| Federal |
BETO Announces Novel State-of-the-Art Workflow Technology To Accelerate Biomanufacturing Research: The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on May 15, 2023, that a new workflow developed by researchers at the Agile BioFoundry (ABF), a BETO-funded consortium of national laboratories, and Agilent Research Laboratories (Agilent) addresses the need for faster analytical tools. According to BETO, the workflow “combines state-of-the-art analytical technologies with a machine learning-based algorithm, providing a faster and more powerful way to process data that could accelerate the Design-Build-Test-Learn framework, a bio-engineering cycle used to improve biomanufacturing research and processes.”
BETO states that the consortium teams set out to create a workflow that could generate high-quality analytical Test data that could feed into the Learn step. The workflow they developed includes several components:
- A high-throughput analytical method developed in collaboration with Agilent that enables a three-fold reduction in sample analysis time (compared to previous conventional approaches) by using optimized liquid chromatography conditions;
- The Automated Method Selection Software tool, which predicts the best liquid chromatography method to use for analyzing new molecules of interest; and
- PeakDecoder, a novel algorithm that processes multi-dimensional metabolite data and automatically calculates errors in metabolite identification.
To test the workflow’s effectiveness, the researchers used it to study metabolites of various strains of microorganisms engineered by ABF. The microorganisms they tested all have the capacity to make various bioproducts, such as polymer and diesel fuel precursors. According to BETO, using their workflow, the researchers were able to interpret 2,683 metabolite features across 116 microbial samples.
BETO Launches New Renewable Carbon Resources Web Page: DOE’s BETO has launched a new, comprehensive web page dedicated to one of its priority subprograms, Renewable Carbon Resources (RCR), which helps develop RCR technologies and creates strategies for bioenergy and bioproducts production. In its May 19, 2023, announcement, BETO states that RCR supports applied research and pilot-scale projects for the production, harvesting/collection, supply logistics, storage, and preprocessing of biomass and wastes to feedstock. According to BETO, RCRs are carbon-based resources generated through photosynthesis (plants and algae) or through waste generation (non-recycled portions of municipal solid waste, biosolids, sludges, plastics, and carbon dioxide and industrial waste gases). The subprogram aims to optimize responsibly the use of each of these resources using sustainability indicators such as land-use changes, greenhouse gas (GHG) emissions, biodiversity, resource conservation, wildlife habitat, fire mitigation, food security, social well-being, and water, soil, and air quality.
DOE Intends New Energy Earthshot To Decarbonize Transportation And Industrial Sectors: DOE announced on May 24, 2023, the launch of the Clean Fuels & Products ShotTM, a new initiative that aims to reduce significantly GHGs from carbon-based fuels and products. DOE notes that this is its seventh DOE Energy Earthshot, which focuses on reducing carbon emissions from the fuel and chemical industry through alternative, more sustainable sources of carbon to achieve a minimum of 85 percent lower GHG emissions as compared to fossil-based sources by 2035. According to DOE, the Clean Fuels & Products ShotTM supports the national goal of achieving net-zero emissions by 2050 by developing the sustainable feedstocks and conversion technologies necessary to produce crucial fuels, materials, and carbon-based products that are better for the environment than current petroleum-derived components. It aims to meet projected 2050 net-zero emissions demands for 100 percent of aviation fuel; 50 percent of maritime, rail, and off-road fuel; and 50 percent of carbon-based chemicals by using sustainable carbon resources.
DOE notes that a ribbon-cutting took place on May 30, 2023, for the Biofuels National User Facility, a $15 million, three-year-long facility upgrade at Idaho National Laboratory funded by DOE’s BETO and an important asset to reach the goals of the Clean Fuels & Products ShotTM. According to DOE, the facility “is designed to solve critical biofuels production challenges associated with the feeding, handling and preprocessing of diverse biomass and waste materials.” DOE states that industry use of the facility “will enable rapid technology development and large-scale commercialization of biofuels and bioproducts, an important component of the Biden-Harris Administration’s goals related to clean fuels and products.”
EPA Proposes Updates To TSCA New Chemicals Regulations; Comments Due July 25, 2023: On May 26, 2023, the U.S. Environmental Protection Agency (EPA) proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 34100. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg Act), improve EPA’s efficiency in the review process, and “update the regulations based on existing policies and experience implementing the New Chemicals Program.” EPA states that the proposed rule includes amendments that would “reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review.” EPA proposed several amendments to the regulations for low volume exemptions (LVE) and low release and exposure exemptions (LoREX), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, and toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA’s 1999 PBT policy. Comments are due July 25, 2023. More information on the proposed rule is available in our May 24, 2023, memorandum.
When EPA receives a premanufacture notice (PMN), significant new use notice (SNUN), or microbial commercial activity notice (MCAN), EPA states that it is required to assess the risk associated with the new chemical substance or significant new use that is the subject of the notice under the conditions of use and make a determination for the chemical substance pertaining to the likelihood of such risk. EPA notes that under TSCA, the term “chemical substance” includes microorganisms. To improve the effectiveness and efficiency of these reviews, EPA proposes to amend the procedural regulations at 40 C.F.R. Parts 720, 721, and 725 to align with the requirements in TSCA Section 5, as amended by the Lautenberg Act, and to make additional updates. In particular, EPA proposes to amend the regulations to specify that EPA must make a determination on each PMN, SNUN, and MCAN received before the submitter may commence manufacturing or processing of the chemical substance, and to list the five possible determinations and the actions required in association with those determinations. In addition, EPA proposes to clarify the level of detail expected for the information that a submitter is required to include in a PMN, SNUN, or exemption notice for the notice to be considered complete. EPA also proposes amendments to the procedures for reviewing PMNs and SNUNs; specifically, procedures for addressing PMNs and SNUNs that have errors or are incomplete or that are amended during the applicable review period.
EPA Issues Final Rule Intended To Accelerate Use Of Plant-Incorporated Biotechnologies: On May 31, 2023, EPA issued a final rule that exempts a class of plant-incorporated protectants (PIP) created using genetic engineering from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. EPA states that the final rule includes exemptions as described in its October 2020 proposal for PIPs, now termed “PIPs created through genetic engineering from a sexually compatible plant” and “loss-of-function PIPs.” It also includes the process through which EPA determines their eligibility for exemption and the associated recordkeeping requirements. According to EPA, the exemptions reflect the biotechnological advances made since 2001, when EPA first exempted PIPs derived through conventional breeding and excluded from the exemptions those PIPs created through biotechnology. EPA notes that it anticipates that the exemptions will benefit the public by ensuring that human health and the environment are adequately protected, while also reducing the regulatory burden for the regulated community. These exemptions may also result in increased research and development activities, commercialization of new pest control options for farmers, particularly in minor crops, and increase the diversity of options for pest and disease management, which could provide environmental benefits. The final rule will be effective on July 31, 2023. More information will be available in our forthcoming memorandum.
Events
“DOE Workshop On Transitioning To A Sustainable, Circular Economy For Plastics” On June 8-9, 2023
DOE’s 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.
More information is available in our May 10, 2023, blog item.
“ChemCatBio Webinar On Perspectives On Engineered Catalyst Design And Forming” On June 14, 2023
DOE’s BETO announced on May 30, 2023, that the Chemical Catalysis for Bioenergy Consortium (ChemCatBio) will hold a webinar on June 14, 2023, on “Perspectives on Engineered Catalyst Design and Forming.” ChemCatBio is a consortium of eight DOE national laboratories overseen by BETO. To leverage the fundamental advancements ChemCatBio has made in catalyst technology, BETO states that the consortium recently implemented a new vision to address risks by focusing on process integration and fuel production with engineered catalysts. In the webinar, Bruce Adkins (Oak Ridge National Laboratory), Frederick Baddour (National Renewable Energy Laboratory), and Matthew Greaney (Clariant) will present critical considerations for the “engineered” catalyst; an industrial perspective on catalyst design and forming; and ChemCatBio’s industry-informed capabilities that support the transition to more commercially relevant catalyst forms. The webinar will end with a question and answer session.
| ABOUT THE FIRM B&C® helps companies making and using chemicals commercialize their products, maintain compliance, and achieve competitive advantage as they market their products around the world. We provide powerful solutions for regulatory, political, and scientific challenges in any jurisdiction. | BERGESON & CAMPBELL, P.C. 2200 Pennsylvania Ave., N.W. Suite 100W Washington, D.C. 20037 (202) 557-3800 (202) 557-3836 (fax) www.lawbc.com |