On June 13, 2025, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that its Biotechnology Regulatory Services (BRS) has launched an updated Pre-Application Questionnaire that will replace the BRS Permitting Assistant in APHIS eFile. According to APHIS, applicants using APHIS eFile will experience: An interface that leads applicants through a series of questions to determine if their application qualifies for a notification or if a permit...
Regulatory, legal, policy, and business developments in renewable chemicals, biofuels, and other biobased products
The Clean Air Act (CAA) requires the U.S. Environmental Protection Agency (EPA) to determine the applicable volume requirements for the Renewable Fuel Standard (RFS) for years after those specified in the statute. On June 17, 2025, EPA proposed the applicable volumes and percentage standards for 2026 and 2027 for cellulosic biofuel, biomass-based diesel (BBD), advanced biofuel, and total renewable fuel. 90 Fed. Reg. 25784. EPA notes that the proposed rule also includes a number of regulatory...
June 6, 2025
Call for Evidence for Impact Assessment of the European Biotech Act Will Close June 11, 2025
The European Commission (EC) began a call for evidence on May 14, 2025, for an impact assessment of the European Biotech Act. The EC states that the overall objective is to improve the size and competitiveness of the biotechnology sector in the European Union (EU) while maintaining high safety standards. The new European Biotech Act will aim to ensure that the EU makes the most of the biotechnology revolution for the benefit of society, the environment, and the economy, while making it easier to...
On June 3, 2025, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) began a public comment period on a draft plant pest risk assessment (PPRA) and draft environmental assessment (EA) regarding a petition from Bayer U.S.-Crop Science seeking a determination of nonregulated status for maize (corn) event MON 95379 that was developed “using genetic engineering to produce two insecticidal proteins to protect against feeding damage caused by target lepidopteran...
On June 5, 2025, the House Science and Technology Subcommittees on Energy and on Research and Technology will hold a joint hearing on “Pursuing the Golden Age of Innovation: Strategic Priorities in Biotechnology.” The Subcommittees will hear from the following witnesses: Dr. Drew Endy, Hoover Institution Science and Senior Fellow, Martin Family Fellow in Undergraduate Education for Bioengineering, Stanford University; Ms. Deborah Gracio, Associate Lab Director, National Security Directorate,...
May 30, 2025
BETO Updates 45ZCF-GREET Model to Incorporate New Methods of Alternative Fuel Production
On May 30, 2025, the U.S. Department of Energy (DOE) Bioenergy Technologies Office (BETO) announced that it “removed barriers to domestic bioenergy production by updating its 45ZCF-GREET modeling tool to account for new feedstocks and methods of production, including ethanol from corn wet-milling and natural gas from coal-mine methane.” According to BETO, these measures will allow a wider range of farmers and companies to do business in the alternative fuels market. BETO notes that the U.S....
On May 7, 2025, Representatives Nikki Budzinski (D-IL) and Zach Nunn (R-IA) introduced the Agricultural Biorefinery Innovation and Opportunity Act (Ag BIO Act) (H.R. 3253), a bipartisan bill that would support the biofuel economy. According to Budzinski’s May 8, 2025, press release, the bill would update the U.S. Department of Agriculture’s (USDA) Section 9003 program to expand access to grants, streamline loan guarantees, and provide $100 million in mandatory funding over five years. The...
April 30, 2025
National Biotechnology Initiative Act Would Implement Recommendations from NSCEB’s Final Report
As reported in our April 25, 2025, blog item, the National Security Commission on Emerging Biotechnology (NSCEB) announced on April 8, 2025, the availability of its final report and action plan, “urging Congressional action to bring the full weight of American innovation to improve and maintain U.S. global leadership in biotechnology.” On April 9, 2025, Senator Alex Padilla (D-CA), an NSCEB Commissioner, and the other three Congressional Commissioners introduced the bipartisan, bicameral...
The U.S. Environmental Protection Agency (EPA) announced on April 28, 2025, that it has issued an emergency fuel waiver allowing the sale of gasoline blended with 15 percent ethanol (E15) nationwide in summer 2025. EPA notes that this is consistent with President Trump’s Executive Order (EO) Declaring a National Energy Emergency, directing EPA to consider issuing emergency waivers to allow for year-round E15 sales. According to EPA, currently, in about half of the country, E15 cannot be sold...
The National Security Commission on Emerging Biotechnology (NSCEB) announced on April 8, 2025, the availability of its final report and action plan, “urging Congressional action to bring the full weight of American innovation to improve and maintain U.S. global leadership in biotechnology.” After an extensive study that included “more than 1,800 stakeholder consultations, a holistic review of unclassified and classified material, site visits across the United States, and meetings with...
April 2, 2025
USDA Will Fund 543 Projects in 29 States Through Higher Blends Infrastructure Incentive Program
On March 31, 2025, the U.S. Department of Agriculture (USDA) announced that it will release obligated funding under the Higher Blends Infrastructure Incentive Program (HBIIP) for 543 projects totaling $537 million in 29 states. According to the press release, USDA is “aggressively exploring additional ways to unleash American energy and incentivize the production and use of homegrown U.S. biofuels, including working alongside the Environmental Protection Agency (EPA) to develop Renewable...
The European Commission (EC) began a public consultation on March 31, 2025, on the upcoming European Union (EU) Bioeconomy Strategy. The EC states in its March 31, 2025, press release that the Strategy “marks a significant step forward in harnessing the opportunities of the bioeconomy to support European businesses and drive progress towards the EU’s environmental, climate and competitiveness objectives.” According to the call for evidence, the Strategy’s main aims include: Ensuring the...
March 31, 2025
APHIS Evaluates Petitions Reviewed under 2012 Process, Will Use Process Consistent with USDA Biotechnology Regulations Going Forward
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 27, 2025, that it will no longer use the process it outlined in 2012 for reviewing petitions seeking a determination that a modified plant should not be subject to the regulations for the introduction of organisms altered or produced through genetic engineering (modified organisms) that are plant pests or that there is reason to believe are plant pests. On March 6, 2012, APHIS...
March 27, 2025
EPA Extends 2024 RFS Compliance Reporting Deadline
The U.S. Environmental Protection Agency (EPA) issued a final rule on March 14, 2025, extending the Renewable Fuel Standard (RFS) compliance reporting deadline for the 2024 compliance year. 90 Fed. Reg. 12109. As reported in our January 8, 2025, blog item, EPA published a proposed rule on December 12, 2024, that would partially waive the 2024 cellulosic biofuel volume requirement and revise the associated percentage standard under the RFS program due to a shortfall in cellulosic biofuel...
On March 14, 2025, President Trump signed Executive Order (EO) 14236, rescinding 19 executive actions, including former President Biden’s September 2022 EO 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” 90 Fed. Reg. 13037. According to the White House’s March 14, 2025, fact sheet, EO 14081 “funneled Federal resources into radical biotech and biomanufacturing initiatives under the guise of environmental...
March 17, 2025
Council of the EU Agrees on Negotiating Mandate on Plants Obtained by New Genomic Techniques
The Council of the European Union (EU) announced on March 14, 2025, that the Committee of the Permanent Representatives of the Governments of the Member States to the EU (Coreper) endorsed the Council’s negotiating mandate on the regulation on plants obtained by new genomic techniques (NGT) and their food and feed. The regulation proposed by the European Commission (EC) would create two ways for NGT plants to be placed on the market: Category 1 NGT plants: Could occur naturally or through...
On January 16, 2025, Senators Jerry Moran (R-KS), Chuck Grassley (R-IA), Tammy Duckworth (D-IL), Pete Ricketts (R-NE), Amy Klobuchar (D-MN), and Joni Ernst (R-IA) reintroduced the Farm to Fly Act (S. 144), which would help accelerate the production and development of sustainable aviation fuel (SAF) through existing U.S. Department of Agriculture (USDA) programs to allow further growth for alternative fuels to be used in the aviation sector and create new markets for American farmers. According...
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on February 7, 2025, that its 2025 Project Peer Review, initially planned for April 22-25, 2025, is postponed until a future, yet to be determined, date. According to BETO, approximately 200 projects in its research, development, and demonstration portfolio “will be presented to the public and systematically reviewed by experts from industry, academia, and federal agencies.” BETO notes that the 2025...
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on February 27, 2025, that it will begin to accept petitions for nonregulated status according to APHIS biotechnology regulations at 7 C.F.R. Part 340 (2019) on March 3, 2025. APHIS notes that its biotechnology regulations enable developers to petition for a determination that an “article” is not regulated. The petition process applies only to plants that meet the regulatory definition...
The U.S. Environmental Protection Agency (EPA) announced on January 21, 2025, the availability of a final document entitled “Biofuels and the Environment: Third Triennial Report to Congress” (Third Report). 90 Fed. Reg. 7135. The document was prepared by EPA’s Offices of Research and Development (ORD) and Air and Radiation (OAR), in consultation with the U.S. Departments of Agriculture (USDA) and Energy (DOE). The Third Report builds on the first and second triennial reports, released in...
February 5, 2025
Biden USDA Issues Technical Guidelines for Climate-Smart Agriculture Crops Used as Biofuel Feedstocks
On January 17, 2025, the Biden U.S. Department of Agriculture (USDA) issued an interim final rule with a request for comment that establishes technical guidelines for quantifying, reporting, and verifying the greenhouse gas (GHG) emissions associated with agricultural production of biofuel feedstock commodity crops grown in the United States in the context of environmental service markets. 90 Fed. Reg. 5497. The rule establishes guidelines for the reporting and verification of practices and...
February 3, 2025
House Committee Will Hold Hearing on “The State of U.S. Science and Technology: Ensuring U.S. Global Leadership”
The House Committee on Science, Space, and Technology will hold a hearing on February 5, 2025, on “The State of U.S. Science and Technology: Ensuring U.S. Global Leadership.” According to the Hearing Charter, the purpose of the hearing is “to assess the current condition of the United States’s science and technology enterprise and its vital role in the global innovation race.” By examining public and private investments in the United States, the Committee will also have the opportunity...
The European Commission (EC) announced on January 29, 2025, that it launched a Biotech and Biomanufacturing Hub to support companies -- particularly start-ups and small and medium-sized enterprises (SME) -- in bringing innovative products to the European Union (EU) market and increase their competitiveness. According to the EC, the Hub will also help companies identify available support at the EU level and how to access this support to help them expand and grow. The EC states that the Biotech...
January 27, 2025
ChemCatBio Will Hold January 29 Webinar on Programmable Catalysis for Chemical Energy Innovation
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office’s (BETO) Chemical Catalysis for Bioenergy Consortium (ChemCatBio) will hold a webinar on January 29, 2025, on programmable catalysis for chemical energy technology. ChemCatBio states that catalysis enables new frontiers in energy, such as converting biomass to high-value products and storing energy from abundant renewable energy. Challenges remain, however, when catalysts are slow, expensive, or produce too many side...
On January 8, 2025, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) and the U.S. Environmental Protection Agency (EPA) announced $6 million in funding for three projects that will advance biofuel development and support U.S. leadership in energy and emissions innovation. According to BETO, the projects will support research to improve performance and reduce costs of high-impact biofuel production technologies; scale up production systems with industry; and support...
January 8, 2025
EPA Proposes Partial Waiver of 2024 Cellulosic Biofuel Volume Requirement and Extension of 2024 Compliance Deadline
The U.S. Environmental Protection Agency (EPA) published a proposed rule on December 12, 2024, that would partially waive the 2024 cellulosic biofuel volume requirement and revise the associated percentage standard under the Renewable Fuel Standard (RFS) program due to a shortfall in cellulosic biofuel production. 89 Fed. Reg. 100442. As a result of this proposed change, EPA proposes to extend the RFS compliance reporting deadline for the 2024 compliance year. According to the proposed rule, EPA...
The U.S. Department of Agriculture (USDA) announced on December 20, 2024, that the United States prevailed in its dispute under the United States-Mexico-Canada Agreement (USMCA) challenging certain Mexican biotechnology measures concerning genetically engineered (GE) corn. Under a February 2023 presidential decree, Mexico banned immediately the use of GE corn in dough and tortillas and instructed government agencies to eliminate gradually the use of GE corn for other food uses and in animal...
January 6, 2025
FY 2025 NDAA Includes Biotechnology Provisions
The National Security Commission on Emerging Biotechnology announced on December 18, 2024, that the fiscal year 2025 National Defense Authorization Act includes “a suite of recommendations designed to galvanize action on biotechnology” for the U.S. Department of Defense (DOD). According to the Commission, the bill includes new authorities and requirements -- derived from its May 2024 proposals -- that will position DOD and the intelligence community (IC) to maximize the benefits of...
January 3, 2025
White House OSTP Announces Availability of Federal Sustainable Chemistry Strategic Plan
On December 19, 2024, the White House Office of Science and Technology Policy (OSTP) announced the availability of the Federal Sustainable Chemistry Strategic Plan (Strategic Plan). As reported in our January 19, 2021, memorandum, Subtitle E of TII of the National Defense Authorization Act for Fiscal Year 2021 (NDAA for FY2021) includes the text of the bipartisan Sustainable Chemistry Research and Development Act of 2019. Subtitle E establishes an interagency working group led by OSTP to...
January 2, 2025
APHIS Restarts Permitting and “Am I Regulated” Processes for Products of Biotechnology
As reported in our December 5, 2024, blog item, on December 4, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it acknowledges the U.S. District Court for the Northern District of California’s December 2, 2024, ruling prospectively vacating USDA’s May 2020 final rule for organisms developed using genetic engineering. National Family Farm Coalition, et al. v. Vilsack (No. 3:21-cv-05695-JD). As reported in our May 18, 2020,...
December 31, 2024
DOE Announces Intent to Fund R&D to Advance Biofuels and Bioproducts
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on December 16, 2024, its intent to fund research and development (R&D) projects in two priority areas, sustainable propane and renewable chemicals, and algal system cultivation and preprocessing: Sustainable Propane and Renewable Chemicals (SPARC) Funding Opportunity: According to BETO, producing chemicals and propane/liquid petroleum gas (LPG) from domestic renewable feedstock resources could help...
The Rural Business-Cooperative Service (RBCS), an agency of the Rural Development mission area within the U.S. Department of Agriculture (USDA), issued a final rule on December 9, 2024, that adopts changes from the Agriculture Improvement Act of 2018 (2018 Farm Bill) that apply to the Biobased Markets (BioPreferred) Program. 89 Fed. Reg. 97459. RBCS notes that these changes include the merger of the Guidelines for Designating Biobased Products for Federal Procurement and the Voluntary Labeling...
December 17, 2024
EPA Updates Recommendations of Specifications, Standards and Ecolabels for Federal Purchasing
The U.S. Environmental Protection Agency (EPA) announced on December 5, 2024, that it published updates to its Recommendations of Specifications, Standards and Ecolabels for Federal Purchasing (Recommendations). EPA notes that this is the first time in almost ten years that it has comprehensively evaluated private-sector standards and ecolabels and expanded the Recommendations. According to EPA, the Recommendations “help buyers cut through the clutter to identify thousands of products and...
The Congressional Research Service (CRS) posted a November 30, 2024, update to its report entitled “Gene-Edited Plants: Regulation and Issues for Congress.” Gene-edited plants are regulated under the U.S. Coordinated Framework for Regulation of Biotechnology, which coordinates how the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) regulate biotechnology products to ensure their safety. Over time, the...
December 5, 2024
District Court Grants Summary Judgment in Part to Plaintiffs, Vacating and Remanding Final SECURE Rule to USDA
On December 4, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it acknowledges the U.S. District Court for the Northern District of California’s December 2, 2024, ruling prospectively vacating USDA’s May 2020 final rule for organisms developed using genetic engineering. National Family Farm Coalition, et al. v. Vilsack (No. 3:21-cv-05695-JD). As reported in our May 18, 2020, memorandum, the final Sustainable, Ecological,...
December 4, 2024
DOE’s Idaho National Laboratory Will Hold Webinar on Bioenergy Feedstock Library on December 11, 2024
On December 11, 2024, the U.S. Department of Energy’s (DOE) Idaho National Laboratory (INL) will hold a webinar on its Bioenergy Feedstock Library, “a cornerstone database resource funded by DOE’s Bioenergy Technologies Office (BETO), and how it supports bioenergy research.” According to DOE, the Bioenergy Feedstock Library provides information and knowledge on over 100,000 bioenergy feedstock samples, supporting U.S. bioeconomy development by providing standardized data on biomass...
December 3, 2024
APHIS Revises and Adds Exemptions for Plants Modified or Produced through Genetic Engineering
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on November 13, 2024, that it added modifications a plant may contain and qualify for exemption from regulations governing movement of organisms modified or produced using genetic engineering because the modifications are achievable through conventional breeding. 89 Fed. Reg. 89569. As reported in our November 16, 2023, blog item, APHIS had proposed five types of modifications: Plants that...
November 27, 2024
DOE Releases New Report on Pathways to Commercial Liftoff for Sustainable Aviation Fuel
The U.S. Department of Energy (DOE) announced on November 13, 2024, the release of its latest Pathways to Commercial Liftoff report, “Pathways to Commercial Liftoff: Sustainable Aviation Fuel,” which analyzes the technical and commercial readiness of several sustainable aviation fuel (SAF) production pathways and highlights steps that both the public and private sector can take to make the United States a global leader in SAF production as soon as 2030. According to DOE, key findings from...
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) will host the next Project Peer Review from April 22-25, 2025, in Arlington, Virginia. During the 2025 Project Peer Review, around 200 projects in BETO’s research, development, and demonstration portfolio will be presented to the public and systematically reviewed by external subject-matter experts from academia, industry, and federal agencies. BETO notes that the Project Peer Review will have several simultaneous...
November 23, 2024
DOE Releases SAF Grand Challenge Roadmap Implementation Framework
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on November 20, 2024, the release of the Sustainable Aviation Fuel (SAF) Grand Challenge Roadmap Implementation Framework. Developed by an interagency team led by DOE, the U.S. Department of Agriculture (USDA), and U.S. Department of Transportation’s (DOT) Federal Aviation Administration (FAA), the framework is a supplemental document to the roadmap. Whereas the roadmap identified the actions needed to...
November 20, 2024
Biomanufacturing Interagency Working Group Identifies Actions to Increase U.S. Biomanufacturing Capacity
On November 15, 2024, the White House Office of Science and Technology Policy (OSTP) released a report by the Biomanufacturing Interagency Working Group entitled “Building a Vibrant Domestic Biomanufacturing Ecosystem.” The Working Group includes representatives from the U.S. Department of Defense, U.S. Department of Energy, U.S. Department of Commerce, U.S. Department of Agriculture, U.S. Department of Health and Human Services, National Science Foundation, U.S. Department of State, the...
On October 28, 2024, the National Academies of Sciences, Engineering, and Medicine (NASEM) announced that a new NASEM initiative, the International Bioeconomy Forum, will launch in early 2025. According to NASEM, its International Bioeconomy Roundtable and the Association of Biotechnology Led Enterprises (ABLE) met on September 13, 2024, during the Global Bio-India 2024 conference in New Delhi, India, to discuss the scope of the International Bioeconomy Forum. NASEM states that the forum will...
November 8, 2024
DOE’s Agile BioFoundry and Advanced Biofuels and Bioproducts Process Development Unit Partner with Industrial Microbes to Scale Up Biobased Process
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on October 7, 2024, that researchers at its Agile BioFoundry (ABF) and Advanced Biofuels and Bioproducts Process Development Unit (ABPDU) successfully scaled up a biobased process that converts ethanol into “a valuable precursor for consumer products, such as paints, coatings, and diapers.” The researchers worked with industry partner Industrial Microbes to develop the process. Although acrylic acid is...
November 7, 2024
APHIS Releases Final Guide to Submitting Reports and Notices in APHIS eFile and Response to Comments
On November 6, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) announced the completion of the final version of the Guide to Submitting Data for Reports and Notices in APHIS eFile and the Response to Comments: Guide to Submitting Data for Reports and Notices in APHIS eFile. In October 2023, to clarify and streamline its biotechnology regulations further, BRS published for comment a draft guide to...
November 6, 2024
Registration Opens for USDA’s 101st Agricultural Outlook Forum
The U.S. Department of Agriculture (USDA) has opened registration for the 101st Agricultural Outlook Forum. The event, entitled “Meeting Tomorrow’s Challenges, Today,” will be held at the Crystal City Gateway Marriott in Arlington, Virginia, on February 27-28, 2025. Additionally, USDA will livestream all Forum sessions on a virtual platform. According to USDA, the program will feature a presentation on the 2025 outlook for the U.S. agricultural economy and trade by USDA Chief Economist...
November 5, 2024
USDA Announces $239 Million to Increase Access to Domestic Biofuels
The U.S. Department of Agriculture (USDA) announced on October 29, 2024, that it is awarding $39 million in grants to U.S. business owners to increase the availability of domestic biofuels in 18 states and provide cleaner, more affordable fuel options. USDA will also make $200 million available through the new Biobased Market Access and Development Grants made possible by Commodity Credit Corporation (CCC) funds. According to USDA, the awards and funding are made possible through the Higher...
In October 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) reviewed the following plants modified using genetic engineering to determine whether they posed an increased plant pest risk relative to non-modified comparators: SoilCea, sweet orange with improved resistance to citrus greening; Pioneer, corn with fungal disease resistance; GreenLab, Inc., modified corn to produce an enzyme that degrades cellulose and for herbicide resistance to...
November 2, 2024
Treasury Department and IRS Issue Guidance for SAF Credit
On October 18, 2024, the U.S. Department of the Treasury (Treasury Department) and the Internal Revenue Service (IRS) issued Notice 2024-74 for the Sustainable Aviation Fuel (SAF) credit created by the Inflation Reduction Act (IRA). According to the IRS’ October 18, 2024, press release, the SAF credit ranges from $1.25 to $1.75 for each gallon of SAF in a qualified mixture. To qualify for the credit, the SAF must have a minimum reduction of 50 percent in lifecycle greenhouse gas (GHG)...
October 31, 2024
BRS Will Hold Annual Stakeholder Meeting on November 14, 2024
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) will hold its annual stakeholder meeting on November 14, 2024. The meeting will take place in person at the USDA Center at Riverside, 4700 River Road, Riverdale, Maryland, with an option for virtual attendance. The meeting agenda includes the following items: Program Highlights: An overview of BRS’ fiscal year (FY) 2024 successes; Regulatory Status Review...
October 2, 2024
EPA, FDA, and USDA Release Tool to Help Companies Developing Microbial Biotechnology Products Navigate Regulatory Landscape
On October 2, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) announced the release of a new web-based tool on the Unified Website for Biotechnology Regulation for companies that develop microbial biotechnology products. EPA notes that biotechnology products include plants, animals, and microorganisms developed through genetic engineering or the targeted manipulation of genetic information. According to EPA,...