Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture (USDA) announced on August 23, 2022, that USDA is accepting applications for $100 million in grants to increase the sale and use of biofuels derived from U.S. agricultural products. 87 Fed. Reg. 51641. The funding is available through the Higher Blends Infrastructure Incentive Program (HBIIP). The program seeks to market higher blends of ethanol and biodiesel by sharing the costs to build and retrofit biofuel-related infrastructure such as pumps, dispensers, and storage tanks. Applications are due by 4:30 p.m. (EST) on November 21, 2022.
 
Under HBIIP, USDA provides grants to transportation fueling and distribution facilities. These grants lower the out-of-pocket costs for businesses to install and upgrade infrastructure and related equipment. The $100 million will support a variety of fueling operations, including filling stations, convenience stores, and larger retail stores that also sell fuel. The funds will also support fleet facilities, including rail and marine, and fuel distribution facilities, such as fuel terminal operations, midstream operations, and distribution facilities, as well as home heating oil distribution centers.
 
The grants will cover up to 50 percent of total eligible project costs -- but not more than $5 million -- to help owners of transportation fueling and fuel distribution facilities convert to higher blends of ethanol and biodiesel. These higher-blend fuels must be greater than ten percent for ethanol and greater than five percent for biodiesel.
 


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 22, 2022, that as part of its commitment to re-evaluate policies and practices under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure they adhere to statutory requirements and the Biden Administration’s executive orders and directives, it has updated its policy to discontinue the use of exposure modeling thresholds when assessing the health and environmental risks of new chemicals under TSCA. According to EPA, due in part to the automation of modeling, it has become less burdensome to complete these calculations. Furthermore, according to EPA, removing the thresholds supports President Biden’s Executive Order 13985, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” which calls on federal agencies to advance equity, including by reviewing and revising as needed government policies and programs impacting underserved communities.
 
The New Chemicals Program will implement this change by making minimal changes to the coding in the New Chemical Review application to remove the thresholds and will update standard operating procedures and training materials for exposure and human health risk assessors. EPA states that it will implement this policy change “as soon as feasible.” According to EPA, despite the resource challenges it is currently facing in the TSCA program, it anticipates that the change “will have minimal impact on the amount of time it takes to complete new chemical reviews and that the benefits gained from a more comprehensive accounting of all potential air and water releases will help ensure any needed protections are in place before a new chemical can come to market.”
 
More information and a detailed commentary that discusses thresholds of toxicological concern (TTC) are available in our August 22, 2022, memorandum.


 
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 By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on August 11, 2022, that a research team from Pacific Northwest National Laboratory investigated how potassium in biomass feedstocks poisons a catalyst. The researchers focused their study on potassium, a common alkali metal found in biomass feedstocks, since previous analysis of deactivated catalysts after catalytic fast pyrolysis (CFP) of woody biomass feedstock revealed potassium accumulation on the catalysts’ surface.
 
The research team simulated catalyst poisoning at different potassium levels to trigger deactivation during industrial operations. They then analyzed the catalysts and conducted kinetic measurements to determine how the catalysts’ ability to catalyze chemical reaction changed with the introduction of potassium. According to BETO, the team found potassium poisoning could be substantially mitigated with a developed regeneration method -- a water washing process -- that can successfully remove most of the loaded potassium, restoring more than 90 percent of the catalytic activities.
 
BETO states that the results of these studies provide new insights for the bioenergy industry that will foster improved catalyst design and regeneration for longer lasting catalysts. The studies also created “a solid knowledge base for developers of biomass conversion technologies to continue to build upon, making new and innovative conversion technologies less risky to research and develop.” According to BETO, the work “also supports accelerated process development that can help industry convert biomass feedstocks commercially, leading to more effective and inexpensive production of biofuels.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 18, 2022, that it is accepting nominations for the 2023 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. The awards again include a category to recognize technology that reduces or eliminates greenhouse gas (GHG) emissions. EPA will hold a webinar on September 28, 2022, from 2:00 to 3:30 p.m. (EDT) to educate stakeholders on the Green Chemistry Challenge Awards and the nomination process. Registration for the webinar is open. Nominations are due to EPA by December 9, 2022.
 
EPA states that green chemistry is the design of chemical products and processes that reduce or eliminate the generation and use of chemicals that are hazardous to the environment and people’s health. According to EPA, its efforts to “speed the adoption of this revolutionary and diverse discipline” have led to significant environmental benefits, innovation, and a strengthened economy. Green chemistry aims to prevent pollution before it is created, making it the preferred approach for providing solutions to some of the most significant environmental challenges.
 
An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2023 nominations and make recommendations to EPA for the 2023 winners. EPA anticipates giving awards to outstanding green chemistry technologies in six categories in fall 2023.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On July 26, 2022, Senators Chuck Grassley (R-IA) and Joni Ernst (R-IA) introduced the bipartisan and bicameral Next Generation Fuels Act (S. 4621), which would aim to leverage higher-octane fuels to improve engine efficiency and performance. According to Grassley’s July 26, 2022, press release, allowing the sale of fuels with greater octane levels would increase the amount of ethanol that can be used in the fuel supply, in turn lowering prices at the pump for consumers. The press release states that due to ethanol’s high-octane rating, greater ethanol blends result in both additional fuel efficiency and significant greenhouse gas (GHG) reduction. Ethanol is also priced lower than gasoline, making it the most cost-effective octane source. Under the bill, the U.S. Environmental Protection Agency (EPA) would be required to carry out a study of the emissions effects of ethanol-blended fuels in light-duty vehicles and light-duty trucks, for the purpose of updating the Motor Vehicle Emission Simulator modeling system. The bill would establish a minimum research octane number (RON) standard of 98 for gasoline, which is higher than the typical octane rating of 91 RON today. It would also require sources of the added octane value to reduce carbon emissions by at least 40 percent compared to baseline gasoline. The bill was referred to the Senate Committee on Finance.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 11, 2022, that it updated the Safer Chemical Ingredients List (SCIL), “a living list of chemicals by functional-use class that EPA’s Safer Choice program has evaluated and determined meet the Safer Choice Standard.” EPA added 22 chemicals to the SCIL. EPA states that to expand the number of chemicals and functional-use categories on the SCIL, it encourages manufacturers to submit their safer chemicals for review and listing on the SCIL. In support of the Biden Administration’s goals, the addition of chemicals to the SCIL “incentivizes further innovation in safer chemistry, which can promote environmental justice, bolster resilience to the impacts of climate change, and improve water quality.” According to EPA, chemicals on the SCIL “are among the safest for their functional use.”
 
EPA also changed the status for one chemical on the SCIL and will remove the chemical from the list in one year “because of a growing understanding of the potential health and environmental effects.” According to EPA, the chemical was originally listed on the SCIL based on data from a closely related substance that EPA marked with a grey square earlier this year. EPA’s process for removing a chemical from the SCIL is first to mark the chemical with a grey square on the SCIL web page to provide notice to chemical and product manufacturers that the chemical may no longer be acceptable for use in Safer Choice-certified products. A grey square notation on the SCIL means that the chemical may not be allowed for use in products that are candidates for the Safer Choice label, and any current Safer Choice-certified products that contain this chemical must be reformulated unless relevant health and safety data are provided to justify continuing to list the chemical on the SCIL. EPA states that the data required are determined on a case-by-case basis. In general, data useful for making such a determination provide evidence of low concern for human health and environmental impacts. Unless information provided to EPA adequately justifies continued listing, EPA then removes the chemical from the SCIL 12 months after the grey square designation.
 
According to EPA, after this update is made, there will be 1,055 chemicals listed on the SCIL. EPA is committed to updating the SCIL with safer chemicals on a regular basis. EPA states that the SCIL is a resource that can help many different stakeholders:

  • Product manufacturers use the SCIL to help make high-functioning products that contain safer ingredients;
  • Chemical manufacturers use the SCIL to promote the safer chemicals they manufacture;
  • Retailers use the SCIL to help shape their sustainability programs; and
  • Environmental and health advocates use the SCIL to support their work with industry to encourage the use of the safest possible chemistry.

EPA’s Safer Choice program certifies products containing ingredients that have met the program’s rigorous human health and environmental safety criteria. The Safer Choice program allows companies to use its label on products that meet the Safer Choice Standard. The EPA website contains a complete list of Safer Choice-certified products.


 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. In June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under the Toxic Substances Control Act (TSCA) and common issues that cause EPA to have to rework risk assessments for these submissions. EPA has posted the meeting slides online.
 
During the webinar, EPA presented an example of a rework case. According to EPA, from its analysis, it observes that:

  • Information on material balance parameters, environmental releases, environmental release media, and engineering controls cause nearly 80 percent of all rework;
     
  • In most cases, companies provide additional information that deviates from EPA model defaults and assumptions; and
     
  • Companies often lack understanding on what information is needed for a Section 5 engineering assessment, including the level of detail needed to support their statements relating to environmental release and worker exposure.

As noted in the meeting slides, EPA plans to hold two additional webinars in fall 2022 that will cover:

  • How EPA evaluates quantitative and qualitative information, with examples on the level of detail needed to support the submitted information to be accepted by EPA; and
     
  • The types of information commonly missing in Section 5 submissions, how EPA evaluates environmental release information on sites not controlled by the submitter, and their impact on engineering assessment.

More information is available in our July 28, 2022, 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 26, 2022, that it “has achieved a significant milestone in decreasing the minimum fuel selling price (MFSP) of drop-in biofuels, which are fuels made from biomass and other waste carbon sources, and that are compatible with existing petroleum fuel infrastructure and conventional vehicles.” BETO partnered with T2C-Energy, LLC (T2C) to validate pilot-scale production of drop-in biofuels with a price of $3 per gallon of gas equivalent (GGE) and at least 60 percent lower greenhouse gas (GHG) emissions than petroleum, using T2C’s TRIFTS® process.
 
According to BETO, the TRIFTS process converts anaerobic digestor produced biogas (or landfill gas) to liquid transportation fuels. TRIFTS has allowed drop-in renewable diesel fuel to reach an MFSP of $2.91/GGE without the use of credits from the U.S. Renewable Fuel Standard (RFS), California Low Carbon Fuels Standard, or other carbon credits while reducing GHG emissions by 130 percent when compared to traditional petroleum diesel fuel.

Tags: DOE, BETO, Biofuel

 
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By Lynn L. Bergeson and Carla N. Hutton

The National Academies of Sciences, Engineering, and Medicine (NASEM) announced on July 21, 2022, publication of a new report entitled The Importance of Chemical Research to the U.S. Economy. The National Science Foundation (NSF), the Department of Energy (DOE), the National Institute of Standards and Technology (NIST), and the American Chemical Society (ACS) asked NASEM to convene a committee to consider strategies to sustain and enhance the economic activity driven by fundamental research investments in the chemical sciences. The chapter on “Sustainability for the Chemical Economy” includes the following general conclusions:

  • Implementing a circular economy will require a paradigm shift in the way products are designed, manufactured, and used, and how the waste products are collected and reused. These new processes, and the use of clean energy and new feedstocks to enable these processes, will require novel chemistries, tools, and new fundamental research at every stage of design;
     
  • Transitioning the chemical economy into a new paradigm around sustainable manufacturing, in which environmental sustainability is balanced with the need for products that will improve quality of life, enhance security, and increase U.S. competitiveness, will require substantial investment and innovation from industry, government, and their academic partners to create and implement new chemical processes and practices;
  • As fundamental chemical research continues to evolve, the next generation of research directions will prioritize the future of environmental sustainability and new energy technologies. Keeping sustainability principles in mind during every stage of research and development will be critical to accomplishing this goal;
     
  • Chemical research will have the greatest impact addressing energy and environmental sustainability if researchers and practitioners develop and use tools to quantify and mitigate environmental and human health impacts of new discoveries, are aware of the societal implications of their work, and if the research is driven by policies that identify specific environmental sustainability outcomes; and
     
  • As the world moves deeper into its current energy transition, including the switch to electric vehicles, the implementation of clean energy alternatives, and the use of new feedstock sources, coupled with an increasing focus on circularity, decarbonization, computation, measurement, and automation will significantly alter the operations and processes of current industries, creating new opportunities and challenges that will benefit from fundamental chemistry and chemical engineering advances.

 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on August 1, 2022, a 15-day public comment period on two additional peer review candidates for the external peer review of the Biofuels and the Environment: Third Triennial Report to Congress (RtC3). 87 Fed. Reg. 46958. EPA previously requested comment on an initial pool of 20 candidates announced in a May 9, 2022, Federal Register notice. EPA states that after considering public comments and the balance and collective expertise of the reviewers, it asked ERG, the independent contractor organizing the peer review, to identify additional candidates to strengthen expertise gaps and allow a more balanced panel. EPA seeks public comment on additional peer review candidates to strengthen underrepresented areas of expertise, specifically economics, water quality, and ecology disciplines. According to EPA, ERG will ensure the peer reviewers’ combined expertise best spans the following disciplines: economics, engineering, agronomics, land use change, remote sensing, air quality, biogeochemistry, water quality, hydrology, conservation biology, limnology, and ecology. Comments are due August 16, 2022.
 
The first report to Congress (RtC1), completed in 2011, provided an assessment of the environmental and resource conservation impacts associated with increased biofuel production and use. The second report to Congress (RtC2) was completed in 2018 and reaffirmed the overarching conclusions of RtC1. RtC3 builds on the previous two reports and provides an update on the impacts to date of the RFS Program on the environment. It assesses air, water, and soil quality; ecosystem health and biodiversity; and other effects. RtC3 also includes new analyses not previously included in RtC1 and RtC2.


 
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By Lynn L. Bergeson and Carla N. Hutton

According to an item in the U.S. Department of Agriculture’s (USDA) Unified Agenda, which was published on June 21, 2022, USDA intended to publish in June 2022 a proposed rule that would codify BioPreferred Program guidance. According to the item, USDA expects this action to reduce burden on both it and the applicants by reducing requirements, clarifying requirements, streamlining the application and certification process, and increasing efficiencies in program delivery. The item states that codification for all Program guidance “will ensure consistency in how programs are administered.” Improvements will also “facilitate the sales of the business using the labeling program.”
 
The BioPreferred Program is intended to spur economic development, create new jobs, and provide new markets for farm commodities. The two major parts of the Program are:

  • Mandatory purchasing requirements for federal agencies and their contractors; and
     
  • A voluntary labeling initiative for biobased products.

 
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By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) announced on June 24, 2022, that it is “conducting a broad outreach effort to describe and discuss with stakeholders how the Agency evaluates data provided for new chemicals submissions and common issues that cause EPA to have to reconduct risk assessments (‘rework’) for these submissions.” According to EPA, its goal is to reduce rework of initial risk assessments for new chemicals submissions caused by submitters supplementing incomplete initial new chemicals review submissions, contributing to delays in EPA’s review of these chemicals, and stretching already limited resources. EPA notes that it shares an interest with stakeholders in reducing process inefficiencies while also ensuring a protective review of new chemical risks. EPA states that it anticipates this outreach effort will be “particularly helpful” for Low Volume Exemptions (LVE), which constitute about 60 percent of Toxic Substances Control Act (TSCA) Section 5 submissions annually.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, July 27, 2022, from 1:00 - 2:00 p.m. (EDT). During the webinar, EPA will provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) before taking questions from the audience. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under the Toxic Substances Control Act (TSCA) and common issues that cause EPA to have to rework risk assessments for these submissions.
 
Registration for the July 27, 2022, webinar is open. According to EPA, subsequent webinars over the coming months will communicate its considerations in evaluating qualitative claims or quantitative data, especially when they deviate from model defaults such as those used in the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER) and its considerations for evaluating information about sites not controlled by the submitter. EPA will release information about these webinars, including dates and instructions on how to register, as it becomes available.


 
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By  Lynn L. Bergeson

On June 6, 2022, EPA announced the winners of the 2022 Green Chemistry Challenge Awards. EPA states that green chemistry “is the design of chemical products and processes that reduce or eliminate the generation and use of hazardous substances.” According to EPA, the winners “have developed new and innovative green chemistry technologies that provide solutions to significant environmental challenges and spur innovation and economic development.” In support of the Biden Administration’s commitment to tackle the climate crisis, EPA added a new award category recognizing technology that reduces or eliminates greenhouse gas (GHG) emissions. The 2022 winners include:

  • Professor Song Lin of Cornell University, Ithaca, New York, for developing a new, more efficient process to create large and complicated molecules that are widely used in the pharmaceutical industry. EPA states that the new technology avoids using hazardous materials and has the potential to reduce both energy use and wasteful byproducts.
  • Merck, Rahway, New Jersey, for developing a greener way to make LAGEVRIO™ (molnupiravir), an antiviral treatment for COVID-19. According to EPA, Merck significantly improved the manufacturing process for this antiviral drug in a short time, producing ingredients more efficiently and greatly reducing solvent waste and energy use.
  • Amgen, Thousand Oaks, California, for an improved manufacturing process for LUMAKRAS™ (sotorasib), a novel drug for the treatment of certain non-small cell lung cancers. EPA states that Amgen’s innovation decreased manufacturing time, lowered the amount of solvent waste generated, and established a recycling process for a high-value waste stream.
  • Provivi, Santa Monica, California, for creating ProviviFAW®, a biological pheromone-based product that controls the fall armyworm, a destructive pest of corn. The product’s pheromone active ingredients are produced through innovative green chemistry using renewable plant oils. According to EPA, ProviviFAW™ can reduce the need for conventional pesticides, which can be harmful to beneficial insects, such as pollinators.
  • Professor Mark Mascal of the University of California, Davis, California, in partnership with Origin Materials, for a technology that reduces GHG emissions by producing chemicals for making polyethylene terephthalate (PET) plastic from biomass derived from sugar fructose rather than petroleum. EPA states that this novel chemistry could have significant climate impacts by replacing fossil-based products with carbon-neutral, biobased products, especially when the technology is scaled to an entire industry.

EPA recognized the winners during the American Chemical Society Green Chemistry & Engineering Conference. EPA states that since 1996, EPA and the American Chemical Society, which co-sponsor the awards, have received more than 1,800 nominations and presented awards to 133 technologies that decrease hazardous chemicals and resources, reduce costs, protect public health, and spur economic growth. According to EPA, winning technologies are responsible for reducing the use or generation of nearly one billion pounds of hazardous chemicals, saving over 20 billion gallons of water, and eliminating nearly eight billion pounds of carbon dioxide equivalents released to the air.


 
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Bergeson & Campbell, P.C. (B&C®) is pleased to present “TSCA New Approach Methodologies,” a complimentary webinar featuring Lynn L. Bergeson, Richard E. Engler, Ph.D., James W. Cox, M.S., and Kristie Sullivan, MPH. The 2016 amendments to TSCA require EPA “to reduce and replace” vertebrate animals to the extent practicable, scientifically justified, and consistent with TSCA policies. EPA is also required to “develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment of chemical substances or mixtures.”

These are tall orders, and EPA has worked hard to fulfill Congress’s expectations. This webinar will:

  • Highlight examples of EPA’s use of non-vertebrate testing strategies, commonly referred to as “new approach methodologies” or NAMs, in its evaluation of new and existing chemical substances under TSCA Sections 5 and 6, respectively;
     
  • Provide examples of successful collaborations between EPA and external partners to advance the understanding and use of NAMs for informing regulatory scientific questions;
     
  • Provide perspectives from former EPA scientists and non-governmental organization scientists on the types of data needs required to advance the acceptance and use of NAMs over existing vertebrate alternatives; and
     
  •  Provide a proposed roadmap for engaging EPA scientists on the types of questions EPA scientists will likely ask when considering proposals for utilizing NAMs as part of regulatory filings.

Register now.

Tags: TSCA, NAM, Testing

 
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