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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By Lynn L. Bergeson 

On July 10, 2020, DOE EERE announced that it has selected eight projects totaling more than $5 million to conduct R&D needed to accelerate the U.S. biomanufacturing sector. These projects are a part of the Agile BioFoundry (ABF) consortium and will leverage National Laboratory capabilities to address challenges in biomanufacturing. Each of these ABF selected projects has been invited to collaborate with National Laboratory research facilities to conduct their proposed research. The seed awards provide up to $500,000 in DOE funds to the laboratories for up to two years. Full awards, however, will receive up to $2 million for up to three years. The aim is for the projects to develop novel microbial hosts and bioproducts, use artificial intelligence and machine learning in synthetic biology, and address the problem of production heterogeneity in industrial microbiology. Each awardee has committed to a minimum of 20 percent cost-share contribution.

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By Lynn L. Bergeson

On February 13, 2019, the University of Manchester was awarded £10 million by UK Research and Innovation (UKRI), an organization sponsored by the UK Department for Business, Energy and Industrial Strategy (BEIS) to foster research and innovation. These funds are to be used in the launching of a country-wide biomanufacturing research hub to lead the way in new medicines and sustainable energy solutions. To be led by Professor Niguel Scrutton, the Future Biomanufacturing Research Hub (FBRH) will focus on the development of biotechnologies in three sectors:  pharmaceuticals, chemicals, and engineering materials. Professor Scrutton stated: “With the Manchester Institute of Biotechnology (MIB), the University already has one of Europe’s leading industry-interfaced institutes, with world-leading capabilities in bio-based chemicals synthesis and manufacture. Now, with the addition of the Future Biomanufacturing Research Hub, it will take it to an even higher level.” Part of a £30 million government investment into the UK’s research and manufacturing sector, the funding comes from the Engineering and Physical Sciences Research Council (EPSRC) and the Biotechnology and Biological Sciences Research Council (BBSRC). FBRH intends to bring together 67 partners from industry, public sector, and universities to revolutionize industrial biotechnology.

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On February 26, 2016, the U.S. Department of Energy (DOE) announced the upcoming Agile Biomanufacturing Industry Listening Workshop that is being held by nine national laboratories to increase understanding of industry needs around synthetic biology. The national laboratories are working to create an agile biomanufacturing platform using synthetic biology tools to quickly engineer biofuels and biochemical in response to industry demands. A successful platform will help organizations to develop biological processes to create biobased products, while reducing associated risks. The workshop is occurring on March 15, 2016, in Berkeley, California from 8:00 a.m. to 6:30 p.m. Those wishing to attend should register online by March 4, 2016.

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