ASM Responds to National Biotechnology Initiative RFI
January 20, 2023
Dr. Alondra Nelson
Office of Science and Technology Policy
1650 Pennsylvania Avenue, NW
Washington, D.C. 20501
Federal support for basic research has generated some of our most important scientific discoveries, and this has enabled researchers to use microbes to address complex energy and environmental problems, to prevent and combat disease and to increase agricultural productivity. The federal government has also created incentives for translation of foundational research to innovative products. However, if the U.S. wishes to fully compete in the global bioeconomy, Congress and the Administration must address the existing and evolving barriers to innovation by increasing support for transdisciplinary research, managing vast amounts of data and demystifying biotechnology regulation and oversight.
ASM appreciates the engagement of Congress and the Administration with the research and innovation communities as they seek to expand and advance the bioeconomy, and we have provided responses to several questions in the RFI below.
Microbiome is one area of foundational research with the potential to advance human, animal and environmental health through the bioeconomy. More than 20 federal agencies support research in which microbiomes are known to play a critical role, and their investment has led to biotechnology breakthroughs. Notably, human microbiome research advanced significantly under the Human Microbiome Project (HMP), which was funded through the National Institutes of Health’s (NIH) Common Fund, a dedicated, trans-NIH funding mechanism. Launched in 2007, the HMP was tasked by the NIH with creating resources and methods that link interactions between humans and their microbiomes to health-related outcomes. Thanks to this dedicated investment at NIH, epidemiology and model systems can now identify associations between changes in the microbiome and conditions ranging from autism to cancer, to the efficacy of drugs used to treat cardiac conditions, to the impact of gut microbiome on immunity and mental health.
This foundational work directly connects to recent advances in human health. In November 2022, the Food and Drug Administration (FDA) approved the first fecal microbial transplant (FMT) therapy to treat Clostridium difficile (C. diff) infection. FMT therapy is possible because of the investment in basic, translational and clinical research into the microbiome and the innovative use of microbes to address a serious and costly condition affecting as many as 500,000 Americans every year.
The HMP created a toolbox for understanding individual microbes in the context of systems and the ecosystems in which they live. Likewise, we need a similar movement that reaches across sectors, including agriculture. Farmers and scientists apply similar techniques to characterize, monitor and manipulate the microbiome of plants, animals and soil to increase agricultural production and maintain ecosystems. For example, researchers are studying honeybee gut microbiota, with the goal of supporting pollinator health and their integral role in food production. This has led to advancements such as the first vaccine to protect honeybees against American foulbrood, an aggressive bacterial disease. However, research in this area is stymied by inadequate federal funding levels for agricultural research and the absence of microbiome data systems that integrate multi-omic microbiome data across sectors.
Human and animal therapeutics, microbial inoculants, carbon capture and industrial applications of biomanufacturing are burgeoning sectors that incorporate microbiome research and are economically essential to the U.S. scientific enterprise. As science advances and research accelerates, the need for interagency coordination has grown. ASM strongly recommends that OSTP renew the charter of the federal Microbiome Interagency Working Group to assess the current state of microbiome research and to work on a new Interagency Strategic Plan for Microbiome Research, which could help ensure microbiome research and other new promising areas receive consistent attention and support in the future. A sustained effort to coordinate microbiome research across agencies would increase efficiency and collaboration and catalyze applications of microbiome research.
The federal government should also consider mechanisms that fund academic microbiome centers of excellence and microbiome center consortia that support transdisciplinary collaboration, and that do not prohibit collaboration between human and non-human research. Ad-hoc networks of microbiome centers have attempted to regularly convene researchers to promote the common adoption of data standards and ethical guidelines as the field of microbiome science moves from discovery to translation. The centers and consortia are supported by a patchwork of institutional, federal and private sources of funding, each with their own administrative requirements, timelines and restrictions. They struggle with finding consistent support for the vital work of convening and coordinating their members due to the lack of sustained funding for transdisciplinary collaboration. Although microbiome research is funded at the institutional and grant levels by nearly every federal science agency, there are barriers to funding transdisciplinary activities across federal science agency siloes, which in turn hinders scientific discovery.
The President’s recent Executive Order on Advancing Biotechnology and Biomanufacturing specifically notes the need to foster a biological data ecosystem that advances innovative solutions in health, energy, climate change and food security. As noted in the previous section, the unique, interdisciplinary nature of microbiome research, which spans 20 federal agencies and four National Laboratories, can serve as a model in this area.
While omics technologies are powerful, they must be employed in a way in which data can be effectively shared and utilized by other groups, enabling data comparison and analysis across diverse ecosystems and microbial communities. The National Microbiome Data Collaborative (NMDC) is a model that can be applied to other disciplines. The long-term vision of the NMDC is to support microbiome data exploration through a sustainable data discovery portal that promotes open science and shared ownership. Established by the Department of Energy Office of Science in 2019, the NMDC prioritizes collaboration, going beyond infrastructure for data collection to grow a pipeline of researchers who understand the importance of data sharing and collaboration. Increased support for the NMDC and similar programs such as AgBioData at USDA will also support the goals of increasing access to federally funded research by providing a portal to vetted multi-omic microbiome data across sectors.
Newly authorized and funded partnerships and collaboration between public health and academic and research institutions will enable cutting edge science in research institutions to swiftly flow to the front lines of public health, leveraging the strengths of both systems. ASM has championed significant investment in CDC’s Advanced Molecular Detection Program (AMD) to improve innovation in pathogen genomics, molecular epidemiology and bioinformatics. Targeting evolving pathogens with AMD, we can develop more effective vaccines and more accurate laboratory tests. The importance of the AMD program and the unique partnerships supported by this program has only grown in the wake of the COVID-19 pandemic.
Expanding training and increasing the diversity of problem solvers and innovators around microbial processes also will expand the breadth of possible solutions. The implementation of Title V of the CHIPS and Science Act will play a key role in diversifying access to biomanufacturing and biotechnology jobs, and OSTP should consider how these provisions can apply to the broader bioeconomy workforce. This includes identifying and addressing cultural and institutional barriers to the recruitment, retention and advancement of women and underrepresented minorities in all STEM careers.
The current model for sustaining the network cannot meet the extraordinary operations costs of these unique facilities. Absent a global effort to deploy qualified experts to ensure that these facilities meet the highest possible standards, the global proliferation of biocontainment laboratories now underway increases the risk of accidental release of dangerous pathogens and threatens misuse by nefarious actors.
On a more practical level, basic and applied research often depends on having access to highly specialized equipment and instrumentation; routine service and maintenance of these critical resources is hampered by the inability of service personnel to easily enter the biocontainment space. Similarly, the need for comprehensive documentation, record keeping and complete external audit of records that is required by the Food and Drug Administration makes the conduct of well-documented studies to demonstrate the efficacy of candidate vaccines and therapeutics in laboratory animals extremely challenging.
Successful operation of biocontainment laboratories to preserve national security will require federal support to increase the scientific workforce as well as the next generation of skilled building engineers and safety officers who are adept at managing the unique requirements of these complex facilities. Collectively, the workforce associated with biocontainment laboratories requires a major investment by universities that are home to this critical national infrastructure, and the federal government should support the infrastructure needed to carry out this important work.
In addition to providing the necessary financial support for the operations of these laboratories and for training the workforce, there is a need for scientific diplomacy to ensure that these laboratories are being set up around the world safely. The U.S. leads the world in biosafety and biosecurity measures, but to ensure global health security, we must have better channels and mechanisms for lending our expertise, within national security parameters, to ensure that other countries are adhering to the highest possible standards.
The microbial sciences are truly a global ecosystem. Microbes know no borders, and it is imperative that we consider this when committing resources and developing tools to addressing infectious diseases, antimicrobial resistance and emerging threats.The U.S. should seek international partnership to ensure appropriate oversight of data sharing, biosafety and biosecurity at home and abroad. Policymakers should consider how our current positions on international collaboration impact the long-term growth and security of the U.S. bioeconomy.
The tools, technologies and applications of the bioeconomy are topics of sustained international interest, yet the °®¶¹´«Ã½ States has not ratified the Convention on Biological Diversity (CBD). This limits the U.S.’s ability to fully participate in decisions regarding global research and development, in particular affecting polices under the Nagoya Protocol and the Cartagena Protocol on Biodiversity. Decisions adopted at the CBD may affect the strategic competitiveness of biotechnology researchers and companies, including how and where they can operate, as well as the use of their applications and products.
In closing, federally funded basic research has shown how microbes can form the basis of a strong bioeconomy. Microbes have a legacy of providing products for society, especially when one considers their impact on the food, beverage, pharmaceutical, biotechnology, wastewater treatment, chemical and other industries. Despite these advances, consistent support for transdisciplinary science and scaling of new technologies remains challenging. Thank you for the opportunity to comment on these critical issues. ASM and our members look forward to supporting the implementation of the National Biotechnology and Biomanufacturing Initiative. If we can be of further assistance, please contact Amalia Corby, ASM Senior Federal Affairs Officer at acorby@asmusa.org.
Sincerely,
Allen D. Segal
ASM Chief Advocacy Officer
Dr. Alondra Nelson
Office of Science and Technology Policy
1650 Pennsylvania Avenue, NW
Washington, D.C. 20501
RFI Response: National Biotechnology and Biomanufacturing Initiative
°®¶¹´«Ã½ (ASM) appreciates the opportunity to respond to the White House Office of Science and Technology Policy’s recent request for information regarding the National Biotechnology and Biomanufacturing Initiative. With more than 30,000 members in the U.S. and around the world, ASM’s mission is to promote and advance the microbial sciences. Our members include basic, translational and clinical researchers with expertise in genomic science and related biotechnologies that contribute to clean energy development, public health and the burgeoning bioeconomy. Microbial research is foundational to the bioeconomy.Federal support for basic research has generated some of our most important scientific discoveries, and this has enabled researchers to use microbes to address complex energy and environmental problems, to prevent and combat disease and to increase agricultural productivity. The federal government has also created incentives for translation of foundational research to innovative products. However, if the U.S. wishes to fully compete in the global bioeconomy, Congress and the Administration must address the existing and evolving barriers to innovation by increasing support for transdisciplinary research, managing vast amounts of data and demystifying biotechnology regulation and oversight.
ASM appreciates the engagement of Congress and the Administration with the research and innovation communities as they seek to expand and advance the bioeconomy, and we have provided responses to several questions in the RFI below.
Harnessing Biotechnology and Biomanufacturing R&D To Further Societal Goals
A strong bioeconomy will have a profound and lasting positive impact on human and animal health, air, soil and water quality, food production and national security across the °®¶¹´«Ã½ States and around the world. It has potential to create new sources of income for families and communities, possibly tens of millions of jobs nationwide, yield new and unique products, as well as sustainable replacements for high value products from resources that are often considered wastes. Attempts to quantify and assign value to the bioeconomy will be inaccurate without a consensus definition of bioeconomy, bioproducts and biomanufacturing, and a regulatory and funding environment consistent with a national bioeconomy and biomanufacturing strategy. Further, the value of the bioeconomy may be enhanced or hindered by legislation and regulatory policies, impacting both the investments and the return on investments.Microbiome is one area of foundational research with the potential to advance human, animal and environmental health through the bioeconomy. More than 20 federal agencies support research in which microbiomes are known to play a critical role, and their investment has led to biotechnology breakthroughs. Notably, human microbiome research advanced significantly under the Human Microbiome Project (HMP), which was funded through the National Institutes of Health’s (NIH) Common Fund, a dedicated, trans-NIH funding mechanism. Launched in 2007, the HMP was tasked by the NIH with creating resources and methods that link interactions between humans and their microbiomes to health-related outcomes. Thanks to this dedicated investment at NIH, epidemiology and model systems can now identify associations between changes in the microbiome and conditions ranging from autism to cancer, to the efficacy of drugs used to treat cardiac conditions, to the impact of gut microbiome on immunity and mental health.
This foundational work directly connects to recent advances in human health. In November 2022, the Food and Drug Administration (FDA) approved the first fecal microbial transplant (FMT) therapy to treat Clostridium difficile (C. diff) infection. FMT therapy is possible because of the investment in basic, translational and clinical research into the microbiome and the innovative use of microbes to address a serious and costly condition affecting as many as 500,000 Americans every year.
The HMP created a toolbox for understanding individual microbes in the context of systems and the ecosystems in which they live. Likewise, we need a similar movement that reaches across sectors, including agriculture. Farmers and scientists apply similar techniques to characterize, monitor and manipulate the microbiome of plants, animals and soil to increase agricultural production and maintain ecosystems. For example, researchers are studying honeybee gut microbiota, with the goal of supporting pollinator health and their integral role in food production. This has led to advancements such as the first vaccine to protect honeybees against American foulbrood, an aggressive bacterial disease. However, research in this area is stymied by inadequate federal funding levels for agricultural research and the absence of microbiome data systems that integrate multi-omic microbiome data across sectors.
Human and animal therapeutics, microbial inoculants, carbon capture and industrial applications of biomanufacturing are burgeoning sectors that incorporate microbiome research and are economically essential to the U.S. scientific enterprise. As science advances and research accelerates, the need for interagency coordination has grown. ASM strongly recommends that OSTP renew the charter of the federal Microbiome Interagency Working Group to assess the current state of microbiome research and to work on a new Interagency Strategic Plan for Microbiome Research, which could help ensure microbiome research and other new promising areas receive consistent attention and support in the future. A sustained effort to coordinate microbiome research across agencies would increase efficiency and collaboration and catalyze applications of microbiome research.
The federal government should also consider mechanisms that fund academic microbiome centers of excellence and microbiome center consortia that support transdisciplinary collaboration, and that do not prohibit collaboration between human and non-human research. Ad-hoc networks of microbiome centers have attempted to regularly convene researchers to promote the common adoption of data standards and ethical guidelines as the field of microbiome science moves from discovery to translation. The centers and consortia are supported by a patchwork of institutional, federal and private sources of funding, each with their own administrative requirements, timelines and restrictions. They struggle with finding consistent support for the vital work of convening and coordinating their members due to the lack of sustained funding for transdisciplinary collaboration. Although microbiome research is funded at the institutional and grant levels by nearly every federal science agency, there are barriers to funding transdisciplinary activities across federal science agency siloes, which in turn hinders scientific discovery.
Data for the Bioeconomy
Data is fundamental to the bioeconomy, and ASM supports the federal government’s ongoing efforts to advance open access to federally funded research outcomes and harmonization efforts to better share and communicate research results. Improved data coordination between individual research groups and national databases is necessary for broad data utilization. Data harmonization across fields is needed as well and will be necessary to build consensus on research and data collection protocols.The President’s recent Executive Order on Advancing Biotechnology and Biomanufacturing specifically notes the need to foster a biological data ecosystem that advances innovative solutions in health, energy, climate change and food security. As noted in the previous section, the unique, interdisciplinary nature of microbiome research, which spans 20 federal agencies and four National Laboratories, can serve as a model in this area.
While omics technologies are powerful, they must be employed in a way in which data can be effectively shared and utilized by other groups, enabling data comparison and analysis across diverse ecosystems and microbial communities. The National Microbiome Data Collaborative (NMDC) is a model that can be applied to other disciplines. The long-term vision of the NMDC is to support microbiome data exploration through a sustainable data discovery portal that promotes open science and shared ownership. Established by the Department of Energy Office of Science in 2019, the NMDC prioritizes collaboration, going beyond infrastructure for data collection to grow a pipeline of researchers who understand the importance of data sharing and collaboration. Increased support for the NMDC and similar programs such as AgBioData at USDA will also support the goals of increasing access to federally funded research by providing a portal to vetted multi-omic microbiome data across sectors.
Newly authorized and funded partnerships and collaboration between public health and academic and research institutions will enable cutting edge science in research institutions to swiftly flow to the front lines of public health, leveraging the strengths of both systems. ASM has championed significant investment in CDC’s Advanced Molecular Detection Program (AMD) to improve innovation in pathogen genomics, molecular epidemiology and bioinformatics. Targeting evolving pathogens with AMD, we can develop more effective vaccines and more accurate laboratory tests. The importance of the AMD program and the unique partnerships supported by this program has only grown in the wake of the COVID-19 pandemic.
Biotechnology and Biomanufacturing Workforce
Federal, state and local governments can play a role in educating the general public and future workforce on the goals and societal benefits of a strong bioeconomy. The technical foundation of the bioeconomy will require a workforce with significant training in STEM-intensive fields. The success of the bioeconomy will also depend on a workforce with capacity, interest and ability to be part of interdisciplinary and collaborative teams that span field, laboratory and computational settings. As part of ASM’s commitment to connecting the clinical microbiology laboratories with the use of technology in public health, we have established a training program for clinical microbiologists in genomic sequencing technology to both strengthen the workforce and support partnerships with public health laboratories.Expanding training and increasing the diversity of problem solvers and innovators around microbial processes also will expand the breadth of possible solutions. The implementation of Title V of the CHIPS and Science Act will play a key role in diversifying access to biomanufacturing and biotechnology jobs, and OSTP should consider how these provisions can apply to the broader bioeconomy workforce. This includes identifying and addressing cultural and institutional barriers to the recruitment, retention and advancement of women and underrepresented minorities in all STEM careers.
Reducing Risk by Advancing Biosafety and Biosecurity
Unique and critical components of the national bioeconomy are those which deal with biodefense and mitigating the risk to public health and national security arising from emerging pathogens such as Ebola virus and antibiotic resistant microbes. The national network of biocontainment laboratories plays an indispensable role in our ability to address these dangerous threats. ASM and its members have become increasingly concerned about the sustainability of this important infrastructure given the high operational costs and the need for a highly trained workforce. We urge the Administration to support a greater investment in the network of eight “BSL-4” biocontainment laboratories in the U.S. that are in both the health and agricultural sectors.The current model for sustaining the network cannot meet the extraordinary operations costs of these unique facilities. Absent a global effort to deploy qualified experts to ensure that these facilities meet the highest possible standards, the global proliferation of biocontainment laboratories now underway increases the risk of accidental release of dangerous pathogens and threatens misuse by nefarious actors.
On a more practical level, basic and applied research often depends on having access to highly specialized equipment and instrumentation; routine service and maintenance of these critical resources is hampered by the inability of service personnel to easily enter the biocontainment space. Similarly, the need for comprehensive documentation, record keeping and complete external audit of records that is required by the Food and Drug Administration makes the conduct of well-documented studies to demonstrate the efficacy of candidate vaccines and therapeutics in laboratory animals extremely challenging.
Successful operation of biocontainment laboratories to preserve national security will require federal support to increase the scientific workforce as well as the next generation of skilled building engineers and safety officers who are adept at managing the unique requirements of these complex facilities. Collectively, the workforce associated with biocontainment laboratories requires a major investment by universities that are home to this critical national infrastructure, and the federal government should support the infrastructure needed to carry out this important work.
In addition to providing the necessary financial support for the operations of these laboratories and for training the workforce, there is a need for scientific diplomacy to ensure that these laboratories are being set up around the world safely. The U.S. leads the world in biosafety and biosecurity measures, but to ensure global health security, we must have better channels and mechanisms for lending our expertise, within national security parameters, to ensure that other countries are adhering to the highest possible standards.
International Engagement
In the past, U.S. biosafety experts were able to instruct scientists working in new facilities outside the U.S. on best practices for safe and secure operations of their facilities. Unfortunately, funding for such activities is no longer available and understandable concerns about how some countries are operating such facilities have made this work more challenging. Unfortunately, this leaves an alarming gap in global security as more and more biocontainment facilities obtain dangerous pathogens and begin their own independent investigations, oftentimes without the benefit of adequate training or the experience and good counsel that U.S. experts traditionally provided. The risk of accidental release or purposeful misuse of dangerous pathogens is greater without meaningful engagement between U.S. and our colleagues working in biocontainment around the world.The microbial sciences are truly a global ecosystem. Microbes know no borders, and it is imperative that we consider this when committing resources and developing tools to addressing infectious diseases, antimicrobial resistance and emerging threats.The U.S. should seek international partnership to ensure appropriate oversight of data sharing, biosafety and biosecurity at home and abroad. Policymakers should consider how our current positions on international collaboration impact the long-term growth and security of the U.S. bioeconomy.
The tools, technologies and applications of the bioeconomy are topics of sustained international interest, yet the °®¶¹´«Ã½ States has not ratified the Convention on Biological Diversity (CBD). This limits the U.S.’s ability to fully participate in decisions regarding global research and development, in particular affecting polices under the Nagoya Protocol and the Cartagena Protocol on Biodiversity. Decisions adopted at the CBD may affect the strategic competitiveness of biotechnology researchers and companies, including how and where they can operate, as well as the use of their applications and products.
In closing, federally funded basic research has shown how microbes can form the basis of a strong bioeconomy. Microbes have a legacy of providing products for society, especially when one considers their impact on the food, beverage, pharmaceutical, biotechnology, wastewater treatment, chemical and other industries. Despite these advances, consistent support for transdisciplinary science and scaling of new technologies remains challenging. Thank you for the opportunity to comment on these critical issues. ASM and our members look forward to supporting the implementation of the National Biotechnology and Biomanufacturing Initiative. If we can be of further assistance, please contact Amalia Corby, ASM Senior Federal Affairs Officer at acorby@asmusa.org.
Sincerely,
Allen D. Segal
ASM Chief Advocacy Officer
