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
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
The U.S. Environmental Protection Agency (EPA) announced on August 18, 2022, that it is accepting nominations for the 2023 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. The awards again include a category to recognize technology that reduces or eliminates greenhouse gas (GHG) emissions. EPA will hold a webinar on September 28, 2022, from 2:00 to 3:30 p.m. (EDT) to educate stakeholders on the Green Chemistry Challenge Awards and the nomination process. Registration for the webinar is open. Nominations are due to EPA by December 9, 2022.
EPA states that green chemistry is the design of chemical products and processes that reduce or eliminate the generation and use of chemicals that are hazardous to the environment and people’s health. According to EPA, its efforts to “speed the adoption of this revolutionary and diverse discipline” have led to significant environmental benefits, innovation, and a strengthened economy. Green chemistry aims to prevent pollution before it is created, making it the preferred approach for providing solutions to some of the most significant environmental challenges.
An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2023 nominations and make recommendations to EPA for the 2023 winners. EPA anticipates giving awards to outstanding green chemistry technologies in six categories in fall 2023.
By Lynn L. Bergeson and Carla N. Hutton
According to an item in the U.S. Department of Agriculture’s (USDA) Unified Agenda, which was published on June 21, 2022, USDA intended to publish in June 2022 a proposed rule that would codify BioPreferred Program guidance. According to the item, USDA expects this action to reduce burden on both it and the applicants by reducing requirements, clarifying requirements, streamlining the application and certification process, and increasing efficiencies in program delivery. The item states that codification for all Program guidance “will ensure consistency in how programs are administered.” Improvements will also “facilitate the sales of the business using the labeling program.”
The BioPreferred Program is intended to spur economic development, create new jobs, and provide new markets for farm commodities. The two major parts of the Program are:
- Mandatory purchasing requirements for federal agencies and their contractors; and
- A voluntary labeling initiative for biobased products.
By Lynn L. Bergeson
On June 6, 2022, EPA announced the winners of the 2022 Green Chemistry Challenge Awards. EPA states that green chemistry “is the design of chemical products and processes that reduce or eliminate the generation and use of hazardous substances.” According to EPA, the winners “have developed new and innovative green chemistry technologies that provide solutions to significant environmental challenges and spur innovation and economic development.” In support of the Biden Administration’s commitment to tackle the climate crisis, EPA added a new award category recognizing technology that reduces or eliminates greenhouse gas (GHG) emissions. The 2022 winners include:
- Professor Song Lin of Cornell University, Ithaca, New York, for developing a new, more efficient process to create large and complicated molecules that are widely used in the pharmaceutical industry. EPA states that the new technology avoids using hazardous materials and has the potential to reduce both energy use and wasteful byproducts.
- Merck, Rahway, New Jersey, for developing a greener way to make LAGEVRIO™ (molnupiravir), an antiviral treatment for COVID-19. According to EPA, Merck significantly improved the manufacturing process for this antiviral drug in a short time, producing ingredients more efficiently and greatly reducing solvent waste and energy use.
- Amgen, Thousand Oaks, California, for an improved manufacturing process for LUMAKRAS™ (sotorasib), a novel drug for the treatment of certain non-small cell lung cancers. EPA states that Amgen’s innovation decreased manufacturing time, lowered the amount of solvent waste generated, and established a recycling process for a high-value waste stream.
- Provivi, Santa Monica, California, for creating ProviviFAW®, a biological pheromone-based product that controls the fall armyworm, a destructive pest of corn. The product’s pheromone active ingredients are produced through innovative green chemistry using renewable plant oils. According to EPA, ProviviFAW™ can reduce the need for conventional pesticides, which can be harmful to beneficial insects, such as pollinators.
- Professor Mark Mascal of the University of California, Davis, California, in partnership with Origin Materials, for a technology that reduces GHG emissions by producing chemicals for making polyethylene terephthalate (PET) plastic from biomass derived from sugar fructose rather than petroleum. EPA states that this novel chemistry could have significant climate impacts by replacing fossil-based products with carbon-neutral, biobased products, especially when the technology is scaled to an entire industry.
EPA recognized the winners during the American Chemical Society Green Chemistry & Engineering Conference. EPA states that since 1996, EPA and the American Chemical Society, which co-sponsor the awards, have received more than 1,800 nominations and presented awards to 133 technologies that decrease hazardous chemicals and resources, reduce costs, protect public health, and spur economic growth. According to EPA, winning technologies are responsible for reducing the use or generation of nearly one billion pounds of hazardous chemicals, saving over 20 billion gallons of water, and eliminating nearly eight billion pounds of carbon dioxide equivalents released to the air.
The American Chemical Society’s Green Chemistry Institute® (ACS GCI) will host its 26th Annual Green Chemistry & Engineering (GC&E) Conference in Reston, VA, from June 6 to June 8, 2022. The theme for the 2022 GC&E Conference is “Thinking in Systems: Designing for Sustainable Use.” This theme will explore how green and sustainable chemistry and engineering contribute to the development and commercialization of products for sustainable use.
On June 6, 2022,B&C will moderate a session organized by B&C’s Director of Chemistry, Richard E. Engler, Ph.D., and Ligia Duarte Botelho, Regulatory Assistant, titled “The Role of Sustainable Thinking in New Chemical Reviews.” B&C’s symposium will explore the “new chemical bias” and how it continues to pose a barrier to market acceptance of novel chemistry and sustainable thinking. Organized as a panel discussion, company representatives, EPA scientists, and invited speakers from non-governmental organizations will explore the “new chemicals bias,” as it is called, and how it continues to pose a barrier to market acceptance of novel chemistry and sustainable thinking. Attendees will gain an understanding of the regulatory landscape of TSCA implementation and how EPA might change its approach to reduce barriers to circular economy innovations. Ms. Botelho, the moderator, will introduce the topic, and following brief introductory remarks, the panelists will engage in 20 minutes of practical discussion, including a question and answer session to engage with the audience. Registration information is available here.
Bergeson & Campbell, P.C.’s (B&C®) May 18, 2022, webinar “Domestic Chemical Regulation and Achieving Circularity” is now available for on-demand viewing. During this one-hour webinar, Lynn L. Bergeson, Managing Partner, B&C, moderated a timely and fascinating review of the state of sustainable chemical regulation in the United States with Kate Sellers, Technical Fellow, ERM; Mathy Stanislaus, Vice Provost, Executive Director, The Environmental Collaboratory, Drexel University; and Richard E. Engler, Ph.D., Director of Chemistry, B&C.
A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful lives. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. During the webinar, Ms. Sellers outlined barriers and enablers to the circular economy, including practical challenges like supply chain limitations and industry frameworks; Dr. Engler highlighted how the Toxic Substances Control Act (TSCA) regulates discarded substances used as feedstocks by others and articles that may contain contaminants that could affect how an article is classified by the U.S. Environmental Protection Agency (EPA) under TSCA; and Mr. Stanislaus reviewed policy issues, including waste management hierarchy, circular economy hierarchy, and other mechanisms that incentivize sustainability.
We encourage you to view the webinar, listen to the All Things Chemical® episodes “Trends in Product Sustainability and Circularity — A Conversation with Kate Sellers” and “How Can Battery Production Be Greener? — A Conversation with Mathy Stanislaus,” read ERM’s report Circularity: From Theory to Practice, and subscribe to B&C’s informative blogs and newsletters.
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On April 9, 2022, researchers from the University of Groningen’s Stratingh Institute for Chemistry and the Department of Chemistry, Organic and Bioorganic Chemistry at the University of Graz, published a study in the journal Green Chemistry titled “A molecular motor from lignocellulose.” The study explores lignin’s use as the largest natural source of functionalized aromatics on the planet and its inherent structural features. The authors showcase the synthesis of a novel light-driven unidirectional motor from a specific aromatic platform chemical that can be obtained through a reductive catalytic fractionation strategy of lignocellulose. Taking into account the principles of green chemistry, the synthetic path used in the study aims to maintain the intrinsic functionality of the lignin-derived platform molecule. The molecular motor is synthesized for the first time from exclusively renewable building blocks sourced from renewable feedstock. According to the study, this concept can be applied as a general strategy that opens paths for future machines, motors, and nanoscience made from sustainable sources. This strategy would benefit the environment and decrease expenses related to hazardous waste management.
By Lynn L. Bergeson
On December 22, 2021, Cargill announced an agreement with Croda to acquire the majority of its performance technologies and industrial chemicals business in Summer 2022, pending regulatory approvals. This investment includes biobased and renewable technologies used in the automotive, polymer, and food packaging industries, as well as production facilities across Europe and Asia. “The bioindustrial space is a priority for Cargill, as we strive to support our customers with innovative, nature-based solutions that deliver real-world benefits,” said Colleen May, President of Cargill’s Bioindustrial business. “Combining our diverse, global supply chain and deep operational expertise with Croda’s extensive industrial business capabilities and broad bio-based portfolio will spark a new wave of innovation and create tremendous value for our customers.”
By Lynn L. Bergeson