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 National Academies of Sciences, Engineering, and Medicine (NASEM) announced on October 19, 2022, the release of a report finding that life cycle assessments (LCA) of transportation fuels are valuable tools for measuring environmental impacts, but uncertainties remain in the current models and further research should be conducted to strengthen their reliability. The report recommends ways to improve models, increase reporting and transparency, perform targeted verification of emissions, and other avenues that will better inform policymaking for reducing greenhouse gas (GHG) emissions from transportation fuels. According to NASEM, LCAs have been increasingly applied in the development of transportation fuel policy to estimate and help reduce GHG emissions from fuels such as electricity, biofuels, synthetic fuels, and hydrogen. NASEM states that the report finds that there is no single LCA method capable of answering all questions related to the climate impacts of a transportation fuel, and that both attributional LCA (ALCA) and consequential LCA (CLCA) have important roles to play. CLCA, which considers the consequences of a policy or decision, such as the market effects of production changes, should be used to understand wide-ranging impacts of proposed changes on net GHG emissions. ALCA, which assigns portions of observed environmental impacts from human activities to specific goods and services, can be used to attribute emissions in well-defined supply chains and help identify opportunities to reduce carbon intensity throughout that supply chain. Hybrid methods that use a combination of process-based and economic input-output methodologies can also be useful in some circumstances. In all cases, modelers should provide transparency, justification, and sensitivity or robustness analysis for modeling choices.
 
NASEM notes that the report contains a number of other findings and recommendations for assessing the emissions of specific transportation fuels and their feedstocks, including the following for biofuels:

• Study of land use changes from biofuels has been the topic of intense study over the last decade. Substantial uncertainties remain on key components of the models used to assess the impacts. More research into this area should be supported; and
• Biofuel production facilities typically produce additional products. The distinction between what qualifies as a co-product, byproduct, or waste can be unclear, creating uncertainty in LCA models.

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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.

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By Lynn L. Bergeson and Carla N. Hutton

The National Academies of Sciences, Engineering, and Medicine (NASEM) announced on July 21, 2022, publication of a new report entitled The Importance of Chemical Research to the U.S. Economy. The National Science Foundation (NSF), the Department of Energy (DOE), the National Institute of Standards and Technology (NIST), and the American Chemical Society (ACS) asked NASEM to convene a committee to consider strategies to sustain and enhance the economic activity driven by fundamental research investments in the chemical sciences. The chapter on “Sustainability for the Chemical Economy” includes the following general conclusions:

• Implementing a circular economy will require a paradigm shift in the way products are designed, manufactured, and used, and how the waste products are collected and reused. These new processes, and the use of clean energy and new feedstocks to enable these processes, will require novel chemistries, tools, and new fundamental research at every stage of design;
   
• Transitioning the chemical economy into a new paradigm around sustainable manufacturing, in which environmental sustainability is balanced with the need for products that will improve quality of life, enhance security, and increase U.S. competitiveness, will require substantial investment and innovation from industry, government, and their academic partners to create and implement new chemical processes and practices;
• As fundamental chemical research continues to evolve, the next generation of research directions will prioritize the future of environmental sustainability and new energy technologies. Keeping sustainability principles in mind during every stage of research and development will be critical to accomplishing this goal;
   
• Chemical research will have the greatest impact addressing energy and environmental sustainability if researchers and practitioners develop and use tools to quantify and mitigate environmental and human health impacts of new discoveries, are aware of the societal implications of their work, and if the research is driven by policies that identify specific environmental sustainability outcomes; and
   
• As the world moves deeper into its current energy transition, including the switch to electric vehicles, the implementation of clean energy alternatives, and the use of new feedstock sources, coupled with an increasing focus on circularity, decarbonization, computation, measurement, and automation will significantly alter the operations and processes of current industries, creating new opportunities and challenges that will benefit from fundamental chemistry and chemical engineering advances.

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