Biobased Products News and Policy Report – Update from Bergeson & Campbell, P.C.

March 7, 2024

Federal

DOE Intends To Issue Funding To Support Mixed Algae And Wet Waste Feedstocks R&D For Biofuels And Bioproducts: The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) and Office of Fossil Energy and Carbon Management (FECM) announced on February 13, 2024, their intent to issue funding to support research and development (R&D) projects for converting algae and other wet waste feedstocks to low-carbon fuels, chemicals, and agricultural products. DOE states that the intended Mixed Algae Conversion Research Opportunity (MACRO) funding would address gaps in the use of carbon dioxide (CO2), conversion technologies, and product development that limits the use of wet algal feedstocks. According to DOE, “[a] wide range of feedstocks, such as seaweed, other algae, and other wet waste feedstocks, will be needed to achieve the Biden-Harris administration’s goal of an equitable, clean energy future of net-zero emissions, economy-wide, by no later than 2050.” The funding would focus on the following topic areas:

  • Topic Area 1 — Conversion of Seaweeds and Waste Algae to Low-Carbon Fuels and Products; and
     
  • Topic Area 2 — Conversion of Algal Biomass for Low-Carbon Agricultural Products.

DOE states that the intended Funding Opportunity Announcement (FOA) is expected to be released in March 2024 and could include up to $18.8 million in federal funding. BETO and FECM envision awarding multiple financial assistance awards for R&D activities in the form of cooperative agreements lasting approximately two to three years.

EPA And DOE Announce Funding To Spur Development Of Advanced Biofuels: The U.S. Environmental Protection Agency (EPA) and DOE announced on February 22, 2024, the release of an FOA, “Inflation Reduction Act Funding for Advanced Biofuels,” for up to $9.4 million for the development of advanced biofuels. According to EPA, the funding will support “high-impact biofuel technology projects to improve the performance and reduce the cost of biofuel production technologies, scale up production systems in partnership with industry, and accelerate the nation’s bioeconomy.” The FOA will fund selected projects in two priority areas:

  • Projects aimed at scaling up key process steps in advanced biofuel production; and
     
  • Projects to develop and pilot-test key technology innovations for processing biointermediates, which are feedstocks that have been partially converted at one facility but are then sent to a separate facility for final processing into a renewable fuel.

Domestic businesses, educational institutions, and nonprofits are eligible to apply for the funding, which will be administered by DOE’s BETO. The FOA concept paper deadline is 5:00 p.m. (EDT) on March 22, 2024, and full applications are due at 5:00 p.m. (EDT) on May 24, 2024.

FDA Issues Guidance For Industry On Foods Derived From Plants Produced Using Genome Editing: The U.S. Food and Drug Administration (FDA) has posted a February 2024 guidance entitled “Foods Derived from Plants Produced Using Genome Editing: Guidance for Industry.” According to FDA, one purpose of the guidance is to clarify how its 1992 policy statement “Statement of Policy: Foods Derived from New Plant Varieties” (NPV policy) (57 Fed. Reg. 22984) applies to foods derived from NPVs produced using genome editing. The NPV policy provides scientific and regulatory guidance on foods from NPVs, laying out broad, risk-based principles for ensuring the safety of foods from NPVs. The guidance explains that the principles outlined in the NPV policy apply to foods from genome-edited plant varieties and reminds developers of NPVs of their obligations under Section 403(w) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which was enacted after FDA issued the NPV policy. FDA notes that the guidance describes two processes through which developers may voluntarily inform FDA of steps taken to ensure the safety of foods from their new genome-edited plant varieties: voluntary premarket consultations and voluntary premarket meetings. The voluntary process FDA recommends for a new food “is based on the objective characteristics of the new food, especially those related to food safety.”

USDA Seeks Comments On Petition To Deregulate Corn Developed Using Genetic Engineering: The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 4, 2024, that it received a petition from Bayer U.S.-Crop Science seeking a determination of nonregulated status for maize (corn) event MON 95379 that has been developed using genetic engineering to produce two insecticidal proteins to protect against feeding damage caused by target lepidopteran pests. 89 Fed. Reg. 15542. APHIS is making the petition available for review and comment to help it “identify potential issues and impacts that we may determine should be considered in our evaluation of the petition.” Comments are due May 3, 2024.

APHIS notes that it is evaluating the petition under the version of the regulations effective at the time that it received the petition. As reported in our May 18, 2020, memorandum, APHIS issued a final rule, published in the May 18, 2020, Federal Register (85 Fed. Reg. 29790), that revises 7 C.F.R. Part 340; the final rule was implemented in phases, however. The new Regulatory Status Review (RSR) process, which replaces the petition for determination of nonregulated status process, became effective on April 5, 2021, for corn, soybean, cotton, potato, tomato, and alfalfa. The RSR process was effective for all crops as of October 1, 2021. As stated in the final rule, “[u]ntil RSR is available for a particular crop . . . APHIS will continue to receive petitions for determination of nonregulated status for the crop in accordance with the [legacy] regulations at 7 CFR 340.6,” however. APHIS is evaluating the petition in accordance with the regulations at 7 C.F.R. Section 340.6 (2020) as it was originally received by APHIS on July 23, 2020.

International

Library Of Congress Publishes Article On South Korea’s Act On Promoting The Green Bio Industry: On February 7, 2024, the Library of Congress posted an article entitled “South Korea: Act to Promote Green Bio Industry Published.” According to the article, South Korea published the Act on Promoting the Green Bio Industry (Green Bio Act) on January 2, 2024. The Green Bio Act, which will enter into force on January 3, 2025, “aims to promote the application of biotechnology to agricultural bioresources and increase the added value of agriculture, develop the green bio industry, and realize sustainable agriculture.” Under the Green Bio Act, the Minister of Agriculture, Food and Rural Affairs (MAFRA) will establish and implement a basic plan for the development of the green bio industry every five years. To support persons who wish to start businesses and venture companies related to the green bio industry, MAFRA and the heads of local governments will provide:

  • Loans for start-up funds;
     
  • Spaces, such as facilities for starting a business, or subsidies to rent such spaces;
     
  • Prototypes for production of green bio products;
     
  • Channels for the sale and promotion of green bio products;
     
  • Legal, tax, and accounting consultation for starting a business; and
     
  • Other support considered necessary by MAFRA.

The article states that MAFRA “will promote the creation and use of data related to the green bio industry, such as genome information of agricultural bioresources.” To promote the purchase of green bio products, the government can request that public institutions take measures such as preferential purchase of green bio products.

European Industries Call For “Bold And Impactful” Biotechnology And Biomanufacturing Initiative: EuropaBio, the European Association for Bioindustries, announced on February 21, 2024, the release of a position paper calling for “bold ambition, and five core principles to ensure impactful industrial growth.” According to the position paper, “EC Initiative on Biotechnology and Biomanufacturing: Principles for an impactful Europe,” the European Commission’s (EC) forthcoming Biotechnology and Biomanufacturing Initiative “is a unique opportunity for the [European Union (EU)] to build on its strong research and innovation base towards clear industrial, societal and market targets.” The position paper states that the following five core principles should underpin goals for Europe’s approach to biotechnology and biomanufacturing, not only within the proposed Initiative, but integral to the EU’s implementation of industrial strategy across sectors:

  • Recognize societal and economic benefits from biotechnology and biomanufacturing, with a predictable and coherent policy framework throughout value chains that enables growth and transformation across sectors;
     
  • Ensure competitive market access for biotechnology and biomanufactured products in Europe and allow European companies to be active contributors into globally resilient supply chains, with informed citizen confidence, including clear regulatory pathways for innovative advances;
     
  • Unlock the full potential of Europe’s Single Market for biotechnology processes and biomanufacturing, including for people, goods, services, and capital;
     
  • Create investment frameworks for biotechnology and biomanufacturing, including access to risk capital within Europe, to facilitate multi-scale production facilities and biorefineries and achieve pan-European capacity; and
     
  • Apply innovation principles within R&D priorities for biotechnology (including digital and artificial intelligence (AI) advancement), enhance intellectual property protection, and develop skills to accelerate industrial transition and production through innovation.

According to EuropaBio, signatories will be added through 2024, “working to highlight Initiative priorities for their own sectors and creating a shared voice for the transformation of Europe’s industry at a time of unprecedented global commitment to biomanufacturing.”

Events

EPA Announces Pollution Prevention In Action: New Webinar Series With OCSPP: On March 1, 2024, EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) announced a new webinar series, “Pollution Prevention in Action.” Jennie Romer, EPA Deputy Assistant Administrator for Pollution Prevention, will host webinars featuring businesses, Pollution Prevention grantees, and other experts about innovations and successes in implementing source reduction strategies to advance sustainability across sectors. The first webinar will be held on March 13, 2024, 2:00-3:00 p.m. (EDT) on Using EPA’s Sustainable Procurement Tools to Achieve Sustainability Goals. Participants will learn how EPA’s sustainable procurement tools can help government and institutional purchasers meet sustainability goals and mandates. The webinar will review a new interactive tool for EPA’s Recommendations of Specifications, Standards, and Ecolabels and show how it can identify the ecolabels that address per- and polyfluoroalkyl substances (PFAS) and plastics. Industry experts and EPA grantees will discuss how they incorporate these resources in their work. Speakers will include:

  • Allison Thompson, EPA Environmentally Preferable Purchasing;
     
  • Susan Klosterhaus and Esther Julier, Cradle to Cradle;
     
  • Christa McDermott, Portland State University; and
     
  • Katie Saha, Sustainable Purchasing Leadership Council;

More information is available in our March 1, 2024, blog item.

DOE Will Host Virtual Clean Fuels & Products ShotTM Summit April 8-9, 2024: DOE will host the Clean Fuels & Products Shot™ Summit on April 8, 2024, from 11:00 a.m. – 2:00 p.m. (EDT), and April 9, 2024, from 11:00 a.m. – 4:00 p.m. (EDT). The virtual event will gather stakeholders across government, industry, academia, and non-profit organizations to engage on the objectives, progress, priorities, and future plans for the seventh DOE Energy Earthshot™. According to DOE, the Clean Fuels & Products Shot aims to lower carbon emissions from the fuels and chemicals industry by using more environmentally friendly carbon sources, targeting a minimum reduction of 85 percent in greenhouse gas (GHG) emissions compared to fossil-based sources by 2035. Additionally, it aims to meet 2050 projected demand 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. Summit participants will learn more about “the research, development, and demonstration strategy to establish the United States as a world leader in clean fuel and clean carbon-based chemical production.”

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