By Lynn L. Bergeson and Carla N. Hutton
 
The Office of Management and Budget (OMB) published a request for information (RFI) on April 27, 2023, seeking public input on existing or potential bioeconomy-related industries and products that are established, emerging, or currently embedded in existing industry/manufacturing processes. 88 Fed. Reg. 25711. As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” Under the EO, the Chief Statistician of the United States (CSOTUS) in OMB’s Office of Information and Regulatory Affairs (OIRA) was charged with improving and enhancing federal statistical data collection designed to characterize and measure the economic value of the U.S. bioeconomy. The CSOTUS was also charged with establishing an Interagency Technical Working Group (Working Group) to recommend bioeconomy-related revisions for the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS). OMB states that the bioeconomy refers to a segment of the total economy utilizing or derived from biological resources and includes manufacturing processes, technologies, products, and services. These may encompass, wholly or in part, industries and products including fuel, food, medicine, chemicals, and technology. To ensure consideration of comments on potential bioeconomy-related industries and products solicited in the RFI, OMB asked that all comments be submitted “as soon as possible,” but no later than June 12, 2023.
 
The Working Group, through OMB, seeks input on how to identify, classify, and measure best bioeconomy manufacturing, technology, and products, including those that are primarily or exclusively: (a) biobased, (b) components of traditional manufacturing processes, and (c) nascent biobased processes and products. Importantly, according to OMB, input should include information on how particular industries or products are linked to the bioeconomy and, where appropriate and available, evidence should be provided. OMB states that this will afford the Working Group the opportunity to use existing evidence to inform its recommendations. The RFI includes the following questions:

• What information and what high-priority concerns should the Working Group consider in making these recommendations for potential revisions to the NAICS and NAPCS that would enable characterization of the economic value of the U.S. bioeconomy?
   
• Which quantitative economic indicators and processes are currently used to measure the contributions of the U.S. bioeconomy? Are these indicators reasonably accurate measures of the product components, scope, and value of the bioeconomy? Please explain why.
   
• Which industries not currently measured as unique classifications in NAICS related to the bioeconomy should be considered? Similarly, which products not currently measured as unique classifications in NAPCS related to the bioeconomy should be considered? Please describe how a unique classification for such industry or product would meet the principles of NAICS and NAPCS. Please include a description of the industry or product, with specific examples. Please also provide an explanation of how such industry or product would advance understanding of measuring the bioeconomy.
   
• How might potential changes to the NAICS impact existing industry measurements, such as assessing changes in the economic output across current industries, time series measures, or data accuracy?
   
• What role can the NAPCS fill in order to advance measurement of biomanufacturing and biotechnology?
   
• Biobased processes and products that are embedded in traditional industries pose challenges for differentiation and measurement. Are there methodologies that can differentiate these bioeconomy processes from current manufacturing processes to enable measurement? If yes, please explain.
   
• What potential bioeconomy measurement strategies might be considered other than revisions to and inclusion in the NAICS or NAPCS? For example, are there ways the federal government could better collect information to provide better measurement on biobased processes or products in current industries?

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By Lynn L. Bergeson and Carla N. Hutton
 
As part of the National Biotechnology and Biomanufacturing Initiative, the U.S. Department of Defense (DOD) announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. As reported in our March 30, 2023, blog item, on March 22, 2023, DOD released its Biomanufacturing Strategy to guide these investments, and its broader efforts in this critical technology field. According to the Biomanufacturing Strategy, as commercial use of new technologies expands, if the United States fails to invest in its domestic manufacturing capabilities, market forces could drive manufacturing overseas, often at the expense of the national economy and potentially creating vulnerabilities in the DOD supply of these products.
 
The Biomanufacturing Strategy is focused around three core principles:

• Establish DOD transition partners for early-stage innovations: Establishing DOD customers for biomanufactured capabilities will guide DOD technology investments. The core of the DOD Biomanufacturing Strategy is a culture shift throughout DOD that both recognizes and prioritizes, where applicable, biotechnology-based solutions to prevent strategic surprise.
• Develop the field of biomanufacturing through innovations in practice and application; According to the Biomanufacturing Strategy, research is required in scaling-up biomanufacturing to produce at a scale sufficient to prototype these products. The Biomanufacturing Strategy states although this is a hurdle in adopting biotechnology-based solutions to DOD mission needs, “it is also an incredible opportunity to develop biomanufacturing at home and with allies and partners to create a self-sustaining domestic biomanufacturing ecosystem.” It will also contribute to the United States remaining the “world leader in innovation,” guarantee DOD interests are protected, and ensure that U.S. global competitiveness in biotechnology is maintained.
• Map the domestic biomanufacturing ecosystem and the changes that occur over time for identification and tracking of metrics to support future implementation and refinement of the biomanufacturing strategy: According to the Biomanufacturing Strategy, for DOD to build enduring advantage through the implementation of the Biomanufacturing Strategy, DOD needs to address implementation risk. Concurrent with DOD’s need to prioritize where it places its resources in biomanufacturing, DOD “will support an upfront assessment of the biomanufacturing ecosystem, along with continued evaluation during and following early investments, allowing for more precise tailoring” of DOD resource allocation as the biomanufacturing ecosystem develops. The Biomanufacturing Strategy states that mapping the biomanufacturing ecosystem and establishing metrics to evaluate the bioeconomy “is central to mitigating implementation risk.”

In support of the Biomanufacturing Strategy, DOD issued a formal request for information (RFI) on biomanufactured products and process capabilities that could help address defense needs and whose development and commercialization could be addressed by DOD investment. The intent of the RFI is to gather information about U.S. national security industrial base shortcomings, risks, and opportunities that may be addressed by investments made under the provisions in Title III of the Defense Production Act (DPA). According to the RFI, biomanufactured products of interest include those that “enable capabilities within the following application and operational spaces of interest, and will bring revolutionary changes to military capabilities, the operations environment, and supply chain resiliency.” Such application and operational spaces may include, but are not necessarily limited to:

• Manufacture specialty chemicals and materials that are needed by DOD in an available and affordable manner (e.g., biomanufactured fuels and energetic precursors, biosynthetic fibers such as but not limited to spider silk, polymers, natural rubber/latex rubber, solvents);
• Enable reduced logistic costs, time, and energy through bio-composite and living materials (e.g., tunable materials with enhanced properties, self-healing materials);
• Maintain persistent sensing capabilities for sustained human and environmental intelligence (e.g., sensors for water quality monitoring, biobased energy harvesting in maritime systems);
• Augment human systems by impacting performance and protection (e.g., tailored proteins, but specifically excluding biopharma and probiotics); and
• Enable manufacturing defense relevant materials in a manner to reduce the impact on the environment while meeting or exceeding product performance requirements.

Responses are due by April 19, 2023, at 12:00 p.m. (EDT). The RFI notes that if late information is received, the government reviewers may consider it, depending on agency time constraints.

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By Lynn L. Bergeson and Carla N. Hutton

As reported in our March 30, 2023, blog item, on March 22, 2023, the White House Office of Science and Technology Policy (OSTP) released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals. The report includes five sections, each presenting goals that highlight what could be possible with the power of biology. The goals set ambitious national targets for the next two decades to help establish research and development (R&D) priorities that will be critical to advance the bioeconomy. Each section also outlines the essential R&D needed to achieve these goals for the U.S. bioeconomy, opportunities for public-private collaboration, and recommendations for enhancing biosafety and biosecurity. The report notes that achieving these goals will require significant prioritization of R&D investments and other efforts across the U.S. government, as well as actions from the private sector; state, local, and Tribal governments; and international partners.
 
The report states that bold goals for the U.S. bioeconomy include, for example:

• Climate: In 20 years, demonstrate and deploy cost-effective and sustainable routes to convert biobased feedstocks into recyclable-by-design polymers that can displace more than 90 percent of today’s plastics and other commercial polymers at scale;
• Food and Agriculture: By 2030, reduce methane emissions from agriculture, including by increasing biogas capture and utilization from manure management systems, reducing methane from ruminant livestock, and reducing methane emissions from food waste in landfills, to support the U.S. goal of reducing greenhouse gas (GHG) emissions by 50 percent and the global goal of reducing methane emissions by 30 percent;
• Supply Chain: In 20 years, produce at least 30 percent of the U.S. chemical demand via sustainable and cost-effective biomanufacturing pathways;
• Health: In 20 years, increase the manufacturing scale of cell-based therapies to expand access, decrease health inequities, and decrease the manufacturing cost of cell-based therapies tenfold; and
• Cross-Cutting Advances: In five years, sequence the genomes of one million microbial species and understand the function of at least 80 percent of the newly discovered genes.

According to this report, reaching these goals will require progress in other areas beyond R&D to ensure that innovation can lead to safe, effective, and equitable products that will grow the bioeconomy. The report states that in forthcoming reports and plans, departments and agencies will outline recommendations and steps that are underway to advance the following:

• Data for the bioeconomy -- Establishing a Data Initiative to ensure that high-quality, wide-ranging, easily accessible, and secure biological data sets can drive breakthroughs for the U.S. bioeconomy;
• Domestic biomanufacturing infrastructure -- Expanding domestic capacity to manufacture all the biotechnology products invented in the United States and to support a resilient supply chain;
• Workforce development -- Growing training and educational opportunities for the biotechnology and biomanufacturing workforce of the future;
• Regulatory clarity and efficiency -- Improving the clarity and efficiency of the regulatory process for biotechnology products to help ensure products come to market safely and efficiently;
• Biosafety and biosecurity -- Creating a Biosafety and Biosecurity Innovation Initiative to reduce risks associated with advances in biotechnology and biomanufacturing; and
• International engagement R&D -- Pursuing cooperation through joint research projects and data sharing, while mitigating risks and reaffirming democratic values.

According to the report, OSTP will lead the development of a strategy and implementation plan to execute on R&D priorities and other actions identified in the report.

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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our September 13, 2022, blog item, President Joseph Biden signed an Executive Order (EO) on September 12, 2022, creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” On March 22, 2023, the White House Office of Science and Technology Policy (OSTP) published a fact sheet announcing “new bold goals and priorities that will catalyze action inside and outside of government to advance American biotechnology and biomanufacturing”:

• Harnessing Biotechnology and Biomanufacturing Research and Development (R&D) to Further Societal Goals: On March 22, 2023, OSTP released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals, outlining a vision for what is possible with the power of biotechnology and biomanufacturing and the R&D needs to achieve this ambitious vision. Biden’s EO called on federal departments and agencies to assess the potential for biotechnology and biomanufacturing R&D to further five societal goals: climate change solutions; food and agricultural innovation; supply chain resilience; human health; and crosscutting advances. The report includes individual sections authored by the Department of Energy (DOE), the U.S. Department of Agriculture (USDA), the Department of Commerce (DOC), the Department of Health and Human Services (DHHS), and the National Science Foundation (NSF), in consultation with other agencies and departments, that are responsive to the President’s EO. The goals and R&D needs outlined in the report serve as a guide for public- and private-sector efforts to harness the full potential and power of biotechnology and biomanufacturing to develop innovative solutions in different sectors, create jobs at home, build stronger supply chains, lower costs for families, and achieve our climate goals. According to the fact sheet, OSTP will now lead the development of an implementation plan to address the R&D needs outlined in the report.
   
• Establishing Biomanufacturing Priorities for DOD: As part of the National Biotechnology and Biomanufacturing Initiative, DOD announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. On March 22, 2023, DOD released its Biomanufacturing Strategy to guide these investments, and its broader efforts in this critical technology field. This strategy, which will guide research efforts and collaboration with the private sector and allies, sets three key priorities: establishing the customers within DOD that stand to benefit from early-stage innovations, advancing biomanufacturing capabilities through innovation, and mapping the biomanufacturing ecosystem and tracking metrics that support future efforts. In support of the strategy, DOD issued a formal request for information on biomanufactured products and process capabilities that could help address defense needs and whose development and commercialization could be addressed by DOD investment.
   
• Assessing the Economic Value of the Nation’s Bioeconomy: DOC’s Bureau of Economic Analysis released a new report that assesses the feasibility of measuring the economic contributions of the U.S. bioeconomy. The report also includes an assessment of what is needed to measure these contributions better and more accurately.

According to the fact sheet, other deliverables from the EO are in development, including: a plan to expand training and education opportunities for the biotechnology and biomanufacturing workforce, a report on data needs for the bioeconomy, a national strategy for expanding domestic biomanufacturing capacity, actions to improve biotechnology regulation clarity and efficiency, and a plan for strengthening and innovating biosafety and biosecurity for the bioeconomy.

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By Lynn L. Bergeson and Carla N. Hutton
 
That National Academies of Sciences, Engineering, and Medicine (NASEM) hosted an October 2022 workshop on successes and challenges in biomanufacturing. The workshop brought together biomanufacturing stakeholders across industry, academia, and government with expertise across diverse fields, including United States-based and international speakers. According to NASEM, discussions spanned the breadth of biomanufacturing contexts and applications, including bioindustrial and biopharmaceutical manufacturing. NASEM’s Proceedings of a Workshop-in Brief provides a high-level summary of the topics addressed at the workshop. Topics covered include:

• Biomanufacturing for Sustainability and a Circular Bioeconomy;
• Regulation and Standards;
• Biomanufacturing Workforce Development and Education;
• Economic Considerations and Challenges in Biomanufacturing;
• Biomanufacturing Ecosystems and Partnerships;
• Translating Lessons from Different Biomanufacturing Sectors;
• Modeling, Data, Analysis, and Process Control;
• Biomanufacturing Platform Development; and
• Biomanufacturing Infrastructure and Tools for Scaling.

NASEM notes that the summary should not be viewed as consensus conclusions or recommendations of NASEM.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) recently announced the selection of five external collaborations totaling over $3.7 million to conduct research and development (R&D) needed to accelerate the U.S. biomanufacturing sector. Working with scientists at the Agile BioFoundry (ABF) consortium, these industry and academic groups will leverage national laboratory capabilities to address challenges in biomanufacturing. The projects include:

• University of California, Berkeley will address the pressing need for a scalable method for double-stranded ribonucleic acid (RNA) production for agricultural pesticide applications, employing microbial strain engineering and fermentation scale-up;
• Birch Biosciences will develop improved technologies that enable engineering of high-performance enzymes for economical and sustainable plastic recycling;
• Kiverdi will develop a platform for sequestering carbon dioxide to produce secreted recombinant proteins;
• University of Nebraska-Lincoln will expand the synthetic biology biosensor toolkit for Methanosarcina, a promising archaeal host organism that can be used to create fuels and renewable chemicals; and
• Azolla will leverage ABF’s capabilities to engineer a bacterium capable of using sunlight and carbon dioxide to produce nanocellulosic fiber to replace current unsustainable production practices in the textile industry.

The selected projects all directly contribute to producing renewable biofuels and biobased chemicals and materials. They also help ABF build foundational technologies critical for the decarbonization of the industrial and transportation sectors. Funded by BETO, ABF aims to advance biomanufacturing by uniting and expanding the capabilities of the national laboratories.

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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative (NBBI) to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. On December 20, 2022, the White House Office of Science and Technology Policy (OSTP) published two requests for information (RFI) related to the NBBI. In the first one, OSTP, on behalf of the primary agencies that regulate the products of biotechnology -- the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) -- requests relevant data and information, including case studies, that may assist in identifying any regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology, particularly with regard to new and emerging biotechnology products. 87 Fed. Reg. 77900. According to the RFI, the information provided will inform regulatory agency efforts to improve the clarity and efficiency of the regulatory processes for biotechnology products. The RFI includes the following questions:

1. Describe any ambiguities, gaps, inefficiencies, or uncertainties regarding statutory authorities and/or agency roles, responsibilities, or processes for different biotechnology product types, particularly for product types within the responsibility of multiple agencies.
    
   1. Describe the impact, including economic impact, of these ambiguities, gaps, inefficiencies, or uncertainties.
       
2. Provide any relevant data or information, including case studies, that could inform improvement in the clarity or efficiency (including the predictability, transparency, and coordination) of the regulatory system and processes for biotechnology products.
    
3. Describe any specific topics the agencies should address in plain language on the regulatory roles, responsibilities, and processes of the agencies.
    
4. Describe any specific issues the agencies should consider in developing a plan to implement regulatory reform, including any updated or new regulations or guidance documents.

5. Describe any new or emerging biotechnology products (e.g., microbial amendments to promote plant growth; food plants expressing non-food substances or allergens from non-plant sources) that, based on lessons learned from past experiences or other information, the agencies should pay particular attention to in their evaluation of ambiguities, gaps, or uncertainties regarding statutory authorities and/or agency roles or processes.

6. Describe any new or emerging categories of biotechnology products on the horizon that the regulatory system and processes for biotechnology products should be preparing to address. Describe any specific recommendations for regulating these new or emerging categories of biotechnology products to guide agency preparations.

7. What is the highest priority issue for the agencies to address in the short term (i.e., within the next year) and in the long term.

OSTP, EPA, FDA, and USDA will host a virtual public listening session on January 12, 2023. The virtual listening session will allow OSTP, EPA, FDA, and USDA to hear, firsthand, from stakeholders who wish to provide feedback on any of the seven questions outlined in the RFI. Comments are due on or before 5 p.m. (EST) February 3, 2023. More information on the Coordinated Framework for the Regulation of Biotechnology is available in our January 9, 2017, memorandum.
 
The second RFI seeks public input on how advances in biotechnology and biomanufacturing can help achieve goals that were previously out of reach and what steps can be taken to provide the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy. 87 Fed. Reg. 77901. OSTP invites input from interested stakeholders, including industry and industry association groups; academic researchers and policy analysts; civil society and advocacy groups; individuals and organizations that work on biotechnology, biomanufacturing, or related topics; and members of the public. OSTP seeks responses to one, some, or all of the following questions:

Harnessing Biotechnology and Biomanufacturing Research and Development (R&D) to Further Societal Goals

1. For any of the four categories outlined above (health, climate and energy, food and agriculture, and supply chain resilience):
    
   1. What specific bold goals can be achieved through advances in biotechnology and biomanufacturing in the short term (five years) and long term (20 years)? In your answers, please suggest quantitative goals, along with a description of the potential impact of achieving a goal. Listed below are illustrative examples of quantitative goals:
       
      1. Develop domestic bio-based routes of production, including the entire supply chain, for X percent of active pharmaceutical ingredients.
          
      2. Utilize X tons of sustainable biomass annually as input to biomanufacturing processes to displace Y percent of U.S. petroleum consumption.
         ​
   2. What R&D is needed to achieve the bold goals outlined in (a), with a focus on cross-cutting or innovative advances? How would the government support this R&D, including through existing federal programs, creation of new areas of R&D, and/or development of new mechanisms?
       
   3. How else can the government engage with and incentivize the private sector and other organizations to achieve the goals outlined in (a)?
       
2. Public engagement and acceptance are of critical importance for successful implementation of biotechnology solutions for societal challenges. How might social, behavioral, and economic sciences contribute to understanding possible paths to success and any hurdles? What public engagement and participatory models have shown promise for increasing trust and understanding of biotechnology?

Data for the Bioeconomy

3. What data types and sources, to include genomic and multiomic information, are most critical to drive advances in health, climate, energy, food, agriculture, and biomanufacturing, as well as other bioeconomy-related R&D? What data gaps currently exist?

4. How can the federal government, in partnership with private, academic, and non-profit sectors, support a data ecosystem to drive breakthroughs for the U.S. bioeconomy? This may include technologies, software, and policies needed for data to remain high-quality, interoperable, accessible, secure, and understandable across multiple stakeholder groups.

Building a Vibrant Domestic Biomanufacturing Ecosystem

5. What is the current state of U.S. and global biomanufacturing capacity for health and industrial sectors, and what are the limits of current practice?

6. What can the federal government do to expand and scale domestic biomanufacturing capacity and infrastructure? What level of investment would be meaningful, and what incentive structures could be employed?

7. What are barriers that must be addressed to enable better domestic supply chains for biomanufacturing (e.g., feedstocks, reagents, consumables)?

8. How can the federal government partner with state and local governments to expand domestic biomanufacturing capacity, with a particular focus on underserved communities?

Biobased Products Procurement

9. What are new, environmentally sustainable biobased products that the federal government could purchase through its BioPreferred Program? How can the federal government incentivize development of new categories of sustainable biobased products?

   Biotechnology and Biomanufacturing Workforce

10. How can the U.S. strengthen and expand the biotechnology and biomanufacturing workforce to meet the needs of industry today and in the future? What role can government play at the local, state, and/or federal level?

11. What strategies and program models have shown promise for successfully diversifying access to biomanufacturing and biotechnology jobs -- including those involving Historically Black Colleges and Universities (HBCU), Tribal Colleges and Universities, and other Minority Serving Institutions? What factors have stymied progress in broadening participation in this workforce?

Reducing Risk by Advancing Biosafety and Biosecurity

12. What can the federal government do to support applied biosafety research and biosecurity innovation to reduce risk while maximizing benefit throughout the biotechnology and biomanufacturing life cycles?
     
13. How can federal agencies that fund, conduct, or sponsor life sciences research incentivize and enhance biosafety and biosecurity practices throughout the United States and international research enterprises?

 Measuring the Bioeconomy

14. What quantitative indicators, economic or otherwise, are currently used to measure the contributions of the U.S. bioeconomy? Are there new indicators that should be developed?

15. How should the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS) be revised to enable characterization of the economic value of the U.S. bioeconomy? Specifically, which codes or categories do not distinguish between functionally identical biobased and fossil fuel-based commodities?

International Engagement

16. What are opportunities for the U.S. government to advance R&D, a skilled workforce, regulatory cooperation, and data sharing for the bioeconomy through international cooperation? Which partnerships and fora are likely keys to advance these priority areas?
     
17. What risks are associated with international biotechnology development and use, and how can the U.S. government work with allies and partners to mitigate these risks?

Comments are due on or before 5:00 p.m. (EST) on January 20, 2023.

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By Lynn L. Bergeson and Carla N. Hutton
 
EuropaBio announced on November 14, 2022, a new cross-sectoral Biomanufacturing Platform. EuropaBio states that the Platform has the mission to represent biomanufacturing at the highest policy levels in Europe and to ensure that it is visible and recognized within the industrial strategy and Europe’s green and digital transitions. The Platform will address the policy and wider frameworks through which biomanufacturing is delivered. EuropaBio states that together with members and stakeholders, the Platform will address how economic growth, employment, and resilience are achieved through policy, legal frameworks, and regulation at the European Union (EU) and national levels. Platform activities will build an economic evidence base for biomanufacture across sectors; reflect policy priorities from EuropaBio’s Healthcare, Industrial Biotechnology, and National Association Councils; and build case studies to demonstrate diversity and impact of biomanufacture.
 
The Biomanufacturing Platform will host its first policy summit on March 15, 2023, in Brussels. The summit will set the vision for Europe’s global innovation, competitiveness, and sustainability through the lens of biomanufacturing and set a baseline for its understanding and recognition within policy.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy (DOE) Bioenergy Technologies Office (BETO) and the Agile BioFoundry (ABF) will hold a webinar on September 22, 2022, highlighting technologies used by the ABF to accelerate biomanufacturing. According to BETO, the ABF consortium collaborates with industry and academia to develop technologies that enable commercially relevant biomanufacturing of sustainable bioproducts. During the webinar, attendees will hear from ABF scientists on how they use state-of-the-art machine learning, deep learning, testing, and modeling techniques to guide the bioengineering process and speed up bioproduct development.
 
The webinar will feature the following speakers:

• Nathan Hillson, staff scientist at Lawrence Berkeley National Laboratory and the principal investigator of the ABF. Dr. Hillson leads the consortium’s Integrated Design-Build-Test-Learn task;
• Taraka Dale, scientist and principal investigator at Los Alamos National Laboratory and co-lead of ABF’s Host Onboarding and Development task;
• Hector Garcia Martin, staff scientist at Lawrence Berkeley National Laboratory and co-lead of ABF’s Learn subtask, and
• Philip Laible, biophysicist at Argonne National Laboratory and co-lead of ABF’s Learn subtask.

Registration for the webinar is open. 

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By Lynn L. Bergeson and Carla N. Hutton
 
On September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” On September 14, 2022, the White House will host a Summit on the National Biotechnology and Biomanufacturing Initiative during which cabinet agencies will announce a wide range of new investments and resources that will allow the United States to harness the full potential of biotechnology and biomanufacturing and advance the President’s Executive Order.
 
According to a White House fact sheet, the initiative will accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. It will “drive advances in biomanufacturing that substitute fragile supply chains from abroad with strong chains at home, anchored by well-paying jobs in communities all across America.” It will improve food and energy security, and promote agricultural innovation while mitigating the impacts of climate change.
 
Specifically, the initiative will:

• Grow Domestic Biomanufacturing Capacity: The initiative will build, revitalize, and secure national infrastructure for biomanufacturing across America, including through investments in regional innovation and enhanced bio-education, while strengthening the U.S. supply chain that produces domestic fuels, chemicals, and materials.
   
• Expand Market Opportunities for Biobased Products: The fact sheet notes that the U.S. Department of Agriculture’s (USDA) BioPreferred Program “is the standard for sustainable procurement by government agencies, both providing an alternative to petroleum-based products and supporting good-paying jobs for American workers.” The initiative will increase mandatory biobased purchasing by federal agencies and ensure that the Office of Management and Budget (OMB) and USDA regularly publish progress assessments. The fact sheet states that doing so “will provide specific directions to industry about gaps in biobased product options, leading to the creation of new products and new markets.” Together, the initiative will grow and strengthen the BioPreferred Program, increase the use of renewable agricultural materials, and “position American companies to continue to lead the world in bio-innovation.”
   
• Drive Research and Development (R&D) to Solve Our Greatest Challenges: According to the fact sheet, focused government support for biotechnology can quickly produce solutions, “as seen with the first-of-their-kind mRNA vaccines during the COVID-19 pandemic.” This initiative directs federal agencies to identify priority R&D needs to translate bioscience and biotechnology discoveries into medical breakthroughs, climate change solutions, food and agricultural innovation, and stronger U.S. supply chains.
   
• Improve Access to Quality Federal Data: Combining biotechnology with massive computing power and artificial intelligence can produce significant breakthroughs for health, energy, agriculture, and the environment. The Data for the Bioeconomy Initiative will ensure that biotechnology developers have streamlined access to high-quality, secure, and wide-ranging biological data sets that can drive solutions to urgent societal and global problems.
   
• Train a Diverse Skilled Workforce: The United States is facing a shortage of relevant talent spanning all levels, from community college to graduate school. The initiative will expand training and education opportunities for all Americans in biotechnology and biomanufacturing, with a focus on advancing racial and gender equity and support for talent development in underserved communities.
   
• Streamline Regulations for Products of Biotechnology: Advances in biotechnology are rapidly altering the agricultural, industrial, technological, and medical products landscape, which can create challenges for developers and innovators. The initiative will improve the clarity and efficiency of the regulatory process for products of biotechnology so that valuable inventions and products can come to market faster without sacrificing safety.
   
• Advance Biosafety and Biosecurity to Reduce Risk: The initiative will prioritize investments in applied biosafety research and incentivize innovations in biosecurity to reduce risk throughout the biotechnology R&D lifecycles.
   
• Protect the U.S. Biotechnology Ecosystem: The initiative will protect the U.S. biotechnology ecosystem by advancing privacy standards and practices for human biological data, cybersecurity practices for biological data, standards development for bio-related software, and mitigation measures for risks posed by foreign adversary involvement in the biomanufacturing supply chain.
   
• Build a Thriving, Secure Global Bioeconomy with Partners and Allies: According to the fact sheet, the initiative advances international cooperation to leverage biotechnology and biomanufacturing to tackle the most urgent global challenges -- from climate change to health security -- and to work together to ensure that biotechnology product development and use aligns with our shared democratic ethics and values, and that biotechnology breakthroughs benefit all citizens.

The White House has posted a transcript of the press call announcing the Executive Order.

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