By Lynn L. Bergeson and Carla N. Hutton
 
President Joseph Biden’s September 12, 2022, Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative directs the U.S. Department of Commerce’s (DOC) Bureau of Economic Analysis (BEA) to assess “the feasibility, scope, and costs of developing a national measurement of the economic contributions of the bioeconomy.” As reported in our March 30, 2023, blog item, BEA released a March 2023 report on Developing a National Measure of the Economic Contributions of the Bioeconomy 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 report, in the case of the bioeconomy, researchers, potential data users, and other stakeholders have different (and competing) ideas of how the bioeconomy should be defined and which industries should be included or excluded. The report states that these different ideas can be summarized into three distinct visions for the bioeconomy:

• Biotechnology: The biotechnology vision focuses on emerging industries and products enabled by innovation in the life sciences, particularly in genetic engineering; in this vision, established industries such as agriculture and forestry are typically not included;
• Bioresources: The bioresources vision focuses on understanding the flow of biological resources, such as biomass and biofuels, through the economy; in this vision, the agriculture and forestry industries are included as foundational components of the bioeconomy; and
• Bioecology: The bioecology vision focuses on the contributions of the bioeconomy to sustainability and the environment; this vision may specifically exclude some products or industries, such as genetically engineered crops.

The report states that it finds that developing a comprehensive bioeconomy satellite account encompassing all concepts of the bioeconomy appears technically feasible. The report notes that “[s]uch a broad approach would roughly correspond to similar efforts by the European Union (EU) and other international organizations but would not address data users’ preferences for an account more focused on a specific vision of the bioeconomy.” The report states that “[d]eveloping a consistent, ongoing bioeconomy satellite account broken down along the lines of specific visions of the bioeconomy, such as biotechnology, is likely infeasible at this time due to both a lack of existing data on which to base such an account and a lack of consensus on practical measurement definitions.”

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By Lynn L. Bergeson

On March 10, 2020, EPA announced that it issued a final rule to add two strains of microorganisms to the list of microorganisms eligible for an exemption from certain reporting requirements under the Toxic Substances Control Act (TSCA). EPA states that manufacturers of new intergeneric Trichoderma reesei (strain QM6a) and Bacillus amyloliquefaciens (subspecies amyloliquefaciens) may now be eligible to undergo a streamlined review process under TSCA’s new chemicals review program with reduced TSCA fees. The final rule is intended to ensure the safety of human health and the environment while reducing regulatory burden for the biotechnology industry.

EPA states that after reviewing all relevant health and safety data, it determined that the two microorganisms can be added to the list of microorganisms eligible for exemption. Under TSCA, manufacturers of a new intergeneric microorganism may be eligible to submit an exemption request in lieu of a microbial commercial activity notice (MCAN) if the organism is on the list of species eligible for an exemption and meets other criteria. EPA is including these two microorganisms on the list because it determined that the microorganisms “will not present an unreasonable risk of injury to health or the environment provided that the other criteria relating to the introduced genetic material and the physical containment of the new microorganisms have been met.”

According to EPA, both microorganisms have a long history of safe use to produce a variety of commercial enzymes used in industrial and food-related industries. Trichoderma reesei is used by the animal feed, baking, beverages, textile processing, detergent, pulp and paper, industrial chemicals, and biofuels industries. Bacillus amyloliquefaciens has been used to produce commercial enzymes for more than 50 years. It produces carbohydrases, proteases, nucleases, xylanases, and phosphatases that have applications in the food, brewing, distilling, and textile industries.

The final rule will be effective April 9, 2020.

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

On September 17, 2019, U.S. Senator Lisa Murkowski (R-AK) chaired a hearing to discuss the use and sourcing of minerals needed for clean energy technologies. Highlighting the fact that renewable technologies such as batteries and wind turbines are built from minerals, Senator Murkowski stated that “[t]he United States is capable of being a leader in the development of the minerals needed for clean energy technologies.” As Chairman for the Committee on Energy and Natural Resources, she further argued that for this to be achieved, the production, manufacturing, and recycling of minerals must expand to rebuild a robust domestic supply chain. In her opening statement, Senator Murkowski announced the release of a report by the Congressional Research Service. The report summarizes analyses of the quantity of materials needed to meet renewable and greenhouse gas (GHG) emission goals. The report includes an analysis of a World Bank Group (WB) study, which forecasts that demand for certain minerals will increase under an aggressive scenario to limit warming. The other two analyses in the report consist of DOE critical mineral demand projections and a gross domestic product (GDP) electricity demand study by Halada et al.

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By Lynn L. Bergeson

In early January 2019, the International Renewable Energy Agency (IRENA) published a report called A New World: The Geopolitics of Energy Transformation. Analyzing the geopolitical implications of the global energy sector that is being driven by renewables, the report was created by the Global Commission on the Geopolitics of Energy Transformation in early 2018. A ten-month project, the deliberations by the Commission consider the move of renewables to the center of the global energy landscape. The report claims that global energy transformation driven by renewables “will reshape relations between states and lead to fundamental structural changes in economies and society. […] Global power structures and arrangements will change in many ways and the dynamics of relationships within states will also be transformed.” Arguing that power will become more decentralized and diffused, states that are heavily invested in renewable technologies (such as China) will have greater influence. In contrast, states that rely on fossil fuel to a greater extent will lose influence. Furthermore, the abilities for countries to achieve energy independence will enhance their development, security, sustainability, and equity. As an important step in the direction of addressing climate change, combatting pollution, and promoting prosperity and sustainable development, states must be prepared to create a foundation for dialogue, debate, and policy actions focused on energy transformation.

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By Lynn L. Bergeson

On March 28, 2018, Bioenergy Australia and the Queensland University of Technology (QUT) released “Biofuels to bioproducts: A growth industry for Australia.” The paper calls for the implementation of a Five-Point Plan creating a bioenergy policy framework to spur growth in Ausralia’s bioeconomy.  The paper also argues that the current lack of policy and programs encouraging the bioenergy industry have hurt Australia as it has missed out on economic, social, and environmental benefits that other countries have experienced as a result of bioeconomy growth. It is suggested that “increased use of 10 per cent ethanol-blended petrol (E10) in Australia could create more than 8600 direct & indirect jobs, attract $1.56 billion in investment and generate more than $1.1 billion in additional revenue each year in regional areas.” The researchers proposed a Five-Point Plan in the paper, which includes:

1. Developing a national biofuels, biobased products, and bioeconomy strategy;
2. Implementing a national biofuels mandate supporting the introduction of higher quality fuels;
3. Providing supporting mechanisms of education, incentives, and infrastructure;
4. Establishing policy frameworks for advanced/drop-in biofuels, biochemical, and biobased products; and
5. Supporting commercial developments through industry and research collaboration.

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By Kathleen M. Roberts

On July 31, 2017, the U.S. Energy Information Administration (EIA) released its monthly biodiesel production report for May 2017.  According to the report, U.S. biodiesel production increased by nine million gallons between April and May of this year, and by 1 million gallons compared to May 2016.  The Midwest (Petroleum Administration for Defense District 2) accounted for 69 percent of the total U.S. biodiesel produced.  The report also states that 66 million gallons of 100 percent biodiesel (B100) were sold, and an additional 82 million gallons of B100 were sold in biodiesel blends.  Of the 1,054 million pounds of feedstocks used to produce biodiesel in May 2017, soybean oil remained the largest biodiesel feedstock with 546 million pounds consumed in May.

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By Kathleen M. Roberts

On July 20, 2017, USDA released its technology transfer report for fiscal year 2016.  The report outlines the public release of information, tools, and solutions and the adoption and enhancement of research outcomes by collaborative partners and formal Cooperative Research and Development Agreements (CRADA) that occurred in 2016.
 
The report highlights several research initiatives by ARS scientists focused on supporting the bioeconomy, including:

• Development of a new yeast strain with a unique cellulolytic enzyme that efficiently breaks down biofeedstock, shows resistance to inhibitory compounds, and eliminates the need to add other enzymes to the production process;
• Engineering a yeast strain from a Brazilian ethanol plant to convert plant xylose to ethanol and then identifying a strain with excellent performance;
• dentification of a strain of yeast capable of converting inulin, a major polysaccharide derived from coffee processing waste, into cellulosic ethanol;
• Development of genetic methods to control the conversion of agricultural sugars to compounds called liamocins using yeast; and
• Studying the use of lytic enzymes as an alternative to antibiotics for preventing and controlling bacterial contamination of fuel ethanol fermentations during biorefining.

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By Lauren M. Graham, Ph.D.

On July 14, 2017, the Royal Academy of Engineering (Academy) published a report on the sustainability pros and cons of biofuels, which was commissioned by the Department of Transport and the Department for Business, Energy and Industrial Strategy.  The report aims to provide advice on the future strategy for the development of biofuels in the United Kingdom (UK).  In its statement announcing the report, the Academy stated that biofuels, particularly second generation biofuels from waste and byproducts, have a role to play in meeting the UK commitment to climate change mitigation.  While such biofuels have the potential to be sustainable and make a real impact, the Academy warned that action is needed to manage risks, improve traceability, and avoid fraudulent practice. 
 
The report calls on government to incentivize the development of second generation biofuels in the UK, specifically those derived from wastes and agricultural, forest, and sawmill residues, and to incentivize the use of marginal land, such as land unsuitable for food production or housing, for the production of biofuels.  The Academy also recommended that the government properly regulate the biofuels sector with clear and consistent categorization of wastes and residues to help avoid unintended market distortions within the UK and internationally, and that other sustainability issues, such as competitiveness of biofuels with fossil fuels; food, energy and water security; employment provision; rural development; and human health impacts, be evaluated.

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By Lauren M. Graham, Ph.D.

On June 30, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released the final version of its report Preparing for Future Products of Biotechnology, which is the result of a collaboration by a committee of experts convened by NAS.  The report provides an overview of the committee’s discussion on “the future products of biotechnology that are likely to appear on the horizon, the challenges that the regulatory agencies might face, and the opportunities for enhancing the regulatory system to be prepared for what might be coming.”  The committee reached consensus on its conclusions and recommendations regarding actions that can be taken to enhance the capabilities of the biotechnology regulatory system to prepare for the anticipated future of biotechnology products, which are also presented in the report.
 
More information on the NAS report is available in the Biobased and Renewable Product Advocacy Group (BRAG^®) blog post “NAS Releases Final Report on Preparing for Future Products of Biotechnology.”

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By Lynn L. Bergeson and Margaret R. Graham

On June 30, 3017, the National Academies of Sciences, Engineering, and Medicine (NAS) released its final version of its report Preparing for Future Products of Biotechnology, which it states “analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making [and] … identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.”  This report is a collaboration among a committee of experts including the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System (Committee), the Board on Life Sciences, the Board on Agriculture and Natural Resources, the Board on Chemical Sciences and Technology, and the Division on Earth and Life Studies and sponsored by the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA).  Lynn L. Bergeson was an external contributor to the Committee’s deliberations and presented before the Committee on the subject of the biotechnology regulatory system.  

The report includes sections on emerging trends and products of biotechnology; the current biotechnology regulatory system; understanding risks related to future biotechnology products; opportunities to enhance the capabilities of the biotechnology regulatory system; and an index on congressionally defined product categories that FDA regulates; as well as conclusions and recommendations that were included in our blog item on the prepublication version.

More information on the regulatory issues of biotechnology products is available on our biobased products blog under key word biotechnology, as well as the Bergeson & Campbell, P.C. (B&C®) regulatory developments website under key phrase biobased products, biotechnology.

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