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By Lynn L. Bergeson and Carla N. Hutton
 
The Congressional Research Service (CRS) published a CRS report, updated on September 19, 2022, entitled The Bioeconomy: A Primer. The report provides an overview of the bioeconomy, details the efforts of the United States and other selected nations pertaining to the bioeconomy, and offers policy considerations for strengthening the role of the United States in the global bioeconomy. The report does not examine the policies and programs of individual sectors that contribute to the bioeconomy (e.g., biofuels, biomanufacturing, pharmaceuticals, or agriculture), but instead discusses the bioeconomy from a macro level perspective.
 
According to the report, issues for consideration regarding advancement of the U.S. bioeconomy that could be pursued by Congress include:

  • Development and Implementation of a National Strategy: The National Academies of Sciences, Engineering, and Medicine (NASEM) and others have recommended that the federal government develop and regularly update a national bioeconomy strategy. As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed Executive Order (EO) 14081 “to coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.” According to the report, the policies and activities included in the EO appear to respond to NASEM’s recommendation for a more comprehensive vision and approach to advancing the U.S. bioeconomy. If Congress is interested in further supporting the U.S. bioeconomy, it may consider codifying some of the efforts initiated under the EO or establishing an alternative high-level coordination body tasked with developing, implementing, and evaluating a comprehensive U.S. bioeconomy strategy. It could also continue to support a more decentralized framework that encourages sector specific programs and activities related to the bioeconomy. The report states that “[r]egardless of the approach, sustainment of bioeconomy policies and programs across presidential Administrations and Congresses will likely be necessary for maintaining U.S. leadership in the future bioeconomy.” The report acknowledges that ensuring long-term engagement, including the provision of sufficient resources, “is often challenging.”
     
  • Investment in Research and Development (R&D): According to the report, many experts call for increased federal investment in R&D to maintain U.S. leadership in the bioeconomy. In general, experts highlight the life sciences, computing and information sciences, engineering, and biotechnology for increased support, and many also emphasize the convergence of such disciplines. Beyond investments in basic and applied research in areas deemed critical to advancing the bioeconomy, some call for improvements in bioeconomy-related R&D infrastructure, including biomanufacturing platforms and pilot facilities. The report states that Congress may find that a more holistic view of its investments in and oversight of biological research, infrastructure, and data is necessary. At least 25 federal agencies and departments support biological R&D, and the jurisdiction of such agencies spans multiple congressional committees, making coordination, oversight, and coherence of bioeconomy policies and investments more challenging.
     
  • Promotion of Regional Efforts: The report states that to have ready access to biological resources (e.g., crops, forests), implementation of many aspects of the bioeconomy will occur at the regional scale and involve rural communities. According to the report, policies to encourage the development of bioeconomy clusters and regions, including resources for planning and the creation of networks that facilitate collaboration between diverse stakeholders, including firms from divergent sectors and small businesses, are common. The report notes that it is unclear if existing programs and efforts to support regional innovation and technology-based economic development, including in rural areas, are sufficient to advance the bioeconomy. Congress may examine the size, scope, effectiveness, and synergy of existing programs, in addition to creating new programs or modifying existing programs to promote regional bioeconomy efforts.
     
  • Creating a Market for Biobased Products: The report states that an analysis by the Organization for Economic Cooperation and Development (OECD) found that bioeconomy-related policies focus primarily on supply-side or technology push measures (i.e., support for R&D and demonstration efforts). According to the report, OECD emphasized the importance of public procurement in helping to create a market for biobased products and recognized the U.S. Department of Agriculture’s (USDA) BioPreferred Program “as the most advanced effort in this regard.” Despite the relative success of the program, NASEM identified some areas for improvement, including updating the reporting mechanisms involved in the federal procurement of biobased products, setting procurement targets, and increasing funding for the program to enable increased awareness and standardized reporting.
     
  • Developing a Bioeconomy Workforce: According to the report, “[t]here is broad consensus that access to a skilled workforce is essential to advancing the bioeconomy,” and “it is also clear that bioeconomy education and training should be multidisciplinary in nature.” As noted by OECD, “the long-standing conundrum of multidisciplinary education is the need for both breadth and depth to graduate people with problem-solving abilities,” however. Additionally, according to OECD, the bioeconomy workforce needs more undergraduates than doctorates. The report states that Congress may examine federal investments in bioeconomy training, education, and workforce development and the progress of the federal government in attaining the goals outlined in its strategic plan on science, technology, engineering, and mathematics (STEM) education.
     
  • Public Engagement and Acceptance: The report states that due to the significance of public acceptance, a number of countries are pursuing public engagement and awareness activities and policies. In a 2017 study, NASEM recommended that federal agencies invest in new methods of understanding the ethical, legal, and societal implications (ELSI) of future biotechnology products. Congress may conduct additional oversight on federal efforts to enhance public awareness and acceptance of biobased products and services and may also consider the level of resources allocated toward ELSI-related research across federal agencies, as well as the coordination of such efforts.
     
  • International Collaboration: According to the report, most bioeconomy-related policies and strategies are focused at the national level with some exceptions (e.g., the European Union (EU)). In the United States, some states, such as Maine and Michigan, have engaged in bilateral collaborations. The report states that Congress “may examine the state of international collaboration on the bioeconomy and the need for congressional direction in this regard.”
     
  • Sustainability and Creating a Circular Economy: A number of nations, especially those in the EU, are increasingly connecting their bioeconomy strategies and policies to action plans associated with creating a more sustainable and circular economy. Many countries see a connection between the bioeconomy and a circular economy as a means to address a number of the Sustainable Development Goals (SDG). Congress may consider the degree to which U.S. bioeconomy policies and activities can or should be tied to and aligned with achieving the SDGs. Additionally, while the use of waste material as a feedstock is central to a circular economy, there are often challenges to its use. Congress may examine any regulatory impediments or other barriers to creating a circular economy.

The crosscutting nature of the bioeconomy, in addition to the diversity of potential benefits associated with its growth and advancement, offer a number of reasons for increased congressional interest in bioeconomy policies. The crosscutting nature of the bioeconomy also poses potential challenges to effective policymaking, including the harmonization of policies and coherent governance. Moreover, it likely means that the growth and success of the U.S. bioeconomy will depend, in part, on effective public-private partnerships in research, innovation, education, and workforce development. Transitioning to a biobased economy would take sustained commitment, including balancing short-term actions and long-term planning, removing barriers to such a transition, and creating the opportunity for radical innovation. Congress may decide there is no need to reorganize or group together federal activities, including some long-standing efforts, under a bioeconomy framework. It may decide to pursue bioeconomy-related policies through new or existing sector-specific focused efforts, or it may decide current policies and activities are sufficient. Regardless, other countries are adopting policies and strategies to advance their bioeconomies. Such efforts have the potential to challenge U.S. leadership in biotechnology and other bioeconomy-related sectors that many view as critical to national security and economic competitiveness.


 

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 Carla N. Hutton

Come learn about the 2023 Green Chemistry Challenge Awards program and the nomination process. This year the program will recognize winners in six categories, including: Greener Synthetic Pathways; Greener Reaction Conditions; The Design of Greener Chemicals; Specific Environmental Benefit: Climate Change; Small Business; and Academic.

Registration is open.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340:

These resources, along with other information on the revised biotechnology regulations, are available on the APHIS website. For additional questions regarding the regulation of modified microorganisms, contact APHIS at .(JavaScript must be enabled to view this email address). For questions regarding confirmation requests, contact APHIS at .(JavaScript must be enabled to view this email address).


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 25, 2022, Natural Resources Canada (NRC) announced a call for project proposals to support the establishment of biomass supply chains to ensure that a steady and usable supply of sustainable feedstock is available to clean fuel production facilities across Canada. According to NRC, as a component of the Clean Fuels Fund, this dedicated biomass call includes three project streams that are expected to enable emissions reductions while benefiting communities, leveraging private sector investments, creating jobs, and providing opportunities for Indigenous-led businesses and communities. Application is open to legal entities validly incorporated or registered in Canada, including not-for-profit and for-profit organizations such as:

  • Electricity or gas utilities;
  • Private sector companies;
  • Industry associations;
  • Research associations;
  • Standards organizations;
  • Indigenous and community groups;
  • Canadian academic institutions; and
  • Provincial, territorial, regional, or municipal governments, or their departments or agencies where applicable.

Eligible projects include:

  • Capital biomass supply chain projects that use technologies in advanced stages of technological readiness (TRL-9) and that are designed for commercial deployment; and
  • Feasibility studies, basic engineering studies, and detailed front-end engineering studies to assess the new build or expansion of low carbon fuel production facilities. In addition, feasibility studies to assess the feasibility of establishing a regional biomass supply chain risk rating.

All projects must be completed by March 31, 2026. Projects could receive up to 50 percent of eligible costs to a maximum of $5 million in funding. Applications will be accepted until November 23, 2022, for non-Indigenous applicants. Indigenous applications will be received on a continuous intake basis until funding is no longer available.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that registration was open for the 2022 Conference on the State of the Science on Development and Use of New Approach Methods (NAM) for Chemical Safety Testing. EPA notes that there will be limited availability in person at EPA headquarters in Washington, DC, on October 12-13, 2022, and a virtual option will also be available. Conference topics include:

  • Variability and Relevance of Traditional Toxicity Tests;
  • Evolution of Validation and Scientific Confidence Frameworks to Incorporate 21st Century Science; and
  • Breakout groups discussing Variability of Traditional Toxicity Tests, Relevance of Traditional Toxicity Tests, and Feedback on EPA Scientific Confidence Framework.

EPA asks that attendees register for the NAMs conference before October 7, 2022.
 
On October 18, 2022, EPA will provide training on the Computational Toxicology (CompTox) Chemicals Dashboard, which is part of a suite of databases and web applications developed by EPA to support the development of innovative methods to evaluate chemicals for potential health risks. The computational toxicology tools and data in the Dashboard help prioritize chemicals based on potential health risks. Specifically targeted for decision-makers, the training will provide:

  • An overview of the Dashboard content and function;
  • Application-oriented use-case demonstrations in the areas of general use, hazard/bioactivity, exposure/absorption, distribution, metabolism, and excretion (ADME)-in vitro to in vivo extrapolation (IVIVE), and chemistry; and
  • Opportunities for participatory learning and engagement.

The training will offer information about the latest release of the Dashboard and how it can be used to gather actionable information about chemical properties and risks through case examples, demonstrations, and hands-on exercises. Registration is now open (attendees must register for the training portions individually):


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture (USDA) announced on August 23, 2022, that USDA is accepting applications for $100 million in grants to increase the sale and use of biofuels derived from U.S. agricultural products. 87 Fed. Reg. 51641. The funding is available through the Higher Blends Infrastructure Incentive Program (HBIIP). The program seeks to market higher blends of ethanol and biodiesel by sharing the costs to build and retrofit biofuel-related infrastructure such as pumps, dispensers, and storage tanks. Applications are due by 4:30 p.m. (EST) on November 21, 2022.
 
Under HBIIP, USDA provides grants to transportation fueling and distribution facilities. These grants lower the out-of-pocket costs for businesses to install and upgrade infrastructure and related equipment. The $100 million will support a variety of fueling operations, including filling stations, convenience stores, and larger retail stores that also sell fuel. The funds will also support fleet facilities, including rail and marine, and fuel distribution facilities, such as fuel terminal operations, midstream operations, and distribution facilities, as well as home heating oil distribution centers.
 
The grants will cover up to 50 percent of total eligible project costs -- but not more than $5 million -- to help owners of transportation fueling and fuel distribution facilities convert to higher blends of ethanol and biodiesel. These higher-blend fuels must be greater than ten percent for ethanol and greater than five percent for biodiesel.
 


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 22, 2022, that as part of its commitment to re-evaluate policies and practices under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure they adhere to statutory requirements and the Biden Administration’s executive orders and directives, it has updated its policy to discontinue the use of exposure modeling thresholds when assessing the health and environmental risks of new chemicals under TSCA. According to EPA, due in part to the automation of modeling, it has become less burdensome to complete these calculations. Furthermore, according to EPA, removing the thresholds supports President Biden’s Executive Order 13985, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” which calls on federal agencies to advance equity, including by reviewing and revising as needed government policies and programs impacting underserved communities.
 
The New Chemicals Program will implement this change by making minimal changes to the coding in the New Chemical Review application to remove the thresholds and will update standard operating procedures and training materials for exposure and human health risk assessors. EPA states that it will implement this policy change “as soon as feasible.” According to EPA, despite the resource challenges it is currently facing in the TSCA program, it anticipates that the change “will have minimal impact on the amount of time it takes to complete new chemical reviews and that the benefits gained from a more comprehensive accounting of all potential air and water releases will help ensure any needed protections are in place before a new chemical can come to market.”
 
More information and a detailed commentary that discusses thresholds of toxicological concern (TTC) are available in our August 22, 2022, memorandum.


 

 By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on August 11, 2022, that a research team from Pacific Northwest National Laboratory investigated how potassium in biomass feedstocks poisons a catalyst. The researchers focused their study on potassium, a common alkali metal found in biomass feedstocks, since previous analysis of deactivated catalysts after catalytic fast pyrolysis (CFP) of woody biomass feedstock revealed potassium accumulation on the catalysts’ surface.
 
The research team simulated catalyst poisoning at different potassium levels to trigger deactivation during industrial operations. They then analyzed the catalysts and conducted kinetic measurements to determine how the catalysts’ ability to catalyze chemical reaction changed with the introduction of potassium. According to BETO, the team found potassium poisoning could be substantially mitigated with a developed regeneration method -- a water washing process -- that can successfully remove most of the loaded potassium, restoring more than 90 percent of the catalytic activities.
 
BETO states that the results of these studies provide new insights for the bioenergy industry that will foster improved catalyst design and regeneration for longer lasting catalysts. The studies also created “a solid knowledge base for developers of biomass conversion technologies to continue to build upon, making new and innovative conversion technologies less risky to research and develop.” According to BETO, the work “also supports accelerated process development that can help industry convert biomass feedstocks commercially, leading to more effective and inexpensive production of biofuels.”


 
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