Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.

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 (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.” The White House hosted a Summit on Biotechnology and Biomanufacturing on September 14, 2022. According to the White House fact sheet on the summit, federal departments and agencies, with funding of more than $2 billion, will take the following actions:

  • Leverage biotechnology for strengthened supply chains: The Department of Health and Human Services (DHHS) will invest $40 million to expand the role of biomanufacturing for active pharmaceutical ingredients (API), antibiotics, and the key starting materials needed to produce essential medications and respond to pandemics. The Department of Defense (DOD) is launching the Tri-Service Biotechnology for a Resilient Supply Chain program with a more than $270 million investment over five years to turn research into products more quickly and to support the advanced development of biobased materials for defense supply chains, such as fuels, fire-resistant composites, polymers and resins, and protective materials. Through the Sustainable Aviation Fuel Grand Challenge, the Department of Energy (DOE) will work with the Department of Transportation and the U.S. Department of Agriculture (USDA) to leverage the estimated one billion tons of sustainable biomass and waste resources in the United States to provide domestic supply chains for fuels, chemicals, and materials.
     
  • Expand domestic biomanufacturing: DOD will invest $1 billion in bioindustrial domestic manufacturing infrastructure over five years to catalyze the establishment of the domestic bioindustrial manufacturing base that is accessible to U.S. innovators. According to the fact sheet, this support will provide incentives for private- and public-sector partners to expand manufacturing capacity for products important to both commercial and defense supply chains, such as critical chemicals.
     
  • Foster innovation across the United States: The National Science Foundation (NSF) recently announced a competition to fund Regional Innovation Engines that will support key areas of national interest and economic promise, including biotechnology and biomanufacturing topics such as manufacturing life-saving medicines, reducing waste, and mitigating climate change. In May 2022, USDA announced $32 million for wood innovation and community wood grants, leveraging an additional $93 million in partner funds to develop new wood products and enable effective use of U.S. forest resources. DOE also plans to announce new awards of approximately $178 million to advance innovative research efforts in biotechnology, bioproducts, and biomaterials. In addition, the U.S. Economic Development Administration’s $1 billion Build Back Better Regional Challenge will invest more than $200 million to strengthen America’s bioeconomy by advancing regional biotechnology and biomanufacturing programs.
     
  • Bring bioproducts to market: DOE will provide up to $100 million for research and development (R&D) for conversion of biomass to fuels and chemicals, including R&D for improved production and recycling of biobased plastics. DOE will also double efforts, adding an additional $60 million, to de-risk the scale-up of biotechnology and biomanufacturing that will lead to commercialization of biorefineries that produce renewable chemicals and fuels that significantly reduce greenhouse gas emissions from transportation, industry, and agriculture. The new $10 million Bioproduct Pilot Program will support scale-up activities and studies on the benefits of biobased products. Manufacturing USA institutes BioFabUSA and BioMADE (launched by DOD) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) (launched by the Department of Commerce (DOC)) will expand their industry partnerships to enable commercialization across regenerative medicine, industrial biomanufacturing, and biopharmaceuticals.
     
  • Train the next generation of biotechnologists: The National Institutes of Health (NIH) is expanding the Innovation Corps (I-Corps™), a biotech entrepreneurship bootcamp. NIIMBL will continue to offer a summer immersion program, the NIIMBL eXperience, in partnership with the National Society for Black Engineers, which connects underrepresented students with biopharmaceutical companies, and support pathways to careers in biotechnology. In March 2022, USDA announced $68 million through the Agriculture and Food Research Initiative to train the next generation of research and education professionals.
     
  • Drive regulatory innovation to increase access to products of biotechnology: The Food and Drug Administration (FDA) is spearheading efforts to support advanced manufacturing through regulatory science, technical guidance, and increased engagement with industry seeking to leverage these emerging technologies. For agricultural biotechnologies, USDA is building new regulatory processes to promote safe innovation in agriculture and alternative foods, allowing USDA to review more diverse products.
     
  • Advance measurements and standards for the bioeconomy: DOC plans to invest an additional $14 million next year at the National Institute of Standards and Technology for biotechnology research programs to develop measurement technologies, standards, and data for the U.S. bioeconomy.
     
  • Reduce risk through investing in biosecurity innovations: DOE’s National Nuclear Security Administration plans to initiate a new $20 million bioassurance program that will advance U.S. capabilities to anticipate, assess, detect, and mitigate biotechnology and biomanufacturing risks, and will integrate biosecurity into biotechnology development.
     
  • Facilitate data sharing to advance the bioeconomy: Through the Cancer Moonshot, NIH is expanding the Cancer Research Data Ecosystem, a national data infrastructure that encourages data sharing to support cancer care for individual patients and enables discovery of new treatments. USDA is working with NIH to ensure that data on persistent poverty can be integrated with cancer surveillance. NSF recently announced a competition for a new $20 million biosciences data center to increase our understanding of living systems at small scales, which will produce new biotechnology designs to make products in agriculture, medicine and health, and materials.

A recording of the White House summit is available online.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that registration was open for the 2022 Conference on the State of the Science on Development and Use of New Approach Methods (NAM) for Chemical Safety Testing. EPA notes that there will be limited availability in person at EPA headquarters in Washington, DC, on October 12-13, 2022, and a virtual option will also be available. Conference topics include:

  • Variability and Relevance of Traditional Toxicity Tests;
  • Evolution of Validation and Scientific Confidence Frameworks to Incorporate 21st Century Science; and
  • Breakout groups discussing Variability of Traditional Toxicity Tests, Relevance of Traditional Toxicity Tests, and Feedback on EPA Scientific Confidence Framework.

EPA asks that attendees register for the NAMs conference before October 7, 2022.
 
On October 18, 2022, EPA will provide training on the Computational Toxicology (CompTox) Chemicals Dashboard, which is part of a suite of databases and web applications developed by EPA to support the development of innovative methods to evaluate chemicals for potential health risks. The computational toxicology tools and data in the Dashboard help prioritize chemicals based on potential health risks. Specifically targeted for decision-makers, the training will provide:

  • An overview of the Dashboard content and function;
  • Application-oriented use-case demonstrations in the areas of general use, hazard/bioactivity, exposure/absorption, distribution, metabolism, and excretion (ADME)-in vitro to in vivo extrapolation (IVIVE), and chemistry; and
  • Opportunities for participatory learning and engagement.

The training will offer information about the latest release of the Dashboard and how it can be used to gather actionable information about chemical properties and risks through case examples, demonstrations, and hands-on exercises. Registration is now open (attendees must register for the training portions individually):


 

 By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on August 11, 2022, that a research team from Pacific Northwest National Laboratory investigated how potassium in biomass feedstocks poisons a catalyst. The researchers focused their study on potassium, a common alkali metal found in biomass feedstocks, since previous analysis of deactivated catalysts after catalytic fast pyrolysis (CFP) of woody biomass feedstock revealed potassium accumulation on the catalysts’ surface.
 
The research team simulated catalyst poisoning at different potassium levels to trigger deactivation during industrial operations. They then analyzed the catalysts and conducted kinetic measurements to determine how the catalysts’ ability to catalyze chemical reaction changed with the introduction of potassium. According to BETO, the team found potassium poisoning could be substantially mitigated with a developed regeneration method -- a water washing process -- that can successfully remove most of the loaded potassium, restoring more than 90 percent of the catalytic activities.
 
BETO states that the results of these studies provide new insights for the bioenergy industry that will foster improved catalyst design and regeneration for longer lasting catalysts. The studies also created “a solid knowledge base for developers of biomass conversion technologies to continue to build upon, making new and innovative conversion technologies less risky to research and develop.” According to BETO, the work “also supports accelerated process development that can help industry convert biomass feedstocks commercially, leading to more effective and inexpensive production of biofuels.”


 

By Lynn L. Bergeson

On March 16, 2022, the House Science, Space, and Technology Subcommittee on Energy held a hearing on “Bioenergy Research and Development for the Fuels and Chemicals of Tomorrow.” According to the hearing charter, the purpose of the hearing was to examine the status of bioenergy research, development, and demonstration (RD&D) activities carried out by the U.S. Department of Energy (DOE). The hearing also considered advancements in bioenergy research and the potential role of this resource in a cleaner energy transition. Lastly, the hearing was intended to help inform future legislation to support and guide the United States’ bioenergy RD&D enterprise. Read more in Bergeson & Campbell, P.C.’s (B&C®) March 18, 2022, memorandum, “House Committee Holds Hearing on Bioenergy RD&D for the Fuels and Chemicals of Tomorrow."


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency will hold a virtual public meeting April 20-21, 2022, to seek individual input on the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. In addition, EPA announced the availability of and is soliciting public comment on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” EPA states that the Office of Chemical Safety and Pollution Prevention (OCSPP) is proposing to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. According to EPA, the effort will be performed in partnership with its Office of Research and Development (ORD) and other federal entities to leverage their expertise and resources. Written comments are due April 26, 2022. Registration for the meeting is now open.

According to EPA, the research program will refine existing approaches and develop and implement new approach methodologies (NAM) to ensure the best available science is used in TSCA new chemical evaluations. Key areas proposed in the TSCA New Chemicals Collaborative Research Program include:

  • Updating OCSPP’s approach to using data from structurally similar chemicals to determine potential risks from new chemicals, also known as read-across. According to EPA, this will increase the efficiency of new chemical reviews, promoting the use of the best available data to protect human health and the environment.
  • Digitizing and consolidating information on chemicals to include data and studies that currently exist only in hard copy or in various disparate TSCA databases. EPA will combine the information with publicly available sources to expand the amount of information available, enhancing chemical reviews and enabling efficient sharing of chemical information across EPA. Safeguards for confidential business information (CBI) will be maintained as appropriate in this process.
  • Updating and augmenting the models used for predicting a chemical’s physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics to provide a suite of models to be used for new chemicals assessments. The goal of this effort is to update the models to reflect the best available science, increase transparency, and establish a process for updating these models as science evolves.
  • Exploring ways to integrate and apply NAMs in new chemicals assessments, reducing the use of animal testing. EPA states that as this effort evolves, the goal is to develop a suite of accepted, fit-for-purpose NAMs that could be used by external stakeholders for data submissions under TSCA, as well as informing and expanding new chemical categories.
  • Developing a decision support tool that integrates the various information streams specifically used for new chemical risk assessments. The decision support tool will integrate more efficiently all the data streams (e.g., chemistry, fate, exposures, hazards) into a final risk assessment and transparently document the decisions and assumptions made. Simply put, this will facilitate the new chemicals program tracking decisions over time and evaluating consistency within and across chemistries.

EPA states that additional information on each of these areas will be provided in the draft collaborative research plan that will be available in the docket by March 14, 2022. Later in 2022, EPA plans to engage its Board of Scientific Counselors (BOSC), a federal advisory committee, for peer review. EPA also intends to issue a Federal Register notice announcing the BOSC meeting and to open a docket for public comments.

Although the notice states that EPA’s background documents and the related supporting materials to the draft are available in the docket established for this meeting, Docket ID Number EPA-HQ-OPPT-2022-0218, nothing is available at this time. EPA states that it will provide additional background documents as the materials become available. After the virtual public meeting, EPA will prepare meeting minutes summarizing the individual comments received at the meeting. EPA will post the meeting minutes on its website and in the relevant docket.


 

By Lynn L. Bergeson 

On February 1, 2022, DOE EERE BETO issued two new requests for information (RFI) on biomass conversion R&D and community organic waste programs. The RFI titled “Biomass Conversion Research, Development, and Analysis Programs” focuses on biomass conversion R&D and seeks to address improved robustness of microbial cells, catalytic processes, and state-of-technology analyses in the BETO research portfolio. Through this program, BETO is interested in receiving feedback on barriers, capabilities, tools, and other general information needed to prioritize future R&D programs in the areas of organism and catalyst development. BETO also seeks input on which analyses are most useful to the broader bioenergy research and industrial community. Responses to this RFI must be submitted by March 11, 2022, and are required to be provided as an attachment via e-mail to .(JavaScript must be enabled to view this email address).

DOE EERE BETO’s RFI titled “Community-scale Resource and Energy Recovery from Waste Solutions” requests feedback from industry, academia, research laboratories, government agencies, and other stakeholders on issues related to community programs for organic waste. DOE EERE wishes to understand better which wastes related to economic, environmental, and social impacts are of highest priority to communities and how DOE can make its Conversion R&D program more effective in addressing these types of challenges. BETO is particularly interested in input on five different waste streams: dairy manure, swine manure, food waste, municipal wastewater residuals, and fats/oils/greases. Responses to this RFI must also be submitted by March 11, 2022, and provided as an attachment via e-mail to .(JavaScript must be enabled to view this email address). In lieu of providing written responses to this RFI, BETO is also accepting requests for a 30-minute individual discussion via e-mail. Additional information on both RFIs is available here.


 

By Lynn L. Bergeson 

On January 10, 2022, the Massachusetts Institute of Technology (MIT) announced that a team of its researchers has developed a promising approach to control methane emissions and remove methane from the air using zeolite clay. Zeolite clay is inexpensive and abundant. The MIT team found that, when treated with copper, the material is very effective at absorbing methane from the air even at low concentrations. According to researcher and Associate Professor of Civil and Environmental Engineering, Desiree Plata, Ph.D., this process is advantageous over other approaches to removing methane from the air, as other methods tend to use more expensive catalysts that require high temperatures. The method converts methane into carbon dioxide that, according to Plata, is much less impactful in the atmosphere than methane. Methane is about 80 times stronger as a greenhouse gas (GHG) over the first 20 years, and approximately 25 times stronger for the first century.
 
MIT researchers still have outstanding engineering details to address in this process. To do so, the U.S. Department of Energy (DOE) awarded a $2 million grant for MIT to continue to develop specific equipment for methane removal in places with concentrated sources of methane, such as dairy barns and coal mines. Plata reported that the next phase of the project will focus largely on ways to structure the clay material in a multiscale, hierarchical configuration to demonstrate a proof of concept that this method can work in the field.
 


 

By Lynn L. Bergeson

On November 11, 2021, the University of Iowa announced that its Department of Biology scientists discovered a new type of genetic variation in yeast that can improve the production of ethanol. According to the study conducted by the University’s biologists, yeast strains with certain alleles of gene MED15 are more efficient at fermentation. The study was led by Professor Jan Fassler, who states that these findings may assist scientists in engineering a better yeast strain to produce more efficiently bioethanol for fuel and wine.


 

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

On November 23, 2021, ACS announced that it is accepting applications for its Heh-Won Chang, Ph.D. Fellowship in Green Chemistry. This opportunity provides $5,000 in financial support to full-time graduate students conducting research in green chemistry. This one-time payment may be used for any purpose, including conference travel, professional development, and living expenses while the recipient is in graduate school. This opportunity is open to full-time graduate students across the globe who have at least one full year of study remaining in their graduate programs. Recipients must present their research at the annual ACS GC&E, where the award will be presented formally. Applications are due by December 31, 2021. Additional information on application requirements is available here.


 

By Lynn L. Bergeson 

On October 1, 2021, EPA announced a series of virtual meetings of the Board of Scientific Counselors (BOSC) Chemical Safety for Sustainability and Health and Environmental Risk Assessment (CSS HERA) Subcommittee to review recent progress and activities of the Chemical Safety Analytics (CSA) and Emerging Materials and Technologies (EMT) research areas. Meetings are open to the public, and EPA is accepting comments until November 3, 2021. Interested parties may also request the draft agenda or request to present at any of the meetings by November 3, 2021.

The initial meeting will be held over a two-day period via videoconference on November 4 and 5, 2021, from 12:00 p.m. to 5:00 p.m. (EDT). Registration is required by November 3, 2021. The following meetings are also scheduled:

  • BOSC Deliberation Videoconference: November 18, 2021, from 11:00 a.m. to 2:00 p.m. (EST) – Registration is required by November 17, 2021.
     
  • Final BOSC Deliberation Videoconference: December 10, 2021, from 11: 00 a.m. to 2:00 p.m. (EST) – Registration is required by December 9, 2021.

Meeting times are subject to change.

Tags: EPA, BOSC, Research

 
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