U.S.-EU Trade Agreement Negotiations: Trade in Food and Agricultural Products

Summary: The Office of the U.S. Trade Representative (USTR) officially notified the Congress of the Trump Administration's plans to enter into formal trade negotiations with the European Union (EU) in October 2018. In January 2019, USTR announced its negotiating objectives for a U.S.-EU trade agreement, which included agricultural policiesâboth market access and non-tariff measures. However, the EU's negotiating mandate, released in April 2019, stated that the trade talks would exclude agricultural products.

Summary: U.S.-EU27 Agricultural Trade, 1990-201 9

Summary: Improving market access remains important to U.S. agricultural exporters, especially given the sizable and growing U.S. trade deficit with the EU in agricultural products (see figure). Some market access challenges stem in part from commercial and cultural practices that are often enshrined in EU laws and regulations and vary from those of the United States. For food and agricultural products, such differences are focused within certain non-tariff barriers to agricultural trade involving Sanitary and Phytosanitary (SPS) measures and Technical Barriers to Trade (TBTs), as well as Geographical Indications (GIs).

Summary: SPS and TBT measures refer broadly to 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 and diseases, or from additives, toxins, or contaminants in food, beverages, or feedstuffs. SPS and TBT barriers have been central to some longstanding U.S.-EU trade disputes, including those involving EU prohibitions on hormones in meat production and pathogen reduction treatments in poultry processing, and EU restrictions on the use of biotechnology in agricultural production. As these types of practices are commonplace in the United States, this tends to restrict U.S. agricultural exports to the EU.

Summary: GI protections refer to naming schemes that govern product labeling within the EU and within some countries that have a formal trade agreement with the EU. These protections tend to restrict U.S. exports to the EU and to other countries where such protections have been put in place.

Summary: Plans for U.S.-EU trade negotiations come amid heightened U.S.-EU trade frictions. In March 2018, President Trump announced tariffs on steel and aluminum imports on most U.S. trading partners after a Section 232 investigation determined that these imports threaten U.S. national security. Effective June 2018, the EU began applying retaliatory tariffs of 25% on imports of selected U.S. agricultural and non-agricultural products. In October 2019, the United States imposed additional tariffs on imports of selected EU agricultural and non-agricultural products, as authorized by World Trade Organization (WTO) dispute settlement procedures in response to the longstanding Boeing-Airbus subsidy dispute.

Summary: Public statements by U.S. and EU officials in January 2020, however, signaled that the U.S.-EU trade talks might include SPS and regulatory barriers to agricultural trade. Statements by U.S. Department of Agriculture (USDA) officials cited in the press call for certain SPS issues as well as GIs to be addressed in the trade talks. However, other press reports of statements by EU officials have downplayed the extent that specific non-tariff barriers would be part of the talks. More formal discussions are expected in the spring of 2020.

Summary: Previous trade talks with the EU, as part of the Transatlantic Trade and Investment Partnership (T-TIP) negotiations during the Obama Administration, stalled in 2016 after 15 rounds. During those negotiations, certain regulatory and administrative differences between the United States and the EU on issues of food safety, public health, and product naming schemes for some types of food and agricultural products were areas of contention.

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.

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 ).

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 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.

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 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.

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."

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.

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.


National Institutes of Health (NIH) Funding: FY1995-FY2021

Summary: This report details the National Institutes of Health (NIH) budget and appropriations process with a focus on FY2020 and FY2021, and on coronavirus supplemental funding for NIH. The report also provides an overview of funding trends in regular appropriations to the agency from FY1995 to FY2021. Appendix A includes funding tables by account and program-specific funding levels for FY2020 and FY2021.

Summary: The NIH is the primary federal agency charged with conducting and supporting medical, health, and behavioral research, and it is made up of 27 Institutes and Centers and the Office of the Director (OD). About 80% of the NIH budget funds extramural research through grants, contracts, and other awards. About 10% of NIH funding goes to intramural researchers at NIH-operated facilities. Almost all of NIH's funding is provided in the annual Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act. NIH also receives smaller amounts of funding from Interior/Environmental appropriations and a mandatory budget authority for type 1 diabetes research.

Summary: NIH has an FY2020 program level of $41.685 billion and has received emergency supplemental appropriations in three coronavirus supplemental appropriations acts, totaling over $3.59 billionâan 8.6% funding increase over regular enacted FY2020 appropriations. The administration's FY2021 budget request, as amended by a March 2020 letter, proposes an FY2021 program level of $39.133 billionâa 6.1% decrease from the FY2020 program level (regular appropriations).

Summary: NIH has seen periods of high and low funding growth during the period covered by this report, as illustrated in Figure 1 . Between FY1994 and FY1998, funding for NIH grew from $11.0 billion to $13.7 billion (nominal dollars). Over the next five years, Congress and the President doubled the NIH budget to $27.2 billion in FY2003. In each of FY1999 through FY2003, NIH received annual funding increases of 14% to 16%. From FY2003 to FY2015, NIH funding increased more gradually in nominal dollars. In some years (FY2006, FY2011, and FY2013), funding for the agency decreased in nominal dollars. From FY2016 through FY2020, NIH has seen funding increases of over 5% each year. The largest increase was from FY2017 to FY2018, where the program level increased by $3.0 billion (+8.7%), making this the largest single-year nominal dollar increase since FY2003.

Summary: When looking at NIH funding adjusted for inflation (in projected constant FY2021 dollars using the Biomedical Research and Development Price Index; BRDPI), the purchasing power of NIH funding peaked in FY2003âthe last year of the five-year doubling periodâand then declined fairly steadily for more than a decade until back-to-back funding increases were provided in each of FY2016 through FY2020. The FY2021 budget request would provide a program level that is 13.0% below the peak FY2003 program level.

This report provides a historical overview of federal funding provided to the National Institutes of Health (NIH) between FY1995 and FY2021. It also provides a brief explanation of the discretionary spending funding sources for NIH associated with the annual appropriations process (via the Labor, HHS, and Education and Interior/Environment Appropriations Acts) and the mandatory funding for special program on type 1 diabetes research.

NIH is the primary federal agency for medical, health, and behavioral research. It is the largest of the eight health-related agencies that make up the Public Health Service (PHS) within the Department of Health and Human Services (HHS). NIH consists of the Office of the Director (OD) and 27 Institutes and Centers (ICs) that focus on aspects of health, human development, and biomedical science. The OD sets overall policy for NIH and coordinates the programs and activities of all NIH components, particularly in areas of research that involve multiple institutes.

NIH activities cover a wide range of basic, clinical, and translational research, focused on particular diseases, areas of human health and development, or more fundamental aspects of biology and behavior. Its mission also includes research training and health information collection and dissemination. More than 80% of the NIH budget funds extramural research (i.e., external) through grants, contracts, and other awards. This funding supports research performed by more than 300,000 individuals who work at over 2,500 hospitals, medical schools, universities, and other research institutions around the country. About 10% of the agency's budget supports intramural research (i.e., internal) conducted by nearly 6,000 NIH physicians and scientists, most of whom are located on the NIH campus in Bethesda, Maryland.

Funding for NIH comes primarily from annual Labor, HHS, and Education (LHHS) Appropriations Acts, with an additional smaller amount for the Superfund Research Program from the Interior/Environment Appropriations Act. Those two bills provide NIH discretionary budget authority.

Through LHHS appropriations, some funding is also transferred to NIH pursuant to the PHS Evaluation Set-Aside or the "PHS Evaluation Tap" transfer authority. Authorized by Section 241 of the Public Health Service Act, the evaluation tap allows the Secretary of HHS, with the approval of appropriators, to redistribute a portion of eligible PHS agency appropriations across HHS for program evaluation and implementation purposes. The PHSA section limits the set-aside to not less than 0.2% and not more than 1% of eligible program appropriations. However, LHHS Appropriations Acts have commonly established a higher maximum percentage for the set-aside and have distributed specific amounts of "tap" funding to selected HHS programs. Since FY2010, and including in FY2020, this higher maximum set-aside level has been 2.5% of eligible appropriations. Readers should note that totals in this report and NIH source documents include amounts "transferred in" pursuant to PHS tap but do not include any amounts "transferred out" under this same authority.

NIH also receives funding through LHHS appropriations, subject to different budget enforcement rules than the rest of the NIH funding in the actâappropriations to the NIH Innovation Account created by The 21 st Century Cures Act ("the Cures Act," P.L. 114-255 ) to fund programs authorized by the act. For appropriated amounts to the accountâup the limit authorized for each fiscal yearâthe amounts are subtracted from any cost estimate for enforcing discretionary spending limits (i.e., the budget caps). In effect, appropriations to the NIH Innovation Account as authorized by the Cures Act are not subject to discretionary spending limits. The NIH Director may transfer these amounts from the NIH Innovation Account to other NIH accounts, but only for the purposes specified in the Cures Act. If the NIH Director determines that the funds for any of the four Innovation Projects are not necessary, the amounts may be transferred back to the NIH Innovation Account. All amounts authorized by the Cures Act have been fully appropriated to the Innovation Account from FY2017 to FY2020, including $492 million for FY2020. For FY2021, $404 million is authorized to be appropriated.

In addition, NIH has received mandatory funding of $150 million annually that is provided in Public Health Service Act (PHSA) Section 330B, for a special program on type 1 diabetes research, most recently extended through FY2020 by the CARES Act ( P.L. 116-136 ), with additional partial-year FY2021 funding of $25,068,493 for October 1, 2020, through November 30, 2020.

The total funding available for NIH activities, taking account of add-ons and PHS tap transfers, is referred to as the NIH "program level."

The enacted FY2020 NIH program level is made up of the following:

$40.228 billion in discretionary LHHS appropriations, including the $492 million authorized for the Cures Act Innovation Account; $1.231 billion pursuant to the PHS program evaluation transfer and a $225 million transfer from the HHS non-recurring expenses fund (NEF); $81 million for the Superfund research program in Interior/Environment appropriations; and $150 million in annual funding for the mandatory type 1 diabetes research program.

Accounting for transfers and other adjustments, cited FY2021 budget documents from the Administration show the NIH FY2020 program level as $41.685 billion.

NIH has also received emergency supplemental appropriations to several IC accounts as provided by the first and third, coronavirus supplemental appropriations acts, shown in Table 1 , totaling $1.8 billion. In addition to these appropriations, the fourth coronavirus supplemental required that a total of not less than $1.8 billion of $25 billion appropriated to the Public Health and Social Services Emergency Fund be transferred to two NIH institutes and the Office of the Director. When accounting for these transfers, total funding directed to the NIH would come to not less than $3.6 billion across the three actsâan 8.6% funding increase over regular enacted FY2020 appropriations.

These acts also include various other transfer authorities that would allow for additional transfers to and from NIH accounts (explained in the table notes).

By convention, CRS does not add amounts provided as an emergency requirement to the NIH program levels in the remainder of this report. The FY2020 regular and emergency appropriations amounts are presented separately.

President Trump's FY2021 initial budget request (February 10, 2020) proposed that NIH be provided with a total program level of $38.694 billion, a decrease of $2.99 billion (-7.2%) from FY2020-enacted levels. The proposed FY2020 program level would have been made up of

$37.630 billion in LHHS appropriations, including the $404 million for the Cures Act Innovation Account (the full amount authorized for FY2021); $741 million in transfers to NIH pursuant to the PHS Evaluation Tap authority; $74 million for the Superfund Research Program in Interior/Environment appropriations; and $150 million in proposed annual funding for the mandatory type 1 diabetes program.

Under the request, all existing IC accounts would receive a decrease compared to FY2020-enacted levels (see Appendix A ). The Building and Facilities account would receive an increase in LHHS budget authority, from $200 million in FY2020 to $300 million in FY2021.

Subsequently, on March 17, 2020, the Office of Management and Budget submitted an amendment to President Trump's original request that would increase funding for the National Institute of Allergy and Infectious Disease (NIAID) by $440 million relative to the original request. The purpose of this additional requested funding was "to ensure [NIAID] has the resources beginning October 1, 2020, to continue critical basic and applied research on coronaviruses and other infectious diseases." This amendment to the original proposal, if enacted, would result in NIAID receiving an increase of $9.3 million above the FY2020 level. Taking into account this amendment, as of the date of this report, the FY2021 budget request would provide NIH with a total program level of $39.133 billion, a decrease of $2.55 billion (-6.1%) from FY2020-enacted levels, with a total of $38.811 billion by provided by LHHS appropriations.

In addition, the FY2021 budget request proposes consolidating the Agency for Healthcare Research and Quality (AHRQ) into NIH, forming a 28 th ICâthe National Institute for Research on Safety and Quality (NIRSQ). The creation of a new NIH institute would require amendments to the PHSA, especially Section 401(d), which specifies that "[i]n the National Institutes of Health, the number of national research institutes and national centers may not exceed a total of 27." Under the FY2021 request, NISRQ would receive a total appropriation of $355.112 million, including $256.66 million in discretionary LHHS budget authority and $98.452 million in mandatory appropriations from the Patient-Centered Outcomes Research Trust Fund (PCORTF) in Social Security Act Section 1181. Congress did not adopt the Administration's similar proposals to consolidate AHRQ into NIH as NIRSQ in FY2018 through FY2020.

The budget request proposes select specified FY2021 funding levels for programs and activities within and across the NIH accounts based on the Administration's research priorities, as summarized in Table A-3 . If adopted, these funding levels would likely be specified in report and/or explanatory statement language accompanying LHHS appropriations bills. For the most part, Congress does not specify NIH funding for particular diseases or areas of research, instead allowing the ICs to award funding within their mission areas. Funding awards are generally made on a competitive basis through various funding mechanisms intended to balance scientific opportunity with health priorities.

Table 2 outlines NIH program level funding over the previous 25 years; Figure 1 illustrates funding trends in both current (also called nominal dollars) and projected constant (i.e., inflation-adjusted) FY2021 dollars (funding shown is total budget authority).

NIH has seen periods of high and low funding growth. Between FY1994 and FY1998, funding for NIH grew from $11.0 billion to $13.7 billion (nominal dollars). Over the next five years, Congress and the President doubled the NIH budget to $27.2 billion in FY2003. In each of FY1999 through FY2003, NIH received annual funding increases of 14% to 16%. From FY2003 to FY2015, NIH funding increased more gradually in nominal dollars. In some years, (FY2006, FY2011, and FY2013) funding for the agency decreased in nominal dollars. From FY2016 through FY2020, NIH has seen funding increases of over 5% each year. The largest increase was from FY2017 to FY2018, where the program level increased by $3.0 billion (+8.7%), making this the largest single-year nominal dollar increase since FY2003.

The lower half of Figure 1 shows NIH funding adjusted for inflation (in projected constant FY2021 dollars) using the Biomedical Research and Development Price Index (BRDPI). It shows that the purchasing power of NIH funding peaked in FY2003 (the last year of the five-year doubling period) and then declined fairly steadily for more than a decade until back-to-back funding increases were provided in each of FY2016 through FY2020. The FY2021 budget request would provide a program level that is 13.0% below the peak FY2003 program level.

In recent years, Congress and the President have increasingly specified funding levels for programs or research areas within NIH accounts throughout the budget and appropriations process. Congress uses language in reports and explanatory statements accompanying appropriations bills to designate funding for specified purposes. The Administration requests NIH program-specific funding, as outlined in the HHS and NIH budget request documents. For the most part, Congress does not specify NIH funding for particular diseases or areas of research, instead allowing the ICs to award funding within their mission areas. Funding is generally awarded on a competitive basis through various funding mechanisms intended to balance scientific opportunity with health priorities.

In FY2020, Congress used explanatory statement language to specify a certain amount of IC funding for designated purposes, as summarized in Table A-2 . Sometimes the language specifies that "no less than" a certain amount can be designated for a certain purpose; in other cases, language "provides" or "recommends" that an amount be spent on a certain purpose. For FY2020, while the House report ( H.Rept. 116-62 ) also included funding levels for some of the below programs, the amounts in the explanatory statement supersede those. Both the explanatory statement and the House report include many additional statements directing the agency to prioritize certain programs or areas of research, as well as expressing the opinion or concerns of Congress regarding NIH; these broad statements are not summarized here.


COVID-19: Overview of FY2020 LHHS Supplemental Appropriations

Summary: The legislative response to the global pandemic of Coronavirus Disease 2019 (COVID-19) has included the enactment of laws to provide authorities and supplemental funding to prevent, prepare for, and respond to the pandemic. This report focuses on supplemental FY2020 discretionary appropriations provided to programs and activities traditionally funded by the Departments of Labor, Health and Human Services, and Education, and Related Agencies (LHHS) appropriations bill.

Summary: As of the date of this report, LHHS supplemental appropriations for COVID-19 response have been provided in four separate supplemental appropriations measures:

Summary: Title III, Division A, of the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 ( P.L. 116-123 ), enacted on March 6, 2020, provided approximately $6.4 billion in supplemental LHHS funds. Title V, Division A, of the Families First Coronavirus Response Act (FFCRA, P.L. 116-127 ), enacted on March 18, 2020, provided $1.25 billion in supplemental LHHS funds. Title VIII, Division B, of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act, P.L. 116-136 ), enacted on March 27, 2020, provided $172.1 billion in supplemental LHHS funds. Title I, Division B, of the Paycheck Protection Program and Health Care Enhancement Act (PPPHCEA, P.L. 116-139 ), enacted on April 24, 2020, provided $100 billion in supplemental LHHS funds.

Summary: In total, LHHS has received roughly $280 billion in supplemental discretionary appropriations from these COVID-19 response measures. These supplemental funds are in addition to roughly $195 billion in regular FY2020 LHHS discretionary appropriations provided in Division A of P.L. 116-94 , the FY2020 omnibus appropriations act containing full-year LHHS appropriations that was enacted on December 20, 2019. Unlike the annual discretionary appropriations, however, these additional funds were designated as an "emergency requirement" and thus were effectively exempted from otherwise applicable budget enforcement requirements (such as the statutory discretionary spending limits). Overall, the COVID-19 supplemental funds have increased FY2020 LHHS discretionary appropriations by approximately 143%.

Summary: The Department of Health and Human Services (HHS) received funding in all four COVID-19 supplemental appropriations acts, whereas the Department of Labor (DOL), Department of Education (ED), and entities funded under the "Related Agencies" heading received funding in the third supplemental only. In total, HHS received $248 billion, or 89% of all COVID-19 LHHS supplemental appropriations. ED received the second-largest share at $31 billion, or 11%. DOL and the Related Agencies received approximately 0.1% and 0.2% of the LHHS COVID-19 supplemental funds, respectively.

The global pandemic of Coronavirus Disease 2019 (COVID-19) is affecting communities around the world and throughout the United States, with case counts growing daily. Containment and mitigation efforts by federal, state, and local governments have been undertaken to flatten the curve âthat is, to curb widespread transmission that could overwhelm the nation's health care system. Federal response efforts have included the enactment of laws to provide authorities and supplemental funding to prevent, prepare for, and respond to the pandemic. This report focuses on supplemental FY2020 discretionary appropriations provided to programs and activities traditionally funded by the Departments of Labor, Health and Human Services, and Education, and Related Agencies (LHHS) appropriations bill.

Title III, Division A, of the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 ( P.L. 116-123 ), enacted on March 6, 2020. Title V, Division A, of the Families First Coronavirus Response Act (FFCRA, P.L. 116-127 ), enacted on March 18, 2020. Title VIII, Division B, of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act, P.L. 116-136 ), enacted on March 27, 2020. Title I, Division B, of the Paycheck Protection Program and Health Care Enhancement Act (PPPHCEA, P.L. 116-139 ), enacted on April 24, 2020.

In total, LHHS has received roughly $280 billion in supplemental discretionary appropriations from these COVID-19 response measures. These funds are in addition to roughly $195 billion in regular FY2020 LHHS discretionary appropriations provided in Division A of P.L. 116-94 , the FY2020 LHHS omnibus appropriations act that was enacted on December 20, 2019. Unlike the annual discretionary appropriations, however, these additional funds were designated as an "emergency requirement" and thus were effectively exempted from otherwise applicable budget enforcement requirements (such as the statutory discretionary spending limits). Overall, the COVID-19 supplemental funds have increased FY2020 LHHS discretionary appropriations by approximately 143%.

The relevant legislative history of each of the four enacted laws containing LHHS supplemental appropriations is detailed below.

P.L. 116-123 (H.R. 6074), Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020

In the weeks leading up to the supplemental appropriations action in Congress, Alex Azar, the Secretary of the U.S. Department of Health and Human Services (HHS), took administrative steps to allocate existing funding to COVID-19 response efforts. These included issuing a determination on January 25, 2020, allowing the allotment of $105 million from the Infectious Diseases Rapid Response Reserve Fund (IDRRRF). He also reportedly informed Congress on February 2 that he would potentially exercise his authority to transfer $136 million in existing funds within HHS to increase the budgetary resources of several operating divisions and offices that were tasked with COVID-19 response. In response, the Chair of the House Appropriations Committee, Representative Nita Lowey, and the Chair of the LHHS Subcommittee, Representative Rosa DeLauro, sent the Secretary a letter expressing concern that budgetary resources available to HHS at that time would not be sufficient.

On February 24, 2020, the Trump Administration sent Congress a request for supplemental appropriations of $1.25 billion for the Public Health and Social Services Emergency Fund (PHSSEF) at HHS. The request letter included a number of other proposals, largely but not exclusively related to re-purposing existing funds toward response efforts. All told, the Administration estimated needing to allocate approximately $2.5 billion toward COVID-19 response efforts. (For the most part, amounts for other LHHS aspects of the request generally were unspecified in the publicly released request letter.)

Several days after the Administration's request, the Chair of the House Appropriations Committee introduced H.R. 6074 on March 4, 2020. The measure passed the House that same day by a vote of 415-2, passed the Senate on March 5 by a vote of 96-1, and was signed into law ( P.L. 116-123 ) on March 6.

According to the Congressional Budget Office (CBO), P.L. 116-123 provided a total of $7.8 billion in supplemental appropriations in Division A, of which roughly $6.4 billion (about 83%) was for LHHS accounts and activities. (Division B contained authorization provisions related to certain LHHS programs and activitiesâproviding the HHS Secretary authority to temporarily waive or modify the application of certain Medicare requirements with respect to telehealth services. The mandatory spending budgetary effects of these provisions are outside the scope of this report.)

P.L. 116-127 (H.R. 6201), Families First Coronavirus Response Act (FFCRA)

A second COVID-19 response measure was developed by Congress and the Administration soon after the first was enacted. Initially, H.R. 6201 was introduced by the Chair of the House Appropriations Committee on March 11, 2020. The House amended and passed the measure by a vote of 363-40 on March 14, but further alterations to the final legislative package were negotiated over the next two days. On March 16, the House (by unanimous consent) considered and agreed to a resolution ( H.Res. 904 ) that directed the Clerk to make changes to the legislation when preparing the final, official version of the House-passed bill ( engrossment ). The engrossed version was sent to the Senate and ultimately passed without amendment by a vote of 90-8 on March 18. The President signed the bill into law ( P.L. 116-127 ) the same day.

Division A of P.L. 116-127 was estimated by CBO to provide a total of $2.5 billion in supplemental appropriations, of which $1.25 billion (approximately 51%) was for LHHS accounts and activities. (Other divisions of the act contained authorization provisions that in some cases relate to LHHS programs and activitiesâfor instance, provisions providing a 6.2% increase to the federal matching assistance percentage for Medicaid and certain other programs. The mandatory spending budgetary effects of such provisions are outside scope of this report.)

P.L. 116-136 (H.R. 748), Coronavirus Aid, Relief, and Economic Security Act (CARES Act)

On March 17, 2020, the Administration released a second request for FY2020 supplemental appropriations of $45.8 billion for COVID-19 response, of which $11.1 billion was for LHHS accounts and activities.

Over the next several days, Congress and the Administration negotiated the scope and scale of this legislative response, which was expected to involve authorities and additional funding for numerous programs across the federal government. The legislative vehicle that was ultimately chosen for this package was H.R. 748 , an unrelated measure that had been passed previously by the House. Prior to when a deal was reached between Congress and the Administration, the Senate voted on March 22 (47-47) and March 23 (49-46) not to invoke cloture on the motion to proceed to H.R. 748 . The measure was ultimately laid before the Senate by unanimous consent and passed with a substitute amendment by a vote of 96-0 on March 25. The House subsequently took up the Senate amendment on March 27, and agreed to it by a voice vote. The bill was signed into law ( P.L. 116-136 ) by the President that same day.

According to CBO, P.L. 116-136 provided about $330 billion in supplemental appropriations in Division B, of which $172.1 billion (approximately 57%) was for LHHS accounts and activities. (Division A contained authorization provisions that in some cases relate to LHHS programs and activitiesâfor instance, $1.320 billion in mandatory funds for the HRSA health centers program. The mandatory spending budgetary effects of such provisions are outside the scope of this report.)

P.L. 116-139 (H.R. 266), Paycheck Protection Program and Health Care Enhancement Act (PPPHCEA)

About three weeks after the enactment of the CARES Act, Congress and the President came to an agreement that, among other provisions, provided additional supplemental appropriations to HHS for the Provider Relief Fund and to support COVID-19 testing. The legislative vehicle that was used for the agreement was H.R. 266 , an unrelated appropriations bill that had been passed previously by the House. On April 21, 2020, the measure was laid before the Senate by unanimous consent and passed with a substitute amendment by voice vote. The House adopted the Senate version of the proposal on April 23 by a vote of 388-5. The President signed the bill into law ( P.L. 116-139 ) the following day.

According to CBO, P.L. 116-139 provided $162.1 billion in supplemental appropriations in Division B, of which $100 billion (approximately 62%) was for LHHS. (Division A contained no provisions related to LHHS programs and activities. The mandatory spending budgetary effects of the authorization provisions in Division A are outside the scope of this report.)

As previously mentioned, LHHS has received in total roughly $280 billion in supplemental discretionary appropriations from the COVID-19 response measures ( Table 1 ). HHS received funding in all four supplemental appropriations acts, whereas the Department of Labor (DOL), the Department of Education (ED), and entities funded under the Related Agencies (RA) heading received funding in the third supplemental only.

HHS received the vast majority of all LHHS COVID-19 supplemental fundsâ$248 billion, or 89%. ED received the second-largest shareâ$31 billion, or 11%. DOL and RA received approximately 0.1% and 0.2%, respectively.

The remainder of this report provides highlights for HHS, DOL, ED, and RA, and includes a detailed table ( Table 2 ) organized by department or agency and by account, program, or activity.

The majority of DOL funds ($345 million) in the third measure are for dislocated worker assistance through activities authorized by the Workforce Innovation and Opportunity Act (WIOA). Specifically, the DOL funds are for the WIOA National Reserve, which provides National Dislocated Worker Grants (NDWGs) to states and localities to assist with worker dislocation resulting from natural disasters and mass layoffs. These funds are generally expected to address workforce-related effects of the COVID-19 pandemic.

The majority of HHS funds (93%) in the supplemental appropriations measures have been appropriated to the Public Health and Social Services Emergency Fund (PHSSEF). The PHSSEF account is used by the HHS Secretary for one-time or short-term funding, such as emergency supplemental appropriations, and for some ongoing public health preparedness activities in the Office of the HHS Assistant Secretary for Preparedness and Response (ASPR).

Accounts at the Centers for Disease Control and Prevention (CDC) received approximately 3% of the supplemental HHS appropriations provided in the COVID-19 response measures. Accounts at the Administration for Children and Families (ACF) received a similar amount. Remaining funds were provided in smaller amounts to the National Institutes of Health (NIH), the Administration for Community Living (ACL), the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Centers for Medicare and Medicaid Services (CMS).

While amounts shown in Table 2 are displayed as appropriated, readers should note that the first, third, and fourth COVID-19 supplemental appropriations acts authorized HHS to transfer funds made available in these acts, provided the transfers are made to prevent, prepare for, and respond to the pandemic. (This broad authority giving HHS discretion over certain transfers is in addition to provisions in these three measures that direct HHS to make specific transfers.) The first measure broadly allowed for HHS to transfer funds among accounts at CDC, NIH, and PHSSEF. The third measure allowed for transfers among amounts at CDC, PHSSEF, ACF, ACL, and NIH. The fourth measure allowed for transfers among accounts at CDC, NIH, PHSSEF, and the Food and Drug Administration, but limited the amounts available for such transfers (e.g., it excluded from this authority $75 billion provided to the PHSSEF for the "Provider Relief Fund"). The acts require HHS to notify the House and the Senate appropriations committees 10 days in advance of such transfers.

The PHSSEF received about $232 billion in funding across the four measures. This accounts for 83% of all LHHS funds provided in the acts (and 93% of the HHS funds in the LHHS titles of the bills). These PHSSEF funds may support various activities, including health care surge capacity and the development and purchase of medical countermeasures, including vaccines. In general, PHSSEF supplemental funding has been provided for four main sets of activities.

Medical Countermeasures and Surge Capacity: The first and third measures each provided funding to support the development, and in some cases federal purchase, of COVID-19 medical countermeasures, such as diagnostic tests, treatments, vaccines, and medical supplies, as well as for healthcare workforce and other surge capacity activities. In total, approximately $30.4 billion has been provided for these activities. Note that the bills also specify that some of these funds are to be transferred elsewhere (e.g., to other federal agencies for the care of persons under federal quarantine) or reserved for specific purposes or activities (e.g., deposits to the Strategic National Stockpile). These activities may be carried out by various ASPR components, especially the Biomedical Advanced Research and Development Authority (BARDA) for countermeasure development and procurement.

COVID-19 Testing for the Uninsured : The second supplemental measure included $1 billion to provide reimbursements for COVID-19 testing and related services for persons who are uninsured. In addition, the fourth measure specified that up to $1 billion out of the amounts appropriated for broader COVID-19 testing purposes (discussed below) may be used to cover the costs of testing for the uninsured. Both measures provide for these payments to be made according to the National Disaster Medical System (NDMS) definitive care reimbursement mechanism. However, the program is administered by HRSA.

Provider Relief Fund: The third and fourth supplemental measures each provided funding for a "Provider Relief Fund" to assist health care providers and facilities affected by the COVID-19 pandemic. These funds are intended to reimburse eligible health care providers for health care-related expenses or lost revenues that are attributable to COVID-19. The measures define eligible providers broadly as any that provide "diagnoses, testing, or care for individuals with possible or actual cases of COVID-19." In total, $175 billion has been appropriated for the Provider Relief Fund.

COVID-19 Testing , Surveillance, and Contact Tracing : The fourth supplemental measure provided $25 billion to augment national capacity for COVID-19 containment, including expanded testing capacity, and workforce and technical capacity for disease surveillance and contact tracing. The bill directed HHS to reserve some of these funds for specific purposes (e.g., not less than $11 billion is for states, localities, territories, tribes, tribal organizations, urban Indian health organizations, or health service providers to tribes). In addition, the bill specified that certain funds are to be transferred to other agencies and accounts (e.g., $600 million is to be transferred to the FDA for diagnostic, serological, antigen, and other tests).

In addition to the activities specified above, PHSSEF appropriations in the first, third, and fourth supplemental measures called for some portion of the funds to be transferred to other agencies or accounts for particular activities. For instance, some PHSSEF funds are required to be transferred to the HRSA for health centers, rural health, the Ryan White HIV/AIDS program, and health care systems.

Further public health-related funding for preparedness and response was appropriated to the CDC ($6.5 billion) and NIH ($1.8 billion) in the first and third supplemental measures. In addition, the fourth supplemental explicitly directed certain PHSSEF appropriations to be transferred to CDC and NIH for COVID-19 response activities. When accounting for these transfers, total funding directed to the CDC would come to not less than $7.5 billion and total funding directed to NIH would come to not less than $3.6 billion. The CDC funding was intended, among other things, to support grants, or cooperative agreements with grants to states, localities, tribes and other entities, for public health activities (e.g., surveillance, infection control, diagnostics, laboratory support, and epidemiology), as well as for global disease detection and modernization of public health data collection. The funds may also be used to support public outreach campaigns, and provide guidance to physicians, health care workers, and others. Most of the NIH funding was provided to several institutes to support basic scientific research as well as research on potential vaccines, therapeutics, and diagnostics related to COVID-19.

ACL received a total of $1.2 billion in the second and third response measures. The majority of this funding ($750 million) was spread across a variety of activities that the agency undertakes to help provide meals to low-income seniors.

SAMHSA received $425 million in the third measure, with $250 million for Certified Community Behavioral Health Clinics, $50 million for suicide prevention programs, and not less than $15 million for Indian Tribes. The measure specified that not less than $100 million be made available as emergency response grants for state governments for crisis intervention services, mental health and substance use disorder treatment, and recovery supports for individuals affected by the pandemic.

CMS received $200 million in the third measure. At least half of this appropriation was to be spent on additional infection control surveys for federally certified facilities with populations vulnerable to severe illness from COVID-19.

ACF received $6.3 billion in the third measure. These funds were directed to a number of human services programs. For instance, the Child Care and Development Block Grant received $3.5 billion to provide continued assistance to child care providers in the event of decreased enrollment or program closures. These funds may also be used to support child care facilities that are open and operating, including those providing care for the children of essential workers. Several other ACF programs received funding, including the Community Services Block Grant ($1 billion), Head Start ($750 million), and the Low Income Home Energy Assistance Program ($225 million).

Almost all of the $30.925 billion in supplemental ED appropriations provided in the third measure are for the Education Stabilization Fund (ESF). The ESF is composed of three emergency relief funds: (1) a Governor's Emergency Education Relief (GEER) Fund (Â§18002), (2) an Elementary and Secondary School Emergency Relief Fund (ESSERF; Â§18003), and (3) a Higher Education Emergency Relief (HEER) Fund (Â§18004). The third measure provided a total of $30.750 billion for the ESF and specified that these funds are to remain available through September 30, 2021.

The GEER Fund may be used to provide emergency support through grants to local educational agencies (LEAs) that the state educational agency (SEA) or governor determines to have been the most significantly impacted by COVID-19. Emergency support may also be provided through grants to institutions of higher education (IHEs) serving students within the state that the governor determines to have been the most significantly impacted by COVID-19. A governor may also choose to provide emergency support to any other IHE, LEA, or education-related entity within the state that he or she deems "essential for carrying out emergency educational services" to students for a broad array of purposes ranging from any activity authorized under various federal education laws to the provision of child care and early childhood education, social and emotional support, and the protection of education-related jobs.

Funds from the ESSERF are to be awarded to states based on their relative shares of grants awarded under Title I-A of the Elementary and Secondary Education Act (ESEA), as amended. SEAs are required to provide at least 90% of the funds to LEAs to be used for myriad purposes such as any activity authorized under various federal education laws (e.g., ESEA), coordination of preparedness and response to the COVID-19 pandemic, technology acquisition, mental health, and activities related to summer learning. Funds retained by the SEA must be used for emergency needs, as determined by the SEA, to address issues in response to the COVID-19 pandemic and for administration.

The HEER Fund is to distribute funds to IHEs to address needs directly related to the COVID-19 pandemic, including, but not limited to, transitioning courses to distance education and grant aid to students for their educational costs such as food, housing, course materials, health care, and child care.

The Social Security Administration (SSA) received the largest amount ($300 million) among the related agencies. These funds were provided to the SSA Limitation on Administrative Expenses account to support the salaries and benefits of all SSA employees affected as a result of office closures. The funds are also to be used for costs associated with telework, phone, and communication services for employees; for overtime costs and supplies; and for processing disability and retirement benefit workloads and backlogs.

Detailed LHHS Programs and Activities Supplemental Amounts

Table 2 displays funding directed to LHHS programs and activities, as enacted, across the four COVID-19 supplemental appropriations acts. It is organized by department or agency and by account, program, or activity. The table also indicates a number of cases in which appropriations language reserved funds within a particular account for specific programs or activities, or directed that funds be transferred to other accounts. It makes note of instances in which these reservations are for not less than (NLT) or not more than (NMT) a certain dollar amount. In cases where the bill text calls for transfers, funds are shown in the account to which they were appropriated, not in the account to which they are to be transferred.