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.

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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.”

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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?

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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.

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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 and Carla N. Hutton
 
As part of the National Biotechnology and Biomanufacturing Initiative, the U.S. Department of Defense (DOD) announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. As reported in our March 30, 2023, blog item, on March 22, 2023, DOD released its Biomanufacturing Strategy to guide these investments, and its broader efforts in this critical technology field. According to the Biomanufacturing Strategy, as commercial use of new technologies expands, if the United States fails to invest in its domestic manufacturing capabilities, market forces could drive manufacturing overseas, often at the expense of the national economy and potentially creating vulnerabilities in the DOD supply of these products.
 
The Biomanufacturing Strategy is focused around three core principles:

• Establish DOD transition partners for early-stage innovations: Establishing DOD customers for biomanufactured capabilities will guide DOD technology investments. The core of the DOD Biomanufacturing Strategy is a culture shift throughout DOD that both recognizes and prioritizes, where applicable, biotechnology-based solutions to prevent strategic surprise.
• Develop the field of biomanufacturing through innovations in practice and application; According to the Biomanufacturing Strategy, research is required in scaling-up biomanufacturing to produce at a scale sufficient to prototype these products. The Biomanufacturing Strategy states although this is a hurdle in adopting biotechnology-based solutions to DOD mission needs, “it is also an incredible opportunity to develop biomanufacturing at home and with allies and partners to create a self-sustaining domestic biomanufacturing ecosystem.” It will also contribute to the United States remaining the “world leader in innovation,” guarantee DOD interests are protected, and ensure that U.S. global competitiveness in biotechnology is maintained.
• Map the domestic biomanufacturing ecosystem and the changes that occur over time for identification and tracking of metrics to support future implementation and refinement of the biomanufacturing strategy: According to the Biomanufacturing Strategy, for DOD to build enduring advantage through the implementation of the Biomanufacturing Strategy, DOD needs to address implementation risk. Concurrent with DOD’s need to prioritize where it places its resources in biomanufacturing, DOD “will support an upfront assessment of the biomanufacturing ecosystem, along with continued evaluation during and following early investments, allowing for more precise tailoring” of DOD resource allocation as the biomanufacturing ecosystem develops. The Biomanufacturing Strategy states that mapping the biomanufacturing ecosystem and establishing metrics to evaluate the bioeconomy “is central to mitigating implementation risk.”

In support of the Biomanufacturing Strategy, DOD issued a formal request for information (RFI) on biomanufactured products and process capabilities that could help address defense needs and whose development and commercialization could be addressed by DOD investment. The intent of the RFI is to gather information about U.S. national security industrial base shortcomings, risks, and opportunities that may be addressed by investments made under the provisions in Title III of the Defense Production Act (DPA). According to the RFI, biomanufactured products of interest include those that “enable capabilities within the following application and operational spaces of interest, and will bring revolutionary changes to military capabilities, the operations environment, and supply chain resiliency.” Such application and operational spaces may include, but are not necessarily limited to:

• Manufacture specialty chemicals and materials that are needed by DOD in an available and affordable manner (e.g., biomanufactured fuels and energetic precursors, biosynthetic fibers such as but not limited to spider silk, polymers, natural rubber/latex rubber, solvents);
• Enable reduced logistic costs, time, and energy through bio-composite and living materials (e.g., tunable materials with enhanced properties, self-healing materials);
• Maintain persistent sensing capabilities for sustained human and environmental intelligence (e.g., sensors for water quality monitoring, biobased energy harvesting in maritime systems);
• Augment human systems by impacting performance and protection (e.g., tailored proteins, but specifically excluding biopharma and probiotics); and
• Enable manufacturing defense relevant materials in a manner to reduce the impact on the environment while meeting or exceeding product performance requirements.

Responses are due by April 19, 2023, at 12:00 p.m. (EDT). The RFI notes that if late information is received, the government reviewers may consider it, depending on agency time constraints.

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By Lynn L. Bergeson and Carla N. Hutton

As reported in our March 30, 2023, blog item, on March 22, 2023, the White House Office of Science and Technology Policy (OSTP) released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals. The report includes five sections, each presenting goals that highlight what could be possible with the power of biology. The goals set ambitious national targets for the next two decades to help establish research and development (R&D) priorities that will be critical to advance the bioeconomy. Each section also outlines the essential R&D needed to achieve these goals for the U.S. bioeconomy, opportunities for public-private collaboration, and recommendations for enhancing biosafety and biosecurity. The report notes that achieving these goals will require significant prioritization of R&D investments and other efforts across the U.S. government, as well as actions from the private sector; state, local, and Tribal governments; and international partners.
 
The report states that bold goals for the U.S. bioeconomy include, for example:

• Climate: In 20 years, demonstrate and deploy cost-effective and sustainable routes to convert biobased feedstocks into recyclable-by-design polymers that can displace more than 90 percent of today’s plastics and other commercial polymers at scale;
• Food and Agriculture: By 2030, reduce methane emissions from agriculture, including by increasing biogas capture and utilization from manure management systems, reducing methane from ruminant livestock, and reducing methane emissions from food waste in landfills, to support the U.S. goal of reducing greenhouse gas (GHG) emissions by 50 percent and the global goal of reducing methane emissions by 30 percent;
• Supply Chain: In 20 years, produce at least 30 percent of the U.S. chemical demand via sustainable and cost-effective biomanufacturing pathways;
• Health: In 20 years, increase the manufacturing scale of cell-based therapies to expand access, decrease health inequities, and decrease the manufacturing cost of cell-based therapies tenfold; and
• Cross-Cutting Advances: In five years, sequence the genomes of one million microbial species and understand the function of at least 80 percent of the newly discovered genes.

According to this report, reaching these goals will require progress in other areas beyond R&D to ensure that innovation can lead to safe, effective, and equitable products that will grow the bioeconomy. The report states that in forthcoming reports and plans, departments and agencies will outline recommendations and steps that are underway to advance the following:

• Data for the bioeconomy -- Establishing a Data Initiative to ensure that high-quality, wide-ranging, easily accessible, and secure biological data sets can drive breakthroughs for the U.S. bioeconomy;
• Domestic biomanufacturing infrastructure -- Expanding domestic capacity to manufacture all the biotechnology products invented in the United States and to support a resilient supply chain;
• Workforce development -- Growing training and educational opportunities for the biotechnology and biomanufacturing workforce of the future;
• Regulatory clarity and efficiency -- Improving the clarity and efficiency of the regulatory process for biotechnology products to help ensure products come to market safely and efficiently;
• Biosafety and biosecurity -- Creating a Biosafety and Biosecurity Innovation Initiative to reduce risks associated with advances in biotechnology and biomanufacturing; and
• International engagement R&D -- Pursuing cooperation through joint research projects and data sharing, while mitigating risks and reaffirming democratic values.

According to the report, OSTP will lead the development of a strategy and implementation plan to execute on R&D priorities and other actions identified in the report.

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By Lynn L. Bergeson and Carla N. Hutton
 
To celebrate its 125th anniversary, ASTM International invited case study submissions from committee members to highlight standards that have made a significant impact in society. One of the winning entries is on a set of standards for biodegradable plastic from Committee D20 on Plastics. According to ASTM International’s article, standard test methods for determining the biobased content of solid, liquid, and gaseous samples using radiocarbon analysis (D6866) allows industry, regulators, and government to determine experimentally the percent biobased carbon present in a product or fuel. The article notes that the U.S. Department of Agriculture’s (USDA) BioPreferred^® program, mandated by Congress in the 2018 Farm Bill, authorizes the procurement of biobased products by the federal government. The article states that this standard is required to be used to report the percent biobased content of product for federal procurement, as well as for labeling a product with the BioPreferred logo showing biobased content.
 
The article states that there are two companion specification standards for compostable plastics and paper coatings, “redesigning plastic polymers for biodegradability in industrial composting for an environmentally responsible, managed end-of-life”:

• Standard specification for labeling of plastics designed to be aerobically composted in municipal or industrial facilities (D6400); and
• Standard specification for labeling of end items that incorporate plastics and polymers as coatings or additives with paper and other substrates designed to be aerobically composted in municipal or industrial facilities (D6868).

The standard specifications, which are “grounded in strong science and driven by consensus, provided much-needed clarity and credibility for acceptance in the marketplace and by regulatory bodies in states like California, Washington, Minnesota, Rhode Island, and Connecticut.” The article states that the BioPreferred program mandates D6866 as the only accepted standard for determining and reporting biobased content of products, and that the U.S. Environmental Protection Agency (EPA) requires the standard for reporting on biobased content in fuels. According to the article, industry uses D6400 and D6868 exclusively for making claims of biodegradability under industrial composting conditions. These standards are also the basis of certifications issued by U.S. and European organizations. The article notes that many stakeholders require that compostable products meet D6400 for plastics and D6868 for coatings on paper, and that industrial composters also require certification that the compostable products are certified to these standards.

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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our September 13, 2022, blog item, President Joseph Biden signed an Executive Order (EO) on September 12, 2022, 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 March 22, 2023, the White House Office of Science and Technology Policy (OSTP) published a fact sheet announcing “new bold goals and priorities that will catalyze action inside and outside of government to advance American biotechnology and biomanufacturing”:

• Harnessing Biotechnology and Biomanufacturing Research and Development (R&D) to Further Societal Goals: On March 22, 2023, OSTP released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals, outlining a vision for what is possible with the power of biotechnology and biomanufacturing and the R&D needs to achieve this ambitious vision. Biden’s EO called on federal departments and agencies to assess the potential for biotechnology and biomanufacturing R&D to further five societal goals: climate change solutions; food and agricultural innovation; supply chain resilience; human health; and crosscutting advances. The report includes individual sections authored by the Department of Energy (DOE), the U.S. Department of Agriculture (USDA), the Department of Commerce (DOC), the Department of Health and Human Services (DHHS), and the National Science Foundation (NSF), in consultation with other agencies and departments, that are responsive to the President’s EO. The goals and R&D needs outlined in the report serve as a guide for public- and private-sector efforts to harness the full potential and power of biotechnology and biomanufacturing to develop innovative solutions in different sectors, create jobs at home, build stronger supply chains, lower costs for families, and achieve our climate goals. According to the fact sheet, OSTP will now lead the development of an implementation plan to address the R&D needs outlined in the report.
   
• Establishing Biomanufacturing Priorities for DOD: As part of the National Biotechnology and Biomanufacturing Initiative, DOD announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. On March 22, 2023, DOD released its Biomanufacturing Strategy to guide these investments, and its broader efforts in this critical technology field. This strategy, which will guide research efforts and collaboration with the private sector and allies, sets three key priorities: establishing the customers within DOD that stand to benefit from early-stage innovations, advancing biomanufacturing capabilities through innovation, and mapping the biomanufacturing ecosystem and tracking metrics that support future efforts. In support of the strategy, DOD issued a formal request for information on biomanufactured products and process capabilities that could help address defense needs and whose development and commercialization could be addressed by DOD investment.
   
• Assessing the Economic Value of the Nation’s Bioeconomy: DOC’s Bureau of Economic Analysis released a new report 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 fact sheet, other deliverables from the EO are in development, including: a plan to expand training and education opportunities for the biotechnology and biomanufacturing workforce, a report on data needs for the bioeconomy, a national strategy for expanding domestic biomanufacturing capacity, actions to improve biotechnology regulation clarity and efficiency, and a plan for strengthening and innovating biosafety and biosecurity for the bioeconomy.

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By Lynn L. Bergeson and Carla N. Hutton
 
On March 27, 2023, the U.S. Environmental Protection Agency (EPA) announced that its Safer Choice program is accepting submissions for its 2023 Safer Choice Partner of the Year Awards. 88 Fed. Reg. 18135. The Safer Choice program certifies products containing ingredients that have met the program’s specific and rigorous human health and environmental toxicological criteria. According to EPA, the Safer Choice program allows companies to use its label on certified products that contain safer ingredients and perform, as determined by expert evaluation. EPA states that it developed the Partner of the Year Awards to recognize the leadership contributions of Safer Choice partners and stakeholders who have shown achievement in the design, manufacture, selection, and use of products with safer chemicals that further outstanding or innovative source reduction.
 
Similar achievement in the design, manufacture, selection, and use of Design for the Environment (DfE)-certified products will also make an organization eligible for the Partner of the Year Awards. The DfE program is a companion program to Safer Choice and certifies antimicrobial products. EPA states that the DfE logo may be used on certified products and helps consumers and commercial buyers identify products that meet the health and safety standards of the pesticide registration process required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well as the Safer Choice program’s stringent criteria for efficacy and effects on human health and the environment.
 
All Safer Choice stakeholders and program participants in good standing are eligible for recognition. Interested parties who would like to be considered for the award should submit to EPA an application detailing their accomplishments and contributions during calendar year 2022. EPA “especially encourages submission of award applications that show how the applicant’s work in the design, manufacture, selection, and use of those products promotes environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, improves drinking water quality, or advances innovation in packaging.” Submissions are due May 31, 2023. EPA will recognize award winners at a Safer Choice Partner of the Year Awards ceremony in fall 2023. More information on the 2023 Safer Choice Partner of the Year Awards, including the application form, submission process, and past winners, is available on EPA’s website.

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