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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

  1. 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?

  2. 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

  1. 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?

  2. 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?

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

  4. 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

  1. 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

  2. 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?

  3. 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

  1. 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?
     
  2. 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

  1. 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?

  2. 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

  1. 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?
     
  2. 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.


 

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.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On October 6, 2022, the European Maritime Safety Agency (EMSA) announced the availability of a report entitled Update on Potential of Biofuels in Shipping, updating a previous study developed by EMSA on biofuels and examining the full range of biofuels from the perspective of current production capacity, storage and distribution infrastructure, and power-generation technologies. According to EMSA, the report also features techno-economic analyses and includes risk-based case studies to evaluate the potential of biofuels for the maritime sector. According to EMSA, among the broad spectrum of technology and fuel-solution pathways available for ship designers, builders, owners, and operators, biofuels potentially offer medium- and long-term marine fuel alternatives that can enter the market relatively quickly; they also offer the potential, if sustainability criteria are met, to reduce carbon output compared to traditional carbon-based fossil fuels. EMSA notes that although the current use of biofuels in marine-engine applications is very limited, there is significant potential for biofuels to capture a larger share of the total maritime fuel consumption and support the European Union (EU) and International Maritime Organization’s (IMO) greenhouse gas (GHG)-reduction ambitions for the maritime industry. EMSA states that “[r]ecent regulatory developments in the EU covering GHG emissions and the lifecycle aspect of fuels provide a basket of measures in line with the climate goals that could accelerate their adoption.” The “drop-in” characteristics of biofuels -- the possibility to replace conventional petroleum-refined hydrocarbons without substantial modifications to engines, fuel tanks, pumps, or supply systems -- may offer “an immediate, attractive and cost-effective solution, for the existing fleet.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a final rule on September 2, 2022, establishing an optional alternative renewable identification number (RIN) retirement schedule for small refineries under the Renewable Fuel Standard (RFS) program for the 2020 compliance year. 87 Fed. Reg. 54158. Small refineries that elect to use the alternative RIN retirement schedule will have to comply fully with their 2020 RFS obligations, including any RIN deficits from 2019 carried forward into the 2020 compliance year, by February 1, 2024. According to the final rule, the goal of the alternative RIN retirement schedule is to support small refineries in their transition into positions where they will be able to comply with their renewable volume obligations (RVO) on an ongoing basis. EPA notes that this will also ensure the use of renewable fuels in the United States as required by the RFS program and help provide certainty in the RFS program and fuels markets, given the “unique circumstances” as a result of its June 2022 actions, denying 60 small refinery exemption (SRE) petitions for the 2016-2021 compliance years that were still pending. The final rule was effective on September 2, 2022.

Tags: RIN, RFS, Biofuel

 

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. 


 

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.


 

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On April 18, 2022, EPA announced the opportunity for public comment on its proposed analysis of the lifecycle greenhouse gas (GHG) emissions associated with biofuels produced from canola/rapeseed oil. EPA’s assessment considers diesel, jet fuel, heating oil, naphtha, and liquefied petroleum gas (LPG) produced from canola/rapeseed oil through a hydrotreating process. EPA is proposing to find that these pathways would meet the lifecycle GHG emissions reduction threshold of 50 percent required for advanced biofuels and biomass-based diesel under the Renewable Fuel Standard (RFS) program. Based on its analyses, EPA is also proposing to approve these fuel pathways, making them eligible to generate Renewable Identification Numbers (RIN) if they meet the definitional and RIN generation criteria for renewable fuel specified in the RFS regulations.

Comments must be submitted by May 18, 2022.

Tags: EPA, GHG, Biofuel, RFS, RIN

 

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
 
On December 10, 2021, the U.S. Environmental Protection Agency (EPA) announced that it will hold a virtual public hearing on its proposal for the “Renewable Fuel Standard (RFS) Program: RFS Annual Rules” signed on December 7, 2021. The virtual public hearing is scheduled for January 4, 2022, from 9:00 a.m. to 5:00 p.m. (EST). If necessary, EPA will hold an additional virtual session on January 5, 2022, to accommodate the number of testifiers.
 
EPA is proposing the 2020, 2021, and 2022 renewable fuel standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel. It is also proposing to:

  • Address the remand of the 2016 standard-setting rulemaking;
  • Extend certain RFS compliance and attest engagement reporting deadlines for the 2019, 2020, and 2021 compliance years; and
  • Implement several regulatory changes to the RFS program.

 

By Lynn L. Bergeson 
 
On August 27, 2021, DOE’s EERE, in partnership with the Clean Energy Smart Manufacturing Institute (CESMII), announced the selections of four new Smart Manufacturing Innovation Centers (SMICs). SMICs offer specialized training and direct industry engagement to help U.S. manufacturers implement smart manufacturing technologies to optimize their use of materials and energy. CESMII, an institute funded by DOE’s Advanced Manufacturing Office, focuses on accelerating the adoption of smart manufacturing through integration of advanced sensors, data analytics, platforms, and controls. SMICs allow manufacturers to tap into CESMII’s manufacturing resources, helping CESMII expand institute-developed technologies, training, and hands-on demonstrations.


 

By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On March 31, 2021, the U.S. Department of Energy (DOE) Office of Energy Efficiency & Renewable Energy (EERE) announced a new request for proposals (RFP) and $4 million in selections for projects aimed at accelerating the adoption of Smart Manufacturing practices. In support of the Biden Administration’s efforts to encourage innovation and reduce the carbon footprint of the manufacturing sector, the new $2 million RFP will expand DOE’s Clean Energy Smart Manufacturing Innovation Institute’s (CESMII) Smart Manufacturing Innovation Centers (SMIC). SMICs consist of a network of individuals and organizations from industry, government, and academia who allow manufacturers of all sizes to benefit from the network’s assets and competencies and to create test beds. CESMII has also selected 14 new research and development (R&D) projects that will apply Smart Manufacturing solutions to real-world manufacturing process and operation challenges to improve performance, quality, and efficiency of energy productivity.


 
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