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	Background

CMS and states jointly administer the Medicaid program and generally  share in the financing of Medicaid payments according to a formula  established in law. States may deliver health care services to Medicaid  beneficiaries through fee-for-service payments to participating providers  or through Medicaid managed care plans, through which states pay plans  a fixed amount per beneficiary—typically per member per month—to  provide a specific set of Medicaid-covered services. States finance their  share (nonfederal share) of Medicaid program spending in a variety of  ways, including state funds, such as state general funds appropriated to  the state Medicaid program and funds collected through taxes levied on  health care providers. Within limits, however, states may also use other  sources of funds—including funding from local government providers,  such as county-owned or county-operated hospitals, or from local  governments on behalf of government providers. Federal law allows  states to finance up to 60 percent of the nonfederal share of Medicaid  payments from local government funds.

		Medicaid Payments to Hospitals

State Medicaid agencies have two primary mechanisms for making  payments to hospitals—base payments and supplemental payments— and both can qualify for federal matching funds.
Base payments are payments to hospitals for specific services  provided to Medicaid beneficiaries through both fee-for-service and  managed care. These payments are set by state Medicaid programs  or managed care plans, and can vary considerably across states for  the same services. Payment amounts for the same service may also  vary within a state. States’ Medicaid base payments are typically  lower than other payers’, and often are below the costs of providing  services.
Supplemental payments are typically lump sum payments made to  hospitals that are not specifically tied to an individual’s care. Like all  Medicaid payments, supplemental payments are required to be  economical and efficient. Supplemental payments can be grouped  into two broad categories: (1) DSH payments, which states are  required to make to certain hospitals; and (2) non-DSH payments,  which states are allowed to make, but are not required by law.

			DSH Payments

DSH payments are designed to help offset uncompensated care costs for  hospitals serving a high proportion of Medicaid beneficiaries and  uninsured low-income patients. In fiscal year 2017, total DSH payments  to hospitals nationally were about $18.1 billion. States may distribute  DSH payments to any eligible hospital in the state; however, under  federal law, the total amount of DSH payments to a hospital must not be  more than the total amount of uncompensated care provided by the  hospital (both the Medicaid shortfall and uncompensated costs for care  for the uninsured). To be eligible for a DSH payment, hospitals must meet  minimum requirements such as having a Medicaid inpatient utilization  rate of at least 1 percent. States are required to make DSH payments to  certain hospitals—termed deemed-DSH hospitals—with a Medicaid inpatient utilization rate of at least one standard deviation above the mean  for hospitals in the state that receive Medicaid payments, or a low-income  utilization rate that exceeds 25 percent.
The amount of federal funding each state may claim for DSH payments is  limited by federal law. Since fiscal year 1993, each state is subject to a  federal DSH allotment that establishes the maximum federal funding  available for the payments. A state’s DSH allotment is largely based on its  fiscal year 1992 DSH spending, although Congress has since made  several incremental adjustments to these allotments. Ultimately, however,  the states that spent the most in fiscal year 1992 continue to have the  largest allotments; conversely, the states that spent the least in fiscal year  1992 have the smallest allotments.
States may choose to make DSH payments to institutions for mental  disease (IMD), which can include state-operated psychiatric hospitals.  Prior to 1997, a large share of DSH payments went to state-operated  IMDs, where they were used to pay for services not covered by Medicaid  and any remaining funds were returned to the state treasuries. In general,  Medicaid excludes fee-for-service base payments for beneficiaries aged  21-64 who are residents of IMDs—called the IMD exclusion—and using  DSH payments allowed states to support the costs of IMDs. In 1997,  Congress restricted the total amount of DSH payments a state could  make to IMDs as a group by establishing an annual limit on payments to  IMDs for each state. Any unspent funds within the IMD-designated limit  can be used for other hospital types.

			Non-DSH Payments

Non-DSH payments include four types of supplemental payments that  states may make, but are not required to do so, to hospitals and other  providers.
Medicaid upper payment limit (UPL) payments are lump-sum  payments that are made in addition to fee-for-service base payments.  The UPL is a limit or ceiling on the amount of a state’s Medicaid  payments for which the federal government will match spending. The  UPL is based on the difference between Medicaid fee-for-service  base payments and an estimate of what Medicare would pay for  comparable services. The UPL is not a hospital-specific limit, but is  applied in the aggregate across certain categories of providers. States  have some flexibility in deciding which hospitals will receive a UPL  payment, and how to allocate UPL payments among hospitals. In  fiscal year 2017, UPL payments totaled nearly $13 billion.
Uncompensated care pool payments are payments that some states  make to hospitals specifically for uncompensated care costs in  conjunction with section 1115 demonstration waivers and pilot  projects for which they have received approval from the Secretary of  HHS. Specifically, section 1115 of the Social Security Act authorizes  the Secretary of HHS to waive certain federal Medicaid requirements  and allow costs that would not otherwise be eligible for federal  matching funds for experimental, pilot, or demonstration programs  that, in the Secretary’s judgment, are likely to assist in promoting  Medicaid objectives. States have received approval to make  supplemental payments for hospital uncompensated care in their  Medicaid programs. In fiscal year 2017, states reported total spending  of about $8 billion through uncompensated care pools.
Delivery system reform incentive payment (DSRIP) programs, which  have also been authorized under section 1115 demonstrations, allow  states to make supplemental payments to providers engaging in  various improvement projects that align with state delivery system  reform objectives. Examples of reform objectives include improving  care for patients with specific conditions or increasing capacity. In  fiscal year 2017, DSRIP program payments totaled about $7.3  billion.
Graduate medical education payments help support teaching  hospitals, and can include teaching costs, such as physician resident  salaries, though states are not required to make such payments to  teaching hospitals. States have significant flexibility in designing and  administering these payments; however, the payments are subject to  the UPL. In fiscal year 2017, Medicaid graduate medical education  payments totaled about $2 billion.

		The Patient Protection and Affordable Care Act (PPACA) and DSH Allotments

Effective January 1, 2014, PPACA allowed states to expand Medicaid  eligibility to certain non-pregnant, non-elderly individuals. PPACA also  required a phased reduction in DSH allotments to states, reflecting the  expectation that the number of uninsured individuals would decline—and  so would hospital spending on uncompensated care. As of May 2019,  there were 37 “expansion states”—those states that chose to expand  Medicaid eligibility—and 14 “non-expansion states”—those that did not  choose to expand Medicaid. Congress has delayed the reduction in DSH  allotments several times. The reductions are scheduled to begin in fiscal  year 2020.
Between 2013 and 2014, both expansion and non-expansion states  reported different degrees of change in care for the uninsured and  Medicaid shortfall. In particular, MACPAC reported that between 2013  and 2014, the year in which most state Medicaid expansions took effect,  expansion states’ uncompensated care costs for the uninsured declined  by $2.2 billion (19 percent), while non-expansion states’ uncompensated  care costs for the uninsured increased by $0.6 billion (5 percent). During  the same period, expansion states’ Medicaid shortfall increased by $2.2  billion (36 percent), and non-expansion states’ Medicaid shortfall  increased by $1.8 billion (546 percent).

	States Increasingly Made Supplemental Payments to Hospitals

States’ use of supplemental payments has grown in recent decades,  partly due to the flexibility supplemental payments provide. This flexibility  is twofold: supplemental payments provide states with flexibility in  financing the nonfederal share of supplemental payments, and flexibility  to target the payments to specific hospitals or types of hospitals.

		States Increasingly Made Supplemental Payments to Hospitals, while Reducing or Freezing Hospitals’ Base Payments

Total supplemental payments to hospitals have grown over time, while  states’ base payments have often been frozen or reduced. Congress  imposed limits on DSH spending in the 1990s, and since then states’ use  of non-DSH payments has grown. Between fiscal year 2000 and fiscal  year 2017, DSH payments increased about 16 percent, from $15.6 billion  to $18.1 billion. In prior work, we reported that in fiscal year 2006 state  Medicaid agencies made at least $6.3 billion in non-DSH payments,  though the exact amounts are unknown, because states did not report all  their payments to CMS. By fiscal year 2017, the amount of non-DSH  payments had increased to $30.4 billion. Both uncompensated care  pool payments and DSRIP programs are relatively new types of non-DSH  payments, and thus contributed to the overall increase in supplemental  payments. In prior work, we reported that, as of February 2017, CMS  authorized nearly $38.7 billion in DSRIP spending nonconsecutively over  2011 to 2022 in four states with the largest DSRIP programs.
Our prior work found that new or increased supplemental payments  helped mitigate the increasing gap between Medicaid base payments and  hospital costs. While supplemental payments increased, the number of  states reducing or freezing base payments to hospitals has increased, in  part, because states reported challenges paying the nonfederal share  with state general funds. Our work found that from 2008 to 2011, across  all providers, the number of states making at least one base payment  reduction grew from 13 to 34, while the number of states increasing at  least one base payment fell over the same period. Across all 4 years,  states most frequently reported reducing base payments for hospitals.
The Kaiser Family Foundation’s annual survey data shows the trend  continued in more recent years. Specifically, over half of states froze or  reduced inpatient hospital base payments each fiscal year from 2011 to  2018, ranging from a low of 28 states in 2011 and 2018, to a high of 39  states in 2012. (See table 1.)
In a September 2018 study of five states, MACPAC found that hospitals  and state Medicaid officials often prefer increases to supplemental  payments rather than increases to base payments, because supplemental payments come with more predictability. MACPAC found  that all five states reported reducing hospital base payments from 2007 to  2011. After 2011, all five states kept base payments frozen with no  adjustment for inflation. As a result, base payments to hospitals in these  states were lower in 2018 relative to other payers and hospital costs. To  address the growing gap between base payments and hospital costs,  states collaborated with hospitals to establish or increase supplemental  payments. In the five states, supplemental payments ranged from 18  percent to 61 percent of total hospital payments.

		States Have Relied on Multiple Sources of Funds to Finance Their Nonfederal Share

More often than with base payments, states have relied on sources other  than state general funds to finance the nonfederal share of supplemental  payments. For example, states may receive funds for the nonfederal  share of supplemental payments through taxes levied on health care  providers. (See fig. 1.) In previous work, we found that funds from local  governments and health care providers constituted about 50 percent of  the nonfederal share for DSH and non-DSH payments in fiscal years  2008 through 2012. In contrast, funds from local governments and  health care providers constituted approximately 30 percent of base  payments during the same time period. The MACPAC study of five states  also found that states and hospitals preferred supplemental payments,  because hospitals can track the extent to which their tax assessments are  recouped through supplemental payments.
In a July 2014 report, we found that the number of states relying on  provider taxes increased, and that provider tax revenues were then used  for the nonfederal share of supplemental payments. In particular, the  total number of provider taxes increased from 119 taxes in 42 states in  2008 to 159 taxes in 47 states in 2012—a 34 percent increase. Kaiser  Family Foundation data show this trend has continued. According to  state survey data, the number of states using inpatient hospital provider  taxes has steadily increased from fiscal year 2011 to 2018, ranging from  a low of 34 states in 2011, to a high of 42 states in 2017 and 2018. (See  table 2.)

		Supplemental Payments Allow States to Target Payments to Certain Hospitals or Types of Hospitals

Supplemental payments provide states with flexibility that allows them to  address states’ goals by targeting payments to particular hospitals or  hospital types, such as public hospitals or teaching hospitals. States may  choose to target supplemental payments to hospitals that may not have  the highest uncompensated care costs. Our prior work found some states’  DSH payments were not proportionally targeted to hospitals with the  highest uncompensated care costs, which DSH payments are designed  to address. Based on our prior analysis of annual hospital-specific 2010 DSH data, we reported that in 30 of 42 states, hospitals receiving the  largest share of state DSH payments did not provide the largest share of  total uncompensated care. Moreover, our prior review of the independent  DSH audits found that
41 states made DSH payments to 717 hospitals that exceeded the  individual hospitals’ uncompensated care costs as calculated by the  auditors,
9 states did not accurately calculate the uncompensated care costs of  206 hospitals in those states for purposes of making DSH payments,  and
15 states made DSH payments to a total of 58 hospitals that either did  not retain their DSH payments or were not qualified to receive them.
States’ criteria for identifying eligible DSH hospitals and how much  funding they receive vary, but were often related to hospital ownership,  hospital type, and geographic factors. Our prior work found that 2006  DSH payments to individual hospitals varied widely, ranging from 1 cent  to about $395 million. For example, California reported both the lowest  and highest 2006 DSH payment amounts; the state made a total of only  $160 in DSH payments to 96 private hospitals and paid $2 billion in DSH  payments to 51 government hospitals.
Based on our analysis of 2014 DSH audits, several states targeted DSH  payments to certain hospitals and hospital types, including the following:
Public hospitals: States targeting nearly all (93 percent or higher) of  their DSH funding to public hospitals included Arkansas (99 percent),  California (100 percent), Illinois (99 percent), Iowa (93 percent), Maine  (100 percent), and Washington (97 percent).
Nonprofit hospitals: Nebraska targeted 98 percent of its DSH funding  to nonprofit hospitals.
High-teaching hospitals: Arkansas targeted 98 percent of DSH  funding to high-teaching hospitals, defined as teaching hospitals with  an intern-and-resident-to-bed ratio of 0.25 or greater.
IMDs: Maine makes DSH payments to the two state-run IMDs. In  2014, 18 states directed their entire IMD-designated DSH limit to  IMDs. (For additional information on DSH payments to IMDs, see  table 9 in app. II).
Similarly, states can target UPL payments to certain hospitals. We and  the HHS Office of the Inspector General have reported that some states  concentrated these payments to a small number of providers.

		GAO and Others Have Noted Concerns With States’ Use of Supplemental Payments

Our work has highlighted a number of concerns about the use of non- DSH payments from various perspectives, highlighting the need for  transparent reporting, ensuring expenditures meet Medicaid purposes,  and concerns regarding arrangements that shift costs from the states to  the federal government. For example, in November 2012, we  recommended that Congress consider requiring CMS to improve the  transparency of and accountability for non-DSH payments by requiring  facility-specific payment reporting and annual audits. The report noted  that the annual DSH reports and audits that states began submitting in  2010 were important steps toward improving transparency and  accountability for Medicaid DSH payments; however, similar information  is lacking for non-DSH payments. Moreover, the report stated that the  limited information available on non-DSH payments shows that a large  share of these payments are paid to a small number of hospitals; when  these payments are combined with Medicaid base payments, hundreds of  hospitals may be receiving Medicaid payments well in excess of their  actual costs of providing Medicaid services. As of March 2019, Congress  has not taken any action, but CMS announced in fall 2018 that it was  planning a proposed rule on supplemental payments that, if finalized,  would improve transparency by requiring states to provide CMS with  certain information on Medicaid supplemental payments. The agency  plans to release the proposed rule for comment by fall 2019.
In 2014, we recommended that CMS develop a data collection strategy  ensuring states report accurate and complete data on all sources of funds  used to finance the nonfederal share of Medicaid payments. Such data  are needed to (1) track trends in financing the nonfederal share, and (2)  oversee compliance with current limits on sources of financing the  nonfederal share. CMS did not concur with our recommendation, but did  acknowledge the agency does not have sufficient data to oversee  compliance with the 60 percent limit on local government contributions to  a state’s nonfederal share.

	Hospital Uncompensated Care Costs and DSH Payments Varied by State; Some Types of Hospitals Received a Greater Proportion of DSH Payments

		Uncompensated Care Costs Varied by State and Were Mainly for Costs Related to Treating Uninsured Patients

Among hospitals receiving DSH payments in 2014, total uncompensated  care costs varied by state, ranging from $5.9 million in North Dakota to  $6.2 billion in New York. In the hospitals, most uncompensated care costs  were related to costs to care for uninsured patients, rather than the  Medicaid shortfall. For example, among hospitals receiving DSH  payments in the 48 states studied:
Costs related to care for the uninsured comprised about two-thirds  (67.9 percent) of total uncompensated care costs for DSH hospitals.  The remaining share of DSH hospital uncompensated care costs  consisted of the Medicaid shortfall.
In 34 states, costs for care for the uninsured exceeded the Medicaid  shortfall. In the remaining 14 states, the Medicaid shortfall exceeded  costs related to care for the uninsured.
In 15 states, Medicaid paid hospitals more than the total cost of  services provided to Medicaid beneficiaries, resulting in a surplus of  Medicaid payments—even prior to receiving DSH payments. Termed  a negative Medicaid shortfall, these surplus funds can be the result of  non-DSH Medicaid supplemental payments. The remaining 33 states  had some Medicaid shortfall. (See table 3.) No states had a surplus of  total uncompensated care costs.  (For additional information on state uncompensated care costs and DSH  payments in 2014, see table 10 in app. II.)

		Across States, DSH Payments Varied Significantly in Amounts, Percentage of Uncompensated Care Costs Covered, and Percentage of States’ Medicaid Spending on Hospitals

DSH payments—both the federal and nonfederal share—varied  significantly in the amount that each state paid to hospitals in 2014. (See  table 4 and fig. 2.) Wyoming made the smallest amount of DSH payments  at about $500,000, while New York made the largest amount in DSH  payments at $3.5 billion. Differences in DSH payments are largely the  result of differences in the state allocations established in law.
The proportion of total DSH hospital uncompensated care costs covered  by total DSH payments in 2014 also varied considerably by state.  Nationally, DSH payments ($18.3 billion) covered about half of DSH  hospital uncompensated care costs ($36.2 billion). Nineteen states made  DSH payments totaling at least 50 percent of uncompensated care costs  for the states’ DSH hospitals, while 29 states made DSH payments of  less than 50 percent of uncompensated care costs for the states’ DSH  hospitals. (See table 5.) Four states (California, Illinois, Maryland, and  Missouri) made DSH payments that exceeded aggregate hospital  uncompensated care costs. (For additional information on state  uncompensated care costs and DSH payments in 2014, see table 10 in  app. II.)
Among hospitals receiving them, DSH payments accounted for 13.6  percent of total Medicaid payments, nationally, but there was  considerable variation across states. For example, DSH payments  comprised 96.6 percent of Medicaid payments to DSH hospitals in Maine  and 0.7 percent of Medicaid payments to DSH hospitals in Tennessee.  In 40 states, DSH payments accounted for less than 20 percent of total  Medicaid payments to hospitals, but in 8 states, it exceeded 20 percent.  (See table 6.) (For additional information on state Medicaid payments to  hospitals, see table 11 in app. II.)

		Deemed-DSH, Public, and Teaching Hospitals Received a Greater Share of DSH Payments Relative to their Proportion of Uncompensated Care Costs

Among deemed and non-deemed DSH hospitals, overall deemed-DSH  hospitals received larger relative DSH payments compared to non- deemed DSH hospitals. Deemed-DSH hospitals received 69.9 percent  of DSH payments in 2014, but carried 51.2 percent of uncompensated  care costs, relative to all hospitals receiving DSH payments that year.  Each of the 48 states that distributed DSH payments in 2014 had at least  one deemed-DSH hospital. (See table 7 for hospital type definitions.)  Most of these states (36) provided deemed-DSH hospitals with a greater  share of DSH payments relative to their share of total uncompensated  care costs. (See table 8 for a summary of how states’ DSH payments to  deemed-DSH hospitals compared to the hospitals’ share of  uncompensated care costs, and table 12 in app. II for additional  information by state.)
In terms of ownership and teaching hospital status, hospitals that were  publicly owned or teaching hospitals also generally received a greater  proportion of DSH payments relative to their share of total  uncompensated care costs.
Among the three different ownership groups (public, non-profit, and  private), public hospitals generally received a larger share of DSH  payments relative to their share of uncompensated care. Among  hospitals receiving DSH payments in 2014, public (36.7 percent) and  nonprofit (53.7 percent) hospitals accounted for more uncompensated  care costs than that of privately owned hospitals (9.6 percent). States  generally provided more DSH payments to public hospitals (62.8  percent) relative to their share of total uncompensated care costs  (36.7 percent). (For additional information on DSH payments and  hospitals’ uncompensated care costs by ownership, see table 13 in  app. II.)
States distribute DSH payments to teaching hospitals at different  rates, but generally provided a greater proportion of DSH payments to  high-teaching hospitals (56.5 percent) relative to their share of total  DSH hospital uncompensated care costs (44.0 percent). (For  additional information on DSH payments and hospitals’  uncompensated care costs by hospital teaching status, see table 14 in  app. II.)
Nationally, urban hospitals received a greater share of DSH payments  relative to rural hospitals, with 89.6 percent of DSH funds distributed  to urban hospitals and the remaining 10.4 percent distributed to rural  hospitals. This proportion corresponds to a similar distribution of  uncompensated care costs, with 88.2 percent of uncompensated care  costs among DSH hospitals carried by urban hospitals and the  remaining 11.8 percent carried by rural hospitals. (For additional  information on DSH payments and hospitals’ uncompensated care  costs by urban/rural status, see table 15 in app. II.)
For additional information on variation in uncompensated care and DSH  payments by hospital category and sole community provider status, and  state characteristics, see tables 16 through 19 in appendix II.

	Agency Comments

We provided a draft of this report to HHS for review. HHS provided  technical comments, which we incorporated as appropriate.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies to appropriate congressional  committees, to the Secretary of Health and Human Services, the  Administrator of CMS, and other interested parties. In addition, the report  will be available at no charge on the GAO website at http://www.gao.gov.
If you or your staff have any questions about this report, please contact  me at (202) 512-7114, or yocomc@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.

Appendix I: Selected Bibliography

This bibliography contains citations for the eight Kaiser Family Foundation  reports referenced in the report.
Kaiser Family Foundation and Health Management Associates. States  Focus on Quality and Outcomes Amid Waiver Changes: Results from a  50-State Medicaid Budget Survey for State Fiscal Years 2018 and 2019.  Washington, D.C.: Kaiser Family Foundation, and National Association of  Medicaid Directors, October 2018.
Kaiser Family Foundation and Health Management Associates. Medicaid  Moving Ahead in Uncertain Times: Results from a 50-State Medicaid  Budget Survey for State Fiscal Years 2017 and 2018. Washington, D.C.:  Kaiser Family Foundation, October 2017.
Kaiser Family Foundation and Health Management Associates.  Implementing Coverage and Payment Initiatives: Results from a 50-State  Medicaid Budget Survey for State Fiscal Years 2016 and 2017.  Washington, D.C.: Kaiser Family Foundation and National Association of  Medicaid Directors, October 2016.
Kaiser Family Foundation and Health Management Associates. Medicaid  Reforms to Expand Coverage, Control Costs and Improve Care: Results  from a 50-State Medicaid Budget Survey for State Fiscal Years 2015 and  2016. Washington, D.C.: Kaiser Family Foundation and National  Association of Medicaid Directors, October 2015.
Kaiser Family Foundation and Health Management Associates. Medicaid  in an Era of Health & Delivery System Reform: Results from a 50-State  Medicaid Budget Survey for State Fiscal Years 2014 and 2015.  Washington, D.C.: Kaiser Family Foundation, and National Association of  Medicaid Directors, October 2014.
Kaiser Family Foundation and Health Management Associates. Medicaid  in a Historic Time of Transformation: Results from a 50-State Medicaid  Budget Survey for State Fiscal Years 2013 and 2014. Washington, D.C.:  Kaiser Commission on Medicaid and the Uninsured, Kaiser Family  Foundation, October 2013.
Kaiser Family Foundation and Health Management Associates. Medicaid  Today; Preparing for Tomorrow: A Look at State Medicaid Program  Spending, Enrollment and Policy Trends Results from a 50-State  Medicaid Budget Survey for State Fiscal Years 2012 and 2013.  Washington, D.C.: Kaiser Commission on Medicaid and the Uninsured,  Kaiser Family Foundation, October 2012.
Kaiser Family Foundation and Health Management Associates. Moving  Ahead Amid Fiscal Challenges: A Look at Medicaid Spending, Coverage  and Policy Trends Results from a 50-State Medicaid Budget Survey for  State Fiscal Years 2011 and 2012. Washington, D.C.: Kaiser Commission  on Medicaid and the Uninsured, Kaiser Family Foundation, October 2011.

Appendix II: Data on Disproportionate Share Hospital Payments and Hospital Uncompensated Care Costs by State

To conduct this analysis, we used data compiled by Acumen for the  Medicaid and CHIP Payment and Access Commission. These data  consist of measures from several sources. The measures used within this  report were collected from state disproportionate share hospital (DSH)  audits and Medicare cost reports. The 2014 DSH audits, which report  data on hospital uncompensated care costs and DSH payments to  hospitals, were submitted by 48 states and the District of Columbia.  These data do not include a census of all hospitals, but only those  hospitals that were reported in the 2014 DSH audits. As a result, these  data do not capture all uncompensated care costs in each state, only  uncompensated care costs for those hospitals reported in the 2014 DSH  audits. Two states, Massachusetts and Hawaii, did not submit a 2014  DSH audit, because they did not make DSH payments. Additionally, while  South Dakota submitted a 2014 DSH audit, we excluded the state from  our analysis because of concerns about the reliability of the reported cost  measures.
In addition, not all hospitals reported every data element we analyzed. As  a result, total uncompensated care costs and total DSH payments vary  between tables, as hospitals were excluded from a given table if they did  not report the characteristic described by the table. The numbers of  hospitals excluded because they did not report a given data element are  noted in each table for which this is the case. Likewise, as  uncompensated care costs are an important focus of the report, we also  excluded from all analyses 13 hospitals that did not report a value for  uncompensated care costs.

Appendix III: GAO Contacts and Staff Acknowledgments

	GAO Contacts

	Staff Acknowledgments

In addition to the contact named above, Lori Achman (Assistant Director),  Dawn Nelson (Analyst-in-Charge), Sean Miskell, and Jeffrey Tamburello  made key contributions to this report. Also contributing were Tim  Bushfield, Drew Long, Vikki Porter, and Emily Wilson.


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I n October 2018, the Office of the U.S. Trade Representative (USTR) officially notified the Congress, under Trade Promotion Authority (TPA), of the Trump Administration's plans to enter into formal trade negotiations with the European Union (EU). This action followed a July 2018 U.S.-EU Joint Statement by President Trump and then-European Commission (EC) President Juncker announcing that they would work toward a trade agreement to reduce tariffs and other trade barriers, address unfair trading practices, and increase U.S. exports of soybeans and certain other products. Previously, in 2016, U.S.-EU negotiations as part of the Transatlantic Trade and Investment Partnership (T-TIP) stalled after 15 rounds under the Obama Administration.
The outlook for new U.S.-EU talks remains uncertain. There continues to be disagreement about the scope of the negotiations, particularly the EU's intent to exclude agriculture from the talks on the basis that it "is a sensitivity for the EU side." EU sensitivities stem in part from commercial and cultural practices that are often embodied in EU laws and regulations and vary from those of the United States. For food and agricultural products, such differences include regulatory and administrative differences between the United States and the EU on issues related to food safety and public healthâor Sanitary and Phytosanitary (SPS) measures, and Technical Barriers to Trade (TBTs). Other differences include product naming schemes for some types of food and agricultural products subject to protections involving Geographical Indications (GIs). Addressing food and agricultural issues in the negotiations remains important to U.S. exporters given the sizable and growing U.S. trade deficit with the EU in agricultural products.
Renewed trade talks also come amid heightened U.S.-EU trade frictions. In March 2018, President Trump announced 25% steel and 10% aluminum tariffs on most U.S. trading partners, including the EU, after a Section 232 investigation determined that these imports threaten U.S. national security. In response, the EU began applying retaliatory tariffs of 25% on certain U.S. exports to the EU. Additionally, as part of the Boeing-Airbus subsidy dispute, in October 2019 the United States began imposing additional, World Trade Organization (WTO)-sanctioned tariffs on $7.5 billion worth of certain U.S. imports from the EU.
This report provides an overview of U.S.-EU trade in agriculture and background information on selected U.S.-EU agricultural trade issues concerning a potential trade liberalization agreement between the United States and the EU. Following a review of U.S.-EU agricultural trade trends, this report describes recent agricultural trade trends and tariff actions affecting certain U.S.-EU traded food and agricultural goods. It then describes potential issues in U.S.-EU trade agreement negotiations involving food and agricultural trade. Figure 1 shows a timeline of selected events.
Figure 1. Selected Timeline of Events Related to U.S.-EU Agricultural TradeSource: CRS. Actions related to the U.S.-EU Trade Agreement negotiations are shown in red.Note: USTR = U.S. Trade Representative (USTR). WTO = World Trade Organization. EU27 includes the current 27 EU member states, excluding the United Kingdom (UK). EU28 includes the UK.

	Trade Data and Statistics

Following are trade data and statistics for the current 27 EU member states (EU27). Unless otherwise noted, these figures exclude the United Kingdom (UK), which formally exited the EU in January 2020. Moving forward, U.S. trade negotiations with the EU are expected to exclude the UK, which may enter into trade discussions with the United States separately.
Trade data presented here are compiled from U.S. Department of Agriculture (USDA) trade statistics for "Agricultural and Related Products." As defined by USDA, this product grouping includes agricultural products (including bulk and intermediate products and also consumer-oriented products) and agricultural-related products (including fish and shellfish products, distilled spirits, forest products, and ethanol and biodiesel blends). Additional information on the various data sources is discussed in the t ext box .
The United States and the EU are the world's largest trade and investment partners. While food and agricultural trade between the United States and the EU27 accounts for less than 1% of the value of overall trade in total goods and services ( Figure 2 ), the EU27 remains a leading market for U.S. agricultural exports. It accounted for about 8% of the value of all U.S. exports and ranked as the fifth-largest market for U.S. food and farm exports in 2019âafter Canada, Mexico, China, and Japan. Data depicted in Figure 2 do not reflect trade in fish and seafood, distilled spirits, and bioenergy products.
During the past two decades, growth in U.S. agricultural exports to the EU has not kept pace with growth in trade to other U.S. markets. U.S. agricultural imports from the EU27 currently exceed U.S. exports to the EU27. In 2019, U.S. exports of agricultural and related products to the EU27 totaled $12.4 billion, while U.S. imports of agricultural and related products from the EU27 totaled $29.7 billion, resulting in a U.S. trade deficit of approximately $17.3 billion. This reverses the U.S. agricultural trade surpluses with the EU27 during the early 1990s ( Figure 3 ). Leading U.S. agricultural exports to the EU27 were corn and soybeans, tree nuts, distilled spirits, fish products, wine and beer, planting seeds, and processed foods. Leading U.S. imports from the EU27 were wine and spirits, beer, drinking waters, olive oil, cheese, and processed foods.
While data shown in the graphic reflect total trade in "Agricultural and Related Products," including agricultural products, fish and shellfish products, distilled spirits, and other agricultural related products, the trade picture may vary by product category (as shown in Table 1 ). Trade data presented here do not include the UK, which is a major importer of U.S. agricultural products. In 2019, U.S. agricultural and related product exports to the UK totaled $2.8 billion, which roughly equaled the value of imports from the UK ( Figure 4 ).

	U.S.-EU Tariff Retaliation

The U.S.-EU trade negotiations come amid heightened U.S.-EU trade frictions. In March 2018, President Trump announced 25% steel and 10% aluminum tariffs on most U.S. trading partners after a Section 232 investigation determined that these imports threaten to impair U.S. national security. The EU was not among the trading partners with whom the Trump Administration negotiated permanent exemptions from tariffs or alternative quota arrangements, and U.S. tariffs on U.S. imports from the EU went into effect in June 2018. The EU views the U.S. national security justification as groundless and the U.S. tariffs to be inconsistent with WTO rules. The EU has challenged the U.S. actions at the WTO.
Effective June 2018, the EU began applying retaliatory tariffs of 25% on imports of U.S. whiskies, corn, rice, kidney beans, preserved and mixed vegetables, orange juice, cranberry juice, peanut butter, and tobacco products, along with selected non-agricultural products ( Figure 5 ). This action includes the EU27 countries and the UK (EU28), as U.S. exports to the UK remain subject to the additional tariffs. The value of U.S. agricultural exports to the EU28 targeted by these additional tariffs is estimated to have been approximately $1.2 billion in 2018, or nearly 9% of total U.S. agricultural exports to the EU28 (excluding nonagricultural products) ( Table 2 ). Some analysts estimate that U.S. agricultural exports subject to tariff retaliation in 2018-2019 experienced a 33% decline in the EU28 market.
In October 2019, U.S.-EU trade tensions escalated further when the United States imposed additional tariffs on $7.5 billion worth of certain U.S. imports from the EU, or about 1.5% of all U.S. imports from the EU28 in 2018 (including the UK and nonagricultural products). This action, authorized by WTO dispute settlement procedures, followed a USTR investigation initiated in April 2019 under Section 301 of the Trade Act of 1974. The USTR determined that the EU had denied U.S. rights under WTO agreements. Specifically, USTR concluded that the EU and certain member states (including the UK) had not complied with a WTO Dispute Settlement Body ruling recommending the withdrawal of WTO-inconsistent EU subsidies to Airbus for the manufacture of large civil aircraft.
The list of products subject to additional tariffs stemming from the Airbus subsidy dispute targets mainly the EU member states responsible for the illegal subsidies. It includes agricultural products such as spirits and wine, cheese and dairy products, meat products, fish and seafood, fresh and prepared fruit products, coffee, and bakery goods. Agricultural imports account for about 56% of the total value of EU28 products subject to these additional tariffs. As of February 2020, tariff increases are limited to 25% on agricultural products, and they target primarily France, Germany, UK, and Spain ( Figure 6 ). By agricultural product category, whiskies, liqueurs, and wine (mainly from UK and France) account for approximately 38%, and other food and agricultural products (mainly from Spain and France) account for 19% ( Table 3 ). In December 2019, USTR began a review to determine if the list of imports subject to additional tariffs should be revised or tariff rates increased. In February 2020, USTR made some changes to the list of products affected by Section 301 tariffs. In terms of U.S. agricultural imports from the EU, the only change will be the removal of prune juice from the list, which will not be subject to additional 25% tariffs effective March 5, 2020.
U.S.-EU trade negotiations could be affected further if the EU retaliates and imposes tariffs on U.S. exports, in response to either these U.S. actions or an upcoming WTO decision in the parallel EU dispute case against the United States. Later this year a WTO arbitrator is expected to authorize the EU to seek remedies in the form of tariffs on U.S. exports to the EU, after the WTO determined in early 2019 that the United States had also failed to abide by WTO subsidies rules in supporting Boeing.

	Selected U.S.-EU Agricultural Trade Issues

In January 2019, USTR announced its negotiating objectives for a U.S.-EU trade agreement, following a public comment period and a hearing involving several leading U.S. agricultural trade associations. These objectives include agricultural policiesâboth market access and non-tariff measures such as tariff rate quotas (TRQ) administration and other regulatory issues. Among regulatory issues, key U.S. objectives include harmonizing regulatory processes and standards to facilitate trade, including SPS standards, and establishing specific commitments for trade in products developed through agricultural biotechnologies. The U.S. objectives also include addressing GIs by protecting generic terms for common use. U.S. agricultural interests generally support including agriculture in a U.S.-EU trade agreement. The stated overarching goal for the U.S. side is addressing the U.S. trade deficit in agricultural products with the European Union.
Early on, the EU indicated that it was planning for a more limited negotiation that does not include agricultural products and policies. The EU negotiating mandate, dated April 2019, states that a key EU goal is "a trade agreement limited to the elimination of tariffs for industrial goods only, excluding agricultural products." Several Members of Congress opposed the EU's decision to exclude agricultural policies in its negotiating mandate. A letter to USTR from a bipartisan group of 114 House members states that "an agreement with the EU that does not address trade in agriculture would be, in our eyes, unacceptable." Senate Finance Committee Chairman Chuck Grassley reiterated, "Bipartisan members of the Senate and House â¦ have voiced their objections to a deal without agriculture, making it unlikely that such a deal would pass Congress."
Then, in January 2020, public statements by U.S. and EU officials signaled the possibility that the U.S.-EU trade talks might include negotiation on SPS and regulatory barriers to agricultural trade. It is not clear, however, that both sides agree on which specific types of non-tariff trade barriers might actually be part of the U.S.-EU trade talks. As reported in the press, statements by some USDA officials have suggested that selected SPS barriers as well as GIs would need to be addressed by the trade talks. Meanwhile, other press reports indicate that some EU officials have downplayed the extent that certain non-tariff barriersâsuch as biotechnology product permits, approval of certain pathogen rinses for poultry, regulations on pesticides, or food standardsâwould be part of the talks; instead, regulatory barriers might be lowered for certain "non-controversial" foods. The United States continues to push for additional concessions from the EU. More formal discussions are expected in the spring of 2020âin an effort to ease trade tensions regarding the imposition of retaliatory tariffs.
The EU has taken certain measures to avoid escalating agricultural trade tensions with the United States. For example, it has expanded the U.S.-specific quota for EU imports of hormone-free beef, increased imports of U.S. soybeans as a source of biofuels, approved a number of long-pending genetically engineered products for food and feed uses, and proposed to lift a ban on certain pest-resistant American grapes in EU wine production, and other trade-related measures.
In a separate but indirectly related action, in August 2019, USTR asked the U.S. International Trade Commission (USITC) to conduct an investigation examining SPS barriers related to pesticide maximum residue levels (MRLs) across all U.S. markets, including Europe.
Previously, during T-TIP negotiations, both market access and non-tariff barriers were part of the U.S. negotiating objectives. At that time, non-tariff barriers to agricultural tradeâincluding SPS and TBT measures, and GIsâwere among the agricultural issues actively debated. In addition, regulatory coherence and cooperation was part of USTR's stated objectives. Some of the same issues that proved to be challenging during the T-TIP talks may continue to challenge negotiators. Various studies at the time reported that removing tariff and non-tariff barriers in U.S.-EU trade would result in economic benefits to the U.S. and EU agricultural sectors. Another study by the European Parliament acknowledged that gains from tariff cuts would be limited unless regulatory and administrative barriers were also addressed.

		Market Access

Market access issues are not slated to be discussed in the U.S.-EU trade talks. However, these issues remain important for U.S. agricultural exporters. This is especially true regarding the EU's use of restrictive tariff rate quotas (TRQs) on certain agricultural products. TRQs allow imports of fixed quantities of a product at a lower tariff. Once the quota is filled, a higher tariff is applied on additional imports. The EU allocates TRQs to importers using licenses issued by the member states' national authorities. Only companies established in the EU may apply for import licenses. For exports under a U.S.-specific TRQ, a certificate of origin must be supplied. The EU applies TRQs on many types of beef and poultry products, sheep and goat meat, dairy products, cereals, rice, sugar, and fruit and vegetables. Some products are heavily protected by both TRQs and non-tariff SPS measures.
Import tariffs for agricultural products into Europe tends to be relatively high compared to tariffs for similar products into the United Sates. The WTO reports that the simple average most-favored-nation (MFN) tariff applied to agricultural products entering the United States is about 5%, compared to an average tariff of about 13% for products entering the EU. Including all products imported under an applied tariff or a TRQ, USDA reports that the calculated average rate across all U.S. agricultural imports is roughly 12%, well below the EU's average of 30%. By commodity group, EU tariffs average more than 40% for imported meat products, grains, and grain products and average at or above 20% for most fruit and vegetable products. For some products, EU tariffs are even greater, averaging more than 80% for imported dairy products, more that 50% for sugar cane and sweeteners, and nearly 350% for sugar beets. The EU has concluded preferential trade agreements with more than 35 non-EU countries and continues to negotiate agreements with several others. This preferential access provides U.S. export competitors an advantage over U.S. agricultural exporters, particularly in countries where the United States does not have a preferential agreement in place.
Previously, during the T-TIP negotiations, Senate leadership sent a letter to USTR reiterating that a final agreement would need to include "a strong framework for agriculture," including "tariff elimination on all productsâincluding beef, pork, poultry, rice, and fruits and vegetables" and that "liberalization in all sectors of agriculture" was a priority, if the agreement were to obtain the support of Congress. The letter also addressed the importance of "longstanding regulatory barriers," including the EU's import approval process of U.S. biotechnology products and GI protections promoted by the EU.

		Non-Tariff Barriers to Trade

High tariff barriers are further exacerbated by additional non-tariff barriers that may limit U.S. agricultural exports, including SPS measures, and other types of non-tariff barriers. Non -t ariff m easures (NTMs) generally refer to policy measures other than tariffs that may have a negative economic effect on international trade. NTMs include both technical and nontechnical measures. Technical measures include both SPS and TBTs and pre-shipment formalities and related requirements that are intended to govern public health and food safety. Nontechnical measures include quotas, price control measures, rules of origin requirements, and government procurement restrictions.
Non-tariff barriers affect agricultural trade in various ways, including delays in reviews of biotech products (creating barriers to U.S. exports of grain and oilseed products), prohibitions on growth hormones in beef production and certain antimicrobial and pathogen reduction treatments (creating barriers to U.S. meat and poultry exports), and burdensome and complex certification requirements (creating barriers to U.S. processed foods, animal products, and dairy products). Extensive EU regulations and difficulty finding up-to-date information are among the primary concerns of U.S. businesses, particularly for makers of processed foods. U.S. businesses report a lack of a science-based focus in establishing SPS measures, difficulty meeting food safety standards and obtaining product certification, differences across countries in food labeling requirements, and stringent testing requirements that are often applied inconsistently across EU member nations.
Non-tariff barriers to agricultural tradeâincluding SPS and TBT measures, and GIsâwere among the agricultural issues actively debated in the T-TIP negotiation. Previous negotiations were complicated by longstanding trade disputes between the United States and EU involving food safety and product standards that are often embodied in laws and regulations in the United States and EU, as well as separate requirements that may be in force within individual EU member states. For example, the EU restricts some types of genetically engineered (GE) seed varieties and also prohibits the use of hormones in meat production and certain pathogen reduction treatments in poultry production. As these types of practices are commonplace in the United States, this tends to restrict U.S. agricultural exports to the EU. Other EU regulations and standards involve pesticide residues on foods, drug residues in animal production, and certain animal welfare requirements that may vary from those in the United States. The United States has also opposed the EU's GI protections that govern product labeling on products within the EU and within some countries that have a formal trade agreement with the EU. Such GI protections also tend to restrict U.S. agricultural exports to the EU and to some other countries where such protections have been put in place.
As part of a trade negotiation, non-tariff barriers tend to be broadly grouped along with other issues related to regulatory coherence. The U.S. Chamber of Commerce defines regulatory coherence as "good regulatory practices, transparency, and stakeholder engagement in a domestic regulatory process" and regulatory cooperation as "the process of interaction between U.S. and EU regulators, founded on the benefits regulators can achieve through closer partnership and greater regulatory interoperability." Related terminology may refer interchangeably to regulatory convergence, cooperation, and/or harmonization. Trade negotiations involving regulatory and intellectual property rights issues have focused, in part, on the goals of ensuring greater transparency, harmonization, and coherence to improve cooperation and streamline the regulatory approval process among the trading partners.
Previous USDA estimates calculated the ad valorem equivalent effects of EU non-tariff barriers to U.S. agricultural exports, which were estimated to range from 23% to 102% for some more heavily protected products, including meat products, fruits and vegetables, and some crops.
In general, SPS and related regulatory issues tend to be addressed in free trade agreements (FTAs) within an agreement's agriculture chapter or chapter on regulatory coherence, while GIs tend to be addressed along with other types of intellectual property rights (IPR) issues, in an FTA's IPR chapter. The following section provides additional background on SPS and TBT measures, as well as GI protections.

			SPS/TBT Issues

SPS measures are laws, regulations, standards, and procedures that governments employ as "necessary to protect human, animal or plant life or health" from the risks associated with the spread of pests, diseases, or disease-carrying and causing organisms, or from additives, toxins, or contaminants in food, beverages, or feedstuffs. Examples include product standards, requirements for products to be produced in disease-free areas, quarantine and inspection procedures, sampling and testing requirements, residue limits for pesticides and drugs in foods, and limits on food additives. TBT measures cover both food and non-food traded products. TBTs in agriculture include SPS measures, but also include other types of measures related to health and quality standards, testing, registration, and certification requirements, as well as packaging and labeling regulations. Both SPS and TBT measures regarding food safety and related public health protection are addressed in various multilateral trade agreements and are regularly notified to and debated within both the SPS Agreement and TBT Agreement within the WTO.
In general, under the SPS and TBT agreements, WTO members agree to apply such measures, based on scientific evidence and information, only to the extent necessary to protect human, animal, or plant life and health and to not arbitrarily or unjustifiably discriminate between WTO members where identical standards prevail. Member countries are also encouraged to observe established and recognized international standards. Improper use of SPS and TBT measures can create substantial barriers to trade when they are disguised protectionist barriers, are not supported by scientific evidence, or are otherwise unwarranted. Bilateral and regional FTAs between the United States and other countries regularly address SPS and TBT matters. Provisions in most U.S. FTAs have generally reaffirmed rights and obligations of both parties under the WTO SPS and TBT agreements. Some FTAs have established standing bilateral committees to enhance understanding of each other's measures and to consult regularly on related matters. Other FTAs have included side letters or agreements for the parties to continue to cooperate on scientific and technical issues, which in some cases may be related to certain specific market access concerns. Most FTAs have not addressed specific non-tariff trade concerns directly.

				Differences in U.S. and EU Laws and Regulations

Regulatory differences between the United States and EU have contributed to trade disputes regarding SPS and TBT rules between the two trading blocs. The United States has several formal WTO trade disputes regarding SPS and TBT measures with the EU. These include concerns regarding the EU's prohibitions on the use of growth-promoting hormones (and ractopamine ) in meat production, the EU's restrictions on chemical treatments ("pathogen reduction treatments" or "PRTs") on U.S. poultry, and the EU's approval process of biotechnology products. Other SPS concerns have involved regulations related to bovine spongiform encephalopathy (BSE, commonly known as mad cow disease) and regulations involving plant processing, chemical residues, endocrine-disrupting chemicals, antibiotics, and animal welfare.
There are major differences in how the United States and the EU regulate food safety and related public health protection, including various administrative and technical review differences, which in turn influences how each applies various SPS and TBT measures. Such differences have often been central to SPS and TBT disputes, including those involving the use of hormones in meat production and pathogen reduction treatments in poultry processing. Other disputes invoking the SPS and TBT agreements between the U.S. and EU have included beef and poultry products, eggs, frozen bovine semen, milk products, animal byproducts, seafood, pesticide and animal drug residues, seeds, wheat, wine and spirits, and food packaging requirements.
Differences are also evident in how the United States and EU regard biotechnology in agricultural production. In general, EU officials have been cautious in allowing genetically engineered cropsâcommonly referred to in Europe as genetically modified organisms (or GMOs)âto enter the EU market. As such, any GE-derived food and feed must be labeled accordingly. The EU's regulatory framework regarding biotechnology is generally regarded as one of the most stringent systems worldwide. During the T-TIP negotiations, U.S. agricultural and food groups actively called for changes to the EU's approach for approving and labeling biotechnology products.
The EU has reported concerns about perceived U.S. SPS barriers to EU exports of sheep and goat meat, egg products, beef, certain dairy products, live bivalve mollusks, apples, and pears, along with difficulties protecting its own GIs on certain food and drinks. Other EU concerns have involved the use of "Buy American" restrictions in the United States governing public procurement. During the T-TIP negotiations, some expressed concern that including "Buy American" provisions could affect local food procurement, including restricting bidding contract preferences contained in U.S. and EU farm-to-school programs.
The EU's application of the so-called precautionary principle remains central to the EU's risk management policy regarding food safety and animal and plant health and is often cited as the rationale behind the EU's more risk-averse approach. The precautionary principle was reportedly referenced as part of the 1992 Treaty on European Union that further integrated the EU, and its use was further outlined in a 2000 communication and then formally established in EU food legislation in 2002 (Regulation EC No 178/2002). The EU's 2000 communication further outlines guidelines for implementation, the basis for invoking the principle, and the general standards of application. Regarding international trade, under EU law, the precautionary principle provides for "rapid response" to address "possible danger to human, animal, or plant health, or to protect the environment" and can be used to "stop distribution or order withdrawal from the market of products likely to be hazardous." Although the principle may not be used as a pretext for protectionist measures, many countries have challenged some EU actions that invoke the precautionary principle as "protectionist." The EU, however, continues to invoke the precautionary principle to justify its policies regarding various regulatory issues and generally rejects arguments, on the grounds of risk management, that the lack of clear evidence of harm is not evidence of the absence of harm.
No universally agreed-upon definition of the precautionary principle exists, and many differently worded or conflicting definitions can be found in international law. However, within the context of the WTO and the SPS agreement, the precautionary principle (or precautionary approach) allows a country to set higher standards and methods of inspecting products. It also allows countries to take "protective action"âincluding restricting trade of products or processesâif they believe that scientific evidence is inconclusive regarding their potential impacts on human health and the environment (provided the action is consistent and not arbitrary). The WTO has generally acknowledged that the need to take precautionary actions in the face of scientific uncertainty has long been widely accepted, particularly in the fields of food safety and plant and animal health protection. Examples might include a sudden outbreak of an animal disease that is suspected of being linked to imports, which may require a country to impose certain trade restrictions while the outbreak is assessed.
Application of the precautionary principle by some countries remains an ongoing source of contention in international trade, particularly for the United States, and is often cited as a reason why some countries may restrict imports of some food products and processes.

				Addressing SPS and TBT Measures in FTA Negotiations

In the lead up to the previous T-TIP and Trans-Pacific Partnership (TPP) negotiations, there were active efforts to "go beyond" the rules, rights, and obligations in the WTO SPS Agreement and TBT Agreement, as well as commitments in existing U.S. FTAs. These efforts were referred to as "WTO-Plus" rules or, alternatively, as "SPS-Plus" and "TBT-Plus" rules. Related efforts called for improvements in regulatory cooperation and coherence, along with enhanced partnerships and interactions among regulators in each country.
Modernizing the rules governing the application of SPS and TBT measures in U.S.-EU trade by incorporating "SPS-Plus" and "TBT-Plus" rules as part of a trade agreement could represent a positive step for U.S. food and agricultural exporters. Changes regarding SPS and TBT measures agreed to in the U.S.-Mexico-Canada Agreement (USMCA) and the U.S.-China Phase One Trade Agreement incorporated policy changes regarding SPS and TBT measures consistent with previous "SPS-Plus" and "TBT-Plus" efforts. According to USITC, USMCA "goes further in requiring transparency and encouraging harmonization or equivalence of SPS measures" and incorporates all of the proposed enhanced TPP disciplines "in the areas of equivalence, science and risk analysis, transparency, and cooperative technical consultations." Some industry representatives claim that USMCA "goes beyond TPP in establishing deadlines for 'import checks,' by requiring importing parties to inform exporters or importers within five days of shipments being denied entry." Both agreements contain language that directly relates to the use of biotechnology.
Alternative efforts to modify the EU's application of the precautionary principle could present more of a challenge for U.S. agricultural producers and exporters. Previously, during the T-TIP negotiations, some in the U.S. agriculture and food industry urged U.S. negotiators to address the EU's use and application of the precautionary principle. Many U.S. agricultural and food organizations contended that the EU's application of the precautionary principle undermines sound science and innovation and results in "unjustifiable restrictions" on U.S. exports, allowing the EU "to put in place restrictions on products or processes when they believe that scientific evidence on their potential impact on human health or the environment is inconclusive." Some asserted that application of the principle results in a bias against new technologies, such as biotechnology and nanotechnology. As a result, these groups said that "science-based decision making and not the precautionary principle must be the defining principle in setting up mechanisms and systems" to address SPS concerns. The U.S. Chamber of Commerce supported a "science-based approach to risk management, where risk is assessed based on scientifically sound and technically rigorous standards" and opposed "the domestic and international adoption of the precautionary principle as a basis for regulatory decision making." Many in Congress also called for "effective rules and enforceable rules to strengthen the role of science" to resolve international trade differences.
More recently, the EU's SPS were among the issues that raised the most concerns during a WTO review of the EU's trade policies. Among the cited concerns were certain SPS measures that were viewed to be not based on science or on international standards, and that were also deemed to not allow for adequate opportunity to take into account for the views of third countries.

				Efforts to Resolve SPS and TBT Measures Outside FTA Negotiations

Outside of the FTA negotiation process, various U.S. federal agencies regularly address trade concerns involving SPS and TBT measures as part of their day-to-day oversight and regulatory responsibilities. For example, USDA's Animal and Plant Health Inspection Service (APHIS) administers various regulatory and control programs pertaining to animal and plant health and quarantine, humane treatment of animals, and the control and eradication of pests and diseases. APHIS also oversees SPS certification requirements for imported and exported agricultural goods. This work is ongoing.
The United States also maintains ongoing interagency processes and mechanisms to identify, review, analyze, and address foreign government standards-related measures that may be barriers to trade. These activities are coordinated through the USTR-led Trade Policy Staff Committee, which is composed of representatives from several federal agencies, including USDA, the Department of Commerce, and the State Department. USTR also chairs an interagency group (i.e., both USDA and non-USDA agencies with SPS and TBT responsibilities) that reviews SPS and TBT measures that are notified to the WTO, as required under the SPS and TBT agreements. These agency officials also work with their international counterparts on concerns involving SPS and TBT measures. USTR tracks issues related to such measures as part of its annual reports.

			Geographical Indications

GIs are geographical names that act to protect the quality and reputation of a distinctive product originating in a certain region. The term GI is most often applied to wines, spirits, and agricultural products. GIs allow some food producers to differentiate their products in the marketplace. GIs may also be eligible for relief from acts of infringement or unfair competition. While GIs may protect consumers from deceptive or misleading labels, they can also impair trade when names that are considered common or generic in one market are protected in another. Examples of registered or established GIs include Parmigiano Reggiano cheese and Prosciutto di Parma ham from the Parma region of Italy, Toscano olive oil from the Tuscany region of Italy, Roquefort cheese from France, Champagne from the region of the same name in France, Irish whiskey, Darjeeling tea, Florida oranges, Idaho potatoes, Vidalia onions, Washington State apples, and Napa Valley wines.
GIs are an example of IPR, along with patents, copyrights, trademarks, and trade secrets. The use of GIs has become a contentious international trade issue, particularly for U.S. wine, cheese, and sausage makers. In general, some consider GIs to be protected intellectual property, while others consider them to be generic or semi-generic terms. GIs are included among other IPR issues in the current U.S. trade agenda. GIs were an active area of debate during the T-TIP negotiations. Laws and regulations governing GIs differ markedly between the United States and EU, which further complicates this issue.
GIs are protected by the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which sets binding minimum standards for intellectual property protection that are enforceable by the WTO's dispute settlement procedure. Under TRIPS, WTO members must recognize and protect GIs as intellectual property. Both the United States and the EU are signatories of TRIPS and therefore subject to its rights and obligations. Accordingly, under TRIPS, the United States and EU have committed to providing a minimum standard of protection for GIs (i.e., protecting GI products to avoid misleading the public and prevent unfair competition) and an "enhanced level of protection" to wines and spirits that carry a GI, subject to certain exceptions. TRIPS builds on treaties administered by the World Intellectual Property Organization, a specialized agency in the United Nations with the mission to "lead the development of a balanced and effective international intellectual property (IP) system." It also oversees the "International Register of Appellations of Origin" established in the Lisbon Agreement for the Protection of Appellations of Origin and their International Registration. The agreement's multilateral register covers food products and beverages and related products, as well as non-food products.
The EU's GI program remains a contentious issue for some U.S. producer groups, particularly among wine, cheese, and sausage makers. Some have long expressed their concerns about EU protections for GIs, which they claim are being misused to create market and trade barriers. Much of this debate involves certain terms used by cheesemakers, such as parmesan, asiago, and feta cheese, which the U.S. cheese sectors consider to be generic terms. For example, feta cheese produced in the United States may not be exported for sale in the EU, since only feta produced in countries or regions currently holding GI registrations may be sold commercially. A 2019 study commissioned by the U.S. dairy industry forecasts declining U.S. cheese exports due to expanding restrictions on parmesan, asiago, and feta cheese. Another study concluded that up to $15 million in cheese trade might need to be relabeled due to the restriction on certain GI terms, while other traded foods, such as oilseeds and vinegars, would experience little impact.
Some U.S. industry groups, however, are trying to institute protections for U.S. productsâsimilar to those in the EU GI systemâto promote certain distinctive American agricultural products. The American Origin Products Association represents certain U.S. potato, maple syrup, ginseng, coffee, and chile pepper producers and certain U.S. winemakers, among other regional producer groups. It seeks to work with federal authorities to create "a list of qualified U.S. distinctive product names, which correspond to the GI definition."

				Differences in U.S. and EU Laws and Regulations

Laws and regulations governing GIs differ markedly between the United States and EU. In the United States, GIs generally fall under the common law right of possession or "first in time, first in right" as trademarks or collective or certification marks under the purview of the existing trademark regime, administered by the U.S. Patent and Trademark Office (PTO) and protected under the U.S. Trademark Act. Trademarks are distinctive signs that companies use to identify themselves and their products or services to consumers and can take the form of a name, word, phrase, logo, symbol, design, image, or a combination of these elements. Trademarks do not refer to generic terms, nor do they refer exclusively to geographical terms. Trademarks may refer to geographical names to indicate the specific qualities of goods either as certification marks or as collective marks. PTO does not have a special database register for GIs in the United States. PTO's trademark register, the U.S. Trademark Electronic Search System, contains GIs registered as trademarks, certification marks, and collective marks. USTR says that EU farm products hold nearly 12,000 trademarks. These register entries are not designated with any special field (such as "geographical indications") and cannot be readily compiled into a complete list of registered GIs. In the United States, the Alcohol and Tobacco Tax and Trade Bureau (TTB) also plays a role overseeing the labeling of wine, malt beverages, beer, and distilled spirits.
In the EU, a series of regulations governing GIs was initiated in the early 1990s covering agricultural and food products, wine, and spirits. Legislation adopted in 1992 covering agricultural products (not including wines and spirits) was replaced by changes enacted in 2006 following a WTO panel ruling that found some aspects of the EU's scheme inconsistent with WTO rules. The new rules came into force in January 2013. The EU laws and regulations provide product registration markers for the different quality schemes. The EU regulations establish provisions regarding products from a defined geographical area given linkages between the characteristics of products and their geographical origin. The EU defines a GI as "a distinctive sign used to identify a product as originating in the territory of a particular country, region or locality where its quality, reputation or other characteristic is linked to its geographical origin."
EU registered products often fall under GI protections in certain third-country markets, and some EU GIs have been trademarked in some non-EU countries. This has become a concern for U.S. agricultural exporters following a series of trade agreements the EU has concluded with Canada, Japan, South Korea, South Africa, and other countries that in many cases are also trading partners of the United States. For example, Canada has agreed to recognize a list of 143 EU GIs in Canada, and Japan has agreed to recognize more than 200 EU GIs in Japan. These GI protections could limit U.S. sales of certain products to these countries. The EU is in the process of negotiating FTAs with several other U.S. trading partners, including Mexico, Australia, New Zealand, and the Mercosur states (Argentina, Brazil, Paraguay, and Uruguay). Each of these efforts includes a selected list of GIs that would become protected under an FTA between these countries and the European Union. In December 2019, the EU also entered into an agreement with China regarding GIs that would protect a reported 100 EU GIs in China. As of January 2020, 3,316 product names are registered and protected in the EU for foods, wine, and spirits originating in both EU member states and other countries.

				Addressing GI Barriers in FTA Negotiations

GIs continue to be actively debated as part of the official U.S. trade agenda, involving concerns about their possible improper use as well as the lack of transparency and due process under some country GI systems. USTR is working "to advance U.S. market access interests in foreign markets and to ensure that GI-related trade initiatives of the EU, its Member States, like-minded countries, and international organizations, do not undercut such market access," and states that the EU's GI agenda "significantly undermines the scope of trademarks and other [IPR] held by U.S. producers and imposes barriers on market access for American-made goods that rely on the use of common names." Statements by USDA officials in early 2020 have signaled that this issue could resurface as part of the U.S.-EU trade talks.
Previously, during T-TIP negotiations, U.S. officials indicated that the United States would likely not agree to EU demands to reserve certain food names for EU producers and have expressed concerns about the EU's system of protections for GIs. At the time, U.S. trade policy objectives regarding the EU's GI protections was to ensure that they "do not undercut U.S. industries' market access" and to defend the use of certain "common food names." In general, the United States is seeking protection for current U.S. owners of trademarks that overlap with EU-protected GIs, the ability to use U.S. trademarked names in third countries, and the ability to use U.S. trademarked names in the EU.
In recent developments, according to USITC, USMCA "increases the transparency of applications, approvals, and cancellations" regarding GIs and "provides guidelines for determining whether a term is customary in common use." In addition, a side letter between the United States and Mexico commits Mexico to not restrict market access for a list of more than 30 cheeses. USITC says this could "help prevent future losses of U.S. market access for cheeses with common names" such as "blue" or "Swiss" cheese. The final U.S.-China Phase One Trade Agreement also addresses longstanding concerns regarding IPR, including GIs, building on previous commitments regarding IPR and GIs. The agreement is expected to require that China ensure that it will "not undermine market access for U.S. exports to China of goods" and will apply relevant factors when providing certain GI protections, as well as provide the United States with "necessary opportunities to raise disagreement" regarding GIs. GI provisions in these two recent U.S. FTAs, however, could prove to be incompatible with other EU agreements regarding GIs with these countries. For Mexico and Canada, these include GI protections that are likely to be part of the EU-Mexico Global Agreement, as well as existing GI protections in the EU-Canada Comprehensive Economic and Trade Agreement. For China, these include GI protections agreed to in the 2019 EU-China agreement protecting certain EU GIs in China.

	Next Steps

The U.S.-EU Trade Agreement negotiations present Congress with the challenge of determining to what extent food and agriculture issues will be addressed in the trade talks, if at all. Although market access and tariff reductions may be off the table, addressing regulatory restrictions and other non-tariff barriers to U.S. agricultural trade are considered important for many U.S. producers. Some press reports indicate that certain non-tariff barriers and regulatory cooperation could become part of the new trade talks, while other press reports raise questions about the EU's willingness to address specific types of non-tariff barriers as part of the negotiation. Even if regulatory coherence and cooperation become part of the U.S.-EU trade talks, their resolution in a manner that benefits U.S. agricultural exporters is far from assured. Instead, some of the same non-tariff and regulatory barriers to U.S. trade that proved to be challenging during the T-TIP negotiation could prove to be equally intractable today.
The UK's exit from the EU could also complicate future trade negotiations. The UK is a close ally of the United States and has been one of its strongest advocates among the EU bloc. In general, the regulatory framework and actions taken by the UK's Food Standards Agency are more aligned with those in the United States. Now that the UK is no longer part of the EU, the EU trade gains for U.S. agriculture could be reduced while its agricultural trade deficit may become more pronounced, given a more favorable trade situation with the UK.