By Lynn L. Bergeson and Carla N. Hutton
 
On August 29, 2023, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced that through the funding opportunity entitled “Accelerating Innovations in Biomanufacturing Approaches through Collaboration Between [the U.S. National Science Foundation (NSF)] and the DOE BETO funded Agile BioFoundry (ABF),” researchers will collaborate with the ABF consortium’s synthetic and bioengineering research projects. BETO and NSF have selected the following projects:

• Enabling Scalable Redox Reactions in Biomanufacturing (University of California, Irvine, and University of California, Davis): This project will enhance the carbon and energy efficiency of a biomanufacturing process by upgrading carboxylic acids into precursors for biofuels and chemicals used in industry. The goal is to create a more efficient process for carboxylic acid reduction that does not release any carbon into the atmosphere. The team will work to identify the principles necessary to enhance efficiency in the enzymes used in the process. Through outreach efforts, the researchers will provide hands-on exposure to science, technology, engineering, and math (STEM) fields for largely Hispanic populations and women, both groups underrepresented in science and engineering.
   
• A Synthetic Biology Toolbox for Studying Bacterial Transporters (University of Wisconsin -- Madison): This project will develop and use tools to close knowledge gaps surrounding transporters in Gram negative bacteria to facilitate the development of superior biomanufacturing hosts. Specifically, they will work to identify proteins that enhance the uptake of nutrients into the cells of microbes and the removal of toxic products. The work will enable the development of superior biomanufacturing microbial hosts and support translational research. Activities that teach biomanufacturing concepts to K-8 students and recruitment of underrepresented researchers will broaden the impacts of the work.
   
• Leveraging the Unique Metabolism of Megasphaera elsdenii for Metabolic Engineering to Medium and Long Chain Organic Acids for Use in Jet Fuels and Biomaterials (University of Georgia): The project will work to increase understanding of the metabolic pathways that allow the microorganism Megasphaera elsdenii to produce hexanoic acid, that can be engineered to create sustainable aviation fuel among a host of other products. Understanding how octanoic acid is created in this organism will enable scientists better to convert plant sugars to longer chain molecules and will provide paths for alternative approaches to bioprocessing. The team will recruit students from underrepresented groups and create classroom resources for use in elementary schools.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency announced on August 4, 2023, that it is providing resources to help biotechnology developers exercise the full benefits of the exemptions available under the Plant Incorporated Protectants (PIP) exemption rule. These resources are available on EPA’s public website and include the following:

• Fact sheet and background information on PIPs rule;
• Examples of genetic modifications that are exempt under the rule;
• Description of how to submit a self-determination or a request for EPA confirmation of exemption under the rule; and
• Sample documents for submitting a self-determination or request for confirmation.

The PIPs Exemption Final Rule went into effect on July 31, 2023.  More information on the final rule is available in our June 2, 2023, memorandum.

Background

On May 31, 2023, EPA released a final rule exempting two categories of PIPs created using genetic engineering from certain 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 rule ensures that human health and the environment are protected while reducing costs for the regulated community, consistent with the September 2022 Executive Order 14081 on Advancing Biotechnology. According to EPA, the rule may also result in increased research and development activities, commercialization of new pest control options for farmers, and reduced use of conventional pesticides.
 
EPA notes that the final rule reflects the biotechnological advances made since 2001, when it first exempted PIPs derived through conventional breeding from FIFRA registration and FFDCA tolerance requirements, but did not at that time exempt PIPs created through biotechnology. Specifically, the final rule exempts PIPs derived through genetic engineering from FIFRA registration and FFDCA tolerance requirements in cases where the PIPs are essentially equivalent to those exempted by the 2001 rule.
 
The rule contains conditions for exempting:

• PIPs in which genetic engineering has been used to insert a gene from a sexually compatible plant or to modify a gene to match a gene found in a sexually compatible plant. This category of PIPs requires EPA confirmation of eligibility for the exemption; and 
   
• Loss-of-function (LoF) PIPs, in which a gene is modified through genetic engineering to reduce or eliminate the activity of that gene. The loss of the activity of that gene then results in the pesticidal effect. EPA states that for this category of PIP, “biotechnology developers can make a self-determination that their PIP meets the exemption criteria, which requires notification but no EPA review, or request EPA confirmation of eligibility for the exemption.”

EPA notes that it indicated in the preamble to the final rule that it would consider exempting additional categories of PIPs from both FIFRA registration and FFDCA tolerance requirements and expanding the categories of PIPs that are allowed the option to self-determine and do not require EPA confirmation of eligibility for the exemption.

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By Lynn L. Bergeson and Carla N. Hutton
 
The Independent Commodity Intelligence Services (ICIS) search for the very best in innovation in the chemical industry. The ICIS Innovation Awards are intended to recognize and reward companies paving the way in product, process, and digital innovations that demonstrate a commitment to sustainability. The awards were open to any company in the chemical industry that successfully executed innovative projects that solve problems and provide solutions for companies, their customers, and society, as well as benefiting the environment and progressing sustainability. ICIS will recognize the 2023 winners on October 17, 2023. The 2023 winners include:

Best Digital Innovation from a Large Company

• Joint Winners:
  • Evonik Operations GmbH: COATINO^® Defect Detection -- Quantifying coating defects by using advanced image recognition methods; and
  • Dow: Dow^™ Paint Vision: Shaping the modern digital lab for paint formulation.
• Finalists:
  • Sewage and recycled water networks, Dubai municipality: Development of Fog Watch -- A digital platform to manage fat, oil, and grease waste;
  • Fatima Fertilizer Company: Sarsabz Pakistan (Fatima Fertilizers Farmer Application); and
  • Fatima Fertilizer Company: Sarsabz Asaan (Fatima Fertilizers Dealers Application).

Best Process Innovation from a Large Company

• Winner:
  • UPM Biochemicals, part of UPM -- The Biofore Company: UPM Biochemicals: Future beyond fossils.
• Finalists:
  • Nouri Petrochemical Company, PGPIC: Diagnosis, optimization, and compromising the bottlenecks of the benzene extraction process by designing an innovative tower’s internal;
  • Wanhua Chemical Group Co., Ltd.: Methylene diphenyl diisocyanate (MDI) byproduct amine-containing waste brine recycling technology;
  • Wanhua Chemical Group Co., Ltd.: Automatic continuous formaldehyde-free adhesive spray plywood panel process;
  • PPG: PPG Zero Discharge Project; and
  • Indorama Ventures: Optimization of cycle reaction propoxylation process time.

Best Product Innovation from a Large Company

• Winner:
  • Arkema: Recycling of monomaterial shoe.
• Finalists:
  • Dow: DEXCARE^™ CD-1 Polymer: Boost your shampoo’s conditioning effectiveness with Dow’s renewable, bioderived deposition aid;
  • Dow Chemical: EcoSense^™ GL-60 HA/HL Surfactants: Novel sustainable biosurfactants for personal care rinse-off and leave-on applications;
  • Celanese International Corp: Achieve even lower carbon footprint with Santoprene^® ECO-R Series thermoplastic vulcanizate (TPV) products; and
  • Corteva Agriscience: A modern nematicide with soil health benefits: Salibro^™ nematicide with Reklemel^™ Active from Corteva Agriscience.

Best Process Innovation from Small and Medium Enterprises (SME)

• Winner:
  • Botanical Solution Inc: Growing and extracting from plants in the lab to produce new fungicides for agriculture and QS-21 vaccine adjuvants for human health.
• Finalists:
  • LanzaTech: Pollution to products;
  • AmSty: Innovative PolyRenew^® circularity solution for accelerating plastics recycling;
  • Origin Materials: Origin materials; and
  • GDB Paint & Coatings: Making every drop count: GDB’s commitment toward a net-zero waste paint industry.

Best Product Innovation from an SME

• Winner:
  • Viridis Chemical Company: Commercial scale biobased ethyl acetate with lower greenhouse gas (GHG) emissions.
• Finalists:
  • ECO GLAS Environmental Limited: Septic Tank Smart Box;
  • Locus Ingredients: Leading the charge: Optimizing sophorolipids for real-world applications;
  • LanzaTech: CarbonSmart ethylene from carbon dioxide (CO₂); and
  • Oberon Fuels: Decarbonizing the global liquefied petroleum gas (LPG) industry, with new, negative-carbon intensity (CI) ingredient.

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By Lynn L. Bergeson and Carla N. Hutton
 
On July 12, 2023, the U.S. Environmental Protection Agency (EPA) published a final rule establishing the applicable volumes and percentage standards for 2023 through 2025 for cellulosic biofuel, biomass-based diesel (BBD), advanced biofuel, and total renewable fuel. 88 Fed. Reg. 44468. The final rule also establishes the second supplemental standard addressing the judicial remand of the 2016 standard-setting rulemaking. Finally, according to EPA, the rule makes several regulatory changes to the Renewable Fuel Standard (RFS) program, including changes related to the treatment of biogas and other modifications to improve the program's implementation. As reported in our June 28, 2023, blog item, the final volume targets (billion Renewable Identification Numbers (RIN)) are as follows:
 

 
^a BBD is given in billion gallons.
 
The rule will be effective September 11, 2023, except for amendatory instruction 30, which will be effective February 1, 2024, and amendatory instructions 41 and 42, which will be effective April 1, 2024.

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By Lynn L. Bergeson and Carla N. Hutton
 
On July 27, 2023, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced that its Feedstock-Conversion Interface Consortium (FCIC) recently published eight new technical reports and case studies. According to BETO, the publications examine the environmental and economic impacts of a variety of feedstock characteristics and processing techniques:

• Life-Cycle Greenhouse Gas Emission Impacts of Forest Residue Preprocessing with Wet Milling;
• Comparative Techno-Economic Analysis of Available Feedstocks for High-Temperature Conversion: Whole Tree Thinning’s and Mature Pine Residues;
• Techno-Economic Case Study: Low-Temperature Conversion Performance Based on Isolated Anatomical Fractions of Corn Stover;
• Value Proposition of Coatings or New Alloys on Hammer Wear;
• Air Classification of Forest Residue for Tissue and Ash Separation Efficiency;
• Failure Mode and Effects Analysis Summary Report (FY22);
• Impact of Anatomical Fractionation of Corn Stover on Hammer Mill Throughput and Energy Consumption; and
• Particle Scale Impacts on Deconstruction Energy of Pine Residues.

BETO states that the FCIC “is an integrated and collaborative network of nine DOE national laboratories dedicated to addressing the technical risks that integrated pioneer biorefineries face.” According to BETO, the goal of the FCIC “is to develop science-based knowledge and tools to understand biomass feedstock and process variability, improving overall operational reliability, conversion performance, and product quality across the biomass value chain.”

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy (DOE) Bioenergy Technologies Office (BETO) announced on July 17, 2023, that it will host a Bioenergy Cybersecurity Workshop, a virtual event organized by Sandia National Laboratories on September 11, 2023, to identify cybersecurity risks in biofuel and bioproduct manufacturing, and develop an approach to address these risks. According to BETO, the workshop will raise awareness of the importance of cybersecurity in biomanufacturing safety, operational continuity, and competitiveness. It will consist of panel presentations by bioprocessing and cybersecurity experts. Participants will discuss the state of biofuel and bioproduct cybersecurity practices, and the security of biobased processes to help identify and define cybersecurity technologies and research needed for cybersecure bioenergy production. Workshop objectives will include:

• Exploring the risks and potential consequences to biofuel and bioproduct production that stem from cybersecurity vulnerabilities;
• Discussing the state of practice in biofuel and bioproduct cybersecurity;
• Gathering stakeholder input on what research and development is needed to fill capability gaps in cybersecurity for bioenergy facilities; and
• Building connections across the bioenergy cybersecurity community.

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By Lynn L. Bergeson and Carla N. Hutton
 
On July 24, 2023, Senators Amy Klobuchar (D-MN), Joni Ernst (R-IA), Debbie Stabenow (D-MI), and Pete Ricketts (R-NE) introduced the Biomanufacturing and Jobs Act to strengthen the U.S. Department of Agriculture’s (USDA) BioPreferred program. According to Klobuchar’s July 24, 2023, press release, the bill would:

• Strengthen markets for farmers while also supporting well-paying manufacturing jobs;
• Allow the Secretary of Agriculture to set acceptable price premiums under the program;
• Require each federal agency to increase their procurement of biobased-only contracts or biobased volume purchased under those contracts; and
• Improve reporting of biobased products that are purchased through online federal procurement systems.

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By Lynn L. Bergeson and Carla N. Hutton
 
On June 30, 2023, EuropaBio announced that it “set[] in stone the first European recommendations on biomanufacturing with the publication of its Biomanufacturing Policy Summit 2023 report.” On March 15, 2023, EuropaBio hosted its inaugural Biomanufacturing Policy Summit in Brussels, “marking the first major milestone from its newly established Biomanufacturing Platform.” The Summit captured priorities of 80 industry leaders, policy makers, and stakeholders to highlight the crucial role of cross-sectoral biomanufacturing for Europe’s future. The recommendations include:

• Recognizing cross-sectoral biomanufacturing within high-level European strategies, such as the European Union (EU) Industrial Strategy, Pharma Strategy, Bioeconomy Strategy, and Green Deal Industrial Plan;
• Creating targets for increasing biomanufacturing within the EU economy, supported by policy strategies that identify and recognize its economic, social, and environmental contributions across sectors;
• Coordinating at a policy level the alignment between research and development (R&D) focus, industrial priorities, and commercial applications toward delivering sustainable products and processes through biomanufacturing;
• Recognizing and addressing critical points and vulnerabilities within biomanufacturing value chains to improve European competitiveness;
• Aligning legislation to address unintentional barriers to biomanufacturing scale up for Europe;
• Positioning regulatory frameworks and resources for product rather than process-driven criteria to increase agility and accelerate Europe’s green transition;
• Recognizing Europe’s improved resilience resulting from biomanufacturing capacity for healthcare preparedness and supply chain resilience across sectors;
• Supporting the uptake of European innovation converted into value-added businesses and economic development and incentivizing investment into start-ups and small- and medium-sized enterprises (SME) to scale-up biomanufacturing within Europe;
• Creating a skills pathway for biomanufacturing and advanced manufacturing to ensure access to critical re-skilling and up-skilling in all European countries; and
• Ensuring a global level playing field for transition to sustainable biomanufacturing processes and products.

According to EuropaBio, the recommendations from the Summit will underpin its growth of the Biomanufacturing Platform, working with industry across sectors to ensure that it receives the visibility and recognition required.

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By Lynn L. Bergeson and Carla N. Hutton
 
The July 2023 issue of the Organization for Economic Cooperation and Development’s (OECD) Chemical Safety and Biosafety Progress Report includes a summary of the April 2023 meeting of the Party on the Harmonization of Regulatory Oversight in Biotechnology (WP-HROB). During the meeting, WP-HROB agreed on next steps for preparing several consensus documents: “Environmental Considerations for Risk/Safety Assessment for the Release of Transgenic Plants” (led by the WP-HROB Bureau); “Revised Biology of Wheat” (led by Australia and the United States), both expected for publication in 2023; “Biology of the Mosquito Anopheles gambiae” (led by Australia, the African Union Development Agency -- New Partnership for Africa’s Development (AUDA-NEPAD), and the Agriculture & Food Systems Institute (AFSI)); and “Photoautotrophic Micro-algae for Biomass Production” (led by Canada and the United States). In addition, WP-HROB agreed on two proposals for new projects on the biology of mosquitoes, Anopheles albimanus and Anopheles stephensi (led by the United Kingdom, Brazil, and AUDA-NEPAD).
 
Three projects jointly developed by WP-HROB and the Working Party for the Safety of Novel Foods and Feeds (WP-SNFF) were reviewed at a joint session in April 2023:

• Revision of the OECD Council Recommendation on the safety of recombinant DNA organisms (2006), for which a revised draft was provisionally agreed for most provisions. A progress report will be delivered at the Chemicals and Biotechnology Committee (CBC) meeting in July 2023;
• Enhanced information exchange on new breeding techniques, for which a first set of information has been collected from delegations through a questionnaire; and
• The proposal on the “Safer-Innovation-Approach” in biotechnology, which was formally approved by WP-HROB in follow-up to a two-year pilot project.

The OECD Product Database, containing information on genetically engineered plant varieties approved for cultivation or use in foods and feeds, continues to be updated. A total of 393 entries of 26 crops, flowers, and trees are now available in the system, keeping pace with new information provided by OECD member countries, as well as a number of non-members.

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By Lynn L. Bergeson and Carla N. Hutton
 
On June 27, 2023, the Office of Science and Technology Policy (OSTP) announced the release of a new action plan intended to “rapidly and equitably expand biotechnology and biomanufacturing education and job training programs in the United States.” According to OSTP, biomanufacturing “is a critical aspect of advanced manufacturing that can drive new, sustainable alternatives across industries” and “can unlock new solutions in health, climate change, clean energy, food security, agriculture, supply chain resilience, and national and economic security.” OSTP states that the action plan will help propel continued investment in the bioeconomy and maintain America’s leadership in this sector by preparing more Americans for these jobs and build a diverse pipeline that includes women, people of color, people living in rural communities, and others underrepresented in emerging fields.
 
The action plan includes the following core recommendations, along with select new and ongoing actions that the Biden Administration is taking and will take -- in collaboration with employers, unions; state, local, and Tribal governments; high schools; institutions of higher education; industry associations; and other stakeholders:

• Expand and diversify the talent pool for biotechnology and biomanufacturing jobs and careers to promote innovation and advance equity;
• Strengthen worker-centered sector strategies and other partnerships between employers, labor organizations, community colleges, and other training providers to grow and diversify the bioworkforce;
• Develop and rigorously evaluate innovative approaches to education and training for biotechnology and biomanufacturing jobs and careers, scaling and promoting those found to be most effective;
• Partner with state, local, and Tribal governments, education and training providers, bioscience associations, unions and other worker-serving organizations, and other stakeholders to raise awareness about the promise and potential of careers in the bioworkforce; and
• Improve data and analytic capacity and cross-sector collaboration to advance equity and support effective workforce development -- including the development of industry-recognized credentials and competency models.

According to OSTP, the Biden Administration is already beginning to implement the action plan by taking the following actions:

• The National Science Foundation (NSF), the U.S. Department of Energy (DOE), and the U.S. Department of Agriculture (USDA) will take action to expand partnerships with Historically Black Colleges and Universities (HBCU), Tribal Colleges and Universities (TCU), and Minority Serving Institutions (MSI);
• The U.S. Department of Education will create cross-sector collaborations through the Unlocking Career Success Initiative and launch a professional learning series focused on bioworkforce needs and the role of K-12 schools and postsecondary institutions;
• The U.S. Department of Labor (DOL) is prioritizing advanced manufacturing, including biomanufacturing, in key grant programs, such as the State Apprenticeship Expansion Formula grant;
• The U.S. Department of Commerce (DOC) will support a National Institute for Innovation in Manufacturing Biopharmaceuticals pilot program designed to attract high school students into biopharmaceutical manufacturing career pathways; and
• NSF, in partnership with DOL, DOC, and other agencies, will convene a forum to build alignment on recognized competency models, development of new competency models where needed, and exploration of credentialing mechanisms for the bioworkforce.

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