By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on September 7, 2023, that the upcoming 2023 Safer Choice Partner of the Year Awards Ceremony will be held October 2, 2023, and the Partner and Stakeholder Summit will be held October 3-4, 2023. EPA states that during the Partner of the Year Awards Ceremony, it will recognize the 2023 Safer Choice Partners of the Year “for their outstanding achievement in the design, manufacture, selection and use of products that meet the Safer Choice program’s stringent health and environment standards.” The Partner and Stakeholder Summit is a two-day meeting that will include informational sessions, panelist discussions, and networking opportunities with a focus on dialogue and developing solutions, which will help advance the Safer Choice program. Both events will be held at the Cooperative Plaza Conference Center in Arlington, Virginia, with virtual attendance options available. The events are free to attend, but registration is required. Registration is now open.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) will hold their annual Stakeholder Meeting on November 15, 2023. BRS will offer in-person -- at the USDA Center at Riverside, 4700 River Road, Riverdale, Maryland 20737 -- and virtual options for attendance. The Stakeholder Meeting will include:

• Highlights from fiscal year 2023;
• Key updates for fiscal year 2024;
• New and revised guides to help navigate regulatory processes; and
• Strategic planning.

BRS invites feedback on discussion topics for the meeting. Suggestions on potential topics of interest are due October 1, 2023, and should be submitted to .(JavaScript must be enabled to view this email address).

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By Lynn L. Bergeson and Carla N. Hutton
 
On August 29, 2023, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced that through the funding opportunity entitled “Accelerating Innovations in Biomanufacturing Approaches through Collaboration Between [the U.S. National Science Foundation (NSF)] and the DOE BETO funded Agile BioFoundry (ABF),” researchers will collaborate with the ABF consortium’s synthetic and bioengineering research projects. BETO and NSF have selected the following projects:

• Enabling Scalable Redox Reactions in Biomanufacturing (University of California, Irvine, and University of California, Davis): This project will enhance the carbon and energy efficiency of a biomanufacturing process by upgrading carboxylic acids into precursors for biofuels and chemicals used in industry. The goal is to create a more efficient process for carboxylic acid reduction that does not release any carbon into the atmosphere. The team will work to identify the principles necessary to enhance efficiency in the enzymes used in the process. Through outreach efforts, the researchers will provide hands-on exposure to science, technology, engineering, and math (STEM) fields for largely Hispanic populations and women, both groups underrepresented in science and engineering.
   
• A Synthetic Biology Toolbox for Studying Bacterial Transporters (University of Wisconsin -- Madison): This project will develop and use tools to close knowledge gaps surrounding transporters in Gram negative bacteria to facilitate the development of superior biomanufacturing hosts. Specifically, they will work to identify proteins that enhance the uptake of nutrients into the cells of microbes and the removal of toxic products. The work will enable the development of superior biomanufacturing microbial hosts and support translational research. Activities that teach biomanufacturing concepts to K-8 students and recruitment of underrepresented researchers will broaden the impacts of the work.
   
• Leveraging the Unique Metabolism of Megasphaera elsdenii for Metabolic Engineering to Medium and Long Chain Organic Acids for Use in Jet Fuels and Biomaterials (University of Georgia): The project will work to increase understanding of the metabolic pathways that allow the microorganism Megasphaera elsdenii to produce hexanoic acid, that can be engineered to create sustainable aviation fuel among a host of other products. Understanding how octanoic acid is created in this organism will enable scientists better to convert plant sugars to longer chain molecules and will provide paths for alternative approaches to bioprocessing. The team will recruit students from underrepresented groups and create classroom resources for use in elementary schools.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency announced on August 4, 2023, that it is providing resources to help biotechnology developers exercise the full benefits of the exemptions available under the Plant Incorporated Protectants (PIP) exemption rule. These resources are available on EPA’s public website and include the following:

• Fact sheet and background information on PIPs rule;
• Examples of genetic modifications that are exempt under the rule;
• Description of how to submit a self-determination or a request for EPA confirmation of exemption under the rule; and
• Sample documents for submitting a self-determination or request for confirmation.

The PIPs Exemption Final Rule went into effect on July 31, 2023.  More information on the final rule is available in our June 2, 2023, memorandum.

Background

On May 31, 2023, EPA released a final rule exempting two categories of PIPs created using genetic engineering from certain registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. EPA states that the rule ensures that human health and the environment are protected while reducing costs for the regulated community, consistent with the September 2022 Executive Order 14081 on Advancing Biotechnology. According to EPA, the rule may also result in increased research and development activities, commercialization of new pest control options for farmers, and reduced use of conventional pesticides.
 
EPA notes that the final rule reflects the biotechnological advances made since 2001, when it first exempted PIPs derived through conventional breeding from FIFRA registration and FFDCA tolerance requirements, but did not at that time exempt PIPs created through biotechnology. Specifically, the final rule exempts PIPs derived through genetic engineering from FIFRA registration and FFDCA tolerance requirements in cases where the PIPs are essentially equivalent to those exempted by the 2001 rule.
 
The rule contains conditions for exempting:

• PIPs in which genetic engineering has been used to insert a gene from a sexually compatible plant or to modify a gene to match a gene found in a sexually compatible plant. This category of PIPs requires EPA confirmation of eligibility for the exemption; and 
   
• Loss-of-function (LoF) PIPs, in which a gene is modified through genetic engineering to reduce or eliminate the activity of that gene. The loss of the activity of that gene then results in the pesticidal effect. EPA states that for this category of PIP, “biotechnology developers can make a self-determination that their PIP meets the exemption criteria, which requires notification but no EPA review, or request EPA confirmation of eligibility for the exemption.”

EPA notes that it indicated in the preamble to the final rule that it would consider exempting additional categories of PIPs from both FIFRA registration and FFDCA tolerance requirements and expanding the categories of PIPs that are allowed the option to self-determine and do not require EPA confirmation of eligibility for the exemption.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. National Science Foundation (NSF), on behalf of the federal agencies and departments participating on the National Science and Technology Council (NSTC) Subcommittee on Scientific Integrity (the Subcommittee), is organizing two virtual listening sessions to hear from members of the public about recommendations, issues, and concerns related to federal department and agency implementation of the NSTC Framework for Federal Scientific Integrity Policy and Practice (the Framework). 88 Fed. Reg. 60713. The Subcommittee is supporting the development of scientific integrity policies at federal departments and agencies and seeks public input on the development and implementation of these policies and associated procedures and practices. According to the notice, perspectives gathered during the virtual listening sessions will inform: (1) federal agencies’ finalization of Scientific Integrity Policies, in response to the Framework and its implementation memorandum from the White House Office of Science and Technology Policy (OSTP); (2) federal agency processes, procedures, and practices related to scientific integrity; and (3) other elements of federal implementation of the Framework. The listening sessions will be held September 15, 2023, 1 p.m. - 3 p.m. (EDT) and September 20, 2023, 5 p.m. - 7 p.m. (EDT). Registration is now open. More information on the Framework is available in our January 19, 2023, blog item.

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By Lynn L. Bergeson and Carla N. Hutton
 
On August 3, 2023, the U.S. Department of Defense (DOD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) proposed to amend the Federal Acquisition Regulation (FAR) to restructure and update the regulations to focus on current environmental and sustainability matters and to implement a requirement for agencies to procure sustainable products and services to the maximum extent practicable. 88 Fed. Reg. 51672. Comments are due October 2, 2023.
 
The proposed rule would define “sustainable products and services” as products and services that are subject to and meet statutory purchasing program requirements or other U.S. Environmental Protection Agency (EPA) purchasing program requirements. The proposed rule states that for the statutory purchasing programs, the definition references the following types of products and includes a reference to the source statute, the lead agency implementing regulations, and the program website:

• Products containing recovered material designated by EPA under the Comprehensive Procurement Guidelines;
• Energy-efficient products that are ENERGY STAR^® certified or Federal Energy Management Program (FEMP)-designated products;
• Biobased products meeting the U.S. Department of Agriculture (USDA) content requirements under the BioPreferred^® program; and
• Acceptable chemicals, products, and manufacturing processes listed under EPA’s Significant New Alternatives Policy (SNAP) program, “which ensures a safe and smooth transition away from substances that contribute to the depletion of stratospheric ozone.”

The definition identifies the following required EPA purchasing programs and provides the link to each associated program website:

• WaterSense^® labeled (water efficient) products and services;
• Safer Choice-certified products (products that contain safer chemical ingredients); and
• Products and services that meet or exceed EPA Recommendations of Specifications, Standards, and Ecolabels.

Under the proposed rule, “biobased product” would be defined as “a product determined by the U.S. Department of Agriculture to be a commercial product or industrial product (other than food or feed) that is composed, in whole or in significant part, of biological products, including renewable domestic agricultural materials and forestry materials, or that is an intermediate ingredient or feedstock. The term includes, with respect to forestry materials, forest products that meet biobased content requirements, notwithstanding the market share the product holds, the age of the product, or whether the market for the product is new or emerging.”

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By Lynn L. Bergeson and Carla N. Hutton
 
On August 3, 2023, the Joint Subcommittee on Environment, Innovation, and Public Health Sustainable Chemistry Strategy Team (Sustainable Chemistry ST) of the National Science and Technology Council (NSTC) published a report entitled Sustainable Chemistry Report: Framing the Federal Landscape. As reported in our January 19, 2021, memorandum, the fiscal year (FY) 2021 National Defense Authorization Act (NDAA) included the text of the bipartisan Sustainable Chemistry Research and Development Act of 2019. It established an interagency working group led by the White House Office of Science and Technology Policy (OSTP) to coordinate federal programs and activities in support of sustainable chemistry. The report establishes the federal landscape and provides a high-level overview of relevant topical areas around sustainable chemistry. The Sustainable Chemistry ST notes that it is a state of science report that includes gaps and opportunities for the federal government. Following the report, the Sustainable Chemistry ST will develop a strategic plan for how the federal government can leverage these opportunities to make significant progress in addressing the identified data gaps.
 
The report includes the following definition of sustainable chemistry:

 
Sustainable chemistry is the chemistry that produces compounds or materials from building blocks, reagents, and catalysts that are readily-available and renewable, operates at optimal efficiency, and employs renewable energy sources; this includes the intentional design, manufacture, use, and end-of-life management of chemicals, materials, and products across their lifecycle that do not adversely impact human health and the environment, while promoting circularity, meeting societal needs, contributing to economic resilience, and aspiring to perpetually use elements, compounds, and materials without depletion of resources or accumulation of waste.
 

More information and an insightful commentary are available in our August 28, 2023, memorandum.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a two-day training on its high throughput toxicokinetic (HTTK) R package as part of its New Approach Methods (NAM) Training Program:

• Day 1: Presentation and demo: Wednesday, November 8, 2023, 10 a.m. - 12 p.m. (EST); and
• Day 2: Expert-led hands-on learning activity: Thursday, November 9, 2023, 10 a.m. - 12 p.m. (EST).

According to EPA, toxicokinetics (TK) provides a bridge between toxicity and exposure assessment by predicting tissue concentrations due to exposure. EPA notes that traditional TK methods can be resource intensive and require chemical-specific data. EPA states that its freely available HTTK R package uses data from in vitro high-throughput screening data sets, which can be used to fill data gaps in traditional TK methods.
 
EPA’s goal for the two-day training is to familiarize those engaged in chemical exposure assessment, including researchers, regulators, and health and environmental safety professionals, with EPA’s generic and open-source models and data for toxicokinetics, including reverse dosimetry and physiologically based pharmacokinetic (PBPK) modeling for internal dose calculation. The training will include an application-oriented presentation and demonstration (Day 1), as well as opportunities for participatory learning and engagement (Day 2).

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By Lynn L. Bergeson and Carla N. Hutton
 
The Congressional Research Service (CRS) published an updated report on August 4, 2023, on the U.S. Department of Agriculture’s (USDA) Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. The revisions note that USDA’s Animal and Plant Health Inspection Service’s (APHIS) five-year Strategic Plan for fiscal years (FY) 2023-2027 states that “one of its objectives is to ensure the safe development of agricultural biotechnology products using a science-based regulatory framework, including efficient permit review for [genetically engineered (GE)] organisms, clear communication of regulations to stakeholders, coordination with other agencies, and harmonization of regulatory oversight for biotechnology products.”
 
As reported in in our September 13, 2022, blog item, in 2022, the Biden Administration issued Executive Order (EO) 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” ordering USDA, the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) to improve further the clarity and efficiency of regulatory processes for biotechnology products and increase coordination and communication among federal regulatory agencies. The report states that FDA “encourages developers of all new plant varieties to request premarket food safety consultations with the agency, which involves a discussion of the safety protocols and regulatory issues before the food is distributed in the market.” The report notes that in response to EO 14081, in May 2023, EPA announced changes to its regulations concerning GE plant-incorporated protectants (PIP). According to the report, these changes exempt certain PIPs from registration and tolerance requirements while implementing a notification process for transparency. EPA “intends to consider additional exemptions and expand the list of categories not requiring EPA confirmation as biotechnology progresses.” EPA’s rule (88 Fed. Reg. 34756) went into effect in July 2023.
 
According to the updated report, Congress “may be interested in monitoring how USDA’s revised regulatory requirements have affected the development and commercialization of GE and genome-edited products.” The updated report suggests that beyond that, Congress may consider monitoring how USDA, FDA, and EPA are assessing the effectiveness of the revised regulations, “as underlined by the self-determination aspect of the exemption status of new GE and genome-edited products.” The updated report states that further, Congress may also oversee how well the three agencies are working together to harmonize the regulation of biotechnology products moving forward.

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By Lynn L. Bergeson and Carla N. Hutton
 
The Independent Commodity Intelligence Services (ICIS) search for the very best in innovation in the chemical industry. The ICIS Innovation Awards are intended to recognize and reward companies paving the way in product, process, and digital innovations that demonstrate a commitment to sustainability. The awards were open to any company in the chemical industry that successfully executed innovative projects that solve problems and provide solutions for companies, their customers, and society, as well as benefiting the environment and progressing sustainability. ICIS will recognize the 2023 winners on October 17, 2023. The 2023 winners include:

Best Digital Innovation from a Large Company

• Joint Winners:
  • Evonik Operations GmbH: COATINO^® Defect Detection -- Quantifying coating defects by using advanced image recognition methods; and
  • Dow: Dow^™ Paint Vision: Shaping the modern digital lab for paint formulation.
• Finalists:
  • Sewage and recycled water networks, Dubai municipality: Development of Fog Watch -- A digital platform to manage fat, oil, and grease waste;
  • Fatima Fertilizer Company: Sarsabz Pakistan (Fatima Fertilizers Farmer Application); and
  • Fatima Fertilizer Company: Sarsabz Asaan (Fatima Fertilizers Dealers Application).

Best Process Innovation from a Large Company

• Winner:
  • UPM Biochemicals, part of UPM -- The Biofore Company: UPM Biochemicals: Future beyond fossils.
• Finalists:
  • Nouri Petrochemical Company, PGPIC: Diagnosis, optimization, and compromising the bottlenecks of the benzene extraction process by designing an innovative tower’s internal;
  • Wanhua Chemical Group Co., Ltd.: Methylene diphenyl diisocyanate (MDI) byproduct amine-containing waste brine recycling technology;
  • Wanhua Chemical Group Co., Ltd.: Automatic continuous formaldehyde-free adhesive spray plywood panel process;
  • PPG: PPG Zero Discharge Project; and
  • Indorama Ventures: Optimization of cycle reaction propoxylation process time.

Best Product Innovation from a Large Company

• Winner:
  • Arkema: Recycling of monomaterial shoe.
• Finalists:
  • Dow: DEXCARE^™ CD-1 Polymer: Boost your shampoo’s conditioning effectiveness with Dow’s renewable, bioderived deposition aid;
  • Dow Chemical: EcoSense^™ GL-60 HA/HL Surfactants: Novel sustainable biosurfactants for personal care rinse-off and leave-on applications;
  • Celanese International Corp: Achieve even lower carbon footprint with Santoprene^® ECO-R Series thermoplastic vulcanizate (TPV) products; and
  • Corteva Agriscience: A modern nematicide with soil health benefits: Salibro^™ nematicide with Reklemel^™ Active from Corteva Agriscience.

Best Process Innovation from Small and Medium Enterprises (SME)

• Winner:
  • Botanical Solution Inc: Growing and extracting from plants in the lab to produce new fungicides for agriculture and QS-21 vaccine adjuvants for human health.
• Finalists:
  • LanzaTech: Pollution to products;
  • AmSty: Innovative PolyRenew^® circularity solution for accelerating plastics recycling;
  • Origin Materials: Origin materials; and
  • GDB Paint & Coatings: Making every drop count: GDB’s commitment toward a net-zero waste paint industry.

Best Product Innovation from an SME

• Winner:
  • Viridis Chemical Company: Commercial scale biobased ethyl acetate with lower greenhouse gas (GHG) emissions.
• Finalists:
  • ECO GLAS Environmental Limited: Septic Tank Smart Box;
  • Locus Ingredients: Leading the charge: Optimizing sophorolipids for real-world applications;
  • LanzaTech: CarbonSmart ethylene from carbon dioxide (CO₂); and
  • Oberon Fuels: Decarbonizing the global liquefied petroleum gas (LPG) industry, with new, negative-carbon intensity (CI) ingredient.

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