Stockpile also held preparedness exercises from 2008 to 2018 for states and tribes to practice requesting, receiving, and delivering the vaccine and to obtain information that could help APHIS develop national vaccination procedures. From 2011 to 2018, APHIS and the California Department of Food and Agriculture worked together to draft detailed procedures for implementing an FMD vaccination strategy in California. The draft procedures and related planning documents are intended to serve as templates to help other states develop such procedures, according to agency officials. APHIS also piloted a workshop on FMD vaccination planning in October 2018 and plans to hold related preparedness exercises with states from 2019 to 2021. Although APHIS has identified dozens of corrective actions for FMD preparedness, it has not consistently followed its SOP for prioritizing all of the actions and monitoring progress in implementing them. Specifically, once corrective actions have been identified, APHIS’s SOP calls for prioritizing the actions in an improvement plan, and monitoring the actions to track their completion. APHIS has sometimes designated actions related to FMD vaccination as high priority during annual management meetings, but not all corrective actions have been prioritized, according to agency officials. For example, a 2016 corrective action called for USDA to conduct an exercise to explore roles, responsibilities, and activities related to recovery from a large-scale animal disease outbreak. However, as of December 2018, this action has not been prioritized in an improvement plan, according to the after-action report and an agency official. In addition, corrective actions have sometimes been identified multiple times without being tracked to completion. For example, an after-action report for a 2007 exercise found that a process for making vaccine- allocation decisions was needed and suggested that a vaccine advisory group could assist with doing so. A 2014 after-action report stated that processes governing vaccine prioritization and allocation were not clear and identified a corrective action calling for USDA to develop a federal- level doctrine for vaccine prioritization and allocation. USDA’s 2016 FMD vaccination policy states that APHIS, in coordination with state, local, and industry stakeholders, should consider developing processes, procedures, and strategies for prioritizing the use of currently available vaccine in an outbreak. However, APHIS has not developed processes, procedures, or strategies for prioritizing and allocating its supply of FMD vaccine, according to agency officials. The officials said they have not developed such a process because of limited resources and competing priorities. Also, it would require participation from state and industry stakeholders, and given the small quantity of FMD vaccine relative to the large number of susceptible animals in the country, the stakeholders have had little incentive to devote the necessary time to the issue, according to agency officials. More generally, agency officials told us that the agency has not prioritized or monitored completion of some corrective actions because they have been responding to actual outbreaks of animal and plant diseases. They also noted that they have limited resources for FMD preparedness, which may make it difficult for them to complete all of the corrective actions that have been identified. However, for avian influenza preparedness, APHIS compiled and prioritized more than 300 corrective actions in a database and tracked more than 200 of them to completion. Through this process, it completed nearly all of the 111 high-priority actions and over 100 moderate-priority actions, according to its database as of May 2018. For example after the 2014 avian influenza outbreak, APHIS completed corrective actions that improved its response to a subsequent outbreak in 2016, according to agency documents. The corrective actions addressed such issues as how to quickly depopulate and dispose of infected poultry and efficiently compensate affected producers. APHIS continues to monitor its progress in implementing the remaining corrective actions for that disease, according to agency officials. APHIS’s SOP calls for prioritizing corrective actions to identify the most beneficial use of resources. The SOP also calls for monitoring corrective actions to track their completion so that APHIS can improve its response capabilities and correct problems or deficiencies identified in exercises or incidents. Without following its SOP to prioritize corrective actions for FMD preparedness, APHIS cannot ensure that it is allocating its limited resources toward implementing the most beneficial actions. And without following its SOP for monitoring the corrective actions, APHIS cannot ensure that the highest-priority actions are completed. APHIS has taken important steps to prepare for an FMD outbreak and to mitigate challenges it may face in responding to one. For example, the agency has developed an extensive collection of strategy and guidance documents, held FMD preparedness exercises to practice response activities, and identified dozens of corrective actions and completed some of these actions. However, APHIS has not yet completed other corrective actions, including actions that have been identified multiple times, such as developing a process for prioritizing and allocating the limited supply of FMD vaccine. APHIS has an SOP for prioritizing and monitoring corrective actions. By following this SOP for avian influenza preparedness, the agency succeeded in prioritizing more than 300 corrective actions and tracking over 200 corrective actions to completion, including nearly all high-priority actions. In contrast, for FMD preparedness, APHIS has not consistently prioritized or monitored the corrective actions it has identified. Without following its SOP to prioritize and monitor corrective actions for FMD preparedness, APHIS cannot ensure that it is allocating its limited resources to the most beneficial actions to prepare for a possible FMD outbreak. We are making the following two recommendations to USDA: The Administrator of the Animal and Plant Health Inspection Service should follow the agency’s SOP to prioritize corrective actions for FMD preparedness. (Recommendation 1) The Administrator of the Animal and Plant Health Inspection Service should follow the agency’s SOP to monitor progress and track completion of corrective actions for FMD preparedness. (Recommendation 2) We provided a draft of this report to USDA and DHS for review and comment. USDA provided comments, reproduced in appendix II, in which it agreed with our recommendations. In addition, USDA and DHS provided technical comments, which we incorporated as appropriate. In response to our recommendations, USDA said that, starting in the second quarter of fiscal year 2019, APHIS will implement the agency’s SOP and prioritize corrective actions to be tracked in its corrective actions database, as we recommended. USDA also said that, starting in the third quarter of fiscal year 2019, APHIS will assess and update the items related to FMD in its corrective actions database, as we recommended. In addition, USDA said that APHIS will track accomplishments it makes under a related provision of the Agriculture Improvement Act of 2018. We are sending copies of this report to the appropriate congressional committees, the Secretary of Agriculture, the Secretary of Homeland Security, and other interested parties. In addition, the report is available at no charge on the GAO website at http://www.gao.gov. If your or your staff have any questions about this report, please contact me at (202) 512-3841 or morriss@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix III. This report (1) describes the U.S. Department of Agriculture’s (USDA) planned approach for responding to a foot-and-mouth disease (FMD) outbreak; (2) identifies what challenges, if any, USDA would face in pursuing its FMD response goals; and (3) examines how USDA identifies, prioritizes, and monitors corrective actions to mitigate these challenges. To describe USDA’s planned approach for responding to an FMD outbreak, we reviewed relevant legislation and USDA strategy and guidance documents. We also interviewed officials from USDA’s Animal and Plant Health Inspection Service (APHIS) at the agency’s headquarters in Riverdale, Maryland; laboratories on Plum Island, New York, and in Ames, Iowa; center for epidemiology and animal health in Fort Collins, Colorado; and center for veterinary biologics in Ames, Iowa; and officials from the Department of Homeland Security (DHS) and the Agricultural Research Service (ARS) at DHS’s Plum Island Animal Disease Center on Plum Island, New York. We selected these officials to interview because of their knowledge about USDA’s planned approach, their involvement in preparing for an FMD outbreak, and the roles they would play in responding to such an outbreak. To identify what challenges, if any, USDA would face in pursuing its FMD response goals, we first came up with a list of potential challenge areas. To develop the list of potential challenge areas, we reviewed USDA documents, reports about FMD outbreaks in other countries, and after- action reports from 41 preparedness exercises in the United States from 2007 to 2018 in which officials practiced responding to simulated FMD outbreaks and identified emerging challenges. The preparedness exercises included small-scale as well as large-scale ones with a variety of participants, durations, and response activities. We also interviewed APHIS headquarters staff and field staff in Iowa (the state with the most livestock); APHIS and ARS laboratory officials; state animal health officials in California, Colorado, Iowa, and North Carolina; representatives from the beef cattle, dairy cattle, swine, and sheep industries; and academic researchers with expertise in this area. We selected the individuals to interview based on their knowledge about challenges that USDA could face in pursuing its FMD response goals, their central role in preparing for an FMD outbreak, and recommendations from other interviewees, as well as diversity in geographic location. We also visited a swine farm and cattle feedlot in Iowa and interviewed the owners. We selected a swine farm and cattle feedlot to visit because swine and cattle were the livestock industries with the greatest populations of animals in the United States in 2016. We identified a list of 11 potential challenge areas. To confirm the significance of the challenge areas, we used a questionnaire with the list of potential challenge areas. To select the questionnaire recipients, we identified four categories of people who are knowledgeable about challenges that USDA could face in pursuing its FMD response goals, including those who could be involved in a response effort. The four categories are (1) federal government officials, (2) state government officials, (3) livestock industry representatives, and (4) academic researchers with expertise in FMD preparedness. For categories with multiple individuals, we selected individuals to represent relevant units within APHIS, ARS, and DHS (e.g. headquarters; field offices; laboratories; surveillance, preparedness and response services; and science, technology, and analysis services); different livestock industries (beef cattle, dairy cattle, swine, and sheep); and states with relatively high livestock populations. We asked the recipients whether USDA would face a significant challenge in each of the 11 areas and whether they knew of other challenge areas we had not listed. We defined significant to mean a challenge that is sufficiently great or important enough to be worthy of USDA action to address the challenge. We initially sent the questionnaire with potential challenges to 39 recipients. Two federal officials had retired from their positions, so we sent the list to their replacements. Of the 39 recipients, we received responses from 28. We also included an additional response that APHIS provided from an official who we had not initially contacted and who had relevant expertise, for a total of 29 responses. Despite two follow-up attempts, we did not receive responses from 11 recipients, including both recipients from ARS, 5 of the 18 from APHIS, 3 of the 10 state animal health officials, and 1 of the 2 national animal health laboratory network officials (these are affiliated with universities). Figure 7 shows the categories of respondents and their responses in each of the11 challenge areas. Since we used a nonprobability sample, the results are not generalizable to all government officials, livestock industry officials, or FMD experts, but the responses helped confirm the list of 11 challenge areas and provided illustrative information about each one. We reviewed challenges related to vaccination for FMD in greater depth than other challenges because of the significant role vaccination could play if reliance solely on stamping out is not feasible. Specifically, we visited DHS’s Plum Island Animal Disease Center on Plum Island, New York, where we interviewed officials from USDA’s Foreign Animal Disease Diagnostic Laboratory and the Agricultural Research Service, as well as DHS officials, about challenges related to FMD vaccination. We also reviewed agency documents on the topic and interviewed other officials from USDA, the North American Vaccine Bank, universities, states, and industry groups about issues related to FMD vaccination. Further, we interviewed officials from the vaccine company that currently produces the majority of FMD vaccine available for use in the United States and a company that has rights to use a modified version of the FMD virus to produce FMD vaccine in the future. To determine how USDA identifies, prioritizes, and monitors corrective actions to mitigate the challenges, we reviewed APHIS and DHS guidance on evaluation and improvement planning and other agency documents, observed an FMD preparedness exercise, reviewed after- action reports from 41 FMD preparedness exercises conducted from 2007 through 2018, and interviewed USDA officials. We reviewed APHIS’s and DHS’s procedures for evaluation and improvement planning to understand how APHIS is to identify, prioritize, and monitor corrective actions. To determine whether APHIS was consistently following these procedures, we observed the preparedness exercise at APHIS’s Riverdale, Maryland, office; reviewed a preliminary after-action report for that exercise; and reviewed after-action reports for the 41 other preparedness exercises. We interviewed APHIS officials about corrective actions identified in the after-action reports and what steps the agency has taken to prioritize the actions and monitor their progress. We reviewed agency documents about these procedures and about actions USDA has taken and identified but not yet taken to mitigate challenges. To find examples of corrective actions that USDA has identified and taken or not yet taken, we reviewed after-action reports for the 41 preparedness exercises; APHIS’s 2018-2020 training and exercise plan for its veterinary services emergency preparedness and response unit; and other agency documents, such as contracts and plans, and interviewed agency officials. The examples of corrective actions in table 1 are illustrative only and do not include or represent all of the actions that USDA has identified. We sent a draft table of examples to APHIS officials and incorporated their comments as appropriate. We also reviewed a GAO report on USDA’s management of highly pathogenic avian influenza (avian influenza) outbreaks; interviewed agency officials; reviewed USDA after-action reports for avian influenza outbreaks; and reviewed USDA’s database of related corrective actions to learn how the agency identifies, prioritizes, and monitors actions to mitigate challenges for that disease. To assess the overall reliability of that database to use information from the database in our report, we reviewed management controls over the information systems that maintain the data and interviewed USDA officials who manage the database. We determined that the database was sufficiently reliable to describe the contents of the database and general status of corrective actions. We conducted this performance audit from May 2017 to March 2019 in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives. In addition to the contact named above, Nico Sloss (Assistant Director), Kevin Bray, Emily Christoff, Mary Denigan-Macauley, Christine Feehan, Jesse Lamarre-Vincent, Cynthia Norris, Anne Rhodes-Kline, and Amber Sinclair made key contributions to this report. Ross Campbell, Barb El Osta, Kathryn Godfrey, Hayden Huang, and Dan Royer also made important contributions to this report. Foot-and-Mouth Disease: USDA’s Evaluations of Foreign Animal Health Systems Could Benefit from Better Guidance and Greater Transparency. GAO-17-373. Washington, D.C.: April 28, 2017. Avian Influenza: USDA Has Taken Actions to Reduce Risks but Needs a Plan to Evaluate Its Efforts. GAO-17-360. Washington, D.C.: April 13, 2017. Emerging Animal Diseases: Actions Needed to Better Position USDA to Address Future Risks. GAO-16-132. Washington, D.C.: December 15, 2015. Federal Veterinarians: Efforts Needed to Improve Workforce Planning. GAO-15-495. Washington, D.C.: May 26, 2015. Homeland Security: An Overall Strategy Is Needed to Strengthen Disease Surveillance in Livestock and Poultry. GAO-13-424. Washington, D.C.: May 21, 2013. Veterinarian Workforce: Actions Are Needed to Ensure Sufficient Capacity for Protecting Public and Animal Health. GAO-09-178. Washington, D.C.: February 4, 2009. High-Containment Biosafety Laboratories: DHS Lacks Evidence to Conclude That Foot-and-Mouth Disease Research Can Be Done Safely on the U.S. Mainland. GAO-08-821T. Washington, D.C.: May 22, 2008. National Animal Identification System: USDA Needs to Resolve Several Key Implementation Issues to Achieve Rapid and Effective Disease Traceback. GAO-07-592. Washington, D.C.: July 6, 2007. Avian Influenza: USDA Has Taken Important Steps to Prepare for Outbreaks, but Better Planning Could Improve Response. GAO-07-652. Washington, D.C.: June 11, 2007. Homeland Security: Much Is Being Done to Protect Agriculture from a Terrorist Attack, but Important Challenges Remain. GAO-05-214. Washington, D.C.: March 8, 2005.

Question: Write a one-page summary of the report 1.

Answer: Title IV of the Higher Education Act (HEA) authorizes programs that provide financial assistance to students to assist them in obtaining a postsecondary education at certain institutions of higher education (IHEs). These IHEs include public, private nonprofit, and proprietary institutions. For students attending such institutions to be able to receive Title IV assistance, an institution must meet basic criteria, including offering at least one eligible program of education (e.g., programs leading to a degree or preparing a student for gainful employment in a recognized occupation). In addition, an IHE must satisfy the program integrity triad, under which it must be licensed or otherwise legally authorized to operate in the state in which it is physically located, accredited or preaccredited by an agency recognized for that purpose by the Department of Education (ED), and certified by ED as eligible to participate in Title IV programs. These requirements are intended to provide a balance between consumer protection, quality assurance, and oversight and compliance in postsecondary education providers participating in Title IV student aid programs. An IHE must also fulfill a variety of other related requirements, including those that relate to institutional recruiting practices, student policies and procedures, and the administration of the Title IV student aid programs. Finally, additional criteria may apply to an institution depending on its control or the type of educational programs it offers. For example, proprietary institutions must meet HEA requirements that are otherwise inapplicable to public and private nonprofit institutions, including deriving at least 10% of their revenues from non-Title IV funds (also known as the 90/10 rule). While an institution is ineligible to participate in Title IV programs if more than 50% of its courses are offered by correspondence or if 50% or more of its students are enrolled in correspondence courses. This report first describes the types of institutions eligible to participate in Title IV programs and discusses the program integrity triad. It then discusses additional issues related to institutional eligibility, including program participations agreements, required campus safety policies and crime reporting, and distance and correspondence education.