By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) and Advanced Materials and Manufacturing Technologies Office (AMMTO) will host a workshop on “Transitioning to a Sustainable, Circular Economy for Plastics.” The June 8-9, 2023, workshop will convene stakeholders for a discussion of the current challenges and opportunities in transitioning to a sustainable domestic economy for plastics. According to DOE, it will include experts in recycling technologies and processes; polymer sciences; biobased plastics innovation and manufacturing; and plastics policy, economy, and sustainability. It will feature facilitated panel presentations and discussions on:

• The current landscape of plastics sustainability and circularity;
• Industry metrics in plastics sustainability and circularity;
• Supply chain and technology gaps;
• Decarbonization opportunities and pathways to achieve them; and
• Collaboration across the plastics value chain to accelerate transition to a more sustainable, circular economy.

DOE states that desired workshop outcomes include:

• Direct connections between stakeholders across the value chain to facilitate collaborations to accelerate innovation toward our collective decarbonization and circular economy goals;
• A publicly available, DOE-issued workshop report recording the discussed problems, research ideas, and industry feedback; and
• Input to ensure the DOE Strategy for Plastics Innovation evolves with the rapidly changing landscape to reflect current needs and challenges related to plastics sustainability and circularity.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 28, 2023, that it issued an emergency fuel waiver to allow E15 gasoline -- gasoline blended with 15 percent ethanol -- to be sold “during the summer driving season.” EPA states that this action will provide relief from ongoing market supply issues “created by Russia’s unprovoked war in Ukraine by increasing fuel supply and offering consumers more choices at the pump.” According to EPA, the waiver will help protect Americans from fuel supply crises by reducing reliance on imported fossil fuels, building U.S. energy independence, and supporting American agriculture and manufacturing. EPA notes that current estimates indicate that, on average, E15 is about 25 cents a gallon cheaper than E10.

By Lynn L. Bergeson and Carla N. Hutton
 
On April 11, 2023, a bipartisan group of legislators led by Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) sent a letter to the U.S. Environmental Protection Agency (EPA), urging it to strengthen the Renewable Fuel Standard (RFS) by maintaining the blending requirements for 2023; denying all pending Small Refinery Exemptions (SRE); eliminating proposed retroactive cuts to the renewable volume obligations (RVO); and setting RFS volumes at the statutory levels. According to Klobuchar’s April 14, 2023, press release, the letter states that the RFS “creates competition in the marketplace, keeping fuel costs low for consumers while bringing down carbon emissions.” By taking the suggested steps, EPA “can set the RFS on a path that provides stability and growth for the U.S. biofuel sector.” This would guarantee that this “essential program” continues to function as intended by reducing emissions, driving economic growth in rural communities, keeping gas prices low, and “bolstering national security by promoting an essential homegrown energy source.”

By Lynn L. Bergeson and Carla N. Hutton
 
On April 25, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it published a new five-year strategic plan. According to APHIS, it incorporates input it received from stakeholders on the strategic framework, a summarized version of the plan that it published in June 2022. The plan includes six strategic goals that focus on working to:

• Protect agriculture from plant and animal diseases and pests. Objective 5 is “Ensure the development of safe agricultural biotechnology products using a science-based regulatory framework.” This includes:
   
  • Conducting efficient risk-based permit review and issuance for organisms developed using genetic engineering to ensure they are safely contained or confined during movement or release;
     
  • Using plain language to communicate clearly APHIS regulations, expectations, and guidance to stakeholders, particularly those working with modified non-plant organisms potentially subject to APHIS regulations; helping stakeholders understand regulations through outreach, workshops, toolkits, and other means; and
     
  • Working with the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) to increase coordination and harmonization of regulatory oversight for biotechnology products within each agency’s existing statutory framework;
     
• Cultivate a talented, diverse, and public service-focused workforce where employees are supported, valued, and engaged;
   
• Reduce the impacts of zoonotic and emerging diseases and climate change. Objective 3 is “Mitigate and adapt to the effects of climate change.” This includes:
   
  • Incorporating climate change scenarios when evaluating the plant pest risk associated with biotechnology products; and
    ​
  • Working with federal partners to develop clear, efficient, predictable, and risk-based regulatory pathways for safely bringing microbial and other new products that help address climate change to market, and helping developers of such products navigate the regulatory system;
     
• Maintain and expand the safe trade of agricultural products nationally and internationally. Objective 2, “Maintain and expand the Agency’s leadership role through international standard setting and collaboration,” includes promoting engagement, collaboration, and harmonization of agricultural biotechnology regulation with trading partners, the Organization for Economic Cooperation and Development (OECD), and other international and regional organizations. Objective 3, “Create safe export opportunities,” includes:
   
  • Communicating to international stakeholders about APHIS’ processes and share outcomes of biotechnology product evaluations;
     
  • Working with trade agencies on technical aspects of trade in biotechnology products; and
     
  • Working with the regulatory authorities of U.S. trading partners to harmonize further regulatory frameworks for biotechnology products;
     
• Manage wildlife damage and threats to agriculture, natural resources, property, and people; and
   
• Promote the welfare of animals.

By Lynn L. Bergeson and Carla N. Hutton
 
Colorado State University (CSU) announced on April 11, 2023, that its chemists, led by Eugene Chen, University Distinguished Professor in the Department of Chemistry, have created a synthetic polyhydroxyalkanoate (PHA) platform. CSU states that PHAs are a class of polymers naturally created by living microorganisms or synthetically produced from biorenewable feedstocks. While they are biodegradable in the ambient environment, they are brittle and cannot easily be melt-processed and recycled. According to CSU, the synthetic PHA platform addresses each of these problems, “paving the way for a future in which PHAs can take off in the marketplace as truly sustainable plastics.”
 
The researchers searched for a strategy to address the intrinsic thermal instability of conventional PHAs. According to CSU, its chemists “made fundamental changes to the structures of these plastics, substituting reactive hydrogen atoms responsible for thermal degradation with more robust methyl groups. This structural modification drastically enhances the PHAs’ thermal stability, resulting in plastics that can be melt-processed without decomposition.” CSU notes that the newly designed PHAs are also mechanically tough, “even outperforming the two most common commodity plastics: high-density polyethylene -- used in products like milk and shampoo bottles -- and isotactic propylene, which is used to make automotive parts and synthetic fibers.” CSU notes that the new PHA can be chemically recycled back to its building-block molecule with a simple catalyst and heat, and the recovered clean monomer can be reused to reproduce the same PHA again.
 
The work was supported by the U.S. Department of Energy’s (DOE) Bio-Optimized Technologies to keep Thermoplastics out of Landfills and the Environment (BOTTLE™), a DOE multi-organization consortium “focused on developing new chemical upcycling strategies for today’s plastics and redesigning tomorrow’s plastics to be recyclable-by-design.” More information is available in a Science article entitled “Chemically circular, mechanically tough, and melt-processable polyhydroxyalkanoates.”

By Lynn L. Bergeson and Carla N. Hutton
 
The Office of Management and Budget (OMB) published a request for information (RFI) on April 27, 2023, seeking public input on existing or potential bioeconomy-related industries and products that are established, emerging, or currently embedded in existing industry/manufacturing processes. 88 Fed. Reg. 25711. As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) 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.” Under the EO, the Chief Statistician of the United States (CSOTUS) in OMB’s Office of Information and Regulatory Affairs (OIRA) was charged with improving and enhancing federal statistical data collection designed to characterize and measure the economic value of the U.S. bioeconomy. The CSOTUS was also charged with establishing an Interagency Technical Working Group (Working Group) to recommend bioeconomy-related revisions for the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS). OMB states that the bioeconomy refers to a segment of the total economy utilizing or derived from biological resources and includes manufacturing processes, technologies, products, and services. These may encompass, wholly or in part, industries and products including fuel, food, medicine, chemicals, and technology. To ensure consideration of comments on potential bioeconomy-related industries and products solicited in the RFI, OMB asked that all comments be submitted “as soon as possible,” but no later than June 12, 2023.
 
The Working Group, through OMB, seeks input on how to identify, classify, and measure best bioeconomy manufacturing, technology, and products, including those that are primarily or exclusively: (a) biobased, (b) components of traditional manufacturing processes, and (c) nascent biobased processes and products. Importantly, according to OMB, input should include information on how particular industries or products are linked to the bioeconomy and, where appropriate and available, evidence should be provided. OMB states that this will afford the Working Group the opportunity to use existing evidence to inform its recommendations. The RFI includes the following questions:

• What information and what high-priority concerns should the Working Group consider in making these recommendations for potential revisions to the NAICS and NAPCS that would enable characterization of the economic value of the U.S. bioeconomy?
   
• Which quantitative economic indicators and processes are currently used to measure the contributions of the U.S. bioeconomy? Are these indicators reasonably accurate measures of the product components, scope, and value of the bioeconomy? Please explain why.
   
• Which industries not currently measured as unique classifications in NAICS related to the bioeconomy should be considered? Similarly, which products not currently measured as unique classifications in NAPCS related to the bioeconomy should be considered? Please describe how a unique classification for such industry or product would meet the principles of NAICS and NAPCS. Please include a description of the industry or product, with specific examples. Please also provide an explanation of how such industry or product would advance understanding of measuring the bioeconomy.
   
• How might potential changes to the NAICS impact existing industry measurements, such as assessing changes in the economic output across current industries, time series measures, or data accuracy?
   
• What role can the NAPCS fill in order to advance measurement of biomanufacturing and biotechnology?
   
• Biobased processes and products that are embedded in traditional industries pose challenges for differentiation and measurement. Are there methodologies that can differentiate these bioeconomy processes from current manufacturing processes to enable measurement? If yes, please explain.
   
• What potential bioeconomy measurement strategies might be considered other than revisions to and inclusion in the NAICS or NAPCS? For example, are there ways the federal government could better collect information to provide better measurement on biobased processes or products in current industries?

By Lynn L. Bergeson and Carla N. Hutton
 
On April 25, 2023, the Council of the European Union (EU) announced that it approved the conclusions on the opportunities of the bioeconomy in light of current challenges, with special emphasis on rural areas. Using biomass to produce food, materials, and energy can help boost rural communities, increase competitiveness, and combat many of the challenges facing the EU. According to the press release, in their conclusions, ministers “highlighted the key role that the bioeconomy could play in achieving the environmental and climate goals under the European Green Deal, while also making the EU more competitive, helping it transition away from fossil-fuel dependency, and strengthening food security in the wake of Russia’s war of aggression against Ukraine.” The ministers also stressed the importance of promoting research and innovation and improving alignment between scientific advances and industry policy. The press release states that the conclusions will provide political guidance for the European Commission (EC) and EU member states on developing the potential of the bioeconomy in Europe.
 
While the Council of the EU welcomed the EC’s progress report on the implementation of the EU Bioeconomy Strategy, ministers put forward a number of recommendations intended to help boost the potential of the bioeconomy in Europe. In particular, they called on the EC to:

• Better integrate bioeconomy into all policies and ensure policy coherence;
• Facilitate knowledge transfer toward less developed regions and rural areas; and
• Update the EU Bioeconomy Strategy and associated action plan and carry out an in-depth assessment of actions being taken at the EU level.

Ministers also noted that the bioeconomy was an integral aspect of the reformed Common Agricultural Policy (CAP) and invited the EC to follow up on how EU member states had incorporated it into their national strategic plans.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Government Accountability Office (GAO) published a “Science & Tech Spotlight” on synthetic biology on April 17, 2023. GAO defines synthetic biology as “a multidisciplinary field of biotechnology that involves engineering the genetic material of organisms -- such as viruses, bacteria, yeast, plants, or animals -- to have new characteristics.” According to GAO, scientists are currently exploring the use of synthetic biology to address environmental challenges by engineering organisms to use carbon dioxide, produce biofuels for vehicles, and transform methane into biodegradable plastics. GAO notes that the synthetic biology market could grow from about $10 billion in 2021 to between $37 billion and $100 billion dollars by 2030. Opportunities include:

• Widely adaptable. Synthetic biology holds the potential to help diagnose and treat diseases, improve industrial processes, and address some environmental challenges;
• More equitable access to biotechnology. Some of the tools needed for synthetic biology are low-cost and widely available, which could make access to beneficial applications more equitable; and
• Conservation efforts. Synthetic biology could support endangered species conservation, for example, by altering the genes of endangered plants to make them resilient to diseases.

GAO notes the following challenges:

• Safety and security concerns. Synthetic biology could pose a significant threat to national security if it were used for nefarious purposes, such as developing new biological or chemical weapons. Additionally, the computational tools used for synthetic biology could be vulnerable to cyberthreats such as automation hacking. For example, a bad actor could manipulate or steal information and use it to create drugs, weapons, or other harmful products.
• Environmental effects. Organisms made using synthetic biology and released into the environment could have unknown, unintended, and potentially irreversible effects on ecosystems. Such effects could be widespread if, for example, these organisms negatively affected food or water systems.
• Public acceptance and access. The public may hesitate to accept certain applications of synthetic biology due to concerns about interfering with nature and about unintended effects. In addition, some medical applications could be inaccessible for some patients due to cost or location of treatment centers.

GAO concludes the “Science & Tech Spotlight” with the following policy context and questions:

• Do policymakers have adequate access to expertise and resources to evaluate the societal effects and public policy implications of synthetic biology research and development?
• How effective is the coordination among 1) domestic and 2) global stakeholders for monitoring and assessing the risks associated with advances in synthetic biology research and applications?
• Is the current regulatory framework sufficient to address ongoing and future applications and their effects without unnecessarily hindering U.S. competitiveness in synthetic biology?

By Lynn L. Bergeson and Carla N. Hutton
 
On April 5, 2023, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) issued a report on the food safety aspects of cell-based food, which is animal agricultural products grown directly from cell cultures. FAO, in collaboration with WHO, developed the report to engage with respective members and relevant stakeholders “by proactively sharing the current knowledge to identify concrete ways to inform consumers and all other stakeholders about the food safety considerations for cell-based food products.” The report includes a literature synthesis of relevant terminology issues, principles of cell-based food production processes, and the global landscape of regulatory frameworks for cell-based food production. The report includes case studies from Israel, Qatar, and Singapore to highlight different scopes, structures, and contexts surrounding their regulatory frameworks for cell-based food. The results of the November 2022 FAO-led expert consultation, where comprehensive food safety hazard identification was conducted, form the core of the report. According to the report, during the expert consultation, all potential hazards were discussed in the four stages of the cell-based food production: cell-sourcing; cell growth and production; cell harvesting; and food processing. According to FAO, the way forward will consist of continuing to invest in research and development to understand whether the alleged benefits in increased sustainability can be realized. FAO states that in this regard, “it will be important to closely observe as to what extent, if any, cell-based foods result in differences from conventionally produced foods.”

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture (USDA) announced on April 11, 2023, that its Agricultural Research Service (ARS) recently developed sustainable, machine-washable antimicrobial wipes that can be used at least 30 times for cleaning hard and nonporous surfaces. According to USDA, ARS researchers developed the antimicrobial wipes “by using raw cotton fiber that naturally produced silver nanoparticles inside the fiber in the presence of a silver precursor.” USDA states that the embedded silver nanoparticles then release silver ions that act as antibacterial agents and kill harmful bacteria. USDA notes that in their research, scientists found that the wipes killed 99.9 percent of harmful bacteria S. aureus and P. aeruginosa on surfaces.
 
USDA states that the advantages to this technology include omitting the conventional pretreatments of raw cotton fibers (such as scouring and bleaching), which consume a large number of chemicals and energy, and not requiring any chemical agents except for a silver precursor. According to USDA, the technology “also transforms cotton fibers themselves into antimicrobial agents rather than serving as a carrier of antimicrobial agents, which is what makes them reusable.” USDA notes that the antimicrobial wipes are made from “natural cotton fibers, rather than conventional petroleum-based synthetic fibers.” The wipes can be reused by being washed in the laundry.
 
More information on the antimicrobial wipes is available in an article in Molecules entitled “Washable Antimicrobial Wipes Fabricated from a Blend of Nanocomposite Raw Cotton Fiber.”

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on April 10, 2023, that it is inviting public comment on a draft Environmental Assessment (EA) and draft Plant Pest Risk Assessment (PPRA). 88 Fed. Reg. 21602. APHIS states that it produced these documents in response to a petition from Pioneer Hi-Bred International, Inc. seeking deregulation of a corn variety developed using genetic engineering to resist corn rootworm and tolerate glufosinate herbicides. APHIS is seeking public comment on these documents for 30 days. APHIS will thoroughly review and consider all public input submitted during the comment period and will use this information to complete and publish final environmental documents and its regulatory determination. Comments are due May 11, 2023. APHIS has posted the following documents:

• Petition;
• Draft Environmental Assessment; and
• Draft Plant Pest Risk Assessment.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold training on May 23, 2023, on Generalized Read-Across (GenRA), a publicly available tool that uses an automated approach to make reproducible read-across predictions of toxicity. EPA states that read-across “is a commonly used data gap filling technique whereby endpoint information for one substance is used to predict the same endpoint for another substance, supported by structural or other feature similarities.” According to EPA, while read-across sometimes relies on subjective or expert judgement, use of the GenRA tool could provide more objective and reproducible read-across predictions. Specifically targeted for decision-makers, this training will provide:

• A presentation overview of GenRA’s purpose and scope;
• A demonstration of GenRA’s interface and navigation; and
• Opportunities for participatory learning and engagement.

The virtual training will feature EPA’s Dr. Grace Patlewicz. The training will include a plenary presentation, small group discussions, and a chance to try out GenRA. EPA has divided the training into two parts to accommodate a variety of interests and schedules. Registration for one or both sessions is free but required.

• Session 1 (Presentation and Questions and Answers (Q&A)) 11:00 a.m. - 12:30 p.m. (EDT)

This session will provide an overview of GenRA content and function with opportunities for participation and Q&A.

• Session 2 (Breakout Sessions) 12:30 - 1:30 p.m. (EDT)

This session will break participants into breakout rooms to work on exercises in small groups, aided by facilitators.

By Lynn L. Bergeson and Carla N. Hutton
 
On March 23, 2023, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced the release of its 2023 Multi-Year Program Plan (MYPP). The MYPP is used as an operational guide, setting forth BETO’s mission, goals, and strategic approach. It also serves as a resource to help manage and coordinate BETO’s activities and communicate its strategy to stakeholders and the public. The new plan identifies BETO’s forthcoming research, development, and demonstration (RD&D) plans and activities and outlines why these undertakings are critical to meeting the energy and sustainability challenges facing our nation. According to BETO, due to the urgency of reducing greenhouse gases (GHG) across all modes of transportation, BETO has shifted its focus to low-carbon and net-zero carbon fuels for the aviation, marine, rail, and heavy-duty, long-haul industries, which have fewer options for reducing carbon impact. The MYPP prioritizes strategies to enable the decarbonization of the industrial sector via the advancement of renewable chemicals and materials, recognizing the potential for bioenergy technologies to decarbonize communities and other economic sectors through sustainable agriculture, improved waste management, and additional beneficial uses of biomass.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Government Accountability Office (GAO) publicly released a report on March 27, 2023, entitled Sustainable Aviation Fuel: Agencies Should Track Progress toward Ambitious Federal Goals. According to GAO, sustainable aviation fuel (SAF) production and use in the United States have increased in recent years; this fuel is now used by airlines at two major commercial airports in California. GAO states that while U.S. production reached 15.8 million gallons in 2022, it accounted for less than 0.1 percent of the total jet fuel used by major U.S. airlines, “fall[ing] well below the previous Federal Aviation Administration goal for U.S. airlines to use 1 billion gallons of SAF per year by 2018.”
 
To reduce greenhouse gas emissions (GHG) from the aviation sector, the White House announced an SAF Grand Challenge in September 2021. The Grand Challenge goal is to supply three billion gallons of SAF per year by 2030 and 100 percent of expected domestic commercial jet fuel use by 2050. GAO was asked to review the federal role in SAF. GAO’s report discusses the state of SAF production and use for the U.S. commercial aviation industry and factors shaping this market, identifies how federal agencies have supported SAF, and assesses how they will monitor progress toward Grand Challenge goals. According to GAO, the roadmap published by the U.S. Department of Transportation (DOT), U.S. Department of Energy (DOE), and U.S. Department of Agriculture (USDA) does not establish performance measures to monitor, evaluate, and report the results of these actions. GAO states that without performance measures, the agencies are not well positioned to evaluate the effectiveness of federal government actions to meet the Grand Challenge goals. In contrast, according to GAO, establishing and using such measures can help identify progress on the extent to which SAF is contributing to emission reductions.
 
GAO recommended that DOT, DOE, and USDA develop and incorporate performance measures into the Grand Challenge roadmap. According to GAO, DOT and USDA concurred. DOE indicated the recommendation is completed and that planned roadmap activities will enable progress to be measured. GAO notes that as discussed in its report, it disagrees that the recommendation is completed.

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.”