# Science and Technology Issues for the 118th Congress

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/crs%3AR47373

## Record

- **Collection:** Congressional research report
- **Document type:** CRS Report
- **Published:** October 15, 2024
- **Citation:** R47373

## Text

Science and Technology Issues for the 118th
Congress
Updated October 15, 2024

Congressional Research Service
https://crsreports.congress.gov
R47373

SUMMARY

Science and Technology Issues for the 118th
Congress
The federal government supports scientific and technological advancement directly by funding
and performing research and development (R&D) and indirectly by creating and maintaining
policies that encourage private sector efforts. Additionally, the federal government regulates
many aspects of science and technology (S&T) activities. Federal S&T support has led to
scientific breakthroughs and new technologies, ranging from jet aircraft and the internet to
communications satellites and defenses against disease.

R47373
October 15, 2024
Nicole T. Carter,
Coordinator
Acting Section Research
Manager

Many S&T policy issues before the 118th Congress represent areas of continuing Member interest. Examples include crosscutting issues that affect scientific and technological progress, agricultural research, climate change, Department of Defense
(DOD) research, earth science, space, and water. Other issues represent new or rapidly transforming areas such as
biotechnology, energy, information technology and social media, financial technology, and telecommunications. Some of
these S&T issue areas are described briefly below.

Cross-Cutting Issues
Issues that cut across multiple S&T disciplines include federal R&D funding, interagency S&T coordination, the role of
patents and other intellectual property policies, and semiconductors.

Agriculture
The federal government funds billions of dollars of agricultural research annually. The 118th Congress may consider issues
related to funding this research.

Climate Change
S&T considerations permeate deliberations on climate change topics: climate-change-related science and the ocean-climate
nexus, decarbonizing the railroads, and carbon capture and sequestration.

Biotechnology and Biomedical Research
Recent advances in biotechnology and biomedical research hold the promise of longer and healthier lives and more
productive industry while raising policy challenges. Some issues that the 118th Congress may face include those relating to
the National Institutes of Health; the Office of the National Coordinator for Health Information Technology; oversight of
engineering biology; regulation of laboratory-developed tests; monitoring of environmental DNA and RNA; and the
convergence of biotechnology, digital data, robotics, and artificial intelligence.

Defense Research and Development
DOD relies on a robust R&D effort to develop new military systems and improve existing systems. Issues before the 118th
Congress regarding DOD’s S&T activities include budgetary concerns and the effectiveness of programs to transition R&D
results into fielded products and how DOD encourages innovation.

Energy, Minerals, and Mining
S&T issues related to energy, minerals, and mining that may come before the 118th Congress include biofuels, electricity
transmission, offshore energy technologies, hydrogen, hydrogen pipelines, critical minerals and materials, and various types
of mining technologies.

Earth Sciences
Earth-science-related issues before the 118th Congress include changes to the National Oceanic and Atmospheric
Administration’s S&T activities and improvements to weather observations, modeling, and forecasting.

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Science and Technology Issues for the 118th Congress

Financial Technology
Financial technology, or fintech, refers to a broad set of technologies being deployed across a variety of financial industries
and activities, including those related to cryptocurrency, investor applications, and consumer finance applications.

Information Technology and Social Media
Rapid advancements in information technologies present several issues for congressional policymakers, including those
related to artificial intelligence, cybersecurity, Big Tech and online platforms, social media, consumer data privacy, children
on the internet, quantum information S&T, law enforcement use of information technologies and social media, and biometric
technologies.

Space and Aviation
Congress has a strong interest in space policy and aviation issues. Issues before the 118th Congress include the funding and
oversight of the National Aeronautics and Space Administration, the commercialization of space, Earth-observing satellites,
and law enforcement use of drones.

Telecommunications
Telecommunications technologies present several issues for policymakers, including those related to 5G technologies,
broadband deployment and the digital divide, undersea cables, federal spectrum auctions and allocations, and Federal
Communications Commission and National Telecommunications and Information Administration spectrum programs.

Water, Accessibility, and Use
Water research and technology topics include issues relating to water data and aquatic ecosystem information, water
infrastructure and water use, and water quality.

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Contents
Introduction ..................................................................................................................................... 1
Cross-Cutting Issues ........................................................................................................................ 1
Federal Funding for Research and Development ...................................................................... 1
White House Office of Science and Technology Policy ........................................................... 2
Federal Efforts to Boost Regional Innovation ........................................................................... 3
Commercializing the Results of Federal Research and Development Investments .................. 4
Patents and Innovation Policy ................................................................................................... 5
Intellectual Property (IP) Law ................................................................................................... 6
The U.S.-China Science and Technology Cooperation Agreement........................................... 7
China’s Science, Technology, and Industrial Policies ............................................................... 8
R&D Security ............................................................................................................................ 9
Semiconductors and the CHIPS Act.......................................................................................... 9
Agriculture......................................................................................................................................11
Agricultural Research Funding ................................................................................................11
Regulation of Agricultural Biotechnology .............................................................................. 12
Biotechnology and Biomedical Research ...................................................................................... 13
National Institutes of Health (NIH) and Biomedical Research ............................................... 13
Advanced Research Projects Agency for Health (ARPA-H) .................................................. 14
Interoperability and the Office of the National Coordinator for Health Information
Technology (ONC) ............................................................................................................... 15
Oversight of Engineering Biology .......................................................................................... 15
Regulation of Laboratory-Developed Tests (LDTs) ................................................................ 16
DNA as Data ........................................................................................................................... 17
Convergence of Biotechnology, Digital Data, Robotics, and Artificial Intelligence .............. 17
Climate Change ............................................................................................................................. 19
Climate-Change-Related Science and the Ocean-Climate Nexus ........................................... 19
Decarbonizing the Railroads ................................................................................................... 20
Carbon Capture and Sequestration .......................................................................................... 20
Defense Research and Development ............................................................................................. 21
Department of Defense (DOD) Research, Development, Test, and Evaluation...................... 21
DOD Innovation Capacity....................................................................................................... 22
Energy, Minerals, and Mining ....................................................................................................... 23
Biofuels ................................................................................................................................... 23
Electricity Transmission .......................................................................................................... 24
Offshore Energy Technologies ................................................................................................ 24
Hydrogen ................................................................................................................................. 25
Hydrogen Pipelines ................................................................................................................. 26
Fusion Energy ......................................................................................................................... 27
Critical Minerals and Materials ............................................................................................... 29
Land-Based Mining and Mineral Processing .......................................................................... 29
Seabed Mining ........................................................................................................................ 30
Earth Sciences ............................................................................................................................... 31
National Oceanic and Atmospheric Administration (NOAA) Organic Act and S&T
Activities .............................................................................................................................. 31
Weather-Related Science and Technology .............................................................................. 32

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Financial Technology, or “Fintech” ............................................................................................... 32
Cryptocurrency ........................................................................................................................ 33
Investment Activities ............................................................................................................... 33
Consumer Products ................................................................................................................. 34
Artificial Intelligence and Machine Learning in Finance ....................................................... 35
Information Technology and Social Media ................................................................................... 36
Artificial Intelligence .............................................................................................................. 36
Artificial Intelligence and Intellectual Property Law .............................................................. 37
Cybersecurity .......................................................................................................................... 38
Big Tech and Online Platforms ............................................................................................... 39
Social Media Platforms ........................................................................................................... 40
Consumer Data Privacy........................................................................................................... 41
Children on the Internet .......................................................................................................... 41
Quantum Information Science and Technology ...................................................................... 42
Evolving Technology and the Debate over “Lawful Access” ................................................. 43
Federal Law Enforcement Use of Facial Recognition Technology ......................................... 44
Law Enforcement Use of Social Media .................................................................................. 44
Immigration: Biometric Entry-Exit System ............................................................................ 45
Web Accessibility .................................................................................................................... 46
Space and Aviation ........................................................................................................................ 46
NASA ...................................................................................................................................... 47
Commercial Space .................................................................................................................. 48
Civil Earth-Observing Satellites.............................................................................................. 49
Law Enforcement Use of Unmanned Aircraft Systems .......................................................... 50
Telecommunications ...................................................................................................................... 51
5G Telecommunications Technologies.................................................................................... 51
Broadband Deployment and the Digital Divide ...................................................................... 52
Undersea Telecommunication Cables ..................................................................................... 53
FCC Spectrum Allocation and Interference Concerns ............................................................ 54
NTIA Federal Spectrum Issues ............................................................................................... 55
Water Availability, Accessibility, and Use ..................................................................................... 56
Water Data and Aquatic Ecosystem Information .................................................................... 56
Water Infrastructure and Water Use ........................................................................................ 57
Water Quality .......................................................................................................................... 58

Contacts
Author Information........................................................................................................................ 59

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Introduction
The federal science and technology (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. Not only are congressional authorities
related to S&T policymaking diffuse, but also 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 (E.O.s) 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, such as the National Science Foundation (NSF). 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 breakup of AT&T in the 1980s), and the admissibility of S&T-related
evidence (e.g., DNA samples).
CRS experts have identified the issues below as particularly relevant to the 118th Congress. Each
section serves as a brief introduction to the topic and identifies other CRS products and the
appropriate CRS experts to contact for further information and analysis.

Cross-Cutting Issues
This section discusses issues that cut across multiple S&T disciplines. It addresses federal R&D
funding, interagency S&T coordination, and federal efforts to boost regional innovation. It also
addresses issues relating to the commercialization of results of federal R&D investments, the role
of patents and other intellectual property (IP) policies, China’s S&T and industrial policies, and
the security of U.S. research.

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

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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 $155.0 billion in FY2017.
A change in R&D accounting by the Office of Management and Budget (OMB) to exclude
certain late-stage development activities—primarily at the Department of Defense (DOD) and the
National Aeronautics and Space Administration (NASA)—from total federal R&D calculations
obscures comparison of funding levels for FY2018 and later years with funding from before
FY2018. As calculated by OMB, current dollar federal R&D funding was $135.8 billion in
FY2018 and has risen annually to an estimated $194.6 billion in FY2024. Concerns by some
about the adequacy of U.S. 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 (reaching an all-time high in
2022)—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 S&T.
As the 118th 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. The CHIPS and Science Act (P.L. 117-167) authorized increases in the budgets of
several leading federal R&D agencies, though the realization of these authorization levels still
requires appropriations. Conversely, 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
Laurie Harris, Analyst in Science and Technology Policy
CRS Video WVB00700, FY2025 Federal Research and Development (R&D) Funding
CRS Video WVB00604, Federal Research and Development (R&D) Funding in President
Biden’s FY2024 Budget
CRS Report R47564, Federal Research and Development (R&D) Funding: FY2024

White House Office of Science and Technology Policy
Congress has a long-standing interest in the development and implementation of S&T policies
across the federal government as well as the effective coordination of multiagency R&D
initiatives. To ensure a permanent source of S&T-related advice and policy coordination within
the White House, Congress established OSTP within the Executive Office of the President
through the National Science and Technology Policy, Organization, and Priorities Act of 1976
(P.L. 94-282).

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In addition to OSTP, the White House S&T advisory structure includes two councils, for which
OSTP provides operational and administrative support: the National Science and Technology
Council (NSTC) and the President’s Council of Advisors on Science and Technology (PCAST).
Established in 1993 by E.O. 12881, the NSTC is composed of representatives from departments
and agencies with significant S&T responsibilities and is charged with coordinating S&T policy
across the federal government. Established in 1990 by E.O. 12700, PCAST is an independent
Federal Advisory Committee composed of external experts who advise the President on matters
involving policy affecting science, technology, and innovation as well as on matters involving
S&T information needed to inform public policy in other areas.
OSTP is statutorily charged with advising the President on S&T matters; coordinating the
implementation of S&T priorities across the federal government; and engaging with external
partners in industry, academia, civil society organizations, and other governmental bodies.
Accordingly, several issues related to the activities and focus of OSTP (as well as the advisory
bodies it supports, the NSTC and PCAST) are of potential interest to the Congress, including
staffing practices and potential conflict-of-interest concerns, workplace culture and past
congressional oversight activity, persistent vacancies of Senate-confirmed leadership positions
within OSTP, the stature and influence of PCAST, and the efficacy of federal S&T coordination
efforts.
For example, Congress has charged the NSTC with specific statutory duties related to the
coordination of multiagency R&D initiatives. The 118th Congress might consider the efficacy of
NSTC coordination efforts in the congressionally mandated areas of quantum information science
and artificial intelligence (AI) R&D. In doing so, Congress may consider issues and options
related to potential resource constraints as well as the adequacy of the NSTC’s organization and
current authorities to maintain continuity across presidential Administrations.
For Further Information
Emily G. Blevins, Analyst in Science and Technology Policy
CRS Report R47635, The White House Office of Science and Technology Policy: Issues and
Options for the 118th Congress
CRS Report R47410, The Office of Science and Technology Policy (OSTP): Overview and Issues
for Congress
CRS Video WVB00602, The White House Office of Science and Technology Policy: Issues for
the 118th Congress

Federal Efforts to Boost Regional Innovation
The geographic concentration of interconnected companies and institutions in a specific industry
can provide opportunities to leverage talent, infrastructure, supply chains, and other spillover
effects that are advantageous to companies and economic growth. For decades, state, local, and
regional stakeholders have pursued cross-sector, multidisciplinary approaches to economic
development through the facilitation of such industry clusters. Industry clusters are generally
designed to address structural or institutional challenges related to entrepreneurship and
innovation, access to capital, infrastructure, and workforce needs and may be implemented in
concert with programs that provide direct assistance to individual firms. Research suggests that
firms in innovation-based industries particularly benefit from the advantages of a regional
innovation ecosystem, including more quickly understanding consumer demand and access to
feedback from other entrepreneurs.

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Recent executive and legislative branch actions indicate increased federal interest and support for
regional innovation efforts. For example, Congress required the establishment of several new
regional innovation programs in the CHIPS and Science Act (P.L. 117-167), including the
Regional Technology and Innovation Hubs Program at the Economic Development
Administration (EDA), the Regional Innovation Engines Program at NSF, and the Regional Clean
Energy Innovation Program at the Department of Energy (DOE). EDA and NSF have started
making awards under their programs and initial projects and activities are beginning.
The 118th Congress may examine the implementation of these new programs, including the
coordination of federal programs and place-based resources; the scale, scope, and duration of
federal involvement; the long-term sustainability of supported efforts; ensuring inclusive
innovation and economic growth; and institutional capacity-building and small business
engagement, among others. A related congressional issue may be the level of funding needed for
both new and existing regional innovation programs.
For Further Information
Marcy E. Gallo, Analyst in Science and Technology Policy
Julie M. Lawhorn, Analyst in Economic Development Policy
Adam G. Levin, Analyst in Economic Development Policy
Emily G. Blevins, Analyst in Science and Technology Policy
CRS Report R47495, Regional Innovation: Federal Programs and Issues for Consideration

Commercializing the Results of Federal Research and Development
Investments
Inventions resulting from research conducted at federally owned laboratories or with federal
funding (e.g., research grants) often have application beyond the scope and goals of the original
research. Without further investment and sufficient private sector incentives, however, the
potential commercial value of federally funded inventions may not be fully realized.
Current mechanisms to encourage the commercialization of federal R&D results are governed by
two main pieces of legislation from the 1980s, as amended: the Stevenson-Wydler Technology
Innovation Act of 1980 (35 U.S.C. §§3710 et seq.) and the Bayh-Dole Act of 1980 (35 U.S.C.
§§200 et seq.).
Significant changes in the global S&T landscape, economic conditions, and national security
posture have led some policymakers and analysts to ask whether aspects of these laws may need
reevaluation. For example, critics point to loopholes in the Bayh-Dole Act’s “Preference for U.S.
Industry” provision (35 U.S.C. §204) that have allowed federally owned IP and covered
inventions to be manufactured abroad. These critics argue that the ability of competitor nations to
access U.S.-developed technology—especially emerging technologies—poses an economic and
national security threat.
Proponents of maintaining the current laws argue that exceptions that permit foreign
manufacturing when U.S. industry is unable to meet production demands are beneficial. They
also maintain that additional restrictions placed on the licensing and manufacturing of federally
funded inventions could reduce incentives for the private sector to commercialize federal R&D.
When considering how best to encourage the commercialization of federally funded research, the
118th Congress may consider increased oversight to ensure agency enforcement of existing U.S.

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manufacturing requirements and whether to enact statutory changes to existing requirements.
Congress might also consider whether digital products that result from work at federal
laboratories should be eligible for copyright and whether current requirements for invention
disclosure and utilization reporting are adequate for assessing the success of commercialization
efforts.
For Further Information
Emily G. Blevins, Analyst in Science and Technology Policy
Marcy E. Gallo, Analyst in Science and Technology Policy
CRS In Focus IF12582, March-In Rights Under the Bayh-Dole Act: Draft Guidance

Patents and Innovation Policy
The U.S. patent system is designed to encourage scientific and technological innovation by
offering a limited-time monopoly on an invention in exchange for its public disclosure. The 118th
Congress, when considering approaches to encouraging innovation and economic growth, may
choose to address certain aspects of patent policy, including patent subject matter eligibility
standards, the Patent Trial and Appeal Board (PTAB), and inventor diversity.
Patent subject matter eligibility standards determine the types of inventions that may be patented
and may significantly influence innovation incentives. In the wake of a series of Supreme Court
decisions that restricted patent eligibility, stakeholders in the biotechnology and computer
software industries (among others) have argued that uncertainty over patent eligibility in their
fields has reduced investment and inhibited innovation. In response, the U.S. Patent and
Trademark Office (USPTO) issued new guidance to patent examiners clarifying how to apply
subject matter eligibility standards. Bills have been introduced in the 118th Congress to change
statutory eligibility standards and abrogate Supreme Court decisions (e.g., H.R. 8134, §7, and S.
2140).
In 2011, Congress created PTAB, an administrative body within USPTO, as a way to improve
patent quality. PTAB proceedings often provide a faster and less expensive forum in which to
challenge the validity of issued patents than federal court litigation. Some stakeholders argue that
PTAB offers a fair and efficient means to adjudicate patent validity issues, but others contend that
the process is biased against patent holders. Several hearings were held in the 117th and 118th
Congresses on PTAB, and a number of bills were introduced in the 118th Congress that sought to
reform or eliminate PTAB processes (e.g., S. 2140 and H.R. 8134, §5).
USPTO does not track patent inventors’ demographic information. If collected through patent
applications, such data could potentially assist policymakers in assessing the existence or scope of
potential systematic inequities embedded in the patent system that might inhibit innovation. Some
critics of collecting this information raise concerns about privacy violations.
For Further Information
Emily G. Blevins, Analyst in Science and Technology Policy
Kevin J. Hickey, Legislative Attorney
CRS Report R48016, The Patent Trial and Appeal Board and Inter Partes Review
CRS Video WVB00690, The Patent Trial and Appeal Board: Legal Developments and Proposed
Reforms
CRS In Focus IF12582, March-In Rights Under the Bayh-Dole Act: Draft Guidance

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CRS In Focus IF12563, Patent-Eligible Subject Matter Reform: An Overview

Intellectual Property (IP) Law
IP rights, including patents and copyrights, play a critical role in encouraging innovation,
creativity, and the dissemination of knowledge. Many areas of IP law may be of interest to the
118th Congress. In addition to the general innovation policy issues discussed above (see “Patents
and Innovation Policy”), a key emerging area concerns the interaction between AI and IP, which
is discussed separately below (“Artificial Intelligence and Intellectual Property Law”).
While patents are important to many industries, they play a particularly critical role in the
pharmaceutical industry. While some stakeholders argue that robust patent rights are necessary to
support costly R&D for new drugs, others argue that patents can unduly delay or deter generic
competition and contribute to higher drug prices. Several bills in the 118th Congress seek to
reduce drug prices by limiting certain alleged pharmaceutical patenting practices, such as
“product hopping,” “patent thickets,” or “pay-for-delay” settlements (e.g., H.R. 6275, H.R. 6436,
S. 142, S. 150, and S. 3583). Other bills seek to facilitate coordination between USPTO and the
U.S. Food and Drug Administration (FDA) on pharmaceutical patents (e.g., H.R. 1717, S. 79, and
S. 2780) or increase generic drug companies’ ability to challenge patent information that may
affect FDA approval of generic drugs (S. 1128).
Copyrights grant authors of original creative works (e.g., books, music, computer code, and
visual art) the exclusive right to reproduce, perform, and sell their works. Two significant
copyright reforms were implemented during the 117th Congress. The Music Modernization Act,
which changed the copyright licensing process for online distribution of musical works, came into
full effect in January 2021. The Copyright Alternative in Small-Claims Enforcement Act of 2020
established the Copyright Claims Board as a small-value copyright claims administrative tribunal,
which began hearing claims in 2022. In addition to bills relating to AI (discussed separately
below), copyright bills introduced in the 118th Congress include proposed reforms to copyright in
technical standards incorporated by reference into law (H.R. 1631 and S. 835) and music
licensing (e.g., H.R. 5576 and H.R. 7763), including whether broadcast radio should pay royalties
to play sound recordings (e.g., H.Con.Res. 13, H.R. 791, S.Con.Res. 5, and S. 253).
As to trademarks—another area of federal IP—the 117th Congress saw increased efforts to
combat fraudulent trademarks through USPTO regulations implementing the Trademark
Modernization Act of 2020. Trademark bills in the 118th Congress include proposals to reduce the
availability of counterfeit goods on online platforms (S. 2934) and strengthen the U.S. Customs
and Border Protection’s authority to prevent the importation of counterfeit goods (S. 3431).
For Further Information
Kevin J. Hickey, Legislative Attorney
CRS Video WVB00567, Introduction to Intellectual Property Law
CRS Report R46679, The Role of Patents and Regulatory Exclusivities in Drug Pricing
CRS In Focus IF12700, “Skinny Labels” for Generic Drugs Under Hatch-Waxman
CRS In Focus IF12644, Patent Listing in FDA’s Orange Book
CRS In Focus IF12582, March-In Rights Under the Bayh-Dole Act: Draft Guidance
CRS Report R47656, Copyright in Standards Incorporated by Reference into Law and the Pro
Codes Act

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CRS Report R47642, On the Radio: Public Performance Rights in Sound Recordings
CRS In Focus IF12456, An Introduction to Trademark Law in the United States

The U.S.-China Science and Technology Cooperation Agreement
For more than 45 years, the United States has engaged with the People’s Republic of China in
joint R&D activities under the U.S.-China Science and Technology Cooperation Agreement
(STA), the first major agreement between the United States and the People’s Republic of China
that was signed in 1979. The STA was a part of U.S. strategy at the time to build ties with China
to counter the influence of the Soviet Union. During the 1980s and 1990s, U.S. strategy shifted
and S&T ties became part of a broader U.S. effort to integrate China into the global system and
influence its development trajectory and behavior. More recent efforts have focused on areas such
as health, energy, and environmental technologies.
Since its inception, U.S. views and strategy toward China have been shifting to protect and
advance U.S. interests vis-à-vis China as a strategic competitor. STA proponents and critics both
say that the current STA does not reflect these shifts or U.S. concerns about China’s S&T
practices and industrial policies. Some say the STA does not address China’s growing research
and technological capabilities and increasingly restrictive and risky operating environment for
cross-border research.
The United States has used the U.S.-China STA as a tool to deepen diplomatic ties, address global
challenges, and advance science. Advocates say it guides U.S. S&T work with China without
mandating activity; provides access and protections for U.S. scientists in China, including in the
social sciences (where access has been more restricted); and benefits U.S. researchers by
providing access to large pools of research subjects and longitudinal health studies. China’s
cooperation has not been consistent, however, as Beijing developed domestic S&T competencies
and has sought to restrict U.S. researcher access in certain areas. STA critics say that China is an
unreliable or untrustworthy research partner, citing data restrictions and a lack of forthrightness in
sharing scientific results.
The STA was to be renewed every five years, subject to modification or extension by the parties.
The STA was last extended on June 27, 2018, and was amended to address U.S. concerns about
China’s approach to technology, innovation, and practices of concern (e.g., lax IP enforcement, IP
theft, and forced technology transfer). Just before the STA was to lapse on August 27, 2023, the
Biden Administration said it would extend renewal for six months to determine how to proceed.
On February 24, 2024, the two sides agreed to another six-month extension to negotiate renewal
terms.
Congress might consider its oversight role with regard to the STA and any U.S. STA-related
activities and negotiations with China. U.S. options regarding the U.S.-China STA (not mutually
exclusive) include (a) renew the U.S.-China STA as is; (b) renew the STA and modify STA subagreements; (c) modify and renew the STA; (d) significantly rework and renegotiate the STA; (e)
let the STA expire; (f) shift focus to deepen other STAs (e.g., with Europe, Japan, and others); and
(g) work with allies and partners to develop a common approach to S&T work, in general and
with regard to China, specifically. Experts debate the extent to which canceling the STA would
affect U.S.-China S&T ties, including sub-agreements and federally funded research.
Renegotiating the STA might or might not address specific concerns that Congress could address
through legislation. It could allow Washington, but also Beijing, to set new terms. Congress might
consider its preferred role in overseeing the U.S.-China STA and its negotiation. The STA is not a
treaty requiring Senate ratification.

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For Further Information
Karen M. Sutter, Specialist in Asian Trade and Finance
Emily Blevins, Analyst in Science and Technology Policy
CRS In Focus IF12510, U.S.-China Science and Technology Cooperation Agreement
CRS In Focus IF10964, “Made in China 2025” Industrial Policies: Issues for Congress

China’s Science, Technology, and Industrial Policies
China’s state-led industrial and related S&T policies aim to create competitive advantages for
China in strategic and emerging industries, in part by accessing basic and applied research,
technology, talent, and training from the United States and U.S. allies. The Chinese government
says it is pursuing a policy of technology independence, but its approach involves sustaining and
expanding its access to U.S. and foreign technology, capabilities, research, and talent.
China’s Medium- and Long-Term Plan in Science in Technology (2006-2020) set technological
innovation as the core driver of China’s development, a focus that was reinforced at the
Communist Party of China’s 20th Party Congress. China’s process of indigenous innovation
involves the acquisition, assessment, distribution, absorption, and adaptation of foreign
technology that China rebrands as indigenous Chinese capabilities.
China’s Made in China 2025 industrial policies aim to establish China’s leadership in emerging
technologies that are critical to future commercial, government, and military capabilities. Priority
areas include advanced manufacturing, aerospace, AI, information technology (IT), new
materials, robotics, and semiconductors. China’s military-civil fusion program seeks to leverage
these Made in China 2025 technological advancements for military development.
China’s 14th Five-Year Plan (FYP) for 2021-2025 and Economic Goals out to 2035 prioritizes
leveraging global basic research to support China’s development of indigenous capabilities in
strategic technologies. China is focusing on currently unrestricted pathways, such as U.S. basic
and applied research and open-source technology platforms. China has incentivized some of its
citizens to participate in U.S. research to acquire capabilities in targeted areas that support
China’s goals. China is also encouraging domestic firms to establish R&D centers overseas to
access foreign technical knowledge and capabilities and is offering incentives for leading foreign
S&T experts to work in China.
China’s industrial and S&T policies have been a U.S. policy focus because of the asymmetrical
tactics that China has used to implement them. U.S. law enforcement and counterintelligence
agencies have highlighted China’s use of forced or incentivized technology transfer, industrial
subsidies, licensing and joint venture requirements, state-directed cyber intrusions and IP theft,
and government-funded acquisitions of foreign firms in strategic sectors. These issues are likely
to remain a key area of focus in the 118th Congress as China seeks to sustain and expand its
access to U.S. innovation and S&T capabilities.
For Further Information
Karen M. Sutter, Specialist in Asian Trade and Finance
Michael D. Sutherland, Analyst in International Trade and Finance
CRS In Focus IF12510, U.S.-China Science and Technology Cooperation Agreement
CRS Report R47558, Semiconductors and the CHIPS Act: The Global Context

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CRS In Focus IF12473, U.S.-China Competition in Emerging Technologies: LiDAR
CRS In Focus IF11667, China’s Economy: Current Trends and Issues

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,
collaboration, and information sharing. When broadly disseminating certain research results
involves releasing proprietary information or presents potential national security concerns,
however, access to such results may be restricted. For example, relevant federal restrictions may
include classification and the use of 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 (DOC) 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 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. Some Members have been concerned with
co-option of U.S. citizen researchers through foreign talent recruitment programs (e.g., 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. Congress has considered 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 118th 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
Emily G. Blevins, Analyst in Science and Technology Policy
Marcy E. Gallo, Analyst in Science and Technology Policy
Karen M. Sutter, Specialist in Asian Trade and Finance
Jill H. Wilson, Analyst in Immigration Policy
CRS In Focus IF12589, Research Security Policies: An Overview
CRS Infographic IG10039, Foreign Students: Screening and Monitoring

Semiconductors and the CHIPS Act
Semiconductors (also known as integrated circuits, microelectronic chips, or computer chips) are
tiny electronic devices (based primarily on silicon or germanium) composed of billions of

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components that can process, store, sense, and move data or signals. Semiconductors are a
uniquely important enabling technology, fundamental to nearly all modern industrial and national
security activities, as well as essential building blocks of other emerging technologies, such as AI,
autonomous systems, and quantum computing. The federal government and U.S. companies
pioneered semiconductor development throughout the 1960s and 1970s, and the United States led
the world in semiconductor manufacturing. A variety of factors subsequently led to a
concentration of semiconductor manufacturing in East Asia. These factors included other nations
subsidizing the construction and operation of semiconductor fabrication facilities (fabs), lowering
of operating costs abroad, outsourcing of manufacturing by semiconductor design firms that
previously manufactured their own chips, and a preference for being physically proximate to
electronics business clusters in the region.
Policymakers became increasingly concerned about the potential implications of this trend for
economic and national security reasons, and noted the risks associated with ensuring an adequate
supply of semiconductors resulting from potential disruption of East Asian manufacturing and
shipping due to trade disputes, natural hazards, or armed conflict. The COVID-19 pandemic and
consequent interruption of semiconductor supplies to the United States—and the subsequent
effects on U.S.-based industries—bolstered these concerns. U.S. overreliance on semiconductor
production in East Asia and its vulnerability to disruption has been an ongoing source of concern
for many Members of Congress.
To address these concerns, Congress enacted the William M. (Mac) Thornberry National Defense
Authorization Act for Fiscal Year 2021 (P.L. 116-283), which authorized an incentive program for
building and equipping semiconductor fabs in the United States, as well as R&D activities to
support U.S. leadership in semiconductor technology. In July 2022, Congress enacted the CHIPS
and Science Act (P.L. 117-167), which President Biden signed into law in August 2022. The
CHIPS Act of 2022 (Division A of P.L. 117-167) establishes and appropriates $39.0 billion to a
CHIPS for America Fund to bolster semiconductor manufacturing capacity in the United States
by providing financial incentives for building, expanding, and equipping domestic fabrication
facilities and companies in the semiconductor supply chain. The fund also provides $11.0 billion
for semiconductor R&D activities at the National Institute of Standards and Technology (NIST)
and in partnership with U.S. industry through a National Semiconductor Technology Center, a
National Advanced Packaging Manufacturing Program, and the establishment of up to three
Manufacturing USA institutes. P.L. 117-167 also provided appropriations for three additional
funds that seek to bolster U.S. semiconductor capabilities for national defense, workforce
development, and international cooperation.
The 118th Congress may continue to oversee the implementation of these provisions to assess
whether incentives awards comply with statutory requirements related to the labor policies of
recipient companies and national security provisions, among others. It also may evaluate what
impact, if any, these programs have had on U.S. semiconductor manufacturing and workforce
development.
For Further Information
Emily Blevins, Analyst in Science and Technology Policy
Karen M. Sutter, Specialist in Asian Trade and Finance
CRS Report R47508, Semiconductors and the Semiconductor Industry
CRS Report R47523, Frequently Asked Questions: CHIPS Act of 2022 Provisions and
Implementation
CRS Report R47558, Semiconductors and the CHIPS Act: The Global Context

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CRS Video WVB00705, Science and Technology Q&A: CHIPS for America: Technology or
Industrial Policy?
CRS Video WVB00589, Science and Technology Q&A: Semiconductors and the CHIPS Act of
2022
CRS Report WPD00105, Science and Technology Q&A: CHIPS for America: Technology or
Industrial Policy?
CRS Report WPD00059, Science and Technology Podcast: Semiconductors and the CHIPS Act
of 2022

Agriculture
The federal government funds billions of dollars of agricultural research annually. The 118th
Congress may consider issues related to funding agriculture that is conducted at research agencies
within the U.S. Department of Agriculture (USDA) or the research conducted in partnership with
the land-grant institutions throughout the nation.

Agricultural Research Funding
The USDA Research, Education, and Economics (REE) mission area consists of four agencies:
the Agricultural Research Service, the Economic Research Service, the National Agricultural
Statistics Service, and the National Institute of Food and Agriculture. Additionally, REE’s Office
of the Chief Scientist coordinates research programs and activities across the department.
REE has the primary federal responsibility for advancing scientific knowledge about agriculture.
Its agencies conduct and fund research that spans the biological, physical, and social sciences
broadly related to agriculture, food, and natural resources. Congress provided the REE mission
area programs and activities approximately $3.9 billion in FY2024 discretionary appropriations
through the Consolidated Appropriations Act, 2024 (P.L. 118-42) and authorized approximately
$122 million of mandatory funding per year through the Agriculture Improvement Act of 2018
(2018 farm bill; P.L. 115-334). USDA directs nearly half of this federal funding to states and local
partners, primarily through grants.
The most recent farm bill (P.L. 115-334), enacted in December 2018, reauthorizes many existing
USDA research and education programs, and authorizes new programs, through FY2023. The
2018 farm bill expired in 2023. Congress extended it by one year through the Further Continuing
Appropriations and Other Extensions Act, 2024 (P.L. 118-22). Congress extended the
authorization for discretionary funding and provided mandatory funding for existing research
programs by one year through the Further Continuing Appropriations and Other Extensions Act,
2024 (P.L. 118-22), until September 30, 2024. The continuing resolution for FY2025 through
December 20, 2024 (P.L. 118-83), continues discretionary funding temporarily but did not extend
the farm bill or its mandatory funding. Without another extension of the farm bill, authority to
operate the Organic Research and Extension Initiative that has mandatory funding and future
mandatory funding for three programs without baseline will expire. While the 118th Congress is
considering a new multiyear farm bill reauthorization, another extension, or expiration, it may
also consider establishing new REE programs or initiatives, revising existing efforts, or
eliminating some programs.
For Further Information
Eleni G. Bickell, Analyst in Agricultural Policy

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CRS Report R48071, The Agricultural Cooperative Extension System: An Overview

Regulation of Agricultural Biotechnology
The 118th Congress may continue to oversee USDA’s implementation of regulations related to the
labeling of bioengineered foods and the regulation of agricultural biotechnology. As plants and
animals that are developed with new biotechnology tools become more common, Congress may
consider whether to revisit the 1986 Coordinated Framework for the Regulation of Biotechnology
that governs U.S. biotechnology regulation.
In 2016, Congress enacted P.L. 114-216, requiring the establishment of a national standard for the
mandatory labeling of foods containing bioengineered or genetically engineered ingredients.
USDA finalized its National Bioengineered Food Disclosure Standard regulations in 2018, and
mandatory compliance began in January 2022. However, in September 2022, a U.S. district court
remanded two provisions in USDA’s regulation that allow genetically engineered foods to be
labeled only with an electronic or digital disclosure (QR code) and allow text message disclosure
on packaging without requiring additional on-package labeling (7 C.F.R. §§66.106 and 66.108).
As a result, USDA is expected to revise these specific provisions while the broader labeling
requirements remain in effect.
New biotechnology tools, such as gene editing technologies, updates to USDA plant
biotechnology regulations, and a proposed change in the regulation of genetically engineered
agricultural animals have sparked concerns among some stakeholders. In 2020, USDA finalized
the SECURE Rule for the regulation of genetically engineered organisms under the Plant
Protection Act (7 U.S.C. §§7701 et seq.), exempting certain engineered plants from regulation
due to low plant pest risk. While some viewed this as supportive of innovation, others criticized it
for lacking oversight.
USDA also has proposed transferring regulation of genetically engineered agricultural animals
from FDA to USDA. In 2021, the two agencies signed a memorandum of understanding outlining
collaborative regulatory frameworks, pre-market evaluations, and post-market monitoring for
genetically engineered animals, with each agency having specific roles based on their authorities
to ensure the safe and efficient entry of genetically engineered species into the market. Congress
may 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. Congress may also examine the implementation of E.O. 14081, “Advancing
Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American
Bioeconomy,” intended to enhance coordination and communication between federal regulatory
agencies and stakeholders to facilitate the development and commercialization of biotechnology
products, including agricultural ones.
For Further Information
Eleni G. Bickell, Analyst in Agricultural Policy
CRS Report R47683, Gene-Edited Plants: Regulation and Issues for Congress
CRS In Focus IF11573, USDA’s SECURE Rule to Regulate Agricultural Biotechnology
CRS Video WVB00713, Science and Technology Q&A: Gene Editing in Agriculture

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Biotechnology and Biomedical Research
Recent advances in biotechnology and biomedical research hold the promise of longer and
healthier lives and more productive industry while raising policy challenges. Some issues that the
118th Congress may face include those relating to the National Institutes of Health (NIH);
oversight of engineering biology; regulation of laboratory-developed tests; monitoring of
environmental deoxyribonucleic acid (DNA) and ribonucleic acid (RNA); and the convergence of
biotechnology, digital data, robotics, and AI.

National Institutes of Health (NIH) and Biomedical Research
NIH, based in the Department of Health and Human Services (HHS), is the lead federal agency
for medical and health research. In FY2023, NIH used its over $47 billion budget to support more
than 300,000 scientists and research personnel working at over 2,800 institutions across the
United States and abroad, as well as to conduct research at its own facilities. The agency consists
of the Office of the Director, in charge of overall policy and program coordination, and 27
Institutes and Centers, each of which focuses on particular diseases or research areas in human
health. NIH represents about one-fifth of total federal R&D spending, and close to half of nonDOD R&D funding.
Congress last reauthorized and comprehensively addressed NIH policy and programs through the
21st Century Cures Act of 2016 (Cures Act, P.L. 114-255). Some Cures Act NIH authorizations
have since expired, for example, the Cancer Moonshot initiative authorization expired in FY2023.
The Cancer Moonshot was originally established with the broad goal of making a decade’s worth
of scientific progress in preventing and treating cancer in just five years. In 2022, President Biden
announced a “reignited” Cancer Moonshot effort focused on a broad set of health strategies in
addition to research. It remains to be seen whether and how Congress might formally authorize or
fund this new effort.
In the 118th Congress, some Members have focused on research security issues at NIH (e.g.,
NIH’s support for risky research on pathogens, including “gain-of-function” research, as well as
NIH’s funding for research involving institutions or foreign nationals of countries of concern).
The PREVENT Pandemics Act (P.L. 117-328, Division FF, Title II), enacted in December 2022,
included several provisions requiring HHS and NIH to develop policies that address security risks
associated with funded research. In addition, leaders in committees of jurisdiction in both the
House and the Senate have published reports on potential NIH reform, with House committee
leaders proposing major structural reforms at the agency.
Other NIH issues during the 118th Congress include
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the balance of NIH’s research portfolio with respect to disease and health areas as
well as types of research (e.g., basic, translational, and clinical),
NIH’s relationship with the new Advanced Research Projects Agency for Health
(ARPA-H),
the affordability of pharmaceutical drugs based on NIH-funded research or IP,
and
animal use in NIH-funded research and associated scientific and ethical concerns.

For Further Information
Kavya Sekar, Analyst in Health Policy

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CRS Report R43341, National Institutes of Health (NIH) Funding: FY1996-FY2025
CRS In Focus IF12504, The Cancer Moonshot: Overview and Issues
CRS In Focus IF12002, Animal Use in Federal Biomedical Research: A Policy Overview
CRS Insight IN12173, Expired and Expiring National Institutes of Health (NIH) Provisions
CRS Report R47649, PREVENT Pandemics Act (P.L. 117-328, Division FF, Title II)

Advanced Research Projects Agency for Health (ARPA-H)
ARPA-H aims to advance high-potential, high-impact biomedical and health research that cannot
be readily accomplished through traditional research or commercial activity. ARPA-H is an
independent agency housed within NIH that was first funded in FY2022 and then codified as part
of the Consolidated Appropriations Act, 2023 (P.L. 117-328). ARPA-H responds to concerns that
traditional health research funding processes are too risk averse—favoring incremental advances
over potentially transformative research.
ARPA-H is modeled after other “ARPAs” in the federal government, especially the Defense
Advanced Research Projects Agency. The “ARPA model” involves an organizational structure
designed to be flat and nimble, staffed by tenure-limited program managers with a high degree of
autonomy to select and fund research projects using a milestone-based contract approach. There
are uncertainties around how well the ARPA model will work in the health and biomedical
research context.
Prior policy debates surrounding ARPA-H focused in large part on where to place the new agency
within HHS and how to ensure its independence. In March 2022, the HHS Secretary chose to
place ARPA-H within NIH, with the ARPA-H Director reporting directly to the HHS Secretary.
ARPA-H was statutorily authorized in December 2022 through the PREVENT Pandemics Act
(P.L. 117-328, Division FF, Title II), which codified this organizational structure.
ARPA-H began establishing its programs and issued its first announcement for funding proposals
in 2023. Congress has thus far provided ARPA-H with over $4 billion in multiyear
appropriations. As ARPA-H continues to develop its programs, ongoing oversight issues for
Congress include the following:
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Are ARPA-H’s programs and focus areas in line with congressional intent for the
new agency?
Is ARPA-H able to recruit people with the appropriate talent and expertise as
program managers?
How is ARPA-H avoiding duplication and ensuring collaboration with other
agencies that fund health research?
What processes and policies are ARPA-H putting into place to facilitate eventual
broader implementation of ARPA-H-supported innovations?
What does success look like for ARPA-H in the short, medium, and long term?

For Further Information
Kavya Sekar, Analyst in Health Policy
CRS Report R47568, Advanced Research Projects Agency for Health (ARPA-H): Overview and
Selected Issues

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Interoperability and the Office of the National Coordinator for
Health Information Technology (ONC)
Information technology (IT) takes many forms and is increasingly used in health care contexts to
improve, and make more efficient, patient care. Numerous federal initiatives have facilitated and
incentivized this transition, including the establishment of ONC, codified by the Health
Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act; P.L. 1115). ONC is a federal staff division within HHS and is in part tasked with advancing nationwide
health IT (HIT) interoperability, or essentially, the capability of different HITs to communicate
with one another and meaningfully exchange and use data. Some topics in the ONC HIT sphere
that may be of particular interest to the 118th Congress include AI, data protection, and efforts to
extend interoperability nationwide and across different categories of health data.
ONC promotes interoperability in numerous ways. For example, ONC develops voluntary federal
standards for HIT under its Health IT Certification Program (Certification Program). In December
2023, ONC operationalized the Trusted Exchange Framework and Common Agreement
(TEFCA). TEFCA in part intends to facilitate the connection of different hubs, or health
information exchanges (HIEs), across the country. Thus, TEFCA’s operationalization is meant to
continue expanding interoperability and the trusted exchange of digital health information
nationwide.
As innovative HIT emerges, ONC has taken a key federal role in developing regulations for these
novel technologies. On January 9, 2024, ONC published a final rule, entitled Health Data,
Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and
Information Sharing (HTI-1), in the Federal Register. Among other things, this rule further
develops ONC policy regarding algorithm transparency, including as it relates to AI, in HIT
contexts. Under this rule, ONC-certified health IT modules that contain AI and other predictive
algorithms must provide clinical users access to consistent, baseline information, in part to better
inform users’ selections of appropriate tools.
For Further Information
Nora Wells, Analyst in Health Policy
CRS In Focus IF12352, The Office of the National Coordinator for Health Information
Technology (ONC)

Oversight of Engineering Biology
Engineering biology is the application of engineering principles and the use of systematic design
tools to enable the reprogramming of living cells at the genetic level for a specific functional
output. As the field of engineering biology is developing rapidly, distinctions are not always clear
among engineering biology, synthetic biology, and other related terms such as genetic
engineering, genome engineering, and biotechnology. Engineering biology may find use in
multiple sectors, including biomanufacturing, medicine, consumer products, agriculture, smart
materials, energy generation, adaption to and mitigation of climate change, environmental
conservation, pollution remediation, and others. On September 12, 2022, President Biden issued
E.O. 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable,
Safe, and Secure American Bioeconomy.” An accompanying White House press release stated
that “global industry is on the cusp of an industrial revolution powered by biotechnology” and
that “other countries are positioning themselves to become the world’s resource for biotechnology
solutions and products.”

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Applications of engineering biology have become more complex, novel, and designed for broader
use in the environment—for example, to control disease transmission and reduce the impacts of
invasive species on natural population. Applications designed for release into the environment
may have biosecurity implications. For example, gene drives, a system of biasing inheritance to
increase the likelihood of sexually reproducing species passing on a modified gene to offspring,
could potentially spread and persist throughout the environment with irreversible effects on
organisms and ecosystems. These potential ecological impacts could have biosecurity and
strategic implications for the United States. For example, if a staple crop or ecosystem were
impacted by an engineering biology application, deliberately or by accident, it could affect U.S.
food and water supply chains and global food security systems.
In the 118th Congress, policymakers may consider whether the current U.S. regulatory system,
research and infrastructure investments, and agency expertise appropriately balance the broad
cross-cutting issues associated with engineering biology (e.g., biosafety, biosecurity, and
ecological impacts) while maintaining U.S. competitiveness and leadership in biotechnology.
For Further Information
Todd Kuiken, Analyst in Science and Technology Policy
CRS Video WVB00526, CRS Science and Technology Seminar Series: Engineering Biology
Issues for the 118th Congress
CRS Report R47849, Artificial Intelligence in the Biological Sciences: Uses, Safety, Security, and
Oversight
CRS Report R48155, Oversight of Laboratory Biosafety and Biosecurity: Current Policies and
Options for Congress

Regulation of Laboratory-Developed Tests (LDTs)
Regulation of LDTs—in vitro diagnostic (IVD) devices that are designed, manufactured, and used
within a single laboratory—has long been debated. FDA has traditionally exercised enforcement
discretion over LDTs, so most have not undergone premarket review. However, FDA has asserted
authority over LDTs it considers higher risk, for example, direct-to-consumer (DTC) genetic
tests. In 2014, FDA published draft guidance outlining a comprehensive risk-based regulatory
framework for LDT, which was never finalized. The COVID-19 pandemic highlighted issues
with FDA regulation of LDTs. Most COVID-19 LDTs were subject to premarket review during
the pandemic, but in August 2020, in a now rescinded policy, HHS announced that FDA was
prohibited from requiring premarket review for LDTs without first undergoing notice-andcomment rulemaking.
The VALID Act (H.R. 6102 and S. 3404), which was initially introduced in the 116th Congress,
would establish a comprehensive regulatory scheme for in vitro clinical tests. The VALID Act
was incorporated into the Senate user fee bill in 2022 (S. 4348) but was not included in final
passed legislation. The VALID Act was again introduced in the House during the 118th Congress
(H.R. 2369).
In the context of the experience with COVID-19 LDTs during the pandemic, as well as the
exclusion of the VALID Act from user fee legislation, in October 2023, FDA published a
proposed rule describing its intention to phase out its general enforcement discretion approach for
LDTs. This rule was finalized in May 2024. The 118th Congress may be interested in revisiting
the VALID Act or similar legislation in light of FDA’s final rule.

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For Further Information
Amanda Sarata, Specialist in Health Policy
CRS In Focus IF12628, Regulation of Laboratory-Developed Tests: FDA’s Proposed Rule

DNA as Data
Environmental deoxyribonucleic acid (eDNA) and environmental ribonucleic acid (eRNA) are
trace amounts of genetic material collected from an environmental sample such as soil,
sediments, water, or air. An eDNA/RNA sample can be compared with a reference from a known
species. The results of that comparison can be used to identify and track a species of interest,
identify the presence of small or rare species, and detect the presence of non-native plants or
animals, as well as various microbes, viruses, and other pathogens. For example, analysis of
eRNA in wastewater and sewage has been used to detect and monitor the presence of the virus
that causes COVID-19.
How sequences and other data are collected, analyzed, and stored in these reference databases
could impact how eDNA/RNA data can be used for research and decisionmaking. The
availability, quality, and selection of a primer, or DNA sequence, from one database over another
can affect the analysis of an eDNA/RNA sample. Whether databases are private or publicly
managed can affect access to datasets for eDNA analysis. Databases that contain genetic sequence
information can also have implications for biosafety and biosecurity. In June 2024, the White
House NSTC released the National Aquatic Environmental DNA Strategy, which focused on
eDNA analysis of aquatic biodiversity.
The 118th Congress may consider the level of federal investment in eDNA/RNA techniques, the
development and maintenance of genetic sequence information databases, and the development of
federal standards/protocols for applying eDNA/RNA tools. Policymakers may also consider
regulation of the collection, use, retention, and access to digital DNA/RNA sequence data and
how local, state, and federal agencies currently use or could use eDNA/RNA for decisionmaking.
For Further Information
Todd Kuiken, Analyst in Science and Technology Policy
Anna E. Normand, Specialist in Natural Resources Policy
Caitlin Keating-Bitonti, Specialist in Natural Resources Policy
Anne A. Riddle, Specialist in Natural Resources Policy
CRS In Focus IF12356, Digital Biology: Implications of Genetic Sequencing
CRS Video WVB00593, Science and Technology Q&A: Environmental DNA (eDNA)
CRS Report WPD00061, Science and Technology Podcast: Environmental DNA (eDNA)

Convergence of Biotechnology, Digital Data, Robotics, and
Artificial Intelligence
As biotechnology has advanced, it has built upon advances in other fields of science and
engineering, such as nanotechnology, AI, robotics, and digital data management. Advances in
DNA sequencing technologies have made it possible to sequence entire genomes (the genetic
information responsible for the development and function of an organism) in greater depth and at
lower cost. The resulting digital sequence information can be stored in proprietary or public

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databases, many of which are publicly funded and freely accessible to interested parties to
download. Gene synthesis technologies can use this information to “write” DNA, turning the data
back into actual genetic material. This ability to both read and write DNA is a fundamental
enabling technology for biotechnology. Biofoundries that combine biology, computer-aided
design, robotics, and engineering technologies in a single facility increasingly provide an
integrated infrastructure that enables the rapid design, construction, and testing of engineered
organisms for biotechnology applications and research.
This has led to the establishment of new industries and the emergence of new communities of
practice. At the same time, increased access to digital sequence information, combined with
advances in AI and robotics, has raised biosafety and biosecurity concerns. Questions include, for
example: Who should have access to these capabilities? What limits should be placed on the
services that may be provided in order to prevent the deliberate or accidental development and
use of a potential biological threat?
AI technologies, methodologies, and applications can be used throughout the biological sciences
and biology R&D, including in engineering biology (e.g., the application of engineering
principles and the use of systematic design tools to reprogram cellular systems for a specific
functional output). This has enabled R&D advances across multiple application areas and
industries. For example, AI can be used to analyze genomic data (e.g., DNA sequences) to
determine the genetic basis of a particular trait and potentially uncover genetic markers linked
with those traits. It has also been used in combination with biological design tools to aid in
characterizing proteins (e.g., 3D structure) and for designing new chemical structures that can
enable specific medical applications, including for drug discovery. The convergence of AI and
other technologies associated with biology can lower technical and knowledge barriers and
increase the number of actors with certain capabilities. These capabilities have potential for
beneficial uses while at the same time raising certain biosafety and biosecurity concerns. For
example, some have argued that when AI is used for biological design, it can be repurposed or
misused to potentially produce biological and chemical compounds of concern.
For federally funded research, the United States has multiple, overlapping policies that provide
biosafety and biosecurity guidance and oversight for certain life sciences research, depending on
factors such as the types of experiments and biological agents used. On May 9, 2024, the White
House OSTP released its most recent policy update, the United States Government Policy for
Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential.
According to the policy, it is “a unified federal oversight framework for conducting and managing
certain types of federally funded life sciences research on biological agents and toxins.” It
addresses oversight of research on biological agents and toxins that, when enhanced, have the
potential to pose risks to public health, agriculture, food security, economic security, or national
security.
In the 118th Congress, policymakers may consider whether current policies to address the
convergence of biotechnology, digital data, robotics, and AI are sufficient and adequately
balanced or whether new oversight authorities are needed to manage emerging biosafety and
biosecurity issues without unduly stifling innovation.
For Further Information
Todd Kuiken, Analyst in Science and Technology Policy
CRS Report R47849, Artificial Intelligence in the Biological Sciences: Uses, Safety, Security, and
Oversight

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CRS Report WPD00077, Science and Technology Podcast: Artificial Intelligence in the
Biological Sciences
CRS Video WVB00642, Science and Technology Q&A: Artificial Intelligence in the Biological
Sciences

Climate Change
S&T considerations are often part of the deliberations on climate change policy. Among the S&T
topics discussed are climate-change-related science and the ocean-climate nexus, decarbonizing
the railroads, and carbon capture and sequestration. Legislation regarding climate change was
enacted in the 117th Congress, influencing debate on related issues during the 118th Congress.

Climate-Change-Related Science and the Ocean-Climate Nexus
Congress may examine and consider recent scientific assessments—domestic and international—
that strengthened and updated previous assessments. For example, in 2023 the U.S. Global
Change Research Program (USGCRP) published the Fifth National Climate Assessment (NCA5),
which found that human-related greenhouse gas (GHG) emissions are accumulating in the
atmosphere, raising global average temperature, and increasing acidity of the global ocean. It
concluded that the increase in GHG emissions is driving global land and ocean warming and
other climate effects (e.g., melting ice and sea level rise). It stated that
[i]t is unequivocal that human activities have increased atmospheric levels of carbon
dioxide and other greenhouse gases. It is also unequivocal that global average temperature
has risen in response.

The USGCRP also coordinates U.S. participation in the Intergovernmental Panel on Climate
Change (IPCC), which provides reports on climate science.
Recently the science of climate change attribution—whether, or to what degree, human influence
may have contributed to extreme climate or specific extreme weather events—has received
increased attention. Attributions of extreme weather to human-induced climate change may affect
how policymakers, understand and manage associated risks.
The ocean is an integral part of the global climate system, as it absorbs, retains, and transports
heat, water, and carbon. This interplay is referred to as the ocean-climate nexus. The absorption of
increased levels of carbon dioxide by the ocean is contributing to ocean acidification thereby
affecting some marine species and putting fisheries at risk. Ocean acidification is an area of
ongoing research by federal science agencies. The U.S. marine economy may be positively or
negatively impacted by climate change (e.g., ocean warming or acidification).
The 118th Congress may examine the role of the federal government in supporting federal climate
and ocean science. Congress may monitor federal support for climate and ocean research,
whether adjustment to the level of federal support is needed, and how federal funding may be
allocated among federal agencies.
For Further Information
Jonathan D. Haskett, Analyst in Environmental Policy
Caitlin Keating-Bitonti, Specialist in Natural Resources Policy
CRS Report R47583, Is That Climate Change? The Science of Extreme Event Attribution
CRS Report R47551, Solar Geoengineering and Climate Change

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CRS Report R47300, Ocean Acidification: Frequently Asked Questions

Decarbonizing the Railroads
Freight railroads, which generally do not receive federal funding, own and control most of the
railroad tracks in the United States and primarily rely on fleets of diesel-powered locomotives
with long service lives (approximately 25 years, longer if remanufactured). Compared to most
other modes of freight and passenger transportation, railroads consume energy more efficiently
and produce fewer emissions. Nevertheless, reducing emissions from U.S. railroads could be of
interest to Congress as part of the nation’s overall strategy to reduce air pollution and reach longterm GHG reduction targets. Congress may consider extending some of the demonstration or
incentive programs in the Infrastructure Investment and Jobs Act (IIJA; P.L. 117-58) and Inflation
Reduction Act (IRA; P.L. 117-169) to apply to railroads, altering project eligibilities under
existing grant and loan programs, or creating new programs or freestanding legislation to promote
one or more mature technologies (e.g., electric trains powered by overhead wires) or emerging
ones (e.g., battery- or hydrogen-powered trains) for rail electrification or decarbonization.
The adoption of any low- or zero-emission railroad technology could present obstacles to an
industry that is accustomed to operating its locomotives effectively barrier free across the entire
national railway network. Large-scale electrification with overhead wires could require up-front
investments in infrastructure that may be cost prohibitive and provide logistical challenges;
electric locomotives would not be able to operate on unelectrified lines unless they were purpose
built to do so, at additional cost. Battery-powered locomotives have practical limits to their power
and range that may not be well suited to long-haul freight. Hydrogen-fueled locomotives could
depend on the future development of affordable hydrogen fuel nationwide.
For Further Information
Ben Goldman, Analyst in Transportation Policy
CRS In Focus IF12707, Options for Railroad Electrification and Decarbonization

Carbon Capture and Sequestration
Carbon capture and sequestration (or storage)—known as CCS—seeks to capture CO2 at its
source, store it underground, or utilize it for another purpose or product. CCS is sometimes
referred to as CCUS—carbon capture, utilization, and sequestration (or storage). The capturing
step is the costliest and most energy-intensive step in the CCS process. CCS could reduce the
amount of CO2 emitted into the atmosphere at large stationary sources. Carbon utilization has
recently gained interest as a means of converting CO2 into potentially commercially viable
products, such as chemicals, fuels, cements, and plastics. Direct air capture, a related emerging
technology, removes atmospheric CO2 directly from the atmosphere. CO2 can also be captured
from seawater in a process known as direct ocean capture.
Federal law and regulations specify certain requirements for CO2 underground injection wells,
which are regulated by the Environmental Protection Agency (EPA) or delegated states.
Currently, 4 federal EPA-permitted geologic sequestration wells and at least 11 state-permitted
wells are in operation in the United States. From FY2010 through FY2024, Congress has
provided a total of $11.5 billion (in constant 2024 dollars) in annual appropriations for the DOE
research arm conducting most federal CCS research activity. Additionally, IIJA provided
supplemental appropriations of $8.5 billion for CCS for FY2022-FY2026 and $3.6 billion for
direct air capture for the same time period. IRA increased the “Section 45Q” tax credit for
underground carbon sequestration, among other provisions.

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Proponents of CCS and some Members of Congress have called for increased federal support for
building CO2 pipeline and storage infrastructure related to CCS. Others oppose investment in
CCS and prefer to focus climate and energy policy on renewable energy exclusively. CCS
technology and the extent of the federal role in development of the U.S. CCS industry may
continue to be of interest in the 118th Congress.
For Further Information
Angela C. Jones, Analyst in Environmental Policy
Ashley J. Lawson, Specialist in Energy Policy
CRS Report R44902, Carbon Capture and Sequestration (CCS) in the United States
CRS In Focus IF11501, Carbon Capture Versus Direct Air Capture
CRS Report R48033, Class VI Carbon Sequestration Wells: Permitting and State Program
Primacy
CRS In Focus IF11861, DOE’s Carbon Capture and Storage (CCS) and Carbon Removal
Programs
CRS In Focus IF11455, The Section 45Q Tax Credit for Carbon Sequestration

Defense Research and Development
S&T play an important role in national defense. DOD relies on a robust research, development,
test, and evaluation (RDT&E) effort to develop new military systems and improve existing
systems. Issues that may come before the 118th Congress regarding DOD’s S&T activities include
budgetary concerns, the effectiveness of programs to transition R&D results into fielded products,
and how DOD encourages innovation.

Department of Defense (DOD) Research, Development, Test, and
Evaluation
DOD spends more than $100 billion per year on RDT&E. In FY2022, enacted RDT&E funding
was $119.3 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. 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 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 various considerations, such as whether DOD has adequately
justified the expenditure or the need for 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

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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 118th Congress.
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 2020, some stakeholders 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 dual-use fields such as AI,
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
Marcy E. Gallo, Analyst in Science and Technology Policy
Kelley M. Sayler, Specialist in Advanced Technology and Global Security
CRS In Focus IF10553, Defense Primer: RDT&E
CRS In Focus IF11105, Defense Primer: Emerging Technologies
CRS Report R46458, Emerging Military Technologies: Background and Issues for Congress

DOD Innovation Capacity
R&D is a global enterprise, with the private sector generally driving technology development.
Some assert that DOD has been slow to react and adapt to this new reality, raising concerns that
the U.S. military may be unable to maintain its historical technological advantages. Congress and
the executive branch have adopted a number of reforms to address the perceived concerns,
including the reestablishment of the position of Under Secretary of Defense for Research and
Engineering, the expansion of other transaction authority, and the creation of new organizations
(e.g., the Defense Innovation Unit and the Air Force’s AFWERX) and programs (e.g., the Rapid
Innovation Program and the Accelerate the Procurement and Fielding of Innovative Technologies
pilot program). Many of these efforts will likely require sustained management focus and
oversight to ensure that DOD transforms into a more innovative, risk-tolerant R&D organization
that delivers new technologies to the warfighter in a timely and relevant manner. As Congress
considers the impact of these reforms and their effectiveness, it may examine any of several
issues, such as
•
•

•
•
•

the adequacy of DOD’s investments in RDT&E programs;
the sufficiency of DOD’s strategic planning as it relates to the development and
deployment of technologies deemed critical for national security, in particular
emerging technologies;
DOD’s ability to attract and retain scientific and technical talent;
how to measure the rate and extent of cultural change in innovation practices
within DOD;
the effectiveness of DOD’s collaborations and cooperation with other federal
agencies and allied nations in the development and implementation of

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•
•

technologies deemed critical for national security, in particular emerging
technologies;
the degree to which DOD is incorporating nontraditional contractors and small
businesses into the defense industrial base; and
how Congress can effectively balance its oversight responsibilities and the desire
for transparency and accountability with the need for DOD to respond flexibly
and nimbly to emergent opportunities.

For Further Information
Marcy E. Gallo, Analyst in Science and Technology Policy
CRS In Focus IF10834, Defense Primer: Under Secretary of Defense for Research and
Engineering

Energy, Minerals, and Mining
S&T issues related to energy, minerals and mining that may come before the 118th Congress
include biofuels, electricity transmission, offshore energy technologies, hydrogen, hydrogen
pipelines, critical minerals and materials, and seabed mining.

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 GHG emissions. Others regard
biofuels as potentially more harmful to the environment (e.g., air and water quality concerns),
more land-intensive, and prohibitively expensive to produce. The debate about biofuels is
complex, as policymakers consider numerous factors (e.g., feedstock cost and supply,
environmental impact of biofuels). The debate can be even more complicated because biofuels
may be produced using numerous biomass feedstocks and conversion technologies.
Congress has 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 supports domestic biofuel production R&D. Congress
has also established tax incentives for biofuels, including the sustainable aviation fuel credit and
the biodiesel credit.
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 began a new phase in 2023 with the EPA Administrator determining
the volume requirements in a multiyear rulemaking for 2023-2025. The RFS is under scrutiny for
various reasons, including concerns about EPA’s lifecycle GHG emissions modeling and
advanced biofuel pathway approval.
The 118th Congress may consider whether to modify existing biofuel policies, establish new
biofuel initiatives, or maintain the status quo. Other topics of potential congressional interest
include the development of a federal low-carbon fuel standard in lieu of or complementing the
RFS, and R&D and commercial production of sustainable fuels for aviation, shipping, and other
applications.

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For Further Information
Kelsi Bracmort, Specialist in Natural Resources and Energy Policy
CRS Report R43325, The Renewable Fuel Standard (RFS): An Overview

Electricity Transmission
The U.S. electricity transmission system (i.e., the grid) is of central importance to maintaining
reliable electricity supply across the country. The grid faces several challenges that could limit its
ability to deliver reliable and affordable electricity moving forward. Many transmission facilities
are at or near the end of their design lifetimes. Cyberattacks and physical attacks against the grid
appear to be on the rise. Extreme weather events can damage the grid or disrupt power flows
through it. Much of the transmission system is not optimally built to access wind and solar
energy, which are becoming a larger share of the national electricity supply.
Many of these challenges can be addressed by constructing new or replacement transmission
facilities or deploying new, innovative grid technologies (or a combination of both). Choices
about what kind of transmission infrastructure to build—and where to build it—are primarily
made by utility companies with the approval of state and local regulators. Regulators are often
balancing an interest in addressing transmission challenges with concerns about raising costs for
consumers, because the costs of new transmission infrastructure are primarily borne by electricity
customers.
The federal government has a role in some aspects of the grid. Mandatory reliability standards,
including cybersecurity and physical security protections, apply to most components of the
transmission system. Financial incentives for deploying innovative grid technologies are available
in those parts of the system under the jurisdiction of the Federal Energy Regulatory Commission
(FERC). FERC regulations also cover some aspects of planning new transmission facilities. IIJA
(P.L. 117-58) and IRA (P.L. 117-169) established several programs at DOE to support electricity
transmission development and modernization. Most of these are administered through DOE’s
Grid Deployment Office.
For Further Information
Ashley J. Lawson, Specialist in Energy Policy
CRS Report R47862, Electricity Transmission: What Is the Role of the Federal Government?
CRS Insight IN12074, Electric Grid Physical Security: Recent Developments
CRS Insight IN11981, Electricity Transmission Provisions in the Inflation Reduction Act of 2022

Offshore Energy Technologies
Technological innovations are key drivers of U.S. ocean energy development. They may facilitate
exploration of previously inaccessible resources, provide cost efficiencies, address safety and
environmental concerns, and enable advances in emerging sectors such as U.S. offshore
renewable energy. Private industry, universities, and government are all involved in ocean energy
R&D. At the federal level, both DOE and the Department of the Interior (DOI) support ocean
energy research.
With respect to U.S. offshore oil and gas, one ongoing interest for developers and federal
regulators is exploration of deepwater areas of the Gulf of Mexico. Industry interest in expanding
deepwater activities has prompted advances in drilling technologies and steps toward automated

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monitoring and maintenance. Government and industry seek to address concerns about safety and
resilience, including oil spill prevention, and security, including cybersecurity. Also of interest are
options for decommissioning offshore oil and gas infrastructure as wells reach the end of their
producing lifetimes. This could potentially include repurposing of assets for hydrogen
transportation or CCS, among other uses. Some companies operating in the Alaskan Arctic are
pursuing technologies (such as ice-resistant drilling units) to extend the drilling season beyond
the periods where sea ice is absent and are pursuing improvements to oil spill response capability
in Arctic conditions. DOE and DOI undertake and fund Arctic energy R&D, including through
DOE’s Arctic Energy Office.
Among renewable ocean energy sources, only wind energy has advanced to the point of
commercial application in U.S. waters. The Biden Administration announced a national goal to
deploy 30 gigawatts of offshore wind by 2030 and a related goal to deploy 15 gigawatts of
floating offshore wind by 2035. Wind energy resources have been identified in the Atlantic
region, the Pacific region, and offshore of the Gulf Coast. Other potential resources are offshore
of Alaska and in the Great Lakes. Identified priorities for offshore wind R&D include (1)
technology advancement for offshore wind plant; (2) improvements of resource and physical site
characterization; (3) environmental impact assessment and siting to reduce radar interference; and
(4) technology improvements in installation, electricity transmission and onshore grid integration,
operations and maintenance, and supply chain issues for the U.S. market. For offshore wind plant
technology advancement, the Biden Administration announced in September 2022 a Floating
Offshore Wind Shot with a goal of reducing the costs of floating technologies by more than 70%
by 2035. Another focus is building the domestic supply chain for offshore wind development,
including port infrastructure and manufacturing capabilities for turbine components and
installation and support vessels. As interest in offshore wind grows in the United States, some
stakeholders have expressed concerns about offshore wind projects’ potential impacts on the
marine ecosystem and associated species, including marine mammals, birds, and fishes. Congress
may continue to consider whether—and, if so, how—to support or incentivize development of
offshore wind and other ocean renewables, as well as how to assess the potential impacts these
technologies may have on the ocean ecosystem.
For Further Information
Laura B. Comay, Specialist in Natural Resources Policy
Corrie E. Clark, Specialist in Energy Policy
CRS Report R41153, Changes in the Arctic: Background and Issues for Congress
CRS Report R46970, U.S. Offshore Wind Energy Development: Overview and Issues for the
118th Congress
CRS Report R47894, Potential Impacts of Offshore Wind on the Marine Ecosystem and
Associated Species: Background and Issues for Congress
CRS In Focus IF12491, Vessel Construction for Offshore Wind Power Generation

Hydrogen
A future “hydrogen economy” using hydrogen as an energy carrier and fuel could offer an
alternative to today’s economy with its prevalent combustion of fossil fuels. Initially thought of as
a new technology for personal mobility services (e.g., cars) and high-value applications such as
provision of electric power during space flight, hydrogen now is receiving attention for industrial

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processes, heavy vehicles, forklifts, portable power, and buffering and balancing of electric
power.
Except for its use as an established industrial chemical (e.g., petroleum refining, ammonia
manufacture), the scope and scale of hydrogen for energy applications is limited to demonstration
scale or early deployment activities. IIJA (P.L. 117-58) authorized and funded the Regional Clean
Hydrogen Hubs—envisaged networks of hydrogen producers, consumers and infrastructure in a
common geography. DOE announced seven finalists for $7 billion in grants for Regional Clean
Hydrogen Hubs in October 2023. DOE announced a further $1 billion for a Demand-side Support
Initiative on July 5, 2023.
The 117th Congress incentivized hydrogen production that meets certain criteria. IRA (P.L. 117169) created a new tax credit for the production of “clean hydrogen.” The amount of the hydrogen
production tax credit (Internal Revenue Code Section 45V) can be up to $3 per kilogram
hydrogen, provided GHG emissions limits and wage and apprenticeship requirements are met.
The Treasury Department and Internal Revenue Service (IRS) published a notice of proposed
rulemaking on the implementation of the 45V tax credit on December 26, 2023.
Congress may consider the coordination and simplification of hydrogen and fuel cell programs.
Questions surround the implementation and oversight of the 45V credit, including how to
determine if the energy inputs used to manufacture the hydrogen will be counted as “clean,” how
to balance concerns about GHG emissions from electricity generation against the goal of
accelerating the development of hydrogen fuel and technology, and whether the uptake of the
production tax credits will be sufficient to support the development of Regional Clean Hydrogen
Hubs.
For Further Information
Martin C. Offutt, Analyst in Energy Policy
Lexie Ryan, Analyst in Energy Policy
Paul W. Parfomak, Specialist in Energy Policy
CRS Report R48196, Hydrogen Production: Overview and Issues for Congress
CRS Report R47487, The Hydrogen Economy: Putting the Pieces Together
CRS Report R47289, Hydrogen Hubs and Demonstrating the Hydrogen Energy Value Chain
CRS In Focus IF12514, DOE Appropriations for Its Hydrogen Program: FY2024, by Martin C.
Offutt
CRS Video WVB00579, Science and Technology Q&A: The Outlook for Hydrogen Fuel
CRS Video WVB00607, The Hydrogen Economy

Hydrogen Pipelines
IIJA (P.L. 117-58, §40315) authorized an $8 billion program of Regional Clean Hydrogen Hubs,
which would be centers of activity involving hydrogen production, delivery, and end use.
Supplying hydrogen from sources such as regional hubs to power plants, industrial facilities, and
vehicular fuel distribution centers could require the development of an expansive hydrogen
pipeline network. Shipping hydrogen by pipeline in the United States is not new, but the existing
pipeline network is small and located almost entirely along the Gulf Coast. The pipeline network
required to support a hydrogen-based U.S. energy strategy would be much larger. Establishing
such a network could pose technical challenges due to the chemical characteristics of hydrogen.

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Hydrogen molecules are the smallest of all molecules and, therefore, are more prone than
methane (the principal component of natural gas) to leak through joints, microscopic cracks, and
seals in pipelines and associated infrastructure. Hydrogen can also permeate directly through
polymer (plastic) materials, such as those typically used to make natural gas distribution pipes.
The presence of hydrogen can deteriorate steel pipe, pipe welds, valves, and fittings through a
variety of mechanisms, particularly embrittlement. Pipeline companies may use specialty steels or
may modify their infrastructure and put other measures in place to manage embrittlement risks.
Nonetheless, the potential for hydrogen embrittlement is a key safety consideration.
Some in Congress have called for federal initiatives to advance hydrogen pipeline-related
research and development (R&D). For example, the chairman of the Senate Energy and Natural
Resources Committee made the following statement at a 2022 committee hearing:
We will certainly need to build some new infrastructure dedicated solely to transporting
and storing hydrogen. There is also potential to adapt our country’s extensive natural gas
delivery network in the near-term to support a blend of hydrogen and natural gas.... More
work is needed to look at the safety and feasibility of these modifications.

In the 117th Congress, the Senate Committee on Appropriations (H.Rept. 117-394) encouraged
DOE to include hydrogen pipeline-related R&D in its plans for transitioning segments of the
economy to low-carbon fuels.
IIJA directs the Secretary of Energy to advance the safe and efficient delivery of hydrogen or
hydrogen-carrier fuels in pipelines, including by retrofitting existing natural gas pipelines
(§40313). Other legislative proposals, including H.R. 6494, H.R. 6510, H.R. 7655, H.R. 9323,
and S. 4983, would mandate studies to examine the potential for, and challenges associated with,
repurposing existing natural gas infrastructure to carry pure hydrogen or hydrogen blends. H.R.
7200 and S. 649 would mandate studies to synthesize the results from research, development, and
demonstration projects on materials for transporting hydrogen and hydrogen blends and to
determine outstanding research questions. H.R. 7073 would support technology demonstration
projects involving the pipeline transportation of hydrogen and hydrogen blends.
Executive agencies, such as the Department of Transportation’s (DOT’s) Pipeline and Hazardous
Materials Safety Administration, fund hydrogen pipeline research under existing research grant
programs and may examine hydrogen pipeline technical issues through advisory committees and
industry partnerships. Such activities may advance hydrogen pipeline design, operations, or safety
research and the development of standards, which could be incorporated into industry practices or
federal pipeline regulations.
For Further Information
Paul W. Parfomak, Specialist in Energy Policy
CRS Report R44201, DOT’s Federal Pipeline Safety Program: Background and Issues for
Congress
CRS Report R47289, Hydrogen Hubs and Demonstrating the Hydrogen Energy Value Chain

Fusion Energy
The federal government has supported fusion energy R&D for decades. In recent years,
congressional interest in fusion has grown in response to scientific progress by fusion researchers,
the emergence of a growing commercial fusion industry, and hope that future fusion power plants
can contribute to the nation’s electricity needs without emitting carbon dioxide—a GHG that
contributes to climate change.

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A fusion power plant would have a number of potential advantages. Unlike today’s fission-based
nuclear reactors, fusion does not require uranium or plutonium, whose use has raised concerns
about nuclear weapon proliferation and uranium imports from countries such as Russia. Fusion
reactors also pose no meltdown risk and create little radioactive waste. Unlike power plants based
on the combustion of fossil fuels, the operation of a fusion reactor would not directly emit carbon
dioxide. On the other hand, developing operational fusion energy systems remains technically
challenging.
Most federally funded fusion energy R&D is supported by the Fusion Energy Sciences program
of the DOE Office of Science. The program focuses on basic research, though in recent years it
has funded applied research, commercialization, and public-private partnerships. A priority for the
program is ITER (initially the International Thermonuclear Experimental Reactor), a fusion
energy research and demonstration facility under construction in France. ITER is an international
collaboration involving the United States, China, India, Japan, South Korea, Russia, and the
European intergovernmental organization Euratom. It has a history of budget and schedule
challenges. The total estimated U.S. share of the project’s cost is $6.5 billion, and full operations
are due to start in 2035. DOE plans to confirm a revised cost and schedule baseline during the
118th Congress. The DOE Advanced Research Projects Agency–Energy (ARPA-E) also supports
some fusion energy projects, along with other projects across the full range of energy
technologies.
In the DOE National Nuclear Security Administration, the Inertial Confinement Fusion program
seeks to use fusion science to improve stewardship of the U.S. nuclear weapons stockpile. The
program includes the National Ignition Facility (NIF), which demonstrated fusion ignition in
December 2022. (Ignition occurs when a fusion reaction releases more energy than was
consumed to initiate and maintain the reaction.) The demonstration of ignition at the NIF
increased interest in using related designs for fusion energy applications.
A new development in recent years is the emergence of a commercial fusion energy industry,
involving several dozen companies and announced private investment approaching $5 billion.
The approaches taken by the commercial fusion sector often use design strategies traditionally
seen as alternative. Most companies are targeting delivery of electricity to the grid by the mid2030s. Some observers consider that an ambitious goal.
In April 2023, after considering various options for the regulation of future commercial fusion
energy systems, the Nuclear Regulatory Commission voted to use the “byproduct material”
framework (10 C.F.R. Part 30). That approach would address any radioactive material present in a
fusion facility but not the detailed operation of the facility. The commercial fusion industry
generally considered this the least burdensome of the options under consideration.
Congress has taken several legislative actions regarding fusion energy in recent years, such as (1)
defining the term advanced nuclear reactor to include fusion reactors, which made fusion R&D
potentially eligible for various DOE nuclear energy programs previously limited to fission; (2)
directing the Fusion Energy Sciences program to place more emphasis on commercialization and
public-private partnerships and to support the design of a pilot plant in order to bring fusion to
commercial viability; and (3) providing supplemental appropriations for fusion-related
construction and equipment. Efforts in the 118th Congress may include oversight of DOE’s
implementation of these actions, oversight of budget and schedule issues with ITER, and
appropriations decisions about funding for fusion R&D.
For Further Information
Todd Kuiken, Analyst in Science and Technology Policy

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CRS In Focus IF12411, Fusion Energy
CRS In Focus IF12692, Department of Energy (DOE) Office of Science

Critical Minerals and Materials
The Energy Act of 2020 (Division Z of P.L. 116-260) amended national minerals and materials
policy and directed various federal agencies to engage in R&D, analysis and forecast, education
and workforce development, and other activities to ensure critical minerals and materials supply
to meet demand. IIJA (P.L. 117-58) amended or added directives and provided some
supplemental appropriations for federal agencies to advance critical minerals and materials
initiatives. Additional laws, including the CHIPS and Science Act (P.L. 117-167) and IRA (P.L.
117-169) included provisions that may increase demand for these critical minerals and materials.
Critical minerals are essential for the U.S. economy and national security, and are susceptible to
vulnerable supply chains. The U.S. Geological Survey (USGS) published a 2022 Critical
Minerals List of 50 minerals that were deemed critical based on past production and
consumption, and began prioritizing research and assessment of potential domestic critical
mineral resources. The USGS Earth Mapping Resources Initiative (EarthMRI) established and
funded by IIJA is working to complete a national assessment of critical mineral resources by
2031.
DOE published a 2023 Critical Materials List that forecast which materials would be critical for
energy technologies in the medium term (2025-2035). DOE categorized and considered these
energy technologies in developing the DOE list: vehicles, stationary storage, hydrogen
electrolyzers, solar energy, wind energy, nuclear energy, electric grid, solid state lighting, and
microchips. DOE is working on critical material initiatives across the department that focus on
research, development, and demonstration, as well as domestic production of these materials.
Congress may consider whether critical minerals and materials policy and initiatives by federal
agencies are sufficient to ensure sustainable supply chains in the future. Legislation introduced in
the 118th Congress would amend policy, programs, and appropriations for critical minerals and
materials initiatives.
For Further Information
Linda R. Rowan, Analyst in Natural Resources and Earth Sciences
Emma Kaboli, Analyst in Energy Policy
CRS Report R47982, Critical Mineral Resources: National Policy and Critical Minerals List
CRS Report R48005, Critical Mineral Resources: The U.S. Geological Survey (USGS) Role in
Research and Analysis
CRS Report R48149, Critical Minerals and Materials for Selected Energy Technologies
CRS Report R47034, Energy and Minerals Provisions in the Infrastructure Investment and Jobs
Act (P.L. 117-58)

Land-Based Mining and Mineral Processing
Two main types of land-based mining are surface and underground mining, used for accessing
mineral lodes at different depths and the type of minerals being extracted. Advances in mining
technology, such as by using advanced mapping technologies and virtually recreating mine sites,
have increased efficiency. Also, autonomous vehicles and drones have been deployed for both

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surveillance of mine sites and “exploration” of mineral resources. AI has also been deployed to
run predictive analytics for mineral ore “location,” as well as in predictive maintenance systems
to monitor equipment health and maintenance schedules on expensive mining equipment.
Mineral processing and recycling technologies have also advanced in recent decades, with a
particular focus on critical minerals. New mineral extraction technologies allow for the possibility
of processing older mine sites to extract critical minerals and rare earth elements. In addition,
domestic recycling capacity for many minerals has potential for expansion to meet increased
demand. For some technologies, such as electric vehicles, research into the recycling of their
components and batteries seeks to separate and reuse valuable mineral components.
Federal support of land-based mining and processing R&D is spread across multiple agencies and
departments. These include DOE, DOI, DOD, and others. The 117th Congress provided authority
in Section 10359 of the CHIPS and Science Act (P.L. 117-167) for the Director of NSF to make
grants for basic research to accelerate innovation to advance critical minerals and mining
strategies and technologies for improving domestic supply resilience.
For Further Information
Emma Kaboli, Analyst in Energy Policy
CRS Video WVB00699, Critical Minerals for Energy: Recycling and Alternatives
CRS Report R48149, Critical Minerals and Materials for Selected Energy Technologies

Seabed Mining
The transition to alternative energy technologies has been driving U.S. interest in securing a
domestic supply of critical minerals. Some scientists estimate that certain critical minerals, such
as cobalt and manganese, are more abundant in seafloor deposits than in land deposits. Most
global interest in deep-seabed mining in areas beyond national jurisdiction is focused primarily
on a 4.5-million-square-kilometer area of the Pacific seafloor located between Hawaii and
Mexico. This area of the Pacific is rich in polymetallic nodules, which contain nickel, manganese,
copper, zinc, cobalt, and other minerals. In tension with the apparent concentration of such
minerals is the technological challenge of extracting resources from such remote locations and the
debate about the impact of these techniques. The emergence of the seabed mining industry raises
questions about the potential impacts seabed mining may have on deep-sea ecosystems.
Government, industry, and universities are all involved in studying the potential environmental
impacts of seabed mining activities.
The 118th Congress may continue to consider whether additional authorities or funding may be
useful in researching and identifying seabed mineral resources on the U.S. outer continental shelf
as well as better understanding potential marine ecosystem impacts from future deep-seabed
mining in domestic or international waters. In the 118th Congress, some Members proposed a
moratorium on seabed mining until its potential impacts on the marine ecosystem are fully
understood and an international regulatory regime is in place. U.S. ocean mapping campaigns
may provide a baseline for understanding whether—and to what degree—deep-sea life is
vulnerable or resilient to human disturbance (e.g., seabed mining). Efforts in the 118 th Congress
may also include oversight of the rate at which federal agencies are mapping, exploring, and
characterizing certain areas of the U.S. seafloor and how these mapping efforts may contribute to
the identification of mineral resources that would serve U.S. national security interests.
For Further Information
Caitlin Keating-Bitonti, Specialist in Natural Resources Policy

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CRS In Focus IF12608, U.S. Interest in Seabed Mining in Areas Beyond National Jurisdiction:
Brief Background and Recent Developments
CRS Infographic IG10053, Seabed Mining in the Clarion-Clipperton Zone
CRS Report R47623, Frequently Asked Questions: Mapping of U.S. Ocean and Coastal Waters
CRS Report R47912, Outer Limits of the U.S. Extended Continental Shelf: Background and
Issues for Congress

Earth Sciences
Earth-science-related S&T issues before the 118th Congress include changes to the National
Oceanic and Atmospheri

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/crs%3AR47373. Public record. Not legal advice.
