# Science and Technology Issues in the 117th Congress > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/crs%3AR46787 ## Record - **Collection:** Congressional research report - **Document type:** CRS Report - **Published:** May 5, 2021 - **Citation:** R46787 ## Text Science and Technology Issues in the 117th Congress May 5, 2021 Congressional Research Service https://crsreports.congress.gov R46787 SUMMARY Science and Technology Issues in the 117th Congress The federal government supports scientific and technological advancement directly by funding and performing research and development, and indirectly by creating and maintaining policies that encourage private sector efforts. Additionally, the federal government regulates many aspects of S&T activities. This report briefly outlines a key set of science and technology policy issues that may come before the 117th Congress. R46787 May 5, 2021 Frank Gottron, Coordinator Specialist in Science and Technology Policy Brian E. Humphreys, Coordinator Analyst in Science and Technology Policy Many of these issues carry over from previous Congresses, and represent areas of continuing Member interest. Examples include policies on taxation, trade, intellectual property, commercialization of basic scientific research and other overarching issues that affect scientific and technological progress. Other issues may represent new or rapidly evolving areas affected by the threats of pandemic diseases, climate change, and malicious cyber activities, among others. Examples covered in this report include infectious disease modeling and forecasting, digital contact tracing and digital exposure notification, hydrogen pipelines, and expansion of emerging information and communications technologies such as 5G. These and other S&T-related issues that may come before the 117th Congress are grouped into 10 categories.   Overarching S&T Policy Issues,         Biotechnology and Biomedical Research and Development, Agriculture, Climate Change and Water, Defense, Energy, Homeland Security, Information Technology, Physical and Material Sciences, and Space. Each of these categories includes concise analysis of multiple policy issues. The material presented in this report should be viewed as illustrative rather than comprehensive. Each section identifies CRS reports, when available, and the appropriate CRS experts to contact for further information and analysis. Congressional Research Service Science and Technology Issues in the 117th Congress Contents Overarching Science and Technology Policy Issues .............................................................. 1 Federal Science and Technology Policymaking Enterprise ............................................... 1 Federal Funding for Research and Development............................................................. 2 Adequacy of the U.S. Science and Engineering Workforce............................................... 2 Tax Incentives for Technological Innovation .................................................................. 3 Federal Scientific Integrity Policies .............................................................................. 4 Technology Transfer from Federal Laboratories ............................................................. 4 R&D Security ........................................................................................................... 5 The Role of Technical Standards in U.S. Trade Policy ..................................................... 6 Intellectual Property Law............................................................................................ 7 Agriculture..................................................................................................................... 8 Agricultural Research Funding .................................................................................... 8 Climate Change Science at USDA................................................................................ 9 ERS and NIFA Operations Following Their Relocation ................................................. 10 Regulation of Agricultural Biotechnology ................................................................... 10 The National Bio and Agro-defense Facility ................................................................ 11 Cell-Cultured Meat .................................................................................................. 12 Biotechnology and Biomedical Research and Development ................................................. 13 CRISPR: Advanced Genome Editing .......................................................................... 13 Bioeconomy ........................................................................................................... 14 National Institutes of Health (NIH) and Biomedical Research......................................... 14 The Food and Drug Administration (FDA): Medical Product Innovation .......................... 15 Regulation of Laboratory-Developed Tests .................................................................. 16 Stem Cells and Regenerative Medicine ....................................................................... 17 Infectious Disease Modeling and Forecasting............................................................... 18 Climate Change and Water ............................................................................................. 19 Climate-Related S&T Expenditures and Activities by the Federal Government ................. 19 Climate Change-Related Science ............................................................................... 20 GHG-Related Technology Research, Development, Demonstration, and Deployment ........ 21 Climate Change and Infrastructure ............................................................................. 22 Science and Technology for Adaptation and Resilience.................................................. 23 Carbon Capture and Sequestration.............................................................................. 24 Water..................................................................................................................... 26 Defense ....................................................................................................................... 28 Department of Defense Research, Development, Test, and Evaluation ............................. 28 Energy......................................................................................................................... 29 Biofuels ................................................................................................................. 29 Hydraulic Fracturing and Horizontal Drilling ............................................................... 30 Electricity Modernization and Decarbonization ............................................................ 31 Advanced Battery Energy Storage.............................................................................. 31 Reprocessing of Spent Nuclear Fuel ........................................................................... 32 Advanced Nuclear Energy Technology........................................................................ 33 Hydrogen Pipelines.................................................................................................. 34 Offshore Energy Development Technologies................................................................ 35 Homeland Security........................................................................................................ 36 Congressional Research Service Science and Technology Issues in the 117th Congress Evolving Technology and the Debate over “Lawful Access”........................................... 36 Federal Law Enforcement Use of Facial Recognition Technology ................................... 37 Critical Infrastructure Security and Resilience.............................................................. 38 Information and Communication Technology .................................................................... 39 Cybersecurity.......................................................................................................... 39 Artificial Intelligence ............................................................................................... 40 Big Tech and Social Media Policy and Regulation ........................................................ 41 Broadband Deployment and the Digital Divide ............................................................ 42 Deployment of the FirstNet Network .......................................................................... 43 5G Telecommunications ........................................................................................... 44 Access to Broadband Networks and the Net Neutrality Debate ....................................... 45 Networking and Information Technology Research and Development Program ................. 45 Quantum Information Science ................................................................................... 46 The Internet of Things .............................................................................................. 47 Digital Contact Tracing and Digital Exposure Notification ............................................. 48 Physical and Material Sciences........................................................................................ 49 National Science Foundation ..................................................................................... 49 Nanotechnology and the National Nanotechnology Initiative.......................................... 50 Space .......................................................................................................................... 51 NASA.................................................................................................................... 51 Commercial Space................................................................................................... 52 Earth-Observing Satellites......................................................................................... 53 Contacts Author Information ....................................................................................................... 54 Congressional Research Service Science and Technology Issues in the 117th Congress Overarching Science and Technology Policy Issues This section provides an overview of the federal science and technology (S&T) policymaking enterprise, followed by discussion of several issues that the enterprise currently addresses. These issues include federal funding for research and development; the adequacy of the science and engineering workforce; the role of tax incentives in promoting advancement of science and technology; federal scientific integrity policies; technology transfer from federal laboratories; research and development security; the role of technical standards in federal trade policy; and intellectual property law. Federal Science and Technology Policymaking Enterprise The federal S&T policymaking enterprise is composed of an extensive and diverse set of stakeholders in the executive, legislative, and judicial branches. The enterprise fosters, among other things, the advancement of scientific and technical knowledge; science, technology, engineering, and mathematics (STEM) education; the application of S&T to achieve economic, national security, and other societal benefits; and the use of S&T to improve federal decisionmaking. Federal responsibilities for S&T policymaking are highly decentralized. Many House and Senate committees have jurisdiction over important elements of S&T policy. In addition, congressional appropriations committees provide funding for federal agency S&T programs. Congress also enacts laws to establish, refine, and eliminate programs, policies, regulations, regulatory agencies, and regulatory processes that affect science, technology, and engineering research and development (R&D) or rely on S&T data and analysis. However, congressional authorities related to S&T policymaking are diffuse. In addition, there are dozens of informal congressional caucuses in areas of S&T policy such as R&D, specific S&T disciplines, and STEM education. The President formulates annual budgets, policies, and programs for consideration by Congress; issues executive orders and directives; and directs the executive branch departments and agencies responsible for implementing S&T policies and programs. The Office of Science and Technology Policy (OSTP), in the Executive Office of the President, advises the President and other Administration officials on S&T issues. Executive agency S&T responsibilities are also diffuse. Some agencies have broad S&T responsibilities (e.g., the National Science Foundation). Others use S&T to meet a specific federal mission (e.g., defense, energy, health, space). Regulatory agencies have S&T responsibilities in areas such as nuclear energy, food and drug safety, and environmental protection. Federal court cases and decisions often affect U.S. S&T policy. Decisions can have an impact on the development of S&T (e.g., decisions regarding the U.S. patent system); S&T-intensive industries (e.g., the break-up of AT&T in the 1980s); and the admissibility of S&T-related evidence (e.g., DNA samples). For Further Information John F. Sargent Jr., Specialist in Science and Technology Policy CRS Report R43935, Office of Science and Technology Policy (OSTP): History and Overview, by John F. Sargent Jr. and Dana A. Shea Congressional Research Service 1 Science and Technology Issues in the 117th Congress Federal Funding for Research and Development The federal government has long supported the advancement of scientific knowledge and technological development through investments in R&D, which have led to scientific breakthroughs and new technologies, from jet aircraft and the internet to communications satellites and defenses against disease. Federal R&D funding seeks to address a broad range of national interests, including national defense, health, safety, the environment, and energy security; advance knowledge generally; develop the scientific and engineering workforce; and strengthen U.S. innovation and competitiveness. Between FY2008 and FY2013, federal R&D funding fell from $140.1 billion to $130.9 billion in current dollars, a reduction of $9.3 billion (6.6%). The decline was a reversal of sustained growth in federal R&D funding for more than half a century, and stirred debate about the potential longterm effects on U.S. technological leadership, innovation, competitiveness, economic growth, and job creation. From FY2013 to FY2017, federal funding grew, rising to an all-time current dollar high of $155.0 billion in FY2017. A change in R&D accounting by the Office of Management and Budget to exclude certain latestage development activities (primarily at the Department of Defense and NASA) from total federal R&D calculations obscures comparison of funding levels for FY2018 and later years to funding from FY2017 and earlier years. As calculated by OMB, current dollar federal R&D funding was $135.8 billion in FY2018, $140.1 billion in FY2019, and $156.0 billion in FY2020. Concerns by some about the adequacy of federal R&D funding have been exacerbated by increases in the R&D investments of other nations (China, in particular); globalization of R&D and manufacturing activities; and trade deficits in advanced technology products, an area in which the United States previously ran trade surpluses (most recently in 2001). In addition, R&D funding decisions may be affected by differing perspectives on the appropriate role of the federal government in advancing science and technology. As the 117th Congress undertakes the appropriations process it may consider two overarching issues: (1) the level of federal R&D investment and (2) how available funding will be prioritized and allocated. Low or negative growth in the federal government’s overall R&D investment may require movement of resources across disciplines, programs, or agencies to address priorities. Congress continues to play a central role in defining the nation’s R&D priorities as it makes decisions with respect to the size and distribution of aggregate, agency, and programmatic R&D funding. For Further Information John F. Sargent Jr., Specialist in Science and Technology Policy CRS Report R46341, Federal Research and Development (R&D) Funding: FY2021, coordinated by John F. Sargent Jr. CRS Report R45715, Federal Research and Development (R&D) Funding: FY2020, coordinated by John F. Sargent Jr. Adequacy of the U.S. Science and Engineering Workforce The adequacy of the U.S. science and engineering (S&E) workforce has been an ongoing concern of Congress for more than 70 years. Scientists and engineers are widely believed to be essential to U.S. technological leadership, innovation, manufacturing, and services, and thus vital to U.S. economic strength, national defense, and other societal needs. Congress has enacted many programs to support the education and development of scientists and engineers. Congress has also Congressional Research Service 2 Science and Technology Issues in the 117th Congress undertaken broad efforts to improve science, technology, engineering, and math skills to prepare a greater number of students to pursue S&E degrees. In addition, some policymakers have sought to increase the number of foreign scientists and engineers working in the United States through changes in visa and immigration policies. Most experts agree that there is no authoritative definition of which occupations comprise the S&E workforce. Rather, the selection of occupations included in any particular analysis of the S&E workforce may vary depending on the objective of the analysis. The policy debate about the adequacy of the U.S. S&E workforce has focused largely on professional-level computer occupations, mathematical occupations, engineers, and physical scientists. Accordingly, much of the analytical focus has been on these occupations. However, some analyses may use a definition that includes some or all of these occupations, as well as life scientists, S&E managers, S&E technicians, social scientists, and related occupations. Many policymakers, business leaders, academics, S&E professional society analysts, economists, and others hold differing views with respect to the adequacy of the S&E workforce and related policy issues. These issues include the question of the existence of a shortage of scientists and engineers in the United States, what the nature of any such shortage might be (e.g., too few people with S&E degrees, mismatches between skills and needs), and whether the federal government should undertake policy interventions or rely upon market forces to resolve any shortages in this labor market. Among the key indicators used by labor economists to assess the existence of occupational labor shortages are employment growth, wage growth, and unemployment rates. For Further Information John F. Sargent Jr., Specialist in Science and Technology Policy CRS Report R43061, The U.S. Science and Engineering Workforce: Recent, Current, and Projected Employment, Wages, and Unemployment, by John F. Sargent Jr. Tax Incentives for Technological Innovation The 117th Congress may consider new federal policies to promote technological innovation, considered a key contributor to long-term economic growth. In general, companies are unlikely to invest as much in R&D as the resulting social benefits might warrant because aggregate social benefits are often not realized as direct monetary returns on R&D investment to companies. Economists regard underinvestment in R&D as a market failure, which can be remedied through various kinds of government intervention. One way many governments address this issue is to provide tax incentives for business R&D investment. The federal government offers two such incentives. One is a research tax credit under Section 41 of the Internal Revenue Code (IRC), and the other is an expensing allowance for the full amount of qualified expenses under Section 174. There are two options for the credit: (1) 20% of qualified expenses above a base amount, or (2) 14% of qualified expenses above a different base amount. Section 174 expensing is scheduled to expire at the end of 2021, and starting in 2022, qualified research costs would have to be amortized over five years. The loss of an expensing option for research expenses is likely to raise the user cost of capital for R&D investments and reduce cash flow for firms investing in R&D. Critics of the current research tax credit argue that it should be altered in two ways. First, they say the credit’s rate should be increased so it might stimulate large, sustained increases in business R&D. Second, in recognition of the key role played by young, small firms in the innovation process, critics Congressional Research Service 3 Science and Technology Issues in the 117th Congress advocate making the credit fully refundable for small research-intensive startup firms in their early years, when many of them are likely to have operating losses, and thus no tax liability. For Further Information Gary Guenther, Analyst in Public Finance CRS Report RL31181, Research Tax Credit: Current Law and Policy Issues for the 114th Congress, by Gary Guenther CRS Report R44829, Patent Boxes: A Primer, by Gary Guenther Federal Scientific Integrity Policies The results of research and development (R&D) help inform the decisions that policymakers and the public reach on a wide range of issues, including human health and safety, the environment, agriculture, energy, and transportation. For example, scientific information is essential to the review and approval of drugs and medical devices and the setting of air quality standards. There is broad agreement among policymakers and the scientific and engineering community about ensuring the integrity of the conduct, communication, and management of R&D, and its use in policy development and decisionmaking. However, some policymakers and others allege that presidential administrations of both parties have violated principles of scientific integrity. Assertions of such violations include weighting the membership of federal advisory committees toward a particular viewpoint or constituency, targeting individual scientists for harassment or adverse actions, appointing agency officials with significant conflicts of interest or antagonistic views toward an agency’s mission or neutrality to science, improperly editing scientific documents, and using the budget process to impede the implementation or formulation of sciencebased policies. Following the guidance of a 2010 memorandum issued by the Office of Science and Technology Policy, more than 20 federal departments and agencies have developed and implemented scientific integrity policies. There is, however, no uniform definition of scientific integrity across the federal government. Some experts have expressed concern over the variation in scope and specificity of federal agency scientific integrity policies and recommended that Congress enact scientific integrity legislation that would create a clear set of standards and mechanisms for enforcement. The 117th Congress may consider such legislation. Additionally, Congress may consider how agencies report and address alleged violations as well as potential strategies for and improvements to interagency coordination of scientific integrity policies. Further Information Marcy E. Gallo, Analyst in Science and Technology Policy CRS Report R46614, Federal Scientific Integrity Policies: A Primer, by Marcy E. Gallo Technology Transfer from Federal Laboratories On an annual basis, approximately one-third of the federal government’s research and development (R&D) spending has been obligated to federal laboratories, including federally funded research and development centers, in support of agency mission requirements. The technology and expertise generated by federal laboratories often has application beyond the immediate goals or intent of the original R&D. Over the years, Congress has established various mechanisms—primarily through the Stevenson-Wydler Technology Innovation Act of 1980 (P.L. Congressional Research Service 4 Science and Technology Issues in the 117th Congress 96-480) and subsequent legislation—to facilitate the transfer of technology and research from federal laboratories to the private sector where it can be further developed and commercialized. Congress is broadly interested in promoting the transfer of technology to address societal needs, promote economic growth, and enhance national welfare and security. Technology transfer from federal laboratories can occur in many forms. In some instances, it can occur through formal partnerships and joint research activities between federal laboratories and private firms, including through cooperative research and development agreements. In other cases, it can occur when the federal government licenses its patent rights to a private firm. Despite efforts to increase the effectiveness and frequency of technology transfer from federal laboratories to the private sector, critics of current mechanisms maintain that working with federal laboratories continues to be difficult and time-consuming. Proponents of current mechanisms assert that federal laboratories are open and receptive to collaborating with private firms, but it remains up to those firms to take advantage of federal laboratory technologies and capabilities. In April 2019, the National Institute of Standards and Technology released a green paper, titled “Return on Investment Initiative for Unleashing American Innovation,” proposing various strategies and actions to accelerate and improve the transfer of technology to the private sector. Several of the proposed actions, including additional mechanisms for collaborating with the private sector and modifying federal technology transfer policies and practices, would require congressional approval and additional legislative authority to implement. The 117th Congress may consider the actions contained in the green paper or other efforts to improve technology transfer. Further Information Marcy E. Gallo, Analyst in Science and Technology Policy CRS Report R44629, Federally Funded Research and Development Centers (FFRDCs): Background and Issues for Congress, by Marcy E. Gallo. R&D Security The federal government invests extensively in science and engineering R&D to achieve national objectives, including economic competitiveness and national security. Many in Congress are concerned about security vulnerabilities in the U.S. R&D enterprise and are interested in protecting it against compromise by foreign competitors and potential military adversaries. In general, U.S. policy for federally funded basic and applied research is to encourage openness and broad dissemination of results (see National Security Decision Directive NSDD-189, 1985). When openness would present a national security concern, however, the federal government can use restrictions such as classification and export controls to prevent certain nations (e.g., Russia, China, Iran, and North Korea) and their proxies from accessing certain results and technologies. Some emerging fields may not yet be subject to these controls, so Congress enacted a provision in the Export Control Reform Act of 2018 (50 U.S.C. §4817) requiring the Bureau of Industry and Security of the Department of Commerce to “establish appropriate controls, including interim controls, on the export, reexport, or transfer (in country) of emerging and foundational technologies.” Some Members may be interested in strengthening these protections. Recently Congress has also focused on the security of U.S. R&D that is significant for economic competitiveness, in light of organized efforts, both licit and illicit, by China and other nations to access economically important U.S. R&D outputs to aid their defense and commercial sectors. Classification and export controls were not designed to address commercial aspects of the R&D Congressional Research Service 5 Science and Technology Issues in the 117th Congress security threat. U.S. law enforcement and counterintelligence agencies have highlighted China’s strategy of using espionage, intellectual property theft, direct and venture capital investment and financial subsidies, corporate acquisitions, forced technology transfer, and talent recruitment to gain access to U.S. R&D outputs. Many in Congress have been concerned with co-option of U.S. citizen researchers through foreign talent recruitment programs (such as China’s Thousand Talents program) and the use of foreign nationals at U.S. universities and other institutions—such as students, faculty, visiting scholars, and postdoctoral researchers—to acquire and report on research activities, progress, and results. It has considered policy options to address these concerns, such as increasing threat awareness among U.S. academic researchers, strengthening disclosure requirements for U.S. researchers with foreign ties, and changing policies for foreign students at U.S. universities. The 117th Congress may continue to monitor threats to the security of U.S. R&D, conduct oversight to examine the progress of ongoing efforts to address those threats, and consider additional measures that may enhance the ability of the United States to protect the results of federally funded R&D. For Further Information Daniel Morgan, Specialist in Science and Technology Policy John F. Sargent, Jr., Specialist in Science and Technology Policy Karen Sutter, Specialist in Asian Trade and Finance Jill H. Wilson, Analyst in Immigration Policy The Role of Technical Standards in U.S. Trade Policy Industrial, technical, and agricultural standards, which often aim to achieve legitimate public policy objectives, can become non-tariff trade barriers and limit economic opportunities for U.S. exporters, depending on how those standards are designed and implemented. These issues are becoming more central as trade expands and supply chains become more globally integrated. Local or national standards that deviate significantly from recognized international standards or favor domestic firms may make it difficult for U.S. firms to enter particular overseas markets. The United States has historically promoted non-discriminatory and transparent standards through its trade agreements, including through the Technical Barriers to Trade (TBT) agreement in the World Trade Organization (WTO) and participation in international standards-setting institutions. As countries make new breakthroughs in fields such as information and communications technology, pharmaceuticals, and advanced manufacturing, the landscape of standards-setting is becoming more competitive. U.S. partners and competitive rivals are actively pursuing domestically-driven standardization strategies at the international level that may give their firms an edge in certain strategic industries of interest to Congress, including fifth-generation wireless technology (5G), machine learning, and “Internet of Things” protocols. The Chinese government is pursuing an ambitious push to set international standards across a range of emerging technologies as part of its forthcoming China Standards 2035 initiative. Additionally, China’s representation in the leadership and administrative staff of international standards-setting organizations is growing. The European Union (EU) is pursuing the concept of “digital sovereignty,” often through new rules and technological standards based on EU values, such as “ethical AI” or the EU’s fundamental right to privacy. The U.S. standards-setting process is traditionally bottom-up, fed by industry innovation, rather than top-down as in China or the EU. Some experts argue that without clear U.S. leadership in Congressional Research Service 6 Science and Technology Issues in the 117th Congress establishing international standards or providing sound U.S. alternatives that can be widely adopted and supported by other countries, as well as more active U.S. government involvement in standards-setting bodies as a national policy priority, other countries may imitate EU or Chinese standards and regulations. This could create additional burdens for U.S. firms serving foreign markets. Increased U.S. involvement in international standard setting could serve as an avenue for ensuring the long-term competitiveness of U.S. firms, particularly in emerging technology sectors. As competition in international standards-setting bodies has intensified, some Members of Congress have expressed concern about the competitiveness of United States’ approach and processes. For Further Information Michael D. Sutherland, Analyst in International Trade and Finance Rachel F. Fefer, Analyst in International Trade and Finance Intellectual Property Law Intellectual property (IP) rights, including patents and copyrights, play a critical role in encouraging innovation, creativity, and the dissemination of knowledge. Given activity on IP issues during the prior Congress, the 117th Congress may consider legislation in several IP-related areas. Patents grant inventors the exclusive right to make, use, sell, and import their patented inventions for a term of years. Patents play a particularly significant role in certain industries, such as information technology and pharmaceuticals. Many recent bills have sought to increase competition and reduce drug prices by limiting certain alleged pharmaceutical patenting practices (e.g., patent “evergreening,” “thickets,” and “pay-for-delay” settlements). Following Supreme Court decisions restricting patent availability in fields such as software and biomedical treatments, the types of inventions that may be patented (“patent-eligible subject matter”) has also received congressional attention. Copyrights grant authors of original creative works (e.g., books, music, computer code) the exclusive right to reproduce, perform, and sell their works. Changes to the Digital Millennium Copyright Act of 1998 (DMCA) is one area of potential copyright-related legislative action. Among other things, the DMCA creates safe harbors to copyright liability for online intermediaries. Whether the DMCA’s attempted balance between copyright holders and online service providers requires updating has been the subject of congressional hearings. Implementation of the CASE Act—originally introduced as H.R. 2426 in the 116th Congress and subsequently enacted under the Consolidated Appropriations Act, 2021 (P.L. 116-260)— established an administrative forum to resolve certain lower-value copyright disputes, and as such is another area of potential congressional interest. Patent rights have also been of interest to Congress during the Coronavirus Disease 2019 (COVID-19) pandemic. Specifically, how patent rights affect affordability and access to COVID19 medical countermeasures (e.g., vaccines and treatments), especially those developed using federal funds, was a topic of interest at several congressional hearings in the 116th Congress. Another emerging issue is how copyright laws should adapt, if at all, to the increased use of webcasting and e-book lending during the pandemic. For example, schools, libraries, and religious groups have raised concerns about potential copyright liability for uses of copyrighted works that would be permitted in person, yet may infringe copyrights when conducted over the internet. Congressional Research Service 7 Science and Technology Issues in the 117th Congress For Further Information Kevin Hickey, Legislative Attorney Kevin Richards, Legislative Attorney CRS Report R46525, Patent Law: A Handbook for Congress, by Kevin T. Richards CRS Report R45666, Drug Pricing and Intellectual Property Law: A Legal Overview for the 116th Congress, coordinated by Kevin J. Hickey CRS Report R46679, Drug Prices: The Role of Patents and Regulatory Exclusivities, coordinated by Erin H. Ward CRS Report R46741, Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress, by Kevin J. Hickey, Kevin T. Richards, and Erin H. Ward CRS Report R45918, Patent-Eligible Subject Matter Reform in the 116th Congress, by Kevin J. Hickey CRS Legal Sidebar LSB10367, The CASE Act of 2019: Establishing a Small-Claims Process for Copyright Disputes, by Kevin J. Hickey CRS In Focus IF11478, Digital Millennium Copyright Act (DMCA) Safe Harbor Provisions for Online Service Providers: A Legal Overview, by Kevin J. Hickey CRS Legal Sidebar LSB10422, COVID-19 Medical Countermeasures: Intellectual Property and Affordability, by Kevin J. Hickey CRS Legal Sidebar LSB10440, Webcasting in the Time of COVID-19: Copyright Implications of Remote Worship & Distance Learning, by Kevin T. Richards CRS Legal Sidebar LSB10453, COVID-19 and Libraries: E-Books and Intellectual Property Issues, by Kevin T. Richards Agriculture The federal government funds billions of dollars of agricultural research annually. The 117th Congress may consider issues related to funding this research as well as specific issues related to climate change science at the United States Department of Agriculture (USDA). Other issues of topical interest include the operations of two USDA research agencies following their relocation in 2019; the regulation of agricultural biotechnology; the National Bio and Agro-defense Facility (NBAF); and cell-cultured meat. Agricultural Research Funding The USDA Research, Education, and Economics (REE) mission area consists of four agencies: the Agricultural Research Service (ARS), the Economic Research Service (ERS), the National Agricultural Statistics Service (NASS), and the National Institute of Food and Agriculture (NIFA). Additionally, REE’s Office of the Chief Scientist (OCS) coordinates research programs and activities across the department. REE has the primary federal responsibility of advancing scientific knowledge for agriculture. Its agencies conduct and fund research that spans the biological, physical, and social sciences related broadly to agriculture, food, and natural resources. The REE mission area received approximately $3.4 billion in FY2020 discretionary appropriations, and is authorized to receive approximately Congressional Research Service 8 Science and Technology Issues in the 117th Congress $215 million of mandatory funding per year. USDA administers nearly half of this federal funding to states and local partners, primarily through grants. The most recent farm bill (P.L. 115-334), the Agriculture Improvement Act of 2018, enacted in December 2018, reauthorizes many existing USDA research and education programs, and authorizes new programs, through FY2023. Congress has not yet appropriated funding for some of the new programs. For example, the 2018 farm bill authorized the Agriculture Advanced Research and Development Authority (AGARDA) pilot program. AGARDA is intended to operate under OCS to address long-term and high-risk research challenges in the agriculture and food sectors. It is modeled on federal advanced research entities like the Defense Advanced Research Projects Agency (DARPA) and the Advanced Research Projects Agency—Energy (ARPA-E). AGARDA has not received an appropriation, and USDA has not established it. The 117th Congress may consider reviewing AGARDA and other new programs established in the 2018 farm bill that have not yet received appropriations. The 2018 farm bill expires in 2023, and Congress may begin to consider new programs or revisions to existing programs for the next farm bill. For Further Information Genevieve Croft, Analyst in Agricultural Policy CRS Report R40819, Agricultural Research: Background and Issues, by Genevieve K. Croft CRS In Focus IF11319, 2018 Farm Bill Primer: Agricultural Research and Extension, by Genevieve K. Croft CRS Report R45897, The U.S. Land-Grant University System: An Overview, by Genevieve K. Croft CRS Report R45715, Federal Research and Development (R&D) Funding: FY2020, coordinated by John F. Sargent Jr. Climate Change Science at USDA The 117th Congress may be interested in research to address climate change and how USDA is carrying out plans to address the needs of agricultural producers in the context of changing climatic conditions. Some farmers and agricultural groups have called on USDA to increase its engagement in helping farmers adapt to changing climatic conditions, which may include increased instances of drought and extreme rainfall; historically unseasonable temperatures; and changes in the dates of first and last frost. Agricultural research can identify best management practices under different environmental conditions. Some Members of Congress have raised concerns that, in recent years, USDA has not publicized its climate change research and has not finalized or publicly released its 2017 USDA Climate Resilience Science Plan. This plan identifies the science that USDA needs to pursue to meet national needs. Some stakeholders have expressed concern that USDA is not meeting its responsibilities to agricultural producers, who need this information to succeed under existing and future climatic conditions. The 117th Congress may consider reviewing whether USDA research programs and policies are meeting concerns about food security and production related to climatic changes. For Further Information Genevieve Croft, Analyst in Agricultural Policy Congressional Research Service 9 Science and Technology Issues in the 117th Congress CRS Report R46454, Climate Change Adaptation: U.S. Department of Agriculture, coordinated by Genevieve K. Croft ERS and NIFA Operations Following Their Relocation In October 2019, USDA relocated the majority of NIFA and ERS staff positions from their headquarters in Washington, DC, to Kansas City, MO. About 75% of employees in these positions (approximately 300, of about 400 whose positions were relocated) declined to relocate, and left the agencies. NIFA administers approximately $1.7 billion in extramural agricultural research and extension funding. ERS conducts its own economic and statistical analyses on topics of interest to Congress, agricultural producers, and agriculture and food stakeholder groups. Media reports indicate that ERS and NIFA have experienced challenges in recruiting and retaining new employees since their relocation. In 2020, the NIFA director departed the agency after less than two years of a six-year term. The 117th Congress may be interested in continuing oversight of how NIFA and ERS are meeting their responsibilities now, with reduced workforces, and in the future, as new staff are hired to work in Kansas City. The House Committee on Appropriations, in its FY2021 agriculture appropriations bill report (H.Rept. 116-446), requested that the National Academies of Sciences, Engineering, and Medicine conduct a symposium to review the effects of the relocation on the agencies. The Senate Committee on Appropriations did not request such a review in its FY2021 agriculture appropriations draft report. For Further Information Genevieve Croft, Analyst in Agricultural Policy CRS In Focus IF11527, Relocation of the USDA Research Agencies: NIFA and ERS, by Genevieve K. Croft Regulation of Agricultural Biotechnology The 117th Congress may provide oversight of issues regarding the labeling of bioengineered foods and the regulation of agricultural biotechnology in light of recent innovations in gene editing. In 2016, Congress enacted P.L. 114-216, mandating the establishment of a national standard for the mandatory labeling of foods containing bioengineered ingredients, which consumers may recognize as genetically engineered (GE) or genetically modified organisms (GMOs). USDA finalized the National Bioengineered Food Disclosure Standard (the Standard) in December 2018. Voluntary compliance began in January 2020, and mandatory compliance begins in January 2022. The 117th Congress may choose to monitor implementation of the new Standard in accordance with its oversight authority. Areas of interest may include consumer perceptions about labeling a food as bioengineered; the emerging views of food manufacturers, retailers, and importers on the Standard; and how the Standard aligns with international labeling requirements. The emergence of new biotechnology tools (e.g., genome editing), a 2020 update to the USDA plant biotechnology regulations, and a proposed change in the regulation of genetically engineered agricultural animals have raised concerns among some stakeholders. In May 2020, USDA finalized the SECURE Rule for its regulation of GE organisms under the Plant Protection Act (7 U.S.C. §7701 et seq.). This new rule exempts certain categories of modified plants, including those consistent with many genome-edited plants, because they are “unlikely to pose an increased plant pest risk compared to conventionally bred plants.” While some producer groups viewed the new rule as supportive of innovation, some consumer and exporter groups criticized it as providing too little oversight and transparency. In December 2020, USDA issued an Advanced Congressional Research Service 10 Science and Technology Issues in the 117th Congress Notice of Proposed Rulemaking, proposing to transfer the regulation of agricultural animals produced or modified with genetic engineering from the Food and Drug Administration to USDA. Congress could consider whether to retain or revisit the 1986 framework that governs U.S. biotechnology regulation (i.e., the Coordinated Framework for the Regulation of Biotechnology), as plants and animals developed with new biotechnology tools become more common, and as federal agencies reconsider their roles and responsibilities in protecting health and the environment without impeding innovation. For Further Information Genevieve Croft, Analyst in Agricultural Policy CRS Report R46737, Agricultural Biotechnology: Overview, Regulation, and Selected Policy Issues, by Genevieve K. Croft CRS Report R46183, The National Bioengineered Food Disclosure Standard: Overview and Select Considerations, by Genevieve K. Croft CRS In Focus IF11573, USDA’s SECURE Rule to Regulate Agricultural Biotechnology, by Genevieve K. Croft and Tadlock Cowan The National Bio and Agro-defense Facility USDA and DHS are coordinating for the eventual transfer of operational responsibility of the National Bio and Agro-defense Facility (NBAF) from DHS to USDA. NBAF is designed to replace the Plum Island Animal Disease Center (PIADC) in New York and serve as a state-of-theart biocontainment facility for federal research on high-consequence foreign animal diseases (e.g., transboundary and zoonotic diseases). NBAF, located in Manhattan, KS, is expected to be the first facility in the United States to provide biosafety level 4 (BSL-4) laboratories capable of housing large livestock. USDA managed PIADC and conducted research there until 2003, at which time Congress transferred management to the newly established DHS. Following this change, USDA has continued to conduct research at the facility. In 2007, DHS announced its intention to establish a new facility to replace the outdated PIADC. Congress appropriated funds to construct this new facility (NBAF), and directed DHS to be responsible for its construction. In 2018, DHS announced its intention to transfer NBAF ownership and management to USDA (through the Agricultural Research Service and the Animal and Plant Health Inspection Service) upon completion of construction and commissioning. USDA had expected completion of the facility would occur in 2022, but reported in September 2020 that construction has been delayed by approximately 2.5 months due to the COVID-19 pandemic. The 117th Congress may be interested in the joint planning between USDA and DHS for managing this transfer, in USDA’s planning for continued research and operations, as well as any future research coordination between the two agencies. Additional areas of interest to Congress may include the ongoing construction, equipping, staffing, and operations of NBAF. For Further Information Genevieve Croft, Analyst in Agricultural Policy CRS In Focus IF11492, National Bio and Agro-Defense Facility: Purpose and Status, by Genevieve K. Croft Congressional Research Service 11 Science and Technology Issues in the 117th Congress Cell-Cultured Meat Cell-cultured meat is grown in laboratories from animal cell-cultures. First developed in the early 2000s, improved technological efficiencies and reduced production costs have allowed cellcultured meat companies to scale up and, in some instances, move closer to commercial viability. Some believe their products could be sold within a few years in certain markets and become widely available in 10 years. A debate surfaced in early 2018 about which federal agency—the Department of Health and Human Services’ (HHS) Food and Drug Administration (FDA) or the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS)—would have regulatory jurisdiction over cell-cultured meat. Currently, FSIS regulates meat and poultry, catfish, and egg products. FDA regulates game-meat, fish and seafood, processed meat products (containing 2%3% meat), and shell eggs. FDA and FSIS often share overlapping responsibilities for some food products and have developed “memoranda of understanding” to facilitate communication and division of responsibilities between the two agencies. In February 2019, in the conference report accompanying the Consolidated Appropriations Act, 2019 (H.J.Res. 31), Congress directed FDA and USDA to establish a formal agreement that would delineate each agency’s responsibilities for regulating cell-cultured meat. In response, in March 2019, FDA and USDA issued a joint Memorandum of Understanding (MOU) outlining the regulatory roles for each agency. Under the MOU, FDA is to issue regulations or guidance on inspections for entities involved in cell collection, cell lines, and the differentiation process. FDA is to ensure that entities follow current Good Manufacturing Practices and preventive control regulations that ensure the substances leaving the culturing process are safe and not adulterated. At the point of harvest, FDA will transfer oversight to USDA. Entities harvesting cells for human food will be subject to FSIS regulations on sanitation, Hazard Analysis and Critical Control Point verification, and testing to ensure the product is unadulterated, wholesome, and properly labeled under the Federal Meat Inspection Act and the Poultry Products Inspection Act. To ensure label accuracy, FSIS is to provide guidance and prior approval of labels for cell-cultured meat and poultry products. Throughout the cell-cultured meat production process, the MOU affirms that FDA and USDA are to share information and collaborate on regulation. During the 116th Congress, three bills were introduced in the House and Senate that would have addressed the regulatory framework that FDA and USDA issued in the March 2019 MOU. These were the Cell-Cultured Meat and Poultry Regulation Act of 2019 (S. 1056), and the Food Safety Modernization for Innovative Technologies Act (S. 3053 and H.R. 5728). The bills were referred the Senate Committee on Agriculture, Nutrition, and Forestry, and the House Committee on Agriculture and the House Committee on Energy and Commerce. For Further Information Joel L. Greene, Analyst in Agricultural Policy CRS In Focus IF10947, Regulation of Cell-Cultured Meat, by Joel L. Greene and Sahar Angadjivand Congressional Research Service 12 Science and Technology Issues in the 117th Congress Biotechnology and Biomedical Research and Development Advances in biotechnology and biomedical research and development underpin improvements in medications and treatments. Some issues that the 117th Congress may face related to these areas include advanced gene genomic editing, the bioeconomy, National Institutes of Health research, the role the Food and Drug Administration in approving new medicines and laboratory tests, and issues related to stem cell-based medicine and infectious disease modelling. CRISPR: Advanced Genome Editing Researchers have long searched for a reliable and simple way to make targeted changes to the genetic material of humans, animals, plants, and microorganisms. To that end, scientists developed a gene editing tool known as CRISPR—clustered regularly interspaced short palindromic repeated DNA sequences—that offers substantial improvement over previous technologies. The characteristics of CRISPR—easier to use, more precise, fewer unintended edits, and less costly—have led many in the scientific and business communities to predict significant advances across a broad range of areas—from medicine and public health to agriculture and the environment. While CRISPR offers a number of potential benefits, its use is also associated with risks and ethical concerns. For example, in 2018 a Chinese researcher used CRISPR to create the first genetically engineered human babies—renewing debate on the ethics of genetic engineering and its potential applications in human embryos, especially those that alter heritable traits. Additionally, some researchers are using CRISPR to reduce or eliminate mosquito populations that serve as the primary vector for the transmission of malaria. While this has the potential to save lives and substantially reduce medical costs, a 2016 report, “Gene Drives on the Horizon,” from the National Academies of Sciences, Engineering, and Medicine indicates that existing mechanisms may be inadequate to assess the potential immediate and long-term environmental and public health consequences associated with such a use of the technology. In the 117th Congress, policymakers may examine the potential benefits and risks associated with the use of CRISPR gene editing, including the ethical and social implications of CRISPR-related biotechnology products. Congress may also consider whether and how to address CRISPR gene editing and future biotechnology products with respect to regulation, research and development, and economic competitiveness, including potentially harmonizing CRISPR-related policies of the United States with those of other countries. For Further Information Marcy E. Gallo, Analyst in Science and Technology Policy John F. Sargent Jr., Specialist in Science and Technology Policy Amanda K. Sarata, Specialist in Health Policy Genevieve Croft, Analyst in Agricultural Policy CRS Report R44824, Advanced Gene Editing: CRISPR-Cas9, by Marcy E. Gallo et al. CRS Report R46737, Agricultural Biotechnology: Overview, Regulation, and Selected Policy Issues, by Genevieve K. Croft Congressional Research Service 13 Science and Technology Issues in the 117th Congress Bioeconomy Advances in the biological sciences—driven, in large part, by the integration of biology with the physical sciences, engineering, and computational sciences—are likely to stimulate economic growth and address societal challenges (e.g., food security and climate change). The McKinsey Global Institute estimates the direct economic impact of bio-based products, services, and processes (e.g., bio-plastics and genetically engineered crops)—often referred to as the bioeconomy—at between $2 trillion and $4 trillion per year globally over the next 10 to 20 years. With nearly 60 countries pursuing bioeconomy-related policies (e.g., increased research and development funding, infrastructure investments, and tax subsidies), some aggressively so, U.S. competitiveness and leadership in the future bioeconomy is uncertain. Policy considerations for strengthening the role of the United States in the global bioeconomy include the development and implementation of a national bioeconomy strategy; increased funding for bioeconomy-related research and development; the development of a bioeconomy workforce; facilitating demand for bio-based products; and efforts to improve public engagement, awareness, and acceptance of the bioeconomy and bio-based products and services. In addition to examining these policy considerations, the 117 th Congress might address risks associated with the bioeconomy, including the misuse of bioeconomy technologies and products, the theft of bioeconomy-related intellectual property, and the accuracy and integrity of federal biological databases and information. For Further Information Marcy E. Gallo, Analyst in Science and Technology Policy National Institutes of Health (NIH) and Biomedical Research The National Institutes of Health (NIH) is the lead federal agency for medical, health, and behavioral research. The agency has been provided with over $40 billion in regular appropriations for each of FY2020 and FY2021 for basic, clinical, and translational research in NIH laboratories as well as in research institutions nationwide. NIH represents about one fifth of total federal research and development spending, and half of non-Department of Defense research and development funding. From FY2016 through FY2020, NIH has seen funding increases of over 5% each year. NIH also received over $4.5 billion in coronavirus emergency appropriations in FY2020 and FY2021. NIH is a large and complex organization made up of 27 institutes and centers (ICs). Each research IC sets its own research priorities and manages its research programs in coordination with the Office of the Director (OD). Congress provides separate appropriations to each research IC and to OD. Funding levels vary widely among the ICs—for example, the National Cancer Institute (NCI) has the highest regular enacted funding level at $6.6 billion for FY2021 and the John E. Fogarty International Center (focus on global health) has the lowest funding level at $84.0 million for FY2021. IC funding levels reflect congressional priorities and inform the overall research direction of the agency. Aside from setting funding levels for individual IC accounts, Congress has not designated funding for specific disease or research areas, except in a few cases. NIH has played a major role in the federal response to the COVID-19 pandemic. The agency has supported related research, including major vaccine, treatment and diagnostic development projects, and published and maintained treatment guidelines for patients. The National Institute of Allergy and Infectious Diseases (NIAID) Director, Dr. Anthony Fauci, developed a significant public profile as a source of health information. Other recent policy issues at the agency include the role of NIH-funded research in the development of certain pharmaceutical drugs and Congressional Research Service 14 Science and Technology Issues in the 117th Congress subsequent pricing of those drugs; and undue foreign influence in NIH research, whereby foreign governments facilitate the transfer of research and proprietary information from NIH-funded projects to foreign institutions. In addition, new restrictions on human fetal tissue research by the Trump Administration has drawn some congressional attention. For Further Information Kavya Sekar, Analyst in Health Policy CRS Report R41705, The National Institutes of Health (NIH): Background and Congressional Issues CRS Report R43341, National Institutes of Health (NIH) Funding: FY1995-FY2021 CRS Report R46427, Development and Regulation of Medical Countermeasures for COVID-19 (Vaccines, Diagnostics, and Treatments): Frequently Asked Questions CRS Insight IN11207, Foreign Interference in NIH Research: Policy Implications CRS Report R44129, Human Fetal Tissue Research: Frequently Asked Questions CRS Report R44720, The 21st Century Cures Act (Division A of P.L. 114-255) The Food and Drug Administration (FDA): Medical Product Innovation The Food and Drug Administration (FDA) regulates the safety of foods, cosmetics, and radiationemitting products; the safety and effectiveness of medical products (i.e., drugs, biologics, and medical devices); and public health aspects of tobacco products. To keep pace with changes in science and emerging safety and security issues, FDA’s regulatory pathways have been subject to modifications through legislation and administrative action. The 21st Century Cures Act (P.L. 114-255), which FDA is in the process of implementing, modified drug and device regulatory pathways to support innovation. The FDA Reauthorization Act (P.L. 115-52) further modified regulatory pathways to expedite generic drug approval and competition. It also reauthorized medical product user fees for five years, which are set to expire at the end of FY2022. User fee legislation historically has been used to address related FDA policy concerns, and the 117th Congress may consider additional modifications to the agency’s regulatory framework, along with reauthorization of the medical product user fee programs. In light of regulatory and supply chain issues highlighted by the COVID-19 pandemic, the 117th Congress may consider legislation to further support development and approval of medical countermeasures (e.g., vaccines) for emerging infectious diseases, as well as to encourage use of advanced manufacturing technologies to prevent medical product supply chain disruptions and shortages. Congress also may consider legislation related to medical devices, which are increasingly connected to the internet, hospital networks, and other devices. While this allows for more accurate disease diagnoses and enhanced health care delivery, the broad scope and rapidly evolving domain of digital health—comprising software as a medical device (SaMD), cybersecurity, health information technology (IT), and telemedicine, among other things —can create regulatory challenges for FDA. To address some of these challenges, FDA launched the Digital Health Center of Excellence to foster partnerships, knowledge sharing, and innovative regulatory approaches. Some of FDA’s regulatory approaches—e.g., a precertification pilot program for SaMD—may require additional statutory authority. Congressional Research Service 15 Science and Technology Issues in the 117th Congress For Further Information Agata Bodie, Analyst in Health Policy, abodie@crs.loc.gov, 7-9455 Victoria Green, Analyst in Health Policy, vgreen@crs.loc.gov, 7-2415 Amanda Sarata, Specialist in Health Policy, asarata@crs.loc.gov, 7-7641 CRS Report R44720, The 21st Century Cures Act (Division A of P.L. 114-255), coordinated by Amanda K. Sarata CRS Report R44961, FDA Reauthorization Act of 2017 (FDARA, P.L. 115-52), coordinated by Amanda K. Sarata CRS Report R44750, FDA Human Medical Product User Fee Programs: In Brief , by Agata Bodie et al. CRS Report R46507, FDA’s Role in the Medical Product Supply Chain and Considerations During COVID-19, by Victoria R. Green, Agata Bodie, and Kate M. Costin CRS Report R46427, Development and Regulation of Medical Countermeasures for COVID-19 (Vaccines, Diagnostics, and Treatments): Frequently Asked Questions, by Agata Bodie et al. CRS In Focus IF11379, Medical Product Innovation and Regulation: Benefits and Risks, by Agata Bodie, Amanda K. Sarata, and Victoria R. Green Regulation of Laboratory-Developed Tests Regulation of laboratory-developed tests (LDTs)—a class of in vitro diagnostic (IVD) devices that is designed, manufactured, and used within a single laboratory—has been debated for many years, driven in part by an increase in the number and complexity of LDT genetic tests. The Food and Drug Administration (FDA) has traditionally exercised enforcement discretion over LDTs, meaning that most have not undergone FDA premarket review; regardless, FDA has asserted authority over certain LDTs that it considers to be higher risk. In 2014, FDA published draft guidance outlining a comprehensive risk-based regulatory framework for LDTs. This was never finalized, although FDA published a discussion paper summarizing the comments received on the draft guidance, and presenting a modified proposed framework for an approach to LDT oversight. The COVID-19 pandemic has highlighted issues around current FDA regulation of LDTs. Specifically, although FDA generally exercises enforcement discretion over LDTs, most COVID19 LDTs had nevertheless been subject to Emergency Use Authorization (EUA) requirements in the same way as other medical products, including other IVDs. To ease testing capacity issues, FDA issued guidance which exempted certain subsets of COVID-19 LDTs from EUA requirements entirely, and allowed others to be used clinically while the EUA submission was under consideration by FDA. In August 2020, HHS announced that FDA was prohibited from requiring premarket review of any kind for all LDTs without first undergoing notice-andcomment rulemaking. Pursuant to this announcement, FDA has halted review of COVID-19 LDT EUA submissions, except for those voluntarily submitted to the agency. Two bills addressing LDT regulation were introduced early in 2020 in response to the longstanding debate and spurred by the COVID-19 pandemic: the VALID Act (H.R. 6102, S. 3404) which would have established a comprehensive regulatory scheme for all in vitro clinical tests, and the VITAL Act (S. 3512), which would exclude LDTs from regulation by the FDA. For Further Information Amanda Sarata, Specialist in Health Policy Congressional Research Service 16 Science and Technology Issues in the 117th Congress CRS Insight IN11548, HHS Announcement on FDA Premarket Review of Laboratory-Developed Tests (LDTs), by Amanda K. Sarata CRS In Focus IF11389, FDA Regulation of Laboratory-Developed Tests (LDTs), by Amanda K. Sarata CRS In Focus IF11516, COVID-19 Testing: Key Issues, by Amanda K. Sarata CRS Report R46261, Development and Regulation of Domestic Diagnostic Testing for Novel Coronavirus (COVID-19): Frequently Asked Questions, by Amanda K. Sarata CRS Report R43438, Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests, by Amanda K. Sarata and Judith A. Johnson Stem Cells and Regenerative Medicine Stem cells have the unique ability to become many types of cells in the body. Scientists are exploring ways of using stem cells to create regenerative medicine therapies that repair damaged or diseased organs and restore them to normal functioning. Stem cells may either be pluripotent or multipotent. Pluripotent stem cells include embryonic stem cells or reprogrammed adult cells that have the ability to become any of the more than 200 cell types in the adult body. Multipotent stem cells have the capacity to become multiple (but not all) types of cells, usually within a particular organ system such as the blood or nervous system. Most adult stem cells are multipotent stem cells. Congress has taken action to boost research and development of clinical applications for stem cells, both pluripotent and multipotent. For instance, the 21 st Century Cures Act (P.L. 114-255) authorized to be appropriated $30 million for FY2017 through FY2020 for regenerative medicine research and a new designation at FDA for certain regenerative medicine therapies, eligible for expedited review. The term “regenerative medicine therapy” includes cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or product. Clinical trials are underway for stem cell therapies to treat eye diseases, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, traumatic brain injury, and others. However, some therapies have shown safety concerns, including potential cancer risks. There has also been a rise in the number of stem cell clinics offering unapproved and potentially unsafe treatments to consumers. In response, FDA has issued guidance on the regulation of therapies using human cells. FDA has also issued warning letters and taken enforcement actions against certain stem cell clinics offering unapproved treatments. Similarly, the Federal Trade Commission has filed complaints against marketing claims made by stem cell clinics. The 117th Congress may consider actions to boost research and clinical development of stem cell therapies, while ensuring the safety of such treatments. Policymakers may also consider addressing the rising use of unapproved stem cell treatments. For Further Information Kavya Sekar, Analyst in Health Policy Agata Dabrowska, Analyst in Health Policy Amanda Sarata, Specialist in Health Policy CRS Report R44720, The 21st Century Cures Act (Division A of P.L. 114-255), coordinated by Amanda K. Sarata Congressional Research Service 17 Science and Technology Issues in the 117th Congress CRS Report RL33540, Stem Cell Research: Science, Federal Research Funding, and Regulatory Oversight, by Judith A. Johnson and Edward C. Liu Infectious Disease Modeling and Forecasting Infectious disease models have played a notable role during the Coronavirus Disease 2019 (COVID-19) pandemic, informing policy responses such as the allocation of scarce resources at the federal and sub-federal levels. These models may be confusing and are easily misunderstood, due to various factors, including inherent scientific uncertainties; availability and quality of the underlying data; differing methodologies and purposes for models; and misunderstandings about how to interpret and use model outputs for decisionmaking. The pandemic highlighted opportunities for innovation and better coordination across agencies; public and private stakeholders have called for expanding research partnerships and supporting innovative techniques—such as the use of artificial intelligence and machine learning—for data management, modeling, and forecasting. In addition, some have called for greater transparency in the ways that models were designed and used to guide key decisions during the COVID-19 response given the amount of discretion inherent in model design. Models can illuminate the current and future spread of diseases, and the potential impacts of public health interventions. However, the accuracy of model outputs is limited by the quality and completeness of the inputs. Early in a disease outbreak, particularly with a novel pathogen such as the COVID-19 virus, inputs such as transmission characteristics, risk factors, and other features may be unknown. Modelers must estimate inputs in these situations, further affecting the accuracy of outputs. As public health officials and researchers gather more information, models are periodically revised to optimize their usefulness in informing public health decisions. During the COVID-19 pandemic, the National Institutes of Health (NIH), the Health and Human Services (HHS) Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention (CDC), the Federal Emergency Management Agency (FEMA), the National Science Foundation (NSF) , and the Department of Defense (DOD) all funded infectious disease modeling and forecasting efforts—generally conducted by nonfederal research institutions. CDC has maintained an “ensemble” forecast that combines over 20 models to estimate new cases, hospitalizations, and deaths. The Government Accountability Office (GAO) reported in May 2020 (GAO-20-372) of a risk for overlap and duplication in agencies’ disparate modeling efforts, as well as missed opportunities to improve and enhance such modeling based on experience from prior infectious disease outbreaks. Recent legislation has addressed infectious disease modeling and forecasting. In 2019, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (P.L. 116-22) included several relevant provisions, including (1) requiring the development of a multi-faceted public health situational awareness network, in consultation with relevant federal agencies and forecasting and modeling experts among others, that would coordinate and develop standards for the collection and analysis of data in a public health emergency; and (2) a new CDC special hiring authority for certain qualified individuals as specified, including experts in “prediction, modeling, or forecasting.” Further, the American Rescue Plan Act of 2021 (P.L. 117-2) provided $500 million to CDC to modernize U.S. infectious disease data and forecasting capabilities. Congress may assess implementation, determine if agencies have adequate resources, and consider new reforms based on experience with the pandemic. For Further Information Kavya Sekar, Analyst in Health Policy Congressional Research Service 18 Science and Technology Issues in the 117th Congress Laurie Harris, Analyst in Science and Technology Policy Climate Change and Water Science and technology considerations permeate deliberations on climate change and may be grouped into six interrelated topics:       federal expenditures on climate change S&T; climate change science; greenhouse gas (GHG)-related technology development and deployment; investment in infrastructure; anticipating, adapting to, and increasing resilience to the impacts of climate changes; and carbon sequestration and utilization technology. Additionally, Congress may face several issues related to ensuring reliable water quality and quantity. Climate change may affect availability of water for drinking, farming, and industry, as well as the overall health of ecosystems that support commercial fishing, recreation, and flood protection. Congress therefore supports a wide array of water research initiatives related to developing, using, and protecting water supplies and aquatic ecosystems. Legislation regarding climate change and water were passed in the 116th Congress, providing a new landscape for charting Congress’s priorities in these domains in the 117th . Climate-Related S&T Expenditures and Activities by the Federal Government According to the most recent report of the Office of Management and Budget, in response to an appropriations directive, federal funding and tax incentives for climate change-related S&T reached almost $17 billion in FY2016. The funding data covered 16 reporting agencies, though some related expenditures may not have been included. Of the S&T total, approximately $6.7 billion, about 42%, were tax incentives for technology deployment. Another 45% funded “clean energy technology,” the large majority at the Department of Energy for R&D and deployment programs. Approximately 15% funded climate change-related science, most of which supported satellites and computing infrastructure. From FY2016 through FY2021, CRS estimates that Congress increased appropriations for “clean energy” technology, while decreasing funding for climate change science reported in the U.S. Global Change Research Program (see below). In the Consolidated Appropriations Act, 2021, Congress also extended tax incentives to deploy energy efficiency and clean energy technologies by almost $700 million in FY2021, in addition to approximately $10.3 previously enacted (preliminary CRS estimate based on budget and appropriations documents). The 117th Congress faces the consideration of appropriations for climate change-related programs and incentives. For Further Information Jane A. Leggett, Specialist in Energy and Environmental Policy CRS Report R43227, Federal Climate Change Funding from FY2008 to FY2014, by Jane A. Leggett, Richard K. Lattanzio, and Emily Bruner CRS Report R46384, Energy and Water Development: FY2021 Appropriations, by Mark Holt and Corrie E. Clark Congressional Research Service 19 Science and Technology Issues in the 117th Congress CRS Report RS22858, Renewable Energy R&D Funding History: A Comparison with Funding for Nuclear Energy, Fossil Energy, Energy Efficiency, and Electric Systems R&D, by Corrie E. Clark CRS Report R44852, The Value of Energy Tax Incentives for Different Types of Energy Resources, by Molly F. Sherlock CRS In Focus IF11455, The Tax Credit for Carbon Sequestration (Section 45Q), by Angela C. Jones and Molly F. Sherlock CRS In Focus IF10225, Coastal Flood Resilience: Policy, Roles, and Funds, by Nicole T. Carter, Harold F. Upton, and Francis X. McCarthy Climate Change-Related Science The Sixth Assessment Report of the Intergovernmental Panel on Climate Change (IPCC) is due to be published in three volumes through 2021, potentially contributing to renewed congressional examination of climate change science, impacts, and greenhouse gas mitigation technologies. The IPCC assessments, and much of the observations and research on which they are founded, have relied on decades of U.S. federal (and nonfederal) investment in global change science, amounting cumulatively to tens of billions of dollars. The U.S. Global Change Research Program (USGCRP) is an interagency mechanism, required by the Global Change Research Act of 1990 (P.L. 101-606), that coordinates and integrates global change research across 13 government agencies. For FY2019, enacted appropriations for this purpose exceeded $2.2 billion, down from more than $2.5 billion enacted for FY2016. In 2017, USGCRP published the Climate Science Special Report, Volume I (CSSR) that found that human-related emissions of greenhouse gases (GHG) are accumulating in the atmosphere, intensifying the natural greenhouse gas effect, and increasing acidity (decreasing alkalinity) of the oceans. It concluded that the increase in GHG is driving global land and ocean warming and other climate changes that are now unprecedented in the history of modern civilization. It also stated, [B]ased on extensive evidence, that it is extremely likely [>95% likelihood] that human activities, especially emissions of greenhouse gases [GHG], are the dominant cause of the observed warming since the mid-20th century. For the warming over the last century, there is no convincing alternative explanation supported by the extent of the observational evidence. The 2018 USGCRP report, the Fourth National Climate Assessment Volume II, found that humaninduced climate change is affecting U.S. communities across the country through extreme weather events and generally warmer temperatures, more variable precipitation, and other observed trends. The report anticipates continued and increasing disruption to infrastructure, economic, and social systems, including economic disparities. Such impacts would not be distributed evenly across the United States and globally. According to its assessment, projected climate change impacts are affecting, and are virtually certain to increasingly affect, the U.S. economy, trade, and other essential U.S. interests. Some stakeholders, including some Members of Congress, consider that the resulting impacts of climate change in the United States and abroad are and would be modest and manageable. The 117th Congress may examine the scope and priorities for federal climate change science, including the data and methods that increasingly support attribution of many observed changes and extreme weather events to human-related GHG emissions and are used to project climate change and understand associated uncertainties. Congress may express its priorities for further scientific research. In light of the state of climate science, Congress may consider options for Congressional Research Service 20 Science and Technology Issues in the 117th Congress appropriations levels and distribution among federal climate-related science programs. For example, deliberations may concern the balance between observations and analysis, between science to increase knowledge and to support private and public decisionmaking, and between physical and social sciences, as well as public access to federally supported information. For Further Information Jane A. Leggett, Specialist in Energy and Environmental Policy CRS Report R45086, Evolving Assessments of Human and Natural Contributions to Climate Change, by Jane A. Leggett GHG-Related Technology Research, Development, Demonstration, and Deployment A large majority of federal climate change-related expenditures is aimed at advancing “clean energy,” with additional programs aimed at technologies for agriculture, forestry, and industrial sources of greenhouse gases. Most human-related GHG emissions come from production, distribution, and combustion of fossil fuels, particularly for electricity generation and transportation, and are primarily emitted as carbon dioxide (CO2 ) and methane (CH4 ). Most scientists agree that halting GHG-induced climate change would require eventually reducing net GHG emissions to near zero; the total amount of change would depend in large part on the cumulative emissions on that pathway. Many analysts see a decades-long path to stabilizing climate change as involving greater advance and deployment of efficiency improvements, decarbonization, and electrification of the world’s economies, along with additional options in multiple sectors. Many options could potentially provide additional security and health benefits, while their costs may depend on public and private investments in research, development, demonstration, and deployment (RDD&D), as well as efforts to facilitate transitions in businesses, employment, and communities . Some see potential carbon capture, utilization, and sequestration (CCUS) technologies as key to preventing CO2 emissions while preserving a large place for coal and other fossil fuels in the energy economy (see below). Still others advocate for developing direct CO2 removal from the atmosphere or geoengineering technologies, along with international governance regimes, to intentionally and directly modify the climate, particularly should the climate change rapidly and adversely. The capacity to reduce GHG emissions to near zero at affordable costs, while maintaining U.S. economic growth and security, and alleviating energy poverty, would depend on deployment of existing and demonstrated technologies supplemented by technological breakthroughs. Members may deliberate on the appropriate degree and means of federal support for advancing and deploying new technologies. Choices the 117th Congress may address include:  whether any policies should be neutral or favor selected technologies (or fuels);  where federal intervention in the technology pipeline, through RDD&D, can be most cost efficient and complement, not “crowd out,” private investment; whether policies are most effective when aimed at pushing the supply of selected technologies or incentivizing demand for low- or no-GHG technologies, or in combination; and how best to engage with the private sector and research institutions in partnerships on RDD&D.   Congressional Research Service 21 Science and Technology Issues in the 117th Congress RDD&D funding has not been evenly distributed across technology types, and those funded include mature, commercialized technology types as well as emerging or novel technology types. Research has been intended to advance fossil fuel combustion, renewable energy, biofuels, efficiency, storage, vehicles and their fuels, nuclear energy, the electricity grid, and direct capture of carbon dioxide from the atmosphere. It also supports development of new technologies and practices for agriculture, industry, and additional sectors. Some incentives focus on “supply-push” of technologies (e.g., R&D funding), while others emphasize “demand-pull” (e.g., tax incentives for purchasers). Numerous examples suggest that coordinated use of both supply and demand side policies could be most effective. Technologies with less associated pollution can produce public health benefits in addition to climate benefits, while shifts in the energy economy can pose transitional challenges to workers and communities. The magnitude of federal expenditures for climate change technologies, the performance of federally supported programs, and priorities for policy tools and technologies may be topics for Congress, particularly in light of budget objectives. For Further Information Jane A. Leggett, Specialist in Energy and Environmental Policy CRS Report RS22858, Renewable Energy R&D Funding History: A Comparison with Funding for Nuclear Energy, Fossil Energy, Energy Efficiency, and Electric Systems R&D, by Corrie E. Clark CRS Report R45204, Vehicle Fuel Economy and Greenhouse Gas Standards: Frequently Asked Questions, by Richard K. Lattanzio, Linda Tsang, and Bill Canis CRS Report R42566, Alternative Fuel and Advanced Vehicle Technology Incentives: A Summary of Federal Programs, by Lynn J. Cunningham et al. CRS Report R45010, Public-Private Partnerships (P3s) in Transportation, by William J. Mallett CRS In Focus IF10979, Greenhouse Gas Emissions and Sinks in U.S. Agriculture, by Renée Johnson Climate Change and Infrastructure Leaders in both chambers of Congress express interest in federal investment in the nation’s infrastructure. In evaluating options for infrastructure, tw o types of linkages with climate change may be considered simultaneously (along with numerous other factors) to optimize investments: infrastructure effects on long-term GHG emissions and potential effects of climate change on long-term infrastructure-related costs and public health and safety. For example, decisions regarding modernization of the electric grid may take account both of possible future policies to reduce GHG emissions and effects on electricity reliability in the context of more extreme weather events and an average increase in summer cooling demand. The first linkage between climate change and infrastructure investment arises from the foundation that infrastructure sets for certain technological choices, and consequently, levels of future U.S. GHG emissions (and the costs of reducing them). Long-lived infrastructure may exert influence on emissions for decades into the future; infrastructure can “lock in” or support flexibility for certain technological options. Infrastructure choices could make adaption to new science, technological advances, and policy priorities more or less expensive. Infrastructure influence on GHG emissions is particularly strong for energy supply, transportation, industry, buildings, and communities. For example, pipeline infrastructure would be critical for deployment of CCUS technologies, particularly for industrial applications. In Congressional Research Service 22 Science and Technology Issues in the 117th Congress transportation, choices among transportation modes, and choices between energy types (e.g., gasoline or biofuels or electricity) would depend in part on the availability of the refueling or charging infrastructure. Similarly, land use decisions—generally made by local governments and maybe influenced by federal funding—affect transportation options, which can have long-term impacts on fossil fuel consumption. For example, land use development patterns designed for private automobiles are often not readily adaptable for installation of mass transit. A second linkage between climate change and infrastructure investment is the ability of infrastructure to avoid damages of climate changes and become more resilient to extreme weather events that scientists expect to increase in frequency and strength. Because much infrastructure is intended to last for decades, projected climate changes in 2030 or 2050 that seem far off for current decisionmaking may have importance for future adequacy, safety, operating costs, and maintenance of investments. Some federal (including military) infrastructure has been severely damaged in recent extreme weather events, while nonfederal water, energy, transportation, urban, and other systems have been disrupted or experienced sustained damage. Congress may consider the merits of federal technical specifications or incentives to harden or increase the resiliency of long-lived infrastructure financed by the federal government, potentially providing model code or demonstrations to other decisionmakers. Policy choices could, on the one hand, increase nearterm costs of building infrastructure; on the other hand, climate-related benefits could include avoiding future losses to life, damages to human health (including mental health), and higher federal outlays that could occur with projected climate change. For Further Information Jane A. Leggett, Specialist in Energy and Environmental Policy CRS Report R45156, The Smart Grid: Status and Outlook, by Richard J. Campbell CRS Report R45105, Potential Options for Electric Power Resiliency in the U.S. Virgin Islands, by Corrie E. Clark, Richard J. Campbell, and D. Andrew Austin CRS Report R45350, Funding and Financing Highways and Public Transportation, by Robert S. Kirk and William J. Mallett CRS Report R46452, Surface Transportation Reauthorization and Climate Change: H.R. 2 and S. 2302, by William J. Mallett CRS In Focus IF10702, Drought Response and Preparedness: Policy and Legislation, by Nicole T. Carter and Charles V. Stern CRS Report R40147, Infrastructure: Green Building Overview and Issues, by Eric A. Fischer and Danielle A. Arostegui Science and Technology for Adaptation and Resilience Congress may review federal programs and funding for S&T to support adaptation or resilience to observed and projected climate change in light of recent scientific assessments and federal outlays for relief and recovery following extreme weather events, some of which have been statistically linked to GHG-induced climate change. Some issues related to infrastructure technology are discussed above, and there are additional science and technology issues associated with adaptation and resilience. For example, technological R&D needs may include new crop seed varieties suited to emerging climate conditions, better means to manage floodwaters, advanced air conditioning technologies for buildings, wildfire management techniques, and others. Further advances in climate forecasting, particularly at the local scale, could assist Congressional Research Service 23 Science and Technology Issues in the 117th Congress assessment of vulnerabilities and preparation for opportunities and risks. Increased research on and improved forecasting of human behavior could assist adaptation and resilience. Congress may address the federal role in supporting S&T that can facilitate effective state, local, and private decisionmaking on adaptation and resilience to climate change. Federal roles, in addition to funding for S&T, may include easing public access to scientific research, climate and seasonal projections, impact assessments, and adaptation decision tools, as well as training to make productive use of them. Congress may examine whether federal financial support for disaster recovery encourages or discourages incorporation of vulnerabilities and adaptation in private, state, and local adaptation decisionmaking, for example regarding flood risk mitigation or agricultural risks. Congress may also review efforts already begun to incorporate climate change projections into federal agency management of federal personnel, lands and waters, infrastructure, and operations. The effectiveness of agency actions to promote adaptation and resilience would depend on the adequacy and appropriate use of scientific information and available technologies. For Further Information Jane A. Leggett, Specialist in Energy and Environmental Policy CRS Report R43915, Climate Change Adaptation by Federal Agencies: An Analysis of Plans and Issues for Congress, coordinated by Jane A. Leggett CRS Report R46454, Climate Change Adaptation: U.S. Department of Agriculture, coordinated by Genevieve K. Croft CRS Report R45017, Flood Resilience and Risk Reduction: Federal Assistance and Programs, by Nicole T. Carter et al. CRS Report R43407, Drought in the United States: Causes and Current Understanding, by Peter Folger CRS Report R44632, Sea-Level Rise and U.S. Coasts: Science and Policy Considerations, by Peter Folger and Nicole T. Carter CRS In Focus IF10728, After the Storm: Highway Reconstruction and Resilience, by Robert S. Kirk Carbon Capture and Sequestration Carbon capture and sequestration (or storage)—known as CCS—involves capturing carbon dioxide (CO2 ) at its source, storing it underground, or utilizing it for another purpose or product. (CCS is sometimes referred to as CCUS—carbon capture, utilization, and storage.) CCS could reduce the amount of CO2 emitted from the burning of fossil fuels at large stationary sources. Carbon utilization recently has gained interest within Congress as a means for capturing CO 2 and converting it into potentially commercially viable products, such as chemicals, fuels, cements, and plastics. Direct air capture (DAC), a related emerging technology, is intended to remove atmospheric CO2 directly from the atmosphere rather than capture the CO 2 emissions from an industrial source. Some view DAC as an important method for achieving “net zero” GHG emissions, given projections for fossil fuel use. Many legislative proposals aimed at supporting CCS also include DAC. In many cases, carbon injection has also occurred for purposes of enhanced oil recovery (EOR), with some permanent CO2 storage occurring as part of the process. CCS includes three main steps: (1) capturing CO 2 ; (2) transporting CO2 ; and (3) injecting it into the subsurface. Following injection, the CO2 would be monitored to verify that it remains underground. Capturing CO2 is the most costly and energy-intensive step in the process (this is Congressional Research Service 24 Science and Technology Issues in the 117th Congress sometimes referred to as the energy penalty or the parasitic load). Globally, two coal-fired power plants have been retrofit to capture CO2 in large quantities (i.e., over 1 million tons per year): the Boundary Dam plant in Canada and the Petra Nova plant in Texas (which suspended CCS operations in 2020). Both plants offset some of the capture costs by selling the captured CO 2 to be used for nearby EOR operations. Emerging technologies for carbon utilization and DAC have been promoted by some CCS advocates. A challenge for utilization is whether the market for products and uses is large enough so that the amount of carbon captured or removed has a measurable effect mitigating climate change. The challenge for DAC is fairly straightforward—how to reduce the cost per ton of CO2 removed. Since FY2010, Congress has provided more than $6 billion total in annual appropriations for DOE’s Fossil Energy Research and Development portfolio (FE R&D), the DOE research arm conducting most federal CCS research activity. Congress provided $740 million to FE R&D in FY2019 and $750 million for FY2020. Several CCS-related bills were introduced in the 116th Congress, with CCS-related provisions in more than 30 measures introduced. The 115th Congress enacted a tax provision (Title II, Section 41119 of P.L. 115-123, which amended Internal Revenue Code, Section 45Q) to incentivize underground carbon injection, including storage and EOR. The amendment increases the tax credit for underground carbon sequestration, whether associated with EOR or injected solely for geologic sequestration. In 2020, the Internal Revenue Service proposed new regulations that would establish 45Q requirements for secure geologic storage of CO2 , DAC, and utilization for purposes of the tax credit. The 117 th Congress may explore how the 45Q tax credit is being implemented and implications for CCS project deployment. In recent years, proponents of CCS and some Members of Congress have called for increased federal support for building out infrastructure related to CCS. The federal role in development of CCS-related infrastructure and associated legislative options may continue to be of interest in the 117th Congress. For Further Information Angela Jones, Analyst in Environmental Policy Ashley Lawson, Analyst in Energy Policy CRS Report R44902, Carbon Capture and Sequestration (CCS) in the United States, by Peter Folger CRS In Focus IF11501, Carbon Capture Versus Direct Air Capture, by Ashley J. Lawson CRS Report R46192, Injection and Geologic Sequestration of Carbon Dioxide: Federal Role and Issues for Congress, by Angela C. Jones CRS In Focus IF11345, Carbon Sequestration Legislation in the 116th Congress, by Angela C. Jones CRS In Focus IF11455, The Tax Credit for Carbon Sequestration (Section 45Q), by Angela C. Jones and Molly F. Sherlock CRS In Focus IF11639, Carbon Storage Requirements in the 45Q Tax Credit, by Angela C. Jones Congressional Research Service 25 Science and Technology Issues in the 117th Congress Water The reliable supply of high quality water in sufficient quantities supports the U.S. population and economy, including public and ecosystem health, agriculture, and industry (e.g., energy production, fisheries, navigation, and manufacturing). Federal research activities and facilities span numerous departments, agencies, and laboratories. The federal government also funds water research through grants to universities and other researchers. In recent years, federal agencies have sponsored prize competitions for water data, science, and technologies and developed cooperative arrangements with various entities. Drinking water contamination and recent droughts, floods, and storms also have increased interest in innovative technologies and practices (including approaches that mimic nature, often referred to as green infrastructure or nature-based infrastructure). The 117th Congress may consider water research and technology topics, which can be broadly divided into water and aquatic ecosystem information, water infrastructure and use, and water quality. Information on water and aquatic ecosystem information includes observations, forecasts, and associated modeling. Science and research agencies collect data remotely and in situ; they use a wide variety of traditional and new technologies and techniques that inform water-related decisions for infrastructure, agriculture, and drinking water and wastewater services. Some of the water and ecosystem information research topics that may be before the 117 th Congress include the following:   water monitoring infrastructure and science programs, including water quality monitoring, stream gauges, buoys, groundwater assessments, and modeling (i.e., the National Water Model and Next Generation Water Observing Systems); water-related weather, climate, and earth system science including storm surge, hurricane, rainfall, and drought forecasts and associated remote sensing investments (see, for example, “Earth-Observing Satellites”);   water conditions in rivers and along coasts (e.g., relative sea-level rise rates); altering the operation of existing reservoirs (e.g., using seasonal forecasts for forecast-informed operations);   monitoring and management of invasive species and harmful algal blooms; access to and use of water data (e.g., Integrated Water Availability Assessments); and coordination of the federal water science and research portfolio, including partnerships with academic and private entities.  Water infrastructure research includes how to prolong and improve the performance of existing coastal and inland water infrastructure as well as the development of next-generation infrastructure technologies. Some infrastructure and water use research topics include:  water augmentation technologies and science to support their adoption, including stormwater capture, water reuse, brackish and seawater desalination, as well as groundwater recharge, storage, and recovery;  technologies and materials for monitoring and rehabilitating aging infrastructure, such as materials selection, construction and repair techniques, and detection technologies (e.g., structural health monitors and leak detection);  water efficiency technologies and practices; and Congressional Research Service 26 Science and Technology Issues in the 117th Congress  gray and green technologies to enhance infrastructure resilience to droughts, floods, hurricanes, and other natural hazards. The quality of drinking water, surface water, and groundwater is important for public health, environmental protection, food security, and other purposes. Technologies for preventing contamination and for identifying and treating existing contamination is an ongoing research topic for the federal government. Some research topics include:  analytical methods and treatment technologies to detect and manage emerging contaminants (e.g., cyanotoxins associated with harmful algal blooms, per- and polyfluoroalkyl substances [PFASs], and microplastics);  technologies to prevent and manage contamination at drinking water treatment plants and in distribution systems (e.g., real-time monitoring, treatment to minimize disinfection byproducts, and lead pipe corrosion control); and  innovative technologies and practices to protect water quality (e.g., nature-based or green infrastructure storm water management), including methods for increasing resilience of drinking water systems against natural disasters and protecting drinking water sources for public water system from contamination (e.g., watershed management approaches and nonpoint source pollution management). For Further Information Anna E. Normand, Analyst in Natural Resources Policy Eva Lipiec, Analyst in Natural Resources Policy Elena H. Humphreys, Analyst in Environmental Policy Nicole T. Carter, Specialist in Natural Resources Policy Laura Gatz, Analyst in Environmental Policy CRS Report R45695, U.S. Geological Survey (USGS) Streamgaging Network: Overview and Issues for Congress, by Anna E. Normand CRS Report R43407, Drought in the United States: Causes and Current Understanding, by Peter Folger CRS Report R45259, The Federal Role in Groundwater Supply, by Peter Folger et al. CRS Report R44632, Sea-Level Rise and U.S. Coasts: Science and Policy Considerations, by Peter Folger and Nicole T. Carter CRS Report R44871, Freshwater Harmful Algal Blooms: Causes, Challenges, and Policy Considerations, by Laura Gatz CRS Report R45998, Contaminants of Emerging Concern under the Clean Water Act, by Laura Gatz CRS Report R45793, PFAS and Drinking Water: Selected EPA and Congressional Actions, by Elena H. Humphreys and Mary Tiemann CRS Report R46416, Forecasting Tropical Cyclones: Overview and Issues for Congress, by Eva Lipiec Congressional Research Service 27 Science and Technology Issues in the 117th Congress Defense Science and technology play an important role in national defense. The Department of Defense (DOD) relies on a robust research and development effort to develop new military systems and improve existing systems. Issues that may come before the 117th Congress regarding the DOD’s S&T activities include budgetary concerns and the effectiveness of programs to transition R&D results into fielded products. Department of Defense Research, Development, Test, and Evaluation The Department of Defense spends more than $100 billion per year on research, development, testing, and evaluation (RDT&E). In FY2020, enacted RDT&E funding was approximately $109 billion. Roughly 80%-85% of this is spent on the design, development, and testing of specific military systems. Examples of such systems include large integrated combat platforms such as aircraft carriers, fighter jets, and tanks, among others. They also include much smaller systems such as blast gauge sensors worn by individual soldiers. The other 15%-20% of the RDT&E funding is spent on what is referred to as DOD’s Science and Technology Program. The S&T Program includes activities ranging from basic science to demonstrations of new technologies in the field. The goal of DOD’s RDT&E spending is to provide the knowledge and technological advances necessary to maintain U.S. military superiority. DOD’s RDT&E budget contains hundreds of individual line items. Congress provides oversight of the program, making adjustments to the amount of funding requested for any number of line items. These changes are based on considerations such as whether the department has adequately justified the expenditure or the need to accommodate larger budgetary adjustments. RDT&E priorities and focus, including those of the S&T portion, do not change radically from year to year, though a few fundamental policy-related issues regularly attract congressional attention. These include ensuring that S&T, particularly basic research, receives sufficient funding to support next generation capabilities; seeking ways to speed the transition of technology from the laboratory to the field; and ensuring an adequate supply of S&T personnel. Additionally, the impact of budgetary constraints, including continuing resolutions, on RDT&E may be of interest to the 116th Congress. Specifically, senior DOD officials have been describing the need to develop and implement a strategy aimed at identifying new and innovative ways to maintain the dominance of U.S. military capabilities into the future, which may require increased investment in RDT&E. In addition, as U.S. federal defense-related R&D funding’s share of global R&D funding has fallen from about 36% in 1960 to about 3% in 2018, some have become concerned about the ability of DOD to direct the development of leading technologies and to control which countries have access to it. Today, commercial companies in the United States and elsewhere in the world are leading development of groundbreaking technologies in fields such as artificial intelligence, autonomous vehicles and systems, and advanced robotics. DOD has sought to build institutional mechanisms (e.g., the Defense Innovation Unit) and a culture for accessing technologies from nontraditional defense contractors. DOD’s ability to maintain a technology edge for U.S. forces may depend increasingly upon these external sources of innovation for its weapons and other systems. For Further Information John F. Sargent Jr., Specialist in Science and Technology Policy Congressional Research Service 28 Science and Technology Issues in the 117th Congress Marcy E. Gallo, Analyst in Science and Technology Policy CRS Report R45403, The Global Research and Development Landscape and Implications for the Department of Defense, by John F. Sargent Jr. and Marcy E. Gallo CRS Report R44711, Department of Defense Research, Development, Test, and Evaluation (RDT&E): Appropriations Structure, by John F. Sargent Jr. CRS Report R45110, Defense Science and Technology Funding, by John F. Sargent Jr. CRS Report R46341, Federal Research and Development (R&D) Funding: FY2021, coordinated by John F. Sargent Jr. Energy Energy-related science and technology issues that may come before the 117th Congress include biofuels; fracking; electricity modernization and decarbonization; hydrogen pipelines; reprocessing of spent nuclear fuel; advances in nuclear energy technology; and offshore energy development technologies. Biofuels Biofuels—transportation fuels produced from biomass—are an alternative to conventional fuels. Some see promise in producing fuels from a domestic feedstock that may reduce dependence on foreign energy sources, improve rural economies, and lower greenhouse gas emissions. Others regard biofuels as potentially more harmful to the environment (e.g., air and w ater quality concerns), more land-intensive, and prohibitively expensive to produce. The debate about biofuels is complex, as policymakers consider numerous factors (e.g., feedstock costs, timeframe to reach commercial-scale advanced biofuel production, environmental impact of biofuels). The debate can be even more complicated because biofuels may be produced using numerous biomass feedstocks and conversion technologies. Congress supported biofuels for decades, with most of its attention on “first-generation” biofuels (e.g., cornstarch ethanol). Starting in 2002, the farm bills have contained an energy title with several programs to assist biofuel production and R&D. In addition, the DOE Office of Energy Efficiency and Renewable Energy (EERE) supports domestic biofuel production R&D. Congress and the executive branch have debated the amount of USDA and DOE funding for biofuel initiatives. While commercial-scale production of “first-generation” biofuels is well established, commercial-scale production for some advanced biofuels (e.g., cellulosic ethanol) is in its infancy. In 2007, Congress expanded the main policy support for biofuel production—the Renewable Fuel Standard (RFS), which requires U.S. transportation fuel to contain minimum volumes of different classes of biofuels. The RFS is under scrutiny for various reasons, including concerns about program implementation, advanced biofuel pathway approval, growth of advanced biofuel production, and RFS compliance. These concerns, among others, create uncertainty for some stakeholders. The 117th Congress may consider whether to modify various biofuel promotional efforts, to establish new biofuel initiatives, or to maintain the status quo. Other topics of congressional interest include the development of a low-carbon fuel standard in lieu of an explicit renewable fuel mandate, and R&D into sustainable fuels for aviation, shipping, and other applications. Congressional Research Service 29 Science and Technology Issues in the 117th Congress For Further Information Kelsi Bracmort, Specialist in Natural Resources and Energy Policy CRS Report R43325, The Renewable Fuel Standard (RFS): An Overview, by Kelsi Bracmort CRS Report R46244, The Renewable Fuel Standard (RFS): Frequently Asked Questions About Small Refinery Exemptions (SREs), by Kelsi Bracmort CRS Insight IN11353, The 2020 Renewable Fuel Standard (RFS): COVID-19 Impacts, by Kelsi Bracmort CRS Report R45943, The Farm Bill Energy Title: An Overview and Funding History, by Kelsi Bracmort Hydraulic Fracturing and Horizontal Drilling Hydraulic fracturing, or fracking, applied to horizontally drilled wells was one of the key technological advancements at the beginning of the 21 st century (along with directional drilling of long horizontal wells) that unlocked natural gas and oil resources from shale and other tight rock formations (also known as unconventional formations). The oil and natural gas released by fracking have catapulted the United States to the lead global producer of both fuels and have made the United States relatively energy independent. Fracking has also made the United States into the fastest growing exporter of both commodities. As hydraulic fracturing became a more prominent form of production, it also raised environmental concerns. These concerns centered initially on water quality issues, including potential contamination of groundwater and surface waters. Concerns have since incorporated other issues, such as water management practices (both consumption and discharge), methane release, land use changes, endangered species impacts, induced seismicity, and air and noise pollution. Other related concerns have centered on the potential long-term and indirect impacts from a reliance on fossil fuels and the resulting greenhouse gas (GHG) emissions. To many, fracking has become synonymous with anything related to extraction of natural gas and oil from unconventional formations. However, fracking has been a part of the industry for decades, emerging as an enhanced recovery method to boost production from nearly all traditional wells in conventional formations. In unconventional formations, hydraulic fracturing is not an optional or additional technique but a necessary one for production. Unconventional resource recovery requires creating a huge connected fracture network leading to the wellbore in order to achieve economic oil or gas recovery. Currently, no alternative to hydraulic fracturing in these formations exists; nor does one appear to be on the horizon. During the 2020 presidential election, fracking became a flash point of the debate, and it portends to be an issue in the 117 th Congress. For Further Information Richard Lattanzio, Specialist in Environmental Policy or Michael Ratner, Specialist in Energy Policy CRS In Focus IF11036, U.S. Oil and Natural Gas Transformation and Effects, by Michael Ratner et al. CRS Report R43836, Human-Induced Earthquakes from Deep-Well Injection: A Brief Overview, by Peter Folger and Mary Tiemann Congressional Research Service 30 Science and Technology Issues in the 117th Congress CRS Report R43152, Hydraulic Fracturing: Selected Legal Issues, by Adam Vann, Brandon J. Murrill, and Mary Tiemann CRS Report R41760, Hydraulic Fracturing and Safe Drinking Water Act Regulatory Issues, by Mary Tiemann and Adam Vann CRS Report R43148, An Overview of Unconventional Oil and Natural Gas: Resources and Federal Actions, by Michael Ratner and Mary Tiemann CRS Report R42986, Methane and Other Air Pollution Issues in Natural Gas Systems, by Richard K. Lattanzio Electricity Modernization and Decarbonization Interest in the modernization of the electricity grid to improve its reliability and resilience is increasing; so too is interest in reducing emissions of carbon dioxide from power generation. The two goals are potentially compatible, as a grid that utilizes more zero-carbon emission electricity resources also can benefit from modernization to move electricity more efficiently and could bolster resilience. To accommodate today’s more complex power flows, serve reliability needs, and meet future projected uses, grid modernization is incorporating electronic intelligence capabilities for power control purposes and operations monitoring. The “Smart Grid” is the name given to this evolving intelligent electric power network. Given ideas for a grid based on renewable energy, an electric power system able to potentially shift energy nationally from where it is generated to where it is needed may require a level of real-time monitoring and control that does not currently exist. Ensuring that the grid is always able to meet electricity needs will likely mean that resources capable of generating power on demand will still be required, and enabling today’s natural gas generation fleet to be able to use hydrogen as a power generation fuel is one option. Other potential options may include nuclear power (both fusion and fission), and carbon capture with sequestration and reuse. The projected need for this base load generating capacity may continue even with advances in energy storage (as some utility executives have speculated we would need to store energy on a seasonal basis—not just for hours or days—for goals approaching 100% renewable energy). More affordable hydrogen could address some of the barriers to sustainable energy. While hydrogen as a fuel for electric power generation does not directly result in carbon dioxide emissions, hydrogen is expensive to produce, difficult to transport or store, and existing combustion turbines would need to be modified for its use. All of these preceding areas are subjects of federal R&D, particularly at the Department of Energy. For Further Information Richard J. Campbell, Specialist in Energy Policy CRS Report R45156, The Smart Grid: Status and Outlook, by Richard J. Campbell CRS Report R46436, Hydrogen in Electricity’s Future, by Richard J. Campbell Advanced Battery Energy Storage Advanced battery energy storage (ABES) technology has the potential to revolutionize the nation’s electric power industry and the transportation sector. In 2019, plug-in hybrid- and battery-electric vehicles (collectively plug-in electric vehicles or PEVs) made up 2% of all lightduty vehicle sales. If PEV use increases, as estimated by a 2018 study from the National Congressional Research Service 31 Science and Technology Issues in the 117th Congress Renewable Energy Laboratory (NREL), energy load profiles might shift, creating additional energy demand during work hours and a greater overnight demand once residents return home. PEV batteries today are mostly based on lithium ion technology using liquid cells. These batteries can be charged a number of times due largely to their high energy density and ability to undergo a number of full power charging cycles. However, liquid cells have been associated with fire risk, and the acquisition of cobalt, a mineral commonly used in PEV batteries, from its major source in the Democratic Republic of the Congo has been associated with child labor and miner safety issues. Research on dry lithium ion batteries, recycling of lithium ion battery components, and alternate chemistries have been identified as keys to the greater deployment of PEV batteries. With PEVs connected to the electric power grid, an opportunity might arise for vehicle batteries to provide energy storage at low energy demand times when grid generation might be high, and EV use might be low. This could help reduce the need for new power plants and reduce overall atmospheric emissions from fossil fuels, if such a regime can be economically implemented. In 2018, battery storage power capacity accounted for less than 1% of total U.S. large-scale electricity storage, but its share is growing. ABES could not only improve grid reliability but also enhance the attractiveness of wind and solar power, which may lead to lower electricity-related emissions. Greater electrification of the transportation sector will not only depend on PEV battery capabilities and designs, but on the development of a national and interstate PEV charging infrastructure that will economically enable large vehicles and trucks to begin to switch from fossil fuels. Such a network could address concerns over the range of purely battery-electric vehicles to meet the needs of the public and transportation industry. In recent years, congressional action on ABES has focused on funding Department of Energy R&D, and on incentives for deployment of PEVs and charging infrastructure. For Further Information Melissa N. Diaz, Analyst in Energy Policy CRS Report R45980, Electricity Storage: Applications, Issues, and Technologies, by Richard J. Campbell CRS Report R45980, Electricity Storage: Applications, Issues, and Technologies, by Richard J. Campbell CRS Report R45747, Vehicle Electrification: Federal and State Issues Affecting Deployment, by Bill Canis, Corrie E. Clark, and Molly F. Sherlock Reprocessing of Spent Nuclear Fuel Spent fuel discharged from commercial nuclear reactors contains most of the original uranium that was used to make the fuel, along with plutonium and other highly radioactive nuclear materials. A fundamental issue in nuclear policy is whether spent fuel should be “reprocessed” (or “recycled”) to extract plutonium and uranium for new reactor fuel, or directly disposed of without reprocessing. Proponents of nuclear power point out that spent fuel still contains substantial energy that reprocessing could recover, and that reprocessing could reduce the long-term hazard of radioactive waste. Reprocessed plutonium could also be used in nuclear weapons, raising proliferation concerns. In the 1950s and 1960s, the federal government expected that all commercial spent fuel would be reprocessed to make new reactor fuel. Increased concern about weapons proliferation in the 1970s Congressional Research Service 32 Science and Technology Issues in the 117th Congress and the slower-than-projected growth of nuclear power prompted President Carter to halt commercial reprocessing efforts in 1977. Subsequent administrations have had a wide range of policies on the issue. The George W. Bush Administration proposed that the Department of Energy (DOE) complete a pilot reprocessing plant by the early 2020s. During the Obama Administration, plans for the pilot plant were halted and DOE research was redirected toward development of technology options for a wide range of nuclear fuel cycle approaches. FY2021 DOE funding related to reprocessing and recycling R&D includes $25 million [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/crs%3AR46787. Public record. Not legal advice.