Federal
EPA Sets Final Renewable Fuels Standards For 2023, 2024, And 2025: 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:
| 2023 | 2024 | 2025 | |
| Cellulosic biofuel | 0.84 | 1.09 | 1.38 |
| BBDa | 2.82 | 3.04 | 3.35 |
| Advanced biofuel | 5.94 | 6.54 | 7.33 |
| Renewable fuel | 20.94 | 21.54 | 22.33 |
| Supplemental standard | 0.25 | n/a | n/a |
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.
APHIS 2022 Impact Report Includes Summary Of Biotechnology Activities: On July 12, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the release of its 2022 impact report. The 2022 impact report lists the following biotechnology activities:
- Fully implemented USDA’s revised biotechnology regulations, which allow APHIS to focus oversight on products that may pose a risk and reduce regulatory burden for developers of organisms that are unlikely to pose plant pest risks, providing over $8 million in annual cost savings;
- Issued two Regulatory Status Review (RSR) decisions, the first under the new RSR process in the revised regulations;
- Responded to nine requests for confirmation that a plant met the criteria for exemption from regulation, confirming all nine and issuing responses within an average of 39 days from receiving the requests;
- With state agricultural officials, performed more than 660 inspections of authorized field trials involving organisms developed using genetic engineering, with an 88 percent rate of compliance;
- Completed one petition for non-regulated status under the legacy regulations, bringing the total number of determinations to 136;
- Delivered more than 13 presentations to international stakeholders representing 40 countries to offer technical information and build capacity abroad for regulating biotechnology; and
- Processed over 758 authorizations in 42 states for the movement or field testing of organisms developed using genetic engineering.
EPA Extends Comment Period On Proposed Updates To TSCA New Chemicals Regulations; Comments Due August 8, 2023: On July 19, 2023, EPA extended the comment period on proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 46125. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg Act), improve EPA’s efficiency in the review process, and “update the regulations based on existing policies and experience implementing the New Chemicals Program.” EPA states that the proposed rule includes amendments that would “reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review.” EPA proposed several amendments to the regulations for low volume exemptions (LVE) and low release and exposure exemptions (LoREX), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, and toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA’s 1999 PBT policy. Comments are due August 8, 2023. More information on the proposed rule is available in our May 24, 2023, memorandum.
Bipartisan Legislation Would Strengthen USDA’s BioPreferred Program: 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 USDA’s 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.
EPA Will Accept Comment On Potential Expansion Of Safer Choice And DfE Programs: On July 25, 2023, EPA announced an opportunity for public input on the potential expansion of the Safer Choice and Design for the Environment (DfE) programs’ certification to new product categories. EPA notes in its July 27, 2023, Federal Register notice that Safer Choice “helps consumers, businesses, and purchasers find products that perform and contain ingredients that are safer for human health and the environment.” 88 Fed. Reg. 48463. DfE “is a similar program currently used by EPA for the purpose of helping consumers and commercial buyers identify antimicrobial products that meet the health and safety standards of the normal pesticide registration process required by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA),” as well as other rigorous criteria required by EPA. According to EPA, Safer Choice and DfE certifications “would likely not expand to certify materials.” EPA states that “the availability of EPA certified products would help give consumers a choice of products that meet EPA’s high standard for human and environmental health and, as part of meeting these criteria, would not contain intentionally added per- and polyfluoroalkyl substances (PFAS).” Comments are due September 11, 2023.
BETO Announces Release Of New Feedstock-Conversion Interface Consortium Case Studies And Technical Reports: 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 Thinnings 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.
EPA Announces First Product Categories For Expansion Of Ecolabel Recommendations For Federal Purchasing: On August 1, 2023, EPA announced the first five product and service categories chosen for the expansion of its Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing (Recommendations). EPA notes that this action supports the broader effort announced last year to expand the Recommendations by assessing additional standards and ecolabels. EPA states that later in 2023, it anticipates announcing the standards and ecolabels that pass the assessment and will be included in the Recommendations. EPA plans to consider additional product and service categories as resources allow. The five product and service categories are:
- Food Service Ware (e.g., containers, cutlery, and dishware);
- Healthcare;
- Laboratories;
- Professional Services; and
- Uniforms and Clothing.
EPA notes that representatives of standards and ecolabels within any of the selected product and service categories above who have not yet applied may contact EPA at epp@epa.gov to request information on eligibility and how to participate. EPA plans to announce additional product and service categories as resources allow.
International
OECD Publishes Consensus Document On Environmental Considerations For The Release Of Transgenic Plants: On July 27, 2023, the Organization for Economic Cooperation and Development (OECD) published a new document in its Series on Harmonization of Regulatory Oversight in Biotechnology, Safety Assessment of Transgenic Organisms in the Environment, Volume 10: OECD Consensus Document on Environmental Considerations for the Release of Transgenic Plants. The document addresses environmental risk/safety assessment at a broader level than previous consensus and guidance documents from the Working Party on the Harmonization of Regulatory Oversight in Biotechnology (WP-HROB). The purpose of the document is to describe an approach and provide illustrative examples for planning and structuring risk/safety assessments for the release of transgenic plants into the environment. It provides general information on key concepts and important points on which risk/safety assessors should focus when planning such assessments. According to OECD, these key features include the comparative approach, the familiarity with the biology of the unmodified plant species, the general protection goals, the assessment endpoints, the potential adverse effects associated with the environmental release, the pathways to harm and corresponding risk hypotheses, relevant information elements, and the use of environmental considerations in planning such assessment.
Annexes A through G describe seven examples of environmental considerations routinely examined by assessors and taken from actual experience gained during risk/safety assessment of transgenic plants intended for environmental release. OECD states that these environmental considerations are:
- Invasiveness and weediness;
- Vertical gene flow;
- Organisms (animals);
- Soil functions;
- Plant health;
- Crop management practices; and
- Biodiversity (protected species and habitats/ecosystems).
According to OECD, the set of science-based information and data contained in the volume “constitutes a solid reference and a practical tool for use during the biosafety assessment planning process.” This publication should be of interest to regulators and assessors from national authorities in charge of evaluating the risk/safety of transgenic plants prior to environmental release, as well as to plant breeders and the wider scientific community. The consensus documents published in Volumes 1 to 10 of the Series are available individually free of charge on the OECD BioTrack website.
Events
“Webinar On Potential Expansion of Safer Choice and DfE Programs” On August 29, 2023
On July 25, 2023, EPA announced an opportunity for public input on the potential expansion of the Safer Choice and DfE programs’ certification to new product categories. EPA will hold a listening session webinar on August 29, 2023. During the listening session, EPA will present its proposed plans to expand Safer Choice and DfE certification to new product categories. After the presentation, there will be time for attendees to submit questions and comments. EPA states that it will respond to the questions and comments as time allows during the listening session. EPA asks for written submission of all comments after the listening session. To receive the webcast meeting link and audio teleconference information before the webinar, the notice states that stakeholders must register by 5:00 p.m. (EST) on August 28, 2023.
“Bioenergy Cybersecurity Workshop” On September 11, 2023
DOE’s 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.
| ABOUT THE FIRM B&C® helps companies making and using chemicals commercialize their products, maintain compliance, and achieve competitive advantage as they market their products around the world. We provide powerful solutions for regulatory, political, and scientific challenges in any jurisdiction. | BERGESON & CAMPBELL, P.C. 2200 Pennsylvania Ave., N.W. Suite 100W Washington, D.C. 20037 (202) 557-3800 (202) 557-3836 (fax) www.lawbc.com |