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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has opened registration for the second ECOTOXicology Knowledgebase (ECOTOX) virtual training on February 7, 2023. ECOTOX is a comprehensive, publicly available tool providing environmental toxicity data on aquatic life, terrestrial plants, and wildlife.  EPA states that the virtual training, which is specifically targeted for decision-makers, will provide:

  • An overview of the database content and function;
     
  • Application-oriented use case demonstrations; and
     
  • Opportunities for participatory learning and engagement.

According to EPA, the virtual training will be a live encore of the training offered in May 2022, presenting the same material and featuring expanded opportunity for live interaction in Session 2. Participants may register for one or both sessions; registration is free but required to attend each session.
 
Session 1 (Presentation and Questions and Answers (Q&A))
11:00 a.m.-12:30 p.m. (EST)
This session will provide an overview of the knowledgebase content and function with opportunities for participation and Q&A.
 
Session 2 (Breakout Sessions)
12:30-1:30 p.m. (EST)
This session will break participants into breakout groups to work on case study exercises in small groups, aided by facilitators.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy (DOE) recently published its new Strategy for Plastics Innovation (SPI), which will guide DOE’s collaborative research and development (R&D) on plastic waste reduction. Four strategic goals focus the scope of the SPI:

  • Deconstruction: Create new chemical, thermal, and biological/hybrid pathways to deconstruct plastics efficiently into useful chemical intermediates;
     
  • Upcycling: Advance the scientific and technological foundations that will underpin new technologies for upcycling chemical intermediates from plastic waste into high-value products;
     
  • Recyclable by Design: Design new and renewable plastics and bioplastics that have the properties of today’s plastics, are easily upcycled, and can be manufactured at scale domestically; and
     
  • Scale and Deploy: Support an energy- and material-efficient domestic plastics supply chain by helping companies scale and deploy new technologies in domestic and global markets, while improving existing recycling technologies such as collection, sorting, and mechanical recycling.

According to the SPI, a lack of robust chemical and biological mechanisms limits the deconstruction of existing plastics. This is further complicated by the need for more robust processes that can convert diverse and contaminated plastic waste streams into useful chemical intermediates that can be upcycled into high-value products. The SPI states that “even when robust processes are developed to deconstruct existing plastics, the demand for plastics remains, leading to a critical need for new plastic materials that have the same advantages as current plastics but can be economically recycled or biodegraded safely in the environment.” The SPI notes that underscoring these goals “is the need to approach this problem in a manner informed by life cycle and techno-economic assessment, ensuring solutions are cost-competitive and environmentally benign.” The SPI identifies key research needs and opportunities for DOE-sponsored R&D and catalogs challenges and opportunities facing SPI efforts. DOE intends the SPI to transform its approach to plastic waste and develop new classes of plastic that are recyclable and upgradable by design.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s Bioenergy Technologies Office (BETO) announced on January 23, 2023, that researchers at the National Renewable Energy Laboratory (NREL) examined the benefits and trade-offs of current and emerging technologies for recycling certain types of plastics to determine the optimal options. According to BETO, the researchers provided a comparison of various closed-loop recycling technologies, which allow for the reuse of plastic through mechanical and chemical reprocessing, eliminating the need for fossil-fuel-derived virgin materials. They considered technical metrics, such as the quality and retention of recycled plastics, as well as environmental metrics, including energy use and greenhouse gas (GHG) emissions. BETO and the Advanced Materials and Manufacturing Technologies Office provided funding for the research as part of the BOTTLE™ Consortium (Bio-Optimized Technologies to keep Thermoplastics out of Landfills and the Environment). The Consortium is a collaborative effort among industry, academia, national labs, and the government to change the way we recycle. More information is available in the January 2023 article “Technical, Economic, and Environmental Comparison of Closed-Loop Recycling Technologies for Common Plastics,” published in ACS Sustainable Chemistry & Engineering.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 27, 2022, that it is extending the deadline for applications from managers of standards development organizations, ecolabel programs, and other similar organizations for assessment and inclusion in the Environmentally Preferable Purchasing (EPP) program’s Recommendations of Specifications, Standards and Ecolabels for Federal Purchasing, a resource intended to help federal purchasers identify and procure environmentally preferable products and services. To apply to have a standard or ecolabel included in the Recommendations, applicants must submit responses to the scoping questions to .(JavaScript must be enabled to view this email address) by January 24, 2023. EPA notes that responses to the scoping questions may be high level and do not need to include detailed information or justifications. EPA will use the responses to determine the applicant's eligibility and scope of assessment. EPA states that it will review applications by product categories. In spring 2023, EPA will announce the order in which product categories will be assessed. In fall 2023, EPA will notify the first round of applicants of the results of its assessment. More information on the new process to expand the Recommendations is available in our November 7, 2022, blog item.


 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative (NBBI) to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. On December 20, 2022, the White House Office of Science and Technology Policy (OSTP) published two requests for information (RFI) related to the NBBI. In the first one, OSTP, on behalf of the primary agencies that regulate the products of biotechnology -- the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) -- requests relevant data and information, including case studies, that may assist in identifying any regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology, particularly with regard to new and emerging biotechnology products. 87 Fed. Reg. 77900. According to the RFI, the information provided will inform regulatory agency efforts to improve the clarity and efficiency of the regulatory processes for biotechnology products. The RFI includes the following questions:

  1. Describe any ambiguities, gaps, inefficiencies, or uncertainties regarding statutory authorities and/or agency roles, responsibilities, or processes for different biotechnology product types, particularly for product types within the responsibility of multiple agencies.
     
    1. Describe the impact, including economic impact, of these ambiguities, gaps, inefficiencies, or uncertainties.
       
  2. Provide any relevant data or information, including case studies, that could inform improvement in the clarity or efficiency (including the predictability, transparency, and coordination) of the regulatory system and processes for biotechnology products.
     
  3. Describe any specific topics the agencies should address in plain language on the regulatory roles, responsibilities, and processes of the agencies.
     
  4. Describe any specific issues the agencies should consider in developing a plan to implement regulatory reform, including any updated or new regulations or guidance documents.
  5. Describe any new or emerging biotechnology products (e.g., microbial amendments to promote plant growth; food plants expressing non-food substances or allergens from non-plant sources) that, based on lessons learned from past experiences or other information, the agencies should pay particular attention to in their evaluation of ambiguities, gaps, or uncertainties regarding statutory authorities and/or agency roles or processes.

  6. Describe any new or emerging categories of biotechnology products on the horizon that the regulatory system and processes for biotechnology products should be preparing to address. Describe any specific recommendations for regulating these new or emerging categories of biotechnology products to guide agency preparations.

  7. What is the highest priority issue for the agencies to address in the short term (i.e., within the next year) and in the long term.

OSTP, EPA, FDA, and USDA will host a virtual public listening session on January 12, 2023. The virtual listening session will allow OSTP, EPA, FDA, and USDA to hear, firsthand, from stakeholders who wish to provide feedback on any of the seven questions outlined in the RFI. Comments are due on or before 5 p.m. (EST) February 3, 2023. More information on the Coordinated Framework for the Regulation of Biotechnology is available in our January 9, 2017, memorandum.
 
The second RFI seeks public input on how advances in biotechnology and biomanufacturing can help achieve goals that were previously out of reach and what steps can be taken to provide the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy. 87 Fed. Reg. 77901. OSTP invites input from interested stakeholders, including industry and industry association groups; academic researchers and policy analysts; civil society and advocacy groups; individuals and organizations that work on biotechnology, biomanufacturing, or related topics; and members of the public. OSTP seeks responses to one, some, or all of the following questions:

Harnessing Biotechnology and Biomanufacturing Research and Development (R&D) to Further Societal Goals

  1. For any of the four categories outlined above (health, climate and energy, food and agriculture, and supply chain resilience):
     
    1. What specific bold goals can be achieved through advances in biotechnology and biomanufacturing in the short term (five years) and long term (20 years)? In your answers, please suggest quantitative goals, along with a description of the potential impact of achieving a goal. Listed below are illustrative examples of quantitative goals:
       
      1. Develop domestic bio-based routes of production, including the entire supply chain, for X percent of active pharmaceutical ingredients.
         
      2. Utilize X tons of sustainable biomass annually as input to biomanufacturing processes to displace Y percent of U.S. petroleum consumption.
    2. What R&D is needed to achieve the bold goals outlined in (a), with a focus on cross-cutting or innovative advances? How would the government support this R&D, including through existing federal programs, creation of new areas of R&D, and/or development of new mechanisms?
       
    3. How else can the government engage with and incentivize the private sector and other organizations to achieve the goals outlined in (a)?
       
  2. Public engagement and acceptance are of critical importance for successful implementation of biotechnology solutions for societal challenges. How might social, behavioral, and economic sciences contribute to understanding possible paths to success and any hurdles? What public engagement and participatory models have shown promise for increasing trust and understanding of biotechnology?

Data for the Bioeconomy

  1. What data types and sources, to include genomic and multiomic information, are most critical to drive advances in health, climate, energy, food, agriculture, and biomanufacturing, as well as other bioeconomy-related R&D? What data gaps currently exist?

  2. How can the federal government, in partnership with private, academic, and non-profit sectors, support a data ecosystem to drive breakthroughs for the U.S. bioeconomy? This may include technologies, software, and policies needed for data to remain high-quality, interoperable, accessible, secure, and understandable across multiple stakeholder groups.

Building a Vibrant Domestic Biomanufacturing Ecosystem

  1. What is the current state of U.S. and global biomanufacturing capacity for health and industrial sectors, and what are the limits of current practice?

  2. What can the federal government do to expand and scale domestic biomanufacturing capacity and infrastructure? What level of investment would be meaningful, and what incentive structures could be employed?

  3. What are barriers that must be addressed to enable better domestic supply chains for biomanufacturing (e.g., feedstocks, reagents, consumables)?

  4. How can the federal government partner with state and local governments to expand domestic biomanufacturing capacity, with a particular focus on underserved communities?

Biobased Products Procurement

  1. What are new, environmentally sustainable biobased products that the federal government could purchase through its BioPreferred Program? How can the federal government incentivize development of new categories of sustainable biobased products?

    Biotechnology and Biomanufacturing Workforce

  2. How can the U.S. strengthen and expand the biotechnology and biomanufacturing workforce to meet the needs of industry today and in the future? What role can government play at the local, state, and/or federal level?

  3. What strategies and program models have shown promise for successfully diversifying access to biomanufacturing and biotechnology jobs -- including those involving Historically Black Colleges and Universities (HBCU), Tribal Colleges and Universities, and other Minority Serving Institutions? What factors have stymied progress in broadening participation in this workforce?

Reducing Risk by Advancing Biosafety and Biosecurity

  1. What can the federal government do to support applied biosafety research and biosecurity innovation to reduce risk while maximizing benefit throughout the biotechnology and biomanufacturing life cycles?
     
  2. How can federal agencies that fund, conduct, or sponsor life sciences research incentivize and enhance biosafety and biosecurity practices throughout the United States and international research enterprises?

 Measuring the Bioeconomy

  1. What quantitative indicators, economic or otherwise, are currently used to measure the contributions of the U.S. bioeconomy? Are there new indicators that should be developed?

  2. How should the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS) be revised to enable characterization of the economic value of the U.S. bioeconomy? Specifically, which codes or categories do not distinguish between functionally identical biobased and fossil fuel-based commodities?

International Engagement

  1. What are opportunities for the U.S. government to advance R&D, a skilled workforce, regulatory cooperation, and data sharing for the bioeconomy through international cooperation? Which partnerships and fora are likely keys to advance these priority areas?
     
  2. What risks are associated with international biotechnology development and use, and how can the U.S. government work with allies and partners to mitigate these risks?

Comments are due on or before 5:00 p.m. (EST) on January 20, 2023.


 

 By Lynn L. Bergeson and Carla N. Hutton
 
On November 30, 2022, the U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) announced that its scientists have determined that plants could be used to produce nanobodies that quickly block emerging pathogens in human medicine and agriculture. The nanobodies are small antibody proteins naturally produced in specific animals like camels, alpacas, and llamas. ARS researchers evaluated nanobodies to prevent and treat citrus greening disease in citrus trees. The scientists are now using their newly developed and patented SymbiontTM technology to show that nanobodies can be easily produced in a plant system with broad agricultural and public health applications. According to ARS, as a proof-of-concept, researchers showed that nanobodies targeting the SARS-CoV-2 virus could be made in plant cells and remain functional in blocking the binding of the SARS-CoV-2 spike protein to its receptor protein: the process responsible for initiating viral infection in human cells.
 
AgroSource, Inc. collaborated with ARS to develop the plant-based production system. According to ARS, they are currently taking the necessary steps to see how they can move this advancement into the commercial sector. ARS notes that this research collaboration is in response to the White House’s Executive Order on advancing biotechnology and biomanufacturing innovation for a sustainable, safe, and secure American bioeconomy.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On November 21, 2022, the U.S. Government Accountability Office (GAO) published a Science & Tech Spotlight on biorecycling of plastics. Biological recycling, or biorecycling, is an emerging technology that uses microbes, such as bacteria or fungi, to break down plastic into its basic components for reuse. GAO states that research suggests that biorecycling of plastics could help promote a circular economy in which plastic waste is continuously reincorporated into new products. According to GAO, entities seeking to engage in biorecycling could face a “complicated legal landscape” that may pose a challenge for the emerging technology. At the federal level, depending on the specifics of the process, aspects of biorecycling or the wastes that may result from that process might be governed by statutes such as the Toxic Substances Control Act (TSCA), the Resource Conservation and Recovery Act (RCRA), and the Microbial Products of Biotechnology Rule. In addition, states, tribal organizations, municipalities, and other stakeholders, including nonprofit organizations, businesses, and other entities, can also play important roles in regulating or supporting recycling in the United States.
 
Opportunities from biorecycling of plastics include:

  • Economic, environmental, and health gains. Biorecycling of plastics could help promote a circular economy by turning waste into more useful products while reducing dependence on fossil fuels for new plastics. Emerging recycling methods could help mitigate the negative health effects of incinerating plastic waste; and
  • Processing efficiency. Biorecycling does not require the same level of sorting for plastic waste compared with mechanical recycling, thereby saving time and money. It also consumes less energy than mechanical and some chemical recycling methods.

GAO identified the following challenges:

  • Implementation costs. Recycling plastics is generally more expensive than creating new plastics. Further, companies may face high start-up costs to develop a biorecycling facility;
  • Limited applicability. The enzymes researchers have identified are currently limited to degrading only a few types of plastic; and
  • Knowledge gaps. Research is needed to address the unintended consequences of biorecycling. For example, researchers have not assessed the risks engineered enzymes might pose if released into the environment.

According to GAO, policy context and questions include:

  • What aspects of biorecycling could be prioritized to help reduce the accumulation of plastic waste and its economic and environmental effects?
  • To what extent do current laws and regulations appropriately address concerns regarding the industrial use of engineered enzymes for biorecycling, while still allowing for their development?
  • What steps could the federal government, states, municipalities, and other stakeholders take if they want to support or implement effective policies for biorecycling of plastic waste?

GAO states that it meets Congressional information needs in several ways, including by providing oversight, insight, and foresight on science and technology issues. GAO notes that it also provides targeted assistance on specific science and technology topics to support Congressional oversight activities and provide advice on legislative proposals.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On November 21, 2022, the U.S. Environmental Protection Agency (EPA) announced that it has improved public access to certain reports submitted by chemical companies in ChemView, EPA’s web application for public access to non-confidential business information (non-CBI) on chemicals regulated under the Toxic Substances Control Act (TSCA), including new chemical notices and notices of substantial risk. EPA has published previously unpublished new chemical notices received under TSCA Section 5 and notices of substantial risk provided by companies under TSCA Section 8(e). EPA states that going forward, it will continue to identify older, previously submitted unpublished information to make available in ChemView and will publish newly received TSCA Section 5 notices and TSCA Section 8(e) reports on a “near real-time basis.” EPA has also published in ChemView chemical health and safety studies received under TSCA Section 8(d).
 
New Chemical Submissions
 
TSCA Section 5 requires EPA to publish a list of new chemical submissions it has received, including premanufacture notices (PMN), significant new use notices (SNUN), microbial commercial activity notices (MCAN), test market exemption (TME) applications, notices of commencement of manufacture or import (NOC), and test information submitted under Section 5. According to EPA, in 2022 it made available in ChemView more than 25,000 new chemical notice records received under TSCA Section 5, including notices received between 2014 and 2019 that had not been published previously. In 2019, EPA began publishing non-CBI notices on an ongoing basis, and “new records are now generally published within five days of receipt.” EPA states that it will also continue to identify and make public older, previously unpublished new chemicals notices.
 
Notices of Substantial Risk
 
TSCA Section 8(e) requires chemical companies to inform EPA of information that reasonably supports the conclusion that a chemical may present a substantial risk of injury to health or the environment. EPA uses these notices to inform new and existing chemical risk assessment activities. According to EPA, in 2022 it has published 3,900 notices of substantial risk records received under TSCA Section 8(e) in ChemView, including more than 3,300 non-CBI notices submitted between January 1, 2019, and December 20, 2021, that were not previously published due to resource limitations. EPA states that over the next several months, it will publish all non-CBI versions of Section 8(e) notices received from December 20, 2021, to the present. Going forward, “EPA will strive to publish 8(e) notices deemed complete within a week of receiving them from companies.” Additionally, EPA will work to identify and publish Section 8(e) notices received before 2019 as resources allow.
 
Health and Safety Data Reporting
 
Regulations promulgated under TSCA Section 8(d) require chemical companies to submit lists and copies of health and safety studies relating to the health and/or environmental effects of specified chemical substances and mixtures. According to EPA, in 2022 it published more than 1,700 health and safety study records received since September 2021 under TSCA Section 8(d) in ChemView. EPA notes that many of these records were in response to EPA’s 2021 Section 8(d) rulemaking, Health and Safety Data Reporting; Addition of 20 High-Priority Substances and 30 Organohalogen Flame Retardants. EPA states that it expects to publish additional Section 8(d) records “in the future.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The 2022 Organization for Economic Cooperation and Development (OECD) Green Growth and Sustainable Development (GGSD) Forum will meet at their headquarters in Paris, France, November 22-23, 2022. Participants will discuss how the impact of economic shocks, such as those caused by the COVID-19 pandemic and Russia’s large-scale aggression against Ukraine, affect mission-oriented approaches for green innovation and the role that low-carbon hydrogen and the bio-economy sectors could play in a sustainable recovery. Participants will also discuss the specific challenges and opportunities faced by small- and medium-sized enterprises (SME) and the lessons learned from the international scientific cooperation that occurred in response to the COVID-19 pandemic for science, technology, and innovation (STI) efforts to address environmental degradation. Registration is open to join online or in person.

Tags: OECD, COVID-19

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 2, 2022, that it launched a new process to expand the Environmentally Preferable Purchasing (EPP) program’s Recommendations of Specifications, Standards and Ecolabels for Federal Purchasing (Recommendations). EPA is inviting managers of standards development organizations, ecolabel programs, and other similar organizations to apply for potential assessment and inclusion in the Recommendations. 87 Fed. Reg. 66176. EPA is also hosting a webinar on November 15, 2022, from 1:00 p.m.-2:30 p.m. (EST) to answer questions from stakeholders about the expansion of the Recommendations and the process for applying. The EPP program’s Recommendations help federal government purchasers use private sector standards and ecolabels to meet sustainable acquisition goals and mandates. According to EPA, they currently include more than 40 private sector environmental performance standards and ecolabels in over 30 purchase categories.
 
EPA states that to apply to have a standard or ecolabel included in the Recommendations, interested applicants should first familiarize themselves with the Framework for the Assessment of Environmental Performance Standards and Ecolabels (Framework), which will be used to assess all eligible applicants. Then, submit responses to the scoping questions to .(JavaScript must be enabled to view this email address) by January 1, 2023. EPA will use the scoping questions to determine eligibility and scope of the assessment. After the application deadline closes, EPA will issue an estimated timeline for full assessments against the Framework by product/service category within 120 days. For each category being assessed, EPA will provide further notice and instruction to applicable applicants.
 
EPA seeks to assess multi-attribute standards and ecolabels that recognize environmental performance leadership and support federal goals and mandates regarding climate, safer chemicals, or other sustainable acquisition priorities of the Biden Administration (e.g., net-zero emissions, low embodied carbon construction materials, and the restriction or elimination of per- or polyfluoroalkyl substances (PFAS) in certified products). EPA is particularly interested in assessing standards and ecolabels in the following sectors: building/construction; infrastructure; landscaping; food and cafeteria services; uniforms/clothing; professional services; and laboratories and healthcare. EPA states that standards and ecolabels that address other sectors already included in the Recommendations are welcome to apply.


 
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