April 4, 2024
Federal
USDA Releases Reports On Economic Impact Analysis Of The U.S. Biobased Products Industry And On Hemp Research And Innovation: On March 8, 2024, the U.S. Department of Agriculture (USDA) honored the second annual National Biobased Products Day, “a celebration to raise public awareness of biobased products, their benefits and their contributions to the U.S. economy and rural communities.” As part of its activities to honor National Biobased Products Day, USDA released two reports:
- “An Economic Impact Analysis of the U.S. Biobased Products Industry: 2023 Update” shows that, based on data from 2021, the biobased products industry has grown nationwide despite the impacts of the global COVID-19 pandemic. USDA notes that the findings span seven major sectors representing the bioeconomy: Agriculture and Forestry; Biobased Chemicals; Biobased Plastic Bottles and Packaging; Biorefining; Enzymes; Forest Products; and Textiles.
- “Hemp Research Needs Roadmap” reflects stakeholder input in identifying the hemp industry’s greatest research needs: breeding and genetics, best practices for production, biomanufacturing for end uses, and transparency and consistency.
More information is available in our March 11, 2024, blog item.
USDA Releases Plan To Strengthen The Bioeconomy Through A More Resilient Biomass Supply Chain: USDA released on March 14, 2024, a report entitled Building a Resilient Biomass Supply: A Plan to Enable the Bioeconomy in America, “a plan that will boost biomass supply chain resiliency for domestic biobased product manufacturing, while also advancing environmental sustainability and market opportunities for small and mid-sized producers.” USDA states that the plan finds that U.S. biomass supplies are abundant, positioning the United States to convert biomass into biobased products if improvements to biomass supply chain logistics and materials handling technology are made and farmers are provided with incentives to produce biomass while reducing risk. USDA also published an Implementation Framework that identifies actions USDA will take in the next year to increase available cultivated biomass, invest in infrastructure for biobased products, and support the responsible development of the biomass supply chain. USDA released a fact sheet outlining its 2023 bioeconomy accomplishments, which include $772 million in investments for research, development, and infrastructure involving biofuels, fertilizer production, crop innovations, biobased products, and more. More information is available in our March 15, 2024, blog item.
DOE Report Outlines How The United States Can Sustainably Produce More Than One Billion Tons Of Biomass Per Year: On March 15, 2024, the U.S. Department of Energy (DOE) announced the release of the Bioenergy Technologies Office’s (BETO) 2023 Billion-Ton Report (BT23), the fourth in a series of assessments of potential biomass resources available in the United States. BT23 analyzes the biomass production capacity of approximately 60 resources, “several of which have never before been the subject of a DOE Billion-Ton assessment.” These include winter oilseed crops, trees and brush harvested from forests to prevent wildfires, macroalgae such as seaweed cultivated in ocean farms, and carbon dioxide from industrial plants. BT23 finds that the wide dispersion and variety of these resources will ensure that the benefits of expanded biomass production extend to both rural and urban areas. More information is available in our April 2, 2024, blog item.
APHIS Seeks Comment On Draft EIS For Deregulation Of Maize Developed Using Genetic Engineering: USDA’s Animal and Plant Health Inspection Service (APHIS) announced on March 22, 2024, that it has prepared a draft environmental impact statement (EIS) and draft plant pest risk assessment (PPRA) evaluating the potential environmental impacts and plant pest risk that may result from the approval of a petition for nonregulated status for maize developed using genetic engineering for dicamba, glufosinate, quizalofop, and 2,4-dichlorophenoxyacetic acid resistance with tissue-specific glyphosate resistance facilitating the production of hybrid maize seed. 89 Fed. Reg. 20424. APHIS states in its March 21, 2024, press release that it prepared these documents in response to a petition from Bayer CropScience U.S. seeking to deregulate their MON 87429 corn cultivar. According to APHIS, Bayer states in its petition that “the MON 87429 cultivar is intended for hybrid seed production and is unlikely to pose plant pest risks.” The draft EIS examines potential environmental and socioeconomic impacts that may result from approving Bayer’s petition to deregulate its MON 87429 corn cultivar. The draft PPRA examines potential plant pest risks. Comments on the draft EIS and draft PPRA are due May 6, 2024.
CRS Publishes Report On Regulation Of Gene-Edited Plants And Issues For Congress: The Congressional Research Service (CRS) published a report on March 22, 2024, on “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 USDA, the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) regulate biotechnology products to ensure their safety. The report notes that the following agency actions align with the goals of President Biden’s September 12, 2022, EO on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy:
- APHIS’s November 15, 2023, proposal for five additional exemptions for plants modified or produced through genetic engineering;
- FDA’s clarification of guidance for industry on voluntary engagement before marketing food from gene-edited plants; and
- EPA’s changes to regulations regarding plant-incorporated protectants (PIP).
According to the report, potential congressional concerns “could include examining whether current policies appropriately weigh the potential risks and rewards of new plant varieties developed using gene editing and whether regulatory agencies are efficiently coordinating their efforts.”
White House Launches National Bioeconomy Board: The White House Office of Science and Technology Policy (OSTP) announced on March 22, 2024, the launch of the National Bioeconomy Board, co-chaired by OSTP, the U.S. Department of Commerce, and the U.S. Department of Defense. According to OSTP, Board members represent the variety of biotechnology and biomanufacturing stakeholders across the federal government, including departments and agencies that promote economic development, sponsor fundamental research, facilitate technology commercialization, focus on safety and security, and engage in workforce training. OSTP states that the Board “will continue to lead the actions required to achieve a sustainable, safe, and secure American bioeconomy.”
AMS Requests Information To Update List Of Bioengineered Foods: On March 28, 2024, USDA’s Agricultural Marketing Service (AMS) requested information about potential additions to or subtractions from the List of Bioengineered Foods (List) as it pertains to the National Bioengineered Food Disclosure Standard (Standard). 89 Fed. Reg. 21484. Under 7 C.F.R. Section 66.1, a bioengineered food is a food that — subject to certain factors, conditions, and limitations — contains detectable genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature. AMS states that it is soliciting comments including data, recommendations, and other information on the inclusion of several specific crops and foods that it has determined are likely to meet the criteria to be added to the List. AMS also seeks information on any additional crops or foods that may meet the criteria to be added to the List, any crops or foods that no longer meet the criteria and should be removed from the List, and any trade names, varieties, or modifiers that it should consider for addition to or subtraction from the items currently appearing on the List. After reviewing the recommendations and information submitted in response to the notice, AMS will use that information, as well as input based on consultation with other government agencies responsible for oversight of biotechnology products, to determine whether it should initiate rulemaking to update the List. AMS will not consider any comments not directly related to updates to the List or any recommendations that are not accompanied by supporting information. Responses are due April 29, 2024.
GAO Will Review EPA’s Practices For Managing And Accessing The Performance Of Its New Chemicals Review Program: EPA provided notice of disclosure on April 2, 2024, to all potentially affected businesses under the Toxic Substances Control Act (TSCA) that submitted information to EPA pursuant to TSCA Section 5 that it will disclose information to the U.S. Government Accountability Office (GAO). 89 Fed. Reg 22713. According to the notice, GAO is initiating a review of EPA’s practices for managing and accessing the performance of EPA’s New Chemicals Review program under TSCA Section 5. To do so, GAO has requested access to records, data, and documents submitted to EPA pursuant to TSCA, the Pollution Prevention Act (PPA), and other applicable statutes administered by EPA’s Office of Pollution Prevention and Toxics (OPPT) from October 1, 2021, through the date of the notice. EPA states that the requested information may include submissions that have been claimed as, or have been determined to be, confidential business information (CBI). EPA notes that “GAO has not indicated which or how many TSCA section 5 submissions they may need to access, but their planned review of this information will likely require the viewing and analysis of some features of unredacted submissions that have been claimed as CBI” and that GAO staff may view CBI material in TSCA Section 5 submissions incidental to their review and examination of the New Chemicals Review program. EPA also intends to disclose any information related to data systems that house new chemicals review information to assess the reliability of system data. At the conclusion of its GAO review, GAO will destroy, delete, or return to EPA all CBI-claimed documents, if applicable. More information on GAO’s February 2023 report entitled “EPA Chemical Reviews: Workforce Planning Gaps Contributed to Missed Deadlines” is available in our February 24, 2023, memorandum.
International
EC Publishes Communication On Biotechnology And Biomanufacturing, Announces Targeted Actions: The European Commission (EC) announced on March 20, 2024, that it has proposed a series of targeted actions to boost biotechnology and biomanufacturing in the European Union (EU). The EC states that its March 20, 2024, Communication on Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU “identifies the challenges and barriers and proposes to tackle them, in line with the Communication on the long-term competitiveness of the EU.” According to the EC, the EU biotechnology and biomanufacturing sector faces several challenges: research and technology transfer to the market; regulatory complexity; access to finance; skills; value chain obstacles; intellectual property; public acceptance; and economic security. To address these issues, the EC puts forward the following actions:
- Leveraging research and boosting innovation;
- Stimulating market demand;
- Streamlining regulatory pathways;
- Fostering public and private investments;
- Strengthening biotech-related skills;
- Elaborating and updating standards;
- Supporting collaboration and synergies;
- Fostering engagement and international cooperation;
- Using artificial intelligence (AI) and generative AI; and
- Reviewing the Bioeconomy Strategy.
The EC posted questions and answers and a fact sheet regarding the Communication. More information is available in our March 28, 2024, blog item.
Events
EPA Reschedules Webinar On Biogas Regulatory Reform Rule Provisions Of RFS Program To April 12, 2024: EPA announced on April 3, 2024, that it has rescheduled its public webinar to discuss the implementation of the Biogas Regulatory Reform Rule (BRRR) provisions promulgated as part of the Renewable Fuel Standard (RFS) final rule for 2023-2025 (the Set Rule) to April 12, 2024. 89 Fed. Reg. 23013. During the webinar, EPA intends to discuss various aspects of the BRRR program, including:
- The implementation timeline for BRRR;
- An implementation overview of the BRRR program;
- EPA Central Data Exchange (CDX) registration for biogas producers, renewable natural gas (RNG) producers, RNG renewable identification number (RIN) separators, and performing required associations;
- Alternative measurement protocols; and
- A curated question and answer session.
All attendees must pre-register for the webinar by notifying RFS-Hearing@epa.gov by April 8, 2024. Those who have already registered for the original webinar date do not need to re-register.
Save The Date For “TSCA Reform — 8 Years Later” On June 26, 2024: Save the date to join Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health for TSCA Reform — 8 Years Later, a day-long conference reflecting on the challenges and accomplishments since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. This year, the conference will be held in person at the George Washington University Milken Institute School of Public Health (and will be livestreamed via YouTube). Continuing legal education (CLE) credit will be offered in select states for in-person attendees only. Please check ELI’s event page in the coming weeks for more information, including an agenda, CLE information, registration, and more. If you have questions in the meantime, please contact Madison Calhoun (calhoun@eli.org).
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