By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) is launching a webinar series in collaboration with the PETA Science Consortium International (PSCI), Institute for In Vitro Sciences (IIVS), and the California Department of Pesticide Regulation (CDPR). According to EPA, the quarterly series will focus on the use of new approach methodologies (NAM), or alternative methods to reduce vertebrate animal testing, for risk assessment within EPA and CDPR. The first webinar in the series will take place on August 23, 2023, from 11:00 a.m.-12:30 p.m. (EDT). The webinar will cover recent updates from the Organization for Economic Cooperation and Development (OECD), including information about its developmental neurotoxicity in vitro test battery. Registration is open.
 
EPA notes that the Toxic Substances Control Act (TSCA) directs EPA to reduce and replace the use of vertebrate animals in the testing of chemical substances or mixtures to the extent practicable and scientifically justified. EPA must also promote the development and timely incorporation of alternative test methods or strategies that do not require new vertebrate animal testing. In 2018, EPA published a strategic plan to reduce the use of vertebrate animals in chemical testing.

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By Lynn L. Bergeson and Carla N. Hutton
 
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:
 

 
^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.

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By Lynn L. Bergeson and Carla N. Hutton
 
On July 25, 2023, the U.S. Environmental Protection Agency (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. EPA will hold a listening session webinar on August 29, 2023, and request stakeholder comment on which new product categories Safer Choice and DfE could expand into and how the potential expansion could offer significant benefits to human health and the environment. 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. Comments are due September 11, 2023.
 
During the listening session, EPA will present its proposed plans to expand Safer Choice and DfE certification to new product categories. 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).” 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.

Background

EPA states that as part of its human health and environmental mission, the Safer Choice program partners with businesses to help consumers and commercial buyers identify products containing chemical ingredients meeting EPA’s criteria for being “safer” without sacrificing quality or performance criteria set by EPA. The Safer Choice program certifies products containing ingredients that have met the program’s criteria and allows companies to use its label on certified products that contain safer ingredients and perform, as determined by expert evaluation. EPA notes that the Safer Choice program certification “represents a high level of achievement in formulating products made with safer ingredients for people and the environment.” More information is available on the Safer Choice website.
 
EPA currently uses the DfE program to help consumers and commercial buyers identify antimicrobial products that meet the health and safety standards of the typical pesticide registration process required by FIFRA, as well as the DfE certification criteria (as described in the Safer Choice Standard). More information is available on EPA’s website. 

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By Lynn L. Bergeson and Carla N. Hutton
 
On August 1, 2023, the U.S. Environmental Protection Agency (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.
 
EPA states that its Environmentally Preferable Purchasing (EPP) program’s Recommendations help U.S. federal government purchasers identify private sector standards and ecolabels to meet sustainable acquisition goals and mandates. They currently include more than 40 private sector environmental performance standards and ecolabels in over 30 purchase categories. The five product and service categories are:

• Food Service Ware (e.g., containers, cutlery, and dishware);
• Healthcare;
• Laboratories;
• Professional Services; and
• Uniforms and Clothing.

According to EPA, the expansion of the Recommendations is a key step toward implementing President Biden’s Executive Order on Catalyzing Clean Energy Industries and Jobs Through Federal Sustainability, as well as the accompanying Federal Sustainability Plan. EPA notes that the plan set ambitious goals, such as achieving net-zero emissions from federal procurement by 2050, maximizing the procurement of sustainable products and services, including products made with safer chemical ingredients.
 
As reported in our November 7, 2022, blog item, in November 2022, EPA launched the process to expand the Recommendations, inviting representatives of private sector environmental performance standards and ecolabels to apply for potential assessment and inclusion in the Recommendations, resulting in the five product and service categories announced on August 1, 2023. 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 .(JavaScript must be enabled to view this email address) to request information on eligibility and how to participate. EPA plans to announce additional product and service categories as resources allow.

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By Lynn L. Bergeson and Carla N. Hutton
 
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 Thinning’s 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.

BETO states that the FCIC “is an integrated and collaborative network of nine DOE national laboratories dedicated to addressing the technical risks that integrated pioneer biorefineries face.” According to BETO, the goal of the FCIC “is to develop science-based knowledge and tools to understand biomass feedstock and process variability, improving overall operational reliability, conversion performance, and product quality across the biomass value chain.”

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By Lynn L. Bergeson and Carla N. Hutton
 
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 Bio Track website.

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By Lynn L. Bergeson and Carla N. Hutton
 
On July 19, 2023, the U.S. Environmental Protection Agency (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.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy (DOE) Bioenergy Technologies Office (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.

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By Lynn L. Bergeson and Carla N. Hutton
 
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.

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By Lynn L. Bergeson and Carla N. Hutton
 
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 the U.S. Department of Agriculture’s (USDA) 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.

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