91Â鶹¾«Æ·

The Honorable Mike Rounds 716 Hart Senate Office Building Washington, D.C. 20510

The Honorable Martin Heinrich 709 Hart Senate Office Building Washington, D.C. 20510

Dear Senators Rounds and Heinrich,

On behalf of the American Society for Microbiology (ASM), thank you for the opportunity to provide input on processes to accelerate the pace of American technical innovation. As one of the largest life science societies with more than 37,000 members, ASM’s mission is to promote and advance the microbial sciences. As microbial innovations drive the U.S. scientific enterprise forward, the voice of microbiologists is crucial to determining the best paths to accelerate the pace of American technical innovation, including in the critical emerging field of biotechnology. In our answers to your questions, we emphasize the importance of long term, meaningful federal investment for biotechnology research and ways Congress can invest in data infrastructure and workforce pipelines to accelerate American science. 

How should the United States achieve the goal of accelerating the pace of scientific innovation? What roles should be played by Congress, the administration, industry, civil society and academia? (Question #1)

Federal funding fuels the research that drives discovery, spurs innovation and improves the health of animals, humans, the environment and the economy. Given the diverse nature of microbiology, 91Â鶹¾«Æ·works to ensure robust and sustained funding for microbiology research across a range of federal agencies. This includes, but is not limited to, supporting federal research funding at the National Institutes of Health (NIH), the National Science Foundation (NSF), the Department of Energy’s (DOE) Office of Science and the Department of Agriculture (USDA). Funding for biotechnology research and commercialization at these agencies is vital for creating jobs and accelerating the pace of scientific innovation.

The NSF plays a pivotal role in advancing scientific knowledge and accelerating innovation across a broad spectrum of disciplines, including microbiology. Support for NSF, including the Directorate for Biological Sciences, enables new discoveries and biotechnology solutions to advance the bioeconomy. Microorganisms are used in biotechnology for a variety of applications, including the production of biofertilizers and other biobased materials. The NSF supports projects that lead to the development of novel microbial technologies translated into practical applications. This includes the BioFoundries program, which supports user facilities that enable researchers to design, create, test and streamline the development of tools and products to accelerate research to advance the bioeconomy. Without investments in microbial research at NSF, U.S. leadership and competitiveness will decrease on the international stage. 

In order to maintain U.S. competitiveness in emerging technologies, Congress must also support research at the DOE Office of Science. This includes the Biological and Environmental Research (BER) program within the Office of Science, which supports scalable engineering and environmental mechanisms that use microbes to solve energy and environmental problems of the 21st Century. Investing in the BER program allows researchers to harness the power of microbes to develop biofuels and other valuable bioproducts that promote scientific discovery and innovation. The Bioenergy Research Centers within the Office of Science recently reached a milestone by registering more than 1,000 inventions through their shared mission to support the domestic bioeconomy, including the production of plant-based pharmaceuticals and plastics and affordable organic fungicides. 91Â鶹¾«Æ·also encourages Congress to increase support for the Joint Genome Institute, which provides genome sequencing and computational analysis to the research community to enable studies of complex biological and environmental systems. 

91Â鶹¾«Æ·also supports the recommendation of the National Security Commission on Emerging Biotechnology (NSCEB) to establish Centers of Biotechnology within the Department of Energy National Laboratories to support critical research and development infrastructure for emerging biotechnology and encourage high-risk, high-reward biotechnology research projects.

Lastly, Congress should also provide robust funding at the USDA for research and development of biotechnological advancements. Several programs, like the Agriculture and Food Research Initiative and the Biotechnology Risk Assessment Grants program, specifically focus on biotechnology research in areas like plants, animals, insects and microbes. Investing in research at the USDA supports the agriculture sector and rural economies through the production of bioproducts such as biofertilizers, biocements and biochar.  

How can America build the world’s most powerful scientific data ecosystem to accelerate American science? (Question #6)

The biological sciences are hampered by a lack of standardized data formats and data infrastructure to store and share biological data. Advances in computational biology mean that researchers are generating more data than ever. At the same time, artificial intelligence tools are unable to analyze biological data when data is not standardized. Thanks to support from Congress, the Department of Energy’s National Microbiome Data Collective (NMDC) is a strong example of standardized biological data. The NMDC works to support a Findable, Accessible, Interoperable and Reusable (FAIR) microbiome data-sharing network by providing a standardized platform and training for scientists to access, analyze and share data more effectively. 91Â鶹¾«Æ·encourages Congress to invest in data infrastructure to store and share biological data within the parameters of consensus-driven biosafety guidelines.

A from the Society for Industrial Microbiology and Biotechnology recommends creating a database, known as a precompetitive knowledge base, for researchers and industry to share what works and does not work in developing bio-based products. This would allow industry to save limited research and development dollars for products that have not already been proven to be viable. 91Â鶹¾«Æ·supports the creation of this database and recommends providing $10 million over 4 years to establish it, with the DOE serving as the lead agency.

How can we radically increase the scale, speed and impact of scientific collaboration across disciplines, institutions and sectors? (Question #9)

Congress must support additional coordination and government-wide bioeconomy strategy to assess and understand strengths and gaps in bioeconomy research, development, infrastructure and domestic supply chain resiliency. 91Â鶹¾«Æ·supports the passage of the National Biotechnology Initiative Act (H.R. 2756/S. 1387), which would create a National Biotechnology Initiative, an interagency committee and a National Biotechnology Coordination Office located within the White House. A coordinated strategy is essential to ensuring the U.S. increases the scale, speed and impact of scientific collaboration and remains a global leader in biotechnology.  

Currently, innovations that impact both human and animal health struggle to obtain funding due to the scope of research funding at federal agencies. Incorporating a One Health framework for biotechnology research to include human, animal and environmental research funding would help overcome these barriers and promote cross-cutting research to advance the U.S. bioeconomy. 

91Â鶹¾«Æ·supports the NSCEB’s recommendation to create a dedicated office within the Department of Commerce to proactively identify emerging risks and oversight gaps in biotechnology, support basic and applied research in biosecurity and biosafety, promote the development of modernized tools and best practices and provide greater coordination and oversight of federal biosafety, biosecurity and responsible research practices.   

In order to cut the time from discovery to deployment by a factor of 10, what changes are needed in the process of scientific innovation, such as in the regulatory ecosystem, scientific funding models, education and workforce pipelines and the resources that constitute the scientific supply chain? (Question #10)

The USDA, EPA and FDA play a key role in ensuring the safety of biotechnology products through the Coordinated Framework for the Regulation of Biotechnology. Regular updates and revisions to the Coordinated Framework are necessary to keep up with biotechnological innovation. 91Â鶹¾«Æ·supports the NSCEB’s recommendation to create simple pathways to market, exempt familiar products from unnecessary regulations and regulate products created using biotechnology the same as their conventionally made counterparts. The National Biotechnology Initiative Act (H.R. 2756/S. 1387) directs federal agencies to streamline regulatory processes to ease the regulatory burden for types of biotechnology products that have become well understood by regulators. 

Congress must also support workforce training and development programs at federal agencies to prepare the American workforce for future bioeconomy and biomanufacturing jobs. The U.S. bioworkforce is currently underdeveloped and unable to meet the current demand for technical expertise. Biotechnology research and development, along with a highly trained domestic biotechnology workforce, is essential to power innovations and growth in the industry. This includes training in basic and applied microbiology research to support bioprocess engineering, biofuel production and biobased materials development. 

Conclusion

91Â鶹¾«Æ·thanks Senator Rounds and Senator Heinrich for the opportunity to provide input on accelerating the pace of American technical innovation, particularly in the critical emerging biotechnology field. We look forward to working with you to empower scientists with the tools they need to spur innovation. If you have any questions, please contact Nick Cox, Senior Federal Affairs Officer, at ncox@asmusa.org.

Sincerely,


Amalia Corby
Director of Federal Affairs
American Society for Microbiology