January 4, 2023
Bergeson & Campbell, P.C. Releases 2024 Forecast for U.S. Federal and International Chemical Regulatory Policy: Bergeson & Campbell, P.C. (B&C®) and its global consulting affiliate The Acta Group (Acta®) and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are delighted to share with you our Forecast 2024. This carefully curated document represents our seasoned team’s collective take on what to expect regarding global industrial, agricultural, and biocidal chemical initiatives in the New Year.
Federal
Treasury Department And IRS Issue Guidance On SAF Credit: On December 14, 2023, the Treasury Department and the Internal Revenue Service (IRS) issued Notice 2024-06 for the new Sustainable Aviation Fuel (SAF) credit created by the Inflation Reduction Act of 2022 (IRA). According to the IRS’s December 15, 2023, press release, the SAF credit applies to a qualified fuel mixture containing SAF for certain sales or uses in calendar years 2023 and 2024. The SAF credit is $1.25 for each gallon of SAF in a qualified mixture. The IRS states that to qualify for the credit, the SAF must have a minimum reduction of 50 percent in lifecycle greenhouse gas (GHG) emissions. The IRS notes that there is a supplemental credit of one cent for each percent that the reduction exceeds 50 percent, for a maximum increase of $0.50.
The IRA provides two methods to determine the lifecycle GHG emissions reduction percentage that can be used to qualify for and calculate the credit. These are the Carbon Offsetting and Reduction Scheme for International Aviation (CORSIA) method and any similar method that meets certain requirements of the Clean Air Act (CAA). Additionally, the IRA requires certain aspects of each method to be certified by an unrelated party.
According to the IRS, Notice 2024-06 provides additional safe harbors using the U.S. Environmental Protection Agency’s (EPA) Renewable Fuel Standard (RFS) program and related guidance. The RFS program uses a methodology similar to CORSIA and meets the requirements of the CAA, and the safe harbors in Notice 2024-06 can be used to calculate the emissions reduction percentage and for the corresponding unrelated party certification for the SAF credit.
The IRS notes that Notice 2024-06 “explains that the current Greenhouse gases, Regulated Emissions, and Energy use in Transportation (GREET) model of the Argonne National Laboratory and other GREET-based models do not currently satisfy the applicable statutory requirements for the SAF credit.” According to the IRS, the U.S. Department of Energy (DOE) is collaborating with other federal agencies to develop a modified version of the GREET model that would satisfy the statutory requirements for the SAF credit. The agencies developing this modified GREET model currently anticipate its release in early 2024.
BETO Releases Summary Report Following Transition To Sustainable, Circular Economy For Plastics Workshop: DOE’s Bioenergy Technologies Office (BETO) announced on December 20, 2023, that it released a summary report following its June 8-9, 2023, Workshop: Transitioning to a Sustainable, Circular Economy for Plastics. The workshop, hosted by BETO in partnership with DOE’s Advanced Materials and Manufacturing Technologies Office and the Climate Pledge coalition, brought together stakeholders from industry, academia, national laboratories, and non-profit organizations to provide input on current challenges and opportunities to addressing and reducing plastic waste in oceans and landfills. BETO states that this input “is critical to advancing DOE’s vision for its Strategy for Plastics Innovation to develop and deploy technologies that minimize plastic waste and promote energy-efficient and economical plastic and bioplastic reuse and recycling.”
According to BETO, the following key themes emerged from the workshop to inform future research needs:
- Harmonization of policies and regulations;
- Improved data, insight, and tools for assessing impact;
- Expanded plastic feedstock amount and quality;
- New business models to expand reuse;
- Material and recycling technology innovation; and
- Collaboration as key enabler.
According to the summary report, DOE will consider workshop feedback when developing programmatic plans in support of the Strategy for Plastics Innovation and the circular economy. In addition to the summary report, the workshop presentations are also available online.
OSTP Publishes Report On Vision, Needs, And Proposed Actions For Data For The Bioeconomy Initiative: The White House Office of Science and Technology Policy (OSTP) published on December 20, 2023, a report on Vision, Needs, and Proposed Actions for Data for the Bioeconomy Initiative. As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative that establishes a Data for the Bioeconomy Initiative (Data Initiative) to ensure that biotechnology developers have streamlined access to high-quality, secure, and wide-ranging biological data sets that can drive solutions to urgent societal and global problems. Prepared by the Interagency Working Group on Data for the Bioeconomy of the National Science and Technology Council, the report lays the groundwork for the Data Initiative. It describes the existing federal data infrastructure, data gaps, and data and computational infrastructure needs and highlights needed strategic investments in building and maintaining a robust data infrastructure to serve as the foundation for the Data Initiative. The report also outlines a vision for transformative outcomes across the sectors of the bioeconomy, including health, agriculture, the environment, and biomanufacturing. The Data Initiative identifies strategic investments and opportunities to leverage and build upon existing resources. The report states that the Data Initiative requires “consistent whole-of-government coordination and investments” in the following seven Core Actions:
- Dedicated long-term funding mechanisms for data and computational resources and infrastructure;
- Standards to establish common best practices that foster and strengthen a shared U.S. bioeconomy data ecosystem;
- Biodata Catalog to identify extant data and metadata;
- Security practices and policies that secure the data landscape while supporting innovation;
- Workforce to drive U.S. leadership in the bioeconomy of the future;
- Strategically Targeted Areas for Rapid Transformation (START) to determine viability and impact and chart a course for larger investments; and
- Coordination of intergovernmental investments, efforts, and resources.
According to the report, data accessibility will determine the success of the U.S. bioeconomy. The activities and investments proposed in the report “provide a clear path to fill acute gaps and are designed to secure the position of the United States as a leader in biotechnology and biomanufacturing, helping the nation achieve the Bold Goals for U.S. Biotechnology and Biomanufacturing.” More information on these goals is available in our April 3, 2023, blog item.
EPA Registers Novel Pesticide Technology For Potato Crops: EPA announced on December 22, 2023, that it has registered biopesticide products containing the new active ingredient Ledprona for three years, “a timeframe that is consistent with EPA’s approach to other novel biopesticide products.” Ledprona is a new type of pesticide that relies on a natural mechanism, RNA interference (RNAi), used by plants and insects to protect against disease. As reported in our October 12, 2023, blog item, Ledprona is a sprayable double-stranded ribonucleic acid (dsRNA) product targeting the Colorado potato beetle (CPB), a major pest of potato crops grown in the United States. According to EPA, while the CPB is known to develop resistance rapidly to chemical-based insecticides, the sprayable dsRNA product “kills the pest by ‘silencing’ the CPB gene needed to produce the PSMB5 protein, whose role is essential to keeping the CPB alive, without resulting in a genetically modified organism.” EPA notes that this pesticide is “the first sprayable dsRNA pesticide in the world allowed to be used commercially and sprayed on plants.”
Commentary
EPA has reviewed and approved multiple genetically modified crops containing RNAi technology. Ledprona is the first biopesticide active ingredient containing sprayable RNAi technology that reached this milestone, however. EPA states that it supports advancements in novel pesticide technology such as Ledprona “because this technology replaces more toxic chemical-based pesticides, provide[s] an additional tool for farmers to address challenges of climate change, and aids in resistance management.” According to EPA, novel pesticide technology can offer alternatives to chemical-based pesticides that may pose higher potential risks to human health or the environment or have reduced effectiveness because of resistance issues.
APHIS Reopens Comment Period On Proposed Additional Exemptions For Plants Modified Or Produced Through Genetic Engineering: As reported in our November 16, 2023, blog item, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) proposed on November 15, 2023, five new types of genetic modifications a plant can contain and be exempt from the regulations for the movement of organisms modified or produced through genetic engineering because such modifications could otherwise be achieved through conventional breeding methods. 88 Fed. Reg. 78285. Comments were due December 15, 2023, but APHIS has reopened the comment period, and comments are now due January 19, 2024. 88 Fed. Reg. 89362.
According to APHIS’s November 14, 2023, press release, the proposed exemptions include:
- Plants that have any combination of loss-of-function modifications (modifications that reduce or eliminate a gene’s function) in one to all alleles of a single genetic locus in diploid and autopolyploid plants, or in one or both copies of a single genetic locus on up to four pairs of homoeologous chromosomes in allopolyploid plants;
- Diploid or autopolyploid plants with a single contiguous deletion of any size on one or more chromosomes;
- Autopolyploid plants containing any modification described in existing exemptions that previously applied only to diploid plants;
- Plants with up to four modifications made simultaneously or sequentially, provided that each modification individually qualifies for exemption and is at a different genetic locus; and
Plants that have previously completed a voluntary review confirming exempt status and that have subsequently been produced, grown, and observed consistent with conventional breeding methods appropriate for the plant species, could be successively modified in accordance with the exemptions.
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