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 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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By Lynn L. Bergeson

The U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) announced recently a new program that directs USDA to partner with at least one qualified institution to support the scale-up of sustainable bioproduct manufacturing. Up to $5 million is available for each of the fiscal years (FY) 2022 and 2023. NIFA will work in collaboration with USDA Rural Development’s BioPreferred program to seek research proposals that explore the benefits of bioproducts in relation to:

  • “Cost savings relative to other commonly used alternative materials;
  • Greenhouse gas emission reductions and other environmental benefits relative to their commonly used alternative materials;
  • Lifecycle and longevity-extending characteristics relative to other commonly used alternative materials;
  • Lifecycle and longevity-reducing characteristics relative to other commonly used alternative materials;
  • Landfill quantity and waste management cost reductions;
  • Product development and production scale-up; and
  • Any other benefits that the Secretary determines to be appropriate.”

Information on how to apply for the Bioproduct Pilot Program is available here, and NIFA will hold a webinar on July 14, 2022, at 3:00 p.m. (EDT) to discuss the program and answer questions. Registration for the webinar is required.


 
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By Lynn L. Bergeson

On June 23, 2022, DOE’s Office of Energy Efficiency & Renewable Energy (EERE) issued a funding opportunity announcement (FOA) of $70 million to establish the 7th Clean Energy Manufacturing Innovation Institute. DOE EERE states that “[t]his new coalition of industry, academia, and government partners aims to develop and scale technologies to electrify industrial process heating and reduce emissions across the industrial sector.” The institute along with a new federal advisory committee, will focus on decarbonization technologies to help the United States reach its net-zero emissions goal by 2050. The Secretary of Energy will appoint 16 to 20 committee members for the federal advisory committee based on individual qualifications and a need to ensure diverse viewpoints, subject matter expertise, and regional knowledge. Nominations are now open until August 1, 2022, and can be submitted here. The new institute will join DOE’s six Manufacturing USA® institutes funded through EERE’s Advanced Manufacturing Office (AMO). DOE will hold an informational webinar on the new institute on July 14, 2022. Concept papers for the institute are due on August 9, 2022.


 
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By Lynn L. Bergeson

On June 22, 2022, the Senate Committee on Environment and Public Works held a hearing on “Toxic Substances Control Act Amendments Implementation.” This coincides with the sixth anniversary of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) that amended TSCA. The only witness present was Michal Freedhoff, Ph.D., Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). The recording of the hearing is available here.

Tags: TSCA

 
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By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On May 27, 2022, EPA announced that it is seeking nominations for technical experts to serve as Special Government Employees (SGE) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to the Office of Research and Development (ORD). EPA will consider nominees from industry, business, public and private research institutes or organizations, academia, government (federal, state, local, and Tribal), non-governmental organizations, and other relevant interest areas. EPA notes that it values and welcomes diversity. EPA encourages all qualified candidates to apply regardless of gender, race, disability, or ethnicity. The deadline to submit nominations is June 30, 2022, and submissions should be made via the BOSC website. More information on EPA’s Draft Document on “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA” is available in Bergeson & Campbell, P.C.’s (B&C®) March 14, 2022, memorandum.

Tags: SGE, Science, EPA

 
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By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On May 12, 2022, EPA published a proposed rule relating to the assertion and maintenance of confidential business information (CBI) claims under TSCA. EPA states in its May 12, 2022, press release that the proposed rule includes new and amended requirements that, if made final, would increase transparency, modernize reporting and review procedures, and ensure consistency with the 2016 amendments to TSCA. In addition to providing increased clarity for TSCA submitters, EPA expects the changes to allow it to review and make determinations on CBI claims more efficiently, meeting the statutory review deadline in TSCA and more promptly making required notifications to submitters of claims. Comments are due July 11, 2022. Additional information is available here.

Tags: TSCA, CBI

 
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By  Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) announced on February 25, 2022, the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. On March 10, 2022, EPA posted the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” The Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. On April 26, 2022, the TSCA New Chemicals Coalition (NCC) submitted comments to EPA expressing strong support for EPA’s proposed update to its approach to review and evaluate new chemicals under TSCA Section 5:

  • Research Area 1 -- Update and Refine Chemical Categories: The NCC suggests that EPA develop an Integrated Approach to Testing and Assessment (IATA) for each category, and that the IATA include New Approach Methodologies (NAM) both to set boundaries and to provide a tiered approach for testing;
     
  • Research Area 2 -- Develop and Expand Databases Containing TSCA Chemical Information: The NCC suggests that EPA include robust chemical structure information that is searchable by substructure and Markush representations, as appropriate, in the database. The NCC agrees that using IUCLID and the Organization for Economic Cooperation and Development (OECD) harmonized templates would be an efficient way to curate the data and would contribute to interoperability with other data systems (especially as data are transported from other regions that rely upon IUCLID);
     
  • Research Area 3 -- Develop and Refine Quantitative Structure-Activity Relationship and Predictive Models: The NCC suggests that EPA evaluate whether other existing models may serve EPA’s needs. The NCC also suggests that EPA update E-FAST with additional site-specific stream flows;
     
  • Research Area 4 -- Explore New Ways to Integrate and Apply NAMs: The NCC strongly supports expanding the use of NAMs in the assessment of new chemicals. The NCC also strongly suggests that EPA develop and enforce internal policies about in vivo testing of irritating and corrosive substances; and
     
  • Research Area 5 -- Develop a TSCA New Chemicals Decision Support Tool: The NCC supports developing such a decision support tool, but refers EPA to this function within IUCLID. The NCC supports improved transparency on risk assessments and suggests that EPA separate boilerplate explanations of hazard, exposure, and risk from the unique assessment results.

More information on EPA’s draft document is available in our March 14, 2022, memorandum.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On June 6, 2022, the U.S. Environmental Protection Agency (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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