ASM Provides Bioeconomy Priorities to Sen. Gillibrand
| The Honorable Senator Kirsten E. Gillibrand 478 Russell Senate Office Building Washington, D.C. 20201 |
RE: Request for Information (RFI) - Congressional Bioeconomy Priorities
Dear Senator Gillibrand,
On behalf of the more than 32,000 members of the American Society for °®¶¹´«Ã½ (ASM), thank you for the opportunity to provide input on federal bioeconomy policy priorities. As one of the largest life science societies, ASM’s mission is to promote and advance the microbial sciences. Microbial processes such as fermentation are the foundation of the bioeconomy, and microbiologists engage with the bioeconomy, from basic research and bioengineering, to biopharmaceutical development and microbial product innovation. ASM’s membership includes experts on both health and non-health related microbial research, allowing us to give holistic feedback on cross-sector, interdisciplinary issues that affect research and innovation. As microbial innovations drive the U.S. bioeconomy forward, the voice of microbiologists is crucial to determining future bioeconomy priorities.
What existing federal programs should be considered as part of a congressional bioeconomy agenda? Which government programs need more support, improved and modernized authorizations and other support?
Given the breadth of the bioeconomy, most federal agencies and departments play some role in the bioeconomy—a from the National Academies of Science, Engineering and Medicine attempts to define the U.S. bioeconomy, and the 2022 bioeconomy Executive Order () names relevant agencies and programs. ASM supports increased research funding, coordination and a streamlined regulatory process for bioeconomy-related products.Support for the basic research about microbial processes and functions, which underlies core parts of the bioeconomy, has not received federal investment commensurate with the goals laid out in EO 14081. Annual appropriations have failed to meet the ambitions of the CHIPS and Science Act of 2022. Actual funding levels for the National Science Foundation (NSF), the Department of Energy’s (DOE) Office of Science and the National Institute of Standards and Technology (NIST) continue to lag behind authorization levels. ASM supports increasing funding for programs that support the bioeconomy, as well as the designation of a coordinating body for bioeconomy research and development within the executive branch.
Microbiome research is one example of a promising area of research that needs additional support and coordination at the federal level. The microbiome refers to communities of microorganisms—such as bacteria, archaea, viruses, fungi, prions, protozoa and algae—that live on, in and around people, plants, animals, soil, oceans and the atmosphere. These microbial communities play important roles in everything from human growth and development, to food production and climate change. ASM supports further investments and federal coordination of microbiome research and development to fully harness the power of the microbiome and develop microbiome products and treatments, such as microbiome therapeutics.
Microbiome research and innovation is funded by all major federal science agencies—for example, aquatic microbiome research is funded by the National Oceanic and Atmospheric Administration (NOAA), NSF and the Environmental Protection Agency (EPA); agricultural microbiome research and applications are funded by the U.S. Department of Agriculture (USDA), NSF and DOE; human microbiome research is funded by the Department of Defense, National Institutes of Health and the Food and Drug Administration (FDA). This research generates large amounts of data on microbial roles and functions, many with potential overlaps. However, the lack of systematization and coordination among agencies and projects creates inefficiencies in data sharing. ASM has long advocated for a renewed charter of the Microbiome Interagency Working Group and the Interagency Microbiome Strategic Plan, which ended in 2022. As you consider new legislation to support the bioeconomy, we would be happy to provide you with legislative language and additional information regarding microbiome coordination and its potential impact on the bioeconomy.
U.S. biotechnology regulations are based on a patchwork of laws, with the USDA, the EPA and the FDA sharing the responsibility of enforcing biotechnology regulations. Consistent and sustained improvements to the Coordinated Framework for the Regulation of Biotechnology established by these agencies are required. While the EPA, FDA and USDA have made efforts to clarify this framework, such as the release of the new online tool to assist in navigation, efforts to continuously update and revise the Coordinated Framework are necessary to keep up with biotechnological innovation. As part of EO 14081, the EPA, USDA and FDA published a by December 2024 after receiving stakeholder feedback on the current challenges of the framework. These updates come 7 years after the last update in 2017, highlighting the need for more frequent updates as technology advances.
Bills introduced in the House () and Senate () aim to increase clarity and streamlining of biotechnology regulations by establishing an interagency Biotechnology Oversight Coordination Committee. ASM supports these bills and urges Congress to include these provisions in a bioeconomy legislative package.
What new government programs should be considered by Congress?
While EO 14081 provided initial directives toward a coordinated approach to the U.S. bioeconomy, there is still a need for a government-wide bioeconomy strategy and coordination. Additional coordination is needed to assess and understand strengths and gaps in bioeconomy research, development, infrastructure and domestic supply chain resiliency.ASM encourages Congress to consider cross-sector, interagency funding streams that optimize microbial research and product development. Currently, innovations that impact both human and animal health struggle to obtain funding due to restrictions on the work human health and non-health agencies can fund. Adapting a One Health framework for biotechnology research funding, which would incorporate linked human health and animal health and environmental research and products, would overcome these barriers and promote cross-cutting research to advance the U.S. bioeconomy.
There is increasing need for accessible data and sustained data resources. Availability and accessibility of federally funded research data related to the bioeconomy would lower production costs, increase scalability and speed up commercialization of bio-products, services and processes. The Interagency Working Group on Data for the Bioeconomy released a , which recommends long-term funding mechanisms, data standards, a biodata catalog, data security practices, bioworkforce development and cross-agency coordination. The report also identifies priority projects for further research and development. ASM supports legislation to fund long-term data infrastructure for the bioeconomy and to authorize the recommendations of the Interagency Working Group on Data for the Bioeconomy.
What sectors and aspects of the bioeconomy need significant capital investment? How much?
There is a need for significant investments in databases to support the bioeconomy, covering both federally and non-federally funded bioeconomy research. These databases would streamline and accelerate biotechnology commercialization and manufacturing. Databases and their management require consistent and sustained funding to avoid becoming defunct. A recent by the Society for Industrial °®¶¹´«Ã½ and Biotechnology and Schmidt Sciences outlined the challenges and benefits of establishing a pre-competitive knowledgebase with users and contributors across academia, industry and government. Such a program is estimated to cost $10 to $20 million per year over 4 years for the development, and $10 million per year to sustain and manage the pre-competitive knowledgebase.Investments in the study of human, animal, environmental and the built-environment microbiomes can inform and advance many biotechnological innovations. Current federal funding for microbiome research and development is lacking and non-government capital investments into microbiome-focused companies have decreased since 2021, while funding needs in the space have continued to grow.
Where is the U.S. especially falling behind in terms of bioeconomy competitiveness compared to rival states? How can this best be remedied?
The U.S. is falling behind in bioeconomy competitiveness. Between the barriers to commercialization, lack of federal funding, high demand for technical expertise and efforts to restrict our ability to defend ourselves against biotechnological threats, massive investments and a national strategy for the bioeconomy are needed. Much of the federal bioeconomy competition focus is on China, but India and countries in Europe and Latin America have national bioeconomy strategies and legislation, potentially leaving the U.S. even further behind.To increase commercialization of biotechnology innovations and maintaining U.S. competitiveness, the U.S. needs more facilities geared toward scaling and optimizing these products, to streamline the commercialization process and to further clarify the regulatory framework for biotechnology. Sustained and consistent federal funding is needed for research and development of both basic and applied science, specifically concerning microbial products and microbiome research. Investments are also needed in biomanufacturing infrastructure to develop hubs for biomanufacturing.
The U.S. bioworkforce is underdeveloped and unable to meet the current demand for technical expertise. The U.S. needs more accessible technical training outside of 4-year institutions, as many jobs do not require a 4-year degree. Collaborations between industry and academia would allow students to gain experience and create a pipeline into the bioworkforce after receiving their degree.
The best defense against other countries’ bioweaponry is to advance our own research and countermeasures. Current proposals to ban gain-of-function research would impair our ability to defend ourselves internationally and domestically, as this technology is used in a variety of research areas, including vaccine development. Research on disease transmission that supports our ability to understand disease spillover from agricultural animals and wildlife to humans also falls within this broad category. More so, these proposals could further restrict the microbial sciences by banning foundational and applied research dedicated to understanding microbial mechanisms and processes. A 2023 report by ASM’s American Academy of °®¶¹´«Ã½ provides recommendations for enhancing safety and transparency surrounding gain-of-function research.
In conclusion, ASM thanks Senator Gillibrand for the opportunity to give input on federal bioeconomy policy priorities. We appreciate Senator Gillibrand’s commitment to the bioeconomy and her support of the Bioeconomy Research and Development Act as part of the CHIPS and Science Act of 2022. We would be happy to assist in further development of Congressional bioeconomy priorities. If you have any questions, please contact Nicole Zimmerman, Senior Specialist, Federal Affairs at nzimmerman@asmusa.org.
Sincerely,
Amalia Corby
Director of Federal Affairs
American Society for °®¶¹´«Ã½
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